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Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

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AGENCY:

Regulatory Information Service Center.

ACTION:

Introduction to the Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions.

SUMMARY:

Publication of the Unified Agenda of Regulatory and Deregulatory Actions and the Regulatory Plan represent key components of the regulatory planning mechanism prescribed in Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735) and incorporated in Executive Order 13563, “Improving Regulation and Regulatory Review” issued on January 18, 2011 (76 FR 3821). The fall editions of the Unified Agenda include the agency regulatory plans required by E.O. 12866, which identify regulatory priorities and provide additional detail about the most important significant regulatory actions that agencies expect to take in the coming year.

In addition, the Regulatory Flexibility Act requires that agencies publish semiannual “regulatory flexibility agendas” describing regulatory actions they are developing that will have significant effects on small businesses and other small entities (5 U.S.C. 602).

The Unified Agenda of Regulatory and Deregulatory Actions (Unified Agenda), published in the fall and spring, helps agencies fulfill all of these requirements. All federal regulatory agencies have chosen to publish their regulatory agendas as part of this publication. The complete Unified Agenda and Regulatory Plan can be found online at http://www.reginfo.gov and a reduced print version can be found in the Federal Register. Information regarding obtaining printed copies can also be found on the Reginfo.gov Web site (or below, VI. How Can Users Get Copies of the Plan and the Agenda?).

The fall 2015 Unified Agenda publication appearing in the Federal Register consists of The Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act.

The complete fall 2015 Unified Agenda contains the Regulatory Plans of 30 Federal agencies and 59 Federal agency regulatory agendas.

ADDRESSES:

Regulatory Information Service Center (MVE), General Services Administration, 1800 F Street NW., 2219F, Washington, DC 20405.

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FOR FURTHER INFORMATION CONTACT:

For further information about specific regulatory actions, please refer to the agency contact listed for each entry.

To provide comment on or to obtain further information about this publication, contact: John C. Thomas, Executive Director, Regulatory Information Service Center (MVE), U.S. General Services Administration, 1800 F Street NW., 2219F, Washington, DC 20405, (202) 482-7340. You may also send comments to us by email at: risc@gsa.gov.

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SUPPLEMENTARY INFORMATION:

TABLE OF CONTENTS

Introduction to The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions

I. What are The Regulatory Plan and the Unified Agenda?

II. Why are The Regulatory Plan and the Unified Agenda published?

III. How are The Regulatory Plan and the Unified Agenda organized?

IV. What information appears for each entry?

V. Abbreviations.

VI. How can users get copies of the Plan and the Agenda?

Introduction to the Fall 2015 Regulatory Plan

AGENCY REGULATORY PLANS

Cabinet Departments

Department of Agriculture

Department of Commerce

Department of Defense

Department of Education

Department of Energy

Department of Health and Human Services

Department of Homeland Security

Department of Housing and Urban Development

Department of the Interior

Department of Justice

Department of Labor

Department of Transportation

Department of the Treasury

Department of Veterans Affairs

Other Executive Agencies

Architectural and Transportation Barriers Compliance Board

Environmental Protection Agency

Equal Employment Opportunity Commission

General Services Administration

National Aeronautics and Space Administration

National Archives and Records Administration

Office of Personnel Management

Pension Benefit Guaranty Corporation

Small Business Administration

Social Security Administration

Federal Acquisition Regulation

Independent Regulatory Agencies

Consumer Financial Protection Bureau

Consumer Product Safety Commission

Federal Trade Commission

National Indian Gaming Commission

Nuclear Regulatory Commission

AGENCY REGULATORY FLEXIBILITY AGENDAS

Cabinet Departments

Department of Agriculture

Department of Commerce

Department of Defense

Department of Education

Department of Energy

Department of Health and Human Services

Department of Homeland Security

Department of Housing and Urban Development

Department of the Interior

Department of Justice

Department of Labor

Department of Transportation

Department of the Treasury

Other Executive Agencies

Architectural and Transportation Barriers Compliance Board

Environmental Protection Agency

General Services Administration

National Aeronautics and Space Administration

Small Business Administration

Federal Acquisition Regulation

Independent Agencies

Consumer Financial Protection Bureau

Consumer Product Safety Commission

Federal Communication Commission

Federal Reserve System

Nuclear Regulatory Commission

Securities and Exchange Commission

INTRODUCTION TO THE REGULATORY PLAN AND THE UNIFIED AGENDA OF FEDERAL REGULATORY AND DEREGULATORY ACTIONS

I. What are the Regulatory Plan and the Unified Agenda?

The Regulatory Plan serves as a defining statement of the Administration's regulatory and deregulatory policies and priorities. The Plan is part of the fall edition of the Unified Agenda. Each participating agency's regulatory plan contains: (1) A narrative statement of the agency's regulatory and deregulatory priorities, and, for the most part, (2) a description of the most important significant regulatory and deregulatory actions that the agency reasonably expects to issue in proposed or final form during the upcoming fiscal year. This edition includes the regulatory plans of 30 agencies.

The Unified Agenda provides information about regulations that the Start Printed Page 77711Government is considering or reviewing. The Unified Agenda has appeared in the Federal Register twice each year since 1983 and has been available online since 1995. The complete Unified Agenda is available to the public at http://www.reginfo.gov. The online Unified Agenda offers flexible search tools and access to the historic Unified Agenda database to1995. The complete online edition of the Unified Agenda includes regulatory agendas from 61 Federal agencies. Agencies of the United States Congress are not included.

The fall 2015 Unified Agenda publication appearing in the Federal Register consists of The Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Printed entries display only the fields required by the Regulatory Flexibility Act. Complete agenda information for those entries appears, in a uniform format, in the online Unified Agenda at http://www.reginfo.gov.

The following agencies have no entries for inclusion in the printed regulatory flexibility agenda. An asterisk (*) indicates agencies that appear in The Regulatory Plan. The regulatory agendas of these agencies are available to the public at http://reginfo.gov.

Department of State

Department of Veterans Affairs *

Agency for International Development

Commission on Civil Rights

Committee for Purchase From People Who Are Blind or Severely Disabled

Corporation for National and Community Service

Court Services and Offender Supervision Agency for the District of Columbia

Equal Employment Opportunity Commission*

Institute of Museum and Library Services

National Archives and Records Administration*

National Endowment for the Arts

National Endowment for the Humanities

National Science Foundation

Office of Government Ethics

Office of Management and Budget

Office of National Drug Control Policy

Office of Personnel Management*

Peace Corps

Pension Benefit Guaranty Corporation*

Railroad Retirement Board

Social Security Administration*

Commodity Futures Trading Commission

Consumer Product Safety Commission*

Farm Credit Administration

Federal Deposit Insurance Corporation

Federal Energy Regulatory Commission

Federal Housing Finance Agency

Federal Maritime Commission

Federal Trade Commission*

Gulf Coast Ecosystem Restoration Council

National Council on Disability

National Credit Union Administration

National Indian Gaming Commission*

National Labor Relations Board

National Transportation Safety Board

Surface Transportation Board

The Regulatory Information Service Center compiles the Unified Agenda for the Office of Information and Regulatory Affairs (OIRA), part of the Office of Management and Budget. OIRA is responsible for overseeing the Federal Government's regulatory, paperwork, and information resource management activities, including implementation of Executive Order 12866 (incorporated in Executive Order 13563). The Center also provides information about Federal regulatory activity to the President and his Executive Office, the Congress, agency officials, and the public.

The activities included in the Agenda are, in general, those that will have a regulatory action within the next 12 months. Agencies may choose to include activities that will have a longer timeframe than 12 months. Agency agendas also show actions or reviews completed or withdrawn since the last Unified Agenda. Executive Order 12866 does not require agencies to include regulations concerning military or foreign affairs functions or regulations related to agency organization, management, or personnel matters.

Agencies prepared entries for this publication to give the public notice of their plans to review, propose, and issue regulations. They have tried to predict their activities over the next 12 months as accurately as possible, but dates and schedules are subject to change. Agencies may withdraw some of the regulations now under development, and they may issue or propose other regulations not included in their agendas. Agency actions in the rulemaking process may occur before or after the dates they have listed. The Regulatory Plan and Unified Agenda do not create a legal obligation on agencies to adhere to schedules in this publication or to confine their regulatory activities to those regulations that appear within it.

II. Why are the Regulatory Plan and the Unified Agenda published?

The Regulatory Plan and the Unified Agenda helps agencies comply with their obligations under the Regulatory Flexibility Act and various Executive orders and other statutes.

Regulatory Flexibility Act

The Regulatory Flexibility Act requires agencies to identify those rules that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Agencies meet that requirement by including the information in their submissions for the Unified Agenda. Agencies may also indicate those regulations that they are reviewing as part of their periodic review of existing rules under the Regulatory Flexibility Act (5 U.S.C. 610). Executive Order 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” signed August 13, 2002 (67 FR 53461), provides additional guidance on compliance with the Act.

Executive Order 12866

Executive Order 12866, “Regulatory Planning and Review,” signed September 30, 1993 (58 FR 51735), requires covered agencies to prepare an agenda of all regulations under development or review. The Order also requires that certain agencies prepare annually a regulatory plan of their “most important significant regulatory actions,” which appears as part of the fall Unified Agenda. Executive Order 13497, signed January 30, 2009 (74 FR 6113), revoked the amendments to Executive Order 12866 that were contained in Executive Order 13258 and Executive Order 13422.

Executive Order 13563

Executive Order 13563, “Improving Regulation and Regulatory Review,” issued on January 18, 2011, supplements and reaffirms the principles, structures, and definitions governing contemporary regulatory review that were established in Executive Order 12866, which includes the general principles of regulation and public participation, and orders integration and innovation in coordination across agencies; flexible approaches where relevant, feasible, and consistent with regulatory approaches; scientific integrity in any scientific or technological information and processes used to support the agencies' regulatory actions; and retrospective analysis of existing regulations.

Executive Order 13132

Executive Order 13132, “Federalism,” signed August 4, 1999 (64 FR 43255), Start Printed Page 77712directs agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have “federalism implications” as defined in the Order. Under the Order, an agency that is proposing a regulation with federalism implications, which either preempt State law or impose non-statutory unfunded substantial direct compliance costs on State and local governments, must consult with State and local officials early in the process of developing the regulation. In addition, the agency must provide to the Director of the Office of Management and Budget a federalism summary impact statement for such a regulation, which consists of a description of the extent of the agency's prior consultation with State and local officials, a summary of their concerns and the agency's position supporting the need to issue the regulation, and a statement of the extent to which those concerns have been met. As part of this effort, agencies include in their submissions for the Unified Agenda information on whether their regulatory actions may have an effect on the various levels of government and whether those actions have federalism implications.

Unfunded Mandates Reform Act of 1995

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, title II) requires agencies to prepare written assessments of the costs and benefits of significant regulatory actions “that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more . . . in any 1 year . . .” The requirement does not apply to independent regulatory agencies, nor does it apply to certain subject areas excluded by section 4 of the Act. Affected agencies identify in the Unified Agenda those regulatory actions they believe are subject to title II of the Act.

Executive Order 13211

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” signed May 18, 2001 (66 FR 28355), directs agencies to provide, to the extent possible, information regarding the adverse effects that agency actions may have on the supply, distribution, and use of energy. Under the Order, the agency must prepare and submit a Statement of Energy Effects to the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, for “those matters identified as significant energy actions.” As part of this effort, agencies may optionally include in their submissions for the Unified Agenda information on whether they have prepared or plan to prepare a Statement of Energy Effects for their regulatory actions.

Small Business Regulatory Enforcement Fairness Act

The Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121, title II) established a procedure for congressional review of rules (5 U.S.C. 801 et seq.), which defers, unless exempted, the effective date of a “major” rule for at least 60 days from the publication of the final rule in the Federal Register. The Act specifies that a rule is “major” if it has resulted, or is likely to result, in an annual effect on the economy of $100 million or more or meets other criteria specified in that Act. The Act provides that the Administrator of OIRA will make the final determination as to whether a rule is major.

III. How are the Regulatory Plan and the Unified Agenda organized?

The Regulatory Plan appears in part II in a daily edition of the Federal Register. The Plan is a single document beginning with an introduction, followed by a table of contents, followed by each agency's section of the Plan. Following the Plan in the Federal Register, as separate parts, are the regulatory flexibility agendas for each agency whose agenda includes entries for rules which are likely to have a significant economic impact on a substantial number of small entities or rules that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Each printed agenda appears as a separate part. The sections of the Plan and the parts of the Unified Agenda are organized alphabetically in four groups: Cabinet departments; other executive agencies; the Federal Acquisition Regulation, a joint authority (Agenda only); and independent regulatory agencies. Agencies may in turn be divided into subagencies. Each printed agency agenda has a table of contents listing the agency's printed entries that follow. Each agency's part of the Agenda contains a preamble providing information specific to that agency. Each printed agency agenda has a table of contents listing the agency's printed entries that follow.

Each agency's section of the Plan contains a narrative statement of regulatory priorities and, for most agencies, a description of the agency's most important significant regulatory and deregulatory actions. Each agency's part of the Agenda contains a preamble providing information specific to that agency plus descriptions of the agency's regulatory and deregulatory actions.

The online, complete Unified Agenda contains the preambles of all participating agencies. Unlike the printed edition, the online Agenda has no fixed ordering. In the online Agenda, users can select the particular agencies' agendas they want to see. Users have broad flexibility to specify the characteristics of the entries of interest to them by choosing the desired responses to individual data fields. To see a listing of all of an agency's entries, a user can select the agency without specifying any particular characteristics of entries.

Each entry in the Agenda is associated with one of five rulemaking stages. The rulemaking stages are:

1. Prerule Stage—actions agencies will undertake to determine whether or how to initiate rulemaking. Such actions occur prior to a Notice of Proposed Rulemaking (NPRM) and may include Advance Notices of Proposed Rulemaking (ANPRMs) and reviews of existing regulations.

2. Proposed Rule Stage—actions for which agencies plan to publish a Notice of Proposed Rulemaking as the next step in their rulemaking process or for which the closing date of the NPRM Comment Period is the next step.

3. Final Rule Stage—actions for which agencies plan to publish a final rule or an interim final rule or to take other final action as the next step.

4. Long-Term Actions—items under development but for which the agency does not expect to have a regulatory action within the 12 months after publication of this edition of the Unified Agenda. Some of the entries in this section may contain abbreviated information.

5. Completed Actions — actions or reviews the agency has completed or withdrawn since publishing its last agenda. This section also includes items the agency began and completed between issues of the Agenda.

Long-Term Actions are rulemakings reported during the publication cycle that are outside of the required 12-month reporting period for which the Agenda was intended. Completed Actions in the publication cycle are rulemakings that are ending their lifecycle either by Withdrawal or completion of the rulemaking process. Therefore, the Long-Term and Completed RINs do not represent the ongoing, forward-looking nature intended for reporting developing rulemakings in the Agenda pursuant to Executive Order 12866, section 4(b) and 4(c). To further differentiate these two Start Printed Page 77713stages of rulemaking in the Unified Agenda from active rulemakings, Long-Term and Completed Actions are reported separately from active rulemakings, which can be any of the first three stages of rulemaking listed above. A separate search function is provided on http://reginfo.gov to search for Completed and Long-Term Actions apart from each other and active RINs.

A bullet (•) preceding the title of an entry indicates that the entry is appearing in the Unified Agenda for the first time.

In the printed edition, all entries are numbered sequentially from the beginning to the end of the publication. The sequence number preceding the title of each entry identifies the location of the entry in this edition. The sequence number is used as the reference in the printed table of contents. Sequence numbers are not used in the online Unified Agenda because the unique Regulation Identifier Number (RIN) is able to provide this cross-reference capability.

Editions of the Unified Agenda prior to fall 2007 contained several indexes, which identified entries with various characteristics. These included regulatory actions for which agencies believe that the Regulatory Flexibility Act may require a Regulatory Flexibility Analysis, actions selected for periodic review under section 610(c) of the Regulatory Flexibility Act, and actions that may have federalism implications as defined in Executive Order 13132 or other effects on levels of government. These indexes are no longer compiled, because users of the online Unified Agenda have the flexibility to search for entries with any combination of desired characteristics. The online edition retains the Unified Agenda's subject index based on the Federal Register Thesaurus of Indexing Terms. In addition, online users have the option of searching Agenda text fields for words or phrases.

IV. What information appears for each entry?

All entries in the online Unified Agenda contain uniform data elements including, at a minimum, the following information:

Title of the Regulation—a brief description of the subject of the regulation. In the printed edition, the notation “Section 610 Review” following the title indicates that the agency has selected the rule for its periodic review of existing rules under the Regulatory Flexibility Act (5 U.S.C. 610(c)). Some agencies have indicated completions of section 610 reviews or rulemaking actions resulting from completed section 610 reviews. In the online edition, these notations appear in a separate field.

Priority—an indication of the significance of the regulation. Agencies assign each entry to one of the following five categories of significance.

(1) Economically Significant

As defined in Executive Order 12866, a rulemaking action that will have an annual effect on the economy of $100 million or more or will adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. The definition of an “economically significant” rule is similar but not identical to the definition of a “major” rule under 5 U.S.C. 801 (Pub. L. 104-121). (See below.)

(2) Other Significant

A rulemaking that is not Economically Significant but is considered Significant by the agency. This category includes rules that the agency anticipates will be reviewed under Executive Order 12866 or rules that are a priority of the agency head. These rules may or may not be included in the agency's regulatory plan.

(3) Substantive, Nonsignificant

A rulemaking that has substantive impacts, but is neither Significant, nor Routine and Frequent, nor Informational/Administrative/Other.

(4) Routine and Frequent

A rulemaking that is a specific case of a multiple recurring application of a regulatory program in the Code of Federal Regulations and that does not alter the body of the regulation.

(5) Informational/Administrative/Other

A rulemaking that is primarily informational or pertains to agency matters not central to accomplishing the agency's regulatory mandate but that the agency places in the Unified Agenda to inform the public of the activity.

Major — whether the rule is “major” under 5 U.S.C. 801 (Pub. L. 104-121) because it has resulted or is likely to result in an annual effect on the economy of $100 million or more or meets other criteria specified in that Act. The Act provides that the Administrator of the Office of Information and Regulatory Affairs will make the final determination as to whether a rule is major.

Unfunded Mandates—whether the rule is covered by section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). The Act requires that, before issuing an NPRM likely to result in a mandate that may result in expenditures by State, local, and tribal governments, in the aggregate, or by the private sector of more than $100 million in 1 year, agencies, other than independent regulatory agencies, shall prepare a written statement containing an assessment of the anticipated costs and benefits of the Federal mandate.

Legal Authority—the section(s) of the United States Code (U.S.C.) or Public Law (Pub. L.) or the Executive order (E.O.) that authorize(s) the regulatory action. Agencies may provide popular name references to laws in addition to these citations.

CFR Citation—the section(s) of the Code of Federal Regulations that will be affected by the action.

Legal Deadline—whether the action is subject to a statutory or judicial deadline, the date of that deadline, and whether the deadline pertains to an NPRM, a Final Action, or some other action.

Abstract—a brief description of the problem the regulation will address; the need for a Federal solution; to the extent available, alternatives that the agency is considering to address the problem; and potential costs and benefits of the action.

Timetable—the dates and citations (if available) for all past steps and a projected date for at least the next step for the regulatory action. A date displayed in the form 12/00/14 means the agency is predicting the month and year the action will take place but not the day it will occur. In some instances, agencies may indicate what the next action will be, but the date of that action is “To Be Determined.” “Next Action Undetermined” indicates the agency does not know what action it will take next.

Regulatory Flexibility Analysis Required—whether an analysis is required by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) because the rulemaking action is likely to have a significant economic impact on a substantial number of small entities as defined by the Act.

Small Entities Affected—the types of small entities (businesses, governmental jurisdictions, or organizations) on which the rulemaking action is likely to have an impact as defined by the Regulatory Flexibility Act. Some agencies have chosen to indicate likely effects on small entities even though they believe that a Regulatory Flexibility Analysis will not be required.

Government Levels Affected—whether the action is expected to affect levels of government and, if so, whether the Start Printed Page 77714governments are State, local, tribal, or Federal.

International Impacts—whether the regulation is expected to have international trade and investment effects, or otherwise may be of interest to the Nation's international trading partners.

Federalism—whether the action has “federalism implications” as defined in Executive Order 13132. This term refers to actions “that have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Independent regulatory agencies are not required to supply this information.

Included in the Regulatory Plan—whether the rulemaking was included in the agency's current regulatory plan published in fall 2014.

Agency Contact—the name and phone number of at least one person in the agency who is knowledgeable about the rulemaking action. The agency may also provide the title, address, fax number, email address, and TDD for each agency contact.

Some agencies have provided the following optional information:

RIN Information URL—the Internet address of a site that provides more information about the entry.

Public Comment URL—the Internet address of a site that will accept public comments on the entry. Alternatively, timely public comments may be submitted at the Governmentwide e-rulemaking site, http://www.regulations.gov.

Additional Information—any information an agency wishes to include that does not have a specific corresponding data element.

Compliance Cost to the Public—the estimated gross compliance cost of the action.

Affected Sectors—the industrial sectors that the action may most affect, either directly or indirectly. Affected sectors are identified by North American Industry Classification System (NAICS) codes.

Energy Effects—an indication of whether the agency has prepared or plans to prepare a Statement of Energy Effects for the action, as required by Executive Order 13211 “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” signed May 18, 2001 (66 FR 28355).

Related RINs—one or more past or current RIN(s) associated with activity related to this action, such as merged RINs, split RINs, new activity for previously completed RINs, or duplicate RINs.

Statement of Need—a description of the need for the regulatory action.

Summary of the Legal Basis—a description of the legal basis for the action, including whether any aspect of the action is required by statute or court order.

Alternatives—a description of the alternatives the agency has considered or will consider as required by section 4(c)(1)(B) of Executive Order 12866.

Anticipated Costs and Benefits—a description of preliminary estimates of the anticipated costs and benefits of the action.

Risks—a description of the magnitude of the risk the action addresses, the amount by which the agency expects the action to reduce this risk, and the relation of the risk and this risk reduction effort to other risks and risk reduction efforts within the agency's jurisdiction.

V. Abbreviations

The following abbreviations appear throughout this publication:

ANPRM—An Advance Notice of Proposed Rulemaking is a preliminary notice, published in the Federal Register, announcing that an agency is considering a regulatory action. An agency may issue an ANPRM before it develops a detailed proposed rule. An ANPRM describes the general area that may be subject to regulation and usually asks for public comment on the issues and options being discussed. An ANPRM is issued only when an agency believes it needs to gather more information before proceeding to a notice of proposed rulemaking.

CFR—The Code of Federal Regulations is an annual codification of the general and permanent regulations published in the Federal Register by the agencies of the Federal Government. The Code is divided into 50 titles, each title covering a broad area subject to Federal regulation. The CFR is keyed to and kept up to date by the daily issues of the Federal Register.

E.O.—An Executive order is a directive from the President to Executive agencies, issued under constitutional or statutory authority. Executive orders are published in the Federal Register and in title 3 of the Code of Federal Regulations.

FR—The Federal Register is a daily Federal Government publication that provides a uniform system for publishing Presidential documents, all proposed and final regulations, notices of meetings, and other official documents issued by Federal agencies.

FY—The Federal fiscal year runs from October 1 to September 30.

NPRM—A Notice of Proposed Rulemaking is the document an agency issues and publishes in the Federal Register that describes and solicits public comments on a proposed regulatory action. Under the Administrative Procedure Act (5 U.S.C. 553), an NPRM must include, at a minimum:

  • A statement of the time, place, and nature of the public rulemaking proceeding;
  • A reference to the legal authority under which the rule is proposed; and
  • Either the terms or substance of the proposed rule or a description of the subjects and issues involved.

Public Law (or Pub. L.)—A public law is a law passed by Congress and signed by the President or enacted over his veto. It has general applicability, unlike a private law that applies only to those persons or entities specifically designated. Public laws are numbered in sequence throughout the 2-year life of each Congress; for example, Pub. L. 112-4 is the fourth public law of the 112th Congress.

RFA—A Regulatory Flexibility Analysis is a description and analysis of the impact of a rule on small entities, including small businesses, small governmental jurisdictions, and certain small not-for-profit organizations. The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires each agency to prepare an initial RFA for public comment when it is required to publish an NPRM and to make available a final RFA when the final rule is published, unless the agency head certifies that the rule would not have a significant economic impact on a substantial number of small entities.

RIN—The Regulation Identifier Number is assigned by the Regulatory Information Service Center to identify each regulatory action listed in the Regulatory Plan and the Unified Agenda, as directed by Executive Order 12866 (section 4(b)). Additionally, OMB has asked agencies to include RINs in the headings of their Rule and Proposed Rule documents when publishing them in the Federal Register, to make it easier for the public and agency officials to track the publication history of regulatory actions throughout their development.

Seq. No.—The sequence number identifies the location of an entry in the printed edition of the Regulatory Plan and the Unified Agenda. Note that a specific regulatory action will have the same RIN throughout its development but will generally have different sequence numbers if it appears in Start Printed Page 77715different printed editions of the Unified Agenda. Sequence numbers are not used in the online Unified Agenda.

U.S.C.—The United States Code is a consolidation and codification of all general and permanent laws of the United States. The U.S.C. is divided into 50 titles, each title covering a broad area of Federal law.

VI. How can users get copies of the Plan and the Agenda?

Copies of the Federal Register issue containing the printed edition of The Regulatory Plan and the Unified Agenda (agency regulatory flexibility agendas) are available from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15250-7954. Telephone: (202) 512-1800 or 1-866-512-1800 (toll-free).

Copies of individual agency materials may be available directly from the agency or may be found on the agency's Web site. Please contact the particular agency for further information.

All editions of The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions since fall 1995 are available in electronic form at http://reginfo.gov, along with flexible search tools.

The Government Printing Office's GPO FDsys Web site contains copies of the Agendas and Regulatory Plans that have been printed in the Federal Register. These documents are available at http://www.fdsys.gov.

Start Signature

Dated: November 16, 2015.

John C. Thomas,

Executive Director.

End Signature Start Printed Page 77716

INTRODUCTION TO THE 2015 REGULATORY PLAN

Executive Order 12866, issued in 1993, requires the production of a Unified Regulatory Agenda and Regulatory Plan. Executive Order 13563, issued in 2011, reaffirms the requirements of Executive Order 12866. Consistent with these Executive Orders, the Office of Information and Regulatory Affairs (OIRA) is providing the 2015 Unified Regulatory Agenda (Agenda) and the Regulatory Plan (Plan) for public review. The Agenda and Plan are preliminary statements of regulatory and deregulatory policies and priorities under consideration. The Agenda and Plan include “active rulemakings” that agencies could possibly conclude over the next year.

The Plan provides a list of important regulatory actions that agencies are considering for issuance in proposed or final form during the 2016 fiscal year. In contrast, the Agenda is a more inclusive list, including numerous ministerial actions and routine rulemakings, as well as long-term initiatives that agencies do not plan to complete in the coming year but on which they are actively working.

A central purpose of the Agenda is to involve the public, including State, local, and tribal officials, in Federal regulatory planning. The public examination of the Agenda and Plan will facilitate public participation in a regulatory system that, in the words of Executive Order 13563, protects “public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.” We emphasize that rules listed on the Agenda must still undergo significant development and review before they are issued. No regulatory action can become effective until it has gone through the legally required processes, which generally include public notice and comment. Any proposed or final action must also satisfy the requirements of relevant statutes, Executive Orders, and Presidential Memoranda. Those requirements, public comments, and new information may or may not lead an agency to go forward with an action that is currently under contemplation. Among other information, the Agenda also provides an initial classification of whether a rulemaking is “significant” or “economically significant” under the terms of Executive Orders 12866 and 13563. Whether a regulation is listed on the Agenda as “economically significant” within the meaning of Executive Order 12866 (generally, having an annual effect on the economy of $100 million or more) can depend on several factors: Regulations may count as economically significant because they impose costs, confer large benefits, or remove significant burdens.

Executive Orders 13563 and 13610: Regulatory Development, and the Retrospective Review of Regulation

Executive Order 13563 reaffirmed the principles, structures, and definitions in Executive Order 12866, which has long governed regulatory review. Executive Order 13563 explicitly points to the need for predictability and certainty in the regulatory system, as well as for use of the least burdensome means to achieving regulatory ends. These Executive Orders include the requirement that, to the extent permitted by law, agencies should not proceed with rulemaking in the absence of a reasoned determination that the benefits justify the costs. They also establish public participation, integration and innovation, flexible approaches, scientific integrity, and retrospective review as areas of emphasis in regulation. In particular, Executive Order 13563 explicitly draws attention to the need to measure and improve “the actual results of regulatory requirements”—a clear reference to the importance of the retrospective review of regulations.

Executive Order 13563 addresses new regulations that are under development, as well as retrospective review of existing regulations that are already in place. With respect to agencies' review of existing regulations, the Executive Order calls for careful reassessment based on empirical analysis. The prospective analysis required by Executive Order 13563 may depend on a degree of prediction and speculation about a rule's likely impacts, and the actual costs and benefits of a regulation may be lower or higher than what was anticipated when the rule was originally developed.

Executive Order 13610, Identifying and Reducing Regulatory Burdens, issued in 2012, institutionalizes the retrospective—or “lookback”—mechanism set out in Executive Order 13563 by requiring agencies to report to the Office of Management and Budget and to the public twice each year (January and July) on the status of their retrospective review efforts. In these reports, agencies are to “describe progress, anticipated accomplishments, and proposed timelines for relevant actions.”

Executive Orders 13563 and 13610 recognize that circumstances may change in a way that requires reconsideration of regulatory requirements. Lookback analysis allows agencies to reevaluate existing rules and to streamline, modify, or eliminate those regulations that do not make sense in their current form. The agencies' lookback efforts so far during this Administration have yielded approximately $22 billion in savings for the American public over the next five years.

The Administration is continuing to work with agencies to institutionalize retrospective review so that agencies regularly review existing rules on the books to ensure they remain effective, cost-justified, and based on the best available science. The Administration will continue to examine what is working and what is not, and eliminate unjustified and outdated regulations.

Regulatory lookback is an ongoing exercise, and continues to be a high priority for the Administration. In accordance with Executive Orders 13610 and 13563, in July 2015, agencies submitted to OIRA the latest updates of their retrospective review plans, which are publicly available at: https://www.whitehouse.gov/​omb/​oira/​regulation-reform. Federal agencies will again update their retrospective review plans in January 2016. OIRA has asked agencies to continue to emphasize regulatory lookbacks in their latest Regulatory Plans.

Reflecting that focus, the current Agenda lists approximately seventy-five rules under active development that are characterized as retroactively reviewing existing programs. Below are some examples of agency plans to reevaluate current practices in accordance with Executive Orders 13563 and 13610:

—After extensive public engagement and in response to a recent court decision, the Environmental Protection Agency (EPA) is proposing revisions to the 2007 Exceptional Events rule. These revisions will streamline the process that states follow to decide whether air quality monitoring data associated with an “exceptional event” should be included when determining if an area is meeting national air quality standards. Exceptional events include natural events such as wildfires, stratospheric ozone intrusions, and volcanic and seismic activities. Given the possible influence of wildfires on ozone, EPA is also releasing draft guidance that provides states with additional information on preparing exceptional events demonstrations for wildfires as they relate to the ozone standards.

—The Department of Labor (DOL) has taken steps to include retrospective analysis requirements in new Start Printed Page 77717regulations in order to facilitate evaluation of their impacts. For example, DOL's Mine Safety and Health Administration announced in its 2014 Respirable Dust final rule that it will conduct a retrospective review in 2017 to evaluate the data collected using continuous personal dust monitors. Additionally, the Occupational Safety and Health Administration's Recordkeeping and Reporting Requirements final rule—moving from the Standard Industrial Classification System to the North American Industry Classification System for determining which industries are low-hazard and potentially exempt from recordkeeping requirements—includes a commitment to conduct a retrospective review of the agency's recordkeeping regulations. Finally, in DOL's Wage and Hour Division's recent Notice of Proposed Rulemaking to modernize the Fair Labor Standards Act's Overtime Exemptions for Executive, Administrative, Professional, Outside Sales and Computer Employees, the Division proposed to consider a future retrospective review of the rule after it is finalized and implemented.

—The Department of Housing and Urban Development (HUD) is working on a final rule to streamline, in several ways, the inspection and home warranty requirements for the Federal Housing Administration's (FHA) single family mortgage insurance. In doing so, FHA would increase choice and lower the costs for FHA borrowers. First, HUD is considering the removal of regulations that require the use of an inspector from the FHA Inspector Roster as a condition for FHA mortgage insurance. This change is based on the recognition of the sufficiency and quality of inspections carried out by local jurisdictions. Second, this rule would also remove the regulations requiring homeowners to purchase 10-year protection plans from FHA-approved warranty issuers to qualify for high loan-to-value FHA-insured mortgages. This change is based on the increased quality of construction materials and the standardization of building codes and building code enforcement. HUD expects the rule to increase flexibility for homeowners and reduce the regulatory burden on lenders.

Executive Order 13609: International Regulatory Cooperation

In addition to using regulatory lookback as a tool to make the regulatory system more efficient, the Administration has focused on promoting international regulatory cooperation. International regulatory cooperation supports economic growth, job creation, innovation, trade and investment, while also protecting public health, safety, and welfare. In May 2012, President Obama issued Executive Order 13609, Promoting International Regulatory Cooperation, which emphasizes the importance of these efforts as a key tool for eliminating unnecessary differences in regulation between the United States and its major trading partners. Additionally, as part of the regulatory lookback initiative, Executive Order 13609 requires agencies to “consider reforms to existing significant regulations that address unnecessary differences in regulatory requirements between the United States and its major trading partners . . . when stakeholders provide adequate information to the agency establishing that the differences are unnecessary.”

Executive Order 13609 also directed each agency to submit a Regulatory Plan that includes “a summary of its international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations.” Further, Executive Order 13609 requires each agency to “ensure that significant regulations that the agency identifies as having significant international impacts are designated as such” in the Regulatory Agenda.

In furtherance of this focus on international regulatory cooperation, in the summer of 2014, the United States and Canada released the U.S.-Canada Regulatory Cooperation Council (RCC) Joint Forward Plan.[1] The Forward Plan identifies twenty-four areas of cooperation where the United States and Canada will work together over the next three to five years in order to modernize our thinking around international regulatory cooperation and develop a toolbox of strategies to address international regulatory issues as they arise. Building on the Forward Plan, in the Spring of 2015, agencies in the United States and Canada issued joint work plans to guide focused international regulatory cooperation efforts. The Forward Plan and related work represent a significant turning point in the Administration's regulatory cooperation relationship with Canada, and outline new Federal agency-level partnership arrangements to help institutionalize the ways in which our regulators work together. The Forward Plan will help remove unnecessary requirements, develop common standards, and identify potential areas where future regulation may unnecessarily differ. This kind of international cooperation on regulations between the United States and Canada will help eliminate barriers to doing business in the United States or with U.S. companies, grow the economy, and create jobs. The Administration also continues to work with other countries, including Mexico and Brazil, to identify opportunities for regulatory cooperation.

* * * * *

The Administration continues to foster a regulatory system that emphasizes the careful consideration of costs and benefits, public participation, integration, regulatory innovation, flexible regulatory approaches, and science. These considerations are meant to produce a regulatory system that draws on recent learning, that is driven by evidence, and that is suited to the distinctive circumstances of the 21st Century.

Department of Agriculture

Sequence No.TitleRegulation Identifier No.Rulemaking stage
1Payment Limitation and Payment Eligibility—Actively Engaged in Farming0560-AI31Final Rule Stage.
2Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms0579-AE15Prerule Stage.
3General Administrative Regulations; Catastrophic Risk Protection Endorsement; Area Risk Protection Insurance Regulations; and the Common Crop Insurance Regulations, Basic Provisions0563-AC43Final Rule Stage.
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4Enhancing Retailer Eligibility Standards in SNAP0584-AE27Proposed Rule Stage.
5Supplemental Nutrition Assistance Program (SNAP) Photo Electronic Benefit Transfer (EBT) Card Implementation Requirements0584-AE45Proposed Rule Stage.
6National School Lunch and School Breakfast Programs: Nutrition Standards for All Foods Sold in School, as Required by the Healthy, Hunger-Free Kids Act of 20100584-AE09Final Rule Stage.
7Child and Adult Care Food Program: Meal Pattern Revisions Related to the Healthy, Hunger-Free Kids Act of 20100584-AE18Final Rule Stage.
8Requirements for the Disposition of Non-Ambulatory Disabled Veal Calves0583-AD54Final Rule Stage.
9USDA Local and Regional Food Aid Procurement Program0551-AA87Final Rule Stage.
10Program Measures and Metrics0570-AA95Final Rule Stage.
11Rural Broadband Access Loans and Loan Guarantees0572-AC34Final Rule Stage.
12Agricultural Conservation Easement Program0578-AA61Final Rule Stage.
13Environmental Quality Incentives Program (EQIP)0578-AA62Final Rule Stage.
14Conservation Stewardship Program0578-AA63Final Rule Stage.

Department of Defense

Sequence No.TitleRegulation Identifier No.Rulemaking stage
15Sexual Assault Prevention and Response (SAPR) Program0790-AJ40Proposed Rule Stage.
16Sexual Assault Prevention and Response Program Procedures0790-AI36Final Rule Stage.
17Transition Assistance Program (TAP) for Military Personnel0790-AJ17Final Rule Stage.
18Department of Defense (DoD)-Defense Industrial Base (DIB) Cybersecurity (CS) Activities0790-AJ29Final Rule Stage.
19Detection and Avoidance of Counterfeit Electronic Parts—Further Implementation (DFARS Case 2014-D005)0750-AI58Proposed Rule Stage.
20Network Penetration Reporting and Contracting for Cloud Services (DFARS Case 2013-D018)0750-AI61Final Rule Stage.
21TRICARE: Mental Health and Substance Use0720-AB65Proposed Rule Stage.

Department of Education

Sequence No.TitleRegulation Identifier No.Rulemaking stage
22REPAYE1840-AD18Final Rule Stage.
23Workforce Innovation and Opportunity Act1830-AA21Final Rule Stage.

Department of Energy

Sequence No.TitleRegulation Identifier No.Rulemaking stage
24Coverage Determination for Computers and Battery Backup Systems1904-AD04Proposed Rule Stage.
25Energy Conservation Standards for General Service Lamps1904-AD09Proposed Rule Stage.
26Energy Conservation Standards for Residential Non-Weatherized Gas Furnaces1904-AD20Proposed Rule Stage.
27Energy Conservation Standards for Commercial Water Heating Equipment1904-AD34Proposed Rule Stage.
28Energy Conservation Standards for Central Air Conditioners and Heat Pumps1904-AD37Proposed Rule Stage.
29Energy Conservation Standards for Commercial and Industrial Pumps1904-AC54Final Rule Stage.
30Energy Conservation Standards for Small, Large, and Very Large Commercial Package A/C and Heating Equipment1904-AC95Final Rule Stage.

Department of Health and Human Services

Sequence No.TitleRegulation Identifier No.Rulemaking stage
31Increase Number of Patients to which Drug Addiction Treatment Act (DATA)-Waived Physicians Can Prescribe Buprenorphine0930-AA22Proposed Rule Stage.
32Food Labeling: Revision of the Nutrition and Supplement Facts Labels0910-AF22Final Rule Stage.
33Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs0910-AF23Final Rule Stage.
34Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption0910-AG35Final Rule Stage.
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35“Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act0910-AG38Final Rule Stage.
36Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals0910-AG45Final Rule Stage.
37Focused Mitigation Strategies To Protect Food Against Intentional Adulteration0910-AG63Final Rule Stage.
38Foreign Supplier Verification Program0910-AG64Final Rule Stage.
39Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications0910-AG66Final Rule Stage.
40Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products0910-AG94Final Rule Stage.
41Sanitary Transportation of Human and Animal Food0910-AG98Final Rule Stage.
42Programs of All-Inclusive Care for the Elderly (PACE) Update (CMS-4168-P)0938-AR60Proposed Rule Stage.
43Expansion of the CMS Qualified Entity Program (CMS-5061-P)0938-AS66Proposed Rule Stage.
44Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) in Medicare Fee-for-Service (CMS-5517-P)0938-AS69Proposed Rule Stage.
45Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2017 Rates (CMS-1655-P)0938-AS77Proposed Rule Stage.
46CY 2017 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1654-P)0938-AS81Proposed Rule Stage.
47CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1656-P)0938-AS82Proposed Rule Stage.
48Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions related to Third Party Liability (CMS-2390-F)0938-AS25Final Rule Stage.

Department of Homeland Security

Sequence No.TitleRegulation Identifier No.Rulemaking stage
49Chemical Facility Anti-Terrorism Standards (CFATS)1601-AA69Proposed Rule Stage.
50Adjustment of Status to Lawful Permanent Resident for Aliens in T and U Nonimmigrant Status1615-AA60Proposed Rule Stage.
51New Classification for Victims of Criminal Activity; Eligibility for the U Nonimmigrant Status1615-AA67Proposed Rule Stage.
52Exception to the Persecution Bar for Asylum, Refugee, and Temporary Protected Status, and Withholding of Removal1615-AB89Proposed Rule Stage.
53Requirements for Filing Motions and Administrative Appeals1615-AB98Proposed Rule Stage.
54Significant Public Benefit Parole for Entrepreneurs1615-AC04Proposed Rule Stage.
55Retention of EB-1, EB-2, and EB-3 Immigrant Workers and Program Improvements Affecting Highly-Skilled H-1B Alien Workers1615-AC05Proposed Rule Stage.
56Classification for Victims of Severe Forms of Trafficking in Persons; Eligibility for T Nonimmigrant Status1615-AA59Final Rule Stage.
57Application of Immigration Regulations to the Commonwealth of the Northern Mariana Islands1615-AB77Final Rule Stage.
58Special Immigrant Juvenile Petitions1615-AB81Final Rule Stage.
59Enhancing Opportunities for H-1B1, CW-1, and E-3 Nonimmigrants and EB-1 Immigrants1615-AC00Final Rule Stage.
60Expansion of Provisional Unlawful Presence Waivers of Inadmissibility1615-AC03Final Rule Stage.
61Inspection of Towing Vessels1625-AB06Final Rule Stage.
62Transportation Worker Identification Credential (TWIC); Card Reader Requirements1625-AB21Final Rule Stage.
63Air Cargo Advance Screening (ACAS)1651-AB04Proposed Rule Stage.
64Definition of Form I-94 to Include Electronic Format1651-AA96Final Rule Stage.
65Security Training for Surface Mode Employees1652-AA55Proposed Rule Stage.
66Passenger Screening Using Advanced Imaging Technology1652-AA67Final Rule Stage.
67Improving and Expanding Training Opportunities for F-1 Nonimmigrant Students with STEM Degrees and Expanding Cap-Gap Relief for All F-1 Students With Pending H-1B Petitions1653-AA72Proposed Rule Stage.

Department of Housing and Urban Development

Sequence No.TitleRegulation Identifier No.Rulemaking stage
68Narrowing the Digital Divide through Broadband Installation in HUD-Funded New Construction and Substantial Rehabilitation (FR-5890)2501-AD75Proposed Rule Stage.
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69Narrowing the Digital Divide Through Community Planning: Integrating Broadband Planning Into HUD's Consolidated Planning Process (FR-5891)2506-AC41Proposed Rule Stage.

Department of Justice

Sequence No.TitleRegulation Identifier No.Rulemaking stage
70Implementation of the ADA Amendments Act of 2008 (Section 504 of the Rehabilitation Act of 1973)1190-AA60Proposed Rule Stage.
71Nondiscrimination on the Basis of Disability: Accessibility of Web Information and Services of State and Local Governments1190-AA65Proposed Rule Stage.
72Revision of Standards and Procedures for the Enforcement of Section 274B of the Immigration and Nationality Act1190-AA71Proposed Rule Stage.
73Implementation of the ADA Amendments Act of 2008 (Title II and Title III of the ADA)1190-AA59Final Rule Stage.
74Nondiscrimination on the Basis of Disability; Movie Captioning and Audio Description1190-AA63Final Rule Stage.
75Motions To Reopen Removal, Deportation, or Exclusion Proceedings Based Upon a Claim of Ineffective Assistance of Counsel1125-AA68Proposed Rule Stage.
76Recognition of Organizations and Accreditation of Non-Attorney Representatives1125-AA72Proposed Rule Stage.

Department of labor

Sequence No.TitleRegulation Identifier No.Rulemaking stage
77Establishing Paid Sick Leave for Contractors, Executive Order 137061235-AA13Proposed Rule Stage.
78Defining and Delimiting the Exemptions for Executive, Administrative, Professional, Outside Sales, and Computer Employees1235-AA11Final Rule Stage.
79Workforce Innovation and Opportunity Act1205-AB73Proposed Rule Stage.
80Savings Arrangements Established by States for Non-Governmental Employees1210-AB71Proposed Rule Stage.
81Respirable Crystalline Silica1219-AB36Proposed Rule Stage.
82Proximity Detection Systems for Mobile Machines in Underground Mines1219-AB78Proposed Rule Stage.
83Criteria and Procedures for Proposed Assessment of Civil Penalties1219-AB72Final Rule Stage.
84Occupational Exposure to Crystalline Silica1218-AB70Final Rule Stage.
85Improve Tracking of Workplace Injuries and Illnesses1218-AC49Final Rule Stage.

Department of Transportation

Sequence No.TitleRegulation Identifier No.Rulemaking stage
86Use of Mobile Wireless Devices for Voice Calls on Aircraft2105-AE30Proposed Rule Stage.
87Airport Safety Management System2120-AJ38Proposed Rule Stage.
88Pilot Professional Development2120-AJ87Proposed Rule Stage.
89Revision of Airworthiness Standards for Normal, Utility, Acrobatic, and Commuter Category Airplanes2120-AK65Proposed Rule Stage.
90Operation and Certification of Small Unmanned Aircraft Systems2120-AJ60Final Rule Stage.
91National Goals and Performance Management Measures (MAP-21)2125-AF54Proposed Rule Stage.
92National Goals and Performance Management Measures (MAP-21)2125-AF49Final Rule Stage.
93National Goals and Performance Management Measures (MAP-21)2125-AF53Final Rule Stage.
94Carrier Safety Fitness Determination2126-AB11Proposed Rule Stage.
95Entry-Level Driver Training2126-AB66Proposed Rule Stage.
96Commercial Driver's License Drug and Alcohol Clearinghouse (MAP-21)2126-AB18Final Rule Stage.
97Rear Seat Belt Reminder System2127-AL37Proposed Rule Stage.
98Fuel Efficiency Standards for Medium- and Heavy-Duty Vehicles and Work Trucks: Phase 22127-AL52Proposed Rule Stage.
99Transit Asset Management2132-AB07Proposed Rule Stage.
100Public Transportation Agency Safety Plans2132-AB23Proposed Rule Stage.
101Pipeline Safety: Safety of On-Shore Liquid Hazardous Pipelines2137-AE66Proposed Rule Stage.
102Pipeline Safety: Gas Transmission2137-AE72Proposed Rule Stage.
103Hazardous Materials: Oil Spill Response Plans and Information Sharing for High-Hazard Flammable Trains2137-AF08Proposed Rule Stage.
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Environmental Protection Agency

Sequence No.TitleRegulation Identifier No.Rulemaking stage
104Interstate Transport Rule for the 2008 Ozone NAAQS2060-AS05Proposed Rule Stage.
105Oil and Natural Gas Sector: Emission Standards for New and Modified Sources2060-AS30Proposed Rule Stage.
106Model Trading Rules for Greenhouse Gas Emissions From Electric Utility Generating Units Constructed on or Before January 8, 20142060-AS47Proposed Rule Stage.
107Proposed Renewable Fuel Volume Standards for 2017 and Biomass Based Diesel Volume (BBD) for 20182060-AS72Proposed Rule Stage.
108Polychlorinated Biphenyls (PCBs); Reassessment of Use Authorizations2070-AJ38Proposed Rule Stage.
109Trichloroethylene (TCE); Rulemaking Under TSCA Section 6(a)2070-AK03Proposed Rule Stage.
110N-Methylpyrrolidone (NMP) and Methylene Chloride; Rulemaking Under TSCA Section 6(a)2070-AK07Proposed Rule Stage.
111Financial Responsibility Requirements Under CERCLA Section 108(b) for Classes of Facilities in the Hard Rock Mining Industry2050-AG61Proposed Rule Stage.
112User Fee Schedule for Electronic Hazardous Waste Manifest2050-AG80Proposed Rule Stage.
113Modernization of the Accidental Release Prevention Regulations Under Clean Air Act2050-AG82Proposed Rule Stage.
114Review of the National Ambient Air Quality Standards for Lead2060-AQ44Final Rule Stage.
115Greenhouse Gas Emissions and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles—Phase 22060-AS16Final Rule Stage.
116Renewable Fuel Volume Standards, 2014-2016 (Reg Plan)2060-AS22Final Rule Stage.
117Findings That Greenhouse Gas Emissions From Aircraft Cause Or Contribute To Air Pollution That May Reasonably Be Anticipated to Endanger Public Health And Welfare Under CAA Section 231 (Reg Plan)2060-AS31Final Rule Stage.
118Pesticides; Certification of Pesticide Applicators2070-AJ20Final Rule Stage.
119Formaldehyde Emission Standards for Composite Wood Products2070-AJ44Final Rule Stage.

Equal Employment Opportunity Commission

Sequence No.TitleRegulation Identifier No.Rulemaking stage
120The Federal Sector's Obligation To Be a Model Employer of Individuals With Disabilities3046-AA94Proposed Rule Stage.
121Federal Sector Equal Employment Opportunity Process3046-AB00Proposed Rule Stage.
122Amendments to Regulations Under the Genetic Information Nondiscrimination Act of 20083046-AB02Proposed Rule Stage.
123Amendments to Regulations Under the Americans With Disabilities Act3046-AB01Final Rule Stage.

Small Business Administration

Sequence No.TitleRegulation Identifier No.Rulemaking stage
124Small Business Innovation Research Program and Small Business Technology Transfer Program Policy Directive3245-AG64Proposed Rule Stage.
125Small Business Investment Company (SBIC) Program; Impact SBICs3245-AG66Proposed Rule Stage.
126Affiliation for Business Loan Programs and Surety Bond Guarantee Program3245-AG73Proposed Rule Stage.
127Small Business Mentor-Protégé Programs3245-AG24Final Rule Stage.
128Small Business Government Contracting and National Defense Authorization Act of 2013 Amendments3245-AG58Final Rule Stage.

Social Security Administration

Sequence No.TitleRegulation Identifier No.Rulemaking stage
129Vocational Factors of Age, Education, and Work Experience in the Adult Disability Determination Process0960-AH74Prerule Stage.
130Revised Medical Criteria for Evaluating Musculoskeletal Disorders (3318P)0960-AG38Proposed Rule Stage.
131Revised Medical Criteria for Evaluating Digestive Disorders (3441P)0960-AG65Proposed Rule Stage.
132Acceptable Medical Sources, Evaluating Evidence, and Treating Sources (3787P)0960-AH51Proposed Rule Stage.
133Returning Evidence at the Appeals Council Level (3844F)0960-AH64Proposed Rule Stage.
134Removal of the Expiration Date for State Disability Examiner Authority to Make Fully Favorable Quick Disability Determinations and Compassionate Allowances0960-AH70Proposed Rule Stage.
135Anti-Harassment and Hostile Work Environment Case Tracking and Records System Revised0960-AH82Proposed Rule Stage.
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136Amendment to the Education Category, “Illiterate or Unable to Communicate in English” and Clarification of Previous Work Experience Criterion for Persons who are “Illiterate”0960-AH86Proposed Rule Stage.
137Revised Medical Criteria for Evaluating Neurological Impairments (806F)0960-AF35Final Rule Stage.
138Revised Medical Criteria for Evaluating Respiratory System Disorders (859F)0960-AF58Final Rule Stage.
139Revised Medical Criteria for Evaluating Mental Disorders (886F)0960-AF69Final Rule Stage.

U.S. DEPARTMENT OF AGRICULTURE

Fall 2015 Statement of Regulatory Priorities

The U.S. Department of Agriculture (USDA) provides leadership on food, agriculture, natural resources, rural development, nutrition, and related issues based on sound public policy, the best available science, and efficient management. The Department touches the lives of almost every American, every day. Our regulatory plan reflects that reality and reinforces our commitment to achieve results for everyone we serve.

The regulatory plan continues USDA efforts to implement several important pieces of legislation. The 2014 Farm Bill provides authorization for services and programs that impact every American and millions of people around the world. The new Farm Bill builds on historic economic gains in rural America over the past five years, while achieving meaningful reform and billions of dollars in savings for taxpayers. The Healthy, Hunger-Free Kids Act of 2010 (HHFKA) allows USDA, for the first time in over 30 years, opportunity to make real reforms to the school lunch and breakfast programs by improving the critical nutrition and hunger safety net for millions of children.

To assist the country in addressing today's challenges, USDA has developed a regulatory plan consistent with five strategic goals that articulate the Department's priorities.

1. Assist Rural Communities To Create Prosperity So They Are Self-Sustaining, Re-Populating, and Economically Thriving

Rural America is home to a vibrant economy supported by nearly 50 million Americans. These Americans come from diverse backgrounds and work in a variety of industries, including manufacturing, agriculture, services, government, and trade. Today, the country looks to rural America not only to provide food and fiber, but for crucial emerging economic opportunities such as renewable energy, broadband, and recreation. Many of the Nation's small businesses are located in rural communities and are the engine of job growth and an important source of innovation for the country. The economic vitality and quality of life in rural America depends on a healthy agricultural production system. Farmers and ranchers face a challenging global, technologically advanced, and competitive business environment. USDA works to ensure that producers are prosperous and competitive, have access to new markets, can manage their risks, and receive support in times of economic distress or weather-related disasters. Prosperous rural communities are those with adequate assets to fully support the well-being of community members. USDA helps to strengthen rural assets by building physical, human and social, financial, and natural capital.

Enhance rural prosperity, including leveraging capital markets to increase Government's investment in rural America.

USDA is committed to providing broadband to rural areas. Since 2009, USDA investments have delivered broadband service to 1.5 million households, businesses, schools, libraries and community facilities. These investments support the USDA goal to create thriving communities where people want to live and raise families. Consistent with these efforts, the Rural Utilities Service (RUS) published an interim rule on July 30, 2015, implementing Rural Broadband Access Loan and Loan Guarantee Program provisions included in section 6104 of the 2014 Farm Bill. The rule established two funding cycles to review and prioritize applications for the program. It also set a minimum level of acceptable broadband service at 4 megabits downstream and 1 megabit upstream. RUS is currently developing a final rule to implement changes to the administration of the Broadband program based on public comments received. For more information about this rule, see RIN 0572-AC34.

USDA also works to increase the effectiveness of the Government's investment in rural America. To this end, Rural Development will issue a final rule to establish program metrics to measure the economic activities created through grants and loans, including any technical assistance provided as a component of the grant or loan program, and to measure the short and long-term viability of award recipients, and any entities to whom recipients provide assistance using the awarded funds. The action is required by section 6209 of the 2014 Farm Bill, and will not change the underlying provisions of the included programs, such as eligibility, applications, scoring, and servicing provisions. For more information about this rule, see RIN 0570-AA95.

Increase agricultural opportunities by ensuring a robust safety net, creating new markets, and supporting a competitive agricultural system.

In another step to increase the effectiveness of the Government's investment in rural America, the Farm Service Agency (FSA) published a proposed rule on March 26, 2015, on behalf of the Commodity Credit Corporation (CCC) to specify the requirements for a person to be considered actively engaged in farming for the purpose of payment eligibility for certain FSA and CCC programs. These changes will ensure that farm program payments are going to the farmers and farm families that they are intended to help. Specifically, FSA is revising and clarifying the requirements for a significant contribution of active personnel management to a farming operation. These changes are required by the 2014 Farm Bill, and will not apply to persons or entities comprised solely of family members. FSA is currently developing a final rule to implement changes to the rule based on public comments received. For more information about this rule, see RIN 0560-AI31.

The Federal Crop Insurance Program mitigates production and revenue losses from yield or price fluctuations and Start Printed Page 77723provides timely indemnity payments. The 2014 Farm Bill improved the Federal Crop Insurance Program by allowing producers to elect coverage for shallow losses, improved options for growers of organic commodities, and the ability for diversified operations to insure their whole-farm under a single policy. To strengthen further the farm financial safety net, the Risk Management Agency (RMA) published an interim rule on June 30, 2014, that amended the general administrative regulations governing Catastrophic Risk Protection Endorsement, Area Risk Protection Insurance, and the basic provisions for Common Crop Insurance consistent with the changes mandated by the 2014 Farm Bill. RMA is currently developing a final rule to implement changes based on public comments received. For more information about this rule, see RIN 0563-AC43.

2. Ensure Our National Forests and Private Working Lands Are Conserved, Restored, and Made More Resilient to Climate Change, While Enhancing Our Water Resources

National forests and private working lands provide clean air, clean and abundant water, and wildlife habitat. These lands sustain jobs and produce food, fiber, timber, and bio-based energy. Many of our landscapes are scenic and culturally important and provide Americans a chance to enjoy the outdoors. The 2014 Farm Bill delivered a strong conservation title that made robust investments to conserve and support America's working lands, and consolidated, and streamlined programs to improve efficiency and encourage participation. Farm Bill conservation programs provide America's farmers, ranchers and others with technical and financial assistance to enable conservation of natural resources, while protecting and improving agricultural operations. Seventy percent of the American landscape is privately owned, making private lands conservation critical to the health of our nation's environment and ability to ensure our working lands are productive. To sustain these many benefits, USDA has implemented the authorities provided by the 2014 Farm Bill to protect and enhance 1.3 billion acres of working lands. USDA also manages 193 million acres of national forests and grasslands. Our partners include Federal, Tribal, and State governments; industry; non-governmental organizations, community groups and producers. The Nation's lands face increasing threats that must be addressed. USDA's natural resource-focused regulatory strategies are designed to make substantial contributions in the areas of soil health, resiliency to climate change, and improved water quality.

Improve the health of the Nation's forests, grasslands and working lands by managing our natural resources.

The Natural Resources Conservation Service (NRCS) administers the Agricultural Conservation Easement Program (ACEP), which provides financial and technical assistance to help conserve agricultural lands and wetlands and their related benefits. The 2014 Farm Bill consolidated the Wetlands Reserve Program (WRP), the Farm and Ranch Lands Protection Program (FRPP), and the Grassland Reserve Program (GRP) into ACEP. In fiscal year 2014, an estimated 143,833 acres of farmland, grasslands, and wetlands were enrolled into ACEP. Through regulation, NRCS established a comprehensive framework to implement ACEP, and standardized criteria for implementing the program, provided program participants with predictability when they initiate an application and convey an easement. On February 27, 2015, NRCS published an interim rule to implement ACEP. NRCS is currently developing a final rule to implement changes to the administration of ACEP based on public comments received. For more information about this rule, see RIN 0578-AA61.

The Conservation Stewardship Program (CSP) also helps the Department ensure that our national forests and private working lands are conserved, restored, and made more resilient to climate change. Through CSP, NRCS provides financial and technical assistance to eligible producers to conserve and enhance soil, water, air, and related natural resources on their land. NRCS makes funding for CSP available nationwide on a continuous application basis. In fiscal year 2014, NRCS enrolled about 9.6 million acres and now CSP enrollment exceeds 60 million acres, about the size of Iowa and Indiana combined. On November 5, 2014, NRCS published an interim rule to implement provisions of the 2014 Farm bill that amended CSP. Key changes included: Limiting eligible land to that in production for at least 4 of the 6 years preceding February 7, 2014, the date of enactment of the 2014 Farm Bill; requiring contract offers to meet stewardship threshold for at least two priority resource concerns and meet or exceed one additional priority resource concern by the end of the stewardship contract; allowing enrollment of lands that are protected by an agricultural land easement under the newly authorized ACEP; and allowing enrollment of lands that are in the last year of the Conservation Reserve Program. NRCS is currently developing a final rule to implement changes to the administration of CSP based on public comments received. For more information about this rule, see RIN 0578-AA63.

The Environmental Quality Incentives Program (EQIP) is another voluntary conservation program that helps agricultural producers in a manner that promotes agricultural production and environmental quality as compatible goals. Through EQIP, agricultural producers receive financial and technical assistance to implement structural and management conservation practices that optimize environmental benefits on working agricultural land. Through EQIP, producers addressed their conservation needs on over 11 million acres in fiscal year 2014. EQIP has been instrumental in helping communities respond to drought. On December 12, 2014, NRCS published an interim rule that implemented changes mandated by 2014 Farm Bill and addressed a few key discretionary provisions, including, adding waiver authority to irrigation history requirements, incorporation of Tribal Conservation Advisory Councils where appropriate, and clarifying provisions related to Comprehensive Nutrient Management Plans (CNMP) associated with Animal Feeding Operations (AFO). NRCS is currently developing a final rule to implement changes to the administration of EQIP based on public comments received. For more information about this rule, see RIN 0578-AA62.

Contribute to clean and abundant water by protecting and enhancing water resources on national forests and working lands.

The 2014 Farm Bill relinked highly erodible land conservation and wetland conservation compliance with eligibility for premium support paid under the federal crop insurance program. The Farm Service Agency implemented these provisions through an interim rule published on April, 24, 2015. Since publication of the interim rule, more than 98.2 percent of producers met the requirement to certify conservation compliance to qualify for crop insurance premium support payments. Implementing these provisions for conservation compliance is expected to extend conservation provisions for an additional 1.5 million acres of highly erodible lands and 1.1 million acres of wetlands, which will reduce soil erosion, enhance water quality, and create wildlife habitat. Through this action, NRCS modified the existing Start Printed Page 77724wetlands Mitigation Banking Program to remove the requirement that USDA hold easements in the mitigation program. This allows entities recognized by USDA to hold mitigation banking easements granted by a person who wishes to maintain payment eligibility under the wetland conservation provision. FSA is currently developing a final rule to implement changes to the interim rule based on public comments received. For more information about this rule, see RIN 0560-AI26.

3. Help America Promote Agricultural Production and Biotechnology Exports as America Works To Increase Food Security

Food security is important for sustainable economic growth of developing nations and the long-term economic prosperity and security of the United States. Unfortunately, global food insecurity is expected to rise in the next five years. Food security means having a reliable source of nutritious and safe food and sufficient resources to purchase it. USDA has a role in curbing this distressing trend through programs such as Food for Progress and President Obama's Feed the Future Initiative and through new technology-based solutions, such as the development of genetically engineered plants, that improves yields and reduces post-harvest loss.

Ensure U.S. agricultural resources contribute to enhanced global food security.

The Foreign Agriculture Service (FAS) will issue a final rule for the Local and Regional procurement (LRP) Program as authorized in section 3207 of the 2014 Farm Bill. USDA implemented a successful LRP pilot program under the authorities of the 2008 Farm Bill. LRP ties to the President's 2014 Trade Policy Agenda and works with developing nations to alleviate poverty and foster economic growth to provide better markets for U.S. exporters. LRP is expected to help alleviate hunger for millions of individuals in food insecure countries. LRP supports development activities that strengthen the capacity of food-insecure developing countries, and build resilience and address the causes of chronic food insecurity while also supporting USDA's other food assistance programs, including the McGovern Dole International Food for Education and Child Nutrition Program (McGovern-Dole). In addition, the program can be used to fill food availability gaps generated by unexpected emergencies. LRP complements ongoing activities under the McGovern-Dole Program, improves dietary diversity and nutrition, and supports the sustainability of school-feeding programs as they transition to full host-government ownership. The final rule will enable FAS and its partners to strengthen the capacity of host-governments to implement their own homegrown school feeding programs. For more information about this rule, see RIN 0551-AA87.

Enhance America's ability to develop and trade agricultural products derived from new and emerging technologies.

USDA uses science-based regulatory systems to allow for the safe development, use, and trade of products derived from new agricultural technologies. USDA continues to regulate the importation, interstate movement, and field-testing of newly developed genetically engineered (GE) organisms that qualify as “regulated articles” to ensure they do not pose a threat to plant health before they can be commercialized. These science-based evaluations facilitate the safe introduction of new agricultural production options and enhance public and international confidence in these products. As a part of this effort, the Animal and Plant Health Inspection Service (APHIS) will publish a proposed rule to revise its regulations and align them with current authorizations by incorporating the noxious weed authority and regulate GE organisms that pose plant pest or weed risks in a manner that balances oversight and risk, and that is based on the best available science. The regulatory framework being developed will enable more focused, risk-based regulation of GE organisms that pose plant pest or noxious weed risks and will implement regulatory requirements only to the extent necessary to achieve the APHIS protection goal. For more information about this rule, see RIN 0579-AE15.

4. Ensure That All of America's Children Have Access to Safe, Nutritious, and Balanced Meals

A plentiful supply of safe and nutritious food is essential to the well-being of every family and the healthy development of every child in America. Science has established strong links between diet, health, and productivity. Even small improvements in the average diet, fostered by USDA, may yield significant health and economic benefits. However, foodborne illness is still a common, costly—yet largely preventable—public health problem, even though the U.S. food supply system is one of the safest in the world. USDA is committed to ensuring that Americans have access to safe food through a farm-to-table approach to reduce and prevent foodborne illness. To help ensure a plentiful supply of food, the Department detects and quickly responds to new invasive species and emerging agricultural and public health situations.

Improve access to nutritious food.

USDA's domestic nutrition assistance programs serve one in four Americans annually. The Department is committed to making benefits available to every eligible person who wishes to participate in the major nutrition assistance programs, including the Supplemental Nutrition Assistance Program (SNAP), the cornerstone of the nutrition assistance safety net, which helped over 46 million Americans—more than half of whom were children, the elderly, or individuals with disabilities—put food on the table in 2014. The Department will soon propose changes to eligibility requirements for SNAP retail food stores to ensure access to nutrition foods for home preparation and consumption for the families most vulnerable to food insecurity. While the ultimate objective is for economic opportunities to make nutrition assistance unnecessary for as many families as possible, we will ensure that these vital programs remain ready to serve all eligible people who need them.

The Department is also committed to helping ensure children have access to healthy, balanced meals throughout the day, as mandated by HHFKA, through the USDA child nutrition programs, including school, child care and summer meal programs. The summer meal programs have seen a historic increase in participation, with 11 million more meals served in 2015 compared to the previous summer, serving a total of more than 187 million meals at over 50,000 summer meal sites throughout the country.

Promote healthy diet and physical activity behaviors.

The Administration has set a goal to solve the problem of childhood obesity within a generation so that children born today will reach adulthood at a healthy weight. On school days, children who participate in both the breakfast and lunch programs consume as many as half of their calories at school. The Department must ensure that all foods served in school contribute to good health, and the HHFKA provided new authority to set common-sense nutrition standards for food sold throughout the school day. To help accomplish this goal, the Food and Nutrition Service (FNS) will publish three rules implementing provisions of the HHFKA.Start Printed Page 77725

FNS published an interim rule on June 28, 2013, for Nutrition Standards for All Foods Sold in School, as required by HHFKA. Section 208 requires the Secretary to promulgate regulations to establish science-based nutrition standards for all foods sold in schools, outside the school meal programs, on the school campus, and at any time during the school day. FNS is currently developing a final rule to implement changes to the interim rule based on public comments received. For more information about this rule, see RIN 0584-AE09.

FNS published the proposed rule, Meal Pattern Revisions Related to the Healthy Hunger-Free Kids Act of 2010, on January 15, 2015, to implement section 221 of the HHFKA. This section requires USDA to review and update, no less frequently than once every 10 years, requirements for meals served under the Child and Adult Care Food Program (CACFP) to ensure that meals are consistent with the most recent Dietary Guidelines for Americans and relevant nutrition science. FNS is currently developing a final rule to implement changes to the proposed rule based on public comments received. For more information about this rule, see RIN 0584-AE18.

FNS published the proposed rule, Local School Wellness Policy Implementation and School Nutrition Environment Information, on February 28, 2014, to implement section 204 of the HHFKA. As a result of meal pattern changes in the school meals programs, students are now eating 16 percent more vegetables and there was a 23 percent increase in the selection of fruit at lunch. This Act requires each local educational agency participating in Federal child nutrition programs to establish, for all schools under its jurisdiction, a local school wellness policy to maintain this momentum. The HHFKA requires that the wellness policy include goals for nutrition, nutrition education, physical activity, and other school-based activities that promote student wellness. In addition, the HHFKA requires that local educational agencies ensure stakeholder participation in development of local school wellness policies; periodically assess compliance with the policies; and disclose information about the policies to the public. FNS is currently developing a final rule to implement changes to the proposed rule based on public comments received. For more information about this rule, see RIN 0584-AE25.

Protect agricultural health by minimizing major diseases and pests to ensure access to safe, plentiful, and nutritious food.

The Food Safety and Inspection Service (FSIS) continue to enforce and improve compliance with the Humane Methods of Slaughter Act. FSIS published a proposed rule on May 13, 2015, that would require non-ambulatory disabled veal calves that are offered for slaughter to be condemned and promptly euthanized. Currently, FSIS allows veal calves that are unable to rise from a recumbent position to be set aside and warmed or rested, and presented for slaughter if they regain the ability to walk. FSIS has found that this practice may contribute to the inhumane treatment of the veal calves. This rule will improve compliance with the Humane Methods of Slaughter Act by encouraging improved treatment of veal calves, as well as improve inspection efficiency by allowing FSIS inspection program personnel to devote more time to activities related to food safety. FSIS is currently developing a final rule to implement these changes based on public comments received. For more information about this rule, see RIN 0583-AD54.

5. Create a USDA for the 21st Century That Is High Performing, Efficient, and Adaptable

USDA has been a leader in the Federal government at implementing innovative practices to rein in costs and increase efficiencies. By taking steps to find efficiencies and cut costs, USDA employees have achieved savings and cost avoidances of over $1.4 billion in recent years. Some of these results came from relatively smaller, common-sense initiatives such as the $1 million saved by streamlining the mail handling at one of the USDA mailrooms or the consolidation of the Department's cell phone contracts, which is saving taxpayers over $5 million per year. Other results have come from larger-scale activities, such as the focus on reducing non-essential travel that has yielded over $400 million in efficiencies. Overall, these results have allowed us to do more with less during a time when such stewardship of resources has been critical to meeting the needs of those that we serve.

While these proactive steps have given USDA the tools to carry out our mission-critical work, ensuring that USDA's millions of customers receive stronger service, they are matters relating to agency management, personnel, public property, and/or contracts, and as such they are not subject to the notice and comment requirements for rulemaking codified at 5 U.S.C. 553. Consequently, they are not included in the Department's regulatory agenda. For more information about the USDA efforts to cut costs and modernize operations via the Blueprint for Stronger Service Initiative, see http://www.usda.gov/​wps/​portal/​usda/​usdahome?​contentidonly=​true&​contentid=​blueprint_​for_​stronger_​service.html.

Retrospective Review of Existing Regulations

In accordance with Executive Order 13563, “Improving Regulation and Regulatory Review,” and Executive Order 13610, “Identifying and Reducing Regulatory Burdens,” USDA continues to review its existing regulations and information collections to evaluate the continued effectiveness in addressing the circumstances for which the regulations were implemented. As part of this ongoing review to maximize the cost-effectiveness of its regulatory programs, USDA will publish a Federal Register notice inviting public comment to assist in analyzing its existing significant regulations to determine whether any should be modified, streamlined, expanded, or repealed.

USDA has identified the following regulatory actions as associated with retrospective review and analysis. Some of the regulatory actions on the below list are completed actions, which do not appear in the Regulatory Agenda. You can find more information about these completed rulemakings in past publications of the Unified Agenda (search the Completed Actions sections) on www.reginfo.gov. Other entries on this list are still in development and have not yet appeared in the Regulatory Agenda. You can read more about these entries and the Department's strategy for regulation reform at http://www.usda.gov/​wps/​portal/​usda/​usdahome?​navid=​USDA_​OPEN.

AgencyTitleRIN
Animal Plant Health & Inspection Service (APHIS)Participation in the International Trade Data System (ITDS) via the Automated Commercial Environment (ACE)TBD.
Food Safety & Inspection Service (FSIS)Electronic Export Application and Certification Fee0583-AD41.
Agricultural Marketing Service (AMS)Input Export Form Numbers into the Automated Export SystemTBD.
Start Printed Page 77726
AMSRevisions to the Electronic Submission of the Import Request of Shell Eggs0581-AD40.
APHISForms for Declaration Mandated by 2008 Farm Bill (Lacey Act amendments)0579-AD99.
Farm Service Agency (FSA) and Risk Management AgencyAcreage and Crop Reporting Streamlining Initiative0563-0084.
FSAEnvironmental Policies and Procedures; Compliance with the National Environmental Policy Act and Related Authorities0560-AH02.
Natural Resources Conservation ServiceConservation Delivery Streamlining Initiative (CDSI)—Conservation Client Gateway (CCG)TBD.
Rural Business Services (RBS)Business and Industry Loan Guaranteed Program0570-AA85.
Rural Housing ServiceCommunity Facilities Loan and Grants0575-AC91.
FSISElectronic Import Inspection and Certification of Imported Products and Foreign Establishments0583-AD39.
Forest Service (FS)National Environmental Policy Act Efficiencies0596-AD01.
FSAStreamlined Farm Loan Programs Direct Loan Making0560-0237.
Food and Nutrition Service (FNS)Direct Certification for School Meals0584-AE10.
FSISPrior Labeling Approval System: Generic Label Approval0583-AC59.
FSISModernization of Poultry Slaughter Inspection0583-AD32.
FNSSimplified Cost Accounting and Other Actions to Reduce Paperwork in the Summer Food Service Program0584-AD84.
Rural Business Services (RBS)Biorefinery, Renewable Chemical, and Biobased Product Manufacturing Assistance0570-AA73, 0570-0065.
RBSRural Energy for America Program0570-AA76.

USDA—FARM SERVICE AGENCY (FSA)

Final Rule Stage

1. Payment Limitation and Payment Eligibility—Actively Engaged in Farming

Priority: Other Significant.

Legal Authority: 7 U.S.C. 1308-1 note

CFR Citation: 7 CFR 1400.

Legal Deadline: None.

Abstract: The Farm Service Agency (FSA) is revising regulations on behalf of the Commodity Credit Corporation (CCC) to specify the requirements for a person to be considered actively engaged in farming for the purpose of payment eligibility for certain FSA and CCC programs. Specifically, FSA is revising and clarifying the requirements for a significant contribution of active personnel management to a farming operation. These changes are required by the Agricultural Act of 2014 (the 2014 Farm Bill). The provisions of the rule will not apply to persons or entities comprised solely of family members. The rule will not change the existing regulations as they relate to contributions of land, capital, equipment, labor, or the special rules related to landowners with a risk in the crop or spouses.

Statement of Need: This rule is needed to update the FSA regulations to implement a provision in the 2014 Farm Bill.

Summary of Legal Basis: The Agricultural Act of 2014 (Pub. L. 113-79).

Alternatives: There are alternatives about how many managers a farming operation may be able to have qualify for payments based on being actively engaged in farming.

Anticipated Cost and Benefits: A cost-benefit analysis was prepared for this rule and will be made available when the rule is published.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM03/26/1580 FR 15916
NPRM Comment Period End05/26/15
Final Action12/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: None.

Agency Contact: Deirdre Holder, Director, Regulatory Review Group, Department of Agriculture, Farm Service Agency, 1400 Independence Avenue SW., Washington, DC 20250-0572, Phone: 202 205-5851, Fax: 202 720-5233, Email: deirdre.holder@wdc.usda.gov.

RIN: 0560-AI31

USDA—ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS)

Prerule Stage

2. • Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms

Priority: Other Significant.

Legal Authority: Not Yet Determined

CFR Citation: 7 CFR 340.

Legal Deadline: None.

Abstract: USDA uses science-based regulatory systems to allow for the safe development, use, and trade of products derived from new agricultural technologies. USDA continues to regulate the importation, interstate movement, and field-testing of newly developed genetically engineered (GE) organisms that qualify as regulated articles” to ensure they do not pose a threat to plant health before they can be commercialized. These science-based evaluations facilitate the safe introduction of new agricultural production options and enhance public and international confidence in these products. As a part of this effort, the Animal and Plant Health Inspection Service (APHIS) will publish a proposed rule to revise its regulations and align them with current authorizations by incorporating the noxious weed authority and regulate GE organisms that pose plant pest or weed risks in a manner that balances oversight and risk, and that is based on the best available science. The regulatory framework being developed will enable more focused, risk-based regulation of GE organisms that pose plant pest or noxious weed risks and will implement regulatory requirements only to the extent necessary to achieve the APHIS protection goal.

Timetable:

ActionDateFR Cite
Notice of Intent to Prepare an Environmental Impact Statement11/00/15
NPRM07/00/16
Start Printed Page 77727
NPRM Comment Period End09/00/16

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: Local, State.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information: Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.

Agency Contact: Andrea Huberty, Branch Chief, Policy, Program, and Regulatory Consultation Branch, Policy Coordination Program, BRS, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 147, Riverdale, MD 20737-1236, Phone: 301 851-3880.

RIN: 0579-AE15

USDA—FEDERAL CROP INSURANCE CORPORATION (FCIC)

Final Rule Stage

3. General Administrative Regulations; Catastrophic Risk Protection Endorsement; Area Risk Protection Insurance Regulations; and the Common Crop Insurance Regulations, Basic Provisions

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: Pub. L. 113-79

CFR Citation: 7 CFR 400; 7 CFR 457.

Legal Deadline: Final, Statutory, June 30, 2014, 2015 Contract year.

Abstract: The Federal Crop Insurance Corporation amends the General Administrative Regulations—Ineligibility for Programs under the Federal Crop Insurance Act, the Catastrophic Risk Protection Endorsement, the Area Risk Protection Insurance Regulations, and the Common Crop Insurance Regulations, Basic Provisions, to revise those revisions affected by changes mandated by the Agricultural Act of 2014 (commonly referred to as the 2014 Farm Bill), enacted on February 7, 2014.

Statement of Need: This Final rule is needed complete the Interim Final Rule that updates FCIC regulations required to implement provisions of the Agricultural Act of 2014.

Summary of Legal Basis: The Agricultural Act of 2014.

Alternatives: N/A.

Anticipated Cost and Benefits: A benefit-cost analysis was prepared for the Interim Final Rule and no significant changes have been made to this Final Rule which would alter the initial analysis which will be made available when the rule is published.

Risks: None.

Timetable:

ActionDateFR Cite
Interim Final Rule Effective06/30/1479 FR 37155
Interim Final Rule Comment Period End09/02/14
Final Action03/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Timothy Hoffmann, Director, Product Administration and Standards Division, Department of Agriculture, Federal Crop Insurance Corporation, 6501 Beacon Drive, Kansas City, MO 64133, Phone: 816 926-7387.

RIN: 0563-AC43

USDA—FOOD AND NUTRITION SERVICE (FNS)

Proposed Rule Stage

4. Enhancing Retailer Eligibility Standards in SNAP

Priority: Other Significant.

Legal Authority: 3 U.S.C. 2012; 9 U.S.C. 2018

CFR Citation: 7 CFR 271.2; 7 CFR 278.1.

Legal Deadline: None.

Abstract: This rulemaking will address the criteria used to authorize redemption of SNAP benefits (especially by restaurant-type operations).

Statement of Need: The 2014 Farm Bill amended the Food and Nutrition Act of 2008 to increase the requirement that certain SNAP authorized retail food stores have available on a continual basis at least three varieties of items in each of four staple food categories to a mandatory minimum of seven. The 2014 Farm Bill also amended the Act to increase for certain SNAP authorized retail food stores the minimum number of categories in which perishable foods are required from two to three. This rule would codify these mandatory requirements. Further, using existing authority in the Act and feedback from an expansive Request for Information, the rulemaking also proposes changes to address depth of stock, redefine staple and accessory foods, and amend the definition of retail food store to clarify when a retailer is a restaurant rather than a retail food store.

Summary of Legal Basis: Section 3(k) of the Food and Nutrition Act of 2008 (the Act) generally (with limited exception) (1) requires that food purchased with SNAP benefits be meant for home consumption and (2) forbids the purchase of hot foods with SNAP benefits. The intent of those statutory requirements can be circumvented by selling cold foods, which may be purchased with SNAP benefits, and offering onsite heating or cooking of those same foods, either for free or at an additional cost. In addition, section 9 of the Act provides for approval of retail food stores and wholesale food concerns based on their ability to effectuate the purposes of the Program.

Alternatives: Because this proposed rule is under development, alternatives are not yet articulated.

Anticipated Cost and Benefits: The proposed changes will allow FNS to improve access to healthy food choices for SNAP participants and to ensure that participating retailers effectuate the purposes of the Program. FNS anticipates that these provisions will have no significant costs to States.

Risks: None identified.

Timetable:

ActionDateFR Cite
NPRM03/00/16

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: State.

Agency Contact: Charles H. Watford, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-0800, Email: charles.watford@fns.usda.gov.

Lynnette M. Thomas, Chief, Planning and Regulatory Affairs Branch, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-4782, Email: lynnette.thomas@fns.usda.gov.

RIN: 0584-AE27

USDA—FNS

5. Supplemental Nutrition Assistance Program (SNAP) Photo Electronic Benefit Transfer (EBT) Card Implementation Requirements

Priority: Other Significant.

Legal Authority: Pub L. 104-193

CFR Citation: 7 CFR 273; 7 CFR 274; 7 CFR 278.Start Printed Page 77728

Legal Deadline: None.

Abstract: Under section 7(h)(9) of the Food and Nutrition Act of 2008 (the Act), as amended [7 U.S.C. 2016(h)(9)], States have the option to require that SNAP Electronic Benefit Transfer (EBT) card contain a photo of one or more household members. This rule would incorporate into regulation and provide additional clarity on the Food and Nutrition Service (FNS) guidance developed for State agencies wishing to implement the photo EBT card option.

Statement of Need: The regulation would create a clearer structure for those States wishing to exercise the option of placing a photo on EBT cards and ensure uniform accessibility for participants in all States.

Summary of Legal Basis: The Food and Nutrition Act of 2008 requires that any States choosing to issue a photo on the EBT card establish procedures to ensure that all other household members or any authorized representative of the household may utilize the card. Furthermore, applying this option must also preserve client rights and responsibilities afforded by the Act to ensure that all household members are able to maintain uninterrupted access to benefits, that non-applicants applying on behalf of eligible household members are not negatively impacted, and that SNAP recipients using photo EBT cards are treated equitably in accordance with Federal law when purchasing food at authorized retailers.

Alternatives: None.

Anticipated Cost and Benefits: The changes to be proposed are not expected to create serious inconsistencies or otherwise interfere with actions taken or planned by another agency or materially alter the budgetary impacts of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof. The requirements will not raise novel or legal policy issues.

Budgetary impact on FNS is expected to be limited. Photo EBT card implementation in multiple States may require additional Federal staff for review and approval of implementation plans and for on-going monitoring via management evaluations.

As a result of this rule, States that exercise the option to implement photos on EBT cards would incur costs associated with development of an implementation plan, State staff training, client training, and retailer training. It is expected that providing guidance or oversight of these requirements would fall under the standard purview of these agencies and could be absorbed by existing staff. State Agencies are responsible for approximately 50% of SNAP administration costs, which would include the costs associated with implementing and maintaining photo EBT cards.

Risks: FNS recognizes the existence of violating retailers and others buying and using multiple cards and pins to stock their shelves and will propose an alternative to address possession of multiple cards and PINs to allow for additional verification at point-of-sale in some specific instances.

Recent attempts to implement photographs on the EBT card have proven difficult for some States. This rule will expand on current program regulations to provide clarification and more detailed guidance to States implementing the photo EBT option and ensure program access is protected.

Timetable:

ActionDateFR Cite
NPRM11/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Local, State.

Agency Contact: Charles H. Watford, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-0800, Email: charles.watford@fns.usda.gov.

RIN: 0584-AE45

USDA—FNS

Final Rule Stage

6. National School Lunch and School Breakfast Programs: Nutrition Standards for All Foods Sold in School, as Required by the Healthy, Hunger-Free Kids Act of 2010

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect State, local or tribal governments and the private sector.

Legal Authority: Pub. L. 111-296

CFR Citation: 7 CFR 210; 7 CFR 220.

Legal Deadline: None.

Abstract: This rule codifies the two provisions of the Healthy, Hunger-Free Kids Act (Pub. L. 111-296; the Act) under 7 CFR parts 210 and 220. Section 203 requires schools participating in the National School Lunch Program to make available to children free of charge, as nutritionally appropriate, potable water for consumption in the place where meals are served during meal service. Section 208 requires the Secretary to promulgate regulations to establish science-based nutrition standards for all foods sold in schools. The nutrition standards apply to all food sold outside the school meal programs, on the school campus, and at any time during the school day.

Statement of Need: This rule codifies the two provisions of the Healthy, Hunger-Free Kids Act (Pub. L. 111-296; the Act) under 7 CFR parts 210 and 220. Section 203 requires schools participating in the National School Lunch Program to make available to children free of charge, as nutritionally appropriate, potable water for consumption in the place where meals are served during meal service. Section 208 requires the Secretary to promulgate proposed regulations to establish science-based nutrition standards for all foods sold in schools not later than December 13, 2011. The nutrition standards apply to all food sold outside the school meal programs, on the school campus, and at any time during the school day.

Summary of Legal Basis: There is no existing regulatory requirement to make water available where meals are served. Regulations at 7 CFR parts 210.11 direct State agencies and school food authorities to establish regulations necessary to control the sale of foods in competition with lunches served under the NSLP, and prohibit the sale of foods of minimal nutritional value in the food service areas during the lunch periods. The sale of other competitive foods may, at the discretion of the State agency and school food authority, be allowed in the food service area during the lunch period only if all income from the sale of such foods accrues to the benefit of the nonprofit school food service or the school or student organizations approved by the school. State agencies and school food authorities may impose additional restrictions on the sale of and income from all foods sold at any time throughout schools participating in the Program.

Alternatives: None.

Anticipated Cost and Benefits: Expected Costs Analysis and Budgetary Effects Statement: The Congressional Budget Office has determined that these provisions would incur no Federal costs.

Although the complexity of factors that influence overall food consumption and obesity prevent us from defining a level of dietary change or disease or cost reduction that is attributable to the rule, there is evidence that standards like those in the rule will positively influence and perhaps directly improve Start Printed Page 77729food choices and consumption patterns that contribute to students' long-term health and well-being, and reduce their risk for obesity.

Any rule-induced benefit of healthier eating by school children would be accompanied by costs, at least in the short term. Healthier food may be more expensive than unhealthy food either in raw materials, preparation, or both and this greater expense would be distributed among students, schools, and the food industry.

Risks: None known.

Timetable:

ActionDateFR Cite
NPRM02/08/1378 FR 9530
NPRM Comment Period End04/09/13
Interim Final Rule06/28/1378 FR 39067
Interim Final Rule Effective08/27/13
Interim Final Rule Comment Period End10/28/13
Final Action03/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Governmental Jurisdictions.

Government Levels Affected: Local, State.

Federalism: This action may have federalism implications as defined in E.O. 13132.

Agency Contact: James F. Herbert, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email: james.herbert@fns.usda.gov.

Lynnette M. Thomas, Chief, Planning and Regulatory Affairs Branch, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-4782, Email: lynnette.thomas@fns.usda.gov.

RIN: 0584-AE09

USDA—FNS

7. Child and Adult Care Food Program: Meal Pattern Revisions Related to the Healthy, Hunger-Free Kids Act of 2010

Priority: Other Significant.

Legal Authority: Pub. L. 111-296

CFR Citation: 7 CFR 210; 7 CFR 215; 7 CFR 220; 7 CFR 226.

Legal Deadline: None.

Abstract: This final rule will implement section 221 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296, the Act). It requires USDA to review and update, no less frequently than once every 10 years, requirements for meals served under the Child and Adult Care Food Program (CACFP) to ensure those meals are consistent with the most recent Dietary Guidelines for Americans and relevant nutrition science.

Statement of Need: Section 221 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296, the Act) requires USDA to review and update, no less frequently than once every 10 years, requirements for meals served under the Child and Adult Care Food Program (CACFP) to ensure those meals are consistent with the most recent Dietary Guidelines for Americans and relevant nutrition science. The Act also clarifies the purpose of the program, restricts the use of food as a punishment or reward, outlines requirements for milk and milk substitution, and introduces requirements for the availability of water. This rule establishes the criteria and procedures for implementing these provisions of the Act.

Summary of Legal Basis: Section 221 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296).

Alternatives: There are several instances throughout the proposed rule and its associated Regulatory Impact Analysis that offered alternatives for review and comment to the various criteria and procedures discussed.

Anticipated Cost and Benefits: This rule will improve the nutritional quality of meals served and the overall health of children participating in the CACFP. Most CACFP meals are served to children from low-income households. As described in the Regulatory Impact Analysis, the baseline is the current cost of food to CACFP providers. The rule more closely aligns the meals served in CACFP with the Dietary Guidelines in an essentially cost-neutral manner. USDA estimates that the rule will result in a very small decrease in the cost for CACFP providers to prepare and serve meals to program participants, and may result in a small, temporary increase in labor and administrative costs to implement the rule. Therefore, it is projected that no meaningful net change in cost will occur as a result of this rule.

Risks: None identified.

Timetable:

ActionDateFR Cite
NPRM01/15/1580 FR 2037
NPRM Comment Period End04/15/15
NPRM Comment Period Extended04/27/1580 FR 23243
NPRM Comment Period Extended End05/27/15
Final Action03/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Governmental Jurisdictions.

Government Levels Affected: Local, State.

Agency Contact: James F. Herbert, Regulatory Review Specialist, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 305-2572, Email: james.herbert@fns.usda.gov.

Lynnette M. Thomas, Chief, Planning and Regulatory Affairs Branch, Department of Agriculture, Food and Nutrition Service, 3101 Park Center Drive, Alexandria, VA 22302, Phone: 703 605-4782, Email: lynnette.thomas@fns.usda.gov.

RIN: 0584-AE18

USDA—FOOD SAFETY AND INSPECTION SERVICE (FSIS)

Final Rule Stage

8. Requirements for the Disposition of Non-Ambulatory Disabled Veal Calves

Priority: Other Significant.

Legal Authority: Federal Meat Inspection Act (21 U.S.C. 601 et seq.)

CFR Citation: 9 CFR 309.

Legal Deadline: None.

Abstract: Food Safety and Inspection Service (FSIS) is developing final regulations to amend the ante-mortem inspection regulations to remove a provision that permits establishments to set apart and hold for treatment veal calves that are unable to rise from a recumbent position and walk because they are tired or cold (9 CFR 309.13(b)). The regulations permit such calves to proceed to slaughter if they are able to rise and walk after being warmed or rested. FSIS proposed to require that non-ambulatory disabled (NAD) veal calves that are offered for slaughter be condemned and promptly euthanized. The existing regulations require that NAD mature cattle be condemned on ante-mortem inspection and that they be promptly euthanized (9 CFR 309.3(e)). FSIS believes that prohibiting the slaughter of all NAD veal calves would improve compliance with the Humane Methods of Slaughter Act of 1978 (HMSA), and the humane slaughter implementing regulations. It also would improve the Agency's inspection efficiency by eliminating the time that FSIS inspection program personnel Start Printed Page 77730(IPP) spend re-inspecting non-ambulatory disabled veal calves.

Statement of Need: Removing the provision from 9 CFR 309.13(b) would eliminate uncertainty as to what is to be done with veal calves that are non-ambulatory disabled because they are tired or cold, or because they are injured or sick, thereby ensuring the appropriate disposition of these animals. In addition, removing the provision in 9 CFR 309.13(b) would improve inspection efficiency by eliminating the time that FSIS IPP spend assessing the treatment of non-ambulatory disabled veal calves.

Summary of Legal Basis: 21 U.S.C. 603(a) and (b).

Alternatives: The Agency considered two alternatives to the proposed amendment: The status quo and prohibiting the slaughter of non-ambulatory disabled “bob veal,” which are calves generally less than one week old.

Anticipated Cost and Benefits: If the rule is adopted, non-ambulatory disabled veal calves will not be re-inspected during ante-mortem inspection. The veal calves that are condemned during ante-mortem inspection will be euthanized. The estimated annual cost to the veal industry would range between $2,368 and $161,405. The expected benefits of this proposed rule are not quantifiable. However, the rule would ensure the humane disposition of the non-ambulatory disabled veal calves. It also would increase the efficiency and effective implementation of inspection and humane handling requirements at official establishments.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM05/13/1580 FR 27269
NPRM Comment Period End08/12/15
Final Action03/00/16

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Dr. Daniel L. Engeljohn, Assistant Administrator, Office of Policy and Program Development, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW., 349-E JWB, Washington, DC 20250, Phone: 202 205-0495, Fax: 202 720-2025, Email: daniel.engeljohn@fsis.usda.gov.

RIN: 0583-AD54

USDA—FOREIGN AGRICULTURAL SERVICE (FAS)

Final Rule Stage

9. USDA Local and Regional Food Aid Procurement Program

Priority: Other Significant.

Legal Authority: Section 3207 of the Agriculture Act of 2014

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: FAS is issuing a final rule with comment for the USDA Local and Regional Food Aid Procurement Program (USDA LRP Program), authorized in section 3207 of the Agricultural Act of 2014. The USDA LRP Program funds may be used to support development activities that strengthen the capacity of food-insecure developing countries, and build resilience and address the causes of chronic food insecurity and support USDA's other food assistance programs, especially the McGovern Dole International Food for Education and Child Nutrition Program (McGovern-Dole). In addition, funds may be used to fill food availability gaps generated by unexpected emergencies. USDA LRP Program funding used to complement ongoing activities under the McGovern-Dole Program will improve dietary diversity and nutrition, and support the graduation and sustainability of school-feeding programs as they transition to full host-government ownership. LRP funding will enable FAS and its partners to build the capacity of host-governments to implement their own homegrown school feeding programs. A final rule is needed for FAS to begin implementing the program in FY 2016 and will establish awardee obligations regarding financial management and performance standards specifying applicable Departmental regulations and incorporating statutory requirements. The promulgation of a rule to administer the USDA LRP program will require the assignment of a new CFR number.

Statement of Need: It is necessary for Local and Regional Food Aid Procurement Program (LRP) regulations to be put in place before solicitations for application to the LRP program can be made for FY2016. The changes to Section 3207 in the 2014 Farm Bill require USDA to issue new regulations in order to enact the local and regional procurement provisions. The regulations will clarify: Program intent; application process; agreements process; payments; transport; recordkeeping and reporting; monitoring and evaluation; and noncompliance issues. The LRP regulations will be aligned with regulations for existing USDA food assistance programs, including Food for Progress Program and the McGovern-Dole International Food for Education and Child Nutrition Program.

Summary of Legal Basis: 7 U.S.C. 1726c and Sections 3207 of the Agricultural Act of 2014 (Pub. L. 113-79).

Alternatives: N/A.

Anticipated Cost and Benefits: It is anticipated that adopting a local and regional procurement program will bring about several benefits identified under the local and regional pilot project. Primarily, USDA LRP Program will result in cost savings in transport, shipping, and handling; better match between recipients needs and program commodity availability; and time savings between the procurement and delivery of food, which is especially important in emergency situations; and providing a means to strengthen or build local supply chains.

In addition, recipients under the LRP Pilot generally prefer locally and regionally sourced food over food sourced from other areas making it more suitable for food preparation and more accepted by school-aged children. This acceptability and availability would also impact the small scale producers who would experience an increase in demand and help them achieve economies of scale.

Risks: None.

Timetable:

ActionDateFR Cite
Final Rule With Comments02/00/16

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information: International Impacts: This regulatory action will be likely to have international trade and development effects, or otherwise be of international interest.

Agency Contact: Connie Ehrhart, Management Analyst, Department of Agriculture, Foreign Agricultural Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 690-1578, Email: connie.ehrhart@fas.usda.gov.

RIN: 0551-AA87

Start Printed Page 77731

USDA—RURAL BUSINESS—COOPERATIVE SERVICE (RBS)

Final Rule Stage

10. Program Measures and Metrics

Priority: Other Significant.

Legal Authority: Pub. L. 113-79, sec 6209

CFR Citation: 7 CFR 4284, subpart J; 7 CFR 4280, subparts A and D; 7 CFR 4284, subparts E and F; 7 CFR 4279, subparts A and B; 7 CFR 4287, subpart B; 7 CFR 4274, subpart D; 7 CFR 1942, subpart A; 7 CFR 3575, subpart A; 7 CFR 3570, subpart B.

Legal Deadline: None.

Abstract: The Agency is proposing to publish an Interim Rule with request for comments that will codify certain program measures and metrics for included Agency programs and establish the process by which the Agency will collect the data. Section 6209 of the Agricultural Act of 2014 (2014 Farm Bill) (Pub. L. 113-79) requires the Secretary of Agriculture to collect data regarding economic activities created through grants and loans, including any technical assistance provided as a component of the grant or loan program, and measure the short- and long-term viability of award recipients and any entities to whom those recipients provide assistance using award funds. The proposed action will not change the underlying provisions of the included programs (e.g., eligibility, applications, scoring, and servicing provisions).

Statement of Need: This interim rule implements section 6209, Program Measures and Metrics, under the Agricultural Act of 2014 (2014 Farm Bill). The proposed action will codify the measures and metrics identified in section 6209(c)(2)(B) through (D) for each included program and establish the process by which the Agency will collect the data. The proposed action will not change the underlying provisions of the included programs (e.g., eligibility, applications, scoring, and servicing provisions).

To implement section 6209, the Agency plans to publish a single rule that will modify each of the included programs accordingly. While the specific provisions may vary from program to program, the rule will, at minimum, specify for each program:

  • The performance measures required to be collected by the statute (i.e., percentage of increase of employees, number of business starts and clients served, and any benefits such as an increase in revenue or customer base) and other measures in addition to these as determined by the Agency,
  • Who is responsible for providing those metrics, and the time frame over which the metrics will be collected (this could vary depending on whether a grant or a loan/guaranteed loan is awarded).

Summary of Legal Basis:

Alternatives:

Anticipated Cost and Benefits:

Risks:

Timetable:

ActionDateFR Cite
Interim Final Rule05/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: MaryPat Dasal, Department of Agriculture, Rural Business-Cooperative Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 720-7853, Email: marypat.daskal@wdc.usda.gov.

RIN: 0570-AA95

USDA—RURAL UTILITIES SERVICE (RUS)

Final Rule Stage

11. Rural Broadband Access Loans and Loan Guarantees

Priority: Other Significant.

Legal Authority: Pub. L. 107-171; 7 U.S.C. 901 et seq.

CFR Citation: 7 CFR 1738.

Legal Deadline: None.

Abstract: The Rural Utilities Service (RUS) is amending regulations for the Rural Broadband Access Loan and Loan Guarantee program to implement section 6104 of the Agriculture Act of 2014 (2014 Farm Bill), which made changes the Agency must adopt prior to accepting applications for future loans. RUS published this regulation as an interim rule, which took effect upon publication in the Federal Register on July 30, 2015. The rulemaking will allow the Agency to begin accepting applications once again.

In addition, the Agency is seeking comments regarding this interim rule to guide its efforts in drafting the final rule for the Broadband Loan Program. The Comment Date ends September 28, 2015.

Statement of Need: The Rural Utilities Service (RUS) is amending regulations for the Rural Broadband Access Loan and Loan Guarantee program to implement section 6104 of the Agriculture Act of 2014 (2014 Farm Bill) which made changes the Agency must adopt prior to accepting applications for future loans. RUS published this regulation as an interim rule, which took effect upon publication in the Federal Register on July 30, 2015. The rulemaking will allow the Agency to begin accepting applications once again.

Summary of Legal Basis: On May 13, 2002, the Farm Security and Rural Investment Act of 2002, Public Law 107-171 (2002 Farm Bill) was signed into law. The 2002 Farm Bill amended the Rural Electrification Act of 1936 to include title VI, the Rural Broadband Access Loan and Loan Guarantee Program (Broadband Loan Program), to be administered by the Agency. Title VI authorized the Agency to approve loans and loan guarantees for the costs of construction, improvement, and acquisition of facilities and equipment for broadband service in eligible rural communities. Under the 2002 Farm Bill, the Agency was directed to promulgate regulations without public comment. Implementing the program required a different lending approach for the Agency than it employed in its earlier telephone program because of the unregulated, highly competitive, and technologically diverse nature of the broadband market. Those regulations were published on January 30, 2003, at 68 FR 4684.

In an attempt to enhance the Broadband Loan Program and to acknowledge growing criticism of funding competitive areas, the Agency proposed to amend the program's regulations on May 11, 2007, at 72 FR 26742. As the Agency began analysis of the public comments it received on the proposed regulations, the Food, Conservation, and Energy Act of 2008 (2008 Farm Bill) was working its way through Congress. On March 14, 2011, the Agency published an interim rule implementing the requirements of the 2008 Farm Bill and started accepting applications. The Agency did not receive any significant comments to the interim rule and published a final rule on February 6, 2013. With the enactment of the Agricultural Act of 2014 (2014 Farm Bill) section 6104, Public Law 113-79 (Feb. 7, 2014), additional requirements were added to the Broadband Loan Program, including the prioritization of approving applications, a minimum benchmark of broadband service, a more transparent public notice requirement, and the first statutorily required reporting standards, all of which are implemented in the rule.

Alternatives: N/A.

Anticipated Cost and Benefits: Bringing broadband services to rural areas does present some challenges. Start Printed Page 77732Because rural systems must contend with lower household density than urban systems, the cost to deploy fiber-to-the-home (FTTH) and 4G LTE systems in urban communities is considerably lower on a per household basis, making urban systems more economical to construct. Depending upon the technology deployed it can cost three times more, on average, to provide service to rural customers than to customers located in urban areas. Other associated rural issues, such as environmental challenges or providing wireless service through mountainous areas, also can add to the cost of deployment.

Areas with low population size, locations that have experienced persistent population loss and an aging population, or places where population is widely dispersed over demanding terrain generally have difficulty attracting broadband service providers. These characteristics can make the fixed cost of providing broadband access too high, or limit potential demand, thus depressing the profitability of providing service. Clusters of lower service exist in sparsely populated areas, such as the Dakotas, eastern Montana, northern Minnesota, and eastern Oregon. Other low-service areas, such as the Missouri-Iowa border and Appalachia, have aging and declining numbers of residents. Nonetheless, rural areas in some States (such as Nebraska, Kansas, and Vermont) have higher-than expected broadband service, given their population characteristics, suggesting that policy, economic, and social factors can overcome common barriers to broadband expansion.

Most employment growth in the U.S. over the last several decades has been in the service sector, a sector especially conducive for broadband applications. Broadband allows rural areas to compete for low- and high-end service jobs, from call centers to software development. Rural businesses have been adopting more e-commerce and Internet practices, improving efficiency and expanding market reach. Some rural retailers use the Internet to satisfy supplier requirements. The farm sector, a pioneer in rural Internet use, is increasingly comprised of farm businesses that purchase inputs and make sales online. Farm household characteristics such as age, education, presence of children, and household income are significant factors in adopting broadband Internet use, whereas distance from urban centers is not a factor. Larger farm businesses are more apt to use broadband in managing their operation; the more multifaceted the farm business, the more the farm used the Internet.

The 2015 subsidy rate is 18.69 percent. The available FY 2015 budget authority for this program is $4.5 million, which will provide a program level of $24.077 million in outlays at the current subsidy rate. Since the Interim Regulation for the Broadband Program was published in March of 2011, 27 applications have been received for an average of 7 loan applications per year. The applications range in size and may cover requests for funding for many communities. All of the pre-loan data collected by the applicant is generally submitted to RUS at the same time. The annual burden for preparation and submission per respondent for the pre-loan data is estimated to be 400 hours per response, response to the public notice filing requirement is 1.5 hours per response, and the preparation of loan documents is estimated at 24 hours per response.

The Agency estimates the cost to respondents will be at $108,325. The overall hours spent per application and cost to respondents did not change from the former regulation. The projected change in the overall cost to the government is minimal compared with the former projections, only $366. The burden of review breaks out into the following fashion: It is projected that there will be one more hour for the engineering analysis and financial analysis per application. The initial financial review and initial engineering review stay the same as it is under the previous regulation, as does the loan closing attorney and clerical assistance. Finally, it is estimated that the Loan Closing-Analyst time per application will increase by a half hour.

Risks: Without access to advanced telecommunications networks, rural areas suffer from declining educational opportunities, inadequate health care, depressed economies, and high unemployment. In contrast, access to broadband can play a vital role in offsetting the obstacles of distances and isolation that have traditionally stifled rural progress and living standards. With broadband infrastructure in place high volumes of data can be shared easily across distances great and small. This technology is not a luxury service but rather a lifeline to modern everyday transactions. Without this basic utility rural residents do not and will not have adequate medical or educational services; rural businesses unable to thrive; and local governments disorganized and unconnected. Broadband accessibility is as fundamental for the future viability of rural communities today as was the telephone in the 20th century, and as railroads and highways were more than a century ago.

Timetable:

ActionDateFR Cite
Interim Final Rule07/30/1580 FR 45397
Interim Final Rule Effective07/30/15
Interim Final Rule Comment Period End09/28/15
Final Rule07/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Michele L. Brooks, Director, Program Development and Regulatory Analysis, Department of Agriculture, Rural Utilities Service, Room 5159 South Building, STOP 1522, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 690-1078, Fax: 202 720-8435, Email: michele.brooks@wdc.usda.gov.

RIN: 0572-AC34

USDA—NATURAL RESOURCES CONSERVATION SERVICE (NRCS)

Final Rule Stage

12. Agricultural Conservation Easement Program

Priority: Other Significant.

Legal Authority: Pub. L. 113-79

CFR Citation: 7 CFR 1468.

Legal Deadline: Other, Statutory, November 4, 2014, 270 days from enactment of Pub. L. 113-79.

Abstract: The Agricultural Act of 2014 (the 2014 Act) consolidated the Wetlands Reserve Program (WRP), the Farm and Ranch Lands Protection Program (FRPP), and the Grassland Reserve Program (GRP) into a single Agricultural Conservation Easement Program (ACEP). The consolidated easement program has two components: An agricultural land easement component and a wetland reserve easement component. The agricultural land easement component is patterned after the former FRPP with GRP's land eligibility components merged into it. The wetland reserve easement component is patterned after WRP. Land previously enrolled in the three contributing programs is considered enrolled in the new ACEP.

Statement of Need: The Agricultural Act of 2014 (2014 Act) consolidated several of the Title XII (of the Food Security Act of 1985) conservation easement programs and provided for the continued operations of former Start Printed Page 77733programs. NRCS promulgated a consolidated conservation easement regulation to reflect the 2014 Act's consolidation of the WRP, FRPP, and GRP programs. This action is needed to respond to comments received.

Summary of Legal Basis: NRCS published an interim rule to implement the consolidated conservation easement program. This regulation action is pursuant to section 1246 of the Food Security Act of 1985, as amended by the 2014 Act, which requires regulations necessary to implement title II of the 2014 Act through an interim rule with request for comments.

Alternatives: NRCS determined that rulemaking was the appropriate mechanism through which to implement the 2014 Act consolidation of the three source conservation easement programs. Additionally, NRCS determined that the Agency needs standard criteria for implementing the program and program participants need predictability when initiating an application and conveying an easement. The regulation aims to establish a comprehensive framework for working with program participants to implement ACEP. Upon consideration of public comment, NRCS will promulgate final program regulations.

Anticipated Cost and Benefits: The 2014 Act has consolidated three conservation easement programs into a single conservation easement program with two components. The program will be implemented under the general supervision and direction of the Chief of NRCS, who is a Vice President of the Commodity Credit Corporation (CCC). Through ACEP, NRCS will continue to purchase wetland reserve easements directly and will contribute funds to eligible entities for their purchase of agricultural land easements that protect working farm and grazing lands. Participation in the program is voluntary.

The primary benefits associated with this rulemaking are the following:

  • Provides an opportunity for public comment in program regulations.
  • Provides a regulatory framework for NRCS to implement a consolidated conservation easement program.
  • Provides transparency to the public potential applicants on NRCS program requirements.

The primary costs imposed by this regulation are the following:

  • The costs incurred by private landowners are negative or zero, since this is a voluntary program, and they are compensated for the rights that they transfer.
  • Other costs incurred by society through market changes are localized or negligible.

Risks: N/A.

Timetable:

ActionDateFR Cite
Interim Final Rule02/27/1580 FR 11032
Interim Final Rule Comment Period End04/28/15
Interim Final Rule Comment Period Reopened04/30/1580 FR 24191
Interim Final Rule Comment Period Reopened End05/28/15
Final Rule04/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Leslie Deavers, Acting Farm Bill Coordinator, Department of Agriculture, Natural Resources Conservation Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 720-5484, Email: leslie.deavers@wdc.usda.gov.

RIN: 0578-AA61

USDA—NRCS

13. Environmental Quality Incentives Program (EQIP)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: 15 U.S.C. 714b and 714c; 16 U.S.C. 3839AA—3839-8

CFR Citation: 7 CFR 1466.

Legal Deadline: Other, Statutory, November 4, 2014, 270 days from enactment of Pub. L. 113-79.

Abstract: The Natural Resources Conservation Service (NRCS) promulgated the current Environmental Quality Incentives Program (EQIP) regulation on January 15, 2009, through an interim rule. The interim rule incorporated programmatic changes authorized by the Food, Conservation, and Energy Act of 2008 (the 2008 Act). NRCS published a correction to the interim rule on March 12, 2009, and an amendment to the interim rule on May 29, 2009. NRCS has implemented EQIP in FY 2009 through FY 2013 under the current regulation. The Agricultural Act of 2014 (2014 Act) amended chapter 4 of subtitle D of title XII of the Food Security Act of 1985 by making the following changes to EQIP program requirements: (1) Eliminates requirement that contract must remain in place for a minimum of one year after last practice implemented, but keeps requirement that the contract term is not to exceed 10 years; (2) consolidates elements of Wildlife Habitat Incentives Program (WHIP) and repeals WHIP authority; (3) replaces rolling six-year payment limitation with payment limitation for FY 2014-FY 2018; (4) requires Conservation Innovation Grants (CIG) reporting no later than December 31, 2014, and every two years thereafter; (4) establishes payment limitation at $450,000 and eliminates waiver authority; (5) modifies the special rule for foregone income payments for certain associated management practices and resource concern priorities; (6) makes advance payments available up to 50 percent for eligible historically underserved participants to purchase material or contract services instead of the previous 30 percent; (7) provides flexibility for repayment of advance payment if not expended within 90 days; and (8) requires that for each fiscal year from of the FY 2014 to FY 2018, at least 5 percent of available EQIP funds shall be targeted for wildlife-related conservation practices. The 2014 Act further identifies EQIP as a contributing program authorized to accomplish the purposes of the Regional Conservation Partnership Program (RCPP) (subtitle I of title XII of the Food Security Act of 1985, as amended). RCPP replaces the Agricultural Water Enhancement Program (AWEP), Chesapeake Bay Watershed Program (CBWP), Cooperative Conservation Partnership Initiative (CCPI), and the Great Lakes Basin Program for soil erosion and sediment control. Like the programs it replaces, RCPP will operate through regulations in place for contributing programs. The other contributing programs include the Conservation Stewardship Program, the Healthy Forests Reserve Program, and the new Agricultural Conservation Easement Program (ACEP). NRCS published an interim rule to incorporate the 2014 Act changes to EQIP program administration. This regulation action is pursuant to section 1246 of the Food Security Act of 1985, as amended by section 2608 of the 2014 Act, which requires regulations necessary to implement title II of the 2014 Act be promulgated through the interim rule process.

Statement of Need: The Agricultural Act of 2014 (the 2014 Act) consolidated several of the title XII conservation programs and provided for the continued operations of former programs. NRCS updated the EQIP regulation to incorporate the 2014 Act changes, including consolidation of the Start Printed Page 77734purposes formerly addressed through the Wildlife Habitat Incentives Program (WHIP). This action is needed to respond to comments received.

Summary of Legal Basis: The 2014 Act has reauthorized and amended the Environmental Quality Incentives Program (EQIP). EQIP was first added to the Food Security Act of 1985 (1985 Act) (16 U.S.C. 3801 et seq.) by the Federal Agriculture Improvement and Reform Act of 1996 (1996 Act) (16 U.S.C. 3839aa). The program is implemented under the general supervision and direction of the Chief of NRCS, who is a Vice President of the Commodity Credit Corporation (CCC).

Alternatives: NRCS considered only making the changes mandated by the 2014 Farm Bill. This alternative would have missed opportunities to improve the implementation of the program.

Anticipated Cost and Benefits: Through EQIP, NRCS provides assistance to farmers and ranchers to conserve and enhance soil, water, air, and related natural resources on their land. Eligible lands include cropland, grassland, rangeland, pasture, wetlands, nonindustrial private forest land, and other agricultural land on which agricultural or forest-related products, or livestock are produced and natural resource concerns may be addressed. Participation in the program is voluntary.

The primary benefits associated with this rulemaking are the folowing:

  • Provides continued consistency for the NRCS to implement EQIP.
  • Provides transparency to potential applicants on NRCS program requirements.

The primary costs imposed by this regulation are the following:

  • All program participants must follow the same requirements, even though they are very different types of agricultural operations in different resource contexts.
  • Most program participants are required to contribute at least 25 percent of the resources needed to implement program practices. However, such costs are standard for such financial assistance programs.

Risks: N/A.

Timetable:

ActionDateFR Cite
Interim Final Rule12/12/1479 FR 73953
Interim Final Rule Effective12/12/14
Interim Final Rule Comment Period End02/10/15
Final Rule03/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Leslie Deavers, Acting Farm Bill Coordinator, Department of Agriculture, Natural Resources Conservation Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 720-5484, Email: leslie.deavers@wdc.usda.gov.

RIN: 0578-AA62

USDA—NRCS

14. Conservation Stewardship Program

Priority: Other Significant.

Legal Authority: 16 U.S.C. 3838d to 3838g

CFR Citation: 7 CFR 1470.

Legal Deadline: None.

Abstract: NRCS published an interim rule to incorporate the Agriculture Act of 2014 (the 2014 Act) changes to Conservation Stewardship Program (CSP) program administration. This regulatory action is pursuant to section 1246 of the Food Security Act of 1985 (1985 Act), as amended by the 2014 Act, which requires regulations necessary to implement title II of the 2014 Act through an interim rule with request for comments.

Background: The Food, Conservation, and Energy Act of 2008 Act (2008 Act) amended the 1985 Act to establish CSP and authorized the program in fiscal years 2009 through 2013. The 2014 Act re-authorized and revised CSP. The purpose of CSP is to encourage producers to address priority resource concerns and improve and conserve the quality and condition of the natural resources in a comprehensive manner by (1) undertaking additional conservation activities, and (2) improving, maintaining, and managing existing conservation activities. The Secretary of Agriculture delegated authority to the Chief, Natural Resources Conservation Service (NRCS), to administer CSP. Through CSP, NRCS provides financial and technical assistance to eligible producers to conserve and enhance soil, water, air, and related natural resources on their land. Eligible lands include private or tribal cropland, grassland, pastureland, rangeland, non-industrial private forest lands, and other land in agricultural areas (including cropped woodland, marshes, and agricultural land capable of being used for the production of livestock) on which resource concerns related to agricultural production could be addressed. Participation in the program is voluntary. CSP encourages land stewards to improve their conservation performance by installing and adopting additional activities, and improving, maintaining, and managing existing activities on eligible land. NRCS makes funding for CSP available nationwide on a continuous application basis.

Statement of Need: The Agricultural Act of 2014 (the 2014 Act) amended several of the title XII conservation programs and provided for the continued operations of former programs. NRCS updated the CSP regulation to incorporate the 2014 Act changes. This action is responds to comments received.

Summary of Legal Basis: The 2014 Act has reauthorized and amended the Conservation Stewardship Program (CSP). CSP was first added to the Food Security Act of 1985 (1985 Act) (16 U.S.C. 3801 et seq.) by the Food, Conservation, and Energy Act of 2008. The program is implemented under the general supervision and direction of the Chief of NRCS, who is a Vice President of the Commodity Credit Corporation (CCC).

Alternatives: NRCS considered only making the changes mandated by the 2014 Farm Bill. This alternative would have missed opportunities to improve the implementation of the program. NRCS would consider alternatives suggested during the public comment period.

Anticipated Cost and Benefits: CSP is a voluntary program that encourages agricultural and forestry producers to address priority resource concerns by (1) undertaking additional conservation activities and (2) improving and maintaining existing conservation systems. CSP provides financial and technical assistance to help land stewards conserve and enhance soil, water, air, and related natural resources on their land.

CSP is available to all producers, regardless of operation size or crops produced, in all 50 States, the District of Columbia, and the Caribbean and Pacific Island areas. Eligible lands include cropland, grassland, prairie land, improved pastureland, rangeland, nonindustrial private forest land, and agricultural land under the jurisdiction of an Indian tribe. Applicants may include individuals, legal entities, joint operations, or Indian tribes.

CSP pays participants for conservation performance, the higher the performance, the higher the payment. It provides two possible types of payments. An annual payment is available for installing new conservation activities and maintaining existing Start Printed Page 77735practices. A supplemental payment is available to participants who also adopt a resource conserving crop rotation.

Through five-year contracts, NRCS makes payments as soon as practical after October 1 of each fiscal year for contract activities installed and maintained in the previous year. A person or legal entity may have more than one CSP contract but, for all CSP contracts combined, may not receive more than $40,000 in any year or more than $200,000 during any five-year period.

The primary benefits associated with this rulemaking are the following:

  • Provides continued consistency for the NRCS to implement CSP.
  • Provides transparency to potential applicants on NRCS program requirements.

The primary costs imposed by this regulation are that all program participants must follow the same basic programmatic requirements, even though they are very different types of agricultural operations in different resource contexts.

The 2014 Act further identifies CSP as a contributing program authorized to accomplish the purposes of the Regional Conservation Partnership Program (RCPP) (subtitle I of title XII of the Food Security Act of 1985, as amended). RCPP replaces the Agricultural Water Enhancement Program (AWEP), Chesapeake Bay Watershed Program (CBWP), Cooperative Conservation Partnership Initiative (CCPI), and the Great Lakes Basin Program for soil erosion and sediment control. Like the programs it replaces, RCPP will operate through regulations in place for contributing programs. The other contributing programs include the Environmental Quality Incentives Program, the Healthy Forests Reserve Program, and the new Agricultural Conservation Easement Program (ACEP).

Risks:

Timetable:

ActionDateFR Cite
Interim Final Rule11/05/1479 FR 65835
Interim Final Rule Effective11/05/14
Interim Final Rule Comment Period End01/05/15
Final Rule03/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Leslie Deavers, Acting Farm Bill Coordinator, Department of Agriculture, Natural Resources Conservation Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 720-5484, Email: leslie.deavers@wdc.usda.gov.

RIN: 0578-AA63

DEPARTMENT OF COMMERCE (DOC)

Statement of Regulatory and Deregulatory Priorities

Established in 1903, the Department of Commerce (Commerce) is one of the oldest Cabinet-level agencies in the Federal Government. Commerce's mission is to create the conditions for economic growth and opportunity by promoting innovation, entrepreneurship, competitiveness, and environmental stewardship. Commerce has 12 operating units, which are responsible for managing a diverse portfolio of programs and services, ranging from trade promotion and economic development assistance to broadband and the National Weather Service.

Commerce touches Americans daily, in many ways—making possible the daily weather reports and survey research; facilitating technology that all of us use in the workplace and in the home each day; supporting the development, gathering, and transmission of information essential to competitive business; enabling the diversity of companies and goods found in America's and the world's marketplace; and supporting environmental and economic health for the communities in which Americans live.

Commerce has a clear and compelling vision for itself, for its role in the Federal Government, and for its roles supporting the American people, now and in the future. To achieve this vision, Commerce works in partnership with businesses, universities, communities, and workers to:

  • Innovate by creating new ideas through cutting-edge science and technology from advances in nanotechnology, to ocean exploration, to broadband deployment, and by protecting American innovations through the patent and trademark system;
  • Support entrepreneurship and commercialization by enabling community development and strengthening minority businesses and small manufacturers;
  • Maintain U.S. economic competitiveness in the global marketplace by promoting exports, ensuring a level playing field for U.S. businesses, and ensuring that technology transfer is consistent with our nation's economic and security interests;
  • Provide effective management and stewardship of our nation's resources and assets to ensure sustainable economic opportunities; and
  • Make informed policy decisions and enable better understanding of the economy by providing accurate economic and demographic data.

Commerce is a vital resource base, a tireless advocate, and Cabinet-level voice for job creation.

The Regulatory Plan tracks the most important regulations that implement these policy and program priorities, several of which involve regulation of the private sector by Commerce.

Responding to the Administration's Regulatory Philosophy and Principles

The vast majority of the Commerce's programs and activities do not involve regulation. Of Commerce's 12 primary operating units, only the National Oceanic and Atmospheric Administration (NOAA) will be planning actions that are considered the “most important” significant preregulatory or regulatory actions for FY 2016. During the next year, NOAA plans to publish eight rulemaking actions that are designated as Regulatory Plan actions. The Bureau of Industry and Security (BIS) may also publish rulemaking actions designated as Regulatory Plan actions. Further information on these actions is provided below.

Commerce has a long-standing policy to prohibit the issuance of any regulation that discriminates on the basis of race, religion, gender, or any other suspect category and requires that all regulations be written so as to be understandable to those affected by them. The Secretary also requires that Commerce afford the public the maximum possible opportunity to participate in Departmental rulemakings, even where public participation is not required by law.

National Oceanic and Atmospheric Administration

NOAA establishes and administers Federal policy for the conservation and management of the Nation's oceanic, coastal, and atmospheric resources. It provides a variety of essential environmental and climate services vital to public safety and to the Nation's economy, such as weather forecasts, drought forecasts, and storm warnings. It is a source of objective information on the state of the environment. NOAA Start Printed Page 77736plays the lead role in achieving Commerce's goal of promoting stewardship by providing assessments of the global environment.

Recognizing that economic growth must go hand-in-hand with environmental stewardship, Commerce, through NOAA, conducts programs designed to provide a better understanding of the connections between environmental health, economics, and national security. Commerce's emphasis on “sustainable fisheries” is designed to boost long-term economic growth in a vital sector of the U.S. economy while conserving the resources in the public trust and minimizing any economic dislocation necessary to ensure long-term economic growth. Commerce is where business and environmental interests intersect, and the classic debate on the use of natural resources is transformed into a “win-win” situation for the environment and the economy.

Three of NOAA's major components, the National Marine Fisheries Services (NMFS), the National Ocean Service (NOS), and the National Environmental Satellite, Data, and Information Service (NESDIS), exercise regulatory authority.

NMFS oversees the management and conservation of the Nation's marine fisheries, protects threatened and endangered marine and anadromous species and marine mammals, and promotes economic development of the U.S. fishing industry. NOS assists the coastal States in their management of land and ocean resources in their coastal zones, including estuarine research reserves; manages the national marine sanctuaries; monitors marine pollution; and directs the national program for deep-seabed minerals and ocean thermal energy. NESDIS administers the civilian weather satellite program and licenses private organizations to operate commercial land-remote sensing satellite systems.

Commerce, through NOAA, has a unique role in promoting stewardship of the global environment through effective management of the Nation's marine and coastal resources and in monitoring and predicting changes in the Earth's environment, thus linking trade, development, and technology with environmental issues. NOAA has the primary Federal responsibility for providing sound scientific observations, assessments, and forecasts of environmental phenomena on which resource management, adaptation, and other societal decisions can be made.

In the environmental stewardship area, NOAA's goals include: Rebuilding and maintaining strong U.S. fisheries by using market-based tools and ecosystem approaches to management; increasing the populations of depleted, threatened, or endangered species and marine mammals by implementing recovery plans that provide for their recovery while still allowing for economic and recreational opportunities; promoting healthy coastal ecosystems by ensuring that economic development is managed in ways that maintain biodiversity and long-term productivity for sustained use; and modernizing navigation and positioning services. In the environmental assessment and prediction area, goals include: Understanding climate change science and impacts, and communicating that understanding to government and private sector stakeholders enabling them to adapt; continually improving the National Weather Service; implementing reliable seasonal and interannual climate forecasts to guide economic planning; providing science-based policy advice on options to deal with very long-term (decadal to centennial) changes in the environment; and advancing and improving short-term warning and forecast services for the entire environment.

Magnuson-Stevens Fishery Conservation and Management Act

Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) rulemakings concern the conservation and management of fishery resources in the U.S. Exclusive Economic Zone (generally 3-200 nautical miles). Among the several hundred rulemakings that NOAA plans to issue in FY 2016, a number of the preregulatory and regulatory actions will be significant. The exact number of such rulemakings is unknown, since they are usually initiated by the actions of eight regional Fishery Management Councils (FMCs) that are responsible for preparing fishery management plans (FMPs) and FMP amendments, and for drafting implementing regulations for each managed fishery. NOAA issues regulations to implement FMPs and FMP amendments. Once a rulemaking is triggered by an FMC, the Magnuson-Stevens Act places stringent deadlines upon NOAA by which it must exercise its rulemaking responsibilities. FMPs and FMP amendments for Atlantic highly migratory species, such as bluefin tuna, swordfish, and sharks, are developed directly by NOAA, not by FMCs.

FMPs address a variety of issues including maximizing fishing opportunities on healthy stocks, rebuilding overfished stocks, and addressing gear conflicts. One of the problems that FMPs may address is preventing overcapitalization (preventing excess fishing capacity) of fisheries. This may be resolved by market-based systems such as catch shares, which permit shareholders to harvest a quantity of fish and which can be traded on the open market. Harvest limits based on the best available scientific information, whether as a total fishing limit for a species in a fishery or as a share assigned to each vessel participant, enable stressed stocks to rebuild. Other measures include staggering fishing seasons or limiting gear types to avoid gear conflicts on the fishing grounds and establishing seasonal and area closures to protect fishery stocks.

The FMCs provide a forum for public debate and, using the best scientific information available, make the judgments needed to determine optimum yield on a fishery-by-fishery basis. Optional management measures are examined and selected in accordance with the national standards set forth in the Magnuson-Stevens Act. This process, including the selection of the preferred management measures, constitutes the development, in simplified form, of an FMP. The FMP, together with draft implementing regulations and supporting documentation, is submitted to NMFS for review against the national standards set forth in the Magnuson-Stevens Act, in other provisions of the Act, and other applicable laws. The same process applies to amending an existing approved FMP.

Marine Mammal Protection Act

The Marine Mammal Protection Act of 1972 (MMPA) provides the authority for the conservation and management of marine mammals under U.S. jurisdiction. It expressly prohibits, with certain exceptions, the take of marine mammals. The MMPA allows NMFS to permit the collection of wild animals for scientific research or public display or to enhance the survival of a species or stock. NMFS initiates rulemakings under the MMPA to establish a management regime to reduce marine mammal mortalities and injuries as a result of interactions with fisheries. The MMPA also established the Marine Mammal Commission, which makes recommendations to the Secretaries of the Departments of Commerce and the Interior and other Federal officials on protecting and conserving marine mammals. The Act underwent significant changes in 1994 to allow for takings incidental to commercial fishing operations, to provide certain exemptions for subsistence and Start Printed Page 77737scientific uses, and to require the preparation of stock assessments for all marine mammal stocks in waters under U.S. jurisdiction.

Endangered Species Act

The Endangered Species Act of 1973 (ESA) provides for the conservation of species that are determined to be “endangered” or “threatened,” and the conservation of the ecosystems on which these species depend. The ESA authorizes both NMFS and the Fish and Wildlife Service (FWS) to jointly administer the provisions of the MMPA. NMFS manages marine and “anadromous” species, and FWS manages land and freshwater species. Together, NMFS and FWS work to protect critically imperiled species from extinction. Of the approximately 1,300 listed species found in part or entirely in the United States and its waters, NMFS has jurisdiction over approximately 60 species. NMFS' rulemaking actions are focused on determining whether any species under its responsibility is an endangered or threatened species and whether those species must be added to the list of protected species. NMFS is also responsible for designating, reviewing, and revising critical habitat for any listed species. In addition, under the ESA's procedural framework, Federal agencies consult with NMFS on any proposed action authorized, funded, or carried out by that agency that may affect one of the listed species or designated critical habitat, or is likely to jeopardize proposed species or adversely modify proposed critical habitat that is under NMFS' jurisdiction.

NOAA's Regulatory Plan Actions

While most of the rulemakings undertaken by NOAA do not rise to the level necessary to be included in Commerce's regulatory plan, NMFS is undertaking eight actions that rise to the level of “most important” of Commerce's significant regulatory actions and thus are included in this year's regulatory plan. A description of the eight regulatory plan actions is provided below.

1. Revisions to the General section and Standards 1, 3, and 7 of the National Standard Guidelines (0648-BB92): This action would propose revisions to the National Standard 1 (NS1) guidelines. National Standard 1 of the Magnuson-Stevens Fishery Conservation and Management Act states that “conservation and management measures shall prevent overfishing while achieving, on a continuing basis, the optimum yield from each fishery for the United States fishing industry.” The National Marine Fisheries Service (NMFS) last revised the NS1 Guidelines in 2009 to reflect the requirements enacted by the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act of 2006 for annual catch limits and accountability measures to end and prevent overfishing. Since 2007, NMFS and the Regional Fishery Management Councils have been implementing the new annual catch limit and accountability measures requirements. Based on experience gained from implementing annual catch limits and accountability measures, NMFS has developed new perspectives and identified issues regarding the application of the NS1 guidelines that may warrant them to be revised to more fully meet the intended goal of preventing overfishing while achieving, on a continuing basis, the optimum yield from each fishery. The focus of this action is to improve the NS1 guidelines.

2. Designation of Critical Habitat for North Atlantic Right Whale (0648-AY54): The National Marine Fisheries Service proposes to revise critical habitat for the North Atlantic right whale. This proposal would modify the critical habitat previously designated in 1994, based on improved knowledge derived from a variety of studies, internal analysis and surveys since 1994. The improved understanding of right whale ecology and habitat needs over the last 20 years supports the rule's proposed expansion of critical habitat in areas of the northeast important for feeding and in southern calving grounds along the coast from southern North Carolina to northern Florida.

3. Fishery Management Plan for Regulating Offshore Marine Aquaculture in the Gulf of Mexico (0648-AS65): The purpose of this fishery management plan is to develop a regional permitting process for regulating and promoting environmentally sound and economically sustainable aquaculture in the Gulf of Mexico exclusive economic zone. This fishery management plan consists of ten actions, each with an associated range of management alternatives, which would facilitate the permitting of an estimated 5 to 20 offshore aquaculture operations in the Gulf of Mexico over the next 10 years, with an estimated annual production of up to 64 million pounds. By establishing a regional permitting process for aquaculture, the Gulf of Mexico Fishery Management Council will be positioned to achieve their primary goal of increasing maximum sustainable yield and optimum yield of federal fisheries in the Gulf of Mexico by supplementing harvest of wild caught species with cultured product. This rulemaking would outline a regulatory permitting process for aquaculture in the Gulf of Mexico, including: (1) Required permits; (2) duration of permits; (3) species allowed; (4) designation of sites for aquaculture; (5) reporting requirements; and (6) regulations to aid in enforcement.

4. Requirements for Importation of Fish and Fish Products under the U.S. Marine Mammal Protection Act (0648-AY15): With this action, the National Marine Fisheries Service is developing procedures to implement the provisions of section 101(a)(2) of the Marine Mammal Protection Act for imports of fish and fish products. Those provisions require the Secretary of Treasury to ban imports of fish and fish products from fisheries with bycatch of marine mammals in excess of U.S. standards. The provisions further require the Secretary of Commerce to insist on reasonable proof from exporting nations of the effects on marine mammals of bycatch incidental to fisheries that harvest the fish and fish products to be imported.

5. Revision to the Definition of Destruction or Adverse Modification of Critical Habitat (0648-BB80): The U.S. Fish and Wildlife Service's and the National Marine Fisheries Service's revision of the regulatory definition of “destruction or adverse modification” of critical habitat will establish a binding regulatory definition to replace the 1986 definition that was invalidated by Federal courts.

6. Implementing Changes to the Regulations for Designating Critical Habitat (0648-BB79): The U.S. Fish and Wildlife Service's and the National Marine Fisheries Service's rule will amend portions of 50 CFR 424 to clarify procedures for designating and revising critical habitat. The rule makes minor changes to the scope and purpose, alters some definitions, and clarifies the criteria for designating critical habitat.

7. Final Policy Regarding Implementation of Section 4(b)(2) of the Endangered Species Act (0648-BB82): This policy provides the U.S. Fish and Wildlife Service's and the National Marine Fisheries Service's position on how we consider partnerships and conservation plans, conservation plans permitted under section 10 of the ESA, tribal lands, military lands, Federal lands, national security and homeland security impacts, and economic impacts in the exclusion process. The policy will complement the amendment to the regulations regarding impact analyses of critical habitat designations and clarify Start Printed Page 77738critical habitat exclusions under section 4(b)(2) of the ESA and provide for a credible and predictable critical habitat exclusion process.

8. Magnuson-Stevens Fishery Conservation and Management Act; Seafood Import Monitoring Program (0648-BF09): The Magnuson-Stevens Fishery Conservation and Management Act prohibits the importation and trade in interstate commerce of fishery products from fish caught in in violation of any foreign law or regulation.

Bureau of Industry and Security

The Bureau of Industry and Security (BIS) advances U.S. national security, foreign policy, and economic objectives by maintaining and strengthening adaptable, efficient, and effective export control and treaty compliance systems as well as by administering programs to prioritize certain contracts to promote the national defense and to protect and enhance the defense industrial base.

Major Programs and Activities

BIS administers four sets of regulations. The Export Administration Regulations (EAR) regulate exports and reexports to protect national security, foreign policy, and short supply interests. The EAR also regulates U.S. persons' participation in certain boycotts administered by foreign governments. The National Security Industrial Base Regulations provide for prioritization of certain contracts and allocations of resources to promote the national defense, require reporting of foreign Government-imposed offsets in defense sales, provide for surveys to assess the capabilities of the industrial base to support the national defense and address the effect of imports on the defense industrial base. The Chemical Weapons Convention Regulations implement declaration, reporting, and on-site inspection requirements in the private sector necessary to meet United States treaty obligations under the Chemical Weapons Convention treaty. The Additional Protocol Regulations implement similar requirements with respect to an agreement between the United States and the International Atomic Energy Agency.

BIS also has an enforcement component with nine offices covering the United States. BIS export control officers are also stationed at several U.S. embassies and consulates abroad. BIS works with other U.S. Government agencies to promote coordinated U.S. Government efforts in export controls and other programs. BIS participates in U.S. Government efforts to strengthen multilateral export control regimes and to promote effective export controls through cooperation with other Governments.

BIS' Regulatory Plan Actions

In August 2009, the President directed a broad-based interagency review of the U.S. export control system with the goal of strengthening national security and the competitiveness of key U.S. manufacturing and technology sectors by focusing on the current threats and adapting to the changing economic and technological landscape. In August 2010, the President outlined an approach, known as the Export Control Reform Initiative (ECRI), under which agencies that administer export controls will apply new criteria for determining what items need to be controlled and a common set of policies for determining when an export license is required. The control list criteria are to be based on transparent rules, which will reduce the uncertainty faced by our Allies, U.S. industry and its foreign customers, and will allow the Government to erect higher walls around the most sensitive export items in order to enhance national security.

Under the President's approach, agencies are to apply the criteria and revise the lists of munitions and dual-use items that are controlled for export so that they:

  • Distinguish the transactions that should be subject to stricter levels of control from those where more permissive levels of control are appropriate;
  • Create a “bright line” between the two current control lists to clarify jurisdictional determinations and reduce Government and industry uncertainty about whether particular items are subject to the control of the State Department or the Commerce Department; and
  • Are structurally aligned so that they potentially can be combined into a single list of controlled items.

BIS' current regulatory plan action is designed to implement the initial phase of the President's directive, which will add to BIS' export control purview, military related items that the President determines no longer warrant control under rules administered by the State Department.

As the agency responsible for leading the administration and enforcement of U.S. export controls on dual-use and other items warranting controls but not under the provisions of export control regulations administered by other departments, BIS plays a central role in the Administration's efforts to reform the export control system. Changing what we control, how we control it and how we enforce and manage our controls will help strengthen our national security by focusing our efforts on controlling the most critical products and technologies, and by enhancing the competitiveness of key U.S. manufacturing and technology sectors.

In FY 2011, BIS began implementing the ECRI with a final rule (76 FR 35275, June 16, 2011) implementing a license exception that authorizes exports, reexports and transfers to destinations that do not pose a national security concern, provided certain safeguards against diversion to other destinations are taken. Additionally, BIS began publishing proposed rules to add to its Commerce Control List (CCL), military items the President determined no longer warranted control by the Department of State. BIS continued to publish such proposed rules in FY 2012.

In FY 2013, BIS crossed an important milestone with publication of two final rules that began to put ECRI policies into place. An Initial Implementation rule (78 FR 22660, April 16, 2013) set in place the structure under which items the President determines no longer warrant control on the United States Munitions List are controlled on the Commerce Control List. It also revised license exceptions and regulatory definitions, including the definition of “specially designed” to make those exceptions and definitions clearer and to more closely align them with the International Traffic in Arms Regulations, and added to the CCL certain military aircraft, gas turbine engines and related items. A second final rule (78 FR 40892, July 8, 2012) followed on by adding to the CCL military vehicles, vessels of war submersible vessels, and auxiliary military equipment that President determined no longer warrant control on the USML.

BIS continued its ECRI efforts and by the end of fiscal year 2015 had published final rules adding to the CCL additional items that the President determined no longer warrant control under rules administered by the State Department in the following categories: Military training equipment; Explosives and energetic materials; Personal protective equipment; Launch vehicles and rockets; Spacecraft; and Military Electronics. During fiscal year 2015, BIS published proposed rules that would add to the CCL items related to: Fire control, range finder, optical and guidance and control equipment; Toxicological Agents; and Directed energy weapons. BIS expects to continue with publication of proposed and final rules to add items to the CCL as part it the ECRI in fiscal year 2016.Start Printed Page 77739

During fiscal year 2015, BIS initiated a process of evaluating the effectiveness of its ECRI efforts. The first action in this process was publication of a notice seeking public comments on the treatment of military aircraft and gas turbine engines, the first two categories of items added to the CCL by this initiative. The notice sought public input on whether the regulations are clear, do not inadvertently control items in normal commercial use as military items, account for technological developments, and properly implement the national security and foreign policy objectives of the reform effort. BIS anticipates that this will be the first in a series of such notices that will be published after the public has had time to develop experience with each regulation that added categories of items to the CCL.

Promoting International Regulatory Cooperation

As the President noted in Executive Order 13609, “international regulatory cooperation, consistent with domestic law and prerogatives and U.S. trade policy, can be an important means of promoting” public health, welfare, safety, and our environment as well as economic growth, innovation, competitiveness, and job creation. Accordingly, in E.O. 13609, the President requires each executive agency to include in its Regulatory Plan a summary of its international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations.

The Department of Commerce engages with numerous international bodies in various forums to promote the Department's priorities and foster regulations that do not “impair the ability of American business to export and compete internationally.” E.O. 13609(a). For example, the United States Patent and Trademark Office is working with the European Patent Office to develop a new classification system for both offices' use. The Bureau of Industry and Security, along with the Department of State and Department of Defense, engages with other countries in the Wassenaar Arrangement, through which the international community develops a common list of items that should be subject to export controls because they are conventional arms or items that have both military and civil uses. Other multilateral export control regimes include the Missile Technology Control Regime, the Nuclear Suppliers Group, and the Australia Group, which lists items controlled for chemical and biological weapon nonproliferation purposes. In addition, the National Oceanic and Atmospheric Administration works with other countries' regulatory bodies through regional fishery management organizations to develop fair and internationally-agreed-to fishery standards for the High Seas.

BIS is also engaged, in partnership with the Departments of State and Defense, in revising the regulatory framework for export control, through the President's Export Control Reform Initiative (ECRI). Through this effort, the United States Government is moving certain items currently controlled by the United States Military List (USML) to the Commerce Control List (CCL) in BIS' Export Administration Regulations. The objective of ECRI is to improve interoperability of U.S. military forces with those of allied countries, strengthen the U.S. industrial base by, among other things, reducing incentives for foreign manufacturers to design out and avoid U.S.-origin content and services, and allow export control officials to focus Government resources on transactions that pose greater concern. Once fully implemented, the new export control framework also will benefit companies in the United States seeking to export items through more flexible and less burdensome export controls.

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), the Department has identified several rulemakings as being associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. Accordingly, the Agency is reviewing these rules to determine whether action under E.O. 13563 is appropriate. Some of these entries on this list may be completed actions, which do not appear in the Regulatory Plan. However, more information can be found about these completed rulemakings in past publications of the Unified Agenda on Reginfo.gov in the Completed Actions section for the Agency. These rulemakings can also be found on Regulations.gov.

Two rulemakings that are the product of the Agency's retrospective review are from BIS and NOAA. BIS' rule streamlining the support documentation requirements in the Export Administration Regulations, published March 13, 2015, was the first comprehensive revision of these requirements in twenty years. The rule reduced the paperwork burden on U.S. exporters without compromising regulatory objectives and clarified the remaining requirements to aid compliance.

NOAA continues to demonstrate great success in fishery sustainability managed under the Magnuson-Stevens Act, with near-record landings and revenue accomplished while rebuilding stocks across the country and preventing overfishing. Since the Magnuson-Stevens Act reauthorization in 2007, NMFS and the Regional Fishery Management Councils have implemented annual catch limits and accountability measures in every fishery management plan under National Standard One of the act. Informed by a robust public process that gained input through a public summit (Managing our Nation's Fisheries), visits to each region and Council and multiple public hearings, NMFS took the experience gained from 8 years of implementation of National Standard One and has proposed multiple substantive, technical changes to the National Standard One rule that will improve implementation and continue to support healthy fisheries.

For more information, the most recent E.O. 13563 progress report for the Department can be found here: http://open.commerce.gov/​news/​2015/​03/​20/​commerce-plan-retrospective-analysis-existing-rules-0.

DEPARTMENT OF DEFENSE

Statement of Regulatory Priorities

Background

The Department of Defense (DoD) is the largest Federal department consisting of three Military departments (Army, Navy, and Air Force), nine Unified Combatant Commands, 17 Defense Agencies, and ten DoD Field Activities. It has 1,304,807 military personnel and 866,923 civilians assigned as of June 30, 2015, and over 200 large and medium installations in the continental United States, U.S. territories, and foreign countries. The overall size, composition, and dispersion of DoD, coupled with an innovative regulatory program, presents a challenge to the management of the Defense regulatory efforts under Executive Order (E.O.) 12866 “Regulatory Planning and Review” of September 30, 1993.

Because of its diversified nature, DoD is affected by the regulations issued by regulatory agencies such as the Departments of Commerce, Energy, Health and Human Services, Housing Start Printed Page 77740and Urban Development, Labor, State, Transportation, and the Environmental Protection Agency. In order to develop the best possible regulations that embody the principles and objectives embedded in E.O. 12866, there must be coordination of proposed regulations among the regulatory agencies and the affected DoD components. Coordinating the proposed regulations in advance throughout an organization as large as DoD is a straightforward, yet formidable, undertaking.

DoD issues regulations that have an effect on the public and can be significant as defined in E.O. 12866. In addition, some of DoD's regulations may affect other agencies. DoD, as an integral part of its program, not only receives coordinating actions from other agencies, but coordinates with the agencies that are affected by its regulations as well.

Overall Priorities

The Department needs to function at a reasonable cost, while ensuring that it does not impose ineffective and unnecessarily burdensome regulations on the public. The rulemaking process should be responsive, efficient, cost-effective, and both fair and perceived as fair. This is being done in DoD while reacting to the contradictory pressures of providing more services with fewer resources. The Department of Defense, as a matter of overall priority for its regulatory program, fully incorporates the provisions of the President's priorities and objectives under E.O. 12866.

International Regulatory Cooperation

As the President noted in E.O. 13609, “international regulatory cooperation, consistent with domestic law and prerogatives and U.S. trade policy, can be an important means of promoting” public health, welfare, safety, and our environment as well as economic growth, innovation, competitiveness, and job creation. Accordingly, in E.O. 13609, the President requires each executive agency to include in its Regulatory Plan a summary of its international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations.

The Department of Defense, along with the Departments of State and Commerce, engages with other countries in the Wassenaar Arrangement, Nuclear Suppliers Group, Australia Group, and Missile Technology Control Regime through which the international community develops a common list of items that should be subject to export controls. DoD has been a key participant in the Administration's Export Control Reform effort that resulted in a complete overhaul of the U.S. Munitions List and fundamental changes to the Commerce Control List. New controls have facilitated transfers of goods and technologies to allies and partners while helping prevent transfers to countries of national security and proliferation concern. DoD will continue to assess new and emerging technologies to ensure items that provide critical military and intelligence capabilities are properly controlled on international export control regime lists.

Retrospective Review of Existing Regulations

Pursuant to section 6 of E.O. 13563 “Improving Regulation and Regulatory Review (January 18, 2011), the following Regulatory Identification Numbers (RINs) have been identified as associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. Several are of particular interest to small businesses. The entries on this list are completed actions, which do not appear in The Regulatory Plan. However, more information can be found about these completed rulemakings in past publications of the Unified Agenda on Reginfo.gov in the Completed Actions section for DoD. These rulemakings can also be found on Regulations.gov. We will continue to identify retrospective review regulations as they are published and report on the progress of the overall plan biannually. DoD's final agency plan and all updates to the plan can be found at: http://www.regulations.gov/​#!docketDetail;​D=​DOD-2011-OS-0036

RINRule title (*expected to significantly reduce burdens on small businesses)
0703-AA90Guidelines for Archaeological Investigation Permits and Other Research on Sunken Military Craft and Terrestrial Military Craft Under the Jurisdiction of the Department of the Navy.
0703-AA92Professional Conduct of Attorneys Practicing Under the Cognizance and Supervision of the Judge Advocate General.
0710-AA66Civil Monetary Penalty Inflation Adjustment Rule.
0710-AA60Nationwide Permit Program Regulations.*
0750-AG47Safeguarding Unclassified Controlled Technical Information (DFARS Case 2011-D039).
0750-AG62Patents, Data, and Copyrights (DFARS Case 2010-D001).
0750-AH11Only One Offer (DFARS Case 2011-D013).
0750-AH19Accelerated Payments to Small Business (DFARS Case 2011-D008).
0750-AH54Performance-Based Payments (DFARS Case 2011-D045).
0750-AH70Defense Trade Cooperation Treaty With Australia and the United Kingdom (DFARS Case 2012-D034).
0750-AH86Forward Pricing Rate Proposal Adequacy Checklist (DFARS Case 2012-D035).
0750-AH87System for Award Management Name Changes, Phase 1 Implementation (DFARS Case 2012-D053).
0750-AH90Clauses With Alternates—Transportation (DFARS Case 2012-D057).
0750-AH94Clauses with Alternates—Foreign Acquisition (DFARS Case 2013-D005).
0750-AH95Clauses with Alternates—Quality Assurance (DFARS Case 2013-D004).
0750-AI02Clauses with Alternates—Contract Financing (DFARS Case 2013-D014).
0750-AI10Clauses with Alternates—Research and Development Contracting (DFARS Case 2013-D026).
0750-AI19Clauses with Alternates—Taxes (DFARS Case 2013-D025).
0750-AI27Clauses with Alternates—Special Contracting Methods, Major System Acquisition, and Service Contracting (DFARS Case 2014-D004).
0750-AI03Approval of Rental Waiver Requests (DFARS Case 2013-D006).
0750-AI07Storage, Treatment, and Disposal of Toxic or Hazardous Materials—Statutory Update (DFARS Case 2013-D013).
0750-AI18Photovoltaic Devices (DFARS Case 2014-D006).
0750-AI34State Sponsors of Terrorism (DFARS Case 2014-D014).
0750-AI43Inflation Adjustment of Acquisition-Related Thresholds.
0790-AI42Personnel Security Program.
0790-AI54Defense Support of Civilian Law Enforcement Agencies.
0790-AI77Provision of Early Intervention and Special Education Services to Eligible DoD Dependents.
0790-AI86Defense Logistics Agency Privacy Program.
0790-AI87Defense Logistics Agency Freedom of Information Act Program.
Start Printed Page 77741
0790-AI88Shelter for the Homeless.
0790-AJ03DoD Privacy Program.
0790-AJ06Voluntary Education Programs.
0790-AJ10Enhancement of Protections on Consumer Credit for Members of the Armed Forces and Their Dependents.
Pursuant to Executive Order 13563, DoD also removed 32 CFR part 513, “Indebtedness of Military Personnel,” because the part is obsolete and the governing policy is now codified at 32 CFR part 112.

Administration Priorities

1. Rulemakings that are expected to have high net benefits well in excess of costs.

The Department plans to finalize the following Defense Federal Acquisition Regulation Supplement (DFARS) rules:

  • Requirements Relating to Supply Chain Risk (DFARS case 2012-D050). This final rule implements section 806 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011, as amended by section 806 of the NDAA for FY 2013. Section 806 requires contracting officers to evaluate an offerors supply chain risk when purchasing information technology related to national security systems. This rule enables agencies to exclude sources identified as having a supply chain risk from consideration for award of a covered contract, in order to minimize the potential risk for supplies and services purchased by DoD to maliciously degrade the integrity and operation of sensitive information technology systems. The cost impact will vary by solicitation or contract, depending on the level of potential harm to DoD systems that may be avoided by excluding a source with an unacceptable supply chain risk. However, DoD anticipates significant savings to taxpayers by reducing the risk of unsafe products entering the supply chain, which pose a serious threat to sensitive government information technology systems and put in jeopardy the safety of our military forces.
  • Network Penetration Reporting and Contracting for Cloud Services (DFARS case 2013-D018). This final rule implements section 941 of the NDAA for FY 2013 and section 1632 of the NDAA for FY 2015. Section 941 requires cleared defense contractors to report penetrations of networks and information systems and allows DoD personnel access to equipment and information to assess the impact of reported penetrations. Section 1632 requires that a contractor designated as operationally critical must report each time a cyber-incident occurs on that contractor's network or information systems. Ultimately, DoD anticipates significant savings to taxpayers as a result of this rule, by improving information security for DoD information that resides in or transits through contractor systems and a cloud environment. Recent high-profile breaches of Federal information show the need to ensure that information security protections are clearly, effectively, and consistently addressed in contracts. This rule will help protect covered defense information or other Government data from compromise and protect against the loss of operationally critical support capabilities, which could directly impact national security.
  • Detection and Avoidance of Counterfeit Electronic Parts—Further Implementation (DFARS case 2014-D005). This final rule further implements section 818 of the NDAA for FY 2012, as modified by section 817 of the NDAA for FY 2015. Section 818, as modified by section 817, addresses required sources of electronic parts for defense contractors and subcontractors. This rule requires DoD and its contractors and subcontractors, except in limited circumstances, to acquire electronic parts from trusted suppliers. The rule also requires DoD contractors and subcontractors that are not the original component manufacturer, to notify the Government if it is not possible to obtain an electronic part from a trusted supplier and to be responsible for the inspection, test, and authentication of such parts in accordance with existing industry standards. Such validation of new parts and new suppliers are steps that a prudent contractor would take notwithstanding this rule. The benefits associated with avoiding the acquisition of counterfeit electronic parts, which could directly impact national security, far outweigh the minimal cost impact associated with the notification requirement imposed by this rule.

2. Rulemakings of particular interest to small businesses.

The Department plans to propose the following DFARS rule—

  • Temporary Extension of Test Program for Comprehensive Small Business Subcontracting Plans (DFARS case 2015-D013). This proposed rule implements section 821 of the NDAA for FY 2015 regarding the Test Program for Comprehensive Small Business Subcontracting Plans. The Test Program was established under section 834 of the NDAAs for FYs 1990 and 1992 to determine whether the negotiation and administration of comprehensive small business subcontracting plans would result in an increase of opportunities provided for small business concerns under DoD contracts. A comprehensive subcontracting plan (CSP) can be negotiated on a corporate, division, or sector level, rather than contract by contract. This rule proposes to amend the DFARS to: (1) Extend the Test Program through December 31, 2017; (2) require contracting officers to consider an offerors failure to make a good faith effort to comply with its CSP in past performance evaluations; and (3) inform program participants that a CSP will not be negotiated with a contractor that did not meet the small business goals negotiated in its prior CSP. This rule is of particular interest to small businesses because it holds prime contractors that are participating in the program accountable for the small business goals established in their CSP, resulting in increased business opportunities for small business subcontractors.

3. Rulemakings that streamline regulations, reduce unjustified burdens, and minimize burdens on small businesses.

The Department plans to finalize the following DFARS rule—

  • Warranty Tracking of Serialized Items (DFARS case 2014-D026). This final rule requires the use of the electronic contract attachments to record and track warranty data and source of repair information for serialized items in the Product Data Reporting and Evaluation Program (PDREP) system. While contracting officers are encouraged to use the electronic attachments, currently, it is not mandatory in the DFARS. As a result, offerors may propose warranty terms in paper form, which are later manually input into the PDREP system when a contract is awarded. On the other hand, the electronic contract attachments are designed to easily upload to the PDREP system, which reduces: (1) The potential burden of manually entering warranty terms in multiple places, and (2) inaccuracies in Start Printed Page 77742the data reported. By making use of these attachments mandatory, the rule provides DoD the ability to more effectively track warranty data and source of repair information for serialized items in a single repository of warranty terms.

4. Rules to be modified, streamlined, expanded, or repealed to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.

The Department plans to finalize the following DFARS rule—

  • Clauses with Alternates—Small Business Programs (DFARS case 2015-D017). This final rule amends those contract clauses associated with small business programs that are prescribed for use with an “alternate.” A contracting officer selects a basic clause for inclusion in a contract based on the clause prescription contained in the DFARS. Some clause prescriptions require the use of “alternate” text within a basic clause depending on the circumstances of the acquisition. In lieu of listing the basic clause and any alternate text separately, this rule proposes to include in the regulation the full text of both the basic clause with the alternate clause. This new convention will facilitate selection of clauses with alternates using automated contract writing systems and ensure paragraphs from the basic clause that should be superseded by alternate text are not inadvertently included in the solicitation or contract. As a result, the terms of a solicitation and contract are clearly communicated to offerors and contractors who consider such terms during proposal development and contract performance.

5. Rulemakings that have a significant international impact.

The Department plans to propose the following DFARS rule—

  • Contractors Performing Private Security Functions (DFARS case 2015-D021). During contingency operations, humanitarian or peace operations, or other military operations or exercises, DoD employs private security contractors (PSCs) to guard personnel, facilities, designated sites, or property of Federal agencies, the contractor or subcontractor, or a third party. Requirements for DoD contractors performing private security functions outside the United States are currently contained in the Federal Acquisition Regulation, and supplemented by the DFARS. This rule proposes to streamline the regulation by consolidating all terms and conditions for DoD PSCs in a single DFARS clause, which can be updated by DoD in a more efficient and timely manner. This rule will also provide an alternative to the high-level quality assurance standard required by the DFARS for PSCs. Contract quality requirements fall into four general categories, depending on the extent of quality assurance needed by the Government for the acquisition involved. In the case of PSC's, the high-level quality standard, “Management System for Quality of Private Security Company Operations—Requirements with Guidance, ANSI/ASIS PSC.1-2012” is mandatory. The alternative proposed by this rule for PSCs (ISO 18788: Management System Private Security Operations—Requirements with Guidance) is substantially the same as ANSI/ASIS PSC.1-2012 and is more widely accepted on an international basis.

Specific DoD Priorities: For this regulatory plan, there are five specific DoD priorities, all of which reflect the established regulatory principles. DoD has focused its regulatory resources on the most serious health and safety risks. Perhaps most significant is that each of the priorities described below promulgates regulations to offset the resource impacts of Federal decisions on the public or to improve the quality of public life, such as those regulations concerning acquisition, health affairs, transition assistance, and cyber security.

1. Acquisition, Technology, and Logistics/Defense Procurement and Acquisition Policy (DPAP), Department of Defense

DPAP continuously reviews the DFARS and continues to lead Government efforts to—

  • Improve the presentation, clarity, and streamlining of the regulation by: (1) Implementing the new convention to construct clauses with alternates in a manner whereby the alternate clauses are included in full-text; (2) removing guidance that does not have a significant effect beyond the internal operating procedure of the Department or impose a significant cost or administrative impact on contractors or offerors, which is more appropriately addressed in the DFARS Procedures, Guidance, and Information; and (3) removing obsolete reporting or other requirements imposed on contractors. Such improvements ensure that the regulation contracting officers, contractors, and offerors have a clear understanding of the rules for doing business with the Department of Defense.
  • Obtain early engagement with industry on procurement topics of high public interest by: (1) Utilizing the DPAP Defense Acquisition Regulation System Web site to obtain early public feedback on newly enacted legislation that impacts the Department's acquisition regulations, prior to initiating rulemaking to draft the implementing rules; and (2) holding public meetings to solicit industry feedback on proposed rulemakings.
  • Employ methods to facilitate and improve efficiency of the contracting process such as: (1) Requiring the use of electronic forms; and (2) establishing that electronic contract documents contained in Electronic Data Access system are official contract documents. Use of electronic means to accomplish the contracting process: (1) Reduces the burden on both industry and the Department associated with manual and duplicative data entry, and (2) removes limitations on access to information.

2. Health Affairs, Department of Defense

The Department of Defense is able to meet its dual mission of wartime readiness and peacetime health care for those entitled to DoD medical care and benefits by operating an extensive network of military medical treatment facilities supplemented by services furnished by civilian health care providers and facilities through the TRICARE program as administered under DoD contracts. TRICARE is a major health care program designed to improve the management and integration of DoD's health care delivery system.

The Department of Defense's Military Health System (MHS) continues to meet the challenge of providing the world's finest combat medicine and aeromedical evacuation, while supporting peacetime health care for those entitled to DoD medical care and benefits at home and abroad. The MHS brings together the worldwide health care resources of the Uniformed Services (often referred to as “direct care,” usually within military treatment facilities) and supplements this capability with services furnished by network and non-network civilian health care professionals, institutions, pharmacies, and suppliers, through the TRICARE program as administered under DoD contracts, to provide access to high quality health care services while maintaining the capability to support military operations. The TRICARE program serves 9.5 million Active Duty Service Members, National Guard and Reserve members, retirees, their families, survivors, and certain former spouses worldwide. TRICARE continues to offer an increasingly integrated and comprehensive health care plan, refining and enhancing both benefits and programs in a manner consistent with the law, industry Start Printed Page 77743standard of care, and best practices, to meet the changing needs of its beneficiaries. The program's goal is to increase access to health care services, improve health care quality, and control health care costs.

The Defense Health Agency plans to publish the following rule—

  • Proposed Rule: TRICARE Mental Health and Substance Abuse. This rule proposes revisions to the TRICARE regulation to reduce administrative barriers to access to mental health benefit coverage and to improve access to substance use disorder (SUD) treatment for TRICARE beneficiaries, consistent with earlier Department of Defense and Institute of Medicine recommendations, current standards of practice in mental health and addition medicine, and governing laws. This proposed rule has four main objectives: (1) To eliminate of quantitative and qualitative treatment limitations on SUD and mental health benefit coverage and align beneficiary cost-sharing for mental health and SUD benefits with those applicable to medical/surgical benefits; (2) to expand covered mental health and SUD treatment under TRICARE, to include coverage of intensive outpatient programs and treatment of opioid dependence; (3) to streamline the requirements for institutional providers to become TRICARE authorized providers; and (4) to develop TRICARE reimbursement methodologies for newly recognized mental health and SUD intensive outpatient programs and opioid treatment programs. DoD anticipates publishing the proposed rule in the second quarter of FY 2016.

3. Personnel and Readiness, Department of Defense

The Department of Defense plans to publish rules regarding transition assistance for military personnel and sexual assault prevention—

  • Interim Final Rule: Transition Assistance for Military Personnel (TAP). This rule establishes policy, assigns responsibilities, and prescribes procedures for administration of the DoD Transition Assistance Program (TAP). The goal of TAP is to prepare all eligible members of the Military Services for a transition to civilian life, including preparing them to meet Career Readiness Standards (CRS). The TAP provides information and training to ensure Service members leaving Active Duty and eligible Reserve Component Service members being released from active duty are prepared for their next step in life whether pursuing additional education, finding a job in the public or private sector, starting their own business or other form of self-employment, or returning to school or an existing job. Service members receive training to meet CRS through the Transition GPS (Goals, Plans, Success) curricula, including a core curricula and individual tracks focused on Accessing Higher Education, Career Technical Training, and Entrepreneurship. All Service members who are separating, retiring, or being released from a period of 180 days or more of continuous Active Duty must complete all mandatory requirements of the Veterans Opportunity to Work (VOW) Act, which includes pre-separation counseling to develop an Individual Transition Plan (ITP) and identify their career planning needs; attend the Department of Veterans Affairs (VA) Benefits Briefings I and II to understand what VA benefits the Service member earned, how to apply for them, and leverage them for a positive economic outcome; and attend the Department of Labor Employment Workshop (DOLEW), which focuses on the mechanics of resume writing, networking, job search skills, interview skills, and labor market research. DoD anticipates publishing the interim final rule in the first quarter of FY 2016.
  • Interim Final Rule; Amendment: Sexual Assault Prevention and Response (SAPR) Program. The purpose of this rule is to implement DoD policy and assign responsibilities for the SAPR Program on prevention, response, and oversight of sexual assault. The goal is for DoD to establish a culture free of sexual assault through an environment of prevention, education and training, response capability, victim support, reporting procedures, and appropriate accountability that enhances the safety and well-being of all persons. DoD anticipates publishing the interim final rule in the second quarter of FY 2016.
  • Interim Final Rule; Amendment: Sexual Assault Prevention and Response (SAPR) Program Procedures. This rule establishes policy, assigns responsibilities, and provides guidance and procedures for the SAPR Program. It establishes processes and procedures for the Sexual Assault Forensic Examination Kit, the multidisciplinary Case Management Group, and guidance on how to handle sexual assault, SAPR minimum program standards, SAPR training requirements, and SAPR requirements for the DoD Annual Report on Sexual Assault in the Military. The DoD goal is a culture free of sexual assault through an environment of prevention, education and training, response capability, victim support, reporting procedures, and appropriate accountability that enhances the safety and well-being of all persons. DoD anticipates publishing the interim final rule in the second quarter of FY 2016.

4. Chief Information Officer, Department of Defense

The Department of Defense plans to publish the final rule for the Defense Industrial Base (DIB) Cybersecurity (CS) Activities that implements statutory requirements for mandatory cyber incident reporting while maintaining the voluntary cyber threat information sharing program.

  • Interim Final Rule: Defense Industrial Base (DIB) Cyber Security (CS) Activities. DoD revised its DoD-DIB Cybersecurity (CS) Activities regulation to mandate reporting of cyber incidents that result in an actual or potentially adverse effect on a covered contractor information system or covered defense information residing therein, or on a contractor's ability to provide operationally critical support, and modify eligibility criteria to permit greater participation in the voluntary DoD-Defense Industrial Base (DIB) Cybersecurity (CS) information sharing program. DoD anticipates publishing the final rule in the fourth quarter of FY 2016.

DOD—OFFICE OF THE SECRETARY (OS)

Proposed Rule Stage

15. • Sexual Assault Prevention and Response (SAPR) Program

Priority: Other Significant.

Legal Authority: 10 U.S.C. 113; Pub. L. 109-364; Pub. L. 109-163; Pub. L. 108-375; Pub. L. 106-65; Pub. L. 110-417; Pub. L. 111-84; Pub. L. 112-81; Pub. L. 113-66; Pub. L. 113-291

CFR Citation: 32 CFR 103.

Legal Deadline: None.

Abstract: This part implements Department of Defense (DoD) policy and assigns responsibilities for the Sexual Assault Prevention and Response (SAPR) Program on prevention, response, and oversight to sexual assault. It is DoD policy to establish a culture free of sexual assault through an environment of prevention, education and training, response capability, victim support, reporting procedures, and appropriate accountability that enhances the safety and wellbeing of all persons covered by this regulation.

Statement of Need: The purpose of this rule is to implement DoD policy and assign responsibilities for the Sexual Assault Prevention and Response (SAPR) Program on prevention, response, and oversight to sexual assault.Start Printed Page 77744

Summary of Legal Basis: Establishes SAPR minimum program standards, SAPR training requirements, and SAPR requirements for the DoD Annual Report on Sexual Assault in the Military consistent with title 10, United States Code, the DoD Task Force Report on Care for Victims of Sexual Assault and pursuant to DoD Directive (DoDD) 5124.02, DoDD 6495.01, and Public Laws 106-65, 108-375, 109-163, 109-364, 110-417, 111-84, 111-383, 112-81, 112-239, 113-66, and 113-291.

Alternatives: The Department of Defense will lack comprehensive SAPR program policy guidance on the prevention and response to sexual assaults involving members of the U.S. Armed Forces. The DoD will not have guidance to establish a culture free of sexual assault through an environment of prevention, education and training, response capability, victim support, reporting procedures, and appropriate accountability that enhances the safety and well being of all persons covered by this part (32 CFR 103) and 32 CFR 105. DoD will lack the policy guidance to promulgate requirements mandated in the National Defense Authorization Acts.

Anticipated Cost and Benefits: The Fiscal Year 2014 Operation and Maintenance funding for DoD SAPRO was $26.798 million with an additional Congressional allocation of $25.3 million designated for the Special Victims' Counsel program and the Special Victims' Investigation and Prosecution capability that was reprogrammed to the Military Services and the National Guard Bureau. Additionally, each of the Military Services establishes its own SAPR budget for the programmatic costs arising from the implementation of the training, prevention, reporting, response, and oversight requirements established by this rule.

The anticipated benefits associated with this rule include:

(1) A complete and up-to-date SAPR Policy consisting of this part and 32 CFR 105, to include comprehensive SAPR policy guidance on the prevention and response to sexual assaults involving members of the U.S. Armed Forces.

(2) Guidance and policy with which the DoD may establish a culture free of sexual assault, through an environment of prevention, education and training, response capability, victim support, reporting procedures, and appropriate accountability that enhances the safety and well being of all persons covered by this part and 32 CFR 105.

(3) Requirement to provide care that is gender-responsive, culturally competent, and recovery-oriented. Sexual assault patients shall be given priority, and treated as emergency cases. Emergency care shall consist of emergency healthcare and the offer of a Sexual Assault Forensic Examination (SAFE). The victim shall be advised that even if a SAFE is declined the victim is encouraged (but not mandated) to receive medical care, psychological care, and victim advocacy.

(4) Standardized SAPR requirements, terminology, guidelines, protocols, and guidelines for training materials shall focus on awareness, prevention, and response at all levels, as appropriate.

(5) An immediate, trained sexual assault response capability shall be available for each report of sexual assault in all locations, including in deployed locations.

(6) Victims of sexual assault shall be protected from coercion, retaliation, and reprisal.

Risks: The rule intends to enable military readiness by establishing a culture free of sexual assault. This rule aims to mitigate this risk to mission readiness.

Timetable:

ActionDateFR Cite
NPRM03/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: DoD Directive 6495.01, “Sexual Assault Prevention and Response (SAPR) Program”.

Agency Contact: Diana Rangoussis, Department of Defense, Office of the Secretary, Defense Pentagon, Washington, DC 20301, Phone: 703 696-9422.

RIN: 0790-AJ40

DOD—OS

Final Rule Stage

16. Sexual Assault Prevention and Response Program Procedures

Priority: Other Significant.

Legal Authority: 10 U.S.C. ch 47; Pub. L. 106-65; Pub. L. 108-375; Pub. L. 109-163; Pub. L. 109-364; Pub. L. 110-417; Pub. L. 111-84; Pub. L. 111-383; Pub. L. 112-81; Pub. L. 112-239; Pub. L. 113-66; Pub. L. 113-291

CFR Citation: 32 CFR 105.

Legal Deadline: None.

Abstract: The procedures discussed establish a culture of prevention, response, and accountability that enhances the safety and well-being of all DoD members.

Statement of Need: The rule establishes the processes and procedures for the Sexual Assault Forensic Examination (SAFE) kit; the multidisciplinary Case Management Group to include guidance for the group on how to handle sexual assault; SAPR minimum program standards; SAPR training requirements; and SAPR requirements for the DoD Annual Report on Sexual Assault in the Military.

Summary of Legal Basis: In February of 2004, the former Secretary of Defense Donald H. Rumsfeld directed Dr. David S. C. Chu, the former Under Secretary of Defense for Personnel and Readiness, to review the DoD process for treatment and care of victims of sexual assault in the Military Services. One of the recommendations emphasized the need to establish a single point of accountability for sexual assault policy within the Department. This led to the establishment of the Joint Task Force for Sexual Assault Prevention and Response, and the naming of then Brigadier General K.C. McClain as its commander in October 2004. The Task Force focused its initial efforts on developing a new DoD-wide sexual assault policy that incorporated recommendations set forth in the Task Force Report on Care for Victims of Sexual Assault as well as in the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 (Pub. L. 108-375). This act directed the Department to have a sexual assault policy in place by January 1, 2005. Subsequent National Defense Authorization Acts provided additional requirements for the Department of Defense sexual assault prevention and response program in: Section 113 of title 10, United States Code; and Public Laws 109-364, 109-163, 108-375, 106-65, 110-417, 111-84, 112-81, 112-239, 113-66, and 113-291.

Alternatives: The Department of Defense will lack comprehensive Sexual Assault Prevention and Response (SAPR) procedures to implement the DoD Directive 6495.01, Sexual Assault Prevention and Response (SAPR) Program, which is the DoD policy on prevention and response to sexual assaults involving members of the U.S. Armed Forces. The DoD will not have guidance to establish a culture free of sexual assault through an environment of prevention, education and training, response capability, victim support, reporting procedures, and appropriate accountability that enhances the safety and well-being of all persons covered by this part and 32 CFR 103. DoD will lack the implementing procedures to Start Printed Page 77745promulgate requirements mandated in the National Defense Authorization Acts.

Anticipated Cost and Benefits: The preliminary estimate of the anticipated cost associated with this rule for the current fiscal year is approximately $15.010 million. Additionally, each of the Military Services establishes its own SAPR budget for the programmatic costs arising from the implementation of the training, prevention, reporting, response, and oversight requirements established by this rule.

The anticipated benefits associated with this rule include:

(1) A complete SAPR Policy consisting of this part and 32 CFR 103, to include comprehensive SAPR procedures to implement the DoD Directive 6495.01, Sexual Assault Prevention and Response (SAPR) Program, which is the DoD policy on prevention and response to sexual assaults involving members of the U.S. Armed Forces.

(2) Guidance and procedures with which the DoD may establish a culture free of sexual assault, through an environment of prevention, education and training, response capability, victim support, reporting procedures, and appropriate accountability that enhances the safety and well-being of all persons covered by this part (32 CFR 105) and 32 CFR 103.

(3) Requirement that medical care and SAPR services are gender-responsive, culturally competent, and recovery-oriented. A 24 hour, 7 day per week sexual assault response capability for all locations, including deployed areas, shall be established for persons covered in this part. An immediate, trained sexual assault response capability shall be available for each report of sexual assault in all locations, including in deployed locations. Sexual assault victims shall be given priority, and treated as emergency cases. Emergency care shall consist of emergency medical care and the offer of a SAFE. The victim shall be advised that even if a SAFE is declined the victim shall be encouraged (but not mandated) to receive medical care, psychological care, and victim advocacy.

(4) Command sexual assault awareness and prevention programs and DoD law enforcement and criminal justice procedures that enable persons to be held appropriately accountable for their actions, shall be supported by all commanders.

(5) Standardized SAPR requirements, terminology, guidelines, protocols, and guidelines for training materials shall focus on awareness, prevention, and response at all levels, as appropriate.

(6) Sexual Assault Response Coordinators (SARC), SAPR Victim Advocates (VA), and other responders will assist sexual assault victims regardless of Service affiliation.

(7) Service member and adult military dependent victims of sexual assault shall receive timely access to comprehensive medical and psychological treatment, including emergency care treatment and services, as described in this part and 32 CFR 103.

(8) Military Service members who file Unrestricted and Restricted Reports of sexual assault shall be protected from reprisal, or threat of reprisal, for filing a report.

(9) Service members and military dependents 18 years and older who have been sexually assaulted have two reporting options: Unrestricted or Restricted Reporting. Unrestricted Reporting of sexual assault is favored by the DoD. However, Unrestricted Reporting may represent a barrier for victims to access services, when the victim desires no command or DoD law enforcement involvement. Consequently, the DoD recognizes a fundamental need to provide a confidential disclosure vehicle via the Restricted Reporting option. Regardless of whether the victim elects Restricted or Unrestricted Reporting, confidentiality of medical information shall be maintained in accordance with DoD 6025.18-R.

(10) Service members who are on active duty but were victims of sexual assault prior to enlistment or commissioning are eligible to receive SAPR services under either reporting option. The DoD shall provide support to an active duty Military Service member regardless of when or where the sexual assault took place.

(11) Requirement to establish a DoD-wide certification program with a national accreditor to ensure all sexual assault victims are offered the assistance of a SARC or SAPR VA who has obtained this certification.

(12) Implementing training standards that cover general SAPR training for Service members, and contain specific standards for: Accessions, annual, professional military education and leadership development training, pre- and post-deployment, pre-command, General and Field Officers and SES, military recruiters, civilians who supervise military, and responders trainings.

(13) Requires Military Departments to establish procedures for supporting the DoD Safe Helpline in accordance with Guidelines for the DoD Safe Helpline for the referral database provide timely response to victim feedback, publicize the DoD Safe Helpline to SARCs and Service members and at military confinement facilities.

(14) Added additional responsibilities for the DoD SAPRO Director (develop metrics for measuring effectiveness, act as liaison between DoD and other agencies with regard to SAPR, oversee development of strategic program guidance and joint planning objectives, quarterly include Military Service Academies as a SAPR IPT standard agenda item, semi-annually meet with the Superintendents of the Military Service Academies, and develop and administer standardized and voluntary surveys for survivors of sexual assault to comply with section 1726 of the National Defense Authorization Act For Fiscal Year 2014, Public Law 113-66.

(15) Updates text throughout the issuance to reflect Defense Sexual Assault Incident Database (DSAID) interface with MCIO case management systems (rather than Military Service sexual assault case management systems) and procedures for entering final case disposition information into the database.

Risks: The rule intends to enable military readiness by establishing a culture free of sexual assault. This rule aims to mitigate this risk to mission readiness.

Timetable:

ActionDateFR Cite
Interim Final Rule04/11/1378 FR 21715
Interim Final Rule Effective04/11/13
Interim Final Rule Comment Period End06/10/13
Interim Final Rule03/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: DoD Instruction 6495.02, “Sexual Assault Prevention and Response (SAPR) Program Procedures”.

Agency Contact: Teresa Scalzo, Department of Defense, Office of the Secretary, 4000 Defense Pentagon, Washington, DC 20301-1155, Phone: 703 696-8977.

RIN: 0790-AI36

DOD—OS

17. Transition Assistance Program (TAP) for Military Personnel

Priority: Economically Significant. Major under 5 U.S.C. 801.Start Printed Page 77746

Legal Authority: 10 U.S.C. 1141; 10 U.S.C. 1142

CFR Citation: 32 CFR 88.

Legal Deadline: None.

Abstract: The DoD is committed to providing military personnel from across the Services access to the TAP. The TAP prepares all eligible members of the Military Services for a transition to civilian life; enables eligible Service members to meet the CRS as required by this rule; and is the overarching program that provides transition assistance, information, training, and services to eligible transitioning Service members to prepare them to be career ready when they transition back to civilian life. Spouses of eligible Service members are entitled to the DOLEW, job placement counseling, DoD/VA-administered survivor information, financial planning assistance, transition plan assistance, VA-administered home loan services, housing assistance benefits information, and counseling on responsible borrowing practices.

Dependents of eligible Service members are entitled to career change counseling and information on suicide prevention.

These revisions will: Institutionalize the implementation of the VOW Act of 2011; require mandatory participation in the Department of Labor (DOL) Employment Workshop (EW); implement the Transition GPS (Goals, Plans, Success) curriculum; require development of an Individual Transition Plan (ITP); enhance tracking of attendance at TAP events; implement of mandatory Career Readiness Standards (CRS) for separating Service members; and, incorporate a CAPSTONE event to document transition readiness and reinforce Commanding Officer accountability and support for the needs of individual Service members. This rule improves the process of conducting transition services for eligible separating Service members across the Military Services and establishes the data collection foundation to build short-, medium-, and long-term program outcomes.

Statement of Need: In August 2011, President Obama announced his comprehensive plan to ensure America's Post 9/11 Veterans have the support they need and deserve when they leave the military, look for a job, and enter the civilian workforce. A key part of the President's plan was his call for a career-ready military. Specifically, he directed DoD and Department of Veterans Affairs (VA) to work closely with other federal agencies and the President's economic and domestic policy teams to lead a Veterans Employment Initiative Task Force to develop a new training and services delivery model to help strengthen the transition readiness of Service members from military to civilian life. Shortly thereafter, Congress passed and the President signed the VOW to Hire Heroes Act of 2011, Public Law 112-56, sections 201-265, 125 Stat. 715 (VOW Act), which included steps to improve the existing TAP for Service members. Among other things, the VOW Act made participation in several components of TAP mandatory for all Service members (except in certain limited circumstances).

The task force delivered its initial recommendations to the President in December 2011 which required implementation of procedures to document Service member participation, and to demonstrate Military Service compliance with 10 U.S.C. chapter 58 requirements. The Veterans Opportunity to Work (VOW) Act of 2011 mandated transitioning Service member's participation in receiving counseling and training on VA Benefits. VA developed VA Benefits I and II Briefings to meet this mandate. The VOW Act also mandated transitioning Service members to received counseling and informed of services regarding employment assistance. The Department of Labor revised its curriculum to meet this mandate with the Department of Labor Employment Workshop. The VOW requirements have been codified in 10 U.S.C. chapter 58 and attendance to all Transition GPS curricula is now documented.

The redesigned TAP was developed around four core recommendations:

Adopt standards of career readiness for transitioning Service members: Service members should leave the military having met clearly defined standards of career readiness.

Implement a revamped TAP curriculum: Service members should be provided with a set of value-added, individually tailored training programs and services to equip them with the set of tools they need to pursue their post-military goals successfully.

Implement a CAPSTONE: Service members should be afforded the opportunity, shortly before they depart the military, to review and verify that they have met the CRS and received the services they desire and to be steered to the resources and benefits available to them as Veterans.

Implement a Military Life Cycle (MLC) transition model: Transition preparation for Service members should occur over the entire span of their military careers not just in the last few months of their military service.

Implementation of these recommendations transforms a Service member' experience during separating, retiring, demobilizing, or deactivating to make the most informed career decisions by equipping them with the tools they need to make a successful transition.

The rule discusses a redesigned program which implements, the transition-related provisions of the VOW Act and recommendations of the Task Force to offer a tailored curriculum providing Service members with useful and quality instruction with connections to the benefits and resources available to them as Veterans. At the heart of the redesign is the new set of CRS. Just as Service members must meet military mission readiness standards while on Active Duty, Service members will meet CRS before their transition to civilian life.

Spouses of eligible Service members are entitled to the DOLEW, job placement counseling, DoD/VA-administered survivor information, financial planning assistance, transition plan assistance, VA-administered home loan services, housing assistance benefits information, and counseling on responsible borrowing practices. Dependents of eligible service members are entitled to career change counseling and information on suicide prevention.

Summary of Legal Basis: This regulation is proposed under the authority of title 10, U.S.C., chapter 58. Title 10, U.S.C., section 1141 defines involuntary separation; section 1142 provides the time period the Secretary concerned shall provide for individual pre-separation counseling for each member of the armed forces whose discharge or release from active duty is anticipated as of a specific date; section 1143 requires the Secretary of Defense to provide to members of the armed forces a certification or verification of any job skills and experience acquired while on active duty, that may have application to employment in the civilian sector; section 1143a. requires the Secretary of Defense to encourage members and former members of the armed forces to enter into public and community service jobs; section 1144 requires the Secretary of Labor, in conjunction with the Secretaries of Defense, Homeland Security, and Veterans Affairs to establish and maintain a program to furnish counseling, assistance in identifying employment and training opportunities, help in obtaining such employment and training, and other related information and services to members of the armed forces and the spouses of such members who are transitioning; section 1145 Start Printed Page 77747prescribes transitional health benefits; section 1146 describes commissary and exchange benefits for members involuntarily separated from active duty; section 1147 prescribes guidance that may permit individuals who are involuntarily separated to continue, not more than 180 days after the date of separation, to reside (along with other members of the individual's household) in military housing provided or leased by the DoD; section 1148 addresses relocation assistance for personnel overseas; section 1149 provides guidance regarding excess leave and permissive temporary duty; section 1150 prescribes guidance for affiliation with Guard and Reserve units; section 1151 prescribes guidance for retention of assistive technology and services provided before separation; section 1152 allows the Secretary of Defense to enter into an agreement with the Attorney General to establish or participate in a program to assist eligible members and former members to obtain employment with law enforcement agencies; section 1153 allows the Secretary of Defense to provide assistance to separated Service members to obtain employment with health care providers; and section 1154 allows the Secretary of Defense to provide assistance to eligible Service members and former members to obtain employment as teachers (Troops-to-Teachers Program).

Alternatives: The DoD considered several alternatives:

In President Obama's speech in August of 2011 at the Washington Navy Yard, he used the term “Reverse Boot Camp” to demonstrate his vision for a redesigned TAP to increase the preparedness of Service members to successfully transition from military service to civilian communities. The President's use of language initiated an interagency discussion on an approach to mirror the Military Services' basic or initial entry training programs. This approach would require the Military Services to devote approximately 9 to 13 weeks, depending on curriculum development, outcome measures, assessments and individual military readiness and cultural differences, to afford Service members the opportunity to use all aspects of a rigorous transition preparation program.

While no cost estimates were conducted, this approach was deemed both expensive and would jeopardize DoD's ability to maintain mission readiness. Approximately 200,000-250,000 Service members leave DOD each year. To concentrate on transition preparation during the last 9 to 13 weeks of an individual's military career would not be workable since mission readiness could not absorb the impact of the void. Additionally, there would be an increased expense required to activate or mobilize Reserve Component or National Guard personnel for the 9 to 13 weeks prior to transition. Finally, logistical challenges could result from Service members dealing with TAP requirements while deployed. For example, units scheduled to mobilize would be delayed because a returning unit could occupy facilities (such as billeting, classrooms, and training areas) that the deploying units needed to train and prepare for mobilization.

A second alternative considered was establishment of regional residential transition centers staffed by personnel from all Military Services, the Departments of VA, Labor (DOL), and Homeland Security (U.S. Coast Guard), the U.S. Small Business Administration (SBA), and the OPM. Transitioning Service members would be sent on temporary duty for a period of four to six weeks, 12 months prior to their separation or retirement date to receive transition services. Eligible Reserve Component Service members would be assigned to the centers as a continuation of their demobilization out-processing. The potential costs to build or modify existing facilities, or rent facilities that would meet regional residential transition center requirements, as well as costs for Service member travel to and from the regional centers, reduced the viability of this approach.

A third, less expensive option would have left the existing TAP program intact without increasing counselor and curriculum facilitation resources. This option would not have accountability systems and procedures to demonstrate compliance with the VOW Act that mandates pre-separation counseling, attendance at the DOL's three day Employment Workshop (DOLEW), and attendance at two VA briefings. Due to increasing Veteran unemployment and homeless percentages at the time of the decision, and the rebalancing of the military force, this cost neutral approach would not have the outcome based capability intended to develop career ready skills in transitioning Service members. This option, which would not have met the requirements of the law, would cost the Military Services approximately $70M versus the fiscal year 2013 (FY13) $122M for the implementation of the re-designed TAP.

Anticipated Cost and Benefits: The VOW Act mandated pre-separation counseling, VA Benefits Briefings I and II, and the DOLEW and these components were implemented in November 2012. On the same day the VOW Act requirements became mandatory, DoD published a policy to make CRS and Commanding Officer verification that Service members are meeting CRS, mandatory. Vow Act compliance and CRS must be met by all Service members after they have served 180 days in active duty status. Service members must attend Transition GPS (Goals, Plans, Success) curriculum modules that build career readiness if they cannot meet the CRS on their own. In cases where Service members receive a punitive or Under Other Than Honorable Conditions discharge, Commanding Officers have the discretion of determining participation in the other than mandatory Transition GPS curricula. By policy, all Service members who do not meet the CRS will receive a warm handover to DOL, VA, or other resources targeted at improving career readiness in the area where the standard was not met.

The entire Transition GPS curriculum is now available online through Joint Knowledge Online (JKO); however, Service members must attend pre-separation counseling, VA briefings, and the DOLEW in person. All other curriculum can be accessed through the JKO virtual platform. The virtual curriculum (VC) was launched at the beginning of FY14. DoD expected a cost savings in FY14 due to use of the VC but the cost avoidance cannot be calculated as VC utilization is appropriate on a Service member-by-Service member basis.

Further, resource requirements for DoD become more predictable when transition assistance is provided at pre-determined points throughout the MLC TAP model, mitigating the impacts of surge periods when large numbers of Service members separate, demobilize or deactivate.

The FY13 cost to DoD to implement the TAP redesign was $122M and in FY14 DoD costs were $85M. The difference is attributed to both implementation costs of the updated program in FY13, and to efficiencies discovered as implementation was completed throughout FY14. These costs represent only the portion of the interagency program that is paid by the DoD. The cost covers Defense civilian and contracted staff (FTEs) salaries and benefits at 206 world-wide locations. Civilian and contract labor account for approximately 88% of total program costs in both fiscal years. The remaining costs include equipment, computers (purchase, maintenance and operations), Information Technology (IT) and architecture, data collection and sharing, Web site development, performance evaluation and assessments, curriculum development Start Printed Page 77748and modifications, materials (audio-visual, CDs, eNotebooks, handouts, interactive brick and mortar classroom sessions, virtual curriculum, etc.), facilitation training, research, studies, and surveys. Within DoD, the re-designed TAP capitalized upon existing resources, e.g., use of certified financial planners housed in the Military Services' family centers to conduct financial planning or military education counselors used to conduct the Accessing Higher Education (AHE) track. Other efficiencies include reuse or upgrades to current facilities and classrooms used to deliver legacy TAP. Implementation costs in FY13 included equipping classrooms to allow for individual internet access and train-the-trainer workshops to deliver the DoD portions of the Transition GPS curriculum. Examples of efficiencies discovered in FY14 include providing train-the-trainer courses through webinars and savings associated with Service members using the VC.

The DoD provides military spouses the statutory requirements of TAP as prescribed in Title 10, United States Code. Other elements of TAP, prescribed by DoD policy, are available to spouses if resources and space permits. Military spouses can attend the brick and mortar Transition GPS curriculum at no cost on a nearby military installation. They can also take the entire Transition GPS curriculum online, virtually, at any time, from anywhere with a computer or laptop for free.

Many of our Veteran and Military Service Organizations, employers and local communities provide transition support services to local installations. Installation Commanders are strongly encouraged to permit access to Veteran Service Organizations (VSOs) and Military Service Organizations (MSOs) to provide transition assistance-related events and activities in the United States and abroad at no cost to the government. Two memos signed by Secretary of Defense Chuck Hagel reinforce such access. The memos are effective within 60 days of the December 23 signing, and will remain in effect until the changes are codified within DoD. Access to installations is for the purpose of assisting Service members with their post-military disability process and transition resources and services. The costs to VSOs and MSOs would be any costs associated with salaries for paid VSO and MSO personnel. These organizations will pay for any costs associated with travel to and from military installations, as well as any materials they provide to separating Service members and their spouses. Costs to employers and community organizations supporting transition-related events and activities would be similar to those for VSOs and MSOs.

The DoD is dependent upon other federal agencies to deliver the redesigned TAP to transitioning Service members. The VA, DOL, SBA, Department of Education (ED), and Office of Personnel Management (OPM) have proven to be invaluable partners in supporting the Transition GPS curriculum development and delivery, and in providing follow-on services required by a warm handover due to unmet CRS. These interagency partners strongly support TAP governance and performance measurement.

Although DoD cannot estimate the costs for its interagency partners, TAP provides the Service members with resources through the contributions of its interagency partners that should be identified as factors of total program cost. Transition assistance is a comprehensive interagency effort with contributions from every partner leveraged to provide support to the All-Volunteer Force as the Service members prepare to become Veterans. The interagency partners deliver the Transition GPS curriculum and one-on-one services across 206 military installations across the globe. DoD can only speak to TAP costs within the Defense fence line, but can discuss the value provided by interagency partners.

The DOL provides skilled facilitators that deliver the DOLEW, a mandatory element of the Transition GPS standardized curriculum. DOL's American Jobs Centers (AJCs) provide integral employment support to transitioning Service members and transitioned Veterans. The AJCs are identified as resources for the Service members during TAP which may increase visits from the informed Service members. The AJCs also support warm handovers of Service members who have identified employment as a transition goal on their ITP but do not meet the CRS for employment. DOL also provides input to the TAP interagency working groups and governance boards, and is involved in the data collection, performance measurement, and standardization efforts, all of which represent costs to the organization.

The SBA provides the Transition GPS entrepreneurship track, Boots to Business, to educate transitioning Service members interested in starting their own business about the challenges small businesses face. Upon completing the Boots to Business track, the SBA allows Service members to access the SBA on-line entrepreneurship course, free of charge. The SBA then provides Service members the opportunity to be matched to a successful business person as a mentor. This is a tremendous commitment that must create additional costs for the SBA. The SBA offices continue to provide support to Veterans as they pursue business plan development or start up loans; provision of this support is in their charter, but the increased awareness provided through the Transition GPS curriculum is likely to increase the patronage and represent a cost to SBA. The SBA also provides input to the TAP interagency working groups and governance boards. The SBA is engaged with data collection and sharing efforts to determine program outcomes.

VA provides facilitators who deliver the mandatory VA Benefits Briefings I and II as part of the Transition GPS standardized curriculum required to meet VOW Act requirements. The VA facilitators also deliver the two-day track for Career Technical Training that provides instruction to Service members to discern the best choices of career technical training institutions, financial aid, best use of the Post 9/11 GI Bill, etc. Benefits counselors deliver one-on-one benefits counseling on installations, as space permits. As a primary resource for Veterans, VA ensures benefits counselors are able to accept warm handovers of transitioning Service members who do not meet CRS and require VA assistance post separation. The VA hosts the interagency single web portal for connectivity between employers and transitioning Service members, Veterans and military spouses the Veterans Employment Center (VEC). VA provides input to the TAP interagency working groups and governance boards, and is involved in the data collection and sharing efforts to determine program outcomes, all of which represent costs to the organization.

ED serves a unique and highly valued role in the interagency partnership by ensuring the entire curriculum, both in classroom and virtual platform delivery, is based on adult learning principles. Their consultative role, tapped daily by the interagency partners, is critical to a quality TAP. ED also provides input to the TAP interagency working groups and governance boards and keeps a keen eye toward meaningful TAP outcomes, all of which represent costs to the organization.

The OPM contributes federal employment information and resources to the DOLEW, and enables the connectivity between the VEC and USA Jobs Web sites. The OPM also provides input to the TAP interagency working Start Printed Page 77749groups and governance boards and contributes to performance measures.

The costs to DoD's interagency partners were not calculated; implementation of this rule was mandated by the Vow Act and costs for all parties are already incurred. The calculated costs to DoD and unmeasured costs to DoD's interagency partners provide significant resources to Service members resulting in benefits to the Nation.

The benefits of the redesigned TAP to the Service members are increased career readiness to obtain employment, start their own business or enter career technical training or an institution of higher learning at the point of separation from military service. The legacy, end-of-career TAP is replaced by pre-determined opportunities across the MLC for many transition-related activities to be completed during the normal course of business.

Since a direct economic estimate of the value of TAP is difficult for DoD to demonstrate as it would require collection of information from military personnel after they become private citizens, the value of the TAP can be derived by demonstrating qualitatively how Service members value the program and then displaying some changes in economic variables that can be differentiated between Veterans who have access to TAP and non-Veterans who do not have access to the program.

—According to one independent evaluation of the TAP, Service members who had participated in the TAP had, on average, found their first post-military job three weeks sooner than those who did not participate in the TAP.

—An independent survey asked Soldiers who had used the TAP their opinions about the curriculum. The Soldiers reported positive opinions about the usefulness of the TAP.

90% of the Soldiers felt that it was a useful resource in searching for employment and 88% of them would recommend the TAP to a colleague.

According to a curriculum assessment completed at the end of each TAP module, transitioning Service members gave the TAP positive reviews on its usefulness for their job search:

—92% of reported that they found the learning resources useful, including notes, handouts, and audio-visuals.

—83% reported that the modules enhanced their confidence in their own transition planning.

—81% reported that they now know how to access the necessary resources to find answers to transition questions that may arise in the next several months.

—79% said that the TAP was beneficial in helping them gain the information and skills they needed better to plan their transition.

—79% said that they will use what they learned from the TAP in their own transition planning.

—A comparison of unemployment insurance usage suggests that recently separated members of the military (2013 & 2014) were more likely to apply what they learned in the re-designed TAP and were more involved earlier in job training programs than unemployed claimants who did not have military experience (8.5% of UCX claimants versus 5.1% of Military service claimants).

—According to the Bureau of Labor Statistics, the unemployment rate for Veterans of the current conflict declined by 1.8 percentage points from August 2013 to August 2014 coinciding with the time period when all Service members were required to take the re-designed TAP.

The TAP also helps mitigate the adjustment costs associated with labor market transition. Military members must prepare for the adjustments associated with losing military benefits (e.g. housing, health care, child care) to the benefits afforded in private sector or nonmilitary public sector jobs. The TAP addresses this very important aspect based on a regulatory mandate that they attend both the DOLEW and the VA's Veterans Benefits Briefings, and complete a 12 month post-separation financial plan to meet CRS.

The early alignment of military skills with civilian workforce demands and deliberate planning for transition throughout a Service member's career sets the stage for a well-timed flow of Service members to our Nation's labor force. Employers state that transitioning Service members have critical job-related skills, competencies, and qualities including the ability to learn new skills, strong leadership qualities, and flexibility to work well in teams or independently, ability to set and achieve goals, recognition of problems and implementation of solutions, and ability to persevere in the face of obstacles. However, application of these skills and attributes must be translated into employer friendly language. These issues are addressed by the TAP. The rule supports providing private and public sector employers with a direct link to profiles and resumes of separating Service members through the Veterans Employment Center (VEC), where employers can recruit from this talent pipeline.

The rule benefits communities across the country. Civilian communities receive more educated, better trained and more prepared citizens when separating Service members return to communities as Veterans. Service members learn to align their military skills with civilian employment opportunities, which enables the pool of highly trained, adaptable, transitioning Service members a more timely integration into the civilian workforce and local economies.

Service members also learn through TAP about the rich suite of resources available to them from the interagency partners and have, for the asking, one-on-one appointments with interagency partner staff, who can provide assistance to Service members and their families both before and after the Service member leaves active duty. More specifically, the components of the mandatory CRS target deliberate planning for financial preparedness as well as employment, education, housing and transportation plans and, for those Service members with families, child care, schools, and spouse employment. The DoD and interagency partners incorporated the warm handover requirement for any transitioning Service member who does not meet the CRS. The warm handover is meant to serve as an immediate bridge from DoD to the federal partners' staffs, which are committed to providing needed support, resources and services to Service members post separation in the communities to which the Service members are returning. The intention is to provide early intervention before Veterans encounter the challenges currently identified by some communities, e.g., financial struggles, unemployment, lack of social supports that can spiral down into homelessness, risk taking behaviors, etc. Families and communities benefit.

Risks: If this rule is not put into effect, approximately 200,000 Service members per year will return to their local communities ill prepared to assimilate into the civilian workforce, effectively use the Post 9/11 GI Bill benefits and other VA benefits that they have earned, minimize risks to starting small businesses, and will be unaware of community resources to assist them with their reintegration. More specifically, transitioning Service members will be uninformed as to how to best use their Post-9/11 GI Bill benefit—how to apply to a degree completion institution, how to choose the best school for degree completion, or how to choose a technical training program that leads to obtaining a credential—with a negative return on Start Printed Page 77750their investment such as non-graduation, inability to transfer credits, or falling victim to predatory institutions, with an end result of wasting valuable taxpayer dollars. Service members, a most entrepreneurial population, would be poorly prepared to launch small businesses successfully, becoming part of the > 80% statistic of failed start-ups within the first year. Service members will be unprepared to capitalize upon health care benefits due to them, as well as health care mandated by and available through the Affordable Care Act. These avoidable information, education and training gaps could produce negative outcomes such as increased unemployment, financial uncertainty, business bankruptcy, family disruption, and even a possible increase in homelessness. These risks would be felt by local communities to which transitioning Service members return as communities deal with the long term economic and social fallout.

Timetable:

ActionDateFR Cite
Interim Final Rule11/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: DoD Instruction 1332.35, “Transition Assistance Program (TAP) for Military Personnel.”

Agency Contact: Mr. Ronald L. Horne, Director of Policy and Programs, DoD Transition to Veterans Program Office, Department of Defense, Office of the Secretary, 1700 North Moore Street, Suite 1410, Arlington, VA 22209, Phone: 703 614-8631, Email: ronald.l.horne3.civ@mail.mil.

RIN: 0790-AJ17

DOD—OS

18. Department of Defense (DOD)—Defense Industrial Base (DIB) Cybersecurity (CS) Activities

Priority: Other Significant.

Legal Authority: 10 U.S.C. 391; 10 U.S.C. 2224; 44 U.S.C. 3506; 44 U.S.C. 3544; and sec 941; Pub. L. 112-239, 126 Stat. 1632

CFR Citation: 32 CFR 236.

Legal Deadline: None.

Abstract: DoD is revising its DoD-DIB Cybersecurity (CS) Activities regulation to mandate reporting of cyber incidents that result in an actual or potentially adverse effect on a covered contractor information system or covered defense information residing therein, or on a contractor's ability to provide operationally critical support, and modify eligibility criteria to permit greater participation in the voluntary DoD-Defense Industrial Base (DIB) Cybersecurity (CS) information sharing program.

Statement of Need: This rule complies with statutory guidance under section 941 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2013, and section 391 of Title 10, United States Code (U.S.C.), requiring defense contractors to rapidly report cyber incidents on their unclassified networks or information systems that may affect unclassified defense information, or that affect their ability to provide operationally critical support to the Department. This rule underscores the importance of better protecting unclassified defense information against the immediate cyber threat, while preserving the intellectual property and competitive capabilities of our national defense industrial base. The rule enables DoD to better assess, in the near term, when mission critical capabilities and services are affected by cyber incidents and reinforces DoD's overall efforts to defend DoD information, protect U.S. national interests against cyber-attacks, and support military operations and contingency plans worldwide. Cybersecurity is a Congressional priority and this rule supports the Administration's national cybersecurity strategy emphasizing public-private information sharing.

Summary of Legal Basis: The activities in this rule implement DoD statutory authorities to establish programs and activities to protect sensitive DoD information, including when such information resides on or transits information systems operated by contractors or others in support of DoD activities (e.g., 10 U.S.C. 391 and 2224, the Federal Information Security Modernization Act (FISMA), codified at 44 U.S.C. 3551 et seq., section 941 of the NDAA for FY 2013 (Pub. L. 112-239)). Activities under this rule also fulfill important elements of DoD's critical infrastructure protection responsibilities, as the sector specific agency for the DIB sector (see Presidential Policy Directive 21 (PPD-21), Critical Infrastructure Security and Resilience, available at https://www.whitehouse.gov/​the-press-office/​2013/​02/​12/​presidential-policy-directive-critical-infrastructure-security-and-resil).

Alternatives: None. This is revision to an existing regulation (32 CFR part 236).

Anticipated Cost and Benefits: Under this rule, contractors will incur costs associated with requirements for reporting cyber incidents of covered defense information on their covered contractor information system(s) or those affecting the contractor's ability to provide operationally critical support. Costs for contractors include identifying and analyzing cyber incidents and their impact on covered defense information, or a contractor's ability to provide operationally critical support, as well as obtaining DoD-approved medium assurance certificates to ensure authentication and identification when reporting cyber incidents to DoD. Government costs include onboarding new companies under the voluntary DoD-DIB CS information sharing program, and collecting and analyzing cyber incident reports, malicious software, and media.

Risks: Cyber threats to DIB unclassified information systems represent an unacceptable risk of compromise of DoD information and mission and pose an imminent threat to U.S. national security and economic security interests. The combination of the mandatory DoD contractor cyber incident reporting, combined with the voluntary participation in the DIB CS program, will enhance and supplement DoD contractor capabilities to safeguard DoD information that resides on, or transits, DoD contractor unclassified network or information systems.

Timetable:

ActionDateFR Cite
Interim Final Rule10/02/1580 FR 59581
Interim Final Rule Effective10/02/15
Interim Final Rule Comment Period End12/01/15
Final Action08/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Vicki Michetti, Department of Defense, Office of the Secretary, 6000 Defense Pentagon, Washington, DC 20301-6000, Phone: 703 604-3177, Email: vicki.d.michetti.civ@mail.mil.

RIN: 0790-AJ29

Start Printed Page 77751

DOD—DEFENSE ACQUISITION REGULATIONS COUNCIL (DARC)

Proposed Rule Stage

19. • Detection and Avoidance of Counterfeit Electronic Parts—Further Implementation (DFARS Case 2014-D005)

Priority: Other Significant.

Legal Authority: 41 U.S.C. 1303; Pub. L. 112-81, sec 818; Pub. L. 113-291, sec 817

CFR Citation: 48 CFR 202; 48 CFR 212; 48 CFR 246; 48 CFR 252.

Legal Deadline: None.

Abstract: The Department of Defense (DoD) is issuing a proposed rule to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to further implement section 818 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2012, as modified by section 817 of the NDAA for FY 2015, which requires DoD to issue regulations establishing requirements that DoD and DoD contractors and subcontractors, except in limited circumstances, shall acquire electronic parts from trusted suppliers in order to further address the avoidance of counterfeit electronic parts. On May 6, 2014, DoD published a final rule under DFARS Case 2012-D055, entitled Detection and Avoidance of Counterfeit Electronic Parts (78 FR 26092). That final rule constituted the initial partial implementation of section 818. Revisions to this rule will be reported in future status updates as part of DoD's retrospective plan under Executive Order 13563, completed in August 2011. DoD's full plan can be accessed at: http://www.regulations.gov/​#!docketDetail;​D=​DOD-2011-OS-0036.

Statement of Need: DoD is required to implement in the DFARS the requirement for defense contractors and subcontractors, whenever possible, to acquire electronic parts from trusted suppliers, in order to avoid acquisition of counterfeit electronic parts.

Summary of Legal Basis: This regulation is proposed under the authorities of section 818 of the NDAA for FY 2012 (Pub. L. 112-81), as modified by section 817 of the NDAA for FY 2015 (Pub. L. 113-291).

Alternatives: No viable alternatives were identified, as this rule implements section 818 of the NDAA for FY 2012, as modified by section 817 of the NDAA for FY 2015.

Anticipated Cost and Benefits: Cost benefits or burdens associated with this rule are not available. The law requires DoD to issue regulations establishing requirements that DoD and DoD contractors and subcontractors, except in limited circumstances, shall acquire electronic parts from trusted suppliers in order to further address the avoidance of counterfeit electronic parts. DoD contractors and subcontractors that are not the original component manufacturer are required by the rule to notify the contracting officer if it is not possible to obtain an electronic part from a trusted supplier. For those instances where the contractor obtains electronic parts from sources other than a trusted supplier, the contractor is responsible for inspection, test, and authentication in accordance with existing applicable industry standards. Such validation of new parts and new suppliers are steps that a prudent contractor would take notwithstanding this rule. The additional burden imposed is the notification requirement, which should have a minimal cost impact. The rule applies only to contractors subject to the Cost Accounting Standards. This rule enhances DoD's ability to strengthen the integrity of the process for acquisition of electronic parts and benefits both the Government and contractors.

Risks: Failure to implement this rule may cause harm to the Government by resulting in the acquisition of counterfeit electronic parts which could directly impact national security.

Timetable:

ActionDateFR Cite
NPRM11/00/15
NPRM Comment Period End01/00/16
Final Action09/00/16
Final Action Effective09/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Agency Contact: Jennifer Hawes, Department of Defense, Defense Acquisition Regulations Council, 3060 Defense Pentagon, Room 3B941, Washington, DC 20301-3060, Phone: 571 372-6115, Email: jennifer.l.hawes2.civ@mail.mil.

Related RIN: Related to 0750-AH89

RIN: 0750-AI58

DOD—DARC

Final Rule Stage

20. • Network Penetration Reporting and Contracting for Cloud Services (DFARS Case 2013-D018)

Priority: Other Significant.

Legal Authority: 41 U.S.C. 1303; 41 U.S.C. 1707; Pub. L. 112-239, sec 941; Pub. L. 113-291, sec 1632

CFR Citation: 48 CFR 202; 48 CFR 204; 48 CFR 212; 48 CFR 239; 48 CFR 252.

Legal Deadline: None.

Abstract: The Department of Defense (DoD) is issuing an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement section 941 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2013 and section 1632 of the NDAA for FY 2015, both of which require contractor reporting on network penetrations. Section 941 requires cleared defense contractors to report penetrations of networks and information systems and allows DoD personnel access to equipment and information to assess the impact of reported penetrations. Section 1632 requires that a contractor designated as operationally critical must report each time a cyber-incident occurs on that contractor's network or information systems. The rule requires contractors and subcontractors to report cyber incidents that result in an actual or potentially adverse effect on a covered contractor information system or covered defense information residing therein, or on a contractor's ability to provide operationally critical support. This rule also implements policy on the purchase of cloud computing services. The revisions to this rule will be reported in future status updates as part of DoD's retrospective plan under Executive Order 13563, completed in August 2011. DoD's full plan can be accessed at: http://www.regulations.gov/​#!docketDetail;​D=​DOD-2011-OS-0036.

Statement of Need: DoD is required to implement in the DFARS a requirement for contractors to report network penetrations. Additionally, the DoD Chief Information Officer (CIO) released a Cloud Computing Security Requirements Guide on January 13, 2015, which cloud service providers must comply with when providing cloud services to DoD.

Summary of Legal Basis: This rule is required under the authorities of section 941 of the NDAA for FY 2013 (Pub. L. 112-239) and section 1632 of the NDAA for FY 2015 (Pub. L. 113-291).

Alternatives: No viable alternatives were identified, as this rule implements section 941 of the NDAA for FY 2013 and section 1632 of the NDAA for FY 2015, as well as the guidance established by the DoD CIO on security requirements for cloud computing.

Anticipated Cost and Benefits: Cost benefits or burdens associated with this rule are not available. The objective of Start Printed Page 77752the rule is to improve information security for DoD information stored on or transiting through contractor systems as well as in a cloud environment. The rule will reduce the vulnerability of DoD information via attacks on its systems and networks and those of DoD contractors. This rule improves national security benefiting both the Government and contractors. This rule is likely to have a cost impact on all contractors that have covered defense information on their information systems. The cost impact of the rule will vary in relation to the capabilities of each affected contractor to adapt their systems to meet the new security controls. The benefits of the rule would be the potential decrease in the loss or compromise of covered defense information; however, this benefit across DoD is not susceptible to being quantified or measured. Ultimately, DoD anticipates significant savings to taxpayers by improving information security for DoD information that resides in or transits through contractor systems and a cloud environment.

Risks: Recent high-profile breaches of Federal information show the need to ensure that information security protections are clearly, effectively, and consistently addressed in contracts. Failure to implement this rule may cause harm to the Government through the compromise of covered defense information or other Government data, or the loss of operationally critical support capabilities, which could directly impact national security.

Timetable:

ActionDateFR Cite
Interim Final Rule08/26/1580 FR 51739
Interim Final Rule Effective08/26/15
Interim Final Rule Comment Period End10/26/15
Interim Final Rule Comment Period Extended10/22/1580 FR 63928
Interim Final Rule Comment Period Extended End11/20/15
Final Action08/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Agency Contact: Jennifer Hawes, Department of Defense, Defense Acquisition Regulations Council, 3060 Defense Pentagon, Room 3B941, Washington, DC 20301-3060, Phone: 571 372-6115, Email: jennifer.l.hawes2.civ@mail.mil.

RIN: 0750-AI61

DOD—OFFICE OF ASSISTANT SECRETARY FOR HEALTH AFFAIRS (DODOASHA)

Proposed Rule Stage

21. • TRICARE: Mental Health and Substance Use

Priority: Other Significant.

Legal Authority: 10 U.S.C. 1073

CFR Citation: 32 CFR 199.

Legal Deadline: None.

Abstract: This rule proposes revisions to the TRICARE regulation to reduce administrative barriers to access to mental health benefit coverage and to improve access to substance use disorder (SUD) treatment for TRICARE beneficiaries, consistent with earlier Department of Defense and Institute of Medicine recommendations, current standards of practice in mental health and addition medicine, and governing laws. This proposed rule has four main objectives: (1) To eliminate of quantitative and qualitative treatment limitations on SUD and mental health benefit coverage and align beneficiary cost-sharing for mental health and SUD benefits with those applicable to medical/surgical benefits; (2) to expand covered mental health and SUD treatment under TRICARE, to include coverage of intensive outpatient programs and treatment of opioid dependence; (3) to streamline the requirements for institutional providers to become TRICARE authorized providers; and (4) to develop TRICARE reimbursement methodologies for newly recognized mental health and SUD intensive outpatient programs and opioid treatment programs.

Statement of Need: This rule is necessary to comply with the statutory provisions in section 703 of the National Defense Authorization Act for FY 2015 which removed TRICARE statutory day limitations on inpatient mental health services. It is also necessary to adopt the four main objectives listed above. In general, the DoD, pursuant to chapter 55 of title 10 U.S.C., covers health care, including mental health care, services and supplies, which are medically or psychologically necessary to prevent, diagnose, and/or treat a mental or physical illness, injury, or bodily malfunction. In 1996, Congress enacted the Mental Health Parity Act of 1996 (MHPA 1996) which required employment-related health insurance coverage offered in connection with group health plans to provide parity in aggregate lifetime and annual dollar limits for mental health benefits and medical and surgical benefits. In October 2008, the Mental Health Parity and Addictions Equity Act (MHPAEA) was signed into law as part of the Emergency Economic Stabilization Act of 2008. The changes made by MHPAEA consists of new standards, including parity for substance use disorder benefits, as well as amendments to the existing mental health parity provisions exacted in MHPA. This law requires group health insurance plans that provide both medical/surgical and mental health benefits to provide those benefits at parity. Specifically, financial requirements (e.g., deductibles, co-payments, or coinsurance) and treatment limitations (e.g., days of coverage and number of visits) cannot be more restrictive for mental health benefits than they are for medical/surgical benefits. The MHPAEA was amended by the Patient Protection and Affordable Care Act, as amended by the Health Care and Reconciliation Act of 2010, to also apply to individual health insurance coverage. TRICARE is not a group health plan subject to the MHPA 1996, the MHPAEA of 2008, or the Health Care and Reconciliation Act. However, the provisions of these acts serve as a model for TRICARE in proposing changes to existing benefit coverage so as to reduce administrative barriers to treatment and increase access to medically or psychologically necessary mental health care consistent with TRICARE statutory authority.

Summary of Legal Basis: This regulation is proposed under the authorities of 10 U.S.C., section 1073, which authorizes the Secretary of Defense to administer the medical and dental benefits provided in chapter 55 of title 10 U.S.C. The Department is authorized to provide medically necessary and appropriate medical care for mental and physical illnesses, injuries and bodily malfunctions, including hospitalization, outpatient care, drugs, and treatment of mental conditions under 10 U.S.C. 1077(a)(1)-(3) and (5). Although section 1077 identifies the types of health care to be provided in military treatment facilities, these types of health care are incorporated by reference as the types of health care benefits authorized for coverage within the civilian health care sector for active duty family members and retirees and their dependents through sections 1079 and 1086, respectively. In general, the scope of TRICARE benefits covered within the civilian health care sector and the TRICARE authorized providers of those benefits are found at 32 CFR part 199.4 Start Printed Page 77753and 199.6, respectively. Reimbursement is addressed in 32 CFR 199.14.

Alternatives: To the extent this rule implements statutorily required provisions, no alternatives are applicable. Further, any alternative that fails to address administrative barriers to mental health and SUD treatment and increasing access to medically or psychologically necessary mental health care consistent with TRICARE statutory authority is inconsistent with principles of mental health parity and ignores well-validated evidence and current standards of practice in mental health and SUD treatment.

Anticipated Cost and Benefits: This rule is not anticipated to have an annual effect on the economy of $100 million or more. Thus, economically, it is not a substantive, significant rule under the Executive Order and the Congressional Review Act. All services and supplies authorized under the TRICARE Basic Program must be determined to be medically necessary in the treatment of an illness, injury or bodily malfunction before the care can be cost shared by TRICARE. For this reason, DoD anticipates that TRICARE will have a marginal increase in cost associated with increased access to authorized mental health and SUD treatment within the TRICARE Basic Program. Failure to prevent or treat these conditions results in severe and widespread consequences, including increased risk of suicide and exacerbation of mental and physical health disorders. Short-term treatments usually are followed by relapses. These proposed revisions will increase access to mental health and SUD treatment, including long-term outpatient care and other systemic supports, resulting in more comprehensive care and hopefully a greater incentive for beneficiaries to seek the care they need.

Risks: This proposed rule implements statutorily required provisions for adoption and implementation. No risk to the public is applicable as this proposed rule expands access to care, and streamlines requirements for TRICARE authorized provider approval.

Timetable:

ActionDateFR Cite
NPRM01/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Patricia Moseley, Department of Defense, Office of Assistant Secretary for Health Affairs, Defense Pentagon, Washington, DC 22301, Phone: 703 681-0064.

RIN: 0720-AB65

DEPARTMENT OF EDUCATION

Statement of Regulatory Priorities

I. Introduction

The U.S. Department of Education (Department) supports States, local communities, institutions of higher education, and others in improving education and other services nationwide in order to ensure that all Americans, including those with disabilities, receive a high-quality education and are prepared for high-quality employment. We provide leadership and financial assistance pertaining to education and related services at all levels to a wide range of stakeholders and individuals, including State educational and other agencies, local school districts, providers of early learning programs, elementary and secondary schools, institutions of higher education, career and technical schools, nonprofit organizations, postsecondary students, members of the public, families, and many others. These efforts are helping to ensure that all children and students from pre-kindergarten through grade 12 will be ready for, and succeed in, postsecondary education or employment, and that students attending postsecondary institutions are prepared for a profession or career.

We also vigorously monitor and enforce the implementation of Federal civil rights laws in educational programs and activities that receive Federal financial assistance, and support innovative programs, research and evaluation activities, technical assistance, and the dissemination of research and evaluation findings to improve the quality of education.

Overall, the laws, regulations, and programs that the Department administers will affect nearly every American during his or her life. Indeed, in the 2015-2016 school year, about 55 million students will attend an estimated 130,000 elementary and secondary schools in approximately 13,500 districts, and about 21 million students will enroll in degree-granting postsecondary schools. All of these students may benefit from some degree of financial assistance or support from the Department.

In developing and implementing regulations, guidance, technical assistance, and monitoring related to our programs, we are committed to working closely with affected persons and groups. Specifically, we work with a broad range of interested parties and the general public, including families, students, and educators; State, local, and tribal governments; other Federal agencies; and neighborhood groups, community-based early learning programs, elementary and secondary schools, colleges, rehabilitation service providers, adult education providers, professional associations, advocacy organizations, businesses, and labor organizations.

If we determine that it is necessary to develop regulations, we seek public participation at the key stages in the rulemaking process. We invite the public to submit comments on all proposed regulations through the Internet or by regular mail. We also continue to seek greater public participation in our rulemaking activities through the use of transparent and interactive rulemaking procedures and new technologies.

To facilitate the public's involvement, we participate in the Federal Docketing Management System (FDMS), an electronic single Government-wide access point (www.regulations.gov) that enables the public to submit comments on different types of Federal regulatory documents and read and respond to comments submitted by other members of the public during the public comment period. This system provides the public with the opportunity to submit comments electronically on any notice of proposed rulemaking or interim final regulations open for comment, as well as read and print any supporting regulatory documents.

We are continuing to streamline information collections, reduce the burden on information providers involved in our programs, and make information easily accessible to the public.

II. Regulatory Priorities

A. Elementary and Secondary Education Act of 1965, as Amended

We are working with Congress to reauthorize the ESEA. As we do so, we continue to provide flexibility on certain provisions of current law for States that are embracing reform. The mechanisms we are using will ensure continued accountability and commitment to high-quality education for all students while providing States with increased flexibility to implement State and local reforms to improve student achievement. The ESEA, when enacted, will likely require the Department to promulgate conforming regulations.Start Printed Page 77754

B. Workforce Innovation and Opportunity Act

President Obama signed the Workforce Innovation and Opportunity Act (WIOA) into law on July 22, 2014. WIOA replaced the Workforce Investment Act of 1998 (WIA), including the Adult Education and Family Literacy Act (AEFLA), and amended the Wagner-Peyser Act and the Rehabilitation Act of 1973 (Rehabilitation Act). WIOA promotes the integration of the workforce development system's six “core programs”, including AEFLA and the vocational rehabilitation program under Title I of the Rehabilitation Act, into the revamped workforce development system under Title I of WIOA. The Department issued four NPRMs in April, 2015, one joint rule with the Department of Labor (DOL) and three ED-specific packages. We plan to issue final rules for each of the four packages in April, 2016.

C. Borrower Defense Issues

In August 2015, the Department announced its intent to convene a committee to develop proposed regulations for determining which acts or omissions of an institution of higher education (“institution”) a borrower may assert as a defense to repayment of a loan made under the William D. Ford Federal Direct Loan (Federal Direct Loan) Program (“borrower defenses”) and the consequences of such borrower defenses for borrowers, institutions, and the Secretary. Specifically, the Department intends to address: (1) The procedures to be used for a borrower to establish a defense to repayment; (2) the criteria that the Department will use to identify acts or omissions of an institution that constitute defenses to repayment of Federal Direct Loans to the Secretary; (3) the standards and procedures that the Department will use to determine the liability of the institution participating in the Federal Direct Loan Program for amounts based on borrower defenses; and (4) the effect of borrower defenses on institutional capability assessments. The Department is holding public hearings for interested parties to discuss the rulemaking agenda during September 2015, and anticipates that any committee established after the public hearings will begin negotiations in January 2016.

D. Higher Education Act of 1965, as Amended

The Higher Education Act expired at the end of 2013, and its reauthorization, when enacted, will likely require the Department to promulgate conforming regulations. In the meantime, we are continuing to work on several regulatory activities under the Title IV Federal Student Aid programs to improve protections for students and safeguard Federal dollars invested in postsecondary education.

IV. Principles for Regulating

Over the next year, we may need to issue other regulations because of new legislation or programmatic changes. In doing so, we will follow the Principles for Regulating, which determine when and how we will regulate. Through consistent application of those principles, we have eliminated unnecessary regulations and identified situations in which major programs could be implemented without regulations or with limited regulatory action.

In deciding when to regulate, we consider the following:

  • Whether regulations are essential to promote quality and equality of opportunity in education.
  • Whether a demonstrated problem cannot be resolved without regulation.
  • Whether regulations are necessary to provide a legally binding interpretation to resolve ambiguity.
  • Whether entities or situations subject to regulation are similar enough that a uniform approach through regulation would be meaningful and do more good than harm.
  • Whether regulations are needed to protect the Federal interest, that is, to ensure that Federal funds are used for their intended purpose and to eliminate fraud, waste, and abuse.

In deciding how to regulate, we are mindful of the following principles:

  • Regulate no more than necessary.
  • Minimize burden to the extent possible, and promote multiple approaches to meeting statutory requirements if possible.
  • Encourage coordination of federally funded activities with State and local reform activities.
  • Ensure that the benefits justify the costs of regulating.
  • To the extent possible, establish performance objectives rather than specify compliance behavior.
  • Encourage flexibility, to the extent possible and as needed to enable institutional forces to achieve desired results.

ED—OFFICE OF POSTSECONDARY EDUCATION (OPE)

Final Rule Stage

22. Repaye

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: 20 U.S.C. 1078; 20 U.S.C. 1087e

CFR Citation: 34 CFR 682.202; 34 CFR 685.202; 34 CFR 685.208; 34 CFR 685.209.

Legal Deadline: None.

Abstract: On June 9, 2014, the President issued a memorandum (79 FR 33843) directing the Secretary to propose regulations by June 9, 2015, that will allow additional students who borrowed Federal Direct Loans to cap their Federal student loan payments at 10 percent of their income. The memorandum further directed the Secretary to issue final regulations after considering all public comments with the goal of making the repayment option available to borrowers by December 31, 2015.

Statement of Need: The President has issued a memorandum directing the Secretary to propose regulations by June 9, 2015, that will allow additional student borrowers Federal Direct Loans to cap their Federal student loan payments at 10 percent of their income. The memorandum further directed the Secretary to issue final regulations after considering all public comments with the goal of making the repayment option available to borrowers by December 31, 2015.

In addition, the notice of proposed rulemaking will propose the establishment of procedures for Federal Family Education Loan (FFEL) Program loan holders to use the Department of Defense's Defense Manpower Data Center (DDMC) database to identify U.S. military servicemembers who may be eligible for a lower rate on their FFEL Program loans under the Servicemembers Civil Relief Act (SCRA).

Summary of Legal Basis: The President directed the Secretary to propose regulations that will allow additional student borrowers Federal Direct Loans to cap their Federal student loan payments at 10 percent of their income.

These final regulations will amend the Student Assistance General Provisions regulations governing Direct Loan cohort default rates (CDRs) to expand the circumstances under which an institution may challenge or appeal the potential consequences of a draft or final CDR based on the institution's participation rate index (PRI).Start Printed Page 77755

Alternatives: These will be discussed in the final regulations.

Anticipated Cost and Benefits: These will be discussed in the final regulations.

Risks: These will be discussed in the final regulations.

Timetable:

ActionDateFR Cite
Notice of Intent to Establish Negotiated Rulemaking Committee09/03/1479 FR 52273
NPRM07/09/1580 FR 39608
NPRM Comment Period End08/10/15
Final Action11/00/15

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal, Local, State.

URL for Public Comments: www.regulations.gov.

Agency Contact: Barbara Hoblitzell, Department of Education, Office of Postsecondary Education, Room 8019, 1990 K Street NW., Washington, DC 20006, Phone: 202 502-7649, Email: barbara.hoblitzell@ed.gov.

RIN: 1840-AD18

ED—OFFICE OF CAREER, TECHNICAL, AND ADULT EDUCATION (OCTAE)

Final Rule Stage

23. Workforce Innovation and Opportunity Act

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: Pub. L. 113-128; 29 U.S.C. 3101

CFR Citation: 34 CFR 361; 34 CFR 463.

Legal Deadline: Final, Statutory, January 22, 2016.

Abstract: The Departments of Education (ED) and Labor (DOL) are implementing, through final regulations, jointly-administered activities authorized by title I of the Workforce Innovation and Opportunity Act (WIOA) (Pub. L. 113-128). Through these regulations, the Departments will implement job training system reforms and strengthen the nation's workforce development system to put Americans back to work and make the United States more competitive in the 21st century. This joint rule provides guidance for State and local workforce development systems that increase the skill and credential attainment, employment, retention, and earnings of participants, especially those with significant barriers to employment, thereby improving the quality of the workforce, reducing welfare dependency, and enhancing the productivity and competitiveness of the nation.

WIOA strengthened the alignment of the workforce development system's six core programs by imposing unified strategic planning requirements, common performance accountability measures, and requirements governing the one-stop delivery system. In so doing, WIOA placed heightened emphasis on coordination and collaboration at the Federal, State, and local levels to ensure a streamlined and coordinated service delivery system for job seekers, including those with disabilities, and employers. To that end, ED and DOL are issuing final regulations to implement jointly-administered activities under title I of WIOA. These regulations lay the foundation, through coordination and collaboration at the Federal level, for implementing the vision and goals of WIOA.

Statement of Need: WIOA mandates that the Department issue final regulations by January 2016.

Summary of Legal Basis: WIOA mandates that the Department issue final regulations by January 2016.

Alternatives: These will be discussed in the final regulations.

Anticipated Cost and Benefits: These will be discussed in the final regulations.

Risks: These will be discussed in the final regulations.

Timetable:

ActionDateFR Cite
NPRM04/16/1580 FR 20573
NPRM Comment Period End06/15/15
Final Action04/00/16

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

URL for Public Comments: www.regulations.gov.

Agency Contact: Mary Louise Dirrigl, Department of Education, Office of Special Education and Rehabilitative Services, Room 5156, 400 Maryland Avenue SW., Washington, DC 20202, Phone: 202 245-7324, Email: mary.louise.dirrigl@ed.gov.

Cheryl Keenan, Department of Education, Office of Career, Technical, and Adult Education, Room 11-151, PCP, 550 12th Street SW., Washington, DC 20202, Phone: 202 245-7810, Email: cheryl.keenan@ed.gov.

RIN: 1830-AA21

DEPARTMENT OF ENERGY

Statement of Regulatory and Deregulatory Priorities

The Department of Energy (Department or DOE) makes vital contributions to the Nation's welfare through its activities focused on improving national security, energy supply, energy efficiency, environmental remediation, and energy research. The Department's mission is to:

  • Promote dependable, affordable and environmentally sound production and distribution of energy;
  • Advance energy efficiency and conservation;
  • Provide responsible stewardship of the Nation's nuclear weapons;
  • Provide a responsible resolution to the environmental legacy of nuclear weapons production; and
  • Strengthen U.S. scientific discovery, economic competitiveness, and improve quality of life through innovations in science and technology.

The Department's regulatory activities are essential to achieving its critical mission and to implementing major initiatives of the President's National Energy Policy. Among other things, the Regulatory Plan and the Unified Agenda contain the rulemakings the Department will be engaged in during the coming year to fulfill the Department's commitment to meeting deadlines for issuance of energy conservation standards and related test procedures. The Regulatory Plan and Unified Agenda also reflect the Department's continuing commitment to cut costs, reduce regulatory burden, and increase responsiveness to the public.

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), several regulations have been identified as associated with retrospective review and analysis in the Department's retrospective review of regulations plan. Some of the entries on this list may be completed actions, which do not appear in the Regulatory Plan. However, more information can be found about these completed rulemakings in past publications of the Unified Agenda on www.Reginfo.gov in the Completed Actions section. These rulemakings can also be found on www.Regulations.gov. The final agency plan can be found at Start Printed Page 77756 http://www.whitehouse.gov/​sites/​default/​files/​other/​2011-regulatory-action-plans/​departmentofenergyregulatoryreformplanaugust2011.pdf.

Energy Efficiency Program for Consumer Products and Commercial Equipment

The Energy Policy and Conservation Act (EPCA) requires DOE to set appliance efficiency standards at levels that achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified. The Department continues to follow its schedule for setting new appliance efficiency standards. These rulemakings are expected to save American consumers billions of dollars in energy costs.

Estimate of Combined Aggregate Costs and Benefits

In 2014, the Department published final rules that adopted new or amended energy conservation standards for ten different products, including furnace fans, motors, commercial refrigeration equipment, metal halide lamp fixtures, external power supplies, commercial clothes washers; general service fluorescent lamps, and automatic commercial ice makers. The ten standards finalized in 2014 are estimated to reduce carbon dioxide emissions by over 400 million metric tons and save American families and businesses $78 billion in electricity bills through 2030.

Since 2009, the Energy Department has finalized new efficiency standards for more than 30 household and commercial products, including dishwashers, refrigerators and water heaters, which are estimated to save consumers several hundred billion dollars through 2030. To build on this momentum, the Department is committed to continuing to establish new efficiency standards that—when combined with the progress already made through previously finalized standards—will reduce carbon pollution by approximately 3 billion metric tons in total by 2030, equal to more than a year's carbon pollution from the entire U.S. electricity system.

As part of the President's Climate Action Plan, the Energy Department has committed to an ambitious goal of finalizing at least 20 additional energy efficiency standards by the end of 2016. The overall plan for implementing the schedule is contained in the Report to Congress pursuant to section 141 of EPACT 2005, which was released on January 31, 2006. This plan was last updated in the August 2015 report to Congress and now includes the requirements of the Energy Independence and Security Act of 2007 (EISA 2007), the American Energy Manufacturing Technical Corrections Act (AEMTCA), and the Energy Efficiency Improvement Act of 2015. The reports to Congress are posted at: http://energy.gov/​eere/​buildings/​reports-and-publications. While each of these high priority rules will build on the progress made to date, and will continue to move the U.S. closer to a low carbon future, DOE believes that seven rulemakings are the most important of its significant regulatory actions and, therefore, comprise the Department's Regulatory Plan. However, because of the current stage of four of the rulemakings, DOE has not yet proposed candidate standard levels for these products and cannot provide an estimate of combined aggregate costs and benefits for this action. DOE will, however, in compliance with all applicable law, issue standards that provide the maximum improvement in energy efficiency that is technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemakings for central air conditioners and heat pumps, computers and battery backup systems, commercial water heaters, and general service fluorescent lamps. For small, large, and very large commercial package air conditioning and heating equipment, DOE estimates that energy savings from electricity will be 11.7 quads over 30 years and the benefit to the Nation will be between $16.5 billion to $50.8 billion. For non-weatherized gas furnaces, DOE estimates that energy savings from electricity will be 2.78 quads over 30 years and the benefit to the Nation will be between $3.1 billion and $16.1 billion. For commercial and industrial pumps, DOE estimates that the energy savings from electricity will be 0.28 quads over 30 years and the benefit to the Nation will be between $0.41 billion and $1.11 billion.

DOE—ENERGY EFFICIENCY AND RENEWABLE ENERGY (EE)

Proposed Rule Stage

24. Coverage Determination for Computers and Battery Backup Systems

Priority: Economically Significant. Major status under 5 U.S.C. 801 is undetermined

Unfunded Mandates: Undetermined

Legal Authority: 42 U.S.C. 6292(a)(20) and (b)

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: DOE has tentatively determined that computer and battery backup systems (computer systems) qualify as covered products under Part A of Title III of EPCA, as amended. DOE has not previously conducted an energy conservation standard rulemaking for computers systems. If, after public comment, DOE issues a final determination of coverage for computer systems, DOE may prescribe both test procedures and energy conservation standards for computer systems.

Statement of Need: EPCA authorizes DOE to establish minimum energy efficiency standards for certain appliances and commercial equipment, including computer systems. EPCA further requires that DOE review such standards and determine whether to amend them within six years after promulgation.

Summary of Legal Basis: Title III, Part B of the Energy Policy and Conservation Act of 1975 (EPCA or the Act), Pub. L. 94-163 (42 U.S.C. 6291-6309, as codified) established the Energy Conservation Program for Consumer Products Other Than Automobiles, a program covering most major household appliances (collectively referred to as covered products). In addition to specifying a list of covered products, EPCA contains provisions that enable the Secretary to classify additional types of consumer products as covered products. (42 U.S.C. 6292(a)(20)). For a given product to be classified as a covered product, the Secretary must determine that certain criteria are met. (42 U.S.C. 6292(b)(1). For the Secretary to prescribe an energy conservation standard pursuant to 42 U.S.C. 6295(o) and (p) for covered products added pursuant to 42 U.S.C. 6295(b)(1), he must also determine that certain additional criteria are met. (42 U.S.C. 6295(l)(1).

Alternatives: The statute requires DOE to conduct rulemakings to establish standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits: Because DOE has not yet proposed amended energy efficiency standards, DOE cannot provide an estimate of combined aggregate costs and benefits. DOE will, however, in compliance with all applicable laws, issue standards that provide for increased energy efficiency that are economically justified. Start Printed Page 77757Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking.

Risks:

Timetable:

ActionDateFR Cite
Notice of Proposed Determination02/28/1479 FR 11345
NOPD Comment Period End03/31/14
NOPD Comment Period Extended04/03/1479 FR 18661
NOPD Comment Period Extended End04/15/14
Framework Document07/17/1479 FR 41656
Framework Document Comment Period End09/02/14
Framework Document Comment Period Extended08/05/1479 FR 45377
Framework Document Comment Period Extended End10/02/14
NPRM11/00/15
Final Determination07/00/16

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Local, State.

Federalism: Undetermined.

URL for More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​rulemaking.aspx/​ruleid/​78.

URL for Public Comments: www.regulations.gov/​#!docketDetail;​D=​EERE-2013-BT-DET-0035.

Agency Contact: Jeremy Dommu, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 586-9870, Email: jeremy.dommu@ee.doe.gov.

RIN: 1904-AD04

DOE—EE

25. Energy Conservation Standards for General Service Lamps

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined

Unfunded Mandates: Undetermined

Legal Authority: 42 U.S.C. 6295(i)(6)(A) and (B)

CFR Citation: 10 CFR 430.

Legal Deadline: Final, Statutory, January 1, 2017.

Abstract: Amendments to Energy Policy and Conservation Act (EPCA) in the Energy Independence and Security Act of 2007 direct DOE to conduct two rulemaking cycles to evaluate energy conservation standards for GSLs, the first of which must be initiated no later than January 1, 2014. EPCA specifically states that the scope of the rulemaking is not limited to incandescent lamp technologies. EPCA also states that DOE must consider in the first rulemaking cycle the minimum backstop requirement of 45 lumens per watt for general service lamps (GSLs) effective January 1, 2020. This rulemaking constitutes DOE's first rulemaking cycle.

Statement of Need: EPCA requires minimum energy efficiency standards for certain appliances and commercial equipment.

Summary of Legal Basis: Title III of the Energy Policy and Conservation Act of 1975 (EPCA or the Act) Public Law 94163 (42 U.S.C. 6291-6309 as codified) established the Energy Conservation Program for Consumer Products Other Than Automobiles. Pursuant to EPCA any new or amended energy conservation standard that the U.S. Department of Energy (DOE) prescribes for certain products such as general service lamps shall be designed to achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified (42 U.S.C. 6295(o)(2)(A)) and result in a significant conservation of energy (42 U.S.C. 6295(o)(3)(B)).

Alternatives: The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination DOE conducts a thorough analysis of the alternative standard levels including the existing standard based on the criteria specified by the statute.

Anticipated Cost and Benefits: Because DOE has not yet proposed energy efficiency standards, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable law, issue standards that provide for increased energy efficiency that are economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking action.

Risks:

Timetable:

ActionDateFR Cite
Framework Document Availability; Public Meeting12/09/1378 FR 73737
Framework Document Comment Period End01/23/14
Framework Document Comment Period Extended01/23/1479 FR 3742
Framework Document Comment Period Extended End02/07/14
Preliminary Analysis; Notice of Public Meeting; Date 01/20/1512/11/1479 FR 73503
Preliminary Analysis Comment Period End02/09/15
Preliminary Analysis Comment Period Extended01/30/1580 FR 5052
Preliminary Analysis Comment Period Extended End02/23/15
NPRM11/00/15
Final Action10/00/16

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

URL for More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​rulemaking.aspx?​ruleid=​83.

URL for Public Comments: www.regulations.gov/​#!docketDetail;​D=​EERE-2013-BT-STD-0051.

Agency Contact: Lucy DeButts, Office of Buildings Technologies Program, EE-5B, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 287-1604, Email: lucy.debutts@ee.doe.gov.

RIN: 1904-AD09

DOE—EE

26. Energy Conservation Standards for Residential Non-Weatherized Gas Furnaces

Priority: Economically Significant. Major under 5 U.S.C. 801

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 42 U.S.C. 6295(f)(4)(e); 42 U.S.C. 6295(m)(1); 42 U.S.C. 6295(gg)(3)

CFR Citation: 10 CFR 430.Start Printed Page 77758

Legal Deadline: NPRM, Judicial, April 24, 2015. Final, Judicial, April 24, 2016, One year after issuance of the proposed rule.

Abstract: The Energy Policy and Conservation Act of 1975 (EPCA), as amended, prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including residential furnaces. EPCA also requires the DOE to periodically determine whether more-stringent amended standards would be technologically feasible and economically justified and would save a significant amount of energy. DOE is amending its energy conservation standards for residential non-weatherized gas furnaces and mobile home gas furnaces in partial fulfillment of a court-ordered remand of DOE's 2011 rulemaking for these products.

Statement of Need: EPCA requires minimum energy efficiency standards for certain appliances and commercial equipment, including residential furnaces.

Summary of Legal Basis: Title III of the Energy Policy and Conservation Act of 1975 (EPCA or the Act), Public Law 94-163 (42 U.S.C. 6291-6309, as codified), established the Energy Conservation Program for Consumer Products Other Than Automobiles. Pursuant to EPCA, any new or amended energy conservation standard that the U.S. Department of Energy (DOE) prescribes for certain products, such as residential furnaces, shall be designed to achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified (42 U.S.C. 6295(o)(2)(A)) and result in a significant conservation of energy (42 U.S.C. 6295(o)(3)(B)).

Alternatives: The statute requires DOE to conduct rulemakings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits: Because DOE has not yet proposed energy efficiency standards, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable laws, issue standards that provide for increased energy efficiency that are economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking.

Risks:

Timetable:

ActionDateFR Cite
Notice of Public Meeting10/30/1479 FR 64517
NPRM and Public Meeting Date 03/27/1503/12/1580 FR 13120
NPRM Comment Period Extended05/20/1580 FR 28851
NPRM Extended Comment Period End07/10/15
Notice of Data Availability (NODA)09/14/1580 FR 55038
NODA Comment Period End10/14/15
NODA Comment Period Reopened10/23/1580 FR 64370
NODA Comment Period Reopened End11/06/15
Final Action01/00/16

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Local, State.

URL for More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​product.aspx/​productid/​72.

URL for Public Comments: www.regulations.gov/​#!docketDetail;​D=​EERE-2014-BT-STD-0031.

Agency Contact: John Cymbalsky, Office of Building Technologies Program, EE-5B, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 287-1692, Email: john.cymbalsky@ee.doe.gov.

RIN: 1904-AD20

DOE—EE

27. Energy Conservation Standards for Commercial Water Heating Equipment

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: Undetermined.

Legal Authority: 412 U.S.C. 6313(a)(6)(C)(i) and (vi)

CFR Citation: 10 CFR 431.

Legal Deadline: NPRM, Statutory, December 31, 2013, Either proposed rule or determination not to amend standards.

Abstract: Once completed, this rulemaking will fulfill DOE's statutory obligation to either propose amended energy conservation standards for commercial water heaters, hot water supply boilers, and unfired hot water storage tanks or determine that the existing standards do not need to be amended. DOE must determine whether national standards more stringent than those that are currently in place would result in a significant additional amount of energy savings and whether such amended national standards would be technologically feasible and economically justified.

Statement of Need: EPCA requires minimum energy efficiency standards for certain appliances and commercial equipment, including commercial water heating equipment. EPCA further requires that DOE review such standards and determine whether to amend them within six years after promulgation.

Summary of Legal Basis: Title III, Part C of EPCA, Public Law 94163, (42 U.S.C. 62916309, as codified) sets forth a variety of provisions designed to improve energy efficiency and established the Energy Conservation Program for Certain Industrial Equipment, a program covering commercial and industrial equipment, including commercial water heating (CWH) equipment that is the subject of this rulemaking. (42 U.S.C. 6311(1)(K)).

EPCA requires DOE to evaluate and consider amending its energy conservation standards for certain commercial and industrial equipment (i.e., specified heating, air-conditioning, and water heating equipment) each time ASHRAE Standard 90.1 is updated with respect to such equipment. (42 U.S.C. 6313(a)(6)(A)) Pursuant to 42 U.S.C. 6313(a)(6)(A), for CWH equipment, EPCA directs that if ASHRAE Standard 90.1 is amended, DOE must publish in the Federal Register an analysis of the energy savings potential of amended energy conservation standards within 180 days of the amendment of ASHRAE Standard 90.1. (42 U.S.C. 6313(a)(6)(A)(i)) EPCA further directs that DOE must adopt amended standards at the new efficiency level in ASHRAE Standard 90.1, unless clear and convincing evidence supports a determination that adoption of a more-stringent level would produce significant additional energy savings and be technologically feasible and economically justified. (42 U.S.C. 6313(a)(6)(A)(ii)) If DOE decides to adopt as a national standard the efficiency levels specified in the amended ASHRAE Standard 90.1, DOE must establish such standard not later than 18 months after publication of the amended industry standard. (42 U.S.C. Start Printed Page 777596313(a)(6)(A)(ii)(I)) If DOE determines that a more-stringent standard is appropriate under the statutory criteria, DOE must establish such more-stringent standard not later than 30 months after publication of the revised ASHRAE Standard 90.1. (42 U.S.C. 6313(a)(6)(B)(i)).

In addition, EPCA requires DOE to periodically review its already-established energy conservation standards for covered ASHRAE equipment and publish either a notice of proposed rulemaking with amended standards or a determination that the standards do not need to be amended. (42 U.S.C. 6313(a)(6)(C)(i)) DOE's periodic review of ASHRAE equipment must occur [e]very six years. (42 U.S.C. 6313(a)(6)(C)(i)) EPCA also specifies that any amendments to the design requirements with respect to the ASHRAE equipment would trigger DOE review of the potential energy savings under 42 U.S.C. 6313(a)(6)(A)(i). EPCA also requires DOE to initiate a rulemaking to consider amending the energy conservation standards for any covered equipment for which more than 6 years has elapsed since the issuance of the most recent final rule establishing or amending a standard for the product as of December 18, 2012, in which case DOE must publish either: (1) A notice of determination that the current standards do not need to be amended, or (2) a notice of proposed rulemaking containing proposed standards. (42 U.S.C. 6313(a)(6)(C)(vi)).

Alternatives: The statute requires DOE to conduct rule makings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits: Because DOE has not yet proposed amended energy efficiency standards, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable laws, issue standards that provide for increased energy efficiency that are economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking.

Risks:

Timetable:

ActionDateFR Cite
Request for Information10/21/1479 FR 62899
RFI Comment Period End11/20/14
NPRM11/00/15
Final Action07/00/16

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

URL for More Information:www1.eere.energy.gov/​buildings/​appliance_​standards/​product.aspx/​productid/​51.

URL for Public Comments: www.regulations.gov/​#!docketDetail;​D=​EERE-2014-BT-STD-0042.

Agency Contact: Ashley Armstrong, General Engineer, EE-5B, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 586-6590, Email: ashley.armstrong@ee.doe.gov.

RIN: 1904-AD34

DOE—EE

28. Energy Conservation Standards for Central Air Conditioners and Heat Pumps

Priority: Economically Significant. Major status under 5 U.S.C. 801 is undetermined.

Unfunded Mandates: Undetermined.

Legal Authority: 42 U.S.C. 6295(m)(1)

CFR Citation: 10 CFR 430.

Legal Deadline: Final, Statutory, June 6, 2017, Final rule or final determination.

Abstract: DOE must determine whether to amend the current energy conservation standards for residential central air conditioner and heat pump products. According to the Energy Policy and Conservation Act's six-year review requirement (42 U.S.C. 6295(m)(1)), DOE must publish a notice of proposed rulemaking to propose new standards for residential central air conditioner and heat pump products, or a notice of determination that the existing standards do not need to be amended, by June 6, 2017. This rulemaking is to determine whether amended standards for residential central air conditioner and heat pump products would result in a significant amount of additional energy savings, and whether those standards would be technologically feasible and economically justified. On July 14, 2015, DOE announced its intention to establish a negotiated rulemaking working group to negotiate proposed federal standards for the energy efficiency requirements of central air conditioners and heat pumps.

Statement of Need: EPCA requires minimum energy efficiency standards for certain appliances and commercial equipment, including residential central air conditioner and heat pump products. EPCA further requires that DOE review such standards and determine whether to amend them six years after promulgation.

Summary of Legal Basis: Title III, Part B of the Energy Policy and Conservation Act of 1975 (EPCA or the Act), Public Law 94163, (42 U.S.C. 62916309, as codified) sets forth a variety of provisions designed to improve energy efficiency and established the Energy Conservation Program for Consumer Products Other Than Automobiles, a program covering major household appliances (collectively referred to as “covered products”), including residential central air conditioners and heat pumps that are the subject of this rulemaking. (42 U.S.C. 6292(a)(3)) Further, EPCA requires that, not later than six years after the issuance of a final rule establishing or amending a standard, DOE publish a NOPR proposing new standards or a notice of determination that the existing standards do not need to be amended. (42 U.S.C. 6295(m)(1)).

Alternatives: The statute requires DOE to conduct rule makings to review standards and to revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits: Because DOE has not yet proposed amended energy efficiency standards, DOE cannot provide an estimate of combined aggregate costs and benefits for these actions. DOE will, however, in compliance with all applicable laws, issue standards that provide for increased energy efficiency that are economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking.

Risks:

Timetable:

ActionDateFR Cite
Request for Information11/05/1479 FR 65603
Start Printed Page 77760
RFI Comment Period End12/05/14
Notice of Public Meeting of Working Group07/14/1580 FR 40938
NODA Provisional Analysis Tools08/28/1580 FR 52206
Notice of Public Meeting09/10/1580 FR 54444
NPRM11/00/15
NODA Comment Period End12/31/15
Final Action05/00/16

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

URL for More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​rulemaking.aspx?​ruleid=​104.

URL for Public Comments: www.regulations.gov/​#!docketDetail;​D=​EERE-2014-BT-STD-0048.

Agency Contact: Ashley Armstrong, General Engineer, EE-5B, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 586-6590, Email: ashley.armstrong@ee.doe.gov.

RIN: 1904-AD37

DOE—EE

Final Rule Stage

29. Energy Conservation Standards for Commercial and Industrial Pumps

Priority: Economically Significant.

Unfunded Mandates: Undetermined.

Legal Authority: 42 U.S.C. 6311(1)(A)

CFR Citation: 10 CFR 431.

Legal Deadline: None.

Abstract: EPCA, as amended, authorizes the Secretary to determine whether establishing energy conservation standards for commercial and industrial pumps is technically feasible and economically justified and would save a significant amount of energy. On June 13, 2013, DOE published a notice of intent to establish a negotiated rulemaking working group for the commercial and industrial pumps rulemaking under the Appliance Standards and Rulemaking Federal Advisory Committee (ASRAC) in accordance with the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act (NRA) to negotiate proposed Federal standards for the energy efficiency of commercial and industrial pumps (78 FR 44036). The purpose of the working group was to discuss and, if possible, reach consensus on a proposed rule for the energy efficiency of commercial and industrial pumps. The working group negotiated standard levels that were accepted by ASRAC on July 7, 2014. As a result, DOE has proposed to adopt the working groups' recommendations.

Statement of Need: EPCA authorizes DOE to establish minimum energy efficiency standards for certain appliances and commercial equipment, including Commercial and Industrial Pumps.

Summary of Legal Basis: Title III, Part C of EPCA, Public Law 94-163 (42 U.S.C. 6311-6317), established the Energy Conservation Program Certain Industrial Equipment. Pursuant to EPCA, any new or amended energy conservation standard that DOE prescribes for certain equipment, such as commercial and industrial pumps, shall be designed to achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified. (42 U.S.C. 6313(a)(6)(A)(ii)(II)). Furthermore, the new or amended standard must result in a significant conservation of energy. (42 U.S.C. 6313(a)(6)(A)(ii)(II)).

Alternatives: EPCA requires DOE, in conducting a rulemaking to consider standards for commercial and industrial equipment, including pumps, to establish standards that achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits: DOE finds that the benefits to the Nation of the proposed energy standards for Commercial and Industrial Pumps (such as energy savings, consumer average lifecycle cost savings, an increase in national net present value, and emission reductions) outweigh the burdens (such as loss of industry net present value). DOE estimates that energy savings from electricity will be 0.28 quads over 30 years and the benefit to the Nation will be between $0.41 billion to $1.11 billion.

Risks:

Timetable:

ActionDateFR Cite
Request for Information06/13/1176 FR 34192
Availability of Framework Document02/01/1378 FR 7304
NPRM04/02/1580 FR 17826
NPRM Comment Period End06/01/15
Final Action11/00/15

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

URL for More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​rulemaking.aspx/​ruleid/​14.

URL for Public Comments: www.regulations.gov/​#!docketDetail;​D=​EERE-2011-BT-STD-0031.

Agency Contact: John Cymbalsky, Office of Building Technologies Program, EE-5B, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 287-1692, Email: john.cymbalsky@ee.doe.gov.

RIN: 1904-AC54

DOE—EE

30. Energy Conservation Standards for Small, Large, and Very Large Commercial Package A/C and Heating Equipment

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: 42 U.S.C. 6313(a)(6)

CFR Citation: 10 CFR 431.

Legal Deadline: NPRM, Statutory, December 31, 2013, Either proposed rule or determination.

Abstract: The Energy Policy and Conservation Act of 1975, as amended, requires DOE to periodically review its standards for small, large, and very large commercial package air conditioners and heating equipment (which includes commercial unitary air conditioners and heat pumps—or CUACs). Under recent amendments to EPCA made by the American Efficient Manufacturing Technical Corrections Act of 2012 Pub. L. 112-210 (Dec. 18, 2012), DOE must review its standards for this equipment every six years and determine whether they need amending. It also requires that, for those equipment types for which more than six years have elapsed since the most recent final rules establishing or amending a standard for that equipment, DOE must publish a proposal to amend the applicable standard. More than six years has elapsed since the standards for this Start Printed Page 77761equipment were last amended. After reviewing these standards and the available data, DOE has determined that amending the current energy conservation standards for this equipment would be technologically feasible and economically justified. Accordingly, DOE proposed amending the current standards for this equipment. On April 1, 2015, DOE published a notice announcing that a working group was created to potentially develop negotiated standards. 80 FR 17363.

Statement of Need: EPCA requires minimum energy efficiency standards for certain appliances and commercial equipment, including Small, Large, and Very Large Commercial Package A/C and Heating Equipment.

Summary of Legal Basis: Title III, Part B 1 of the Energy Policy and Conservation Act of 1975 (EPCA or the Act), Public Law 94163 (42 U.S.C. 62916309, as codified), established the Energy Conservation Program for Consumer Products Other Than Automobiles. Pursuant to EPCA, any new or amended energy conservation standard that DOE prescribes for certain equipment, such as small, large, and very large air-cooled commercial package air conditioning and heating equipment (also known as commercial unitary air conditioners and heat pumps), shall be designed to achieve the maximum improvement in energy efficiency that is technologically feasible and economically justified. (42 U.S.C. 6313(a)(6)(A)(ii)(II)). Furthermore, the new or amended standard must result in a significant conservation of energy. (42 U.S.C. 6313(a)(6)(A)(ii)(II)).

Alternatives: The statute requires DOE to conduct rulemakings to review and revise standards to achieve the maximum improvement in energy efficiency that the Secretary determines is technologically feasible and economically justified. In making this determination, DOE conducts a thorough analysis of the alternative standard levels, including the existing standard, based on the criteria specified by the statute.

Anticipated Cost and Benefits: DOE finds that the benefits to the Nation of the proposed energy standards for Small, Large, and Very Large Commercial Package A/C and Heating Equipment (such as energy savings, consumer average lifecycle cost savings, an increase in national net present value, and emission reductions) outweigh the burdens (such as loss of industry net present value). DOE estimates that energy savings from electricity will be 11.7 quads over 30 years and the benefit to the Nation will be between $16.5 billion to $50.8 billion.

Risks:

Timetable:

ActionDateFR Cite
Request for Information (RFI); Document Availability02/01/1378 FR 7296
RFI Comment Period End03/04/13
NPRM and Public Meeting09/09/1479 FR 58948
NPRM Comment Period End12/01/14
NPRM Comment Period Reopened12/03/1479 FR 71710
NPRM Comment Period Reopened End12/22/14
Notice of Public Meeting for Working Group05/07/1580 FR 26199
Final Action12/00/15

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

URL for More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​rulemaking.aspx/​ruleid/​59.

URL for Public Comments: www.regulations.gov/​#!docketDetail;​D=​EERE-2013-BT-STD-0007.

Agency Contact: John Cymbalsky, Office of Building Technologies Program, EE-5B, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 287-1692, Email: john.cymbalsky@ee.doe.gov.

RIN: 1904-AC95

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Statement of Regulatory Priorities for Fiscal Year 2016

As the federal agency with principal responsibility for protecting the health of all Americans and for providing essential human services, especially to those most vulnerable, the Department of Health and Human Services (HHS) implements programs that strengthen the health care system; advance scientific knowledge and innovation; and improve the health, safety, and well-being of the American people.

The Department's regulatory priorities for Fiscal Year 2016 reflect this complex mission through planned rulemakings structured to implement the Department's six arcs for implementation of its strategic plan: Leaving the Department Stronger; Keeping People Healthy and Safe; Reducing the Number of Uninsured and Providing Access to Affordable Quality Care; Leading in Science and Innovation; Delivering High Quality Care and Spending Our Health Care Dollars More Wisely; and, Ensuring the Building Blocks for Success at Every Stage of Life. This overview highlights forthcoming rulemakings exemplifying these priorities.

I. Leaving the Department Stronger

The Department's work to improve the efficiency and accountability includes its innovation agenda, program integrity and key human resources initiatives. In particular, the Department plans to issue a regulation revising administrative appeal procedures for Medicare claim appeals to increase efficiency in the Medicare claims review and appeals process. Additionally, consistent with the President's Executive Order 13563, “Improving Regulation and Regulatory Review,” the Department remains committed to reducing regulatory burden on States, health care providers and suppliers, and other regulated entities by updating current rules to align them with emerging health and safety standards, and by eliminating outdated procedural provisions. A full listing of HHS's retrospective review initiatives can be found at http://www.hhs.gov/​retrospectivereview.

II. Keeping People Healthy and Safe

This HHS strategic priority encompasses the Department's work to enhance health, wellness and prevention; detect and respond to a potential disease outbreak or public health emergency; and prevent the spread of disease across borders. Since 1980, the prevalence of obesity among children and adolescents has almost tripled. Obesity has both immediate and long-term effects on the health and quality of life of those affected, increasing their risk for chronic diseases, including heart disease, type 2 diabetes, certain cancers, stroke, and arthritis—as well as increasing medical costs for the individual and the health system. Building on the momentum of Start Printed Page 77762the First Lady's “Let's Move” initiative, HHS has mobilized skills and expertise from across the Department to address this epidemic with research, public education, and public health strategies. Other representative regulations include:

Labeling and Nutrition Information

The Food and Drug Administration (FDA) plans to issue two final rules designed to provide more useful, easy to understand dietary information tools that will help millions of American families identify healthy choices in the marketplace. These rules, each benefiting from input received in extended public comment periods, include:

Food Labeling—Nutrition Information: FDA plans a rule, which, if finalized, revises the nutrition and supplement facts labels on packaged food, which has not been updated since 1993 (when mandatory nutrition labeling of food was first required). The aim of the proposed revision is to provide updated and easier to read nutrition information on the label to help consumers maintain healthy dietary practices; and

Food Labeling—Serving Sizes: FDA plans a rule, which, if finalized, requires serving-size information provided within the food label, providing current nutrition information based on the amount of food that is typically eaten as a serving, to assist consumers in maintaining healthy dietary practices.

Food Safety

FDA will maintain HHS's ongoing effort to promulgate rules required under the Food Safety Modernization Act (FSMA), working with public and private partners to build a new system of food safety oversight. Recently, FDA finalized its preventive controls in the manufacture and distribution of human foods and of animal feeds. This additional suite of regulations, if finalized, constitutes the heart of the FSMA food safety program by instituting uniform practices for the manufacture and distribution of food products, to ensure that those products are safe for consumption and will not cause or spread disease, including, Sanitary Transportation of Human and Animal Food and Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.

Preventing Death and Disease From Tobacco Use

In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act, authorizing FDA to regulate the manufacture, marketing, and distribution of tobacco products, to protect the public health and to reduce tobacco use by minors. Over the next fiscal year, FDA's planned tobacco regulations include proposing requirements that govern the methods used in the pre-production design manufacture, packing, and storage of tobacco products, a proposed rule that would establish a process for the submission of applications for new tobacco products, and finalizing the regulation deeming other tobacco products that meet the statutory definition of “tobacco product” to also be subject to the FD&C Act. This final regulation, known as the “deeming rule,” is necessary to afford FDA the authority to regulate additional products which include hookah, electronic cigarettes, cigars, pipe tobacco, other novel tobacco products, and future tobacco products.

Addressing Substance Use Disorders and Opioid Misuse, Abuse, and Overdose Death Prevention

HHS plans to undertake a number of regulations designed to fight misuse and abuse of prescription opioids and heroin and encourage individuals to seek needed treatment for substance use disorders. These initiatives include an update to the regulation regarding confidentiality of substance abuse treatment records to align with advances in health information technology while maintaining appropriate patient privacy protections. HHS also will undertake an update of the current regulation around prescribing for buprenorphine to increase access to this Food and Drug Administration-approved, evidence-based treatment for opioid dependence and help more people get the treatment necessary for their recovery.

Drugs and Medical Devices

In 2012, Congress provided new authorities under the Food and Drug Administration Safety and Innovation Act to support its mission of safeguarding the quality of medical products available to the public while ensuring the availability of innovative products. FDA is implementing this new authority with a focus on protecting the quality of medical products in the global drug supply chain; improving the availability of needed drugs and devices; and promoting better-informed decisions by health professionals and patients. HHS is updating FDA's regulations to reflect the increased use of generic drugs in the current marketplace, and will describe approaches for brand name and generic drug manufacturers to update product labeling. This rule, if finalized, will revise and clarify procedures for updates to product labeling to reflect certain types of newly acquired safety information through submission of a “changes being effected” supplement.

III. Reducing the Number of Uninsured and Providing Access to Affordable Quality Care

The Affordable Care Act expands access to health insurance through improvements in Medicaid, the establishment of Affordable Insurance Exchanges, and coordination between Medicaid, the Children's Health Insurance Program, and the Exchanges. In implementing the Affordable Care Act over the next fiscal year, HHS will pursue regulations transforming the way our nation delivers care. This includes creating better ways to pay providers, incentivize quality of care and distribute information to build a health care system that is better, smarter and healthier with an engaged, educated, and empowered consumer at the center.

Streamlining Medicaid Eligibility Determinations

A forthcoming final rule will bring to completion regulatory provisions that support our efforts to assist States in implementing Medicaid eligibility determinations, appeals, enrollment changes, and other State health subsidy programs stemming from the Affordable Care Act. The intent of the rule is to afford each State substantial discretion in the design and operation of that State's exchange, with standardization provided only where directed by the Act, or where there are compelling practical, efficiency or consumer-protection reasons.

Parity for Mental Health Treatment

The Mental Health Parity and Addiction Equity Act (MHPAEA) requires parity between mental health or substance use disorder benefits and medical/surgical benefits, with respect to financial requirements and treatment limitations under group health plans. Finalization of this rule will implement MHPAEA by proposing standards for Medicaid alternative benefit plans, Medicaid managed care organizations, and the Children's Health Insurance Program.

Equitable and Non-Discriminatory Treatment

Finalization of the rule implementing the Affordable Care Act's Section 1557 nondiscrimination provisions will ensure access to affordable, quality health care for all Americans—regardless of race, color, national origin, sex, age and ability.Start Printed Page 77763

IV. Leading in Science and Innovation

HHS continues to expand on early successes of more precise approaches in a few areas of medicine with the Precision Medicine Initiative (PMI), and work on 21st Century Cures. In particular, HHS, in collaboration with the President's Office of Science and Technology Policy will finalize revisions to existing rules governing research on human subjects, often referred to as the Common Rule. This rule would apply to institutions and researchers supported by HHS as well as researchers throughout much of the federal government who are conducting research involving human subjects. The proposed revisions codified in the final rule will aim to better protect human subjects while facilitating research, and also reducing burden, delay, and ambiguity for investigators.

V. Delivering High Quality Care and Spending Our Health Care Dollars More Wisely

HHS continues work to build a health care delivery system that results in better care, smarter spending, and healthier people by finding better ways to pay providers, deliver care, and distribute information all while keeping the individual patient at the center. In the coming fiscal year, the department will complete a number of regulations to accomplish this strategic objective:

Medicare Payment Rules

Nine Medicare payment rules will be updated to better reflect the current state of medical practice and to respond to feedback from providers seeking financial predictability and flexibility to better serve patients.

Medicaid Managed Care

This final rule modernizes the Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems. The rule aligns the rules governing Medicaid managed care with those of other major sources of coverage, including coverage through Qualified Health Plans and Medicare Advantage plans, implements statutory provision; strengthens actuarial soundness payment provisions to promote the accountability of Medicaid managed care program rates; ensures appropriate beneficiary protections and enhances expectations for program integrity. The rule also implements provisions of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) and addresses third party liability for trauma codes.

Improvements to Long-Term Care

This final rule would revise the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs. The changes are necessary to reflect advances in the theory and practice of service delivery and safety for patients in long-term care settings. The rule is also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.

VI. Ensuring the Building Blocks for Success at Every Stage of Life

Over the coming year, the Department will continue its support at critical stages of people's lives, from infancy to old age, and topics including early learning, Alzheimer's and dementia. A forthcoming rule from the Administration for Children and Families (ACF) will provide the first comprehensive update of Child Care and Development Fund (CCDF) regulations since 1998. The CCDF is a federal program that provides formula grants to States, territories, and tribes. The program provides financial assistance to low-income families to access child care so that they can work or attend a job-training or educational program. It also provides funding to improve the quality of child care and increase the supply and availability of child care for all families, including those who receive no direct assistance through CCDF. Another ACF rule, when finalized, would modify existing Head Start performance standards to take into account increased knowledge in the early childhood field since the standards were last updated more than 15 years ago. Changes would strengthen requirements on curriculum and assessment, supervision, health and safety, and governance. The rule would also streamline existing regulations to eliminate unnecessary or duplicative requirements.

Both rules are part of the Department's retrospective review initiative and highlight HHS's commitment to protecting the public health and effective human services while pursuing smarter, more efficient regulation over the next fiscal year.

HHS—SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION (SAMHSA)

Proposed Rule Stage

31. • Increase Number of Patients to Which Drug Addiction Treatment Act (DATA)—Waived Physicians Can Prescribe Buprenorphine

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: 21 U.S.C. 823(g)(2)

CFR Citation: 42 CFR 8.

Legal Deadline: None.

Abstract: This rule is needed to improve the national response to the rise in prescribed opioid misuse and heroin use and related morbidity and mortality by proposing an approach to increasing access to buprenorphine treatment while protecting against diversion. Medication assisted treatment (MAT) using buprenorphine, in combination with counseling and other support services, is one important tool for treating opioid addiction. To address this need and help close the gap in treatment services, SAMHSA would propose to address restrictions in the use of buprenorphine imposed by the Drug Addiction Treatment Act (DATA 2000).

Statement of Need: The Drug Addiction Treatment Act of 2000 (DATA) provided the means for physicians to obtain a waiver from the Controlled Substances Act in order to treat opioid use disorders with buprenorphine, an opioid partial opioid-agonist, without certification from SAMHSA as an Opioid Treatment Program (OTP). However, since the implementation of this act, the nation finds itself in the midst of a public health crisis of prescribed opioid misuse and heroin use and related morbidity and mortality. Every day in the United States 105 people die as a result of drug overdose and another 6,748 are treated in emergency departments for the misuse or abuse of drugs.

Responses to this public health problem include: Education of physicians in the appropriate management of pain and the role of opioid analgesics; implementation of effective prescription drug monitoring programs and other strategies to promote patient safety while reducing fraud and abuse; and promoting access to effective treatment for opioid use disorders. Medical and clinical evidence indicates medication-assisted treatment with pharmacotherapies approved for the treatment of substance use disorders are most effective for the treatment of opioid use disorders in particular. The medication-assisted treatment of opioid Start Printed Page 77764use disorders reduces all-cause mortality and reduces the morbidity, social dysfunction and criminality often associated with this condition. However, access to effective treatment has always encountered significant concrete obstacles such as: Lack of awareness of substance use disorders, lack of coverage for needed services, and inadequate treatment capacity. To help close this gap, SAMHSA would like to address restrictions in the use of buprenorphine imposed by the Drug Addiction Treatment Act (DATA 2000).

Summary of Legal Basis: 21 U.S.C. 823(g)(2).

Alternatives: OTPs expansion of buprenorphine, use of naltrexone, expansion of methadone; dose limitations, formulation limitations.

Anticipated Cost and Benefits: As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.

Risks: As we move toward publication, risks of these provisions will be included in the rule.

Timetable:

ActionDateFR Cite
NPRM04/00/16
NPRM Comment Period End06/00/16

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal, Local, State, Tribal.

Agency Contact: Brian Altman, Legislative Director, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Rockville, MD 02857, Phone: 240 276-2009, Email: brian.altman@samhsa.gov.

RIN: 0930-AA22

HHS—FOOD AND DRUG ADMINISTRATION (FDA)

Final Rule Stage

32. Food Labeling: Revision of the Nutrition and Supplement Facts Labels

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371

CFR Citation: 21 CFR 101.9; 21 CFR 101.36.

Legal Deadline: None.

Abstract: FDA is amending the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The rule would modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label. On July 27, 2015, FDA issued a supplemental notice of proposed rulemaking accepting comments on limited additional provisions until October 13, 2015. Also on July 27, 2015, FDA reopened the comment period on the proposed rule as to specific documents until September 25, 2015.

Statement of Need: Almost all of the regulations for the nutrition labeling of foods and dietary supplements have not been amended since mandatory nutrition labeling was first required in 1993. New scientific evidence and consumer research has become available since 1993 that can be used to update the content and appearance of information on the Nutrition Facts and Supplement Facts labels. Consumers can use the updated information to select foods that will assist them to maintain healthy dietary practices.

Summary of Legal Basis: FDA's legal basis derives from sections 201, 403, and 701(a) of the Federal Food, Drug, and Cosmetic Act.

Alternatives: The Agency will consider different options for the amount of time that manufacturers have to come into compliance with the requirements of this regulation, when finalized, so that the economic burden to industry can be minimized.

Anticipated Cost and Benefits: This rule will affect all foods that are currently required to bear nutrition labeling. It will have a significant cost to industry because all food labels will have to be updated. Much of the information currently provided on the Nutrition Facts and Supplement Facts labels is based on old reference values and scientific information. The changes would provide more current information to assist consumers in constructing a healthful diet. The potential economic benefit from the final rule stems from the improvement in diet among the U.S. population. Diet is a significant factor in the reduction in risk of chronic diseases such as coronary heart disease, certain types of cancer, stroke, diabetes, and obesity.

Risks: If information on the Nutrition Facts and Supplement Facts label is not updated, reference values that serve as the basis for the percent daily value will continue to be based on old scientific evidence, and consumers could believe that they are consuming an appropriate amount of nutrients when, in fact, they are not. In addition, consumers would not be able to determine the amount of specific nutrients in a food product because mandatory declaration of those nutrients is not currently required. Furthermore, consumers may overlook information on the label because it is not displayed prominently on the label. Changes to the reference values, nutrients declared on the label, and changes to the format and appearance of the label would reduce the risk of consumers not having information necessary to assist them in maintaining healthy dietary practices.

Timetable:

ActionDateFR Cite
ANPRM07/11/0368 FR 41507
ANPRM Comment Period End10/09/03
Second ANPRM04/04/0570 FR 17008
Second ANPRM Comment Period End06/20/05
Third ANPRM11/02/0772 FR 62149
Third ANPRM Comment Period End01/31/08
NPRM03/03/1479 FR 11879
NPRM Comment Period End06/02/14
Reopening of Comment Period as to Specific Documents07/27/1580 FR 44302
NPRM Comment Period End as to Specific Documents09/25/15
Supplemental NPRM to Solicit Comment on Limited Additional Provisions07/27/1580 FR 44303
Supplemental NPRM to Solicit Comment on Limited Additional Provisions Comment Period End10/13/15
Administrative Docket Update; Extension of Comment Period09/10/1580 FR 54446
Administrative Docket Update; Comment Period End10/13/15
NPRM Reopening of Comment Period for Certain Documents10/20/1580 FR 63477
NPRM Reopening of Comment Period for Certain Documents Comment Period End10/23/15
Final Action03/00/16
Start Printed Page 77765

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, Local.

Federalism: This action may have federalism implications as defined in E.O. 13132.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information: Includes Retrospective Review under E.O. 13563.

Agency Contact: Blakeley Fitzpatrick, Interdisciplinary Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-830), HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-5429, Email: nutritionprogramstaff@fda.hhs.gov.

RIN: 0910-AF22

HHS—FDA

33. Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at one Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCS

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371; Pub. L. 101-535, sec 2(b)(1)(A)

CFR Citation: 21 CFR 101.9; 21 CFR 101.12.

Legal Deadline: None.

Abstract: FDA is amending its labeling regulations for foods to provide updated Reference Amounts Customarily Consumed (RACCs) for certain food categories. This rule would provide consumers with nutrition information based on the amount of food that is customarily consumed, which would assist consumers in maintaining healthy dietary practices. In addition to updating certain RACCs, FDA is also amending the definition of single-serving containers; amending the label serving size for breath mints; and providing for dual-column labeling, which would provide nutrition information per serving and per container or unit, as applicable, under certain circumstances.

Statement of Need: The regulations for serving sizes for the nutrition labeling of foods have not been amended since mandatory nutrition labeling was first promulgated in 1993. New scientific evidence, consumption data, and consumer research has become available since 1993 that can be used to update the serving size information on Nutrition Facts labels to reflect the amount of food customarily consumed. This could allow consumers to use the serving size information more effectively by giving them information to help them select foods that will promote maintenance of healthy dietary practices.

Summary of Legal Basis: FDA's legal basis is derived from sections 201, 403 and 701(a) of the Federal Food, Drug and Cosmetic Act and section 2(b)(1) of the Nutrition Labeling and Education Act of 1990.

Alternatives: The Agency will consider different options for the amount of time that manufacturers have to come into compliance with the requirements of this regulation, so that the economic burden to industry can be minimized. The Agency also intends to publish this regulation simultaneously with other regulations requiring changes to Nutrition Fact labels to ease the economic burden on manufacturers.

Anticipated Cost and Benefits: This rule will affect most foods that are currently required to bear nutrition labeling. It will have a significant cost to industry because food labels on all affected foods will have to be updated. These changes would provide more current information to assist consumers in constructing a healthful diet.

Risks: If the RACCs are not updated, RACCs that serve as the basis for serving sizes will continue to be based on old consumption data. These updates to the RACCs will be based, in part, on current nationwide consumption data. Without these updates, consumers will not have current information to assist them in constructing a healthy diet.

Timetable:

ActionDateFR Cite
ANPRM04/04/0570 FR 17010
ANPRM Comment Period End06/20/05
NPRM/Comment Period Extended03/03/1479 FR 11989
NPRM Comment Period End06/02/14
NPRM Comment Period Extended05/27/1479 FR 29699
NPRM Comment Period End08/01/14
Final Action03/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal, State.

Federalism: This action may have federalism implications as defined in E.O. 13132.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Cherisa Henderson, Nutritionist, Department of Health and Human Services, Food and Drug Administration, HFS-830, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-5429, Fax: 301 436-1191, Email: nutritionprogramstaff@fda.hhs.gov.

RIN: 0910-AF23

HHS—FDA

34. Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 342; 21 U.S.C. 350h; 21 U.S.C. 371; 42 U.S.C. 264; Pub. L. 111-353 (signed on January 4, 2011)

CFR Citation: 21 CFR 112.

Legal Deadline: Final, Judicial, October 31, 2015, To the Office of the Federal Register for publication.

Abstract: This rule will establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death. The purpose of the rule is to reduce the risk of illness associated with fresh produce.

Statement of Need: FDA is taking this action to meet the requirements of the Food Safety Moderhnization Act (FSMA) and to address the food safety challenges associated with fresh produce and, thereby, protect the public health. Data indicate that between 1973 and 1997, outbreaks of foodborne illness in the U.S. associated with fresh produce increased in absolute numbers and as a proportion of all reported foodborne illness outbreaks. The Agency issued general good agricultural practice guidelines for fresh fruits and vegetables over a decade ago. Start Printed Page 77766Incorporating prevention-oriented public health principles, and incorporating what we have learned in the past decade into a regulation is a critical step in establishing standards for the production and harvesting of produce, and reducing the foodborne illness attributed to fresh produce.

Summary of Legal Basis: FDA is relying on the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), provided by section 105 of the FSMA (codified primarily in section 419 of the FD&C Act (21 U.S.C. 350h)). FDA's legal basis also derives in part from sections 402(a)(3), 402(a)(4), and 701(a) of the FD&C Act (21 U.S.C. 342(a)(3), 342(a)(4), and 371(a)). FDA also intends to rely on section 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 264), which gives FDA authority to promulgate regulations to control the spread of communicable disease.

Alternatives: Section 105 of the FSMA requires FDA to conduct this rulemaking.

Anticipated Cost and Benefits: FDA estimates that the costs to more than 300,000 domestic and foreign producers and packers of fresh produce from the proposal would include one-time costs (e.g., new tools and equipment) and recurring costs (e.g., monitoring, training, recordkeeping). FDA anticipates that the benefits would be a reduction in foodborne illness and deaths associated with fresh produce. The monetized annual benefits of this rule are estimated to be $1 billion, and the monetized annual costs are estimated to be $460 million, domestically.

Risks: This regulation would directly and materially advance the Federal Government's substantial interest in reducing the risks for illness and death associated with foodborne infections associated with the consumption of fresh produce. Less restrictive and less comprehensive approaches have not been sufficiently effective in reducing the problems addressed by this regulation. FDA anticipates that the regulation would lead to a significant decrease in foodborne illness associated with fresh produce consumed in the United States.

Timetable:

ActionDateFR Cite
NPRM01/16/1378 FR 3503
NPRM Comment Period End05/16/13
NPRM Comment Period Extended04/26/1378 FR 24692
NPRM Comment Period Extended End09/16/13
NPRM Comment Period Extended08/09/1378 FR 48637
NPRM Comment Period Extended End11/15/13
Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Rule08/19/1378 FR 50358
Notice of Intent To Prepare Environmental Impact Statement for the Proposed Rule Comment Period End11/15/13
NPRM Comment Period Extended11/20/1378 FR 69605
NPRM Comment Period Extended End11/22/13
Environmental Impact Statement for the Proposed Rule; Comment Period Extended03/11/1479 FR 13593
Environmental Impact Statement for the Proposed Rule; Comment Period Extended End04/18/14
Supplemental NPRM09/29/1479 FR 58433
Supplemental NPRM Comment Period End12/15/14
Draft Environmental Impact Statement01/14/1580 FR 1852
Draft Environmental Impact Statement Comment Period End03/13/15
Final Rule11/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Samir Assar, Supervisory Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1636, Email: samir.assar@fda.hhs.gov.

RIN: 0910-AG35

HHS—FDA

35. “Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 301 et seq.; The Federal Food, Drug, and Cosmetic Act; Pub. L. 111-31; The Family Smoking Prevention and Tobacco Control Act

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides the Food and Drug Administration (FDA) authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the FD&C Act. This rule would deem additional products meeting the statutory definition of “tobacco product” to be subject to the FD&C Act, and would specify additional restrictions.

Statement of Need: Currently, the Tobacco Control Act provides FDA with immediate authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Tobacco Control Act also permits FDA to issue regulations deeming other tobacco products that meet the statutory definition of “tobacco product” to also be subject to the FD&C Act. This regulation is necessary to afford FDA the authority to regulate additional products which include hookah, electronic cigarettes, cigars, pipe tobacco, other novel tobacco products, and future tobacco products.

Summary of Legal Basis: Section 901 of the FD&C Act, as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the FD&C Act. Section 906(d) provides FDA with the authority to propose restrictions on the sale and distribution of tobacco products, including restrictions on the access to, and the advertising and promotion of, tobacco products if FDA determines that such regulation would Start Printed Page 77767be appropriate for the protection of the public health.

Alternatives: In addition to the benefits and costs of both options for the proposed rule, FDA assessed the benefits and costs of several alternatives to the proposed rule: e.g., deeming only, but exempt newly deemed products from certain requirements; exempt certain classes of products from certain requirements; deeming only, with no additional provisions; and changes to the compliance periods.

Anticipated Cost and Benefits: The proposed rule consists of two co-proposals, option 1 and option 2. The proposed option 1 deems all products meeting the statutory definition of “tobacco product” except accessories of a proposed deemed tobacco product to be subject to chapter IX of the FD&C Act. Option 1 also proposes additional provisions that would apply to proposed deemed products as well as to certain other tobacco products. Option 2 is the same as option 1 except that it exempts premium cigars. We expect that asserting our authority over these tobacco products will enable us to take further regulatory action in the future as appropriate; those actions will have their own costs and benefits. The proposed rule would generate some direct benefits by providing information to consumers about the risks and characteristics of tobacco products which may result in consumers reducing their use of cigars and other tobacco products. Other potential benefits follow from premarket requirements which could prevent more harmful products from appearing on the market and worsening the health effects of tobacco product use. The proposed rule would impose costs in the form of registration submission labeling and other requirements; other likely costs are not quantifiable based on current data.

Risks: Adolescence is the peak time for tobacco use initiation and experimentation. In recent years, new and emerging tobacco products, sometimes referred to as “novel tobacco products,” have been developed and are becoming an increasing concern to public health due, in part, to their appeal to youth and young adults. Non-regulated tobacco products come in many forms, including electronic cigarettes, nicotine gels, and certain dissolvable tobacco products (i.e., those dissolvable products that do not currently meet the definition of smokeless tobacco under 21 U.S.C. 387(18) because they do not contain cut, ground, powdered, or leaf tobacco, and instead contain nicotine extracted from tobacco), and these products are widely available. This deeming rule is necessary to provide FDA with authority to regulate these products (e.g., registration, product and ingredient listing, user fees for certain products, premarket requirements, and adulteration and misbranding provisions). In addition, the additonal restrictions that FDA seeks to promulgate for the proposed deemed products will protect youth by restricting minors' access to these products and will increase consumer understanding of the impact of these products on public health. This rule is consistent with other approaches that the Agency has taken to address the tobacco epidemic and is particularly necessary, given that consumer use may be gravitating to the proposed deemed products.

Timetable:

ActionDateFR Cite
NPRM04/25/1479 FR 23142
NPRM Comment Period End07/09/14
NPRM Comment Period Extended06/24/1479 FR 35711
NPRM Comment Period End08/08/14
Final Action11/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Gerie Voss, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, MD 20993, Phone: 877 287-1373, Fax: 301 595-1426, Email: ctpregulations@fda.hhs.gov.

RIN: 0910-AG38

HHS—FDA

36. Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals

Priority: Other Significant.

Legal Authority: 21 U.S.C. 360b(l); 21 U.S.C. 371

CFR Citation: 21 CFR 514.80.

Legal Deadline: None.

Abstract: This final rule would require that the sponsor of each approved or conditionally approved antimicrobial new animal drug product submit an annual report to the Food and Drug Administration (FDA or Agency) on the amount of each antimicrobial active ingredient in the drug product that is sold or distributed for use in food-producing animals, including any distributor-labeled product. In addition to codifying these requirements, FDA is exploring other requirements for the collection of additional drug distribution data.

Statement of Need: Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) amended section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that the sponsor of each approved or conditionally appoved new animal drug product that contains an antimicrobial active ingredient submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This legislation was enacted to assist FDA in its continuing analysis of the interactions (including drug resistance), efficacy, and safety of antibiotics approved for use in both humans and food-producing animals (H. Rpt. 110-804). This rulemaking is to codify these requirements. In addition, FDA is exploring the establishment of other reporting requirements to provide for the collection of additional drug distribution data, including reporting sales and distribution data by species.

Summary of Legal Basis: Section 105 of ADUFA (Pub. L. 110-316; 122 Stat. 3509) amended section 512 of the FD&C Act (21 U.S.C. 360b) to require that sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient submit an annual report to the Food and Drug Administration on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. FDA is also issuing this rule under its authority under section 512(l) of the FD&C Act to collect information relating to approved new animal drugs.

Alternatives: This rulemaking codifies the congressional mandate of ADUFA section 105. The annual reporting required under ADUFA section 105 is necessary to address potential problems concerning the safety and effectiveness of antimicrobial new animal drugs. Less Start Printed Page 77768frequent data collection would hinder this purpose.

Anticipated Cost and Benefits: Sponsors of antimicrobial drugs sold for use in food-producing animals currently report sales and distribution data to the Agency under section 105 of ADUFA; this rulemaking will codify in FDA's regulations a current statutory requirement. There may be a minimal additional labor cost if any other reporting requirement is included. Additional data beyond the reporting requirements specified in ADUFA section 105 will help the Agency better understand how the use of medically important antimicrobial drugs in food-producing animals may relate to antimicrobial resistance.

Risks: Section 105 of ADUFA was enacted to address the problem of antimicrobial resistance, and to help ensure that FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals. 154 Congressional Record H7534.

Timetable:

ActionDateFR Cite
ANPRM07/27/1277 FR 44177
ANPRM Comment Period End09/25/12
ANPRM Comment Period Extended09/26/1277 FR 59156
ANPRM Comment Period End11/26/12
Final Rule05/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Sujaya Dessai, Supervisory Veterinary Medical Officer, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 2620, HFV-212, 7519 Standish Place, Rockville, MD 20855, Phone: 240 402-5761, Email: sujaya.dessai@fda.hhs.gov.

RIN: 0910-AG45

HHS—FDA

37. Focused Mitigation Strategies to Protect Food Against Intentional Adulteration

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350g; 21 U.S.C. 350i; 21 U.S.C. 371; 21 U.S.C. 374; Pub. L. 111-353

CFR Citation: 21 CFR 121.

Legal Deadline: Final, Judicial, May 31, 2016, To the Office of the Federal Register for publication.

Abstract: This rule would require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act to address hazards that may be intentionally introduced by acts of terrorism. These food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation.

Statement of Need: FDA is taking this action to meet the requirements of the FSMA and to protect food from intentional adulteration when the intent is to cause large-scale public harm.

Summary of Legal Basis: FDA's authority for issuing this rule is provided by the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by sections 103, 105, and 106 of the Food Safety Modernization Act (FSMA). Section 418 of the FD&C Act addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food and are required to register under section 415 of the FD&C Act (21 U.S.C. 350g). Section 419 of the FD&C Act (21 U.S.C. 350h) addresses intentional adulteration in the context of fruits and vegetables that are raw agricultural commodities. Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high risk foods and exempts farms except for farms that produce milk. FDA is implementing the intentional adulteration provisions in sections 418, 419, and 420 of the FD&C Act in this rulemaking.

Alternatives: Section 103, 105 and 106 of the FDA, Food Safety Modernization Act require FDA to conduct this rulemaking.

Anticipated Cost and Benefits: FDA estimates that the costs from the proposal to domestic and foreign producers and packers of processed foods would include new one-time costs (e.g., adoption of written food defense plans, setting up training programs, etc.) and recurring costs (e.g., training employees, and completing and maintaining records used throughout the facility). FDA anticipates that the benefits would be a reduction in the possibility of illness, death, and economic disruption resulting from intentional adulteration of food.

Risks: This regulation will directly and materially advance the Federal Government's substantial interest in reducing the risk for illness and death associated with intentional adulteration of food.

Timetable:

ActionDateFR Cite
NPRM12/24/1378 FR 78014
NPRM Comment Period Extended03/25/1479 FR 16251
NPRM Comment Period End03/31/14
NPRM Comment Period Extended End06/30/14
Final Rule06/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Jody Menikheim, Supervisory General Health Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-005), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1864, Fax: 301 436-2633, Email: fooddefense@fda.hhs.gov.

RIN: 0910-AG63

HHS—FDA

38. Foreign Supplier Verification Program

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 384a; title III, sec 301 of FDA Food Safety Modernization Act; Pub. L. 111-353, establishing sec 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

CFR Citation: Not Yet Determined.

Legal Deadline: Final, Judicial, October 31, 2015, To the Office of the Federal Register for publication.

Abstract: This rule describes what a food importer must do to verify that its foreign suppliers produce food that is as safe as food produced in the United States. FDA is taking this action to improve the safety of food that is imported into the United States.

Statement of Need: The rule is needed to help improve the safety of food that is imported into the United States. Start Printed Page 77769Imported food products have increased dramatically over the last several decades. Data indicate that about 15 percent of the U.S. food supply is imported. FSMA provides the Agency with additional tools and authorities to help ensure that imported foods are safe for U.S. consumers. Included among these tools and authorities is a requirement that importers perform risk-based foreign supplier verification activities to verify that the food they import is produced in compliance with U.S. requirements, as applicable, and is not adulterated or misbranded. This proposed rule on the content of foreign supplier verification programs (FSVPs) sets forth the proposed steps that food importers would be required to take to fulfill their responsibility to help ensure the safety of the food they bring into this country.

Summary of Legal Basis: Section 805(c) of the FD&C Act (21 U.S.C. 384a(c)) directs FDA, not later than one year after the date of enactment of FSMA, to issue regulations on the content of FSVPs. Section 805(c)(4) states that verification activities under such programs may include monitoring records for shipments, lot-by-lot certification of compliance, annual onsite inspections, checking the hazard analysis and risk-based preventive control plans of foreign suppliers, and periodically testing and sampling shipments of imported products. Section 301(b) of FSMA amends section 301 of the FD&C Act (21 U.S.C. 331) by adding section 301(zz), which designates as a prohibited act the importation or offering for importation of a food if the importer (as defined in section 805) does not have in place an FSVP in compliance with section 805. In addition, section 301(c) of FSMA amends section 801(a) of the FD&C Act (21 U.S.C. 381(a)) by stating that an article of food being imported or offered for import into the United States shall be refused admission if it appears, from an examination of a sample of such an article or otherwise, that the importer is in violation of section 805.

Alternatives: We are considering a range of alternative approaches to the requirements for foreign supplier verification activities. These might include: (1) Establishing a general requirement that importers determine and conduct whatever verification activity would adequately address the risks associated with the foods they import; (2) allowing importers to choose from a list of possible verification mechanisms, such as the activities listed in section 805(c)(4) of the FD&C Act; (3) requiring importers to conduct particular verification activities for certain types of foods or risks (e.g., for high-risk foods), but allowing flexibility in verification activities for other types of foods or risks; and (4) specifying use of a particular verification activity for each particular kind of food or risk. To the extent possible while still ensuring that verification activities are adequate to ensure that foreign suppliers are producing food in accordance with applicable U.S. requirements, we will seek to give importers the flexibility to choose verification procedures that are appropriate to adequately address the risks associated with the importation of a particular food.

Anticipated Cost and Benefits: We are still estimating the cost and benefits for this rule. However, the available information suggests that the costs will be significant. Our preliminary analysis of FY10 OASIS data suggests that this rule will cover about 60,000 importers, 240,000 unique combinations of importers and foreign suppliers, and 540,000 unique combinations of importers, products, and foreign suppliers. These numbers imply that provisions that require activity for each importer, each unique combination of importer and foreign supplier, or each unique combination of importer, product, and foreign supplier will generate significant costs. An example of a provision linked to combinations of importers and foreign suppliers would be a requirement to conduct a verification activity, such as an onsite audit, under certain conditions. The cost of onsite audits will depend, in part, on whether foreign suppliers can provide the same onsite audit results to different importers, or whether every importer will need to take some action with respect to each of their foreign suppliers. The benefits of this rule will consist of the reduction of adverse health events linked to imported food that could result from increased compliance with applicable requirements, and are accounted for in the proposed rules that contain those requirements.

Risks: As stated above, about 15 percent of the U.S. food supply is imported, and many of these imported foods are high-risk commodities. According to recent data from the Centers for Disease Control and Prevention, each year, about 48 million Americans get sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. We expect that the adoption of FSVPs by food importers will benefit the public health by helping to ensure that imported food is produced in compliance with other applicable food safety regulations.

Timetable:

ActionDateFR Cite
NPRM07/29/1378 FR 45729
NPRM Comment Period End11/26/13
NPRM Comment Period Extended11/20/1378 FR 69602
NPRM Comment Period Extended End01/27/14
Supplemental NPRM09/29/1479 FR 58573
Supplemental NPRM Comment Period End12/15/14
Final Rule11/00/15

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Brian L. Pendleton, Senior Policy Advisor, Department of Health and Human Services, Food and Drug Administration, Office of Policy, WO 32, Room 4245, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-4614, Fax: 301 847-8616, Email: brian.pendleton@fda.hhs.gov.

RIN: 0910-AG64

HHS—FDA

39. Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications

Priority: Other Significant.

Legal Authority: 21 U.S.C. 384d; Pub. L. 111-353; sec 307 FDA Food Safety Modernization Act; 21 U.S.C. 371; 21 U.S.C. 381; 21 U.S.C. 384b; . . .

CFR Citation: 21 CFR 1.

Legal Deadline: Final, Judicial, October 31, 2015, To the Office of the Federal Register for publication.

Abstract: This rule establishes regulations for accreditation of third-party auditors to conduct food safety audits. FDA is taking this action to improve the safety of food that is imported into the United States.

Statement of Need: The use of accredited third-party auditors to certify food imports will assist in ensuring the safety of food from foreign origin entering U.S. commerce. Accredited third-party auditors auditing foreign facilities can increase FDA's information about foreign facilities that FDA may not have adequate resources Start Printed Page 77770to inspect in a particular year. FDA will establish identified standards creating overall uniformity to complete the task. Audits that result in issuance of facility or food certification will provide FDA information about the compliance status of the facility. Additionally, auditors will be required to submit audit reports that may be reviewed by FDA for purposes of compliance assessment and work planning.

Summary of Legal Basis: Section 808 of the FD&C Act directs FDA to establish, not later than two years after the date of enactment, a system for the recognition of accreditation bodies that accredit third-party auditors, who, in turn, certify that eligible entities are in compliance with the provisions of the FD&C Act. If within two years after the date of the establishment of the system, FDA has not identified and recognized an accreditation body, FDA may directly accredit third party auditors.

Alternatives: FSMA described in detail the framework for, and requirements of, the accredited third-party auditor program. Alternatives include the degree to which the standards in the requirements are prescriptive or flexible.

Anticipated Cost and Benefits: The benefits of the proposed rule would be less unsafe or misbranded food entering U.S. commerce. Additional benefits include the increased flow of credible information to FDA regarding the compliance status of foreign firms and their foods that are ultimately offered for import into the United States, which information, in turn, would inform FDA's work planning for inspection of foreign food facilities and might result in a signal of possible problems with a particular firm or its products, and with sufficient signals, might raise questions about the rigor of the food safety regulatory system of the country of origin. The compliance costs of the proposed rule would result from the additional labor and capital required of accreditation bodies seeking FDA recognition and of third-party auditors seeking accreditation to the extent that will involve the assembling of information for an application unique to the FDA third-party auditor program, as well as assembling renewal applications and required reports and notifications. The compliance costs associated with certification will be accounted for separately under the costs associated with participation in the Voluntary Qualified Importer Program. The third-party program is funded through revenue neutral-user fees, which will be developed by FDA through rulemaking.

Risks: FDA is proposing this rule to provide greater assurance that the food offered for import into the United States is safe and will not cause injury or illness to animals or humans. The rule would implement a program for accrediting third-party auditors to conduct food safety audits of foreign food entities, including registered foreign food facilities, and based on the findings of the regulatory audit, to issue food or facility certifications. The certifications could be used by importers seeking to participate in the Voluntary Qualified Importer Program for expedited review and entry of product, and would be a means to provide assurance of compliance with the FD&C Act as a food risk-related consideration. The food certifications could be used when FDA makes decisions regarding the importation of foods with safety risks. The rule would apply to any foreign or domestic accreditation body seeking FDA recognition, any foreign or domestic third-party auditor seeking accreditation, any foreign food entity, that chooses to be audited by an accredited third party auditor and any importer seeking to participate in the Voluntary Qualified Importer Program. Fewer instances of unsafe or misbranded food entering U.S. commerce would reduce the risk of serious illness and death to humans and animals.

Timetable:

ActionDateFR Cite
NPRM07/29/1378 FR 45781
NPRM Comment Period End11/26/13
NPRM Comment Period Extended11/20/1378 FR 69603
NPRM Comment Period Extended End01/27/14
Final Action11/00/15

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Undetermined.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Charlotte A. Christin, Acting Director, Division of Enforcement, Office of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Room 2C019, College Park, MD 20740, Phone: 240 402-3708, Email: charlotte.christin@fda.hhs.gov.

RIN: 0910-AG66

HHS—FDA

40. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products

Priority: Other Significant.

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 352; 21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262; . . .

CFR Citation: 21 CFR 314.70; 21 CFR 314.97; 21 CFR 314.150; 21 CFR 601.12.

Legal Deadline: None.

Abstract: This rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change.

Statement of Need: In the current marketplace, approximately 80 percent of drugs dispensed are generic drugs approved in ANDAs. ANDA holders, like NDA holders and BLA holders, are required to promptly review all adverse drug experience information obtained or otherwise received, and comply with applicable reporting and recordkeeping requirements. However, under current FDA regulations, ANDA holders are not permitted to use the changes being effected (CBE) supplement process in the same manner as NDA holders and BLA holders to independently update product labeling with certain newly acquired safety information. This regulatory difference recently has been determined to mean that an individual can bring a product liability action for “failure to warn” against an NDA holder, but generally not an ANDA holder. This may alter the incentives for generic drug manufacturers to comply with current requirements to conduct robust postmarketing surveillance, evaluation, and reporting, and to ensure that their product labeling is accurate and up-to-date. Accordingly, there is a need for ANDA holders to be able to independently update product labeling to reflect certain newly acquired safety information as part of the ANDA holder's independent responsibility to ensure that its product labeling is accurate and up-to-date.

Summary of Legal Basis: The Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the Public Health Service Act (42 U.S.C. 201 et seq.) provide FDA with authority over the labeling for drugs and biological products, and authorize the Agency to enact regulations to facilitate FDA's review and approval of applications regarding Start Printed Page 77771the labeling for those products. FDA's authority to extend the CBE supplement process for certain safety-related labeling changes to ANDA holders arises from the same authority under which FDA's regulations relating to NDA holders and BLA holders were issued.

Alternatives: FDA is considering several alternatives described in comments submitted to the public docket established for the proposed rule.

Anticipated Cost and Benefits: FDA is reviewing comments submitted to the public docket and evaluating the anticipated costs and benefits that would be associated with a final rule.

Risks: This rule is intended to remove obstacles to the prompt communication of safety-related labeling changes that meet the regulatory criteria for a CBE supplement. The rule may encourage generic drug companies to participate more actively with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements. FDA's posting of information on its Web site regarding the safety-related labeling changes proposed in pending CBE supplements would enhance transparency, and facilitate access by health care providers and the public so that such information may be used to inform treatment decisions.

Timetable:

ActionDateFR Cite
NPRM11/13/1378 FR 67985
NPRM Comment Period Extended12/27/1378 FR 78796
NPRM Comment Period End01/13/14
NPRM Comment Period Extended End03/13/14
NPRM Comment Period Reopened02/18/1580 FR 8577
NPRM Comment Period Reopened End04/27/15
Final Rule07/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Agency Contact: Janice L. Weiner, Senior Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6268, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, Email: janice.weiner@fda.hhs.gov.

RIN: 0910-AG94

HHS—FDA

41. Sanitary Transportation of Human and Animal Food

Priority: Economically Significant. Major under 5 U.S.C. 801.

Unfunded Mandates: This action may affect the private sector under Pub. L. 104-4.

Legal Authority: 21 U.S.C. 350e; 21 U.S.C. 373; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 371; . . .

CFR Citation: 21 CFR 1.

Legal Deadline: Final, Judicial, March 31, 2016, To the Office of the Federal Register for publication.

Abstract: This rule would establish requirements for parties including shippers, carriers by motor vehicle or rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated.

Statement of Need: There have been concerns over the past few decades about the need to ensure that food is transported in the United States in a sanitary manner. Congress responded to these concerns by passing the Sanitary Food Transportation Act of 1990 (1990 SFTA) which directed the Department of Transportation (DOT) to establish regulations to prevent food or food additives transported in certain types of bulk vehicles from being contaminated by nonfood products that were simultaneously or previously transported in those vehicles. Following the passage of the 1990 SFTA it became clear that potential sources of food contamination during transport were not just limited to nonfood products. Most notably, a 1994 outbreak of salmonellosis occurred in which ice cream mix became contaminated during transport in tanker trucks that had previously hauled raw liquid eggs. That outbreak affected an estimated 224,000 persons nationwide. In 2005, Congress reallocated authority for food transportation safety to the Food and Drug Administration, Department of Transportation and the United States Department of Agriculture by passing the 2005 Sanitary Food Transportation Act (2005 SFTA), a broader food transportation safety law than the 1990 SFTA in that its focus was not limited only to preventing food contamination from nonfood sources during transportation. The 2005 SFTA amended the Food, Drug, and Cosmetic Act (the FD&C Act), in part, by creating a new section, 416 of the FD&C Act (21 U.S.C. 350e). Section 416(b) of the FD&C Act directed us to issue regulations to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use prescribed sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. In addition, section 111(a) of Food Safety Modernization Act (FSMA), directed us to issue these sanitary transportation regulations not later than 18 months after the date of enactment of FSMA. This action is part of FDA's larger effort to focus on prevention of food safety problems throughout the food chain.

Summary of Legal Basis: FDA's authority for issuing this rule is provided in the Sanitary Food Transportation Act (Pub. L. 109-59) which amended the FD&C Act by establishing section 416 which directed FDA to issue regulations to require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use prescribed sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. FDA is also issuing this rule under section 111(a) of the Food Safety Modernization Act (Pub. L. 111-353), which directed FDA to promulgate these sanitary transportation regulations. In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) authorizes the Agency to issue regulations for the efficient enforcement of the Act.

Alternatives: FSMA requires FDA to promulgate regulations to establish sanitary transportation practices under the authority of the 2005 SFTA.

Anticipated Cost and Benefits: Because no complete data exist to precisely quantify the likelihood of food becoming adulterated during its transport, we are unable to estimate the effectiveness of the requirements of the proposed rule to reduce potential adverse health effects in humans or animals. Furthermore, while we expect small changes in behavior (in the form of safer practices), we do not anticipate large scale changes in practices as a result of the requirements of this proposed rule. Nevertheless, improving food transportation systems could reduce the number of recalls, reduce the risk of adverse health effects related to such contaminated human and animal food and feed, and reduce the losses of contaminated human and animal food and feed ingredients and products. The Start Printed Page 77772compliance costs of the proposed rule would result from the additional labor and capital required to carry out sanitary transportation practices during transportation operations and the costs to train personnel and keep the required records.

Risks: FDA is proposing this rule to establish sanitary transportation practices to provide greater assurance that food will not become adulterated during transportation and will not cause illness or injury to humans or animals. The rule would apply to food transported in the United States by motor vehicle or rail vehicle.

Timetable:

ActionDateFR Cite
ANPRM04/30/1075 FR 22713
ANPRM Comment Period End08/30/10
NPRM02/05/1479 FR 7005
NPRM Comment Period Extended05/23/1479 FR 29699
NPRM Comment Period End05/31/14
NPRM Comment Period Extended End07/30/14
Final Rule04/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: State.

Federalism: This action may have federalism implications as defined in E.O. 13132.

Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety Officer, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Food Safety, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2022, Fax: 301 346-2632, Email: michael.kashtock@fda.hhs.gov.

RIN: 0910-AG98

HHS—CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)

Proposed Rule Stage

42. Programs of All-Inclusive Care for the Elderly (PACE) Update (CMS-4168-P)

Priority: Other Significant.

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395; 42 U.S.C. 1395eee(f); 42 U.S.C. 1396u-4(f)

CFR Citation: 42 CFR 460.

Legal Deadline: None.

Abstract: This proposed rule would update the PACE regulations published on December 8, 2006. The rule would improve the quality of the existing regulations, provide operational flexibility and modifications, and remove redundancies and outdated information. These updates are intended to ensure the health and safety of PACE participants.

Statement of Need: We are proposing to revise and update policies to reflect subsequent changes in the practice of caring for PACE participants and changes in technology based on our experience implementing and overseeing the PACE program. PACE has proven successful in keeping frail elderly individuals, some of whom are eligible for both Medicare and Medicaid benefits (dual eligibles), in the community. However, we believe that we should revise certain regulatory provisions to afford more flexibility as a means to encourage the expansion of the PACE program to more states, increasing access for participants, and further enhancing the program's effectiveness at providing care while reducing costs.

Summary of Legal Basis: Sections 1894(f)(2) and 1934(f)(2) of the Act state that the Secretary shall incorporate the requirements applied to PACE demonstration waiver programs under the PACE Protocol when issuing interim final or final regulations, to the extent consistent with the provisions of sections 1894 and 1934 of the Act, but allow the Secretary to modify or waive these provisions under certain circumstances. Sections 1894(a)(6) and 1934(a)(6) of the Act define the PACE Protocol as the Protocol for PACE as published by On Lok, Inc., as of April 14, 1995, or any successor protocol that may be agreed upon between the Secretary and On Lok, Inc. We issued the 1999 and 2002 interim final rules and the 2006 final rule under this authority.

Alternatives: The requirements for the PACE program have not been comprehensively updated in many years, but the effective and efficient delivery of health care services has changed substantially in that time. We could choose not to make any regulatory changes; however, we believe the changes we are proposing are necessary to ensure the requirements are consistent with current standards of practice and continue to meet statutory obligations. They will ensure that participants receive care that maintains or enhances quality of life and enable them to remain in the community.

Anticipated Cost and Benefits: As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.

Risks: None. The proposals in this rule would update the existing requirements to reflect current standards of practice. In addition, proposed changes would provide added flexibility to providers, improve efficiency and effectiveness, and enhance participant quality of care and life.

Timetable:

ActionDateFR Cite
NPRM02/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Organizations.

Government Levels Affected: Federal, State.

Additional Information: Includes Retrospective Review under E.O. 13563.

Agency Contact: Martha Hennessy, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Centers for Medicare, MS: C4-21-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-0575, Email: martha.hennessy@cms.hhs.gov.

RIN: 0938-AR60

HHS—CMS

43. • Expansion of the CMS Qualified Entity Program (CMS-5061-P)

Priority: Other Significant.

Legal Authority: Pub. L. 114-10, sec 105

CFR Citation: 42 CFR 401.

Legal Deadline: Final, Statutory, July 1, 2016, MACRA requires rule be effective by July 1, 2016.

Abstract: Under the Medicare Access and CHIP Reauthorization Act (MACRA), this proposed rule would implement statutory requirements that expand the permissible uses of Medicare claims data that is obtained by qualified entities in accordance with applicable information, privacy, security and disclosure laws. In doing so, this rule would explain how qualified entities may create non-public analyses and provide or sell such analyses to authorized users, as well as how qualified entities may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users. This rule would also implement certain privacy and security requirements and impose assessments on qualified entities in the case of a violation of a data use agreement.

Statement of Need: The Qualified Entity Program, established by Section 10332 of the Affordable Care Act, Start Printed Page 77773authorizes the disclosure of Medicare claims data to qualified entities for use in public provider performance reporting. New legislation in MACRA expands the use of Medicare data by qualified entities to include additional analyses and access to certain data. Effective July 1, 2016, qualified entities may use the combined Medicare and other claims data to conduct non-public analyses and provide or sell these analyses to select users for non-public use. In addition, qualified entities may sell the combined data or provide the Medicare data at no cost to providers, suppliers, hospital associations, and medical societies for non-public use. While qualified entities are allowed to use the CMS data for other purposes than public reporting, the legislation also includes an assessment on the qualified entity for a breach of a data use agreement and new requirements for annual reporting by the qualified entities. These changes to the qualified entity program are important in driving higher quality, lower cost care in Medicare and the health system in general. Additionally, these changes are expected to drive renewed interest in the qualified entity program, leading to more transparency of provider and supplier performance while ensuring beneficiary privacy.

Summary of Legal Basis: Section 105 of MACRA requires proposed and final rules to be published and effective by July 1, 2016. This legislation expands both the uses of Medicare data by Qualified Entities as well as the data made available to them.

Alternatives: None. This is a statutory requirement.

Anticipated Cost and Benefits: As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.

Risks: The rule would require qualified entities to provide sufficient evidence of data privacy and security protection capabilities in order to avoid increased risks related to the protection of beneficiary identifiable data.

Timetable:

ActionDateFR Cite
NPRM11/00/15

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: None.

Agency Contact: Allison Oelschlaeger, Special Assistant, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Office of Enterprise Data and Analytics, MS: 339D, 7500 Security Blvd., Baltimore, MD 21244, Phone: 202 690-8257, Email: allison.oelschlaeger@cms.hhs.gov.

RIN: 0938-AS66

HHS—CMS

44. • Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMS) in Medicare Fee-for-Service (CMS-5517-P) (Section 610 Review)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: Pub. L. 114-10, sec 101

CFR Citation: Not Yet Determined.

Legal Deadline: Final, Statutory, November 1, 2016, MACRA deadline for establishing physician-focused payment model criteria. Final, Statutory, January 1, 2017, MACRA deadline for requirements and policies for MIPS.

Abstract: This proposed rule would implement provisions of the Medicare Access and CHIP Reauthorization Act (MACRA) related to MIPS and APMs. Section 101 of MACRA authorizes a new MIPS, which repeals the Medicare sustainable growth rate and improves Medicare payments for physician services. MACRA consolidates the current programs of the Physician Quality Reporting System, the Value-Based Modifier, and the Electronic Health Records Incentive Program into one program, MIPS, that streamlines and improves on the three distinct incentive programs. Additionally, MACRA authorizes incentive payments for providers who participate in eligible APMs.

Statement of Need: Under MACRA, payment adjustments to eligible professional (EP) payments through MIPS and incentive payments for qualifying APM participants will be applied beginning January 1, 2019. EPs under MIPS will be assessed a payment adjustment using four performance categories: quality, resource use, clinical practice improvement activities, and meaningful use of certified electronic health record (EHR) technology. Qualifying APM participants must have a specified amount of their Medicare expenditures or patients through an eligible APM that meets legislative criteria that include quality measures comparable to those in MIPS, required use of certified EHR technology, and either more than nominal financial risk or a structure as a medical home model. Additionally, specific to physician-focused APMs, the legislation creates a Technical Advisory Committee whose role is to receive and evaluate proposed APMs from the public and requires that the Secretary establish criteria for physician-focused payment models, including models for specialist physicians, by November 1, 2016.

Summary of Legal Basis: Section 101 of MACRA requires proposed and final rules be published by November 1, 2016, for release of criteria for publicly submitted physician-focused payment models and for the release of the MIPS quality measure list.

Alternatives: None. This is a statutory requirement.

Anticipated Cost and Benefits: As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.

Risks: If this regulation is not published timely, physicians would not have adequate time to prepare for the MIPS.

Timetable:

ActionDateFR Cite
NPRM03/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations.

Government Levels Affected: Federal, Tribal.

Agency Contact: James Sharp, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare & Medicaid Innovation Center, MS: WB-06-05, 7500 Security Blvd., Baltimore, MD 21244, Phone: 410 786-7388, Email: james.sharp@cms.hhs.gov.

RIN: 0938-AS69

HHS—CMS

45. • Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2017 Rates (CMS-1655-P) (Section 610 Review)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh

CFR Citation: 42 CFR 412.

Legal Deadline: NPRM, Statutory, April 1, 2016. Final, Statutory, August 1, 2016.

Abstract: This annual proposed rule would revise the Medicare hospital inpatient and long-term care hospital prospective payment systems for operating and capital-related costs. This rule would implement changes arising Start Printed Page 77774from our continuing experience with these systems.

Statement of Need: Centers for Medicare & Medicaid Services (CMS) annually revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs to implement changes arising from our continuing experience with these systems. In addition, we describe the proposed changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. Also, CMS annually updates the payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). The rule solicits comments on the proposed IPPS and LTCH payment rates and new policies. CMS will issue a final rule containing the payment rates for the FY 2017 IPPS and LTCHs at least 60 days before October 1, 2016.

Summary of Legal Basis: The Social Security Act (the Act) sets forth a system of payment for the operating costs of acute care hospital inpatient stays under Medicare Part A (Hospital Insurance) based on prospectively set rates. The Act requires the Secretary to pay for the capital-related costs of hospital inpatient and long-term care stays under a PPS. Under these systems, Medicare payment for hospital inpatient and long-term care operating and capital-related costs is made at predetermined, specific rates for each hospital discharge. These changes would be applicable to services furnished on or after October 1, 2016.

Alternatives: None. This implements a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for FY 2017.

Risks: If this regulation is not published timely, inpatient hospital and LTCH services will not be paid appropriately beginning October 1, 2016.

Timetable:

ActionDateFR Cite
NPRM04/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Agency Contact: Donald Thompson, Deputy Director, Division of Acute Care, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-26, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6504, Email: donald.thompson@cms.hhs.gov.

RIN: 0938-AS77

HHS—CMS

46. • CY 2017 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1654-P) (Section 610 Review)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh; Pub. L. 114-10

CFR Citation: 42 CFR 409; 42 CFR 410; 42 CFR 414.

Legal Deadline: Final, Statutory, November 1, 2016.

Abstract: This annual proposed rule would revise payment polices under the Medicare physician fee schedule, and make other policy changes to payment under Medicare Part B. These changes would apply to services furnished beginning January 1, 2017.

Statement of Need: The statute requires that we establish each year, by regulation, payment amounts for all physicians' services furnished in all fee schedule areas. This rule would implement changes affecting Medicare Part B payment to physicians and other Part B suppliers. The final rule has a statutory publication date of November 1, 2016, and an implementation date of January 1, 2017.

Summary of Legal Basis: Section 1848 of the Social Security Act (the Act) establishes the payment for physician services provided under Medicare. Section 1848 of the Act imposes an annual deadline of no later than November 1 for publication of the final rule or final physician fee schedule.

Alternatives: None. This rule implements a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for CY 2017.

Risks: If this regulation is not published timely, physician services will not be paid appropriately, beginning January 1, 2017.

Timetable:

ActionDateFR Cite
NPRM06/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Agency Contact: Ryan Howe, Director, Division of Practitioner Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-01-15, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3355, Email: ryan.howe@cms.hhs.gov.

RIN: 0938-AS81

HHS—CMS

47. • CY 2017 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1656-P) (Section 610 Review)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395hh

CFR Citation: 42 CFR 416; 42 CFR 419.

Legal Deadline: Final, Statutory, November 1, 2016.

Abstract: This annual proposed rule would revise the Medicare hospital outpatient prospective payment system to implement statutory requirements and changes arising from our continuing experience with this system. The rule describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule would change the ambulatory surgical center payment system list of services and rates.

Statement of Need: Medicare pays over 4,000 hospitals for outpatient department services under the hospital outpatient prospective payment system (OPPS). The OPPS is based on groups of clinically similar services called ambulatory payment classification groups (APCs). CMS annually revises the APC payment amounts based on the most recent claims data, proposes new payment policies, and updates the payments for inflation using the hospital operating market basket. Medicare pays roughly 5,000 Ambulatory Surgical enters (ASCs) under the ASC payment system. CMS annually revises the payment under the ASC payment system, proposes new policies, and updates payments for inflation. CMS will issue a final rule containing the payment rates for the 2017 OPPS and ASC payment system at least 60 days before January 1, 2017.

Summary of Legal Basis: Section 1833 of the Social Security Act establishes Medicare payment for hospital outpatient services and ASC services. The rule revises the Medicare hospital OPPS and ASC payment system to implement applicable statutory requirements. In addition, the rule describes changes to the outpatient APC Start Printed Page 77775system, relative payment weights, outlier adjustments, and other amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system as well as changes to the rates and services paid under the ASC payment system. These changes would be applicable to services furnished on or after January 1, 2017.

Alternatives: None. This rule is a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for CY 2017.

Risks: If this regulation is not published timely, outpatient hospital and ASC services will not be paid appropriately beginning January 1, 2017.

Timetable:

ActionDateFR Cite
NPRM06/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Agency Contact: Marjorie Baldo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4617, Email: marjorie.baldo@cms.hhs.gov.

RIN: 0938-AS82

HHS—CMS

Final Rule Stage

48. Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability (CMS-2390-F)

Priority: Economically Significant. Major under 5 U.S.C. 801.

Legal Authority: 42 U.S.C. 1302

CFR Citation: 42 CFR 430; 42 CFR 431; 42 CFR 438.

Legal Deadline: None.

Abstract: This final rule modernizes the Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems. The rule aligns the rules governing Medicaid managed care with those of other major sources of coverage, including coverage through Qualified Health Plans and Medicare Advantage plans; implements statutory provisions; strengthens actuarial soundness payment provisions to promote the accountability of Medicaid managed care program rates; ensures appropriate beneficiary protections; and, enhances expectations for program integrity. This rule also implements provisions of the Children's Health Insurance Program Reauthorization Act (CHIPRA) and addresses third party liability for trauma codes.

Statement of Need: This rule modernizes the Medicaid managed care regulations recognizing changes in the usage of managed care delivery systems since the release of the final rule in 2002. As Medicaid managed care programs have developed and matured in the intervening years, States have taken various approaches to implementation. This has resulted in inconsistencies and, in some cases, less than optimal results. To improve consistency and adopt policies and practices from States that have proven the most successful, we include revisions in this rule to strengthen beneficiary protections, support alignment with rules governing managed care in other public and private sector programs, strengthen actuarial soundness and the accountability of rates paid in the Medicaid managed care program, improve quality of care, and implement statutory provisions issued since 2002. The rule also applies some of the Medicaid managed care regulations to the Children's Health Insurance Program (CHIP).

Summary of Legal Basis: Congress enacted specific standards for Medicaid managed care programs in sections 4701 through 4709 of the Balanced Budget Act of 1997 (BBA). The BBA represented the first comprehensive revision to Federal statutes governing Medicaid managed care since the early 1980s. These standards are codified in sections 1903 and 1932 of the Act and implemented in a final rule published June 14, 2002 (67 FR 40989). The Children's Health Insurance Reauthorization Act of 2009 and the Affordable Care Act applied some of the Medicaid managed care statutory provisions to CHIP.

Alternatives: We could choose not to make any regulatory changes; however, while the 2002 final rule has been the guiding regulation for Medicaid managed care, many questions and issues have arisen in the intervening years due to the current version's lack of clarity or detail in some areas. With no guidance in these areas, States have created various standards, leading to inconsistency and, in some cases, less than optimal program performance. Additionally, many issues have arisen from the evolution of managed care that have rendered some provisions nearly obsolete. For example, the existing version gives little acknowledgement to the use of electronic means of communication and no recognition to the recently created health care coverage options offered through the Federal and State marketplaces. This creates gaps that leave States and managed care plans with unclear, non-existent, or confusing guidance and standards for program operation. We believe that with consistent standards and clearly defined flexibilities for States, programs can develop in ways that not only transform the healthcare delivery system and fulfill the mission of the Medicaid program, but can improve the health and wellness of Medicaid enrollees.

Anticipated Cost and Benefits: The overall economic impact for this rule is estimated to be $112 million in the first year of implementation. Additionally, non-quantifiable benefits include improved health outcomes, reduced unnecessary services, improved beneficiary experience, improved access, and improved program transparency which facilitates better decisionmaking.

Risks: None. It is necessary to modernize the Medicaid and CHIP managed care and quality regulations to support health care delivery system reform, improve population health outcomes, and improve the beneficiary experience in a cost effective and consistent manner in all states.

Timetable:

ActionDateFR Cite
NPRM06/01/1580 FR 31097
NPRM Comment Period End07/27/15
Final Action04/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations.

Government Levels Affected: Federal, State, Tribal.

Additional Information: Includes Retrospective Review under E.O. 13563.

Agency Contact: Nicole Kaufman, Technical Director, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicaid and CHIP Services, MS: S2-14-16, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6604, Email: nicole.kaufman@cms.hhs.gov.

RIN: 0938-AS25

Start Printed Page 77776

DEPARTMENT OF HOMELAND SECURITY (DHS)

Fall 2015 Statement of Regulatory Priorities

The Department of Homeland Security (DHS or Department) was created in 2003 pursuant to the Homeland Security Act of 2002, Public Law 107-296. DHS has a vital mission: To secure the Nation from the many threats we face. This requires the dedication of more than 225,000 employees in jobs that range from aviation and border security to emergency response, from cybersecurity analyst to chemical facility inspector. Our duties are wide-ranging, but our goal is clear—keeping America safe.

Our mission gives us six main areas of responsibility:

1. Prevent Terrorism and Enhance Security,

2. Secure and Manage Our Borders,

3. Enforce and Administer Our Immigration Laws,

4. Safeguard and Secure Cyberspace,

5. Ensure Resilience to Disasters, and

6. Mature and Strengthen DHS

In achieving these goals, we are continually strengthening our partnerships with communities, first responders, law enforcement, and government agencies—at the State, local, tribal, Federal, and international levels. We are accelerating the deployment of science, technology, and innovation in order to make America more secure, and we are becoming leaner, smarter, and more efficient, ensuring that every security resource is used as effectively as possible. For a further discussion of our main areas of responsibility, see the DHS Web site at http://www.dhs.gov/​our-mission.

The regulations we have summarized below in the Department's fall 2015 regulatory plan and in the agenda support the Department's responsibility areas listed above. These regulations will improve the Department's ability to accomplish its mission.

The regulations we have identified in this year's fall regulatory plan continue to address legislative initiatives including, but not limited to, the following acts: The Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act), Public Law 110-53 (Aug. 3, 2007); the Consolidated Natural Resources Act of 2008 (CNRA), Public Law 110-229 (May 8, 2008); the Security and Accountability for Every Port Act of 2006 (SAFE Port Act), Public Law 109-347 (Oct. 13, 2006); and the Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009, Public Law 110-329 (Sep. 30, 2008).

DHS strives for organizational excellence and uses a centralized and unified approach in managing its regulatory resources. The Office of the General Counsel manages the Department's regulatory program, including the agenda and regulatory plan. In addition, DHS senior leadership reviews each significant regulatory project to ensure that the project fosters and supports the Department's mission. The Department is committed to ensuring that all of its regulatory initiatives are aligned with its guiding principles to protect civil rights and civil liberties, integrate our actions, build coalitions and partnerships, develop human resources, innovate, and be accountable to the American public.

DHS is also committed to the principles described in Executive Orders 13563 and 12866 (as amended). Both Executive Orders direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

Finally, the Department values public involvement in the development of its regulatory plan, agenda, and regulations, and takes particular concern with the impact its rules have on small businesses. DHS and each of its components continue to emphasize the use of plain language in our notices and rulemaking documents to promote a better understanding of regulations and increased public participation in the Department's rulemakings.

Retrospective Review of Existing Regulations

Pursuant to Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), DHS identified the following regulatory actions as associated with retrospective review and analysis. Some of the regulatory actions on the below list may be completed actions, which do not appear in The Regulatory Plan. You can find more information about these completed rulemakings in past publications of the Unified Agenda (search the Completed Actions sections) on www.reginfo.gov. Some of the entries on this list, however, are active rulemakings. You can find entries for these rulemakings on www.regulations.gov.

RINRule
1601-AA58Professional Conduct for Practitioners Rules and Procedures, and Representation and Appearances
1615-AB95Immigration Benefits Business Transformation, Increment II; Nonimmigrants Classes.
1615-AC00Enhancing Opportunities for H-1B1, CW-1, and E-3 Nonimmigrants and EB-1 Immigrants.
1625-AB38Updates to Maritime Security.
1625-AB80Revision to Transportation Worker Identification Credential (TWIC) Requirements for Mariners.
1625-AC15Seafarers' Access to Maritime Facilities.
1651-AA96Definition of Form I-94 to Include Electronic Format.
1651-AB05Freedom of Information Act (FOIA) Procedures.
1653-AA63Adjustments to Limitations on Designated School Official Assignment and Study By F-2 and M-2 Nonimmigrants.

Promoting International Regulatory Cooperation

Pursuant to sections 3 and 4(b) of Executive Order 13609 “Promoting International Regulatory Cooperation” (May 1, 2012), DHS has identified the following regulatory actions that have significant international impacts. Some of the regulatory actions on the below list may be completed actions. You can find more information about these completed rulemakings in past publications of the Unified Agenda (search the Completed Actions sections) on www.reginfo.gov. Some of the entries on this list, however, are active rulemakings. You can find entries for these rulemakings on www.regulations.gov.Start Printed Page 77777

RINRule
1625-AB38Updates to Maritime Security.
1651-AA70Importer Security Filing and Additional Carrier Requirements.
1651-AA72Changes to the Visa Waiver Program To Implement the Electronic System for Travel Authorization (ESTA) Program.
1651-AA98Amendments to Importer Security Filing and Additional Carrier Requirements.
1651-AA96Definition of Form I-94 to Include Electronic Format.

DHS participates in some international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations. For example, the U.S. Coast Guard is the primary U.S. representative to the International Maritime Organization (IMO) and plays a major leadership role in establishing international standards in the global maritime community. IMO's work to establish international standards for maritime safety, security, and environmental protection closely aligns with the U.S. Coast Guard regulations. As an IMO member nation, the U.S. is obliged to incorporate IMO treaty provisions not already part of U.S. domestic policy into regulations for those vessels affected by the international standards. Consequently, the U.S. Coast Guard initiates rulemakings to harmonize with IMO international standards such as treaty provisions and the codes, conventions, resolutions, and circulars that supplement them.

Also, President Obama and Prime Minister Harper created the Canada-U.S. Regulatory Cooperation Council (RCC) in February 2011. The RCC is an initiative between both Federal Governments aimed at pursuing greater alignment in regulation, increasing mutual recognition of regulatory practices and establishing smarter, more effective and less burdensome regulations in specific sectors. The Canada-U.S. RCC initiative arose out of the recognition that high level, focused, and sustained effort would be required to reach a more substantive level of regulatory cooperation. Since its creation in early 2011, the U.S. Coast Guard has participated in stakeholder consultations with their Transport Canada counterparts and the public, drafted items for inclusion in the RCC Action Plan, and detailed work plans for each included Action Plan item.

The fall 2015 regulatory plan for DHS includes regulations from DHS components—including U.S. Citizenship and Immigration Services (USCIS), the U.S. Coast Guard (Coast Guard), U.S. Customs and Border Protection (CBP), the U.S. Immigration and Customs Enforcement (ICE), and the Transportation Security Administration (TSA), which have active regulatory programs. In addition, it includes regulations from the Department's major offices and directorates such as the National Protection and Programs Directorate (NPPD). Below is a discussion of the fall 2015 regulatory plan for DHS regulatory components, offices, and directorates.

United States Citizenship and Immigration Services

U.S. Citizenship and Immigration Services (USCIS) administers immigration benefits and services while protecting and securing our homeland. USCIS has a strong commitment to welcoming individuals who seek entry through the U.S. immigration system, providing clear and useful information regarding the immigration process, promoting the values of citizenship, and assisting those in need of humanitarian protection. Based on a comprehensive review of the planned USCIS regulatory agenda, USCIS will promulgate several rulemakings to directly support these commitments and goals.

Regulations To Facilitate Retention of High-Skilled Workers and Entrepreneurs

Employment-Based Immigration Modernization. USCIS will propose to implement certain provisions of the American Competitiveness and Workforce Improvement Act of 1998 and the American Competitiveness in the Twenty-First Century Act of 2000, Public Law 106-313, as amended by the Twenty-First Century Department of Justice Appropriations Authorization Act of 2002, Public Law 107-273. USCIS will seek public feedback in codifying its interpretation of these statutes. Additionally, USCIS will propose to amend its regulations to provide greater stability and job flexibility to certain beneficiaries of approved employment-based immigrant petitions during their transition from nonimmigrant to lawful permanent residence status and to enable U.S. businesses to hire and retain highly-skilled foreign-born workers.

Significant Public Benefit Parole for Entrepreneurs. USCIS will propose to establish conditions for paroling foreign entrepreneurs into the United States based on case-by-case discretionary determinations that their entrepreneurial activities in the United States will provide the United States with a significant public benefit. Parole under these conditions would allow individuals who have been awarded substantial U.S. investor financing or otherwise hold the promise of innovation and job creation through the development of new technologies or the pursuit of cutting edge research to pursue development of startup businesses in the United States. This would provide an opportunity for much needed innovation and job creation in the United States.

Enhancing Opportunities for High-Skilled Workers. DHS will issue a final rule following its May 2014, proposed rule designed to encourage and facilitate the employment and retention of certain high-skilled and transitional workers. As proposed, the rule would amend regulations affecting high-skilled workers within the nonimmigrant classifications for specialty occupation professionals from Chile and Singapore (H-1B1) and from Australia (E-3), to include these classifications in the list of classes of aliens authorized for employment incident to status with a specific employer, to extend automatic employment authorization extensions with pending extension of stay requests, and to update filing procedures. The rule would also amend regulations regarding continued employment authorization for nonimmigrant workers in the Commonwealth of the Northern Mariana Islands (CNMI)-only Transitional Worker (CW-1) classification. Finally, the rule would amend regulations related to the immigration classification for employment-based first preference (EB-1) outstanding professors or researchers to allow the submission of comparable evidence. These changes would encourage and facilitate the employment and retention of these high-skilled workers.

Improvements to the Immigration System

Provisional Unlawful Presence Waivers. DHS will issue a final rule following its July 2015, proposed rule regarding the provisional unlawful presence waiver process. As proposed, Start Printed Page 77778this rule would expand access to the provisional unlawful presence waiver program to additional aliens for whom an immigrant visa is immediately available and who can show extreme hardship to a qualifying U.S. citizen or lawful permanent resident spouse or parent.

Requirements for Filing Motions and Administrative Appeals. USCIS will propose to revise the procedural regulations governing appeals and motions to reopen or reconsider before its Administrative Appeals Office, and to require that applicants and petitioners exhaust administrative remedies before seeking judicial review of an unfavorable decision. The changes proposed by the rule will streamline the procedures before the Administrative Appeals Office and improve the efficiency of the adjudication process.

Regulations Related to the Commonwealth of Northern Mariana Islands. This final rule amends DHS and Department of Justice (DOJ) regulations to comply with the Consolidated Natural Resources Act of 2008 (CNRA). The CNRA extends the immigration laws of the United States to the Consolidated Northern Mariana Islands (CNMI). In 2009, USCIS issued an interim final rule to implement conforming amendments to the DHS and DOJ regulations. This joint DHS-DOJ final rule titled “Application of Immigration Regulations to the CNMI” would finalize the 2009 interim final rule.

Regulatory Changes Involving Humanitarian Benefits

Exception to the Persecution Bar for Asylum, Refugee, or Temporary Protected Status, and Withholding of Removal. In a joint rulemaking, DHS and DOJ will propose amendments to existing DHS and DOJ regulations to resolve ambiguity in the statutory language precluding eligibility for asylum, refugee resettlement, temporary protected status, and withholding or removal of an applicant who ordered, incited, assisted, or otherwise participated in the persecution of others. The proposed rule would provide a limited exception for persecutory actions taken by the applicant under duress and would clarify the required level of the applicant's knowledge of the persecution.

“T” and “U” Nonimmigrants. USCIS plans additional regulatory initiatives related to T nonimmigrants (victims of trafficking) and U nonimmigrants (victims of criminal activity). USCIS hopes to provide greater consistency in eligibility, application, and procedural requirements for these vulnerable groups, their advocates, and the community through these regulatory initiatives. These rulemakings will contain provisions to adjust documentary requirements for this vulnerable population and provide greater clarity to the law enforcement community.

Special Immigrant Juvenile Petitions. This final rule makes procedural changes and resolves interpretive issues following the amendments mandated by Congress. It will enable child aliens who have been abused, neglected, or abandoned and placed under the jurisdiction of a juvenile court or placed with an individual or entity, to obtain classification as Special Immigrant Juvenile. Such classification can regularize immigration status for these aliens and allow for adjustment of status to lawful permanent resident.

United States Coast Guard

The U.S. Coast Guard (Coast Guard) is a military, multi-mission, maritime service of the United States and the only military organization within DHS. It is the principal Federal agency responsible for maritime safety, security, and stewardship and delivers daily value to the Nation through multi-mission resources, authorities, and capabilities.

Effective governance in the maritime domain hinges upon an integrated approach to safety, security, and stewardship. The Coast Guard's policies and capabilities are integrated and interdependent, delivering results through a network of enduring partnerships. The Coast Guard's ability to field versatile capabilities and highly-trained personnel is one of the U.S. Government's most significant and important strengths in the maritime environment.

America is a maritime nation, and our security, resilience, and economic prosperity are intrinsically linked to the oceans. Safety, efficient waterways, and freedom of transit on the high seas are essential to our well-being. The Coast Guard is leaning forward, poised to meet the demands of the modern maritime environment. The Coast Guard creates value for the public through solid prevention and response efforts. Activities involving oversight and regulation, enforcement, maritime presence, and public and private partnership foster increased maritime safety, security, and stewardship.

The statutory responsibilities of the Coast Guard include ensuring marine safety and security, preserving maritime mobility, protecting the marine environment, enforcing U.S. laws and international treaties, and performing search and rescue. The Coast Guard supports the Department's overarching goals of mobilizing and organizing our Nation to secure the homeland from terrorist attacks, natural disasters, and other emergencies. The rulemaking projects identified for the Coast Guard in the Unified Agenda, and the rules appearing in the fall 2015 Regulatory Plan below, contribute to the fulfillment of those responsibilities and reflect our regulatory policies.

Inspection of Towing Vessels. The Coast Guard has proposed regulations governing the inspection of towing vessels, including an optional safety management system. The regulations for this large class of vessels would establish operations, lifesaving, fire protection, machinery and electrical systems and equipment, and construction and arrangement standards for towing vessels. This rulemaking also sets standards for the optional towing safety management system (TSMS) and related third-party organizations, as well as procedures for obtaining a certificate of inspection under either the TSMS or Coast Guard annual-inspection option. This rulemaking would implement section 415 of the Coast Guard and Maritime Transportation Act of 2004. The intent of this rulemaking, which would create 46 CFR, subchapter M, is to promote safer work practices and reduce towing vessel casualties.

Transportation Worker Identification Credential (TWIC)—Reader Requirements. In accordance with the Maritime Transportation Safety Act of 2002 (MTSA) and the Security and Accountability For Every Port Act of 2006 (SAFE Port Act), the Coast Guard is establishing rules requiring electronic TWIC readers at high-risk vessels and facilities. These rules would ensure that prior to being granted unescorted access to a designated secure area at a high-risk vessel or facility: (1) The individual will have his or her TWIC electronically authenticated; (2) the status of the individual's credential will be electronically validated against an up-to-date list maintained by the TSA; and (3) the individual's identity will be electronically confirmed by comparing his or her fingerprint or other biometric sample with a biometric template stored on the credential. By promulgating these rules, the Coast Guard is complying with the statutory requirement in the SAFE Port Act, improving security at the highest risk vessels and facilities, and making full use of the electronic and biometric security features integrated into the TWIC and mandated by Congress in MTSA.Start Printed Page 77779

United States Customs and Border Protection

U.S. Customs and Border Protection (CBP) is the Federal agency principally responsible for the security of our Nation's borders, both at and between the ports of entry and at official crossings into the United States. CBP must accomplish its border security and enforcement mission without stifling the flow of legitimate trade and travel. The primary mission of CBP is its homeland security mission, that is, to prevent terrorists and terrorist weapons from entering the United States. An important aspect of this priority mission involves improving security at our borders and ports of entry, but it also means extending our zone of security beyond our physical borders.

CBP is also responsible for administering laws concerning the importation into the United States of goods, and enforcing the laws concerning the entry of persons into the United States. This includes regulating and facilitating international trade; collecting import duties; enforcing U.S. trade, immigration and other laws of the United States at our borders; inspecting imports, overseeing the activities of persons and businesses engaged in importing; enforcing the laws concerning smuggling and trafficking in contraband; apprehending individuals attempting to enter the United States illegally; protecting our agriculture and economic interests from harmful pests and diseases; servicing all people, vehicles and cargo entering the United States; maintaining export controls; and protecting U.S. businesses from theft of their intellectual property.

In carrying out its priority mission, CBP's goal is to facilitate the processing of legitimate trade and people efficiently without compromising security. Consistent with its primary mission of homeland security, CBP intends to issue several rules during the next fiscal year that are intended to improve security at our borders and ports of entry. CBP is also automating some procedures that increase efficiencies and reduce the costs and burdens to travelers. We have highlighted two of these rules below.

Air Cargo Advance Screening (ACAS). The Trade Act of 2002, as amended, authorizes the Secretary of Homeland Security to promulgate regulations providing for the transmission to CBP through an electronic data interchange system, of information pertaining to cargo to be brought into the United States or to be sent from the United States, prior to the arrival or departure of the cargo. The cargo information required is that which the Secretary determines to be reasonably necessary to ensure cargo safety and security. CBP's current Trade Act regulations pertaining to air cargo require the electronic submission of various advance data to CBP no later than either the time of departure of the aircraft for the United States (from specified locations) or four hours prior to arrival in the United States for all other locations. CBP intends to propose amendments to these regulations to implement the Air Cargo Advance Screening (ACAS) program. To improve CBP's risk assessment and targeting capabilities and to enable CBP to target and identify risky cargo prior to departure of the aircraft to the United States, ACAS would require the submission of certain of the advance electronic information for air cargo earlier in the process. In most cases, the information would have to be submitted as early as practicable but no later than prior to the loading of cargo onto an aircraft at the last foreign port of departure to the United States. CBP, in conjunction with TSA, has been operating ACAS as a voluntary pilot program since 2010 and would like to implement ACAS as a regulatory program.

Definition of Form I-94 to Include Electronic Format. DHS issues the Form I-94 to certain aliens and uses the Form I-94 for various purposes such as documenting status in the United States, the approved length of stay, and departure. DHS generally issues the Form I-94 to aliens at the time they lawfully enter the United States. On March 27, 2013, CBP published an interim final rule amending existing regulations to add a new definition of the term “Form I-94.” The new definition includes the collection of arrival/departure and admission or parole information by DHS, whether in paper or electronic format. The definition also clarified various terms that are associated with the use of the Form I-94 to accommodate an electronic version of the Form I-94. The rule also added a valid, unexpired nonimmigrant DHS admission or parole stamp in a foreign passport to the list of documents designated as evidence of alien registration. These revisions enabled DHS to transition to an automated process whereby DHS creates a Form I-94 in an electronic format based on passenger, passport and visa information that DHS obtains electronically from air and sea carriers and the Department of State as well as through the inspection process. CBP intends to publish a final rule during the next fiscal year.

In addition to the regulations that CBP issues to promote DHS's mission, CBP also issues regulations related to the mission of the Department of the Treasury. Under section 403(1) of the Homeland Security Act of 2002, the former-U.S. Customs Service, including functions of the Secretary of the Treasury relating thereto, transferred to the Secretary of Homeland Security. As part of the initial organization of DHS, the Customs Service inspection and trade functions were combined with the immigration and agricultural inspection functions and the Border Patrol and transferred into CBP. It is noted that certain regulatory authority of the U.S. Customs Service relating to customs revenue function was retained by the Department of the Treasury (see the Department of the Treasury Regulatory Plan). In addition to its plans to continue issuing regulations to enhance border security, CBP, during fiscal year 2016, expects to continue to issue regulatory documents that will facilitate legitimate trade and implement trade benefit programs. CBP regulations regarding the customs revenue function are discussed in the Regulatory Plan of the Department of the Treasury.

Federal Emergency Management Agency

The Federal Emergency Management Agency (FEMA) does not have any significant regulatory actions planned for fiscal year 2016.

Federal Law Enforcement Training Center

The Federal Law Enforcement Training Center (FLETC) does not have any significant regulatory actions planned for fiscal year 2016.

United States Immigration and Customs Enforcement

ICE is the principal criminal investigative arm of the Department of Homeland Security and one of the three Department components charged with the civil enforcement of the Nation's immigration laws. Its primary mission is to protect national security, public safety, and the integrity of our borders through the criminal and civil enforcement of Federal law governing border control, customs, trade, and immigration. During fiscal year 2016, ICE will focus rulemaking efforts on improvements in the area of student and exchange visitor programs and to advance initiatives related to F-1 nonimmigrant students:

Improving and Expanding Training Opportunities for F-1 Nonimmigrant Students with STEM Degrees and Expanding Cap-Gap Relief for All F-1 Start Printed Page 77780Students With Pending H-1B Petitions. The Department of Homeland Security will propose a rule to enhance opportunities for F-1 nonimmigrant students graduating with a science, technology, engineering, or mathematics (STEM) degree to further their courses of study through an extension of optional practical training (OPT) with employers enrolled in USCIS's E-Verify employment verification program. DHS anticipates that the rule would replace a 2008 interim final rule (IFR) that was recently held to be procedurally invalid, and that is the subject of a temporarily stayed vacatur. The proposed rule would enhance the academic benefit of the STEM extension and would help ensure that the nation's colleges and universities remain globally competitive in attracting international STEM students to study in the United States prior to returning to their home countries.

National Protection and Programs Directorate

The National Protection and Programs Directorate's (NPPD) vision is a safe, secure, and resilient infrastructure where the American way of life can thrive. NPPD leads the national effort to protect and enhance the resilience of the nation's physical and cyber infrastructure.

Chemical Facility Anti-Terrorism Standards. Recognizing both the importance of the nation's chemical facilities to the American way of life and the need to secure high-risk chemical facilities against terrorist attacks, in December 2014 Congress passed and the President signed into law the Protecting and Securing Chemical Facilities from Terrorist Attacks Act of 2014, Pub. L. 113-254. This legislation provides the Department continuing authority to implement the Chemical Facility Anti-Terrorism Standards (CFATS) regulatory program, a unique regulatory program mandating that high-risk chemical facilities in the United States draft and implement security plans satisfying risk-based performance standards established by DHS.

CFATS has been in effect since 2007, and on August 18, 2014, the Department published an Advance Notice of Proposed Rulemaking (ANPRM) in order to seek public comment on ways to make the program more effective. The Department will continue the rulemaking effort that commenced with the publication of that ANPRM, and intends to publish a Notice of Proposed Rulemaking (NPRM) proposing a number of changes to the CFATS program. The NPRM will propose substantive modifications to CFATS based on public comments received on the ANPRM and based on program implementation experience the Department has gained since 2007. The NPRM will also propose modifications to CFATS in order to align its regulatory text with the requirements of the Protecting and Securing Chemical Facilities from Terrorist Attacks Act of 2014. Accordingly, the Department anticipates that the NPRM will propose both discretionary and non-discretionary modifications to CFATS, with the goals of harmonizing the regulation with its statutory authority and of making the CFATS program more efficient and effective.

Transportation Security Administration

The Transportation Security Administration (TSA) protects the Nation's transportation systems to ensure freedom of movement for people and commerce. TSA is committed to continuously setting the standard for excellence in transportation security through its people, processes, and technology as we work to meet the immediate and long-term needs of the transportation sector.

In fiscal year 2016, TSA will promote the DHS mission by emphasizing regulatory efforts that will allow TSA to better identify, detect, and protect against threats against various modes of the transportation system, while facilitating the efficient movement of the traveling public, transportation workers, and cargo.

Passenger Screening Using Advanced Imaging Technology (AIT). TSA intends to issue a final rule to amend its civil aviation regulations to address whether screening and inspection of an individual, conducted to control access to the sterile area of an airport or to an aircraft, may include the use of advanced imaging technology (AIT). TSA published an NPRM on March 26, 2013, to comply with the decision rendered by the U.S. Court of Appeals for the District of Columbia Circuit in Electronic Privacy Information Center (EPIC) v. U.S. Department of Homeland Security on July 15, 2011, (653 F.3d 1 (D.C. Cir. 2011)). The Court directed TSA to conduct notice-and-comment rulemaking on the use of AIT in the primary screening of passengers.

Security Training for Surface Mode Employees. TSA will propose regulations to enhance the security of several non-aviation modes of transportation. In particular, TSA will propose regulations requiring freight railroad carriers, public transportation agencies (including rail mass transit and bus systems), passenger railroad carriers, and over-the-road bus operators to conduct security training for front line employees. This regulation would implement sections 1408 (Public Transportation), 1517 (Freight Railroads), and 1534 (Over-the-Road Buses) of the Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act), Public Law 110-53, August 3, 2007. In compliance with the definitions of frontline employees in the pertinent provisions of the 9/11 Act, the Notice of Proposed Rulemaking (NPRM) would propose to define which employees are required to undergo training. The NPRM would also propose definitions for transportation security-sensitive materials, as required by section 1501 of the 9/11 Act.

Standardized Vetting, Adjudication, and Redress Process and Fees. TSA is developing a proposed rule to establish and update fees, and revise and standardize the procedures and adjudication criteria for most of the security threat assessments (STAs) of individuals that TSA conducts. The proposal would improve procedures for conducting STAs for transportation workers from almost all modes of transportation, including those covered under the 9/11 Act. In addition, TSA will propose consistent and equitable fees to cover the cost of the STAs. TSA plans to identify new efficiencies in processing STAs and ways to streamline existing regulations by simplifying language and removing redundancies. As part of this proposed rule, TSA will propose revisions to the Alien Flight Student Program (AFSP) regulations. TSA published an IFR for the AFSP on September 20, 2004. TSA regulations require aliens seeking to train at Federal Aviation Administration-regulated flight schools to complete an application and undergo an STA prior to beginning flight training. There are four categories under which students currently fall; the nature of the STA depends on the student's category. TSA is considering changes to the AFSP that would improve equity among fee payers and enable the implementation of new technologies to support vetting.

United States Secret Service

The United States Secret Service does not have any significant regulatory actions planned for fiscal year 2016.

DHS Regulatory Plan for Fiscal Year 2016

A more detailed description of the priority regulations that comprise DHS's fall 2015 regulatory plan follows.

Start Printed Page 77781

DHS—OFFICE OF THE SECRETARY (OS)

Proposed Rule Stage

49. Chemical Facility Anti-Terrorism Standards (CFATS)

Priority: Other Significant.

Legal Authority: sec 550 of the Department of Homeland Security Appropriations Act of 2007 Pub. L. 109-295, as amended

CFR Citation: 6 CFR 27.

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) previously invited public comment on an advance notice of proposed rulemaking (ANPRM) for potential revisions to the Chemical Facility Anti-Terrorism Standards (CFATS) regulations. The ANPRM provided an opportunity for the public to provide recommendations for possible program changes. DHS is reviewing the public comments received in response to the ANPRM, after which DHS intends to publish a Notice of Proposed Rulemaking.

Statement of Need: DHS intends to propose several potential program changes to the CFATS regulation. These changes have been identified in the five years since program implementation.

In addition, in December 2014, a new law (the Protecting and Securing Chemical Facilities from Terrorist Attacks Act of 2014) was enacted which provides DHS continuing authority to implement CFATS. DHS must make several modifications and additions to conform the CFATS regulation with the new law.

Summary of Legal Basis: The Protecting and Securing Chemical Facilities from Terrorist Attacks Act of 2014 (Pub. L. 113-254) added Title XXI to the Homeland Security Act of 2002 (HSA) to authorize in permanent law a Chemical Facility Anti-terrorism Standards (CFATS) program. See 6 U.S.C. 621 et seq. Title XXI supersedes section 550 of the Department of Homeland Security Appropriations Act of 2007, Pub. L. 109-295, under which the CFATS program was originally established in April 2007. Section 2107(a) of the HSA specifically authorizes DHS to “promulgate regulations or amend existing CFATS regulations to implement the provisions under [Title XXI]. 6 U.S.C. 627(a). In addition, section 2107(b)(2) of the HSA requires DHS to repeal any existing CFATS regulation that [DHS] determines is duplicative of, or conflicts with, [Title XXI]. 6 U.S.C. 627(b)(2).

Alternatives:

Anticipated Cost and Benefits: The ANPRM provided an opportunity for the public to provide recommendations for possible program changes. DHS is reviewing the public comments received in response to the ANPRM, after which DHS intends to publish a Notice of Proposed Rulemaking (NPRM).

Risks:

Timetable:

ActionDateFR Cite
ANPRM08/18/1479 FR 48693
ANPRM Comment Period End10/17/14
NPRM07/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal, Local, State.

URL for More Information: www.regulations.gov.

URL for Public Comments: www.regulations.gov.

Agency Contact: Jon MacLaren, Chief, Rulemaking Section, Department of Homeland Security, National Protection and Programs Directorate, Infrastructure Security Compliance Division (NPPD/ISCD), 245 Murray Lane, Mail Stop 0610, Arlington, VA 20528-0610, Phone: 703 235-5263, Fax: 703 603-4935, Email: jon.m.maclaren@hq.dhs.gov.

RIN: 1601-AA69

DHS—U.S. CITIZENSHIP AND IMMIGRATION SERVICES (USCIS)

Proposed Rule Stage

50. Adjustment of Status to Lawful Permanent Resident for Aliens in T and U Nonimmigrant Status

Priority: Other Significant.

Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101 to 1104; 8 U.S.C. 1182; 8 U.S.C. 1184; 8 U.S.C. 1187; 8 U.S.C. 1201; 8 U.S.C. 1224 to 1227; 8 U.S.C. 1252 to 1252a; 8 U.S.C. 1255; 22 U.S.C. 7101; 22 U.S.C. 7105; Pub. L. 113-4

CFR Citation: 8 CFR 204; 8 CFR 214; 8 CFR 245.

Legal Deadline: None.

Abstract: This rule sets forth measures by which certain victims of severe forms of trafficking who have been granted T nonimmigrant status and victims of certain qualifying criminal activity who have been granted U nonimmigrant status may apply for adjustment of status to lawful permanent resident in accordance with Public Law 106-386, Victims of Trafficking and Violence Protection Act of 2000; and Public Law 109-162, Violence Against Women and Department of Justice Reauthorization Act of 2005. The Trafficking Victims Protection Reauthorization Act of 2008, Public Law 110-457, made amendments to the T nonimmigrant status provisions of the Immigration and Nationality Act (INA). The Violence Against Women's Reauthorization Act of 2013, Public Law 113-4, made amendments to the T and U nonimmigrant status and the T and U adjustment of status provisions of the Immigration and Nationality Act. The Department of Homeland Security (DHS) will issue a proposed rule to propose the changes required by recent legislation.

Statement of Need: This regulation is necessary to permit aliens in lawful T or U nonimmigrant status, including derivatives, to apply for adjustment of status to that of lawful permanent residents.

Summary of Legal Basis: This regulation is necessary to permit aliens in lawful T or U nonimmigrant status to apply for adjustment of status to that of lawful permanent residents. T nonimmigrant status is available to aliens who are victims of a severe form of trafficking in persons and who have assisted or are assisting law enforcement in the investigation or prosecution of the acts of trafficking.

U nonimmigrant status is available to aliens who are victims of certain qualifying criminal activity crimes and have been, are being, or are likely to be helpful to the investigation or prosecution of those crimes.

Alternatives: DHS did not consider alternatives to managing T and U applications for adjustment of status. Ease of administration dictates that adjustment of status applications from T and U nonimmigrants would be best handled on a first in, first out basis, because that is the way applications for T and U status are currently handled.

Anticipated Cost and Benefits: DHS uses fees to fund the cost of processing applications and associated support benefits. In the 2008 interim final rule, DHS estimated the fee collection resulting from this rule at approximately $3 million in the first year, $1.9 million in the second year, and an average about $32 million in the third and subsequent years. DHS is in the process of updating these cost estimates.

The anticipated benefits of these expenditures include: Continued assistance to trafficked and other qualifying crime victims and their families, increased investigation and prosecution of traffickers in persons and other qualifying crimes, and the elimination of abuses caused by trafficking and criminal activities.Start Printed Page 77782

Risks: While there is a limit of 5,000 adjustments based on T nonimmigrant status per fiscal year, there is no such limit on those applying for adjustment based on U nonimmigrant status. Eligible applicants for adjustment of status based on T nonimmigrant status will be placed on a waiting list maintained by U.S. Citizenship and Immigration Services (USCIS).

Timetable:

ActionDateFR Cite
Interim Final Rule12/12/0873 FR 75540
Interim Final Rule Effective01/12/09
Interim Final Rule Comment Period End02/10/09
NPRM10/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal, Local, State.

Additional Information: CIS No. 2134-01 Transferred from RIN 1115-AG21.

URL for More Information: www.regulations.gov.

URL for Public Comments: www.regulations.gov.

Agency Contact: Maureen A. Dunn, Chief, Family Immigration and Victim Protection Division, Department of Homeland Security, U.S. Citizenship and Immigration Services, Office of Policy and Strategy, 20 Massachusetts Avenue NW., Suite 1200, Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-1480, Email: maureen.a.dunn@uscis.dhs.gov.

RIN: 1615-AA60

DHS—USCIS

51. New Classification for Victims of Criminal Activity; Eligibility for the U Nonimmigrant Status

Priority: Other Significant.

Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101; 8 U.S.C. 1101 (note); 8 U.S.C. 1102; Pub. L. 113-4

CFR Citation: 8 CFR 103; 8 CFR 204; 8 CFR 212; 8 CFR 214; 8 CFR 299.

Legal Deadline: None.

Abstract: This rule proposes new application and eligibility requirements for U nonimmigrant status. The U classification is for non-U.S. citizen/lawful permanent resident victims of certain crimes who cooperate with an investigation or prosecution of those crimes. There is a limit of 10,000 principals per fiscal year. This rule would propose to establish new procedures to be followed to petition for the U nonimmigrant classifications. Specifically, the rule would address the essential elements that must be demonstrated to receive the nonimmigrant classification, procedures that must be followed to file a petition and evidentiary guidance to assist in the petitioning process. Eligible victims would be allowed to remain in the United States if granted U nonimmigrant status. The Trafficking Victims Protection Reauthorization Act of 2008, Public Law 110-457, and the Violence Against Women Reauthorization Act (VAWA) of 2013, Public Law 113-4, made amendments to the U nonimmigrant status provisions of the Immigration and Nationality Act. The Department of Homeland Security had issued an interim final rule in 2007.

Statement of Need: This regulation is necessary to allow alien victims of certain crimes to petition for U nonimmigrant status. U nonimmigrant status is available to eligible victims of certain qualifying criminal activity who: (1) Have suffered substantial physical or mental abuse as a result of the qualifying criminal activity; (2) the alien possesses information about the crime; (3) the alien has been, is being, or is likely to be helpful in the investigation or prosecution of the crime; and (4) the criminal activity took place in the United States, including military installations and Indian country, or the territories or possessions of the United States. This rule addresses the eligibility requirements that must be met for classification as a U nonimmigrant alien and implements statutory amendments to these requirements, streamlines the procedures to petition for U nonimmigrant status, and provides evidentiary guidance to assist in the petition process.

Summary of Legal Basis: Congress created the U nonimmigrant classification in the Battered Immigrant Women Protection Act of 2000 (BIWPA) to provide immigration relief for alien victims of certain qualifying criminal activity and who are helpful to law enforcement in the investigation or prosecution of these crimes.

Alternatives: To provide victims with immigration benefits and services and keeping in mind the purpose of the U visa as a law enforcement tool, DHS is considering and using suggestions from stakeholders in developing this regulation. These suggestions came in the form of public comment from the 2007 interim final rule as well as USCIS' six years of experience with the U nonimmigrant status program, including regular meetings and outreach events with stakeholders and law enforcement.

Anticipated Cost and Benefits: DHS estimated the total annual cost of the interim rule to petitioners to be $6.2 million in the interim final rule published in 2007. This cost included the biometric services fee, the opportunity cost of time needed to submit the required forms, the opportunity cost of time required and cost of traveling to visit a USCIS Application Support Center. DHS is currently in the process of updating our cost estimates since U nonimmigrant visa petitioners are no longer required to pay the biometric services fee. The anticipated benefits of these expenditures include assistance to victims of qualifying criminal activity and their families and increases in arrests and prosecutions of criminals nationwide. Additional benefits include heightened awareness by law enforcement of victimization of aliens in their community, and streamlining the petitioning process so that victims may benefit from this immigration relief.

Risks: There is a statutory cap of 10,000 principal U nonimmigrant visas that may be granted per fiscal year at 8 U.S.C. 1184(p)(2). Eligible petitioners who are not granted principal U-1 nonimmigrant status due solely to the numerical limit will be placed on a waiting list maintained by U.S. Citizenship and Immigration Services (USCIS). To protect U-1 petitioners and their families, USCIS will use various means to prevent the removal of U-1 petitioners and their eligible family members on the waiting list, including exercising its authority to allow deferred action, parole, and stays of removal, in cooperation with other DHS components.

Timetable:

ActionDateFR Cite
Interim Final Rule09/17/0772 FR 53013
Interim Final Rule Effective10/17/07
Interim Final Rule Comment Period End11/17/07
NPRM10/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal, Local, State.

Additional Information: Transferred from RIN 1115-AG39.

URL for More Information: www.regulations.gov.

URL for Public Comments: www.regulations.gov.

Agency Contact: Maureen A. Dunn, Chief, Family Immigration and Victim Protection Division, Department of Start Printed Page 77783Homeland Security, U.S. Citizenship and Immigration Services, Office of Policy and Strategy, 20 Massachusetts Avenue NW., Suite 1200, Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-1480, Email: maureen.a.dunn@uscis.dhs.gov.

RIN: 1615-AA67

DHS—USCIS

52. Exception to the Persecution Bar for Asylum, Refugee, and Temporary Protected Status, and Withholding of Removal

Priority: Other Significant.

Legal Authority: 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1158; 8 U.S.C. 1254a; Pub. L. 110-229

CFR Citation: 8 CFR 1; 8 CFR 207; 8 CFR 208; 8 CFR 240; 8 CFR 244; 8 CFR 1001; 8 CFR 1208; 8 CFR 1240.

Legal Deadline: None.

Abstract: This joint rule proposes amendments to Department of Homeland Security (DHS) and Department of Justice (DOJ) regulations to describe the circumstances under which an applicant will continue to be eligible for asylum, refugee, or temporary protected status, special rule cancellation of removal under the Nicaraguan Adjustment and Central American Relief Act, and withholding of removal, even if DHS or DOJ has determined that the applicant's actions contributed, in some way to the persecution of others when the applicant's actions were taken under duress.

Statement of Need: This rule resolves ambiguity in the statutory language precluding eligibility for asylum, refugee, and temporary protected status of an applicant who ordered, incited, assisted, or otherwise participated in the persecution of others. The proposed amendment would provide a limited exception for actions taken by the applicant under duress and clarify the required levels of the applicant's knowledge of the persecution.

Summary of Legal Basis: In Negusie v. Holder, 129 S. Ct. 1159 (2009), the Supreme Court addressed whether the persecutor bar should apply when an alien's actions were taken under duress. DHS believes that this is an appropriate subject for rulemaking and proposes to amend the applicable regulations to set out its interpretation of the statute. In developing this regulatory initiative, DHS has carefully considered the purpose and history behind enactment of the persecutor bar, including its international law origins and the criminal law concepts upon which they are based.

Alternatives: DHS did consider the alternative of not publishing a rulemaking on these issues. To leave this important area of the law without an administrative interpretation would confuse adjudicators and the public.

Anticipated Cost and Benefits: The programs affected by this rule exist so that the United States may respond effectively to global humanitarian situations and assist people who are in need. USCIS provides a number of humanitarian programs and protection to assist individuals in need of shelter or aid from disasters, oppression, emergency medical issues, and other urgent circumstances. This rule will advance the humanitarian goals of the asylum/refugee program, and other specialized programs. The main benefits of such goals tend to be intangible and difficult to quantify in economic and monetary terms. These forms of relief have not been available to individuals who engaged in persecution of others under duress. This rule will allow an exception to this bar from protection for applicants who can meet the appropriate evidentiary standard. Consequently, this rule may result in a small increase in the number of applicants for humanitarian programs. To the extent a small increase in applicants occurs, there could be additional fee costs incurred by these applicants.

Risks: If DHS were not to publish a regulation, the public would face a lengthy period of confusion on these issues. There could also be inconsistent interpretations of the statutory language, leading to significant litigation and delay for the affected public.

Timetable:

ActionDateFR Cite
NPRM10/00/16

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Ronald W. Whitney, Deputy Chief, Refugee and Asylum Law Division, Department of Homeland Security, U.S. Citizenship and Immigration Services, Office of Chief Counsel, 20 Massachusetts Avenue NW., Washington, DC 20529, Phone: 415 293-1244, Fax: 415 293-1269, Email: ronald.w.whitney@uscis.dhs.gov.

RIN: 1615-AB89

DHS—USCIS

53. Requirements for Filing Motions and Administrative Appeals

Priority: Other Significant.

Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101; 8 U.S.C. 1103; 8 U.S.C. 1304; 6 U.S.C. 112

CFR Citation: 8 CFR 103; 8 CFR 204; 8 CFR 205; 8 CFR 210; 8 CFR 214; 8 CFR 245a; 8 CFR 320; 8 CFR 105 (new); . . .

Legal Deadline: None.

Abstract: This proposed rule proposes to revise the requirements and procedures for the filing of motions and appeals before the Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS), and its Administrative Appeals Office (AAO). The proposed changes are intended to streamline the existing processes for filing motions and appeals and will reduce delays in the review and appellate process. This rule also proposes additional changes necessitated by the establishment of DHS and its components. The proposed changes are intended to promote simplicity, accessibility, and efficiency in the administration of USCIS appeals. The Department also solicits public comment on proposed changes to the AAO's appellate jurisdiction.

Statement of Need: This rule proposes to make numerous changes to streamline the current appeal and motion processes which: (1) Will result in cost savings to the Government, applicants, and petitioners; and (2) will provide for a more efficient use of USCIS officer and clerical staff time, as well as more uniformity with Board of Immigration Appeals appeal and motion processes.

Summary of Legal Basis: 5 U.S.C. 301; 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101 and notes 1102, 1103, 1151, 1153, 1154, 1182, 1184, 1185 note (sec 7209 of Pub. L. 108-458; title VII of Pub. L. 110-229), 1186a, 1187, 1221,1223, 1225 to 1227, 1255a, and 1255a note, 1281, 1282, 1301 to 1305, 1324a, 1356, 1372, 1379, 1409(c), 1443 to 1444, 1448, 1452, 1455, 1641, 1731 to 1732; 31 U.S.C. 9701; 48 U.S.C. 1901, 1931 note; section 643, Public Law 104-208, 110, Stat. 3009-708; section 141 of the Compacts of Free Association with the Federated States of Micronesia and the Republic of the Marshall Islands, and with the Government of Palau; title VII of Public Law 110-229; Public Law 107-296, 116 Stat. 2135 (6 U.S.C. 1 et seq.); Public Law 82-414, 66 Stat. 173, 238, 254, 264; title VII of Public Law 110-229; Executive Order 12356.

Alternatives: The alternative to this rule would be to continue under the current process without change.Start Printed Page 77784

Anticipated Cost and Benefits: As a result of streamlining the appeal and motion process, DHS anticipates quantitative and qualitative benefits to DHS and the public. We also anticipate cost savings to DHS and applicants as a result of the proposed changes.

Risks:

Timetable:

ActionDateFR Cite
NPRM10/00/16

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Governmental Jurisdictions.

Government Levels Affected: None.

Additional Information: Previously 1615-AB29 (CIS 2311-04), which was withdrawn in 2007.

Agency Contact: Charles “Locky” Nimick, Deputy Chief, Department of Homeland Security, U.S. Citizenship and Immigration Services, Administrative Appeals Office, 20 Massachusetts Avenue NW., Washington, DC 20529-2090, Phone: 703 224-4501, Email: charles.nimick@usics.dhs.gov.

Related RIN: Duplicate of 1615-AB29

RIN: 1615-AB98

DHS—USCIS

54. Significant Public Benefit Parole for Entrepreneurs

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.

Legal Authority: 8 U.S.C. 1182(d)(5)(A)

CFR Citation: 8 CFR 212.5.

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) is proposing to establish a program that would allow for consideration of parole into the United States, on a case-by-case basis, of certain inventors, researchers, and entrepreneurs who will establish a U.S. start-up entity, and who have been awarded substantial U.S. investor financing or otherwise hold the promise of innovation and job creation through the development of new technologies or the pursuit of cutting edge research. Based on investment, job-creation, and other factors, the entrepreneur may be eligible for temporary parole.

Statement of Need: The Immigration and Nationality Act (INA) authorizes the Secretary, in the exercise of discretion, to parole arriving aliens into the United States on a case-by-case basis for urgent humanitarian reasons or significant public benefit. INA section 212(d)(5), 8 U.S.C. 1182(d)(5). No existing regulation explains how DHS determines what provides a significant public benefit to the U.S. economy. This regulation clarifies this standard with respect to entrepreneur parolees.

This regulation focuses specifically on the significant economic public benefit provided by foreign entrepreneurs because of the particular benefit they bring to the U.S. economy. However, the full potential of foreign entrepreneurs to benefit the U.S. economy is limited by the fact that many foreign entrepreneurs do not qualify under existing nonimmigrant and immigrant classifications. Given the technical nature of entrepreneurship, and the limited guidance to date on what constitutes a significant public benefit, DHS believes that it is necessary to establish the conditions of such an economically-based significant public benefit parole by regulation. Combined with a unique application process, the goal is to ensure that the high standard set by the statute authorizing significant public benefit parole is uniformly met across adjudications.

In this rule, DHS is proposing to establish the conditions for significant public benefit parole with respect to certain entrepreneurs and start-up founders backed by U.S. investors or grants. DHS believes that this proposal, once implemented, would encourage entrepreneurs to create and develop start-up entities in the United States with high growth potential to create jobs for U.S. workers and benefit the U.S. economy. U.S. competitiveness would increase by attracting more entrepreneurs to the United States. This proposal provides a fair, transparent, and predictable framework by which DHS will exercise its discretion to adjudicate, on a case-by-case basis, such parole requests under the existing statutory authority at INA section 212(d)(5), 8 U.S.C. 1182(d)(5).

Lastly, this proposed rule provides a pathway, based on authority currently provided to the Secretary, for entrepreneurs to develop businesses in the United States, create jobs for U.S. workers, and, at the same time, establish a track record of experience and/or accomplishments. Such a track record may lead to meeting eligibility requirements for existing nonimmigrant or immigrant classifications.

Summary of Legal Basis: The Secretary's authority for this proposed regulatory amendment can be found in the Homeland Security Act of 2002, Public Law 107-296, section 102, 116 Stat. 2135, 6 U.S.C. 112, and INA section 103, 8 U.S.C. 1103, which give the Secretary the authority to administer and enforce the immigration and nationality laws, as well as INA section 212(d)(5), 8 U.S.C. 1182(d)(5), which refers to the Secretary's discretionary authority to grant parole and provides DHS with regulatory authority to establish terms and conditions for parole once authorized.

Alternatives:

Anticipated Cost and Benefits: DHS estimates the costs of the rule are directly linked to the application fee and opportunity costs associated with requesting significant public benefit parole. DHS does not estimate there will be any negative impacts to the U.S. economy as a result of this rule. Economic benefits can be expected from this rule, because some number of new ventures and research endeavors will be conducted in the United States that otherwise would not. It is reasonable to assume that investment and research spending on new firms associated with this proposed rule will directly and indirectly benefit the U.S. economy and job creation. In addition, innovation and research and development spending are likely to generate new patents and new technologies, further enhancing innovation. Some portion of the immigrant entrepreneurs likely to be attracted to this parole program may develop high impact firms that can be expected to contribute disproportionately to job creation.

Risks:

Timetable:

ActionDateFR Cite
NPRM12/00/15

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Agency Contact: Kevin J. Cummings, Chief, Business and Foreign Workers Division, Department of Homeland Security, U.S. Citizenship and Immigration Services, Office of Policy and Strategy, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, Phone: 202 272-8377, Fax: 202 272-1480, Email: kevin.j.cummings@uscis.dhs.gov.

RIN: 1615-AC04

Start Printed Page 77785

DHS—USCIS

55. Retention of EB-1, EB-2, and EB-3 Immigrant Workers and Program Improvements Affecting Highly-Skilled H-1B Alien Workers

Priority: Other Significant. Major under 5 U.S.C. 801.

Legal Authority: 6 U.S.C. 112; 8 U.S.C. 1154 and 1155; 8 U.S.C. 1184; 8 U.S.C. 1255; 8 U.S.C. 1324a

CFR Citation: 8 CFR 204 to 205; 8 U.S.C. 214; 8 CFR 245; 8 CFR 274a.

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) is proposing to amend its regulations affecting certain employment-based immigrant and nonimmigrant classifications. This rule proposes to amend current regulations to provide stability and job flexibility for the beneficiaries of approved employment-based immigrant visa petitions while they wait to become lawful permanent residents. DHS is also proposing to conform its regulations with the American Competitiveness in the Twenty-First Century Act of 2000 (AC21) as amended by the Twenty-First Century Department of Justice Appropriations Authorization Act (the 21st Century DOJ Appropriations Act), as well as the American Competitiveness and Workforce Improvement Act of 1998 (ACWIA). The rule also seeks to clarify several interpretive questions raised by ACWIA and AC21 regarding H-1B petitions, and incorporate relevant AC21 policy memoranda and an Administrative Appeals Office precedent decision, and would ensure that DHS practice is consistent with them.

Statement of Need: This rule provides needed stability and flexibility to certain employment-based immigrants while they wait to become lawful permanent residents. These amendments would support U.S. employers by better enabling them to hire and retain highly skilled and other foreign workers. DHS proposes to accomplish this, in part, by implementing certain provisions of ACWIA and AC21, as amended by the 21st Century DOJ Appropriations Act. The 21st Century DOJ Appropriations Authorization Act, which will impact certain foreign nationals seeking permanent residency in the United States, as well as H-1B workers. Further, by clarifying interpretive questions related to these provisions, this rulemaking would ensure that DHS practice is consistent with statute.

Summary of Legal Basis: The authority of the Secretary of Homeland Security (Secretary) for these regulatory amendments can be found in section 102 of the Homeland Security Act of 2002, Public Law 107-296, 116 Stat. 2135, 6 U.S.C. 112, and section 103(a) of the Immigration and Nationality Act (INA), 8 U.S.C. 1103(a), which authorize the Secretary to administer and enforce the immigration and nationality laws. In pertinent part, ACWIA authorized the Secretary to impose a fee on certain H-1B petitioners which would be used to train American workers, and AC21 provides authority to increase access to foreign workers as well as to train U.S. workers. In addition, section 274A(h)(3)(B) of the INA, 8 U.S.C. 1324a(h)(3)(B), recognizes the Secretary's authority to extend employment to noncitizens in the United States, and section 205 of the INA, 8 U.S.C. 1155, recognizes the Secretary's authority to exercise discretion in determining the revocability of any petition approved by him under section 204 of the INA.

Alternatives: The alternative would be to continue under current procedures without change.

Anticipated Cost and Benefits: The proposed amendments would increase the incentive of highly-skilled and other foreign workers who have begun the immigration process to remain in and contribute to the U.S. economy as they complete the process to adjust status to or otherwise acquire lawful permanent resident status, thereby minimizing disruptions to petitioning U.S. employers. Attracting and retaining highly-skilled persons is important when considering the contributions of these individuals to the U.S. economy, including advances in entrepreneurial and research and development endeavors, which are highly correlated with overall economic growth and job creation.

Risks:

Timetable:

ActionDateFR Cite
NPRM12/00/15

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.

Additional Information: 1615-AB97 will be merged under this rule, 1615-AC05.

Agency Contact: Kevin Cummings, Branch Chief, Business and Foreign Workers Division, Department of Homeland Security, U.S. Citizenship and Immigration Services, Second Floor, Office of Policy and Strategy, 20 Massachusetts Avenue NW., Washington, DC 20529, Phone: 202 272-1470, Fax: 202 272-1480, Email: kevin.cummings@uscis.dhs.gov.

Related RIN: Related to 1615-AB97

RIN: 1615-AC05

DHS—USCIS

Final Rule Stage

56. Classification for Victims of Severe Forms of Trafficking in Persons; Eligibility for T Nonimmigrant Status

Priority: Other Significant.

Legal Authority: 5 U.S.C. 552; 5 U.S.C. 552a; 8 U.S.C. 1101 to 1104; 8 U.S.C. 1182; 8 U.S.C. 1184; 8 U.S.C. 1187; 8 U.S.C. 1201; 8 U.S.C. 1224 to 1227; 8 U.S.C. 1252 to 1252a; 22 U.S.C. 7101; 22 U.S.C. 7105; Pub. L. 113-4

CFR Citation: 8 CFR 103; 8 CFR 212; 8 CFR 214; 8 CFR 274a; 8 CFR 299.

Legal Deadline: None.

Abstract: The T nonimmigrant classification was created by the Victims of Trafficking and Violence Protection Act of 2000, Public Law 106-386. The classification was designed for eligible victims of severe forms of trafficking in persons who aid law enforcement with their investigation or prosecution of the traffickers, and who can establish that they would suffer extreme hardship involving unusual and severe harm if they were removed from the United States. The rule streamlines application procedures and responsibilities for the Department of Homeland Security (DHS) and provides guidance to the public on how to meet certain requirements to obtain T nonimmigrant status. Several reauthorizations, including the Violence Against Women Reauthorization Act of 2013, Public Law 113-4, have made amendments to the T nonimmigrant status provisions in the Immigration and Nationality Act. This rule implements those amendments.

Statement of Need: This rule addresses the essential elements that must be demonstrated for classification as a T nonimmigrant alien and implements statutory amendments to these elements, streamlines the procedures to be followed by applicants to apply for T nonimmigrant status, and provides evidentiary guidance to assist in the application process.

Summary of Legal Basis: Section 107(e) of the Victims of Trafficking and Violence Protection Act of 2000 Public Law 106-386, as amended, established the T classification to provide immigration relief for certain eligible victims of severe forms of trafficking in persons who assist law enforcement Start Printed Page 77786authorities in investigating and prosecuting the perpetrators of these crimes.

Alternatives: To provide victims with immigration benefits and services, keeping in mind the purpose of the T visa to also serve as a law enforcement tool, DHS is considering and using suggestions from stakeholders in developing this regulation. These suggestions came in the form of public comment to the 2002 interim final rule, as well as from over 10 years of experience with the T nonimmigrant status program, including regular meetings with stakeholders and regular outreach events.

Anticipated Cost and Benefits: Applicants for T nonimmigrant status do not pay application or biometric fees. The anticipated benefits of this rule include: Assistance to trafficked victims and their families; an increase in the number of cases brought forward for investigation and/or prosecution of traffickers in persons; heightened awareness by the law enforcement community of trafficking in persons; and streamlining the application process for victims.

Risks: There is a 5,000-person limit to the number of individuals who can be granted T-1 status per fiscal year. Eligible applicants who are not granted T-1 status due solely to the numerical limit will be placed on a waiting list maintained by U.S. Citizenship and Immigration Services (USCIS). To protect T-1 applicants and their families, USCIS will use various means to prevent the removal of T-1 applicants on the waiting list, and their family members who are eligible for derivative T status, including its existing authority to grant deferred action, parole, and stays of removal, in cooperation with other DHS components.

Timetable:

ActionDateFR Cite
Interim Final Rule01/31/0267 FR 4784
Interim Final Rule Effective03/04/02
Interim Final Rule Comment Period End04/01/02
Interim Final Rule06/00/16

Regulatory Flexibility Analysis Required: No.

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