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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 Unified Agenda of Federal Regulatory and Deregulatory Actions.

SUMMARY:

The Regulatory Flexibility Act requires that agencies publish semiannual regulatory agendas in the Federal Register describing regulatory actions they are developing that may have a significant economic impact on a substantial number of small entities (5 U.S.C. 602). Executive Order 12866 “Regulatory Planning and Review,” signed September 30, 1993 (58 FR 51735), and incorporated in Executive Order 13563, “Improving Regulation and Regulatory Review” issued on January 18, 2011 (76 FR 3821) establish guidelines and procedures for agencies' agendas, including specific types of information for each entry.

The Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda) helps agencies fulfill these requirements. All Federal regulatory agencies have chosen to publish their regulatory agendas as part of the Unified Agenda.

The complete 2013 Unified Agenda and Regulatory Plan, which contains the regulatory agendas for 60 Federal agencies, is available to the public at http://reginfo.gov.

The 2013 Unified Agenda publication appearing in the Federal Register consists of 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.

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), 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 2013 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

Independent Regulatory Agencies

Consumer Financial Protection Bureau

Consumer Product Safety Commission

Federal Trade Commission

National Indian Gaming Commission

Nuclear Regulatory Commission

Agency 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 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

Joint Authority

Department of Defense/General Services Administration/National Aeronautics and Space Administration (Federal Acquisition Regulation)

Independent Regulatory Agencies

Consumer Financial Protection Bureau

Federal Communications Commission

Federal Deposit Insurance Corporation

Federal Reserve System

Nuclear Regulatory Commission

Securities and Exchange Commission

Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

I. What is the Unified Agenda?

The Unified Agenda provides information about regulations that the Government is considering or reviewing. The Unified Agenda has appeared in the Federal Register each year since 1983 and has been available online since 1995. To further the objective of using modern technology to deliver better service to the American people for lower cost, beginning with the fall 2007 edition, the Internet became the basic means for conveying regulatory agenda information to the maximum extent legally permissible. The complete Unified Agenda is available to the public at http://reginfo.gov. The online Unified Agenda offers flexible search tools and access to the historic Unified Agenda database to 1995.

The 2013 Unified Agenda publication appearing in the Federal Register consists of 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://reginfo.gov.

These publication formats meet the publication mandates of the Regulatory Start Printed Page 897Flexibility Act and Executive Order 12866 (incorporated in Executive Order 13563), as well as move the Agenda process toward the goal of online availability, at a substantially reduced printing cost. The current online format does not reduce the amount of information available to the public. The complete online edition of the Unified Agenda includes regulatory agendas from 60 Federal agencies. Agencies of the United States Congress are not included.

The following agencies have no entries identified 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 Housing and Urban Development *

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 Personnel Management *

Peace Corps

Pension Benefit Guaranty Corporation *

Privacy and Civil Liberties Oversight Board

Railroad Retirement Board

Social Security Administration *

Commodity Futures Trading Commission

Consumer Product Safety Commission*

Farm Credit Administration

Federal Energy Regulatory Commission

Federal Housing Finance Agency

Federal Maritime Commission

Federal Trade Commission *

National Credit Union Administration

National Indian Gaming Commission *

National Labor Relations Board

Postal Regulatory Commission

Recovery Accountability and Transparency 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. 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 Unified Agenda does 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 is the Unified Agenda published?

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 entitled “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 entitled “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 13132

Executive Order 13132 entitled “Federalism,” signed August 4, 1999 (64 FR 43255), directs 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 nonstatutory 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.

Executive Order 13563

Executive Order 13563 entitled “Improving Regulation and Regulatory Review,” signed 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 Start Printed Page 898public 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.

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 entitled “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 is the Unified Agenda Organized?

Agency regulatory flexibility agendas are printed in a single daily edition of the Federal Register. A regulatory flexibility agenda is printed 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 parts are organized alphabetically in four groups: Cabinet departments; other executive agencies; the Federal Acquisition Regulation, a joint authority; and independent regulatory agencies. Agencies may in turn be divided into sub-agencies. 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.

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 whose 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 stages 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 Start Printed Page 899Agenda 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 12/00/12 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 governments 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 2013.

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-Start Printed Page 900rulemaking 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.

Some agencies that participated in the 2013 edition of The Regulatory Plan have chosen to include the following information for those entries that appeared in the Plan:

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.

EO—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.

PL (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 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 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 different 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 Agenda?

Copies of the Federal Register issue containing the printed edition of 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.

In accordance with regulations for the Federal Register, 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 Start Printed Page 901documents are available at http://www.fdsys.gov.

Start Signature

Dated: November 26, 2013.

John C. Thomas,

Executive Director.

End Signature

Introduction to the 2013 Unified Regulatory Agenda and 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, reaffirmed the requirements of Executive Order 12866.

Consistent with Executive Orders 12866 and 13563, the Office of Information and Regulatory Affairs is providing the Unified Regulatory Agenda (Agenda) and the Regulatory Plan (Plan) for public review. The Agenda and Plan are a preliminary statement of regulatory and deregulatory policies and priorities under consideration. The Agenda and Plan includes “active rulemakings” that have at least some possibility of issuance over the next year, but, as in previous years, this list may include rules that are not issued in the coming year.

The public examination of the Agenda and Plan will help ensure 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.”

The Plan provides a list of important regulatory actions that are now under contemplation for issuance in proposed or final form during the upcoming 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.

A central purpose of the Agenda is to involve the public, including State, local, and tribal officials, in federal regulatory planning. We emphasize that rules listed on the Agenda must still undergo significant development and scrutiny, both within the agencies and externally, before they are issued. No regulatory action can become effective until it has gone through legally required processes, which generally include public review 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 and that is included here. For example, the directives of Executive Order 13563, emphasizing the importance of careful consideration of costs and benefits, may lead an agency to decline to proceed with a previously contemplated regulatory action.

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) is not an adequate measure of whether it imposes high costs on the private sector. Economically significant actions may impose small costs or even no costs. For example, regulations may count as economically significant because they confer large benefits or remove significant burdens. Moreover, many regulations count as economically significant not because they impose significant regulatory costs on the private sector, but because they involve transfer payments as required or authorized by law. For example, the Department of Health and Human Services issues regulations on an annual basis, pursuant to statute, to govern how Medicare payments are increased each year. These regulations effectively authorize transfers of billions of dollars to hospitals and other health care providers each year.

Executive Order 13563 explicitly points to the need for predictability and for certainty, as well as for use of the least burdensome tools for achieving regulatory ends. It indicates that agencies “must take into account benefits and costs, both quantitative and qualitative.” It explicitly draws attention to the need to measure and to improve “the actual results of regulatory requirements”—a clear reference to the importance of retrospective evaluation.

Executive Order 13563 reaffirms the principles, structures, and definitions in Executive Order 12866, which has long governed regulatory review. In addition, it endorses, and quotes, a number of provisions of Executive Order 12866 that specifically emphasize the importance of considering costs—including 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. Importantly, Executive Order 13563 directs agencies “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” This direction reflects a strong emphasis on quantitative analysis as a means of improving regulatory choices and increasing transparency.

Among other things, Executive Order 13563 sets out five sets of requirements to guide agency regulatory decision making:

  • Public participation. Agencies are directed to promote public participation, in part by making supporting documents available on Regulations.gov to promote transparency and public comment. Executive Order 13563 also directs agencies, where feasible and appropriate, to engage the public, including affected stakeholders, before rulemaking is initiated.
  • Integration and innovation. Agencies are directed to attempt to reduce “redundant, inconsistent, or overlapping” requirements, in part by working with one another to simplify and harmonize rules. This important provision is designed to reduce confusion, redundancy, and excessive cost. An important goal of simplification and harmonization is to promote rather than to hamper innovation, which is a foundation of both growth and job creation. Different offices within the same agency might work together to harmonize their rules; different agencies might work together to achieve the same objective. Such steps can also promote predictability and certainty.
  • Flexible approaches. Agencies are directed to identify and consider flexible approaches to regulatory problems, including warnings, appropriate default rules, and disclosure requirements. Such approaches may “reduce burdens and maintain flexibility and freedom of choice for the public.” In certain settings, they may be far preferable to mandates and bans, precisely because they maintain freedom of choice and reduce costs. The reference to “appropriate default rules” signals the possibility that important social goals can be obtained through simplification—as, for example, in the form of automatic enrollment, direct certification, or reduced paperwork burdens.
  • Science. Agencies are directed to promote scientific integrity, and in a way that ensures a clear separation between judgments of science and judgments of policy.
  • Retrospective analysis of existing rules. Agencies are directed to produce preliminary plans to engage in retrospective analysis of existing significant regulations to determine whether they should be modified, streamlined, expanded, or repealed. Executive Order 13610, Identifying and Reducing Regulatory Burdens, issued in 2012, institutionalizes the “look back” mechanism set out in Executive Order 13563, by requiring agencies to report to Start Printed Page 902OMB and the public twice each year (January and July) on the status of their retrospective review efforts, to “describe progress, anticipated accomplishments, and proposed timelines for relevant actions.” (See below for additional details on Executive Order 13610.)

Executive Order 13563 addresses new regulations that are under development and 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 likely impacts, and that the actual costs and benefits of a regulation may be lower or higher than what was anticipated when the rule was originally developed.

In addition, circumstances may change in a way that requires reconsideration of regulatory requirements. As retrospective or “look back” analysis is undertaken, agencies will be in a position to reevaluate existing rules and to streamline, modify, or eliminate those that do not make sense in their current form. The regulatory look back is an ongoing exercise, and regular reporting about recent progress and coming initiatives is required.

In August 2011, over two dozen agencies developed plans to remove what the President called unjustified rules and “absurd and unnecessary paperwork requirements that waste time and money.” The plans include over 500 initiatives that will reduce costs, simplify the system, and eliminate redundancy and inconsistency—which means many billions of dollars in savings for American businesses. Already, the Administration is on track to save more than $10 billion dollars in the near term, with far more savings to come.

In July 2013, agencies submitted to OIRA their latest updates of their retrospective review plans, pursuant to Executive Orders 13563 and 13610. Many of the initiatives highlighted in the updated plans benefit small businesses. Federal agencies will update their retrospective review plans this winter.

We have asked agencies to emphasize regulatory look backs in their latest Regulatory Plans. The goal is to change the regulatory culture to ensure that rules on the books are reevaluated and are effective, cost-justified, and based on the best available science. By creating regulatory review teams at agencies, we will continue to examine what is working and what is not, and to eliminate unjustified and outdated regulations.

In May 2012 President Obama issued Executive Order 13609, “Promoting International Regulatory Cooperation,” which emphasizes the importance of international regulatory cooperation as a key tool for eliminating unnecessary differences in regulation between the United States and its major trading partners which, in turn, supports economic growth, job creation, innovation, trade and investment, while also protecting public health, safety, and welfare. Among other things, the Executive Order provides that agencies that are required to submit a Regulatory Plan must “include in that plan a summary of its international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations, with an explanation of how these activities advance the purposes of Executive Order 13563” and Executive Order 13609. Further, the Executive Order requires agencies to “ensure that significant regulations that the agency identifies as having significant international impacts are designated as such” in the Agenda. Additionally, as part of the regulatory look back 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.”

The implementation of Executive Order 13609 and 13610 will further strengthen the emphasis that Executive Order 13563 has placed on careful consideration of costs and benefits, public participation, integration and innovation, flexible approaches, and science. These requirements 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 twenty-first century.

Department of Agriculture

Sequence No.TitleRegulation Identifier No.Rulemaking stage
1National Organic Program, Origin of Livestock, NOP-11-00090581-AD08Proposed Rule Stage.
2Environmental Compliance and Related Concerns0560-AH02Proposed Rule Stage.
3Agriculture Priorities and Allocations Systems0560-AH68Final Rule Stage.
4Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products0579-AD64Proposed Rule Stage.
5Brucellosis and Bovine Tuberculosis; Update of General Provisions0579-AD65Proposed Rule Stage.
6Establishing a Performance Standard for Authorizing the Importation and Interstate Movement of Fruits and Vegetables0579-AD71Proposed Rule Stage.
7User Fees for Agricultural Quarantine and Inspection Services0579-AD77Proposed Rule Stage.
8Civil Rights Compliance Requirements0575-AA83Proposed Rule Stage.
9Loan Packager Certification0575-AC88Proposed Rule Stage.
10Child Nutrition Program Integrity0584-AE08Proposed Rule Stage.
11Child and Adult Care Food Program: Meal Pattern Revisions Related to the Healthy, Hunger-Free Kids Act of 20100584-AE18Proposed Rule Stage.
12Enhancing Retailer Eligibility Standards in SNAP0584-AE27Proposed Rule Stage.
13Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages0584-AD77Final Rule Stage.
14Eligibility, Certification, and Employment and Training Provisions of the Food, Conservation, and Energy Act of 20080584-AD87Final Rule Stage.
15Records to be Kept by Official Establishments and Retail Stores That Grind Raw Beef Products0583-AD46Proposed Rule Stage.
16Modernization of Poultry Slaughter Inspection0583-AD32Final Rule Stage.
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17Electronic Export Application and Certification as a Reimbursable Service and Flexibility in the Requirements for Official Export Inspection Marks, Devices, and Certificates0583-AD41Final Rule Stage.
18Common or Usual Name for Raw Meat and Poultry Products Containing Added Solutions0583-AD43Final Rule Stage.
19Descriptive Designation for Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Products0583-AD45Final Rule Stage.
20Forest Service Manual 2020—Ecological Restoration and Resilience Policy0596-AC82Proposed Rule Stage.
21Land Management Planning Rule Policy0596-AD06Final Rule Stage.
22Nondiscrimination in Programs or Activities Conducted by the United States Department of Agriculture0503-AA52Proposed Rule Stage.
23Business and Industry (B&I) Guaranteed Loan Program0570-AA85Proposed Rule Stage.
24Rural Energy for America Program0570-AA76Final Rule Stage.
25BioPreferred Program Guidelines Revisions0599-AA18Final Rule Stage.

Department of Defense

Sequence No.TitleRegulation Identifier No.Rulemaking stage
26Defense Industrial Base (DIB) Cyber Security/Information Assurance (CS/IA) Activities; Amendment0790-AJ14Proposed Rule Stage.
27Service Academies0790-AI19Final Rule Stage.
28Sexual Assault Prevention and Response Program Procedures0790-AI36Final Rule Stage.
29Operational Contract Support0790-AI48Final Rule Stage.
30Mission Compatibility Evaluation Process0790-AI69Final Rule Stage.
31Child Development Programs (CDPs)0790-AI81Final Rule Stage.
32Voluntary Education Programs0790-AJ06Final Rule Stage.
33Safeguarding Unclassified Controlled Technical Information (DFARS Case 2011-D039)0750-AG47Final Rule Stage.
34Requirements Relating to Supply Chain Risk (DFARS Case 2012-D050)0750-AH96Final Rule Stage.
35Enhancement of Contractor Employee Whistleblower Protections (DFARS Case 2013-D010)0750-AH97Final Rule Stage.
36Allowability of Legal Costs for Whistleblower Proceedings (DFARS Case 2013-D022)0750-AI04Final Rule Stage.
37TRICARE; Reimbursement of Long Term Care Hospitals0720-AB47Proposed Rule Stage.
38TRICARE: Certified Mental Health Counselors0720-AB55Final Rule Stage.
39CHAMPUS/TRICARE: Pilot Program for Refills of Maintenance Medications for TRICARE For Life Beneficiaries Through the TRICARE Mail Order Program0720-AB60Final Rule Stage.

Department of Education

Sequence No.TitleRegulation Identifier No.Rulemaking stage
40Gainful Employment1840-AD15Proposed Rule Stage.

Department of Energy

Sequence No.TitleRegulation identifier No.Rulemaking stage
41Energy Conservation Standards for Walk-In Coolers and Walk-In Freezers1904-AB86Proposed Rule Stage.
42Energy Efficiency Standards for Metal Halide Lamp Fixtures1904-AC00Proposed Rule Stage.
43Energy Efficiency Standards for Manufactured Housing1904-AC11Proposed Rule Stage.
44Energy Conservation Standards for Commercial Refrigeration Equipment1904-AC19Proposed Rule Stage.
45Energy Conservation Standards for Residential Furnace Fans1904-AC22Proposed Rule Stage.
46Energy Efficiency Standards for Certain Commercial and Industrial Electric Motors1904-AC28Proposed Rule Stage.
47Energy Efficiency Standards for Battery Chargers and External Power Supplies1904-AB57Final Rule Stage.

Department of Health and Human Services

Sequence No.TitleRegulation Identifier No.Rulemaking stage
48HIPAA Privacy Rule and the National Instant Criminal Background Check System (NICS)0945-AA05Proposed Rule Stage.
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49Food Labeling; Revision of the Nutrition and Supplement Facts Labels0910-AF22Proposed Rule Stage.
50Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs0910-AF23Proposed Rule Stage.
51Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals0910-AG10Proposed Rule Stage.
52“Tobacco Products” Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act0910-AG38Proposed Rule Stage.
53Reports of Distribution and Sales Information for Antimicrobial Active Ingredients Used in Food-Producing Animals0910-AG45Proposed Rule Stage.
54Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages)0910-AG88Proposed Rule Stage.
55Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products0910-AG94Proposed Rule Stage.
56Veterinary Feed Directive0910-AG95Proposed Rule Stage.
57Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines0910-AG56Final Rule Stage.
58Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments0910-AG57Final Rule Stage.
59Fire Safety Requirements for Certain Health Care Facilities (CMS-3277-P)0938-AR72Proposed Rule Stage.
60Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS): Special Payment Rules (CMS-6012-P)0938-AR84Proposed Rule Stage.
61Eligibility, Enrollment, and Appeals Updates (CMS-9949-P)0938-AS02Proposed Rule Stage.
62Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (CMS-1607-P)0938-AS11Proposed Rule Stage.
63CY 2015 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-P)0938-AS12Proposed Rule Stage.
64CY 2015 Hospital Outpatient Prospective Payment System (PPS) Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1613-P)0938-AS15Proposed Rule Stage.
65CLIA Programs and HIPAA Privacy Rule; Patients' Access to Test Reports (CMS-2319-F)0938-AQ38Final Rule Stage.
66Head Start Eligibility Determination0970-AC46Final Rule Stage.
67Child Care and Development Fund Reforms to Support Child Development and Working Families0970-AC53Final Rule Stage.

Department of Homeland Security

Sequence No.TitleRegulation Identifier No.Rulemaking stage
68Ammonium Nitrate Security Program1601-AA52Final Rule Stage.
69Asylum and Withholding Definitions1615-AA41Proposed Rule Stage.
70Exception to the Persecution Bar for Asylum, Refugee, and Temporary Protected Status, and Withholding of Removal1615-AB89Proposed Rule Stage.
71Employment Authorization for Certain H-4 Dependent Spouses1615-AB92Proposed Rule Stage.
72Application of the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 to Unaccompanied Alien Children Seeking Asylum1615-AB96Proposed Rule Stage.
73Administrative Appeals Office: Procedural Reforms To Improve Efficiency1615-AB98Proposed Rule Stage.
74Enhancing Opportunities for H-1B1, CW-1, and E-3 Nonimmigrants and EB-1 Immigrants1615-AC00Proposed Rule Stage.
75Classification for Victims of Severe Forms of Trafficking in Persons; Eligibility for T Nonimmigrant Status1615-AA59Final Rule Stage.
76New Classification for Victims of Criminal Activity; Eligibility for the U Nonimmigrant Status1615-AA67Final Rule Stage.
77Application of Immigration Regulations to the Commonwealth of the Northern Mariana Islands1615-AB77Final Rule Stage.
78Implementation of the 1995 Amendments to the International Convention on Standards of Training, Certification, and Watchkeeping (STCW) for Seafarers, 19781625-AA16Final Rule Stage.
79Vessel Requirements for Notices of Arrival and Departure, and Automatic Identification System1625-AA99Final Rule Stage.
80Transportation Worker Identification Credential (TWIC); Card Reader Requirements1625-AB21Final Rule Stage.
81Offshore Supply Vessels of at Least 6000 GT ITC1625-AB62Final Rule Stage.
82Importer Security Filing and Additional Carrier Requirements1651-AA70Final Rule Stage.
83Changes to the Visa Waiver Program To Implement the Electronic System for Travel Authorization (ESTA) Program1651-AA72Final Rule Stage.
84Implementation of the Guam-CNMI Visa Waiver Program1651-AA77Final Rule Stage.
85Definition of Form I-94 to Include Electronic Format1651-AA96Final Rule Stage.
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86Security Training for Surface Mode Employees1652-AA55Proposed Rule Stage.
87Standardized Vetting, Adjudication, and Redress Services1652-AA61Proposed Rule Stage.
88Aircraft Repair Station Security1652-AA38Final Rule Stage.
89Passenger Screening Using Advanced Imaging Technology1652-AA67Final Rule Stage.
90Adjustments to Limitations on Designated School Official Assignment and Study By F-2 and M-2 Nonimmigrants1653-AA63Proposed Rule Stage.
91Standards To Prevent, Detect, and Respond to Sexual Abuse and Assault in Confinement Facilities1653-AA65Final Rule Stage.
92Rescinding Suspension of Enrollment for Certain F and M Nonimmigrant Students from Libya and Third Country Nationals Acting on Behalf of Libyan Entities1653-AA69Final Rule Stage.

Department of Housing and Urban Development

Sequence No.TitleRegulation Identifier No.Rulemaking stage
93Floodplain Management and Protection of Wetlands; Building Elevations (FR-5717)2501-AD62Proposed Rule Stage.
94Affordability Determination-Energy Efficiency Standards (FR-5647-N-01)2501-AD64Proposed Rule Stage.
95Public Housing Energy Audits and Physical Needs Assessments (FR-5507)2577-AC84Final Rule Stage.

Department of Justice

Sequence No.TitleRegulation Identifier No.Rulemaking stage
96Implementation of the ADA Amendments Act of 2008 (Title II and Title III of the ADA)1190-AA59Proposed Rule Stage.
97Implementation of the ADA Amendments Act of 2008 (Section 504 of the Rehabilitation Act of 1973)1190-AA60Proposed Rule Stage.
98Nondiscrimination on the Basis of Disability; Accessibility of Web Information and Services of Public Accommodations1190-AA61Proposed Rule Stage.
99Nondiscrimination on the Basis of Disability; Movie Captioning and Audio Description1190-AA63Proposed Rule Stage.
100Nondiscrimination on the Basis of Disability: Accessibility of Web Information and Services of State and Local Governments1190-AA65Proposed Rule Stage.
101Machine Guns, Destructive Devices and Certain Other Firearms; Background Checks for Responsible Persons of a Corporation, Trust, or Other Legal Entity With Respect to Making or Transferring a Firearm1140-AA43Proposed Rule Stage.

Department of Transportation

Sequence No.TitleRegulation Identifier No.Rulemaking stage
102Slot Management and Transparency for LaGuardia Airport, John F. Kennedy International Airport, and Newark Liberty International Airport2120-AJ89Proposed Rule Stage.
103Air Ambulance and Commercial Helicopter Operations; Safety Initiatives and Miscellaneous Amendments2120-AJ53Final Rule Stage.
104Safety Management Systems for Part 121 Certificate Holders2120-AJ86Final Rule Stage.
105National Goals and Performance Management Measures (MAP-21)2125-AF49Proposed Rule Stage.
106National Goals and Performance Management Measures (MAP-21)2125-AF53Proposed Rule Stage.
107National Goals and Performance Management Measures (MAP-21)2125-AF54Proposed Rule Stage.
108Carrier Safety Fitness Determination2126-AB11Proposed Rule Stage.
109Commercial Driver's License Drug and Alcohol Clearinghouse (MAP-21)2126-AB18Proposed Rule Stage.
110Electronic Logging Devices and Hours of Service Supporting Documents (MAP-21)2126-AB20Proposed Rule Stage.
111Motorcoach Rollover Structural Integrity (MAP-21)2127-AK96Proposed Rule Stage.
112Require Installation of Seat Belts on Motorcoaches, FMVSS No. 208 (MAP-21)2127-AK56Final Rule Stage.
113Electronic Stability Control Systems for Heavy Vehicles (MAP-21)2127-AK97Final Rule Stage.
114National and Public Transportation Safety Plans (MAP-21) and Transit Asset Management2132-AB20Prerule Stage.
115New and Small Start Projects (MAP-21)2132-AB18Proposed Rule Stage.
116State Safety Oversight (MAP-21)2132-AB19Proposed Rule Stage.
117Hazardous Materials: Rail Petitions and Recommendations to Improve the Safety of Railroad Tank Car Transportation (RRR)2137-AE91Prerule Stage.
118Pipeline Safety: Safety of On-Shore Liquid Hazardous Pipelines2137-AE66Proposed Rule Stage.
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119Pipeline Safety: Gas Transmission (RRR)2137-AE72Proposed Rule Stage.

Architectural and Transportation Barriers Compliance Board

Sequence No.TitleRegulation Identifier No.Rulemaking Stage
120Telecommunications Act Accessibility Guidelines; Electronic and Information Technology Accessibility Standards3014-AA37Proposed Rule Stage.
121Accessibility Guidelines for Pedestrian Facilities in the Public Right-of-Way3014-AA26Final Rule Stage.
122Accessibility Standards for Medical Diagnostic Equipment3014-AA40Final Rule Stage.

Environmental Protection Agency

Sequence No.TitleRegulation Identifier No.Rulemaking stage
123Review of the National Ambient Air Quality Standards for Lead2060-AQ44Proposed Rule Stage.
124Petroleum Refinery Sector Risk and Technology Review and NSPS2060-AQ75Proposed Rule Stage.
125Standards of Performance for Greenhouse Gas Emissions from New Stationary Sources: Electric Utility Generating Units2060-AQ91Proposed Rule Stage.
126Standards of Performance for Greenhouse Gas Emissions from Existing Sources: Electric Utility Generating Units2060-AR33Proposed Rule Stage.
127Standards of Performance for Greenhouse Gas Emissions from Modified Sources: Electric Utility Generating Units2060-AR88Proposed Rule Stage.
128Pesticides; Agricultural Worker Protection Standard Revisions2070-AJ22Proposed Rule Stage.
129Definition of “Waters of the United States” Under the Clean Water Act2040-AF30Proposed Rule Stage.
130Control of Air Pollution From Motor Vehicles: Tier 3 Motor Vehicle Emission and Fuel Standards2060-AQ86Final Rule Stage.
131Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements2060-AR34Final Rule Stage.
132Formaldehyde; Third-Party Certification Framework for the Formaldehyde Standards for Composite Wood Products2070-AJ44Final Rule Stage.
133Formaldehyde Emissions Standards for Composite Wood Products2070-AJ92Final Rule Stage.
134Hazardous Waste Manifest Revisions—Standards and Procedures for Electronic Manifests2050-AG20Final Rule Stage.
135Criteria and Standards for Cooling Water Intake Structures2040-AE95Final Rule Stage.
136Effluent Limitations Guidelines and Standards for the Steam Electric Power Generating Point Source Category2040-AF14Final Rule Stage.

Equal Employment Opportunity Commission

Sequence No.TitleRegulation Identifier No.Rulemaking stage
137Revisions to Procedures for Complaints or Charges of Employment Discrimination Based on Disability Subject to the Americans With Disabilities Act and Section 504 of the Rehabilitation Act of 19733046-AA91Proposed Rule Stage.
138Revisions to Procedures for Complaints/Charges of Employment Discrimination Based on Disability Filed Against Employers Holding Government Contracts or Subcontracts3046-AA92Proposed Rule Stage.
139Revisions to Procedures for Complaints of Employment Discrimination Filed Against Recipients of Federal Financial Assistance3046-AA93Proposed Rule Stage.
140Revisions to the Federal Sector's Affirmative Employment Obligations Regarding Individuals with Disabilities Under Section 501 of the Rehabilitation Act of 1973, as Amended3046-AA94Proposed Rule Stage.

Small Business Administration

Sequence No.TitleRegulation Identifier No.Rulemaking stage
141Small Business Mentor-Protege Programs3245-AG24Proposed Rule Stage.
142Small Business Technology Transfer (STTR) Policy Directive3245-AF45Final Rule Stage.
143Small Business Innovation Research (SBIR) Program Policy Directive3245-AF84Final Rule Stage.
144504 and 7(a) Loan Programs Updates3245-AG04Final Rule Stage.
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Social Security Administration

Sequence No.TitleRegulation Identifier No.Rulemaking Stage
145Revised Medical Criteria for Evaluating Neurological Impairments (806P)0960-AF35Proposed Rule Stage.
146Revised Medical Criteria for Evaluating Immune (HIV) System Disorders (3466P)0960-AG71Proposed Rule Stage.
147Revised Medical Criteria for Evaluating Cancer (Malignant Neoplastic Diseases) (3757P)0960-AH43Proposed Rule Stage.
148Submission of Evidence in Disability Claims (3802P)0960-AH53Proposed Rule Stage.
149Amendments to Regulations Regarding Withdrawals of Applications and Voluntary Suspension of Benefits (3573F)0960-AH07Final Rule Stage.
150Changes to Scheduling and Appearing at Hearings (3728F)0960-AH37Final Rule Stage.
151Conforming Changes to Regulations Regarding Income-Related Monthly Adjustment Amounts to Medicare Part B Premiums (3734I)0960-AH47Final Rule Stage.

DEPARTMENT OF AGRICULTURE (USDA)

Statement of Regulatory Priorities

In FY 2014, USDA's focus will continue to be on programs that create or save jobs, particularly in rural America, while identifying and taking action on those programs that could be modified, streamlined, and simplified; or reporting burdens reduced, particularly with the public's access to USDA programs. USDA anticipates implementing a comprehensive Food, Farm and Jobs Bill (Farm Bill) covering major farm, trade, conservation, rural development, nutrition assistance and other programs. It is anticipated that a number of high priority regulations will be developed during 2014 to implement this legislation should it be enacted. USDA's regulatory efforts in the coming year will achieve the following goals identified in the Department's Strategic Plan for 2010-2015:

  • Assist rural communities to create prosperity so they are self-sustaining, re-populating, and economically thriving. USDA is the leading advocate for rural America. The Department supports rural communities and enhances quality of life for rural residents by improving their economic opportunities, community infrastructure, environmental health, and the sustainability of agricultural production. The common goal is to help create thriving rural communities with good jobs where people want to live and raise families, and where children have economic opportunities and a bright future.
  • Ensure our national forests and private working lands are conserved, restored, and made more resilient to climate change, while enhancing our water resources. America's prosperity is inextricably linked to the health of our lands and natural resources. Forests, farms, ranches, and grasslands offer enormous environmental benefits as a source of clean air, clean and abundant water, and wildlife habitat. These lands generate economic value by supporting the vital agriculture and forestry sectors, attracting tourism and recreational visitors, sustaining green jobs, and producing ecosystem services, food, fiber, timber and non-timber products. They are also of immense social importance, enhancing rural quality of life, sustaining scenic and culturally important landscapes, and providing opportunities to engage in outdoor activity and reconnect with the land.
  • Help America promote agricultural production and biotechnology exports as America works to increase food security. A productive agricultural sector is critical to increasing global food security. For many crops, a substantial portion of domestic production is bound for overseas markets. USDA helps American farmers and ranchers use efficient, sustainable production, biotechnology, and other emergent technologies to enhance food security around the world and find export markets for their products.
  • 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. USDA provides nutrition assistance to children and low-income people who need it; and works to improve the healthy eating habits of all Americans, especially children. In addition, the Department safeguards the quality and wholesomeness of meat, poultry, and egg products; and addresses and prevents loss or damage from pests and disease outbreaks.

Important regulatory activities supporting the accomplishment of these goals in 2014 will include the following:

  • Strengthening Food Safety Inspection. USDA will continue to develop science-based regulations that improve the safety of meat, poultry, and egg products in the least burdensome and most cost-effective manner. Regulations will be revised to address emerging food safety challenges, streamlined to remove excessively prescriptive regulations, and updated to be made consistent with hazard analysis and critical control point principles. In 2014, the Food Safety and Inspection Service (FSIS) plans to finalize regulations to establish new systems for poultry slaughter inspection, which would improve food safety and save money for establishments and taxpayers. Among other actions, USDA will provide export certificates through the use of technology. To assist small entities to comply with food safety requirements, FSIS will continue to collaborate with other USDA agencies and State partners in its small business outreach program.
  • Improving Access to Nutrition Assistance and Dietary Behaviors. As changes are made to the nutrition assistance programs, USDA will work to ensure access to program benefits, improve program integrity, improve diets and healthy eating, and promote physical activity consistent with the national effort to reduce obesity. In support of these activities in 2014, the Food and Nutrition Service (FNS) plans to publish the proposed rule regarding meal pattern revisions for the Child and Adult Care Food Program and finalize a rule updating the WIC food packages. FNS will continue to work to implement rules that minimize participant and vendor fraud in its nutrition assistance programs.
  • Collaborating with Partners to Conserve Natural Resources. USDA will allow the Natural Resources Conservation Service's (NRCS) State Conservationists to remove undue burdens on producers that have acted in good faith on incorrect program information provided by NRCS. The Forest Service will finalize guidance for implementation of the 2012 Planning Rule. This guidance will provide the detailed monitoring, assessment, and documentation requirements that the Start Printed Page 908managers of our national forests and grasslands require to begin revising their land management plans under the 2012 Planning Rule. Currently 70 of the 120 Forest Service's Land Management Plans are expired and in need of revision.
  • Making Marketing and Regulatory Programs More Focused. The Animal and Plant Health Inspection Service (APHIS) plans to amend its veterinary biologics regulations to provide for the use of a simpler, uniform label format to better meet the needs of veterinary biologics consumers. APHIS also plans to revise tuberculosis and brucellosis regulations to better reflect the distribution of these diseases and thereby minimizing the impacts on livestock producers while continuing to address these livestock diseases. In the area of plant health, APHIS proposes to expand the streamlined method of considering the importation and interstate movement of fruits and vegetables. The Agricultural Marketing Service (AMS) will support the organic sector by proposing that all existing and replacement dairy animals from which milk or milk products are intended to be sold as organic must be managed organically from the last third of gestation.
  • Promoting Biobased Products. USDA will continue to promote sustainable economic opportunities to create jobs in rural communities through the purchase and use of biobased products through the BioPreferred® program. USDA will finalize regulations to revise the BioPreferred® program guidelines to continue adding designated product categories to the preferred procurement program, including intermediates and feedstocks and finished products made of intermediates and feedstocks. The Federal preferred procurement and the certified label parts of the program are voluntary; both are designed to assist biobased businesses in securing additional sales.

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), the following initiatives are identified in the Department's Final Plan for Retrospective Analysis. . . . The final agency plan, as well as periodic status updates for each initiative, are available online at: http://www.whitehouse.gov/​21stcenturygov/​actions/​21st-century-regulatory-system.

RINTitleSignificantly reduce burdens on small businesses
0583-AC59Prior Labeling Approval System: Generic Label ApprovalYes.
0583-AD41Electronic Export Application and Certification FeeYes.
0583-AD32Modernization of Poultry Slaughter InspectionYes.
0570-AA76Rural Energy America ProgramYes.
0570-AA85Business and Industry Loan Guaranteed ProgramYes.
0575-AC91Community Facilities Loan and GrantsYes.
0596-AD01National Environmental Policy Act (NEPA) EfficienciesYes.

Subsequent to EO 13563, and consistent with its goals as well as the importance of public participation, President Obama issued EO 13610 on Identifying and Reducing Regulatory Burdens in May 2012. EO 13610 directs agencies, in part, to give priority consideration to those initiatives that will produce cost savings or significant reductions in paperwork burdens. Accordingly, reducing the regulatory burden on the American people and our trading partners is a priority for USDA and we will continually work to improve the effectiveness of our existing regulations. As a result of our ongoing regulatory review and burden reduction efforts, USDA has identified the following burden reducing initiatives:

  • Increase Use of Generic Approval and Regulations Consolidation. FSIS is finalizing a rule that will expand the circumstances in which the labels of meat and poultry products will be deemed to be generically approved by FSIS. The rule will reduce regulatory burden and generate a discounted Agency cost savings of $3.3 million over 10 years (discounted at 7 percent).
  • Implement Electronic Export Application for Meat and Poultry Products. FSIS is finalizing a rule to provide exporters a fee-based option for transmitting U.S. certifications to foreign importers and governments electronically. Automating the export application and certification process will facilitate the export of U.S. meat, poultry, and egg products by streamlining the processes that are used while ensuring that foreign regulatory requirements are met.
  • Streamline Forest Service National Environmental Policy Act (NEPA) Compliance. The Forest Service, in cooperation with the Council on Environmental Quality, completed rulemaking to establish three new Categorical Exclusions for simple restoration activities. These Categorical Exclusions will improve and streamline the NEPA process, and reduce the paperwork burden, as it applies to Forest Service projects without reducing environmental protection.
  • Increase Accessibility to the Rural Energy for America Program (REAP). Under REAP, Rural Development provides guaranteed loans and grants to support the purchase, construction, or retrofitting of a renewable energy system. This rulemaking will streamline the application process for grants, lessening the burden to the customer.
  • Reduced Duplication in Farm Programs. The Farm and Foreign Agricultural Services (FFAS) mission area will reduce the paperwork burden on program participants by consolidating the information collections required to participate in farm programs administered by the Farm Service Agency (FSA) and the Federal crop insurance program administered by the Risk Management Agency (RMA). As a result, producers will be able to spend less time reporting information to USDA. Additionally, FSA and RMA will be better able to share information, thus improving operational efficiency. FFAS will evaluate methods to simplify and standardize, to the extent practical, acreage reporting processes, program dates, and data definitions across the various USDA programs and agencies. FFAS expects to allow producers to use information from their farm-management and precision agriculture systems for reporting production, planted and harvested acreage, and other key information needed to participate in USDA programs. FFAS will also streamline the collection of producer information by FSA and RMA with the agricultural production information collected by the National Agricultural Statistics Service. These process changes will allow for program Start Printed Page 909data that is common across agencies to be collected once and utilized or redistributed to agency programs in which the producer chooses to participate. Full implementation of the Acreage and Crop Reporting Streamlining Initiative (ACRSI) is planned for 2014. When specific changes are identified, FSA and RMA will make any required conforming changes in their respective regulations.

Periodic status updates for these burden reducing initiatives can be found online at: http://www.whitehouse.gov/​21stcenturygov/​actions/​21st-century-regulatory-system.

In additional to regulatory review initiatives identified under EO 13563 and the paper work burden reduction initiatives identified under the EO 13610, USDA has plans to initiate the following additional streamlining initiatives in 2014.

  • Simplify FSA NEPA Compliance. FSA will revise its regulations that implement NEPA to update, improve, and clarify requirements. It will also add new categorical exclusions and remove obsolete provisions. Annual cost savings to FSA as a result of this rule could be $345,000 from conducting 314 fewer environmental assessments per year, while retaining strong environmental protection.
  • Simplify Equipment Contracts for Rural Utilities Service (RUS) Loans. RUS is proposing a rule that would result in a new standard Equipment Contract Form for use by Telecommunications Program borrowers. This new standardized contract would ensure that certain standards and specifications are met and this new form would replace the current process that requires each construction provider to use their own resources to develop a contract for each project.
  • Consolidate Community Facilities Programs Loan and Grant Requirements. The Rural Housing Service (RHS) proposing to consolidate seven of the regulations used to service Community Facilities direct loans and grants into one streamlined regulation. This rule will reduce the time burden on RHS staff and provide the public with a single document that clearly outlines the requirements for servicing Community Facilities direct loans and grants.
  • Update Tuberculosis and Brucellosis Programs. Given the success USDA has had in nearly eradicating tuberculosis and brucellosis in ruminants, APHIS will propose rulemaking to update and consolidate its regulations regarding these diseases to better reflect the current distribution of these diseases and the changes in which cattle, bison, and captive cervid are produced in the United States.

Promoting International Regulatory Cooperation Under EO 13609

President Obama issued EO 13609 on promoting international regulatory cooperation in May 2012. The EO charges the Regulatory Working Group, an interagency working group chaired by the Administrator of Office of Information and Regulatory Affairs (OIRA), with examining appropriate strategies and best practices for international regulatory cooperation. The EO also directs agencies to identify factors that should be taken into account when evaluating the effectiveness of regulatory approaches used by trading partners with whom the U.S. is engaged in regulatory cooperation. At this time, USDA is identifying international regulatory cooperation activities that are reasonably anticipated to lead to significant regulations, while working closely with the Administration to refine the guidelines implementing the EO. Apart from international regulatory cooperation, the Department has continued to identify regulations with international impacts, as it has done in the past. Such regulations are those that are expected to have international trade and investment effects, or otherwise may be of interest to our international trading partners.

USDA is diligently working to carry out the President's EO mandate with regard to regulatory cooperation as new regulations are developed. Several agencies within the Department are also actively engaged in interagency and Departmental regulatory cooperation initiatives being pursued as part of the U.S.-Mexico High Level Regulatory Cooperation Council (HLRCC) and the U.S.-Canada Regulatory Cooperation Council (RCC), as well as other fora. Specific projects are being pursued by USDA agencies such as AMS, APHIS, and FSIS and address a variety of regulatory oversight processes and requirements related to meat, poultry, animal and plant health. Projects related to electronic certification, equivalence, meat nomenclature, and the efficient and safe flow of plant, animal and food across our shared borders are all regulatory cooperation pursuits these agencies are undertaking in order to secure better alignment between our countries without compromising the high standards of safety we have in place in the U.S. relative to food safety and public health, as well as plant and animal health, so critical to American agriculture.

Major Regulatory Priorities

This following represents summary information on prospective priority regulations as called for in EO's 12866 and 13563:

Food and Nutrition Service

Mission: FNS increases food security and reduces hunger in partnership with cooperating organizations by providing children and low-income people access to food, a healthful diet, and nutrition education in a manner that supports American agriculture and inspires public confidence.

Priorities: In addition to responding to provisions of legislation authorizing and modifying Federal nutrition assistance programs, FNS's 2014 regulatory plan supports USDA's Strategic Goal to “ensure that all of America's children have access to safe, nutritious and balanced meals,” and its related objectives:

  • Increase Access to Nutritious Food. This objective represents FNS's efforts to improve nutrition by providing access to program benefits (food consumed at home, school meals, commodities) and distributing State administrative funds to support program operations. To advance this objective, FNS plans to publish a final rule from the 2008 Farm Bill addressing SNAP eligibility, certification, and employment and training issues. FNS will also publish a final rule implementing the Healthy, Hunger-Free Kids Act of 2010's Community Eligibility Provision, which eliminates the burden of household applications and increases access to free school lunches and breakfasts for children in eligible high poverty schools. In addition, FNS plans to publish a proposed rule that would enhance the eligibility standards for SNAP retailers in order to improve the availability of more healthful foods.
  • Improve Program Integrity. FNS also plans to publish a number of rules to increase efficiency, reduce the burden of program operations, and reduce improper payments. Program integrity provisions will continue to be strengthened in the SNAP and Child Nutrition programs to ensure Federal taxpayer dollars are spent effectively. To support this objective, FNS plans to publish a final rule from the 2008 Farm Bill that would provide FNS and OIG the authority to suspend payments to SNAP retailers suspected of being egregious violators. For Child Nutrition, FNS plans to publish a proposed rule to strengthen oversight requirements and institution disqualification procedures, allow the imposition of fines by USDA Start Printed Page 910or State agencies for egregious and/or repeated program violations, and address several deficiencies identified through program audits and reviews.
  • Promote Healthy Diet and Physical Activity Behaviors. This objective represents FNS's efforts to ensure that program benefits meet appropriate standards to effectively improve nutrition for program participants, to improve the diets of its clients through nutrition education, and to support the national effort to reduce obesity by promoting healthy eating and physical activity. In support of this objective, FNS plans to publish proposed rules updating the meal patterns for the Child and Adult Care Food Program to align them with the latest Dietary Guidelines for Americans, establishing professional standards for school food service and State child nutrition program directors. FNS also plans to finalize a rule updating food packages in WIC. FNS's goal is by 2015 to reduce child obesity from 16.9 percent to 15.5 percent, to double the proportion of adults consuming five or more servings of fruits and vegetables daily, and to increase breastfeeding rates among WIC mothers.

Food Safety and Inspection Service

Mission: FSIS is responsible for ensuring that meat, poultry, and egg products in interstate and foreign commerce are wholesome, not adulterated, and properly marked, labeled, and packaged.

Priorities: FSIS is committed to developing and issuing science-based regulations intended to ensure that meat, poultry, and egg products are wholesome and not adulterated or misbranded. FSIS regulatory actions support the objective to protect public health by ensuring that food is safe under USDA's goal to ensure access to safe food. To reduce the number of foodborne illnesses and increase program efficiencies, FSIS will continue to review its existing authorities and regulations to ensure that it can address emerging food safety challenges, to streamline excessively prescriptive regulations, and to revise or remove regulations that are inconsistent with the FSIS' hazard analysis and critical control point (HACCP) regulations. FSIS is also working with the Food and Drug Administration (FDA) to improve coordination and increase the effectiveness of inspection activities. FSIS's priority initiatives are as follows:

  • Implement Poultry Slaughter Modernization. FSIS plans to issue a final rule to implement a new inspection system for young poultry slaughter establishments that would facilitate public health-based inspection. The rule would help prevent thousands of illnesses by allowing front-line inspectors to focus on public health threats such as Salmonella and Campylobacter. The rule would allow for more effective inspection of carcasses and allocation of agency resources, as well as encourage industry to more readily use new technology.
  • Streamline Export Application Processes through the Public Health Information System (PHIS). To support its food safety inspection activities, FSIS is continuing to implement PHIS), a user-friendly and Web-based system that automates many of the Agency's business processes. PHIS also enables greater exchange of information between FSIS and other Federal agencies, such as U.S. Customs and Border Protection, involved in tracking cross-border movement of import and export shipments of meat, poultry, and processed egg products. To facilitate the implementation of some PHIS components, FSIS has proposed to provide for electronic export application and certification processes and will propose similar import processes as alternatives to current paper-based systems.
  • Ensure Accurate Labeling of Meat and Poultry Products that Contain Added Solutions. FSIS is developing final regulations to establish a common or usual name for raw meat and poultry products that contain added solutions, and that do not meet a standard of identity. Without adequate labeling information, consumers likely cannot distinguish between raw meat and poultry products that contain added solutions and single-ingredient meat and poultry products. Added solutions are a characterizing component of a product likely to affect consumers' purchasing decisions. The rule will establish a common or usual name for such products that include an accurate description of the raw meat or poultry component, the percentage of added solution incorporated into the product, and the individual ingredients or multi-ingredient components in the solution.
  • Ensure Accurate Labeling of Mechanically Tenderized Beef. FSIS has concluded that without proper labeling, raw or partially cooked mechanically tenderized beef products could be mistakenly perceived by consumers to be whole, intact muscle cuts. The fact that a cut of beef has been needle or blade tenderized is a characterizing feature of the product and, as such, a material fact that is likely to affect consumers' purchase decisions and that should affect their preparation of the product. The Agency will propose that raw, needle or blade, mechanically tenderized beef products be labeled to indicate that they are “mechanically tenderized.” FSIS has also concluded that the addition of validated cooking instruction is required to ensure that potential pathogens throughout the product are destroyed. Without thorough cooking, pathogens that may have been introduced to the interior of the product during the tenderization process may remain in the product.
  • Improve the Efficiency of Product Recalls. FSIS will propose to amend recordkeeping regulations to specify that all official establishments and retail stores that grind or chop raw beef products for sale in commerce must keep records that disclose the identity of the supplier of all source materials that they use in the preparation of each lot of raw ground or chopped product and identify the names of those source materials. FSIS investigators and public health officials frequently use records kept by all levels of the food distribution chain, including the retail level, to identify and trace back product that is the source of the illness the suppliers that produced the source material for the product. Access to this information will improve FSIS's ability to conduct timely and effective consumer foodborne illness investigations and other public health activities throughout the stream of commerce.
  • FSIS Small Business Implications. The great majority of businesses regulated by FSIS are small businesses. FSIS conducts a small business outreach program that provides critical training, access to food safety experts, and information resources, such as compliance guidance and questions and answers on various topics, in forms that are uniform, easily comprehended, and consistent. FSIS collaborates in this effort with other USDA agencies and cooperating State partners. For example, FSIS makes plant owners and operators aware of loan programs available through USDA's Rural Business and Cooperative programs, to help them in upgrading their facilities. FSIS employees will meet with small and very small plant operators to learn more about their specific needs and explore how FSIS can tailor regulations to better meet the needs of small and very small establishments, while maintaining the highest level of food safety.

Animal and Plant Health Inspection Service

Mission: A major part of the mission of APHIS is to protect the health and value of American agricultural and natural resources. APHIS conducts Start Printed Page 911programs to prevent the introduction of exotic pests and diseases into the United States and conducts surveillance, monitoring, control, and eradication programs for pests and diseases in this country. These activities enhance agricultural productivity and competitiveness and contribute to the national economy and the public health. APHIS also conducts programs to ensure the humane handling, care, treatment, and transportation of animals under the Animal Welfare Act.

Priorities: APHIS continues to pursue initiatives to update our regulations to make them more flexible and performance-based. For example, in the area of animal health, APHIS has prepared a proposal to amend its veterinary biologics regulations to provide for the use of a simpler, uniform label format that would allow biologics licensees and permittees to more clearly communicate product performance information to the end user. In addition, the rule would simplify the evaluation of efficacy studies and reduce the amount of time required by APHIS to evaluate study data, thus allowing manufacturers to market their products sooner. APHIS is also preparing a proposed rule that would revise and consolidate its regulations regarding bovine tuberculosis and brucellosis to better reflect the distribution of these diseases and the current nature of cattle, bison, and captive cervid production in the United States. In the area of plant health, APHIS is preparing a proposed rule that would establish performance standards and a notice-based process for approving the interstate movement of fruits and vegetables from Hawaii and the U.S. Territories and the importation of those articles from other countries. In addition, APHIS will revise agricultural quarantine and inspection user fees so that fees collected are commensurate with the cost of providing the activity.

Agricultural Marketing Service

Mission: The Agricultural Marketing Service (AMS) provides marketing services to producers, manufacturers, distributors, importers, exporters, and consumers of food products. AMS also manages the government's food purchases, supervises food quality grading, maintains food quality standards, supervises the Federal research and promotion programs, and oversees the country of origin labeling program as well as the National Organic Program (NOP).

Priorities: AMS is committed to ensuring the integrity of USDA organic products in the U.S. and throughout the world. The agency is moving forward with the following rulemaking that affect the organic industry.

  • Transitioning Dairy Animals into Organic Production. Members of the organic community, including dairy producers, organic interest groups, and the National Organic Standards Board have advocated for rulemaking on the allowance for transitioning dairy animals into organic production. Stakeholders have interpreted the current standard differently, creating inconsistencies across dairy producers. AMS is developing a proposed rule to address this issue by specifying that dairy farms have a one-time opportunity to transition animals into organic production. This proposed change to the organic standards will meet consumer expectations of organic dairy products and level the playing for organic dairy producers.

Farm Service Agency

Mission: FSA's mission is to deliver timely, effective programs and services to America's farmers and ranchers to support them in sustaining our Nation's vibrant agricultural economy, as well as to provide first-rate support for domestic and international food aid efforts. FSA supports USDA's strategic goals by stabilizing farm income, providing credit to new or existing farmers and ranchers who are temporarily unable to obtain credit from commercial sources, and helping farm operations recover from the effects of disaster. FSA administers several conservation programs directed toward agricultural producers. The largest program is the Conservation Reserve Program, which protects millions of acres of environmentally sensitive land.

Priorities: FSA is focused on providing the best possible service to producers while protecting the environment by updating and streamlining environmental compliance. FSA is also strengthening its ability to help the Nation respond to national defense emergencies. FSA's priority initiatives are as follows:

  • Streamline Environmental Compliance (NEPA). FSA will revise its regulations that implement NEPA. The changes improve the efficiency, transparency, and consistency of NEPA implementation. Changes include aligning the regulations to NEPA regulations and guidance from the President's Council on Environmental Quality; providing a single set of regulations that reflect the agency's current structure; clarifying the types of actions that require an Environmental Assessment (EA); and adding to the list of actions that are categorically excluded from further environmental review because they have no significant effect on the human environment.
  • Establish Agriculture Priorities and Allocations Systems (APAS). USDA is developing APAS as part of a suite of rules that are being modeled after the Defense Priorities and Allocations System (DPAS). Under APAS, USDA would secure food and agriculture-related resources as part of preparing for, and responding to, national defense emergencies by placing priorities on orders or by using resource allocation authority. APAS is authorized by the Defense Production Act Reauthorization Act of 2009 (DPA). The authorities under DPA have already been implemented by the Department of Commerce (DOC) via memoranda of understanding with other Departments. The suite of DPA rules relieves DOC from implementation responsibility for items outside their jurisdiction and places these responsibilities with the relevant Departments.

Forest Service

Mission: The mission of the Forest Service is to sustain the health, productivity, and diversity of the Nation's forests and rangelands to meet the needs of present and future generations. This includes protecting and managing National Forest System lands, providing technical and financial assistance to States, communities, and private forest landowners, plus developing and providing scientific and technical assistance, and the exchange of scientific information to support international forest and range conservation. Forest Service regulatory priorities support the accomplishment of the Department's goal to ensure our National forests are conserved, restored, and made more resilient to climate change, while enhancing our water resources.

Priorities: The Forest Service is committed to developing and issuing science-based regulations intended to ensure public participation in the management of our Nation's national forests and grasslands, while also moving forward the Agency's ability to plan and conduct restoration projects on National Forest System lands. The Forest Service will continue to review its existing authorities and regulations to ensure that it can address emerging challenges, to streamline excessively burdensome business practices, and to revise or remove regulations that are inconsistent with the USDA's vision for restoring the health and function of the lands it is charged with managing. FS' priority initiatives are as follows:

  • Implement Land Management Planning Framework. The Forest Start Printed Page 912Service promulgated a new Land Management Planning rule at 36 CFR part 219 in April 2012 that sets out the requirements for developing, amending, and revising land management plans for units of the National Forest System. The planning directives, once finalized, will be used to implement the planning framework which fosters collaboration with the public during land management planning, and is science-based, responsive to change, and promotes social, economic, and ecological sustainability.
  • Strengthen Ecological Restoration Policies. This policy would recognize the adaptive capacity of ecosystems, and includes the role of natural disturbances and uncertainty related to climate and other environmental change. The need for ecological restoration of National Forest System lands is widely recognized, and the Forest Service has conducted restoration-related activities across many programs for decades. “Restoration” is a common way of describing much of the Agency's work and the concept is threaded throughout existing authorities, program directives, and collaborative efforts such as the National Fire Plan, a 10-year comprehensive strategy and implementation plan, and the Healthy Forests Restoration Act. However, the Agency did not have a definition of restoration established in policy. That was identified as a barrier to collaborating with the public and partners to plan and accomplish restoration work.

Rural Development

Mission: Rural Development (RD) promotes a dynamic business environment in rural America that creates jobs, community infrastructure, and housing opportunities in partnership with the private sector and community-based organizations by providing financial assistance and business planning services, and supporting projects that create or preserve quality jobs and/or promote a clean rural environment, while focusing on the development of single and multi-family housing and community infrastructure. RD financial resources are often leveraged with those of other public and private credit source lenders to meet business and credit needs in under-served areas. Recipients of these programs may include individuals, corporations, partnerships, cooperatives, public bodies, nonprofit corporations, Indian tribes, and private companies.

Priorities: RD regulatory priorities will facilitate sustainable renewable energy development and enhance the opportunities necessary for rural families to thrive economically. RD's rules will minimize program complexity and the related burden on the public while enhancing program delivery and RBS oversight.

  • Streamline the Business and Industry (B&I) Guaranteed Loan Program. RD will enhance current operations of the B&I program, streamline existing practices, and minimize program complexity and the related burden on the public.
  • Increase Accessibility to the Rural Energy for America Program (REAP). Under REAP, Rural Development provides guaranteed loans and grants to support the purchase, construction, or retrofitting of a renewable energy system. This rulemaking will streamline the application process for grants, lessening the burden to the customer. The rulemaking is expected to reduce the information collection. REAP will also be revised to ensure a larger number of applicants will be made available by issuing smaller grants. By doing so, funding will be distributed evenly across the applicant pool and encourage greater development of renewable energy.
  • Modify review of Single Family Housing Direct Loans. RD will finalize the certified loan packager regulation to streamline oversight of the agency's vast network of committed Agency-certified packagers. This action will assist low- and very low-income people become homeowners. It will also reduce burden on program staff enabling them to focus on implementation and delivery or other and will ensure specialized support is available to them to complete the application for assistance, and improving the quality of loan application packages.
  • Update Civil Rights Protections: RD will propose a comprehensive civil rights rule to update and consolidate civil rights compliance regulations for Rural Housing Service, Rural Utilities Service and Rural Business Service. This regulation will provide detailed information on civil rights compliance and enforcement policies and procedures for all Rural Development programs.

Office of the Assistant Secretary for Civil Rights (OASCR)

Mission: OASCR's mission is to provide leadership and direction for the fair and equitable treatment of all USDA customers and employees while ensuring the delivery of quality programs and enforcement of civil rights. OASCR ensures compliance with applicable laws, regulations, and policies for USDA customers and employees regardless of race, color, national origin, sex (including gender identity and expression), religion, age, disability, sexual orientation, marital or familial status, political beliefs, parental status, protected genetic information, or because all or part of an individual's income is derived from any public assistance program. (Not all bases apply to all programs.)

Priorities

  • Strengthen Civil Rights Protections: USDA has made significant strides towards realizing the Secretary's vision of a “New Era for Civil Rights.” In this effort, USDA plans to publish a proposed rule that will standardize the collection of race, ethnicity and gender data across USDA's conducted programs (those where USDA deals directly with the public; much of this data is already being collected). USDA will also expand the protected categories under which program participants may bring complaints of discrimination to the Department; these new protected bases will be gender identity and political beliefs.

Departmental Management

Mission: Departmental Management's mission is to provide management leadership to ensure that USDA administrative programs, policies, advice and counsel meet the needs of USDA programs, consistent with laws and mandates, and provide safe and efficient facilities and services to customers.

Priorities

  • Promote Biobased Products: In support of the Department's goal to increase prosperity in rural areas, USDA's Departmental Management will finalize regulations to revise the BioPreferred® program guidelines to continue adding designated product categories to the preferred procurement program, including intermediates and feedstocks and finished products made of intermediates and feedstocks.

Aggregate Costs and Benefits

USDA will ensure that its regulations provide benefits that exceed costs, but are unable to provide an estimate of the aggregated impacts of its regulations. Problems with aggregation arise due to differing baselines, data gaps, and inconsistencies in methodology and the type of regulatory costs and benefits considered. Some benefits and costs associated with rules listed in the regulatory plan cannot currently be quantified as the rules are still being formulated. For 2014, USDA's focus will be to implement the changes to Start Printed Page 913programs in such a way as to provide benefits while minimizing program complexity and regulatory burden for program participants.

USDA—AGRICULTURAL MARKETING SERVICE (AMS)

Proposed Rule Stage

1. National Organic Program, Origin of Livestock, NOP-11-0009

Priority: Other Significant.

Legal Authority: 7 U.S.C. 6501

CFR Citation: 7 CFR 205.

Legal Deadline: None.

Abstract: The current regulations provide two tracks for replacing dairy animals which are tied to how dairy farmers transition to organic production. Farmers who transition an entire distinct herd must thereafter replace dairy animals with livestock that has been under organic management from the last third of gestation. Farmers who do not transition an entire distinct herd may perpetually obtain replacement animals that have been managed organically for 12 months prior to marketing milk or milk products as organic. The proposed action would eliminate the two track system and require that upon transition, all existing and replacement dairy animals from which milk or milk products are intended to be sold, labeled or represented as organic, must be managed organically from the last third of gestation.

Statement of Need: This action is being taken because of concerns raised by various parties, including the National Organic Standards Board (NOSB), about the dual tracks for dairy replacement animals. The organic community argues that the “two track system” encourages producers to sell their organic young stock and replace them with animals converted from conventional production. The organic community points out that with this continual state of transitioning, animals treated with and fed prohibited substances, prior to conversion, are constantly entering organic agriculture. Some producers have taken this route because it is cheaper and easier to convert or purchase converted animals than to raise organic young stock. As a result, this continual state of transition has discouraged development of a viable organic market for young dairy stock. The organic community has expressed that this is contrary to the intent of organic and the expectations of organic dairy product consumers. These concerns are ultimately rooted in a discrepancy between the regulatory intent and interpretation whereby some organic dairy producers are required to manage/obtain animals that have been raised organically since the last third of gestation, while other producers may continually obtain replacement animals from conventional production, which have been managed organically for 12 months. The proposed action would level the playing field by instituting the same requirements across all producers, regardless of their transition approach.

Summary of Legal Basis: The National Organic Program regulations stipulate the requirements for dairy replacement animals in section 205.236(a)(2) Origin of Livestock. In addition, in response to the final ruling in the 2005 case, Harvey v. Johanns, the USDA committed to rulemaking to address the concerns about dairy replacement animals.

Alternatives: The program considered initiating the rulemaking with an ANPR. It was determined that there is sufficient awareness of the expectations of the organic community to proceed with a proposed rule. As alternatives, we considered the status quo, however, this would continue the disparity between producers who can continually transition conventional dairy animals into organic production and producers who must source dairy animals that are organic from the last third of gestation. Based on the information available, this disparity appears to create a barrier to the development of an organic heifer market. We also considered an action that would restrict the source of breeder stock and movement of breeder stock after they are brought onto an organic operation, however, this would minimize the flexibility of producers to purchase breeder stock from any source as specified under the Organic Foods Production Act.

Anticipated Cost and Benefits: Organic producers who routinely convert conventional dairy livestock to organic will either need to find a source to procure organic replacement animals, or begin to raise replacement animals within their operation. Preliminary analysis suggest that less than 5 percent of organic dairies would face higher costs to comply with this action. Organic operations that converted a whole-herd to organic status and do not convert conventional animals for replacements will be able to readily comply with the rule and may find new market opportunities for organic replacement dairy livestock.

Risks: Continuation of the two-track system jeopardizes the viability of the market for organic heifers. A potential risk associated with the rulemaking would be a temporary supply shortage of dairy replacement animals due to the increased demand.

Timetable:

ActionDateFR Cite
NPRM04/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: None.

Agency Contact: Melissa R Bailey, Director, Standards Division, Department of Agriculture, Agricultural Marketing Service, 14th & Independence Avenue SW., Room 2646—South Building, Washington, DC 20250, Phone: 202 720-3252, Fax: 202 205-7808, Email: melissa.bailey@usda.gov.

RIN: 0581-AD08

USDA—FARM SERVICE AGENCY (FSA)

Proposed Rule Stage

2. Environmental Compliance and Related Concerns

Priority: Other Significant.

Legal Authority: 42 U.S.C. 4321 et seq.

CFR Citation: 7 CFR 799.

Legal Deadline: None.

Abstract: This proposed rule would provide the Farm Service Agency (FSA) with an environmental compliance regulation that updates, improves, and clarifies its requirements to comply with the National Environmental Policy Act; the National Historic Preservation Act; and numerous other environmental and cultural resource laws, regulations, and Executive orders. It would also make the regulation consistent for the Farm Loan Programs and Farm Programs. Also, it would remove outdated regulations used by FSA from chapter XVIII of the Code of Federal Regulations, formerly used by the predecessor to FSA, the Farmers Home Administration.

Statement of Need: This proposed rule is needed to consolidate and update the FSA regulations implementing the National Environmental Policy Act and related laws and guidance.

Summary of Legal Basis: The National Environmental Policy Act (42 U.S.C. 4321-4347) and the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508).

Alternatives: As an alternative to this proposed rule, we could have updated the two separate FSA NEPA regulations, but that would have made it harder for our stakeholders and employees, more difficult to update in the future, and resulted in redundant regulations.Start Printed Page 914

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

Risks: None.

Timetable:

ActionDateFR Cite
NPRM03/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

URL For Public Comments: www.regulations.gov.

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-AH02

USDA—FSA

Final Rule Stage

3. Agriculture Priorities and Allocations Systems

Priority: Other Significant.

Legal Authority: 50 U.S.C. app 2061 et seq.; 42 U.S.C. 5195 et seq.

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: The Secretary of Agriculture is authorized to establish a system to prioritize contracts and make allocations of certain agriculture-related resources, as necessary, to meet national defense priorities. “Stand-by” procedures for the Department of Agriculture to implement this authority are out of date and generally inadequate to meet Government or national needs should a situation arise that calls for exercise of the authority. As a result, the Farm Service Agency is implementing regulations to allow USDA to efficiently place priority ratings on contracts or orders with respect to resources within its authority should the need arise. The new Agriculture Priorities and Allocation System (APAS) regulations will be similar to the Department of Commerce's Defense Priorities and Allocation System (DPAS) for establishing priority ratings for contract performance.

Statement of Need: This rule is needed to implement the USDA delegated responsibilities from the Defense Production Act and related Executive Order.

Summary of Legal Basis: The Defense Production Act (50 U.S.C. App. 2061 to 2170, 2171, and 2172) and the related Executive Order 13603, “National Defense Resources Preparedness,” dated March 16, 2012.

Alternatives: As an alternative to this proposed rule, we could have continued to require the Department of Commerce to implement the USDA authority; however, the reauthorized and amended Defense Production Act requires each of the agencies to implement regulations.

Anticipated Cost and Benefits: A cost benefit analysis was prepared for the related proposed rule and was made available when the proposed rule published.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM05/19/1176 FR 29084
NPRM Comment Period End07/18/11
Final Rule04/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

URL For Public Comments: www.regulations.gov.

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-AH68

USDA—ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS)

Proposed Rule Stage

4. Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products

Priority: Other Significant.

Legal Authority: 21 U.S.C. 151 to 159

CFR Citation: 9 CFR 112.

Legal Deadline: None.

Abstract: This rulemaking would amend the Virus-Serum-Toxin Act regulations to replace the current label format, which reflects any of four different levels of effectiveness, with a single, uniform label format. It would also require biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to the Animal and Plant Health Inspection Service in support of the issuance of a full product license or conditional license. A single label format along with publicly available safety and efficacy data will help biologics producers to more clearly communicate product performance to their customers.

Statement of Need: The intent of this proposal is to address a request made by our stakeholders and to more clearly communicate product performance information to the user by requiring a uniform label format and a summary of efficacy and safety data (with confidential business information removed).

Summary of Legal Basis: APHIS administers and enforces the Virus-Serum-Toxin Act, as amended (21 U.S.C. 151-159). The regulations issued pursuant to the Act are intended to ensure that veterinary biological products are pure, safe, potent, and efficacious when used according to label instructions.

Alternatives: We could retain the current APHIS labeling guidance, but maintaining the status quo would not address the concern reported by stakeholders concerning the interpretation of product performance.

Anticipated Cost and Benefits: APHIS anticipates that the only costs associated with the proposed labeling format would be one-time costs incurred by licensees and permittees in having labels for existing licensed products updated in accordance with the proposed new format. A simpler, uniform label format that would allow biologics licensees and permittees to more clearly communicate product performance information to the end user. In addition, the rule would simplify the evaluation of efficacy studies and reduce the amount of time required by APHIS to evaluate study data, thus allowing manufacturers to market their products sooner.

Risks: APHIS has not identified any risks associated with this proposed action.

Timetable:

ActionDateFR Cite
Notice05/24/1176 FR 30093
Comment Period End07/25/11
NPRM01/00/14
NPRM Comment Period End03/00/14

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Additional Information: Additional information about APHIS and its Start Printed Page 915programs is available on the Internet at http://www.aphis.usda.gov.

Agency Contact: Donna L Malloy, Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 148, Riverdale, MD 20737-1231, Phone: 301 851-3426.

RIN: 0579-AD64

USDA—APHIS

5. Brucellosis and Bovine Tuberculosis; Update of General Provisions

Priority: Other Significant.

Legal Authority: 7 U.S.C. 1622; 7 U.S.C. 8301 to 8317; 15 U.S.C. 1828; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701

CFR Citation: 9 CFR 50 and 51; 9 CFR 71; 9 CFR 76 to 78; 9 CFR 86; 9 CFR 93; 9 CFR 161.

Legal Deadline: None.

Abstract: This rulemaking would consolidate the regulations governing bovine tuberculosis (TB), currently found in 9 CFR part 77, and those governing brucellosis, currently found in 9 CFR part 78. As part of this consolidation, we are proposing to transition the TB and brucellosis programs away from a State status system based on disease prevalence. Instead, States and tribes would implement an animal health plan that identifies sources of the diseases within the State or tribe and specifies mitigations to address the risk posed by these sources. The consolidated regulations would also set forth standards for surveillance, epidemiological investigations, and affected herd management that must be incorporated into each animal health plan, with certain limited exceptions; conditions for the interstate movement of cattle, bison, and captive cervids; and conditions for APHIS approval of tests for bovine TB or brucellosis. Finally, the rulemaking would revise the import requirements for cattle and bison to make these requirements clearer and assure that they more effectively mitigate the risk of introduction of the diseases into the United States.

Statement of Need: The current regulations were issued during a time when the prevalence rates for the disease in domestic, cattle, bison, and captive cervids were much higher than they are today. As a result, the regulations specify measures that are necessary to prevent these diseases from spreading through the interstate movement of infected animals. The regulations are effective in this regard, but do not address reservoirs of tuberculosis and brucellosis that exist in certain States. Moreover, the regulations presuppose one method of dealing with infected herds—whole-herd depopulation—and do not take into consideration the development of other methods, such as test-and-remove protocols, that are equally effective but less costly for APHIS and producers. Finally, our current regulations governing the importation of cattle and bison do not always address the risk that such animals may pose of spreading brucellosis or bovine tuberculosis, and need to be updated to allow APHIS to take appropriate measures when prevalence rates for bovine tuberculosis or brucellosis increase or decrease in foreign regions.

Summary of Legal Basis: Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the Secretary of Agriculture has the authority to issue orders and promulgate regulations to prevent the introduction into the United States and the dissemination within the United States of any pest or disease of livestock.

Alternatives: One alternative would be to leave the current regulations unchanged. As noted above, the current regulations are effective in preventing the interstate movement of infected animals, but do not address reservoirs of brucellosis and tuberculosis that exist in certain States, and thus do not address the root cause of such infection. They also are written in a prescriptive manner which does not allow States to take into consideration scientific developments and other emerging information in determining how best to deal with infected animals and herds. Finally, APHIS' current regulations governing the importation of cattle and bison do not always address the risk that such animals may pose of spreading bovine tuberculosis or brucellosis.

Anticipated Cost and Benefits: Certain additional costs may be incurred by producers as a result of this rule. For example, the proposed rule would impose new interstate movement restrictions on rodeo, event, and exhibited cattle and bison and impose additional costs for producers of such cattle and bison. These new testing requirements could cost, in aggregate, between $651,000 and $1 million. Also, the proposed additional restrictions for the movement of captive cervids could result in additional costs for producers. Adhering to these new requirements may have a total cost to the captive cervid industry of between about $157,000 and $485,000 annually.

States and tribes would incur costs associated with this proposed rule, in particular in developing animal health plans for bovine tuberculosis and brucellosis. The proposed animal health plans for brucellosis and bovine tuberculosis would build significantly on existing operations with respect to these diseases. We anticipate that all 50 States and as many as 3 tribes would develop animal health plans. Based on our estimates of plan development costs, the total cost of the development of these 53 animal health plans could be between about $750,000 and $2.9 million. We expect that under current circumstances, four or five States are likely to develop recognized management area plans as proposed in this rule as part of their animal health plans. Based on our estimates of recognized management area plan development costs, the cost of developing recognized management area plans by these States could total between $56,000 and $274,000.

While direct effects of this proposed rule for producers should be small, whether the entity affected is small or large, consolidation of the brucellosis and bovine tuberculosis regulations is expected to benefit the affected livestock industries. Disease management would be more focused, flexible and responsive, reducing the number of producers incurring costs when disease concerns arise in an area. Also, the competitiveness of the United States in international markets depends on its reputation for producing healthy animals. The proposed rule would enhance this reputation through its comprehensive approach to the control of identified reservoirs of bovine tuberculosis or brucellosis in wildlife populations in certain parts of the United States and more stringent import regulations consistent with domestic restrictions. We expect that the benefits would justify the costs.

Risks: If we do not issue this proposed rule, reservoirs of brucellosis and tuberculosis that exist in certain States will not be adequately evaluated and addressed. Additionally, our current regulations regarding the importation of cattle and bison do not always address the risk that such animals may pose of spreading brucellosis or bovine tuberculosis.

Timetable:

ActionDateFR Cite
NPRM02/00/14
NPRM Comment Period End04/00/14

Regulatory Flexibility Analysis Required: Yes.Start Printed Page 916

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Local, State, Tribal.

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

Agency Contact: Langston Hull, National Center for Import and Export, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 39, Riverdale, MD 20737, Phone: 301 851-3300.

C William Hench, Senior Staff Veterinarian, Ruminant Health Programs, National Center for Animal Health Programs, VS, Department of Agriculture, Animal and Plant Health Inspection Service, 2150 Centre Avenue, Building B-3E20, Ft. Collins, CO 80526, Phone: 970 494-7378.

RIN: 0579-AD65

USDA—APHIS

6. Establishing a Performance Standard for Authorizing the Importation and Interstate Movement of Fruits and Vegetables

Priority: Other Significant.

Legal Authority: 7 U.S.C. 450; 7 U.S.C. 7701 to 7772; 7 U.S.C. 7781 to 7786; 21 U.S.C. 136 and 136a

CFR Citation: 7 CFR 318 and 319.

Legal Deadline: None.

Abstract: This rulemaking would amend our regulations governing the importations of fruits and vegetables by broadening our existing performance standard to provide for consideration of all new fruits and vegetables for importation into the United States using a notice-based process. It would also remove the region- or commodity-specific phytosanitary requirements currently found in these regulations. Likewise, we are proposing an equivalent revision of the performance standard in our regulations governing the interstate movements of fruits and vegetables from Hawaii and the U.S. territories (Guam, Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands) and the removal of commodity-specific phytosanitary requirements from those regulations. This proposal would allow for the consideration of requests to authorize the importation or interstate movement of new fruits and vegetables in a manner that enables a more flexible and responsive regulatory approach to evolving pest situations in both the United States and exporting countries. It would not, however, alter the science-based process in which the risk associated with importation or interstate movement of a given fruit or vegetable is evaluated or the manner in which risks associated with the importation or interstate movement of a fruit or vegetable are mitigated.

Statement of Need: The revised regulations are needed to streamline the administrative process involved in consideration of fruits and vegetables currently not authorized for interstate movement or importation, while continuing to provide opportunity for public comment and engagement on the science and risk-based analysis associated with such imports and interstate movements. The proposal would also enable us to adapt our import requirements more quickly in the event of any changes to a country's pest or disease status or as a result of new scientific information or treatment options.

Summary of Legal Basis: Under section 7701 of the Plant Protection Act (PPA), given that the smooth movement of enterable plants and plant products into, out of, or within the United States is vital to the U.S. economy, it is the responsibility of the Secretary of Agriculture to facilitate exports, imports, and interstate commerce in agricultural products and other commodities that pose a risk of harboring plant pests or noxious weeds in ways that will reduce, to the extent practicable, as determined by the Secretary, the risk of dissemination of plant pests or noxious weeds. Decisions regarding exports, imports, and interstate commerce are required to be based on sound science.

Alternatives: We considered taking no action at this time and leaving the regulations as they are currently written. We decided against this alternative because leaving the regulations unchanged would not address the needs identified immediately above.

Anticipated Cost and Benefits: Consumers and businesses would benefit from the more timely access to fruits and vegetables for which entry or movement would currently require rulemaking. This benefit would be reduced to the extent that certain businesses would face increased competition for the subject fruits and vegetables sooner due to their more timely approval. APHIS has not identified other costs that may be incurred because of the proposed rule.

Risks: The performance-based process more closely links APHIS' decision to authorize importation of a fruit or vegetable with the pest risk assessment and brings us in line with other countries that authorize importation of a fruit or vegetable with the pest risk assessment. Some countries have viewed the rulemakings for fruits and vegetables that follow completion of the pest risk assessment as a non-technical trade barrier and may have slowed the approval of U.S. exports (including, but not limited to, fruits and vegetables) into their markets, or placed additional restrictions on existing exports from the United States.

Timetable:

ActionDateFR Cite
NPRM03/00/14
NPRM Comment Period End05/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

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: Matthew Rhoads, Associate Executive Director, Plant Health Programs, PPQ, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 131, Riverdale, MD 20737-1231, Phone: 301 851-2133.

RIN: 0579-AD71

USDA—APHIS

7. User Fees for Agricultural Quarantine and Inspection Services

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

Legal Authority: 7 U.S.C. 7701 to 7772; 7 U.S.C. 7781 to 7786; 7 U.S.C. 8301 to 8317; 21 U.S.C. 136 and 136a; 49 U.S.C. 80503

CFR Citation: 7 CFR 354.

Legal Deadline: None.

Abstract: This rulemaking would amend the user fee regulations by adding new fee categories and adjusting current fees charged for certain agricultural quarantine and inspection services that are provided in connection with certain commercial vessels, commercial trucks, commercial railroad cars, commercial aircraft, and international passengers arriving at ports in the customs territory of the United States. It would also adjust the fee caps associated with commercial vessels, commercial trucks, and commercial railcars. Based on the conclusions of a third party assessment of the user fee program and on other Start Printed Page 917considerations, we have determined that revised user fee categories and revised user fees are necessary to recover the costs of the current level of activity, to account for actual and projected increases in the cost of doing business, and to more accurately align fees with the costs associated with each fee service.

Statement of Need: Regarding certain agricultural quarantine and inspection services that are provided in connection with certain commercial vessels, commercial trucks, commercial railroad cars, commercial aircraft, and international passengers arriving at ports in the customs territory of the United States, we have determined that revised user fee categories and revised user fees are necessary to recover the costs of the current level of activity, to account for actual and projected increases in the cost of doing business, and to more accurately align fees with the costs associated with each fee service.

Summary of Legal Basis: Section 2509(a) of the Food, Agriculture, Conservation, and Trade (FACT) Act of 1990 (21 U.S.C. 136a) authorizes APHIS to collect user fees for certain agricultural quarantine and inspection (AQI) services. The FACT Act was amended on April 4, 1996, and May 13, 2002. The FACT Act, as amended, authorizes APHIS to collect user fees for AQI services provided in connection with the arrival, at a port in the customs territory of the United States, of commercial vessels, commercial trucks, commercial railroad cars, commercial aircraft, and international passengers. According to the FACT Act, as amended, these user fees should recover the costs of:

  • Providing the AQI services for the conveyances and the passengers listed above;
  • Providing preclearance or preinspection at a site outside the customs territory of the United States to international passengers, commercial vessels, commercial trucks, commercial railroad cars, and commercial aircraft;
  • Administering the user fee program; and
  • Maintaining a reasonable reserve.

In addition, the FACT Act, as amended, contains the following requirement:

  • The fees should be commensurate with the costs with respect to the class of persons or entities paying the fees. This is intended to avoid cross-subsidization of AQI services.

Alternatives: APHIS focused on three alternatives composed of different combinations of paying classes. The first or preferred alternative is the proposed rule; the second alternative differed from the first by not including user fees for recipients of AQI treatment services; and under the third alternative, recipients of commodity import permits and pest import permits would pay user fees, in addition to the classes that would pay fees under the proposed rule. The latter two alternatives were rejected.

Anticipated Cost and Benefits: The proposed changes in user fees would ensure that the program can continue to protect America's agricultural industries and natural resource base against invasive species and diseases while more closely aligning, by class, the cost of AQI services provided and user fee revenue received.

Risks: AQI services benefit U.S. agricultural and natural resources by protecting them from the inadvertent introduction of foreign pests and diseases that may enter the country and the threat of intentional introduction of pests or pathogens as a means of agroterrorism. In the extreme, failure to maintain the nation's biosecurity could disrupt American agricultural production, erode confidence in the U.S. food supply, and destabilize the U.S. economy.

Timetable:

ActionDateFR Cite
NPRM04/00/14
NPRM Comment Period End06/00/14

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

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: William E Thomas, Senior Agriculturist, Office of the Deputy Administrator, PPQ, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 130, Riverdale, MD 20737, Phone: 301 851-2306.

Michael Peranio, Chief, User Fees, Financial Services Branch, FMD, MRPBS, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 55, Riverdale, MD 20737, Phone: 301 851-2852.

RIN: 0579-AD77

USDA—RURAL HOUSING SERVICE (RHS)

Proposed Rule Stage

8. Civil Rights Compliance Requirements

Priority: Other Significant.

Legal Authority: Pub. L. 100-259; 29 U.S.C. 794; Pub. L. 94-135; 42 U.S.C. 6101 et seq.; Pub. L. 94-239; 15 U.S.C. 1601 et seq.; EO 11246; Pub. L. 88-352; 42 U.S.C. 2000d et seq.; Pub. L. 90-284; 42 U.S.C. 3601 to 3619; Pub. L. 100-430; Pub. L. 92-318; 20 U.S.C. 1681 et seq.; Pub. L. 93-112; EO 12898

CFR Citation: 7 CFR 15; 12 CFR 202; 28 CFR 42; 45 CFR 90; 41 CFR 60 to 64; 24 CFR 14; 7 CFR 1901-E; 7 CFR 1940-D.

Legal Deadline: None.

Abstract: In this proposed rule the Rural Housing Service (RHS) proposes to effectuate a comprehensive civil rights regulation to provide detailed guidelines to improve compliance with applicable enacted civil right laws. Mechanisms for monitoring compliance by USDA field offices and recipients of Federal financial assistance at all levels will decrease the Agency's vulnerability that exists due to compliance issues.

Statement of Need: The 1901-E is the current civil rights compliance regulation covering Rural Development programs which was published in 1977. The 1940-D will update and replace the information provided in the 1901-E which addresses limited elements of civil rights compliance and limited information on enforcement policies and procedures. This proposed rule will increase the understanding of civil rights compliance requirements under title VI and applicable civil rights laws which will directly reduce the number of complaints received by customers, applicants, borrowers, grantees, recipients and beneficiaries.

Summary of Legal Basis: This information is used by Rural Development to comply with the Department of Justice (DOJ) title VI Regulation 28 CFR part 42 subpart F to insure that Federal agencies which extend Federal financial assistance properly enforce title VI of the Civil Rights Act and similar provisions in Federal grant statutes. Additionally, section 42.407—“Procedures to Determine Compliance” established Rural Development requirements to conduct pre-award and post-award compliance reviews. The requirement to conduct compliance reviews is also based on the requirements of Executive Order 12250.

Alternatives: The alternative to publishing this rule is to continue to use the 1901-E as it is written.Start Printed Page 918

Anticipated Cost and Benefits: This proposed rule will not impose any new costs for the public (customers, applicants, borrowers, grantees, recipients and/or beneficiaries) of Rural Development's loan and grant programs. The proposed rule will align Rural Development's civil rights enforcement policies with laws and regulations which are already federal law. This rule will also align Rural Development civil rights regulations with USDA departmental regulations. On average Rural Development received 250 complaints each year. It is estimated that each complaint costs on average $10,000 to process. Lawsuits and findings of discrimination add to this cost.

Risks: There are no risks associated with publishing or not publishing this rule but there may be inferred risk to recipients or beneficiaries due to non-compliance issues.

Timetable:

ActionDateFR Cite
NPRM04/00/14

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Agency Contact: Renata Robinson, Department of Agriculture, Rural Housing Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 692-0070, Email: renata.robinson@wdc.usda.gov.

RIN: 0575-AA83

USDA—RHS

9. Loan Packager Certification

Priority: Other Significant.

Legal Authority: 5 U.S.C. 301; 42 U.S.C. 1480

CFR Citation: 7 CFR 3550.

Legal Deadline: None.

Abstract: In the Single Family Housing (SFH) direct loan program, the current loan application packaging process is an informal arrangement and the packagers' level of program knowledge and expertise, as well as their level of service, is inconsistent. To address this, the Rural Housing Service (RHS) is proposing to amend its regulations for the SFH direct loan program to create a certified loan application process. Certified packagers will promote the direct loan program in eligible communities; informally prescreen interested parties to determine their likelihood of qualifying for the program; and fully prepare and document the loan application package on behalf of the applicant for submission to the Agency. The certified loan application process will include the requirements for eligible individuals to obtain the designation of an Agency-certified loan application packager and the requirements for qualified nonprofit organizations and public agencies that employ certified packagers. These requirements will cover experience, training, proficiency, and structure. The process will also include Agency-approved independent nonprofit organizations that serve as intermediaries and perform quality assurance reviews on packaged loan applications prior to submission to the Agency. In addition, RHS is proposing to set limitations on the loan application packaging fee. The fee may not exceed two percent of the average area loan limit nationwide; the Administrator will periodically set a maximum dollar amount for the fee within this limit and set different maximum dollar amounts for certified packagers working with and without intermediaries. These amounts will be published on the Agency's Web site as an attachment to HB-1-3550.

Agency financing of the packaging fee will remain dependent on the borrower's repayment ability and the total secured indebtedness limitation outlined in 7 CFR 3550.63.

Statement of Need: Formalizing the loan application process will allow for Agency oversight; it will also ensure minimum competency standards.

By establishing a vast network of competent, experienced, and committed Agency-certified packagers, this action will benefit low- and very low-income people who wish to achieve homeownership in rural areas by increasing their awareness of the Agency's housing program, increasing specialized support available to them to complete the application for assistance, and improving the quality of loan application packages submitted on their behalf.

Summary of Legal Basis: The SFH direct loan program was authorized by the Housing Act of 1949, as amended.

Alternatives: The alternative to implementing a certified loan application packaging process is maintaining the status quo, which is problematic for the following reasons:

With voluntary early retirement authority and voluntary separation incentive payments offered in the first quarter of Fiscal Years 2012 and 2013, the number of Rural Development staff available to process section 502 loan applications has been severely reduced. Without operational restructuring and redistribution, program participants will experience unprecedented and significant delays in loan application processing.

The current procedure allows loan application packaging under an informal arrangement, which results in inconsistencies in the packagers' level of program knowledge and expertise as well as their level of service.

Limited travel budgets restrict the Rural Development staffs' ability to target underserved areas (such as Indian reservations, colonias counties, and persistent poverty counties).

Anticipated Cost and Benefits:

Cost/benefit to the borrowers: With an interest rate of 3.75%, which is the program's full note interest rate that has been in effect as of September 2013, and with a standard term of 33 years, a packaging fee of $1,500 will cost the borrower $6.62/month ($1,500 x .00441; the amortization factor for this extra loan amount). Because many borrowers receive the maximum payment assistance allowed, the amount billed for the fee may be reduced down to $4.46/month ($1,500 x .00297 the amortization factor for this extra loan amount at 1% for 33 years). In FY 2012, the families served through the direct single family housing program had an average annual income of $27,600. At most, the increase in the monthly payment represents .02 percent of the allowable qualifying ratios ($6.62/$27,600). All other factors aside, the packaging fee should not adversely impact an applicant's eligibility.

For borrowers that choose to apply through the certified loan application packaging process, their increased loan costs are more than offset by the benefits they will experience (largely being made aware of an affordable homeownership program that they may not have otherwise heard of because of the Agency's reduced physical presence in rural areas and having a knowledgeable and committed packager hold their hand through the entire application process).

Cost/benefit to the Agency: The training costs associated with this action is approximately $39,600 per fiscal year in comparison to maintaining the status quo. The one-time cost to modify the program's loan origination system to create a new data element to track applications obtained through the certified loan application process is $100,000.

Implementing a certified loan application process will save the Agency approximately $1.5 million in salaries and expenses per fiscal year in comparison to maintaining the status quo.

Risks: There may be some limited opposition to the loan application Start Printed Page 919packaging fee from affordable housing advocates, but the Agency believes the substantial measure by which the process's merits outweigh potential drawbacks will be widely recognized. The loan application packaging fee outlined in the proposed rule is significantly higher than the amount currently allowed. However, the fee also ensures critical outreach and support for families and individuals who might otherwise have little chance of securing a mortgage. Moreover, engaging the services of a certified packager is completely at the applicant's discretion-the borrower has the option of electing to proceed without the additional assistance afforded by the fee. The allowable fee reflects the additional responsibilities that will be placed on those involved in the certified loan application packaging process (principally submitting viable loan application packages to expedite the Agency's underwriting review); and the fee can be financed with the SFH loan, adding little to the required monthly payment. The rule also furthers the government's partnering opportunities with private organizations. The proposed certification process is not mandatory. Individuals and entities that do not meet the requirements for certification may still package on behalf of an applicant but any fee charged will not be an allowable loan purpose.

Timetable:

ActionDateFR Cite
NPRM08/23/1378 FR 52460
NPRM Comment Period End10/22/13
NPRM Comment Period Extended11/01/1378 FR 65582
Final Action09/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Brooke Baumann, Senior Loan Specialist, Department of Agriculture, Rural Housing Service, STOP 0783, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 720-1474, Fax: 202 720-2232, Email: brooke.baumann@wdc.usda.gov.

RIN: 0575-AC88

USDA—FOOD AND NUTRITION SERVICE (FNS)

Proposed Rule Stage

10. Child Nutrition Program Integrity

Priority: Other Significant.

Legal Authority: Pub. L. 111-296

CFR Citation: 7 CFR part 210; 7 CFR part 215; 7 CFR part 220; 7 CFR part 225; 7 CFR part 226; 7 CFR part 235.

Legal Deadline: None.

Abstract: This rule proposes to codify three provisions of the Healthy, Hunger-Free Kids Act of 2010 (the Act). Section 303 of the Act requires the Secretary to establish criteria for imposing fines against schools, school food authorities, or State agencies that fail to correct severe mismanagement of the program, fail to correct repeat violations of program requirements, or disregard a program requirement of which they had been informed. Section 322 of the Act requires the Secretary to establish procedures for the termination and disqualification of organizations participating in the Summer Food Service Program (SFSP). Section 362 of the Act requires that any school, institution, service institution, facility, or individual that has been terminated from any program authorized under the Richard B. Russell National School Lunch Act or the Child Nutrition Act of 1966, and appears on either the SFSP or the Child and Adult Care Food Program's (CACFP's) disqualified list, may not be approved to participate in or administer any other programs authorized under those two Acts.

Statement of Need: There are currently no regulations imposing fines on schools, school food authorities or State agencies for program violations and mismanagement. This rule will: (1) Establish criteria for imposing fines against schools, school food authorities or State agencies that fail to correct severe mismanagement of the program or repeated violations of program requirements; (2) establish procedures for the termination and disqualification of organizations participating in the Summer Food Service Program (SFSP); and (3) require that any school, institutions, or individual that has been terminated from any Federal Child Nutrition Program and appears on either the SFSP or the Child and Adult Care Food Program's (CACFP's) disqualified list may not be approved to participate in or administer any other Child Nutrition Program.

Summary of Legal Basis: This rule codifies Sections 303, 322, and 362 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296).

Alternatives: None identified; this rule implements statutory requirements.

Anticipated Cost and Benefits: This rule is expected to help promote program integrity in all of the child nutrition programs. FNS anticipates that these provisions will have no significant costs and no major increase in regulatory burden to States.

Risks: None identified.

Timetable:

ActionDateFR Cite
NPRM03/00/14
NPRM Comment Period End05/00/14

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Local, State.

Federalism: This action may have federalism implications as defined in EO 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. Williams, 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.williams@fns.usda.gov.

RIN: 0584-AE08

USDA—FNS

11. 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 226.

Legal Deadline: None.

Abstract: This proposal would implement section 221 of the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296, the Act) which 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.

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 that 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 Start Printed Page 920substitution, and introduces requirements for the availability of water. This rule will establish 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: Because this proposed rule is under development, alternatives are not yet articulated.

Anticipated Cost and Benefits: This rule is expected to 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. At this time, we cannot estimate the financial impact the proposed rule will have on State agencies, sponsoring organizations, and child care institutions, but we expect that there will be a small cost increase associated with the implementation of improved meal pattern requirements. A regulatory impact analysis will be conducted to determine these cost implications.

Risks: None identified.

Timetable:

ActionDateFR Cite
NPRM02/00/14
NPRM Comment Period End05/00/14

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. Williams, 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.williams@fns.usda.gov.

RIN: 0584-AE18

USDA—FNS

12. Enhancing Retailer Eligibility Standards in SNAP

Priority: Other Significant.

Legal Authority: Sec. 3, U.S.C. 2012; Sec. 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: Sections 3(k), (p) and (r), Section 7, and Section 9 of the Food and Nutrition Act and Title 7 Parts 271, 274, and 278 of the Code of Federal Regulations provide factors for determining the eligibility of retail food stores to participate in the Supplemental Nutrition Assistance Program (”SNAP”). The Food and Nutrition Service (FNS) has published a notice requesting information from any and all interested parties on opportunities to enhance retailer definitions and requirements in a manner that improves access to healthy food choices for SNAP participants as well as program integrity, and ensures that only those retailers that effectuate the purpose of SNAP are authorized to accept benefits. FNS is requesting information to understand what policy changes and, as needed, statutory changes, should be considered for retailer authorizations. FNS will use this information in determining how to make positive progress in the available healthy choices for program participants at authorized SNAP retail stores. FNS will propose revisions to existing regulations following this process of gathering stakeholder input.

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
NPRM05/00/14

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. Williams, 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.williams@fns.usda.gov.

RIN: 0584-AE27

USDA—FNS

Final Rule Stage

13. Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Revisions in the WIC Food Packages

Priority: Other Significant.

Legal Authority: 42 U.S.C. 1786

CFR Citation: 7 CFR 246.

Legal Deadline: Final, Statutory, November 30, 2006.

CN and WIC Reauthorization Act of 2004 (Pub. L. 108-265) requires issuance of a final rule within 18 months of the release of the IOM Report.

Abstract: This final rule will affirm and address comments from stakeholders on an interim final rule that went into effect October 1, 2009, governing WIC food packages to align them more closely with updated nutrition science.

Statement of Need: As the population served by WIC has grown and become more diverse over the past 20 years, the nutritional risks faced by participants have changed, and though nutrition science has advanced, the WIC supplemental food packages remained largely unchanged until FY 2010. This rule is needed to respond to comments and experience, and to implement recommended changes to the WIC food packages based on the current nutritional needs of WIC participants and advances in nutrition science.

Summary of Legal Basis: The Child Nutrition Act of 1966, as amended, section 17; especially 17(b)(14) and 17(f)(11).

Alternatives: FNS developed a regulatory impact analysis that addressed a variety of alternatives that Start Printed Page 921were considered in the interim final rulemaking. The regulatory impact analysis was published as an appendix to the interim rule.

Anticipated Cost and Benefits: The regulatory impact analysis for this rule provided a reasonable estimate of the anticipated effects of the rule. The regulatory impact analysis was published as an appendix to the interim rule.

Risks: This rule applies to WIC State agencies with respect to their selection of foods to be included on their food lists. Opportunities for training on and discussion of the revised WIC food packages will be offered to State agencies and other entities as necessary.

Timetable:

ActionDateFR Cite
NPRM08/07/0671 FR 44784
NPRM Comment Period End11/06/06
Interim Final Rule12/06/0772 FR 68966
Interim Final Rule Effective02/04/08
Interim Final Rule Comment Period End02/01/10
Final Rule02/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses, Governmental Jurisdictions.

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

URL For More Information: www.fns.usda.gov/​wic.

URL For Public Comments: www.fns.usda.gov/​wic.

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 Williams, 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.williams@fns.usda.gov.

RIN: 0584-AD77

USDA—FNS

Prorule

14. Eligibility, Certification, and Employment and Training Provisions of the Food, Conservation, and Energy Act of 2008

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

Legal Authority: Pub. L. 110-246; Pub. L. 104-121

CFR Citation: 7 CFR 273.

Legal Deadline: None.

Abstract: This final rule amends the regulations governing the Supplemental Nutrition Assistance Program (SNAP) to implement provisions from the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246) (FCEA) concerning the eligibility and certification of SNAP applicants and participants and SNAP employment and training.

Statement of Need: This rule amends the regulations governing SNAP to implement provisions from the FCEA concerning the eligibility and certification of SNAP applicants and participants and SNAP employment and training. In addition, this rule revises the SNAP regulations throughout 7 CFR part 273 to change the program name from the Food Stamp Program to SNAP and to make other nomenclature changes as mandated by the FCEA. The statutory effective date of these provisions was October 1, 2008. FNS is also implementing two discretionary revisions to SNAP regulations to provide State agencies options that are currently available only through waivers. These provisions allow State agencies to average student work hours and to provide telephone interviews in lieu of face-to-face interviews. FNS anticipates that this rule will impact the associated paperwork burdens.

Summary of Legal Basis: Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246).

Alternatives: Most aspects of the rule are non-discretionary and tied to explicit, specific requirements for SNAP in the FCEA, and others were new program options the FCEA created that State agencies may include in their administration of the program. FNS did consider alternatives within these mandatory and optional FCEA provisions addressed in the rule. For example, under the new optional provision implementing section 4119 of the FCEA, Telephonic Signature Systems, FNS considered what specific conditions must be satisfied for a signature to be considered a spoken signature.

Anticipated Cost and Benefits: The estimated total SNAP costs to the Government of the FCEA provisions implemented in the rule are estimated to be $831 million in FY 2010 and $5.619 billion over the 5 years FY 2010 through FY 2014. These impacts are already incorporated into the President's budget baseline.

There are many potential societal benefits of this rule, including that certain provisions in the rule will reduce the administrative burden for households and State agencies.

Risks: The statutory changes and discretionary ones under consideration would streamline program operations. The changes are expected to reduce the risk of inefficient operations.

Timetable:

ActionDateFR Cite
NPRM05/04/1176 FR 25414
NPRM Comment Period End07/05/11
Final Action03/00/14

Regulatory Flexibility Analysis Required: 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.

Lynnette M Williams, 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.williams@fns.usda.gov.

RIN: 0584-AD87

USDA—FOOD SAFETY AND INSPECTION SERVICE (FSIS)

Proposed Rule Stage

15. Records To Be Kept by Official Establishments and Retail Stores That Grind Raw Beef Products

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

Legal Authority: 21 U.S.C. 601 et seq.

CFR Citation: 9 CFR 320.

Legal Deadline: None.

Abstract: FSIS is proposing to amend its recordkeeping regulations to specify that all official establishments and retail stores that grind raw beef products for sale in commerce must keep records that disclose the identity of the supplier of all source materials that they use in the preparation of each lot of raw ground product and identify the names of those source materials.

Statement of Need: Under the authority of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and its implementing regulations, FSIS investigates complaints and reports of consumer foodborne illness possibly associated with FSIS-regulated meat products. Many such investigations into consumer foodborne illnesses involve Start Printed Page 922those caused by the consumption of raw beef ground by official establishments or retail stores.

FSIS investigators and public health officials frequently use records kept by all levels of the food distribution chain, including the retail level, to identify and trace back product that is the source of the illness to the suppliers that produced the source material for the product. The Agency, however, has often been thwarted in its effort to trace back ground beef products, some associated with consumer illness, to the suppliers that provided source materials for the products. In some situations, official establishments and retail stores have not kept records necessary to allow traceback and traceforward activities to occur. Without such necessary records, FSIS's ability to conduct timely and effective consumer foodborne illness investigations and other public health activities throughout the stream of commerce is also affected, thereby placing the consuming public at risk. Therefore, for FSIS to be able to conduct traceback and traceforward investigations, foodborne illnesses investigations, or to monitor product recalls, the records kept by official establishments and retail stores that grind raw beef products must disclose the identity of the supplier and the names of the sources of all materials that they use in the preparation of each lot of raw ground beef product.

Summary of Legal Basis: Under 21 U.S.C. 642, official establishments and retail stores that grind raw beef products for sale in commerce are persons, firms, or corporations that must keep such records as will fully and correctly disclose all transactions involved in their businesses subject to the Act. This is because they engage in the business of preparing products of an amenable species for use as human food and they engage in the business of buying or selling (as meat brokers, wholesalers or otherwise) in commerce products of carcasses of an amenable species. These businesses must also provide access to, and inspection of, these records by FSIS personnel.

Further, under 9 CFR 320.1(a), every person, firm, or corporation required by section 642 of the FMIA to keep records must keep those records that will fully and correctly disclose all transactions involved in his or its business subject to the Act. Records specifically required to be kept under section 320.1(b) include, but are not limited to, bills of sale; invoices; bills of lading; and receiving and shipping papers. With respect to each transaction, the records must provide the name or description of the livestock or article; the net weight of the livestock or article; the number of outside containers; the name and address of the buyer or seller of the livestock or animal; and the date and method of shipment.

Alternatives: FSIS considered two alternatives to the proposed requirements: The status quo and a voluntary recordkeeping program.

Anticipated Cost and Benefits: Costs occur because about 76,093 retail stores and official establishments will need to develop and maintain records, and make those records available for the Agency's review. Using the best available data, FSIS believes that industry recordkeeping costs would be approximately $1.46 million. Agency costs of approximately $0.01 million would result from record reviews at official establishments and retail stores, as well as travel time to and from retail stores.

Annual benefits from this rule come from estimated averted Shiga toxin-producing E.coli illnesses of $1.06 million and $0.58 million due to averted cases of Salmonellosis.

Total benefits from this rule are estimated to be $1.64 million, with a net annual benefit of $0.13 million.

Non-monetized benefits under this rule include, for the raw ground beef processing industry: (1) An increase in consumers' confidence and greater acceptance of products because mandatory grinding logs will result in a more efficient traceability system, recalls of reduced volume, and reduced negative press; (2) smaller volume recalls will result in higher confidence and acceptability of products including the disposition of product once recovered; (3) improved productivity, which improves profit opportunities.

Avoiding loss of business reputation is an indirect benefit. By identifying and defining the responsible party, FSIS will be able to get to the suspect faster and execute a better targeted recall, meaning that a recall will involve a smaller amount of product. This lower volume per recall will decrease costs for the recalls and the disposition of product. In addition, the Agency expects consumers to benefit from improved traceability and, thus, a reduced incidence of STECs in ground raw beef products due to the rapid removal of those products from commerce. The Agency believes that by having official meat establishments and retail stores that engage in the business of grinding raw beef products keep records, traceability of ground raw beef in the U.S. food supply will be greatly enhanced.

Risks: FSIS estimates that the annual costs of STEC and salmonellosis illnesses that will continue to be incurred without this rule is $1.64 million, which comes from an estimated $1.06 million due to illnesses associated with STECs and an estimated $0.58 million due to cases of salmonellosis.

Timetable:

ActionDateFR Cite
NPRM03/00/14

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Victoria Levine, Program Analyst, Issuances Staff (IS), Department of Agriculture, Food Safety and Inspection Service, Office of Policy and Program Development, 1400 Independence Avenue SW., Room 6079, South Building, Washington, DC 20250-3700, Phone: 202 690-3184, Fax: 202 690-0486, Email: victoria.levine@fsis.usda.gov.

RIN: 0583-AD46

USDA—FSIS

Final Rule Stage

16. Modernization of Poultry Slaughter Inspection

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

Legal Authority: 21 U.S.C. 451 et seq.

CFR Citation: 9 CFR 381.66; 9 CFR 381.67; 9 CFR 381.76; 9 CFR 381.83; 9 CFR 381.91; 9 CFR 381.94.

Legal Deadline: None.

Abstract: FSIS intends to provide a new inspection system for young poultry slaughter establishments that would facilitate public health-based inspection. This new system would be available initially only to young chicken and turkey slaughter establishments. Establishments that slaughter broilers, fryers, roasters, and Cornish game hens (as defined in 9 CFR 381.170) would be considered as “young chicken establishments.” FSIS also intends to revoke the provisions that allow young chicken slaughter establishments to operate under the current streamlined inspection system (SIS) or the new line speed (NELS) inspection system, and to revoke the new turkey inspection system (NTIS). Young chicken and turkey slaughter establishments would be required to operate under the new inspection system or under Traditional Inspection. FSIS anticipates that this proposed rule would provide the framework for action to provide public health-based inspection in all establishments that slaughter amenable poultry species.Start Printed Page 923

Under the new system, young chicken and turkey slaughter establishments would be required to sort chicken carcasses and to conduct other activities to ensure that carcasses are not adulterated before they enter the chilling tank.

Statement of Need: Because of the risk to the public health associated with pathogens on young chicken carcasses, FSIS intends to provide a new inspection system that would allow for more effective inspection of young chicken carcasses, would allow the Agency to more effectively allocate its resources and would encourage industry to more readily use new technology.

This final rule is the result of the Agency's 2011 regulatory review efforts conducted under Executive Order 13563 on Improving Regulation and Regulatory Review. It would likely result in more cost-effective dressing of young chickens that are ready to cook or ready for further processing. Similarly, it would likely result in more efficient and effective use of Agency resources.

Summary of Legal Basis: 21 U.S.C. 451 to 470.

Alternatives: FSIS considered the following options in developing this proposal:

(1) No action.

(2) Propose to implement HACCP-based inspection models pilot in regulations.

(3) Propose to establish a mandatory, rather than a voluntary, new inspection system for young chicken slaughter establishments.

Anticipated Cost and Benefits: The proposed rule estimated that the expected annual costs to establishments would total $24.5 million. Expected annual total benefits were $285.5 million (with a range of $259.5 to $314.8 million). Expected annual net benefits were $261.0 million (with a range of $235.0 million to $290.3 million). These estimates will be updated in the final rule.

Risks: Salmonella and other pathogens are present on a substantial portion of poultry carcasses inspected by FSIS. Foodborne salmonella cause a large number of human illnesses that at times lead to hospitalization and even death. There is an apparent relationship between human illness and prevalence levels for salmonella in young chicken carcasses. FSIS believes that through better allocation of inspection resources and the use of performance standards, it would be able to better address the prevalence of salmonella and other pathogens in young chickens.

Timetable:

ActionDateFR Cite
NPRM01/27/1277 FR 4408
NPRM Comment Period End05/29/1277 FR 24873
Final Action04/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Rachel Edelstein, Assistant Administrator, Office of Policy and Program Development, Department of Agriculture, Food Safety and Inspection Service, 1400 Independence Avenue SW., 350-E JLW Building, Washington, DC 20250-3700, Phone: 202 205-0495, Fax: 202 720-2025, Email: rachel.edelstein@fsis.usda.gov.

RIN: 0583-AD32

USDA—FSIS

17. Electronic Export Application and Certification as a Reimbursable Service and Flexibility in the Requirements for Official Export Inspection Marks, Devices, and Certificates

Priority: Other Significant.

Legal Authority: Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 to 695); Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to 470); Egg Products Inspection Act (EPIA) (21 U.S.C. 1031 to 1056)

CFR Citation: 9 CFR 312.8; 9 CFR 322.1 and 322.2; 9 CFR 350.7; 9 CFR 362.5; 9 CFR 381.104 to 381.106; 9 CFR 590.407; 9 CFR 592.20 and 592.500.

Legal Deadline: None.

Abstract: FSIS is developing final regulations to amend the meat, poultry, and egg product inspection regulations to provide for an electronic export application and certification system. The electronic export application and certification system will be a component of the Agency's Public Health Information System (PHIS). The export component of PHIS will be available as an alternative to the paper-based application and certification process. FSIS intends to charge users for the use of the system. FSIS is establishing a formula for calculating the fee. FSIS is also providing establishments that export meat, poultry, and egg products with flexibility in the official export inspection marks, devices, and certificates. In addition, FSIS is amending the egg product export regulations to parallel the meat and poultry export regulations.

Statement of Need: These regulations will facilitate the electronic processing of export applications and certificates through the Public Health Information System (PHIS), a computerized, web-based inspection information system. This rule will provide the electronic export system as a reimbursable certification service charged to the exporter.

Summary of Legal Basis: 21 U.S.C. 601 to 695; 21 U.S.C. 451 to 470; 21 U.S.C. 1031 to 1056; 7 U.S.C. 1622(h).

Alternatives: The electronic export applications and certification system is being proposed as a voluntary service; therefore, exporters have the option of continuing to use the current paper-based system. Therefore, no alternatives were considered.

Anticipated Cost and Benefits: FSIS is charging exporters an application fee for the electronic export system. Automating the export application and certification process will facilitate the exportation of U.S. meat, poultry, and egg products by streamlining and automating the processes that are in use while ensuring that foreign regulatory requirements are met. The cost to an exporter would depend on the number of electronic applications submitted. An exporter that submits only a few applications per year would not be likely to experience a significant economic impact. Under this rate, inspection personnel workload will be reduced through the elimination of the physical handling and processing of applications and certificates. When an electronic government-to-government system interface or data exchange is used, fraudulent transactions, such as false alterations and reproductions, will be significantly reduced, if not eliminated. The electronic export system is designed to ensure authenticity, integrity, and confidentiality. Exporters will be provided with a more efficient and effective application and certification process. The egg product export regulations provide the same export requirements across all products regulated by FSIS and consistency in the export application and certification process. The total annual paperwork burden to the egg processing industry to fill out the paper-based export application is approximately $32,340 per year for a total of 924 hours a year. The average establishment burden would be 11 hours, and $385.00 per establishment.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM01/23/1277 FR 3159
NPRM Comment Period End03/23/12
Final Action05/00/14
Start Printed Page 924

Regulatory Flexibility Analysis Required: No.

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: Rick Harries, Director, Import/Export Coordination and Policy Development Staff (IECPDS), Department of Agriculture, Food Safety and Inspection Service, Office of Policy and Program Development, 1400 Independence Avenue SW., Room 2147, South Building, Washington, DC 20250-3700, Phone: 202 720-6508, Fax: 202 720-7990, Email: rick.harries@fsis.usda.gov.

RIN: 0583-AD41

USDA—FSIS

18. Common or Usual Name for Raw Meat and Poultry Products Containing Added Solutions

Priority: Other Significant.

Legal Authority: 21 U.S.C. 601 to 695; 21 U.S.C. 451 to 470

CFR Citation: 9 CFR 317.2(e); 9 CFR 381.117(h).

Legal Deadline: None.

Abstract: FSIS is developing final regulations to establish a common or usual name for raw meat and poultry products that contain added solutions, and that do not meet a standard of identity. FSIS proposed to amend the meat and poultry labeling regulations to require that the common or usual name must include an accurate description of the raw meat or poultry component, the percentage of added solution, and the individual ingredients or multi-ingredient components in the solution listed in descending order of prominence by weight. The Agency also proposed that the print for all words in the common or usual name appears in a single easy-to-read type style and color, and on a single color-contrasting background. The Agency also intends to remove the standard of identity for “ready-to-cook poultry products to which solutions are added” (9 CFR 381.169).

Statement of Need: Without adequate labeling information, consumers likely cannot distinguish between raw meat and poultry product that contain added solutions and single-ingredient meat and poultry products. Added solutions are a characterizin component of a product likely to affect consumer's purchasing decisions. Therefore, to ensure that labels adequately inform consumers that a meat and poultry product contains added solutions, the Agency is establishing a common or usual name for products containing added solutions.

Summary of Legal Basis: 21 U.S.C. 601(n)(1), (n)(2), (n)(9); 453(h)(1), (h)(3), (h)(9).

Alternatives:

1. No Action. FSIS considered taking no action but did not select this alternative because a consumer research study submitted to the Agency showed that consumers view information about these additives as important factors in their purchasing decisions.

2. Require the word “enhanced” in the product's common or usual name, or the use of the term “enhanced” in the containing statement, e.g., “enhanced with 15 percent solution.” FSIS did not select this alternative because the word implies that the product is improved by the addition of the solution. The intent of this rule is to increase transparency to consumers, not to suggest that the product is either better or worse than a raw product without the added solution. In addition, consumer research showed that the containing statement, “enhanced with up to 15 percent solution of water salt, and sodium phosphates” was preferred by fewer study participants (about 10 percent fewer) than the use of the description “contains up to 15 percent water, salt, and sodium phosphates.

3. Require that the common or usual name of the added solutions product include an accurate description of the raw meat or poultry component, the percentage of added solution, and the common or usual name of the ingredients in the solution, with all of the print in a single font size, color, and style on a single-color contrasting background (the proposed amendments). FSIS selected this alternative because it is likely to improve consumer awareness and understanding that raw meat or poultry product contains an added solution. Requiring the percentage of the solution and the ingredient of the solution as part of the common or usual name is information consumers need to make informed purchasing decisions.

Anticipated Cost and Benefits: The amendments will require establishments that manufacture raw meat and poultry products with added solution to modify or redesign the product label, effective December 2016, the Uniform Compliance Date for Food Labeling. FSIS's estimates that the one-time total cost of modifying labels for all federally inspected processors is $80 million, as central estimate. The amendments will improve public awareness of product identities by providing truthful and accurate labeling of meat and poultry products to clearly differentiate products containing added solutions from single-ingredient products. Consumers can better determine whether products containing added solutions are suitable for their personal dietary needs through increased product name prominence.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM07/27/1176 FR 44855
NPRM Comment Period End09/26/11
NPRM Comment Period Reopened11/08/1176 FR 69146
NPRM Comment Period End01/09/12
Final Action03/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Rosalyn Murphy-Jenkins, Director, Labeling and Program Delivery Staff (LPDS), Department of Agriculture, Food Safety and Inspection Service, Office of Policy and Program Development, Patriots Plaza 3, 1400 Independence Avenue SW., Room8-148, Mailstop 5273, Washington, DC 20250-5273, Phone: 301 504-0879, Fax: 202 245-4792, Email: rosalyn.murphy-jenkins@fsis.usda.gov.

RIN: 0583-AD43

USDA—FSIS

19. Descriptive Designation for Needle- or Blade-Tenderized (Mechanically Tenderized) Beef Products

Priority: Other Significant.

Legal Authority: 21 U.S.C. 601 to 695

CFR Citation: 9 CFR 317.2(e)(3).

Legal Deadline: None.

Abstract: FSIS has proposed regulations to require the use of the descriptive designation “mechanically tenderized” on the labels of raw or partially cooked needle or blade tenderized beef products, including beef products injected with marinade or solution, unless such products are destined to be fully cooked at an official establishment. Beef products that have been needle or blade tenderized are referred to as “mechanically tenderized” products. This rule would require that the product name for such beef products include the descriptive designation “mechanically tenderized” and accurate description of the beef component. The rule would also require Start Printed Page 925that the print for all words in the descriptive designation as the product name appear in the same style, color, and size and on a single-color contrasting background. In addition, this rule would require that labels of raw and partially cooked needle or blade tenderized beef products destined for household consumers, hotels, restaurants, or similar institutions include validated cooking instructions stating that these products need to be cooked to a specified minimum internal temperature, and whether they need to be held at that minimum internal temperature for a specified time before consumption, i.e., dwell time or rest time, to ensure that they are thoroughly cooked.

Statement of Need: FSIS has concluded that without proper labeling, raw or partially cooked mechanically tenderized beef products could be mistakenly perceived by consumers to be whole, intact muscle cuts. The fact that a cut of beef has been needle or blade tenderized is a characterizing feature of the product and, as such, a material fact that is likely to affect consumers' purchase decisions and that should affect their preparation of the product. FSIS has also concluded that the addition of validated cooking instruction is necessary to ensure that potential pathogens throughout the product are destroyed. Without thorough cooking, pathogens that may have been introduced to the interior of the product during the tenderization process may remain in the product.

Summary of Legal Basis: 21 U.S.C. 601 to 695.

Alternatives: The Agency considered two options: Option 1, extend labeling requirements to include vacuum tumbled beef products and enzyme-formed beef products; and Option 2, extend the proposed labeling requirements to all needle- or blade-tenderized meat and poultry products.

Anticipated Cost and Benefits: The proposed rule estimated the one-time cost to produce labels for mechanically tenderized beef at $1.05 million or $2.62 million, if this rule is in effect before the added solutions rule. The annualized cost is $140,000 for 10 years at a 7 percent discount rate or $349,000 over 10 years at a 7 percent discount rate, if this rule is in effect before the added solutions rule.

The proposed rule estimated the expected number of E. coli O157:H7 illnesses prevented would be 453 per year, with a range of 133 to 1,497, if the predicted percentages of beef steaks and roasts are cooked to an internal temperature of 160 °F (or 145 °F and 3 minutes of dwell time). These prevented illnesses amount to $1,486,000 per year in benefits with a range of $436,000 to $4,912,000.

Therefore, the expected annualized net benefits are $296,000 to $4,772,000 with a primary estimate of $1,346,000. If, however, this rule is in effect before the added solutions rule, the expected annualized net benefits are then $1,137,000, with a range of $87,000 to $4,563,000, plus the unquantifiable benefits of increased consumer information and market efficiency, minus an unquantified consumer surplus loss and an unquantified cost associated with food service establishments changing their standard operating procedures.

Risks: FSIS estimates that approximately 1,965 illnesses annually is attributed to mechanically tenderized beef, either with or without added solutions. If all the servings are cooked to a minimum of 160 °F then the number of illnesses drops to 78. This number of illness is due to a data set for all STEC and not just O157 data. From the risk assessment, 1,887 out of 1,965 illnesses were estimated to be prevented annually if mechanically tenderized meat were cooked to 160 degrees.

Timetable:

ActionDateFR Cite
NPRM06/10/1378 FR 34589
NPRM Comment Period End08/09/13
NPRM Comment Period Extended08/09/1378 FR 48631
Final Action06/00/14

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Rosalyn Murphy-Jenkins, Director, Labeling and Program Delivery Staff (LPDS), Department of Agriculture, Food Safety and Inspection Service, Office of Policy and Program Development, Patriots Plaza 3, 1400 Independence Avenue SW., Room8-148, Mailstop 5273, Washington, DC 20250-5273, Phone: 301 504-0879, Fax: 202 245-4792, Email: rosalyn.murphy-jenkins@fsis.usda.gov.

RIN: 0583-AD45

USDA—FOREST SERVICE (FS)

Proposed Rule Stage

20. Forest Service Manual 2020—Ecological Restoration and Resilience Policy

Priority: Other Significant.

Legal Authority: Not Yet Determined

CFR Citation: None.

Legal Deadline: None.

Abstract: This policy establishes a common definition for ecological restoration and resilience that is consistent with the 2012 Land Planning rule. The directive will provide additional guidance in implementing the definition throughout Forest Service program areas by incorporating it into the Forest Service Manual.

Restoration objectives span a number of initiatives in various program areas, including the invasive species strategy, recovery of areas affected by high-severity fires, hurricanes, and other catastrophic disturbances; fish habitat restoration and remediation; riparian area restoration; conservation of threatened and endangered species; and restoration of impaired watersheds and large-scale watershed restoration projects. The restoration policy will allow agency employees to more effectively communicate Forest Service work in meeting restoration needs at the local, regional, and national levels. Currently an internal Forest Service interim policy for this proposed directive has been implemented in the field units, without any issues. Incorporating the definition into the Forest Service Manual will bring the FS policy into alignment with current ecological restoration science and with congressional and FS authorizations and initiatives.

Statement of Need: There is a critical need for ecological restoration on National Forest System lands and the concept of restoration is threaded throughout existing Agency authorities and collaborative efforts such as the National Fire Plan. However, without a definition in FS' Directive System there has not been consistent interpretation and application. An established policy is necessary for consistency and for the landscape to better weather disturbances, especially under future environmental conditions.

Summary of Legal Basis: The Forest Service proposes to amend the Forest Service Manual (FSM) to add a new title: FSM 2020 Ecological Restoration and Resilience. The proposed directive reinforces adaptive management, use of science, and collaboration in planning and decision making. These foundational land management policies, including use of restoration to achieve desired conditions, underwent formal public review during revision of the Planning Rule (36 CFR 219) and amendment of associated directives (FSM 1900, 1920).

Alternatives: No alternatives were considered as an established policy is necessary for Agency consistency.Start Printed Page 926

Anticipated Cost and Benefits: The promulgation of this directive will have no monetary effect to the Agency or the public. The proposed directive will help agency employees and partners more effectively communicate restoration needs and accomplishments at the local, regional, and national levels.

Risks: There is no risk identified with this rulemaking. The Forest Service has been accomplishing ecological restoration work for many years but has not specifically and consistently referred to it as “restoration” until recently. This final directive brings agency policy into alignment with field operations and current and emerging ecological restoration science and terminology.

Timetable:

ActionDateFR Cite
Proposed Directive09/12/1378 FR 56202
Proposed Directive Comment Period End11/12/13
Final Directive09/00/14

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: LaRenda C King, Assistant Director, Directives and Regulations, Department of Agriculture, Forest Service, ATTN: ORMS, D&R Branch, 1400 Independence Avenue SW., Washington, DC 20250-0003, Phone: 202 205-6560, Email: larendacking@fs.fed.us.

RIN: 0596-AC82

USDA—FS

Final Rule Stage

21. Land Management Planning Rule Policy

Priority: Other Significant.

Legal Authority: 5 U.S.C. 302; 16 U.S.C. 1604; 16 U.S.C. 1613

CFR Citation: 36 CFR 219.

Legal Deadline: None.

Abstract: The Forest Service promulgated a new Land Management Planning rule in April 2012. This rule streamlined the Forest Service's paperwork requirements and expanded the public participation requirements for revising National Forest's Land Management Plans. On February 27, 2013, the Forest Service published proposed directives (78 FR 13316) that will update the current directives, which provide Forest Service internal guidance on how to implement the 2012 planning rule. The directives will allow full implementation of the Land Management Planning rule, which will enable the Forest Service to reduce the time to revise expired plans from 4 to 5 years to 2 to 3 years. These directives, once finalized, will enable the National Forests to revise their management plans under the new rule.

Statement of Need: The existing direction in the Forest Service Manual 1920 and the Forest Service Handbook 1909.12 regarding Land Management Planning needs to be updated to support implementation of the 2012 Planning Rule (36 CFR 219). This will bring the planning directives in line with the new planning rule and clarify substantive and procedural requirements to implement the rule. The updated directives would implement a planning framework that fosters collaboration with the public during land management planning, and is science-based, responsive to change, and promotes social, economic, and ecological sustainability.

Summary of Legal Basis: The Forest Service promulgated a new land management planning regulation at 36 CFR 219 (the “2012 Planning Rule”). The final Planning rule and record of decision was published on April 9, 2012 (77 FR 21162).

Alternatives: The Forest Service must finalize the directives to bring the FS's internal directives in-line with the CFR.

Anticipated Cost and Benefits: No new costs to the agency or the public are associated with these directives. The amended directives would result in more effective and efficient planning within the Agency's capability.

Risks: There are no risks to the public or to the Forest Service associated with this rulemaking.

Timetable:

ActionDateFR Cite
Proposed Rule02/27/1378 FR 13316
Comment Period End04/29/13
Final Rule02/00/14

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: LaRenda C King, Assistant Director, Directives and Regulations, Department of Agriculture, Forest Service, ATTN: ORMS, D&R Branch, 1400 Independence Avenue SW., Washington, DC 20250-0003, Phone: 202 205-6560, Email: larendacking@fs.fed.us.

RIN: 0596-AD06

USDA—OFFICE OF THE SECRETARY (AgSEC)

Proposed Rule Stage

22. Nondiscrimination in Programs or Activities Conducted by the United States Department of Agriculture

Priority: Other Significant.

Legal Authority: 5 U.S.C. 301; 29 U.S.C. 794

CFR Citation: 7 CFR 15d.

Legal Deadline: None.

Abstract: USDA proposes to amend its regulation on nondiscrimination in programs or activities conducted by the Department. This regulation, adopting the nondiscrimination principles of Title VI of the Civil Rights Act of 1964, and applying them to programs and activities conducted by USDA, was first established in 1964. The changes are proposed to clarify the roles and responsibilities of USDA's Office of the Assistant Secretary for Civil Rights and USDA agencies in enforcing nondiscrimination in programs or activities conducted by the Department and to strengthen USDA's civil rights compliance and complaint processing activities to better protect the rights of USDA customers.

Statement of Need: The intent of the proposal is to clarify the roles and responsibilities of OASCR and USDA agencies in enforcing non-discrimination in programs or activities conducted by the Department (“conducted programs”) and to strengthen USDA's civil rights compliance and complaint processing activities to better protect the rights of USDA customers. This regulation does not address those programs for which the Department provides Federal financial assistance [1] (“assisted programs”).

Summary of Legal Basis: 5 U.S.C. 301; 29 U.S.C. 794. This regulation when it was first established adopted the nondiscrimination principles of title VI of the Civil Rights Act of 1964—protections on the bases of race, color, and national origin—and applied them to programs and activities conducted by USDA (see 29 Federal Register (FR) 16966, creating 7 CFR part 15, subpart b, referring to nondiscrimination in direct USDA programs and activities, now found at 7 CFR section 15d). However, in efforts to provide fair services to all program participants, USDA expanded the protected bases for Start Printed Page 927its conducted programs to include religion, sex, age, marital status, familial status, sexual orientation, disability, and whether any portion of a person's income is derived from public assistance programs. The regulation was last revised in 1999 (64 FR 66709, Nov 30, 1999).

Alternatives: Maintaining the status quo would not provide USDA with a uniform requirement for reporting and tabulating the race, ethnicity, and gender data across USDA's diverse program areas. It would also not encourage the early resolution of customers' complaints in accordance with the Secretary of Agriculture's Blueprint for Stronger Service, nor would it strengthen USDA's ability to ensure that all USDA customers receive fair and consistent treatment, and align the regulations with USDA's civil rights goals.

Anticipated Cost and Benefits: OASCR anticipates that there will be a small cost to the public who are served by USDA's conducted programs through the data collection requirement should they volunteer to provide the data.

Risks: OASCR has not identified any risks associated with this proposed action.

Timetable:

ActionDateFR Cite
NPRM11/00/13

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Anna G. Stroman, Acting Chief, Policy Division, Office of the Assistant Secretary for Civil Rights, Department of Agriculture, Office of the Secretary, Reporter's Building, 300 7th St. SW., Room 618, Washington, DC 20024, Phone: 202 205-5953, Email: anna.stroman@ascr.usda.gov.

RIN: 0503-AA52

USDA—RURAL BUSINESS—COOPERATIVE SERVICE (RBS)

Proposed Rule Stage

23. Business and Industry (B&I) Guaranteed Loan Program

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

Legal Authority: Consolidated Farm and Rural Development Act

CFR Citation: 7 CFR 4287; 7 CFR 4279.

Legal Deadline: None.

Abstract: The Business and Industry (B&I) Guaranteed Loan Program regulations were last rewritten in 1996. While there have been some minor modifications to the B&I Guaranteed Loan Program regulations since 1996 to implement Farm Bill provisions etc., some refinements to the regulation need to be made to enhance the program, improve efficiency, correct minor inconsistencies, clarify the regulations to make them more clear and easier to understand, and ultimately reduce delinquencies.

The Agency held several lender meetings throughout the country to see how changes to the program could benefit lenders who utilize the program and make it more attractive for them. The proposed changes being considered should lower the subsidy rate, thereby increasing supportable loan level, which is critical to program success as the program's budget is proposed to be decreased. The proposed rule is intended to increase lending activity, expand business opportunities, and create more jobs in rural areas, particularly in areas that have historically experienced economic distress.

There is no expected cost associated with implementation of the rule.

Statement of Need: With the passage of the 2008 Farm Bill, there is the need to conform certain portions of the B&I Guaranteed Loan Program regulations with requirements found in the 2008 Farm Bill, such as the addition of cooperative equity security guarantees, the locally and regionally grown agricultural food products initiative, and exceptions to the rural area definition. In addition, with the passage of time, the Agency has identified enhancements that will improve program delivery and/or administration, leverage program resources, better align the regulation with the program's goals and purposes, clarify the regulations to make them easier to understand, and reduce delinquencies and defaults. These enhancements will also help to improve program subsidy costs. By lowering program subsidy costs over time, the Agency will be able to better leverage the budget authority provided by Congress. This will allow the Agency to guarantee a higher total dollar amount of loan requests and, assuming the same average size of loans being guaranteed, to guarantee more loans. A reduction in program subsidy costs will manifest in more funds available for additional projects, further improving the economic conditions of rural America. This should result in increased lending activity, the expansion of business opportunities, and the creation of more jobs in rural areas.

Summary of Legal Basis: Consolidated Farm and Rural Development Act, as amended by the 2008 Farm Bill.

Alternatives: The only alternative would be the status quo alternative, which is not an acceptable alternative.

Anticipated Cost and Benefits: The benefits of the enhanced rule are that the rule is expected to reduce loan losses, lower the subsidy rate, and provide program delivery enhancements. The program changes have a cumulative effect of lowering the program cost; however, the amount of the change in cost cannot be estimated with any reasonable precision.

Risks: The only identified risk is not getting the rule published.

Timetable:

ActionDateFR Cite
Proposed Rule04/00/14

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Brenda Griffin, Loan Specialist, B&I Processing Division, Department of Agriculture, Rural Business-Cooperative Service, 1400 Independence Avenue SW., Washington, DC 20250, Phone: 202 720-6802, Fax: 202 720-6003, Email: brenda.griffin@wdc.usda.gov.

RIN: 0570-AA85

USDA—RBS

Final Rule Stage

24. Rural Energy for America Program

Priority: Other Significant.

Legal Authority: 7 U.S.C. 8107

CFR Citation: 7 CFR 4280-B.

Legal Deadline: None.

Abstract: The Agency implemented an interim rule for the Rural Energy for America Program (REAP) on April 14, 2011, to revise and update the existing Renewable Energy System and Energy Efficiency Improvement Program established under the Farm Security and Rural Investment Act of 2002 (2002 Farm Bill).

This interim rule revised and updated the existing Renewable Energy System and Energy Efficiency Improvement Program (7 CFR 4280, subpart) that was implemented in response to the Renewable Energy and Energy Efficiency Program (section 9006 of the 2002 Farm Bill). The interim rule implemented the provisions found in section 9006 of the 2002 Farm Bill as amended and various provisions found in fiscal year 2010 notices of funding availability (NOFAs) published in the Start Printed Page 928 Federal Register. The interim rule provides grants for energy audits and renewable energy development assistance; grants for renewable energy system feasibility studies; and financial assistance (grants, guaranteed loans) for energy efficiency improvements and renewable energy systems. The 2002 Farm Bill as amended directs that at least 20 percent of funds be used for grants of $20,000 or less, up to 10 percent for feasibility studies, and up to 4 percent of mandatory funds for energy audits. Eligible entities for energy audits and renewable energy development assistance include units of State, tribal, or local government; an instrumentality of a State, tribal, or local government; land grant or other institutions of higher education; rural electric cooperatives; or public power entities. Eligible entities for renewable energy feasibility study and financial assistance for energy efficiency improvements and renewable energy systems include agricultural producers and rural small businesses.

The Rural Business-Cooperative Service (RBS) published a Proposed Rule on April 12, 2013, with a 60-day comment period to implement additional changes to REAP to further improve program delivery (e.g., through the simplification of the application process).

Statement of Need: While the interim rule implemented provisions required by the 2008 Farm Bill and included in the fiscal year 2010 NOFAs, there are additional changes to be made in order to reduce the burden to applicants and improve program delivery. In order to achieve these changes, it is necessary to propose changes to 7 CFR 4280, subpart B, and then, at a later date, to implement a final rule.

Summary of Legal Basis: REAP was authorized by the 2002 Farm Bill, which made available $55,000,000 in mandatory funding for 2009, $60,000,000 mandatory funding for 2010, $70,000,000 mandatory funding for 2011 and 2012, and $25,000,000 in discretionary funding for each fiscal year 2009 through 2012. The program provides for grants and guaranteed loans for renewable energy systems and energy efficiency improvements, and grants for feasibility studies and energy audit and renewable energy development assistance. The purpose of the program is to reduce the energy consumption and increase renewable energy production.

Alternatives: The alternatives are to (1) continue operating the program under the 7 CFR 4280, subpart B as it currently is written; (2) revise 7 CFR 4280, subpart B based on public comments received on the interim rule and issue a final rule; or (3) publish a proposed rule and then final rule, taking into account comments received on both the interim rule and the proposed rule.

Anticipated Cost and Benefits: Benefits of the rule may include a reduction in energy consumption, an increase in renewable energy production and reduced burden for certain loan and grant applications.

Risks: The risk associated with this regulatory initiative is that by the time a Final Rule is published, the need will be diminished because there may not be any funding available to the program.

Timetable:

ActionDateFR Cite
Interim Final Rule04/14/1176 FR 21109
Interim Final Rule Effective04/14/11
Interim Final Rule Comment Period End06/13/11
NPRM04/12/1378 FR 22044
Final Action04/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Kelley Oehler, Branch Chief, Department of Agriculture, Rural Business—Cooperative Service, STOP 3225, 1400 Independence Avenue SW., Washington, DC 20250-3225, Phone: 202 720-6819, Fax: 202 720-2213, Email: kelley.oehler@wdc.usda.gov.

RIN: 0570-AA76

USDA—OFFICE OF PROCUREMENT AND PROPERTY MANAGEMENT (OPPM)

Final Rule Stage

25. Biopreferred Program Guidelines Revisions

Priority: Other Significant.

Legal Authority: Pub. L. 110-246

CFR Citation: 7 CFR 3201.

Legal Deadline: None.

Abstract: The 2008 Farm Bill requires USDA to address how the BioPreferred Program will designate complex products and intermediate materials and feed stocks and make other changes to update program guidelines.

Statement of Need: Changes in the Guidelines for Designating Biobased products are necessary for USDA to comply with legislative mandates driving the program. The proposed regulation would be published as final.

Summary of Legal Basis: The Office of Procurement and Property Management (OPPM) published a notice of proposed rulemaking in the Federal Register on May 1, 2012 (77 FR 25632) proposing to amend 7 CFR section 3201, subpart A, the “Guidelines for Designating Biobased Products for Federal Procurement” (Guidelines). Section 3201, which established the Federal biobased products preferred procurement program, was authorized by section 9002 of the Farm Security and Rural Investment Act of 2002 (FSRIA), 7 U.S.C. 8102 and was amended by the Food, Conservation and Energy Act of 2008 (2008 Farm Bill) on June 18, 2008. This regulatory action proposed to revise certain text within the current section 3201 to address program requirements that were changed or added by the 2008 Farm Bill. The proposed amendments provide the framework for implementing the requirements that USDA: (1) Designate biobased “intermediate ingredients and feedstocks” and “finished products” for preferred procurement by Federal agencies; (2) designate items composed of intermediate ingredients and feedstocks that have been designated if the content of the designated intermediate ingredients and feedstocks exceeds 50 percent of the item; and (3) provide information as to the availability, price, performance, and environmental and public health benefits of materials and items that have been designated for Federal preferred procurement.

Alternatives: There are no alternatives as this action was mandated by Congress.

Anticipated Cost and Benefits: We expect that this final rule will result in benefits that justify its cost, but we do not have information necessary to quantify those benefits. This final rule will allow USDA to expand the Federal procurement preference for biobased products to those intermediate ingredients and feedstocks not presently represented in the program. The expansion will create additional market opportunities for manufacturers and vendors of intermediate ingredients and feedstocks as the Government begins to purchase and use such products. As a result of the increased opportunities and use, American farmers and forest landowners should expect to see increased demand for their raw feedstock materials as the demand for biobased products grows. In addition, by increasing the scope of products available under the program, the regulatory action should assist the Government with the goals established for sustainable procurement set under Executive Order 13514. As additional biobased products become available for Federal procurement, Government Start Printed Page 929Agencies will have increased opportunities to buy and use these products.

This rulemaking was determined to be significant for the purposes of Executive Order 12866 (Regulatory Planning and Review), and was reviewed by the Office of Management and Budget. It will not have an annual effect on the economy of $100 million or more and will not result in a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

Risks: After receiving public comment on the proposed rule USDA has determined the new rule poses no significant risks nor will it negatively impact Indian tribal governments or their members.

Timetable:

ActionDateFR Cite
NPRM05/01/1277 FR 25632
NPRM Comment Period End07/02/12
Final Action04/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Agency Contact: Ron Buckhalt, Manager, BioPreferred Program, Office of Procurement and Property Management, Department of Agriculture, Office of Procurement and Property Management, 361 Reporters Building, 300 7th Street SW., Washington, DC 20250, Phone: 202 205-4008, Fax: 202 720-8972, Email: ronb.buckhalt@dm.usda.gov.

RIN: 0599-AA18

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 2013. During the next year, NOAA plans to publish six rulemaking actions that are designated as Regulatory Plan actions. The Bureau of Industry and Security (BIS) will 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 plays 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 Start Printed Page 930Satellite, 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 2013, 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 scientific 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 1,310 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 Start Printed Page 931whether 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 three 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. The three actions implement provisions of the Magnuson-Stevens Fishery Conservation and Management Act, as reauthorized in 2006. The first action may be of particular interest to international trading partners as it concerns the Certification of Nations Whose Fishing Vessels are Engaged in Illegal, Unreported, and Unregulated Fishing or Bycatch of Protected Living Marine Resources. A description of the four regulatory plan actions is provided below.

1. Fishery Management Plan for Regulating Offshore Marine Aquaculture in the Gulf of Mexico (0648-AS65): In January, 2009, the Gulf of Mexico Fishery Management Council approved the Aquaculture Fishery Management Plan, which authorizes NMFS to issue permits to culture species managed by the Council (except shrimp and corals). This was the first time a regional Fishery Management Council approved a comprehensive regulatory program for offshore aquaculture in U.S. Federal waters. On September 3, 2009, the Aquaculture Fishery Management Plan entered into effect. On June 9, 2011, NOAA released the final National Aquaculture Policy and announced that the Agency will move forward with the rulemaking to implement the Aquaculture Fishery Management Plan.

2. Proposed Rule to Designate Critical Habitat for North Atlantic Right Whale (0648-AY54): In 1994, NMFS designated critical habitat for the northern right whale in the North Atlantic Ocean. This critical habitat designation includes portions of Cape Cod Bay and Stellwagen Bank, the Great South Channel, and waters adjacent to the coasts of Georgia and Florida. In 2008, we listed North Atlantic and North Pacific right whales as separate species under the ESA. This action will fulfill the ESA requirement of designating critical habitat following final listing determinations.

3. Final Rule to Designate Critical Habitat for the Hawaiian Monk Seal (0648-BA81): NOAA Fisheries is developing a final rule to designate critical habitat for the Hawaiian monk seal in the main and Northwestern Hawaiian Islands. In response to a 2008 petition from the Center for Biological Diversity, Kahea, and the Ocean Conservancy to revise Hawaiian monk seal critical habitat, NOAA Fisheries published a proposed rule in June 2011 to revise Hawaiian monk seal critical habitat by adding critical habitat in the main Hawaiian Islands and extending critical habitat in the Northwestern Hawaiian Islands. Proposed critical habitat includes both marine and terrestrial habitats (e.g., foraging areas to 500 meter depth, pupping beaches, etc.). To address public comments on the proposed rule, NOAA Fisheries is augmenting its prior economic analysis to better describe the anticipated costs of the designation. NOAA Fisheries is analyzing new tracking data to assess monk seal habitat use in the main Hawaiian Islands. That may lead to some reduction in foraging area critical habitat for the main Hawaiian Islands to better reflect where preferred foraging features may be found.

4. Proposed Rule to List Critical Habitat for Arctic Ringed Seals (0648-BC56): NOAA Fisheries published a final rule to list the Arctic ringed seal as a threatened species under the Endangered Species Act (ESA) in December 2012. This rulemaking would designate critical habitat for the Arctic ringed seal. The proposed critical habitat designation would be in the northern Bering, Chukchi, and Beaufort seas within the current range of the species.

5. Proposed Rule to List Critical Habitat for Beringia Distinct Population of Bearded Seals (0648-BC55): NOAA Fisheries published a final rule to list the Beringia Distinct Population Segment of the bearded seal as a threatened species under the Endangered Species Act (ESA) in December 2012. This rulemaking would designate critical habitat for the Beringia distinct population segment of the bearded seal. The proposed critical habitat designation would be in the northern Bering, Chukchi, and Beaufort seas within the current range of the species.

6. Final Rule for the Removal of the Sunset Provision of the Final Rule Implementing Vessel Speed Restrictions to Reduce the Threat of Ship Collisions With North Atlantic Right Whales (0648-BB20): In 2008 NOAA Fisheries promulgated a regulation designed to reduce the likelihood of deaths and serious injuries to endangered North Atlantic right whales that result from collisions with ships. The rule implemented speed restrictions of no more than 10 knots applying to all vessels 65 ft long or greater in certain locations and times of the year along the east coast of the U.S. In view of uncertainties regarding the manner in which ships and whales interact and the burdens imposed on vessel operators, the rule included a sunset clause under which the rule would expire on December 9, 2013. NOAA Fisheries has proposed removing the sunset provision with the current restrictions remaining in place eliminating or reinstating the sunset provision, studies and metrics that might be used to evaluate the existing rule, and future modifications that should be considered.

At this time, NOAA is unable to determine the aggregate cost of the identified Regulatory Plan actions as several of these actions are currently under development.

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.

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 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 Start Printed Page 932export items in order to enhance national security.

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

Distinguish the types of items that should be subject to stricter or more permissive levels of control for different destinations, end-uses, and end-users;

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.

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 participation of U.S. persons in certain boycotts administered by foreign Governments. The National Defense 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, 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 eight field offices in 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

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 fundamentally 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 took several steps to implement the President's Export Control Reform Initiative (ECRI). BIS published 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. BIS also proposed several rules to control under the EAR items that the President has determined do not warrant control under the International Traffic in Arms Regulations (ITAR), administered by the Department of State rule (76 FR 41957), and its United States Munitions List (USML).

In FY 2012, BIS followed up on its FY 2011 successes with the ECRI and proposed rules that would move items currently controlled in nine categories of the USML to control under the Commerce Control List (CCL), administered by BIS. In addition, BIS proposed a rule to ease the implementation process for transitioning items and re-proposed a revised key definition from the July 15 Rule, “specially designed,” that had received extensive public comment. In FY 2013, after State Department notification to Congress of the transfer of items from the USML, BIS expects to be able to publish a final rule incorporating many of the proposed changes and revisions based on public responses to the proposals.

In FY 2013, BIS activities crossed an important milestone with publication of two final rules that began to put ECRI policies into place. An Initial Implementation rule (73 FR 22660, April 16, 2013) sets in place the structure under which items the President determines no longer warrant control on the United States Munitions List will be controlled on the Commerce Control List. It also revises license exceptions and regulatory definitions, including the definition of “specially designed” to more make those exceptions and definitions clearer and to more close align them with the International Traffic in Arms Regulations, and adds 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 expects to publish additional ECRI final rules in FY 2014.

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 EO 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.” EO 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 Start Printed Page 933items 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. This effort may be accomplished by as early as 2013, when the final rules are published. 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.

Some specific domestic regulatory actions that have resulted from the Department's international regulatory cooperation efforts include the rule on Identification and Certification of Fishing Vessels Engaged in Illegal, Unreported, or Unregulated Fishing or Bycatch of Protected Living Marine Resources (0648-AV51, 76 FR 2011); the Amendments to Implement the Shark Conservation Act and Revise the Definition of Illegal, Unreported, and Unregulated Fishing (0648-BA89); and the proposed rule to comply with the 2010 Shark Conservation Provisions and Other Regulations in the Atlantic Smoothhound Shark Fishery (0648-BB02).

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), the following Regulatory Identifier Numbers (RINs) have been identified as 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. The final Agency retrospective analysis plan can be found at: http://open.commerce.gov/​sites/​default/​files/​Commerce%20Plan%20for%20Retrospective%20Analysis%20of%20Existing%20Rules%20-%202011-08-22%20Final.pdf.

RINTitleExpected to significantly reduce burdens on small businesses?
0648-XC164Final Rule Implementing a Targeted Acadian Redfish Fishery for Sector Vessels
0648-BC50Exempted Fishery for the Spiny Dogfish Fishery in the Waters East and West of Cape Cod, MA
0648-BC25Regulatory amendment to revise requirements for the annual Crab Economic Data Reports under the Bering Sea and Aleutian Islands Crab Rationalization ProgramYes.
0648-BA93Regulatory amendment to modify the Groundfish Retention Standard Program
0648-BB79Proposed Rule to Implement Changes to the Regulations for Designating Critical Habitat under the Endangered Species Act
0648-BB80Proposed Rule to Amend the Definition of Destruction or Adverse Modification of Critical Habitat under the Endangered Species Act
0648-BB81Proposed Rule to Amend the Regulations Governing the Issuance of Incidental Take Statements under Section 7 of the Endangered Species Act
0648-BC24Final Rule to Revise Regulations for Conducting Impact Analyses for Critical Habitat Designations under the Endangered Species Act
0694-AF03Export Control Reform Initiative: Strategic Trade Authorization License Exception
0694-AF17Proposed Revision to the Export Administration Regulations: Control of Items the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF36Proposed Revision to the Export Administration Regulations: Control of Aircraft and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF41Revisions to the Export Administration Regulations: Control of Gas Turbine Engines and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF17Revisions to the Export Administration Regulations: Control of Military Vehicles and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF42Revisions to the Export Administration Regulations: Control of Vessels of War and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF39Revisions to the Export Administration Regulations: Control of Submersible Vessels, Oceanographic Equipment and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF17Revisions to the Export Administration Regulations: Export Control Classification Number 0Y521 Series, Items Not Elsewhere Listed on the Commerce Control List (CCL)
0694-AF53Revisions to the Export Administration Regulations: Control of Energetic Materials and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF51Revisions to the Export Administration Regulations: Auxiliary and Miscellaneous Items that No Longer Warrant Control Under the United States Munitions List and Items on the Wassenaar Arrangement Munitions List
0694-AF58Revisions to the Export Administration Regulations: Control of Personal Protective Equipment, Shelters, and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List
Start Printed Page 934
0694-AF54Revisions to the Export Administration Regulations: Control of Military Training Equipment and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF66“Specially Designed” Definition
0694-AF68Feasibility of Enumerating “Specially Designed” Components
0694-AF65Proposed Revisions to the Export Administration Regulations: Implementation of Export Control Reform; Revisions to License Exceptions After Retrospective Regulatory Review
0694-AF47Revisions to the Export Administration Regulations: Control of Firearms and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF48Revisions to the Export Administration Regulations: Control of Guns and Armament and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF49Revisions to the Export Administration Regulations: Control of Ammunition and Ordnance the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF64Revisions to the Export Administration Regulations: Control of Military Electronic Equipment and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF37Revisions to the Export Administration Regulations (EAR) to Make the Commerce Control List (CCL) Clearer
0694-AF56EAR Revision: Items Related to Launch Vehicles, Missiles, Rockets, and Military Explosive Devices the President Determines No Longer Warrant Control Under the United States Munitions List
0694-AF60Amendment to Licensing Requirements for Exports to Canada of Shotguns, Shotgun Shells and Optical Sighting Devices under the Export Administration RegulationsYes.
0694-AF65Revisions to the Export Administration Regulations: Initial Implementation of Export Control Reform
0694-AF87Export Administration Regulations: Control of Spacecraft Systems and Related Items the President Determines No Longer Warrant Control Under the United States Munitions List
0651-AC82Reduction of Fees for Trademark Applications
0651-AC54Setting and Adjusting Patent Fees

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 1,412,674 military personnel and 886,975 civilians assigned as of June 30, 2013, 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 Energy, Health and Human Services, Housing and Urban Development, Labor, 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.

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 EO 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 Department of State and Department of Commerce, 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.

Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review (January 18, 2011), the following Regulatory Identifier Numbers (RINs) have been identified as associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. All are of particular interest to small businesses. 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 that agency. These rulemakings can also be found on Regulations.gov. The final agency plans can be found at: http://www.regulations.gov/​exchange/​topic/​eo-13563. Start Printed Page 935

RINRule Title (*expected to significantly reduce burdens on small businesses)
0701-AA76Air Force Freedom of Information Act Program.
0701-AA77Air Force Privacy Act Program.
0703-AA87United States Navy Regulations and Official Records.
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-AA91Unofficial Use of the Seal, Emblem, Names, or Initials of the Marine Corps.
0703-AA92Professional Conduct of Attorneys Practicing Under the Cognizance and Supervision of the Judge Advocate General.
0750-AG47Safeguarding Unclassified Controlled Technical Information (DFARS Case 2011-D039).
0750-AG62Patents, Data, and Copyrights (DFARS Case 2010-D001).
0750-AH11Only One Offer—Further Implementation (DFARS Case 2013-D001).
0750-AH54Performance-Based Payments (DFARS Case 2011-D045).
0750-AH86Forward Pricing Rate Proposal Adequacy Checklist (DFARS Case 2012-D035).
0750-AI03Approval of Rental Waiver Requests (DFARS Case 2013-D006).
0790-AI24DoD Freedom of Information Act (FOIA) Program Regulation.
0790-AI30Defense Contract Management Agency (DCMA) Privacy Program.
0790-AI42Personnel Security Program.
0790-AI51DoD Freedom of Information Act (FOIA) Program; Amendment.
0790-AI63Alternative Dispute Resolution.
0790-AI71National Industrial Security Program (NISP): Procedures for Government Activities.Relating to Foreign Ownership, Control or Influence (FOCI).
0790-AI73Withholding of Unclassified Technical Data from Public Disclosure.
0790-AI75Presentation of DoD-Related Scientific and Technical Papers at Meetings.
0790-AI77Provision of Early Intervention and Special Education Services to Eligible DoD Dependents.
0790-AI80National Industrial Security Program: Industrial Security Procedures for Government Activities.
0790-AI84National Defense Science and Engineering Graduate (NDSEG) Fellowships.
0790-AI87Defense Logistics Agency Freedom of Information Act Program.
0790-AI88Shelter for the Homeless.
0790-AI92Inspector General; Privacy Act; Implementation.
0790-AJ03DoD Privacy Program.
0790-AJ04Unlawful Discrimination (On the Basis of Race, Color, National Origin, or Age in Programs or Activities Receiving Federal Financial Assistance From the DoD).
0790-AJ05End Use Certificates (EUCs).
0790-AJ06Voluntary Education Programs.
0790-AJ07Historical Research in the Files of the Office of the Secretary of Defense (OSD).
0790-AJ10Enhancement of Protections on Consumer Credit for Members of the Armed Forces and Their Dependents.
COMPLETED RULES
0710-AA66Civil Monetary Penalty Inflation Adjustment Rule.
0710-AA60Nationwide Permit Program Regulations *.
0750-AH19Accelerated Payments to Small Business (DFARS Case 2011-D008).
0750-AH70Defense Trade Cooperation Treaty With Australia and the United Kingdom (DFARS Case 2012-D034).
0750-AH87System for Award Management Name Changes, Phase 1 Implementation (DFARS Case 2012-D053).
0790-AI54Defense Support of Civilian Law Enforcement Agencies.
0790-AI86Defense Logistics Agency Privacy Program.
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 rule to implement 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 the evaluation of offeror's supply chain risks for information technology purchases relating to national security systems. This rule enables agencies to exclude sources that are identified as having a supply chain risk in order to minimize the potential risk for purchased supplies and services to maliciously introduce unwanted functions and degrade the integrity and operation of sensitive information technology systems.
  • Revise the DFARS to improve awareness, compliance, and enforcement of DoD policies on combating trafficking in persons. The rule will further improve stability, productivity, and certainty in the contingency operations that DoD supports and ensure that DoD contractors do not benefit from the use of coerced labor.
  • Finalize the rule to implement section 818 of the NDAA for FY 2012 relating to the detection and avoidance of counterfeit parts. The rule would address contractor responsibilities for detecting and avoiding the use or inclusion of counterfeit electronic parts or suspect counterfeit electronic parts, the use of trusted suppliers, and requirements for contractors to report counterfeit electronic parts and suspect counterfeit electronic parts. The rule seeks to preclude the introduction of counterfeit material that could compromise DoD weapon and information systems.

2. Rulemakings of Particular Interest to Small Businesses

The Department plans to—Start Printed Page 936

  • Revise the DFARS to implement new prescriptions and clause formats for part 219, Small Business Programs, clauses with alternates. This proposed rule, with its unique prescriptions for the basic version and each alternate for solicitation provisions and clauses, will facilitate the use of automated contract writing systems. The inclusion of the full text of the alternate clause in the regulation should make the terms of the alternate clearer to the offerors and contractors by clarifying paragraph substitutions. As a result, inapplicable paragraphs from the basic clause that are superseded by the alternate will not be included in solicitations or contracts, reducing the potential for confusion.
  • Finalize the DFARS rule to delete text in DFARS Part 219 that implemented 10 U.S.C. 2323 because 10 U.S.C. 2323 has expired. Removal of the obsolete implementing coverage for 10 U.S.C. 2323 will bring DFARS up to date and provide accurate and indisputable regulations affecting the small business and vendor communities.

3. Rulemakings That Streamline Regulations, Reduce Unjustified Burdens, and Minimize Burdens on Small Businesses

The Department plans to—

  • Finalize the rule for DFARS to implement section 803 of the NDAA for FY 2011 to allow a covered litigation support contractor access to technical, proprietary, or confidential data for the sole purpose of providing litigation support.
  • Revise the DFARS to standardize solicitation provisions and contract clauses relating to information technology Cloud Services.
  • Revise the DFARS to reduce the frequency of submission of subcontracting reports.

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.

  • DFARS Cases 2012-D057, 2013-D005, 2013-D014, 2013-D025; and 2013-D026;—Propose a new convention for prescribing clauses with alternates to provide alternate clauses in full text. This will facilitate selection of alternate clauses using automated contract writing systems. The inclusion of the full text of the alternate clauses in the regulation for use in solicitations and contracts should make the terms of the alternate clauses clearer to offerors and contractors by clarifying paragraph substitutions. As a result, inapplicable paragraphs from the basic clause that are superseded by the alternate will not be included in solicitations or contracts, reducing the potential for confusion.
  • DFARS Case 2013-D037—removes redundant DFARS coverage on contractors performing private security functions under a contract that requires performance during contingency operations, in an area of combat operations, or in an area of other significant military operations. These requirements have been incorporated into the FAR, so the DFARS coverage is no longer required.
  • DFARS 2013-D033—deletes unnecessary text from the DFARS to increase clarity of the proposal adequacy checklist. Item 19 on the checklist is being deleted as it overlaps and duplicates other information addressed by other items on the checklist.

Specific DoD Priorities

For this regulatory plan, there are six specific DoD priorities, all of which reflect the established regulatory principles. DoD has focused its regulatory resources on the most serious environmental, 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, security, energy projects, education, and health affairs.

1. Defense Procurement and Acquisition Policy

The Department of Defense continuously reviews the DFARS and continues to lead Government efforts to—

  • Revise the DFARS to provide detailed guidance and instruction to DoD contracting officers for the use of DoD's performance based payments analysis tool when contemplating the use of performance based payments on new fixed-price type contracts.
  • Revise the DFARS to improve information security controls by addressing the requirements for safeguarding unclassified controlled technical information. This rule implements security measures to safeguard unclassified DoD information within contractor information systems from unauthorized access and disclosure and to prescribe reporting to DoD certain cyber intrusion events that affect DoD information resident on or transiting through contractor unclassified information systems.

2. Logistics and Material Readiness, Department of Defense

The Department of Defense plans to finalize a rule on contractors supporting the military in contingency operations:

  • Final Rule: Operational Contract Support. This rule incorporates the latest changes and lessons learned into policy and procedures for operational contract support (OCS), including OCS program management, contract support integration, and the integration of DoD contractor personnel into contingency operations outside the United States. It was required to procedurally close gaps and ensure the correct planning, oversight and management of DoD contractors supporting contingency operations, by updating outdated policy. DoD published an interim final rule on December 29, 2011 (32 CFR part 158, 76 FR 81807-81825) The final rule is expected to be published the first quarter of FY 2014.

3. Installations and Environment, Department of Defense

The Department of Defense plans to finalize a rule regarding the process for evaluating the impact of certain types of structures on military operations and readiness:

  • Final Rule: Mission Compatibility Evaluation Process. This rule implements policy, assigns responsibilities, and prescribes procedures for the establishment and operation of a process for evaluation of proposed projects submitted to the Secretary of Transportation under section 44718 of title 49, United States Code. The evaluation process is established for the purpose of identifying any adverse impact of proposed projects on military operations and readiness, minimizing or mitigating such adverse impacts, and determining if any such projects pose an unacceptable risk to the national security of the United States. The rule also includes procedures for the operation of a central DoD siting clearinghouse to facilitate both informal and formal reviews of proposed projects. This rule is required by section 358 of Public Law 111-383. An interim final rule was published on October 20, 2011 (76 FR 65112). DoD anticipates publishing a final rule in the first quarter of FY 2014.

4. Military Community and Family Policy, Department of Defense

The Department of Defense proposes new policies, responsibilities, and procedures for the operation of voluntary education programs within DoD. Additionally, the Department Start Printed Page 937plans to publish a rule regarding child development programs:

  • Proposed Rule: Voluntary Education Programs. In this proposed rule, the Department of Defense (DoD) discusses new policy, responsibilities, and procedures for the operation of voluntary education programs within DoD. The new policies discussed in the rule include the following. All educational institutions providing education programs through the DoD Tuition Assistance (TA) Program will provide meaningful information to students about the financial cost and attendance at an institution so military students can make informed decisions on where to attend school; not use unfair, deceptive, and abusive recruiting practices; and provide academic and student support services to Service members and their families. New criteria are created to strengthen existing procedures for access to military installations by educational institutions. An annual review and notification process is required if there are changes made to the uniform semester-hour (or equivalent) TA caps and annual TA ceilings. Military Departments will be required to provide their Service members with a joint services transcript (JST). The DoD Postsecondary Education Complaint System is implemented for Service members, spouses, and adult family members to register student complaints. The Military Departments are authorized to establish Service-specific TA eligibility criteria and management controls. DoD anticipates publishing a final rule in the second quarter of FY 2014.
  • Interim Final Rule: Child Development Programs (CDPs): In this interim final rule, the Department of Defense updates policy, responsibilities, and procedures for providing care to minor children birth through age 12 of individuals eligible for care in DoD CDPs to include center-based care, family child care (FCC), school-age care (SAC), supplemental child care, and community based care. The subject areas in this rule include authorizing the publication of supporting guidance for the implementation of CDP policies and responsibilities (including child development training modules, program aids, and other management tools) and establishment of the DoD Effectiveness Rating and Improvement System (ERIS). DoD anticipates publishing a final rule in the second quarter of FY 2014.

5. Health Affairs, Department of Defense

The Department of Defense is able to meet its dual mission of wartime readiness and peacetime health care by operating an extensive network of medical treatment facilities. This network includes DoD's own military treatment facilities supplemented by civilian health care providers, facilities, and services under contract to DoD through the TRICARE program. TRICARE is a major health care program designed to improve the management and integration of DoD's health care delivery system. The program's goal is to increase access to health care services, improve health care quality, and control health care costs.

The TRICARE Management Activity has published or plans to publish the following rules:

  • Proposed Rule: TRICARE; Reimbursement of Long Term Care Hospitals. The proposed rule implements the statutory provision in 10 United States Code 1079(j)(2) that TRICARE payment methods for institutional care shall be determined to the extent practicable in accordance with the same reimbursement rules as those that apply to payments to providers of services of the same type under Medicare. This proposed rule implements a reimbursement methodology similar to that furnished to Medicare beneficiaries for services provided by long term care hospitals. DoD anticipates publishing a proposed rule in the second quarter of FY 2014.
  • Interim Final Rule: CHAMPUS/TRICARE: Pilot Program for Refills of Maintenance Medications for TRICARE Life Beneficiaries through the TRICARE Mail Order Program. This interim final rule implements section 716 of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 112-239), which establishes a 5-year pilot program that would generally require TRICARE for Life beneficiaries to obtain all refill prescriptions for covered maintenance medications from the TRICARE mail order program or military treatment facility pharmacies. Covered maintenance medications are those that involve recurring prescriptions for chronic conditions, but do not include medications to treat acute conditions. Beneficiaries may opt out of the pilot program after 1 year of participation. This rule includes procedures to assist beneficiaries in transferring covered prescriptions to the mail order pharmacy program. This regulation is being issued as an interim final rule in order to comply with the express statutory intent that the program begin in calendar year 2013. DoD anticipates publishing an interim final rule in the first quarter of FY 2014.
  • Final Rule: TRICARE: Certified Mental Health Counselors. This rule was published as an interim final rule on December 27, 2011 (76 FR 80741), in order to meet the congressional requirement set forth in the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011, section 724, which required the Department of Defense to prescribe regulations by June 20, 2011, to establish the criteria, as had previously been studied in accordance with section 717 of the NDAA 2008, that would allow licensed or certified mental health counselors (MHCs) to be able to independently provide care to TRICARE beneficiaries and receive payment for those services. Under current TRICARE requirements, MHCs are authorized to practice only with physician referral and supervision. This IFR establishes a transition period to allow MHCs to gain the requisite education, examination, and post-master's clinical experience for the new category of qualified mental health professionals, “TRICARE Certified Mental Health Counselors,” who will be authorized to practice independently under TRICARE, as well as phase out the category of MHC who require referral and supervision from TRICARE authorized physicians. DoD anticipates finalizing this rule in the second quarter of FY 2014.

6. Sexual Assault Prevention and Response Office, Department of Defense

The Department of Defense plans to publish a final rule regarding Sexual Assault Prevention and Response (SAPR) Program Procedures:

  • Final Rule: Sexual Assault Prevention and Response (SAPR) Program Procedures. This part implements Department of Defense (DoD) policy and assigns responsibilities for the SAPR Program on prevention, response, and oversight to sexual assault. It is DoD policy to establish a culture free of sexual assault by providing an environment of prevention, education and training, response capability, victim support, reporting procedures, and accountability that enhances the safety and wellbeing of all persons covered by the regulation. An interim final rule was published on April 11, 2013 (78 FR 21715). DoD anticipates publishing a final rule in the second quarter of FY 2014.

7. Personnel and Readiness, Department of Defense

The Department of Defense plans to publish a rule regarding Service Academies:

  • Final Rule: Service Academies. This rule establishes policy, assigns responsibilities, and prescribes procedures for Department of Defense oversight of the Service Academies. The Start Printed Page 938proposed rule was published October 18, 2007 (72 FR 59053), and included policy that has since changed. The final rule, particularly the explanation of separation policy, will reflect recent changes in the Don't Ask, Don't Tell policy. It will also incorporate changes resulting from interagency coordination. DoD anticipates publishing the final rule in the first or second quarter of FY 2014.

8. Chief Information Officer, Department of Defense

The Department of Defense plans to amend the voluntary cyber security information sharing program between DoD and eligible cleared defense contractors:

  • Proposed Rule: Defense Industrial Base (DIB) Voluntary Cyber Security/Information Assurance (CS/IA) Activities. The Department proposes to amend the DoD-DIB CS/IA Voluntary Activities regulation (32 CFR part 236) in response to Section 941 National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2013 which requires the Secretary of Defense to establish procedures that require each cleared defense contractor (CDC) to report when a network or information system that meets the criteria reports cyber intrusions. DoD anticipates publishing a proposed rule in the second or third quarter of FY 2014.

DOD—OFFICE OF THE SECRETARY (OS)

Proposed Rule Stage

26. • Defense Industrial Base (DIB) Cyber Security/Information Assurance (CS/IA) Activities; Amendment

Priority: Other Significant.

Legal Authority: E.O. 12829

CFR Citation: 32 CFR 236.

Legal Deadline: None.

Abstract: This rule amends the DoD-DIB CS/IA Voluntary Activities regulation in response to section 941 National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2013 which requires the Secretary of Defense to establish procedures that require each cleared defense contractor (CDC) to report when a network or information system that meets the criteria reports cyber intrusions.

Statement of Need: The Department of Defense (DoD) will amend the DoD-DIB CS/IA Voluntary Activities (32 CFR part 236) regulation to incorporate changes as required by section 941 NDAA for FY 2013 to include mandated cyber intrusion incident reporting by all cleared defense contractors (CDCs).

Summary of Legal Basis: This regulation is proposed under the authorities of section 941 NDAA for FY 2013.

Alternatives: DoD analyzed the requirements in section 941 NDAA for FY 2013 and determined that implementation must be accomplished through the rulemaking process. This will allow the public to comment on the implementation strategy.

Anticipated Cost and Benefits: Implementing the amended rule to meet the requirements of section 941 NDAA for FY 2013 affects approximately 8,700 CDCs. Each company will require DoD approved medium assured certificates to submit the mandatory cyber incident reporting to the DoD access controlled Web site. The cost per certificate is $175. In addition, it is estimated that the average burden per reported incident is 7 hours which includes identifying the cyber incident details, gathering and maintaining the data needed, reviewing the collection of information to be reported, and completing the report. Note, these costs are the same as those associated with 32 CFR part 236 (DoD-DIB CS/IA Voluntary Activities), but are now applicable across a larger population of defense contractors. The benefit of this amended rule is satisfying the legal mandate from section 941 NDAA for FY 2013 as well as informing the Department of incidents that impact DoD programs and information. DoD needs to have the ability to assess the strategic and operational impacts of cyber incidents and determine appropriate mitigation activities.

Risks: There will likely be significant public interest in DoD's implementation of section 941 NDAA for FY2013. DoD will need to assure the public that DoD will provide for the reasonable protection of trade secrets, commercial or financial information, and information that can be used to identify a specific person that may be evident through the cyber incident reporting and media analysis.

Timetable:

ActionDateFR Cite
NPRM04/00/14

Regulatory Flexibility Analysis Required: 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-AJ14

DOD—OS

Final Rule Stage

27. Service Academies

Priority: Other Significant.

Legal Authority: 10 U.S.C. 301

CFR Citation: 32 CFR 217.

Legal Deadline: None.

Abstract: The Department is revising and updating policy guidance and oversight of the military service academies. This rule implements 10 U.S.C. 403, 603, and 903 for the establishment and operation of the United States Military Academy, the United States Naval Academy, and the United States Air Force Academy. The proposed rule was published October 18, 2007 (72 FR 59053), and included policy that has since changed. The final rule, particularly the explanation of separation policy, will reflect recent changes in the Don't Ask, Don't Tell policy.

Statement of Need: The Department of Defense revises and updates the current rule providing the policy guidance and oversight of the military service academies. This rule implements 10 U.S.C. 403, 603, and 903 for the establishment and operation of the United States Military Academy, the United States Naval Academy, and the United States Air Force Academy.

Summary of Legal Basis: 10 U.S.C. chapters 403, 603, 903.

Alternatives: None. The Federal statute directs the Department of Defense to develop policy, assign responsibilities, and prescribe procedures for operations and oversight of the service academies.

Anticipated Cost and Benefits: Administrative costs are negligible and benefits would be clear, concise rules that enable the Secretary of Defense to ensure that the service academies are efficiently operated and meet the needs of the Armed Forces.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM10/18/0772 FR 59053
NPRM Comment Period End12/17/07
Final Action02/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: DoD Instruction 1322.22.Start Printed Page 939

Agency Contact: Paul Nosek, Department of Defense, Office of the Secretary, 4000 Defense Pentagon, Washington, DC 20301-4000, Phone: 703 695-5529.

RIN: 0790-AI19

DOD—OS

28. Sexual Assault Prevention and Response Program Procedures

Priority: Other Significant.

Legal Authority: 10 U.S.C. ch 47 Sec. 113

CFR Citation: 32 CFR 105.

Legal Deadline: None.

Abstract: This rule implements policy, assigns responsibilities, provides guidance and procedures, and establishes the Sexual Assault Advisory Council for the DoD Sexual Assault Prevention and Response (SAPR) program consistent with the Task Force Report on Care for Victims of Sexual Assault, and pursuant to 10 U.S.C. 113 and 32 CFR part 103. The intent of the program is to prevent and eliminate sexual assault within the Department by providing comprehensive procedures to better establish a culture of prevention, response, and accountability that enhances the safety and well-being of all DoD members.

Statement of Need: This rule implements policy, assigns responsibilities, and provides guidance and procedures for the SAPR program. It 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: Section 113 of title 10, United States Code; and Public Laws 109-364, 109-163, 108-375, 106-65, 110-417, and 111-84.

Alternatives: The Sexual Assault Prevention and Response Office (SAPRO) will lack updated and revised rules for implementing DoD policy on prevention and response to sexual assaults involving members of the U.S. Armed Forces if this rule is not implemented.

Anticipated Cost and Benefits: The preliminary estimate of the anticipated cost associated with this rule for the current fiscal year (2011) is approximately $14.819 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) Guidance with which the Department may establish a culture free of sexual assault by providing 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 rule;

(2) Treatment of sexual assault patients as emergency cases, which prevents loss of life or suffering resulting from physical injuries (internal or external), sexually transmitted infections, pregnancy, and psychological distress;

(3) The availability of two reporting options for servicemembers and their dependents who are 18 years of age or older covered by this rule who are victims of sexual assault. The two reporting options are as follows:

(a) Unrestricted reporting allows an eligible person who is sexually assaulted to access medical treatment and counseling and request an official investigation of the allegation using existing reporting channels (e.g., chain of command, law enforcement, health care personnel, the Sexual Assault Response Coordinator [SARC]). When a sexual assault is reported through unrestricted reporting, a SARC shall be notified as soon as possible, respond, assign a SAPR Victim Advocate (VA), and offer the victim medical care and a sexual assault forensic examination (SAFE); and

(b) Restricted reporting allows sexual assault victims to confidentially disclose the assault to specified individuals (i.e., SARC, SAPR VA, or health care personnel), in accordance with DoD Directive (DoDD) 5400.11, and receive medical treatment, including emergency care, counseling, and assignment of a SARC and SAPR VA, without triggering an official investigation. The victim's report to health care personnel (including the information acquired from a SAFE kit), SARCs, or SAPR VAs will not be reported to law enforcement, or to the victim's command to initiate the official investigative process, unless the victim consents or an established exception applies in accordance with DoD Instruction (DoDI) 6495.02.

The Department's preference is for complete unrestricted reporting of sexual assaults to allow for the provision of victims' services and to pursue accountability. However, unrestricted reporting may represent a barrier for victims to access services, when the victim desires no command or law enforcement involvement. Consequently, the Department recognizes a fundamental need to provide a confidential disclosure vehicle via the restricted reporting option.

(4) Service members who are on active duty but were victims of sexual assault prior to enlistment or commissioning are eligible to receive SAPR services and utilize either reporting option. The focus of this rule and DoDI 6495.02 is on the victim of sexual assault. The DoD shall provide support to an active duty Service member regardless of when or where the sexual assault took place; and

(5) Guidance for the development of response capabilities that will enable sexual assault victims to recover, and, if servicemembers, to be fully mission capable and engaged.

Risks: The rule intends to enable military readiness by establishing a culture free of sexual assault. Sexual assault poses a serious threat to military readiness because the potential costs and consequences are extremely high: Chronic psychological consequences may include depression, post-traumatic stress disorder, and substance abuse. In the U.S. Armed Forces, sexual assault not only degrades individual resilience but also may erode unit integrity. An effective fighting force cannot tolerate sexual assault within its ranks. Sexual assault is incompatible with military culture and mission readiness, and risks to mission accomplishment. 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
Final Action11/00/13

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Additional Information: DoD Instruction 6495.02.

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

Start Printed Page 940

DOD—OS

29. Operational Contract Support

Priority: Other Significant.

Legal Authority: Pub. L. 110-181

CFR Citation: 32 CFR 158.

Legal Deadline: None.

Abstract: In accordance with Public Law 110-181 and Public Law 110-417, DoD is revising policy and assigning responsibilities for program management of operational contract support (OCS) in contingency operations and integration of DoD contractor personnel into military contingency operations outside the United States. An interim final rule is required to procedurally close gaps and ensure the correct planning, oversight, and management of DoD contractors supporting contingency operations, by updating the existing outdated policy. The existing policies are causing significant confusion, as they do not reflect current practices and legislative mandates. The apparent mismatch between local Geographic Command guidance and the DoD-wide policies and the Defense Federal Acquisition Regulations Supplement is confusing for those in the field—in particular policy with regard to accountability and visibility requirements. Since the Presidential decision to expand the number of troops in Afghanistan and the subsequent increase of troops and contractors in theater, this issue has become so significant that DoD needs to revise the DoD-wide policies as a matter of urgency.

Statement of Need: This rule revises policy and assigns responsibilities for program management of operational contract support (OCS) in contingency operations and integration of DoD contractor personnel into military contingency operations outside the United States. GAO, the Commission on Wartime Contracting, and the Special Inspector General for Iraq Reconstruction/Afghanistan Reconstruction are among those who have highlighted the urgent requirement to update the policy.

Summary of Legal Basis: Parts of the rule are required by section 861 of the 2008 NDAA, Public Law 110-181 and Public Law 110-417.

Alternatives: Given the legal requirement to revise this regulation and separately publish a corresponding revision to the Federal Acquisition Regulation, we did not consider any alternatives.

Anticipated Cost and Benefits: This regulation establishes policies and procedures for the oversight and management of contractors supporting contingency operations outside the United States; therefore, there is no cost to public. Updated and refined policy regarding contractors supporting contingency operations will result in improved management, oversight and efficiency.

Risks: This rule represents an update to the existing DoD Instruction and incorporates the latest changes in policy and procedures. This revision is required to integrate lessons learned and improvements in practices gleaned from 5 years of operational experience. The risk of not publishing this rule is that there would be outdated policy which doesn't reflect practices in the field. This will lead to inefficient and ineffective management of the contractor workforce supporting contingency operations.

Timetable:

ActionDateFR Cite
Interim Final Rule12/29/1176 FR 81807
Interim Final Rule Effective12/29/11
Interim Final Rule Comment Period End02/27/12
Final Action03/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal.

Additional Information: DoD Instruction 3020.41.

Agency Contact: Kerry Powell, Department of Defense, Office of the Secretary, 3500 Defense Pentagon, Washington, DC 20201-3500, Phone: 703 614-1944, Fax: 703 697-4942, Email: kerry.powell@osd.mil.

RIN: 0790-AI48

DOD—OS

30. Mission Compatibility Evaluation Process

Priority: Other Significant.

Legal Authority: Pub. L. 111-383, sec 358

CFR Citation: 32 CFR 211.

Legal Deadline: None.

Abstract: The Department of Defense (DoD) is issuing this interim final rule to implement section 358 of the Ike Skelton National Defense Authorization Act for Fiscal Year 2011, Public Law 111-383. That section requires that the DoD issue procedures addressing the impacts upon military operations of certain types of structures if they pose an unacceptable risk to the national security of the United States. The structures addressed are those for which an application is required to be filed with the Secretary of Transportation under section 44718 of title 49, United States Code. Section 358 also requires the designation of a lead organization to coordinate DoD review of applications for projects filed with the Secretary of Transportation pursuant to section 44718, and received by the Department of Defense from the Secretary of Transportation. Section 358 also requires the designation of certain officials by the Secretary of Defense to perform functions pursuant to the section and this implementing rule. Section 358 also requires the establishment of a comprehensive strategy for addressing military impacts of renewable energy projects and other energy projects, with the objective of ensuring that the robust development of renewable energy sources and the expansion of the commercial electrical grid may move forward in the United States, while minimizing or mitigating any adverse impacts on military operations and readiness. Implementing that requirement, however, is not required at this time and is not part of this rule. Other aspects of section 358 not required at this time, such as annual reports to Congress, are also not addressed in this rule. Nor does this rule deal with other clearance processes not included in section 358, such as those applied by the Bureau of Land Management, Department of the Interior.

Statement of Need: This rule implements policy, assigns responsibilities, and prescribes procedures for the establishment and operation of a process for evaluation of proposed projects submitted to the Secretary of Transportation under section 44718 of title 49, United States Code. The evaluation process is established for the purpose of identifying any adverse impact of proposed projects on military operations and readiness, minimizing or mitigating such adverse impacts, and determining if any such projects pose an unacceptable risk to the national security of the United States. The rule also includes procedures for the operation of a central DoD siting clearinghouse to facilitate both informal and formal reviews of proposed projects.

Summary of Legal Basis: Public Law 111-383, section 358.

Alternatives: The requirement to have a rule and the policies, responsibilities, and procedures contained in the rule were prescribed by section 358 of Public Law 111-383. In the areas where DoD has discretion, e.g., the internal procedures used within DoD to comply with the law, alternative arrangements Start Printed Page 941would have no impact on the net economic effects of the rule.

Anticipated Cost and Benefits: The Department of Defense has long participated in the Department of Transportation review process, interacting with the Federal Aviation Administration (FAA). Prior to section 358 of Public Law 111-383, DoD's engagement was decentralized—each military service participated separately working with FAA representatives at the regional level. In addition, each service set its own standards for challenging a project application. Section 358 directed that DoD develop a single DoD point of contact for responses, established the threshold level of harm that must be reached before DoD could object to a project application on the basis of national security, and directed that DoD negotiate mitigation with project developers if potential harm is identified. The directed threshold level of harm, identified as “unacceptable risk to national security,” is higher than the standard previously used. This will result in DoD objecting to fewer project applications than before, reducing the impact of DoD reviews on non-DoD economic activity. The requirement to engage in mitigation negotiations may delay some projects (which has a negative impact on non-DoD economic activity), but it may result in still fewer DoD objections (which has a positive impact on non-DoD economic activity). DoD estimates that the net effect of these factors on non-DoD economic activity will be a benefit of approximately $70 million.

The higher standard for objection imposed by section 358 of Public Law 111-383 may allow projects that conflict with military activity, but do not achieve the high level of conflict required by law to object, to proceed. This may impose costs on DoD, e.g., systems testing may have to be moved to alternative test ranges, training, and readiness activities may be curtailed or moved, and changes to operations may have to be implemented to overcome interference with coastal, border, and interior homeland surveillance. The early outreach and negotiation over mitigation required by section 358 may allow modification of some projects to reduce or eliminate their conflict with military activities in cases where the absence of early outreach and negotiation would result in the project proceeding without mitigation. This would provide a benefit to DoD. The net effect of these costs and benefits on DoD has not been quantitatively estimated.

Risks: The higher standard for a DoD objection to a project and the requirement to allow early consultation by developers with DoD will reduce the risk to both developers and to industry of planning a project that is unacceptable to DoD. Per the discussion above, there is a risk to DoD that projects in conflict with military activity, but that do not achieve the high level of conflict required by law to object, will proceed and impair DoD's test and evaluation; training and readiness; and coastal, border, and interior homeland surveillance capabilities.

Timetable:

ActionDateFR Cite
Interim Final Rule10/20/1176 FR 65112
Interim Final Rule Effective10/20/11
Interim Final Rule Comment Period End12/19/11
Final Action01/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

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

Agency Contact: David Belote, Department of Defense, Office of the Secretary, 3400 Defense Pentagon, Washington, DC 20301-3400, Phone: 703 697-7301, Email: david.belote@osd.smil.mil.

RIN: 0790-AI69

DOD—OS

31. Child Development Programs (CDPS)

Priority: Other Significant.

Legal Authority: 10 U.S.C. 1783, 10 U.S.C. 1791 through 1800, 10 U.S.C. 2809, and U.S.C. 2812

CFR Citation: 32 CFR 79.

Legal Deadline: None.

Abstract: This interim final rule revises 32 CFR part 79 to: (a) Update policy, responsibilities, and procedures for providing care to minor children birth through age 12 of individuals eligible for care in DoD Child Development Programs (CDPs) to include center-based care, family child care (FCC), school-age care (SAC), supplemental child care, and community based care; (b) authorize the publication of supporting guidance for the implementation of CDP policies and responsibilities, including child development training modules, program aids, and other management tools; and (c) establish the DoD Effectiveness Rating and Improvement System (ERIS). This rule is being published as an interim final rule to extend child care benefits to same-sex spouses of military service members and DoD civilian employees.

Statement of Need: This interim final rule revises 32 CFR part 79 to update policy, responsibilities, and procedures for providing care to minor children birth through age 12 of individuals eligible for care in DoD CDPs to include center-based care, family child care (FCC), school-age care (SAC), supplemental child care, and community based care.

Summary of Legal Basis: This rule is proposed under the authorities of sections 1783, 1791 through 1800, 2809 and 2812 of title 10, United States Code (U.S.C.).

Alternatives: Without this rule, the Department of Defense's Child Development Programs (CDPs) would be operating according to guidance that is 20 years old and does not take into account necessary critical procedures and policies to ensure that children within DoD CDPs are cared for in a safe and developmentally appropriate setting.

Anticipated Cost and Benefits: The preliminary estimate of the anticipated cost associated with this rule for the fiscal year is approximately $980,000.00. This estimated cost is for the operation of the entire DoD CDP and includes funding from the DoD (from the Office of the Secretary of Defense as well as the military services) and fees paid by parents. These funds provide care to more than 200,000 children and youth in a variety of settings to include child development centers, family child care homes, school age care programs, and community based care. The operation of these programs is a key workforce issue for military members and families. The anticipated benefits associated with this rule include:

(1) The streamlining and consolidating of two outdated instructions into a single instruction providing policy for the DoD CDP.

(2) Guidance and procedures which will provide a safe and secure environment for military children to grow.

(3) Establishment of a more standardized approach to each military services CDP, still allowing for the variances dictated by the unique mission of specific branches and installations.

(4) Clarification of the benefits provided to military members with same sex spouses.

Risks: The degree of risk to the public is minimal. There are no anticipated negative effects of the rule on any entity.

Timetable: Start Printed Page 942

ActionDateFR Cite
Interim Final Rule02/00/14

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Additional Information: DoD Instruction 6060.02.

Agency Contact: Eddy Mentzer, Department of Defense, 4800 Mark Center Drive, Suite 03G15, Alexandria, VA 22350, Phone: 571 372-0857.

RIN: 0790-AI81

DOD—OS

32. • Voluntary Education Programs

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

Legal Authority: 10 U.S.C. 2005; 10 U.S.C. 2007; EO 13607

CFR Citation: 32 CFR 68.

Legal Deadline: None.

Abstract: In this proposed rule, the Department of Defense (DoD) discusses new policy, responsibilities, and procedures for the operation of voluntary education programs within DoD. The new policies discussed in the rule include the following: All educational institutions providing education programs through the DoD Tuition Assistance (TA) Program will provide meaningful information to students about the financial cost and attendance at an institution so military students can make informed decisions on where to attend school; not use unfair, deceptive, and abusive recruiting practices; and provide academic and student support services to servicemembers and their families. New criteria are created to strengthen existing procedures for access to military installations by educational institutions. An annual review and notification process is required if there are changes made to the uniform semester-hour (or equivalent) TA caps and annual TA ceilings. Military Departments will be required to provide their servicemembers with a joint services transcript (JST). The DoD Postsecondary Education Complaint System is implemented for servicemembers, spouses, and adult family members to register student complaints. The Military Departments are authorized to establish service-specific TA eligibility criteria and management controls.

Statement of Need: The Department of Defense (DoD) proposed rule identifies programs that provide active duty Service members with quality educational opportunities to enhance their academic achievement which in turn improves job performance and promotion potential. The overall outcome goal of these programs is to ensure the DoD has the best educated and best military force possible. In the proposed rule, DoD implements policy, assigns responsibilities, and prescribes procedures for the operation of voluntary education programs within DoD.

Summary of Legal Basis: This regulation is proposed under the authorities of sections 2007 and 2005 of title 10, United States Code.

Alternatives: No alternatives are possible.

Anticipated Cost and Benefits: Costs are controlled through limitations emplaced in the DoD Uniform Tuition Assistance policy with course and yearly caps. Subject to appropriations, each servicemember pays no more than $250.00 per semester-unit for tuition and fees combined. Each servicemember participating in off-duty, voluntary education is eligible for up to $4,500.00, in aggregate, for each fiscal year. This limitation allows all servicemembers that voluntarily participate to continue their education. Voluntary education programs include: High School Completion/Diploma; Military Tuition Assistance (TA); Postsecondary Degree Programs; Independent Study and Distance Learning Programs; College Credit Examination Program; Academic Skills Program; and Certification/Licensure Programs. Funding for voluntary education programs during 2012 was $660.5 million, which included tuition assistance and operational costs. This funding provided approximately 539,000 individuals (servicemembers and their adult family members) the opportunity to participate in voluntary education programs around the world.

Voluntary education programs have a positive effect on our servicemembers and their adult family members, providing ways to advance their personal education, career aspirations, and prepare them for future vocational pursuits. Additionally, partnerships with educational institutions also have a positive effect on the global economy. The services have worked with approximately 3,500 colleges and universities worldwide (both regionally and nationally accredited by an accrediting body recognized by the U.S. Department of Education) in reference to TA.

Risks: There are no risks.

Timetable:

ActionDateFR Cite
NPRM08/14/1378 FR 49382
Correction08/21/1378 FR 51678
NPRM Comment Period End09/30/13
Final Action02/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Carolyn Baker, Department of Defense, Office of the Secretary, 4800 Mark Center Drive, Alexandria, VA 22350, Phone: 571 372-5355.

RIN: 0790-AJ06

DOD—DEFENSE ACQUISITION REGULATIONS COUNCIL (DARC)

Final Rule Stage

33. Safeguarding Unclassified Controlled Technical Information (DFARS CASE 2011-D039)

Priority: Other Significant.

Legal Authority: 41 U.S.C. 1303; Pub. L. 112-239

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

Legal Deadline: None.

Abstract: DoD is issuing an interim rule to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to add a DFARS subpart and associated contract clauses to address requirements for the safeguarding of unclassified information within contractor information systems as specified in Executive Order 13556, Controlled Unclassified Information. DoD published an advance notice of proposed rulemaking (ANPR), and notice of public meeting in the Federal Register at 75 FR 9563 on March 3, 2010, to provide the public an opportunity for input into the initial rulemaking process. A proposed DFARS rule was published in the Federal Register at 76 FR 38089 on June 29, 2011, to implement adequate security measures to safeguard unclassified DoD information within contractor information systems from unauthorized access and disclosure, and to prescribe reporting to DoD with regard to certain cyber intrusion events that affect DoD information resident on or transiting through contractor unclassified information systems. After comments were received on the proposed rule it was decided that the scope of the rule would be modified to reduce the information covered. This interim rule addresses safeguarding requirements that cover only unclassified controlled Start Printed Page 943technical information, and reporting the compromise of unclassified controlled technical information. DoD anticipates this rule may have a significant economic impact on a substantial number of small entities. DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.

Statement of Need: The Department of Defense (DoD) interim rule is in support of existing DoD information policy in DoD 5200.1-R, Information Security Program Regulation; Under Secretary of Defense (Intelligence) Directive Type Memorandum (DTM), April 17, 2004; DTM 08-027, entitled Security of Unclassified DoD Information on Non-DoD Information Systems, September 16, 2010, and other applicable DoD issuances. DoD requires this amendment to the DFARS to accomplish the following:

a. Avoid compromise of unclassified computer networks on which controlled technical information is resident on or transiting through contractor information systems, and prevent the exfiltration of controlled technical information.

b. Improve the protection of controlled technical information by employing enhanced security measures, as identified in the clause, to appropriately protect controlled technical information from unauthorized disclosure, loss, or exfiltration.

c. Implement tracking and reporting of controlled technical information incursions to (1) assess the impact of loss; and (2) better understand methods of loss.

d. Standardize procedures for tracking and reporting intrusions.

Additionally, this interim rule is part of DoD's effort to enhance the protection of DoD information, and it also partially implements the National Defense Authorization Act (NDAA) for Fiscal Year 2013 section 941 requirement to mandate contractor reporting of information created by or for DoD that has been potentially compromised by a penetration of a contractor network.

Summary of Legal Basis: 41 U.S.C. 1303 and section 941 of the National Defense Authorization Act of Fiscal Year 2013.

Alternatives: There are no significant alternatives to accomplish the stated objectives of this rule. DoD considered regulatory requirements that were deemed to be complementary, but not adequate as an alternative to this rule.

Anticipated Cost and Benefits: This rule improves national security by implementing safeguards that strengthen information security controls to unclassified controlled technical information within contractor information systems from unauthorized access and disclosure. This rule benefits both the Government and contractors.

Risks: None.

Timetable:

ActionDateFR Cite
ANPRM03/03/1075 FR 9563
ANPRM Comment Period End05/03/10
NPRM06/29/1176 FR 38089
NPRM Comment Period End08/29/11
NPRM Comment Period Extended12/16/1176 FR 55297
NPRM Comment Period Extended10/28/1176 FR 66889
NPRM Comment Period End12/16/11
Final Action11/00/13

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Agency Contact: Manuel Quinones, Department of Defense, Defense Acquisition Regulations Council, 4800 Mark Center Drive, Suite15D07-2, Alexandria, VA 22350, Phone: 571 372-6088, Email: manuel.quinones@osd.mil.

RIN: 0750-AG47

DOD—DARC

34. Requirements Relating to Supply Chain Risk (DFARS Case 2012-D050)

Priority: Other Significant.

Legal Authority: 41 U.S.C. 1303; Pub. L. 111-383, sec 806; Pub. L. 112-239, sec 806

CFR Citation: 48 CFR 208; 48 CFR 212; 48 CFR 215; 48 CFR 233.

Legal Deadline: Final, Statutory, July 7, 2011, 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.

Within 180 days from enactment of the National Defense Authorization Act for Fiscal Year 2011, which was enacted on January 7, 2011.

Abstract: DoD is issuing an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011, as amended by the NDAA for FY 2013. This interim rule revises the DFARS to implement section 806 of the Ike Skelton National Defense Authorization Act for Fiscal Year 2011, Public Law 111-383; entitled “Enhancement of Whistleblower Protections for Contractor Employees,” made extensive changes to 10 U.S.C. 2409, entitled “Contractor employees: protection from reprisal or disclosure.

Statement of Need: The Department of Defense is required to implement in the Defense Federal Acquisition Regulation protection against risks to the supply chain affecting National Security Systems (NSSs). Additionally, DOD Instruction (DODI) 5200.44 (November 5, 2012) Protection of Mission Critical Functions to Achieve Trusted Systems and Networks (TSN), recognizes the need to improve supply chain risk management.

Summary of Legal Basis: This interim rule is required under the authorities of section 806 of the National Defense Authorization Act (NDAA) for Fiscal Year 2011 (Pub. L. 111-383), as amended by section 806 of the NDAA for FY 2013 (Pub. L. 112-239).

Alternatives: DoD considered two possible alternatives to protect against risks to the National Security Systems. However, consistent with the stated objectives of Section 806 of the NDAA for FY 2011, as amended, and Department of Defense Instruction 5200.44 (November 5, 2012), no viable alternatives exist. The first possible alternative included having all contractors report, on all contracts, the nature of the supply chain risk mitigation efforts they have applied to their manufacturing processes. This alternative would be unduly burdensome for both contractors and the government and was therefore rejected. The second alternative is not to have section 806 clauses applicable to commercial and commercial off-the-shelf (COTS) items and purchases below the simplified acquisition threshold. However, the requirements of section 806 should apply to the procurement of commercial items (including COTS items); because the intent of the statute is to protect the supply chain, which in turn protects all NSSs. Commercial and commercial off-the-shelf information technology supplies and services often become parts of the NSSs. To protect the NSSs, using the authority of Public Law 111-383, as amended by Public Law 112-239, requires application in all information technology supply and services contacts. Therefore, exempting commercial (including COTS) items from application of the statute would negate the intended effect of the statute. This second alternative was also rejected as a viable alternative.

Anticipated Cost and Benefits: This interim rule will mitigate the risk and potential harm to the National Security Start Printed Page 944Systems (NSS) and protect the integrity of the supply chain to NSS by avoiding sabotage, maliciously introducing unwanted functions, or other subversion of the design, integrity, manufacturing, production, installation, operation or maintenance of systems. Ultimately, DoD anticipates significant savings to taxpayers by reducing the risk of unsafe products entering our supply chain, which pose serious threats or risks to sensitive government information technology systems.

Risks: There is risk to the National Security Systems if unwanted functions are allowed to penetrate the DoD supply chain. This risk to NSS, if left unmitigated, threatens the security of sensitive information technology systems and puts in jeopardy the safety of our military forces.

Timetable:

ActionDateFR Cite
Interim Final Rule11/00/13

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Manuel Quinones, Department of Defense, Defense Acquisition Regulations Council, 4800 Mark Center Drive, Suite15D07-2, Alexandria, VA 22350, Phone: 571 372-6088, Email: manuel.quinones@osd.mil.

RIN: 0750-AH96

DOD—DARC

35. Enhancement of Contractor Employee Whistleblower Protections (DFARS Case 2013-D010)

Priority: Other Significant.

Legal Authority: 41 U.S.C. 1303; Pub. L. 112-239, sec 827

CFR Citation: 48 CFR 203; 48 CFR 252.

Legal Deadline: Final, Statutory, January 2, 2013, section 827 of the NDAA for Fiscal Year 2013 (Pub. L. 112-239). July 2, 2013 or within 180 days from enactment of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2013 (Pub. L. 112-239), which was enacted on Jan 2, 2013.

Abstract: DoD is issuing an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement statutory amendments to whistleblower protections for contractor employees. DoD is revising the DFARS to implement a policy enhancing the whistleblower protections for contractor employees as modified by section 827 of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 112-239, enacted January 2, 2013). Section 827, entitled “Requirements for Information Relating to Supply Chain Risk,” as amended by section 806 of the NDAA for FY 2013 (Pub. L. 112-239), and allows the DoD to consider the impact of supply chain risk in specified types of procurements related to National Security Systems (NSS). Section 806 defines supply chain risk as ”the risk that an adversary may sabotage, maliciously introduce unwanted function, or otherwise subvert the design, integrity, manufacturing, production, distribution, installation, operation, or maintenance of a covered system so as to surveil, deny, disrupt, or otherwise degrade the function, use, or operation of such system.”

Statement of Need: The Department of Defense (DoD) is issuing an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement amendments made by section 827 of the National Defense Authorization Act for Fiscal Year 2013. Section 827 amends 10 U.S.C. 2409 and 10 U.S.C. 2324(k), making the changes applicable to DoD and NASA. Each agency is amending its FAR supplement.

Summary of Legal Basis: Public Law 112-239, section 827 and 41 U.S.C. 1303.

Alternatives: There are no significant alternatives to accomplish the stated objectives of this rule. DoD considered several alternatives with emphasis on reducing the burden on small entities. Because of the terms used in the statute, DoD is unable to exempt small entities or to establish a dollar threshold for coverage. Regardless of the size of the business, a whistleblower employee must be protected from retaliation by his/her employer.

Anticipated Cost and Benefits: The costs associated with implanting the amendments to existing protections for contractor whistleblower employees, as a result of changes to the law, are minimal. Benefit: The rule proposes to strengthen protections for contractor personnel who disclose incidents of fraud, waste, and abuse of DoD contracts.

Risks: There is potential risk to the public on cases involving fraud, waste, and abuse of DoD contracts going unreported for fear of inadequate protections for whistleblowers under the law.

Timetable:

ActionDateFR Cite
Interim Final Rule11/00/13

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Manuel Quinones, Department of Defense, Defense Acquisition Regulations Council, 4800 Mark Center Drive, Suite15D07-2, Alexandria, VA 22350, Phone: 571 372-6088, Email: manuel.quinones@osd.mil.

RIN: 0750-AH97

DOD—DARC

36. • Allowability of Legal Costs for Whistleblower Proceedings (DFARS Case 2013-D022)

Priority: Other Significant.

Legal Authority: 41 U.S.C. 1303; Pub. L. 112-239, sec 827; 10 U.S.C. 2324(k)

CFR Citation: 48 CFR 216; 48 CFR 231; 48 CFR 252.

Legal Deadline: Final, Statutory, January 2, 2013, section 827(g) and (i) of the NDAA for fiscal year 2013 (Pub. L. 113-239).

Abstract: DoD is issuing an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2013 that amends the allowability of legal costs incurred by a contractor related to whistleblower proceedings. This interim rule is to implement paragraphs 827(g) and (i) of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 113-239). Section 827(g) expands the cost principle at 10 U.S.C. 2324(k) to apply the cost principle on allowability of costs related to legal and other proceedings to costs incurred by contractors in proceedings commenced by a contractor employee submitting a complaint under 10 U.S.C. 2409 (whistleblowing), and include as specifically unallowable, legal costs of a proceeding that results in an order to take corrective action under 10 U.S.C. 2409.

Statement of Need: DoD requires this action to implement paragraphs 827(g) and (i) of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 113-239). Section 827(g) expands the cost principle at 10 U.S.C. 2324(k) to apply the cost principle on allowability of costs related to legal and other proceedings to costs incurred by contractors in proceedings commenced by a contractor employee submitting a complaint under 10 U.S.C. 2409 (whistleblowing), and include as specifically unallowable, legal costs of a proceeding that results in an order to take corrective action under 10 U.S.C. 2409.Start Printed Page 945

This interim rule revises the DFARS subparts 216.3 and 231.2 and adds a new clause at 252.216 to implement paragraphs (g) and (i) of section 827 of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 113-239).

Summary of Legal Basis: The legal basis for this rule is section 827(g) of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 112-239), enacted on January 2, 2013.

Alternatives: DoD was unable to identify any alternatives to the rule that would reduce the impact on the public, particularly on small entities, and still meet the requirements of the statute.

Anticipated Cost and Benefits: There is no significant cost to the Government; however, there is potential cost to a contractor involved in the submission of a whistleblower complaint that results in a monetary penalty to the contractor or an order for the contractor to take corrective measures. Benefits include potential savings to taxpayers, since costs incurred by the contractor are disallowed as a result of one of its employee's filing a complaint under 10 U.S.C. 2409.

Risks: There is risk to a contractor if a contractor employee commenced a proceeding by submitting a complaint under 10 U.S.C. 2409, and if that proceeding resulted in imposition of a monetary penalty or an order to take corrective action under 10 U.S.C. 2409.

Timetable:

ActionDateFR Cite
Interim Final Rule11/00/13

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Manuel Quinones, Department of Defense, Defense Acquisition Regulations Council, 4800 Mark Center Drive, Suite 15D07-2, Alexandria, VA 22350, Phone: 571 372-6088, Email: manuel.quinones@osd.mil.

RIN: 0750-AI04

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

Proposed Rule Stage

37. Tricare; Reimbursement of Long Term Care Hospitals

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

Legal Authority: 10 U.S.C. 1079(j)(2)

CFR Citation: 32 CFR 199.

Legal Deadline: None.

Abstract: The proposed rule implements the statutory provision in 10 United States Code 1079(j)(2) that TRICARE payment methods for institutional care shall be determined to the extent practicable in accordance with the same reimbursement rules as those that apply to payments to providers of services of the same type under Medicare. This proposed rule implements a reimbursement methodology similar to that furnished to Medicare beneficiaries for services provided by long-term care hospitals.

Statement of Need: The rule is necessary to meet the statutory provision to use Medicare reimbursement rules to the extent practicable.

Summary of Legal Basis: Congress established enabling legislation under section 707 of the National Defense Authorization Act of Fiscal year 2002 (NDAA-02), Public Law 107-107 (December 28, 2001) changing the statutory authorization in 10 U.S.C. 1079(j)(2) that TRICARE payment methods for institutional care shall be determined to the extent practicable, in accordance with the same reimbursement rules used by Medicare.

Alternatives: This rule implements statutorily required provisions for adoption and implementation of Medicare institutional reimbursement rules which are consistent with well established congressional objectives. No other alternative is applicable.

Anticipated Cost and Benefits: It is projected that implementation of this rule will result in a health care savings of $71 million in year one of implementation.

Risks: The proposed rule implements statutorily required provisions for adoption and implementation of Medicare institutional reimbursement systems which are consistent with well established congressional objectives. No risk to the public is applicable.

Timetable:

ActionDateFR Cite
NPRM02/00/14

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal.

Agency Contact: Ann N. Fazzini, Department of Defense, Office of Assistant Secretary for Health Affairs, 1200 Defense Pentagon, Washington, DC 20301, Phone: 303 676-3803.

RIN: 0720-AB47

DOD—DODOASHA

Final Rule Stage

38. Tricare: Certified Mental Health Counselors

Priority: Other Significant.

Legal Authority: 5 U.S.C. 301; 10 U.S.C. ch 55

CFR Citation: 32 CFR 199.

Legal Deadline: Final, Statutory, June 20, 2011, section 724 of NDAA 2011.

Congressional requirement set forth in the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011, section 724, which required the Department of Defense to prescribe regulations by June 20, 2011, to establish the criteria, as had previously been studied in accordance with section 717 of the NDAA 2008, that would allow licensed or certified mental health counselors to be able to independently provide care to TRICARE beneficiaries and receive payment for those services.

Abstract: This rule was published as an interim final rule (IFR) in order to meet the congressional requirement set forth in the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2011, section 724, which required the Department of Defense to prescribe regulations by June 20, 2011, to establish the criteria, as had previously been studied in accordance with section 717 of the NDAA 2008, that would allow licensed or certified mental health counselors (MHCs) to be able to independently provide care to TRICARE beneficiaries and receive payment for those services. Under current TRICARE requirements, MHCs are authorized to practice only with physician referral and supervision. This IFR establishes a transition period to allow MHCs to gain the requisite education, examination, and post-master's clinical experience for the new category of qualified mental health professionals, “TRICARE Certified Mental Health Counselors,” who will be authorized to practice independently under TRICARE, as well as phase out the category of MHC who require referral and supervision from TRICARE authorized physicians.

Statement of Need: The Interim Final Rule provides 9.6 million TRICARE beneficiaries access to a new category of qualified mental health professionals whose qualifications confirm their ability to diagnose and treat mental health disorders found in the military population, as well as the psychosocial issues experienced by military members, retirees, and family members. During the transition period of the IFR, the criteria for the MHCs have not changed and will allow continuity of care for beneficiaries who are receiving Start Printed Page 946services from supervised MHCs under the current system. A continued robust, quality provider pool is available for TRICARE beneficiaries to access when seeking medically necessary and appropriate mental health counseling services in the MHS purchased care system.

Summary of Legal Basis: The legal authority for this interim final rule is section 724 of the National Defense Authorization Act for Fiscal Year 2011, Public Law 111-383, which required the Department of Defense to prescribe regulations to establish the criteria that would allow licensed or certified mental health counselors to be able to independently provide care to TRICARE beneficiaries and receive payment for those services.

Alternatives: This action is required by statute, therefore, there are no alternatives.

Anticipated Cost and Benefits: The anticipated cost associated with this rule is under $100 million in 1995 dollars, updated annually for inflation. The benefits are that TRICARE will be in compliance with its statutory provisions, and mental health of beneficiaries who receive services from TRICARE Certified Mental Health Counselors will be improved.

Risks: Failure to implement this will mean that TRICARE regulations are not most appropriately implementing the changes legislated by TRICARE statutory provisions.

Timetable:

ActionDateFR Cite
Interim Final Rule12/27/1176 FR 80741
Interim Final Rule Effective12/27/11
Interim Final Rule Comment Period End02/27/12
Final Action11/00/13

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-AB55

DOD—DODOASHA

39. CHAMPUS/TRICARE: Pilot Program for Refills of Maintenance Medications for Tricare for Life Beneficiaries Through the TRICARE Mail Order Program

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

Legal Authority: 5 U.S.C. 301; 10 U.S.C. ch 55

CFR Citation: 32 CFR 199.

Legal Deadline: None.

Abstract: This interim final rule implements section 716 of the National Defense Authorization Act for Fiscal Year 2013 (Pub. L. 112-239), which establishes a 5-year pilot program that would generally require TRICARE for Life beneficiaries to obtain all refill prescriptions for covered maintenance medications from the TRICARE mail order program or military treatment facility pharmacies. Covered maintenance medications are those that involve recurring prescriptions for chronic conditions, but do not include medications to treat acute conditions. Beneficiaries may opt out of the pilot program after 1 year of participation. This rule includes procedures to assist beneficiaries in transferring covered prescriptions to the mail order pharmacy program. This regulation is being issued as an interim final rule in order to comply with the express statutory intent that the program begin in calendar year 2013.

Statement of Need: The Department of Defense (DoD) proposed rule establishes processes for the new program of refills of maintenance medications for TRICARE for Life beneficiaries through military treatment facility pharmacies and the mail order pharmacy program.

Summary of Legal Basis: This regulation is proposed under 5 U.S.C. 301; 10 U.S.C. ch 55; 32 CFR section 199.21.

Alternatives: The rule fulfills a statutory requirement, therefore, there are no alternatives.

Anticipated Cost and Benefits: The effect of the statutory requirement, implemented by this rule, is to shift a volume of prescriptions from retail pharmacies to the most cost effective points-of-service venues of military treatment facility pharmacies and the mail order pharmacy program. This will produce savings to the Department of approximately $104 million per year and savings to beneficiaries of approximately $34 million per year in reduced copayments.

Risks: Loss of savings to both the Department and beneficiaries. No risk to the public.

Timetable:

ActionDateFR Cite
Interim Final Rule11/00/13

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: RADM Thomas McGinnis, Department of Defense, Office of Assistant Secretary for Health Affairs, 1200 Defense Pentagon, Washington, DC 20301-1200, Phone: 703 681-2890.

RIN: 0720-AB60

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 nationwide and in helping to ensure that all Americans receive a quality education. We provide leadership and financial assistance pertaining to education at all levels to a wide range of stakeholders and individuals, including State educational 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 and that student 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 we administer will affect nearly every American during his or her life. Indeed, in the 2013-2014 school year about 55 million students will attend an estimated 130,000 elementary and secondary schools in approximately 13,600 districts, and about 21 million students will enroll in degree-granting postsecondary schools. All of these Start Printed Page 947students 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; 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 Governmentwide 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. The Higher Education Act of 1965, as Amended

Gainful Employment. The Secretary proposes amendments to the regulations for the Federal Student Aid programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA). The proposed amendments follow a negotiated rulemaking conducted by the Department in the fall of 2013. Specifically, a negotiating committee met in September and November of 2013 to prepare proposed regulations regarding measures for determining whether certain postsecondary educational programs lead to gainful employment in a recognized occupation, the conditions under which these educational programs remain eligible for the title IV Federal Student Aid programs, and requirements for reporting and disclosure of relevant information.

150% Regulations. The Secretary published interim final regulations with a request for public comment on May 16, 2013 (78 FR 28954), to amend the William D. Ford Federal Direct Loan Program (Direct Loan Program) regulations to reflect changes made to the program by the Moving Ahead for Progress in the 21st Century Act (MAP-21), Pub. L. 112-141. Specifically, these interim final regulations reflected the provisions in MAP-21 that amended the HEA to extend the 3.4 percent interest rate on Direct Subsidized Loans from July 1, 2012, through June 30, 2013, and to ensure that a new borrower on or after July 1, 2013, may not receive Direct Subsidized Loans for more than 150 percent of the published length of the educational program in which the borrower is enrolled. Under the changes made by MAP-21, if the borrower exceeds this Direct Subsidized Loan limit, the borrower also becomes responsible for the accruing interest on the Direct Subsidized Loans. We intend to publish final regulations by January 2014.

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

In 2010 the Administration released the Blueprint for Reform: The Reauthorization of the Elementary and Secondary Education Act, the President's plan for revising the Elementary and Secondary Education Act of 1965 (ESEA) and replacing the No Child Left Behind Act of 2001 (NCLB). The blueprint can be found at the following Web site: http://www2.ed.gov/​policy/​elsec/​leg/​blueprint/​index.html.

Additionally, as we continue to work with Congress on reauthorizing the ESEA, we are implementing a plan to provide flexibility on certain provisions of current law for States that are willing to embrace reform. The mechanisms we are using will ensure continued accountability and commitment to quality education for all students while providing States with increased flexibility to implement State and local reforms to improve student achievement.

C. Carl D. Perkins Career and Technical Education Act of 2006

In 2012, we released Investing in America's Future: A Blueprint for Transforming Career and Technical Education, our plan for a reauthorized Carl D. Perkins Career and Technical Education Act of 2006 (2006 Perkins Act). The Blueprint can be found at the following Web site: http://www2.ed.gov/​about/​offices/​list/​ovae/​pi/​cte/​transforming-career-technical-education.pdf.

The 2006 Perkins Act made important changes in Federal support for career and technical education (CTE), such as the introduction of a requirement that all States offer “programs of study.” These changes in the 2006 Perkins Act helped to improve the learning experiences of CTE students but did not go far enough to systemically create better outcomes for students and employers competing in a 21st-century global economy. The Administration's Blueprint would usher in a new era of rigorous, relevant, and results-driven CTE shaped by four core principles: (1) Alignment. Effective alignment between high-quality CTE programs and labor market needs to equip students with 21st-century skills and prepare them for in-demand occupations in high-growth industry sectors; (2) Collaboration. Strong collaboration among secondary and postsecondary institutions, employers, and industry partners to improve the quality of CTE programs; (3) Accountability. Meaningful accountability for improving academic outcomes and building technical and employability skills in CTE programs for all students, based upon common definitions and clear metrics for performance; and (4) Innovation. Increased emphasis on innovation supported by systemic reform of State policies and practices to support CTE implementation of effective practices at the local level. The Administration's Blueprint proposal reflects a commitment to promoting equity and quality across these alignment, collaboration, accountability, and innovation efforts in order to ensure that more students have access to high-quality CTE programs.

D. Individuals With Disabilities Education Act

The Secretary published a notice of proposed rulemaking on September 18, 2013 (78 FR 57324), to amend regulations under Part B of the Individuals with Disabilities Education Act (IDEA) regarding local maintenance of effort (MOE) to ensure that all parties involved in implementing, monitoring, Start Printed Page 948and auditing local educational agency (LEA) compliance with MOE requirements understand the rules. Specifically, we are seeking public comment on proposed amendments to the regulation regarding local MOE to clarify existing policy and make other related changes regarding: (1) The compliance standard; (2) the eligibility standard; (3) the level of effort required of an LEA in the year after it fails to maintain effort under section 613(a)(2)(A)(iii) of the IDEA; and (4) the consequence for a failure to maintain local effort.

III. Retrospective Review of Existing Regulations

Pursuant to section 6 of Executive Order 13563 “Improving Regulation and Regulatory Review” (Jan. 18, 2011), the following Regulatory Identifier Numbers (RINs) have been identified as associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. Some of the entries on this list may be completed actions that 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. These rulemakings can also be found on Regulations.gov. The final agency plan can be found at: www.ed.gov.

RINTitle of rulemakingDo we expect this rulemaking to significantly reduce burden on small businesses?
1810-AB16Title I—Improving the Academic Achievement of the DisadvantagedNo.
1820-AB64Assistance to States for the Education of Children with Disabilities—Public Benefits or InsuranceNo.
1820-AB65Assistance to States for the Education of Children with Disabilities—Maintenance of EffortNo.
1820-AB66American Indian Vocational Rehabilitation Services ProgramNo.
1820-AB67Disability and Rehabilitation Research Projects and Centers Program: Disability and Rehabilitation Research: Research Fellowships; Special Projects and Demonstrations for Spinal Cord InjuriesNo.
1840-AD05Title IV of the Higher Education Act of 1965, as Amended—Income-Based Repayment, Income-Contingent Repayment, and Total and Permanent DisabilityNo.
1840-AD08Titles III and V of the Higher Education Act, as AmendedNo.
1840-AD11Federal Pell Grant ProgramYes.
1840-AD12Transitioning from the FFEL Program to the Direct Loan Program and Loan Rehabilitation under the FFEL, Direct Loan, and Perkins Loan ProgramsUndetermined.
1840-AD14Negotiated Rulemaking Under Title IV of HEAUndetermined.
1840-AD15Gainful EmploymentNo.
1890-AA14Direct Grant Programs and Definitions that Apply to Department RegulationsNo.

IV. Principles for Regulating

Over the next year other regulations may be needed because of new legislation or programmatic changes. In developing and promulgating regulations we follow our Principles for Regulating, which determine when and how we will regulate. Through consistent application of the following 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)

Proposed Rule Stage

40. • Gainful Employment

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

Legal Authority: 20 U.S.C. 1001 to 1003; 20 U.S.C. 1070g; 20 U.S.C. 1085; 20 U.S.C. 1088; 20 U.S.C. 1091 to 1092; 20 U.S.C. 1094; 20 U.S.C. 1099c; 20 U.S.C. 1099c-1

CFR Citation: 34 CFR 668.

Legal Deadline: None.

Abstract: The Secretary proposes amendments to the regulations for the Federal Student Aid programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA). The proposed amendments follow a negotiated rulemaking conducted by the Department in the fall of 2013. Specifically, a negotiating committee met in September and November of 2013 to prepare proposed regulations regarding measures for determining whether certain postsecondary educational programs lead to gainful employment in a recognized occupation, the conditions under which these educational programs remain eligible for the title IV Federal Student Aid programs, and requirements for reporting and disclosure of relevant information.

Statement of Need: The Secretary proposes amendments to the regulations for the title IV, HEA Federal Student Aid programs. The proposed amendments follow a negotiated rulemaking conducted by the Department in September and November of 2013 to prepare proposed regulations regarding measures for determining whether certain Start Printed Page 949postsecondary educational programs lead to gainful employment in a recognized occupation, the conditions under which these educational programs remain eligible for the title IV Federal Student Aid programs, and requirements for reporting and disclosure of relevant information.

Summary of Legal Basis: The Secretary proposes amendments to the regulations for the Federal Student Aid programs authorized under title IV of the Higher Education Act of 1965, as amended (HEA).

Alternatives: To be determined.

Anticipated Cost and Benefits: To be determined.

Risks: To be determined.

Timetable:

ActionDateFR Cite
NPRM02/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Organizations.

Government Levels Affected: None.

Agency Contact: John A. Kolotos, Department of Education, Office of Postsecondary Education, Room 8018, 1990 K Street NW., Washington, DC 20006-8502, Phone: 202 502-7762, Email: john.kolotos@ed.gov.

RIN: 1840-AD15

DEPARTMENT OF ENERGY (DOE)

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), the following Regulatory Identifier Numbers (RINs) have been identified as associated with retrospective review and analysis in the Department's final retrospective review of regulations plan. 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 that agency. These rulemakings can also be found on Regulations.gov. The final agency plan can be found at http://www.whitehouse.gov/​sites/​default/​files/​other/​2011-regulatory-action-plans/​departmentofenergyregulatoryreformplanaugust2011.pdf.

Rulemakings Subject to Retrospective Analysis

RINTitleSmall business burden reduction
1904-AB57Standards for Battery Chargers and External Power Supplies
1904-AC46Alternative Efficiency Determination Methods and Alternate Rating MethodsThis rule is expected to reduce burden on small manufacturers of covered products and equipment.
1904-AC70Waiver and Interim Waiver for Consumer Products and Commercial and Industrial EquipmentThis rule is expected to reduce burden on small manufacturers of covered products and equipment.

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 Distribution Transformer and Microwave Oven standards, which were already published in 2013, have an estimated net benefit to the nation of up to $16.3 billion over 30 years. By 2045, these standards are estimated to save enough energy to operate the current inventory of all U.S. homes for about three months.

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.

The overall plan for implementing the schedule is contained in the Report to Congress under section 141 of EPACT 2005, which was released on January 31, 2006. This plan was last updated in the August 2012 report to Congress and now includes the requirements of the Energy Independence and Security Act of 2007 (EISA 2007). The reports to Congress are posted at: http://www.eere.energy.gov/​buildings/​appliance_​standards/​schedule_​setting.html.

Estimate of Combined Aggregate Costs and Benefits

The regulatory actions included in this Regulatory Plan for battery chargers Start Printed Page 950and external power supplies, walk-in coolers and freezers, metal halide lamp fixtures, manufactured housing, commercial refrigeration equipment, residential furnace fans, and commercial and industrial electric motors may provide significant benefits to the Nation. DOE believes that the benefits to the Nation of the proposed energy standards for metal halide lamp fixtures, commercial refrigeration equipment and walk-in coolers and freezers (energy savings, consumer average lifecycle cost savings, increase in national net present value, and emission reductions) outweigh the costs (loss of industry net present value and life-cycle cost increases for some consumers). In the proposed rulemakings, DOE estimated that these regulations would produce energy savings of 7.19 to 7.49quads over thirty years. The net benefit to the Nation was estimated to be between $11.16 billion (seven-percent discount rate) and $31.57 billion (three-percent discount rate). DOE believes that the proposed energy standards for external power supplies, residential furnace fans, and commercial and industrial electric motors will also be beneficial to the Nation. However, because DOE has not yet proposed candidate standard levels for this equipment, DOE 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 energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemakings for external power supplies, residential furnace fans, and commercial and industrial electric motors.

DOE—ENERGY EFFICIENCY AND RENEWABLE ENERGY (EE)

Proposed Rule Stage

41. Energy Conservation Standards for Walk-in Coolers and Walk-in Freezers

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. 6313(f)(4)

CFR Citation: 10 CFR 431.

Legal Deadline: Final, Statutory, January 1, 2012.

Abstract: The Energy Independence and Security Act of 2007 amendments to the Energy Policy and Conservation Act require that DOE establish maximum energy consumption levels for walk-in coolers and walk-in freezers and directs the Department of Energy to develop performance based energy conservation standards that are technologically feasible and economically justified.

Statement of Need: EPCA requires minimum energy efficiency standards for certain appliances and commercial equipment, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis: Section 312 of EISA 2007 establishes definitions and standards for walk-in coolers and walk-in freezers. EISA 2007 directs DOE to establish performance-based standards for this equipment (42 U.S.C. 6313 (f)(4)).

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: DOE believes that the benefits to the Nation of the proposed energy standards for commercial refrigeration 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 5.39 quads over 30 years and the benefit to the Nation will be between $8.6 billion and $24.3 billion.

Timetable:

ActionDateFR Cite
Notice: Public Meeting, Framework Document Availability01/06/0974 FR 411
Notice: Public Meeting, Data Availability04/05/1075 FR 17080
NPRM Comment Period Extended04/14/1075 FR 41103
Comment Period End05/28/10
NPRM09/11/1378 FR 55781
NPRM Comment Period End11/12/13
Final Action04/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Local, State.

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

Additional Information: Comments pertaining to this rule may be submitted electronically to WICF-2008-STD-0015@ee.doe.gov.

URL for More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​rulemaking.aspx/​ruleid/​30.

URL for Public Comments: www.regulations.gov.

Agency Contact: Charles Llenza, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 586-2192, Email: charles.llenza@ee.doe.gov.

Related RIN: Related to 1904-AB85.

RIN: 1904-AB86

DOE—EE

42. Energy Efficiency Standards for Metal Halide Lamp Fixtures

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

Unfunded Mandates: Undetermined.

Legal Authority: 42 U.S.C. 6295(hh)(2)

CFR Citation: 10 CFR 431.

Legal Deadline: Final, Statutory, January 1, 2012.

Abstract: Section 324 of the Energy Independence and Security Act of 2007 amends the Energy Policy and Conservation Act to require DOE issue a final rule by January 1, 2012, to determine if the energy conservation standards should be amended.

Statement of Need: EPCA requires minimum energy efficiency standards for certain appliances and commercial equipment, including metal halide lamp fixtures.

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 metal halide lamp fixtures, 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 Start Printed Page 951significant 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: DOE believes that the benefits to the Nation of the proposed energy standards for metal halide lamp fixtures (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 range from 0.80 quads to 1.1 quads over 30 years and the benefit to the Nation will be between $0.95 billion and $3.2 billion.

Timetable:

ActionDateFR Cite
Notice: Public Meeting, Framework Document Availability12/30/0974 FR 69036
Comment Period End01/29/10
Notice: Public Meeting, Data Availability04/01/1176 FR 18127
Comment Period End05/16/11
NPRM08/20/1378 FR 51464
NPRM Comment Period End10/21/13
Final Action01/00/14

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

URL For More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​commercial/​metal_​halide_​lamp_​ballasts.html.

URL For Public Comments: www.regulations.gov.

Agency Contact: Lucy DeButts, Office of Buildings Technologies Program, EE-2J, 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-AC00

DOE—EE

43. Energy Efficiency Standards for Manufactured Housing

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

Unfunded Mandates: Undetermined.

Legal Authority: 42 U.S.C. 17071

CFR Citation: 10 CFR 460.

Legal Deadline: Final, Statutory, December 19, 2011.

Abstract: The rule would establish energy efficiency standards for manufactured housing and a system to ensure compliance with, and enforcement of, the standards.

Statement of Need: EISA 2007 requires minimum energy efficiency standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis: Section 413 of EISA 2007, 42 U.S.C. 17071, directs DOE to develop and publish energy standards for manufactured housing.

Alternatives: The statute requires DOE to conduct a rulemaking to establish standards based on the most recent version of the International Energy Conservation Code (IECC), except in cases in which the Secretary finds that the IECC is not cost effective or a more stringent standard would be more cost effective based on the impact of the IECC on the purchase price of manufactured housing and on total lifecycle construction and operating costs.

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.

Timetable:

ActionDateFR Cite
ANPRM02/22/1075 FR 7556
ANPRM Comment Period End03/24/10
Request for Infommation06/25/1378 FR 37995
NPRM09/00/14

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

URL For More Information: www.energycodes.gov/​status/​mfg_​housing.stm.

URL For Public Comments: www.regulations.gov.

Agency Contact: Mohammed Khan, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 586-7892, Email: mohammed.khan@ee.doe.gov.

RIN: 1904-AC11

DOE—EE

44. Energy Conservation Standards for Commercial Refrigeration Equipment

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

Unfunded Mandates: Undetermined.

Legal Authority: 42 U.S.C. 6313(c)(5)

CFR Citation: 10 CFR 431.

Legal Deadline: Final, Statutory, January 1, 2013.

Abstract: DOE is reviewing and updating energy conservation standards, as required by the Energy Policy and Conservation Act, to reflect technological advances. All amended standards must be technologically feasible and economically justified. As required by EPCA, DOE published previously a final rule establishing energy conservation standards for ice-cream freezers, self-contained commercial refrigerators, freezers, and refrigerator-freezers without doors, for equipment manufactured after January 1, 2012. (74 FR 1092, Jan. 9, 2009) DOE is required to issue a final rule for this second review of energy conservation standards for commercial refrigeration equipment no later than January 1, 2013.

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

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 commercial refrigeration equipment, 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 Start Printed Page 952standards 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: DOE believes that the benefits to the Nation of the proposed energy standards for commercial refrigeration 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 1 quad over 30 years and the benefit to the Nation will be between $1.61 billion and $4.07 billion.

Timetable:

ActionDateFR Cite
Notice: Public Meeting, Framework Document Availability05/06/1075 FR 24824
Comment Period End06/07/10
Notice: Public Meeting, Data Availability03/30/1176 FR 17573
Comment Period End05/16/11
NPRM09/11/1378 FR 55889
NPRM Comment Period End11/12/13
Final Action02/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

URL for More Information: www1.eere.energy.gov/​buildings/​appliance_​standard/​rulemaking.aspx/​ruleid/​27.

URL for Public Comments: www.regulations.gov.

Agency Contact: Charles Llenza, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585. Phone: 202 586-2192, Email: charles.llenza@ee.doe.gov.

RIN: 1904-AC19

DOE—EE

45. Energy Conservation Standards for Residential Furnace Fans

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)(D)

CFR Citation: 10 CFR 430.

Legal Deadline: Final, Statutory, December 31, 2013.

Abstract: DOE is initiating its first rulemaking to consider new energy conservation standards or energy use standards for purposes of circulating air through duct work, as required under 42 U.S.C. 6295(f)(4)(D). DOE commonly refers to these products as “residential furnace fans.” EPCA, as amended, requires DOE to publish a final rule establishing any final energy conservation or energy use standards not later than December 31, 2013.

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

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 furnace fans, 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 candidate standard levels for this equipment, 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 the maximum energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking for this equipment.

Timetable:

ActionDateFR Cite
Notice: Public Meeting, Framework Document Availability06/03/1075 FR 31323
Comment Period End07/06/10
Preliminary Analysis07/10/1277 FR 40530
Comment Period End09/10/12
NPRM; Public Meeting10/25/1378 FR 64067
NPRM Comment Period End12/24/13
Public Meeting12/03/13
Final Action12/00/13

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

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

URL for Public Comments: www.regulations.gov.

Agency Contact: Ronald B. Majette, Program Manager, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 586-7935, Email: ronald.majette@ee.doe.gov.

Related RIN: Related to 1904-AC21.

RIN: 1904-AC22

DOE—EE

46. Energy Efficiency Standards for Certain Commercial and Industrial Electric Motors

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. 6313(b)(4)(B)

CFR Citation: 10 CFR 431.25.

Legal Deadline: Final, Statutory, December 19, 2012.

Abstract: Consistent with changes made by the Energy Independence and Security Act of 2007 (EISA 2007), DOE is amending its electric motor standards by expanding the scope of the electric Start Printed Page 953motors that would be regulated. Under the Energy Policy and Conservation Act (EPCA), as amended, DOE must publish a final rule determining whether to amend its standards no later than 24 months after the effective date of the previous final rule.

Statement of Need: EPCA requires minimum energy efficiency standards for certain appliances and commercial equipment, including commercial and industrial electric motors.

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 electric motors, 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 candidate standard levels for this equipment, 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 the maximum energy savings that are technologically feasible and economically justified. Estimates of energy savings will be provided when DOE issues the notice of proposed rulemaking for this equipment.

Timetable:

ActionDateFR Cite
Notice: Public Meeting; Framework Document Availability09/28/1075 FR 59657
Comment Period End11/24/10
Preliminary Analysis07/23/1277 FR 43015
Comment Period End09/07/12
NPRM11/00/13
Final Action05/00/14

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

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

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/​commercial/​electric_​motors.html.

URL For Public Comments: www.regulations.gov.

Agency Contact: James Raba, Office of Building Technologies Program, EE-2J, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW., Washington, DC 20585, Phone: 202 586-8654, Email: jim.raba@ee.doe.gov.

Related RIN: Duplicate of 1904-AC14.

RIN: 1904-AC28

DOE—EE

Final Rule Stage

47. Energy Efficiency Standards for Battery Chargers and External Power Supplies

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

Legal Authority: 42 U.S.C. 6295(u)

CFR Citation: 10 CFR 430.

Legal Deadline: Final, Statutory, July 1, 2011.

Abstract: In addition to the existing general definition of “external power supply,” the Energy Independence and Security Act of 2007 (EISA) defines a “class A external power supply” and sets efficiency standards for those products. EISA directs DOE to publish a final rule to determine whether the standards set for class A external power supplies should be amended along with standards for other classes of external power supplies that DOE determines satisfy the necessary statutory criteria. EISA also requires DOE to issue a final rule prescribing energy conservation standards for battery chargers, if technologically feasible and economically justified or to determine that no energy conservation standard is technically feasible and economically justified.

Statement of Need: EPCA requires minimum energy standards for appliances, which has the effect of eliminating inefficient appliances and equipment from the market.

Summary of Legal Basis: Title III of EPCA sets forth a variety of provisions designed to improve energy efficiency. Part A of title III (42 U.S.C. 6291 to 6309) provides for the Energy Conservation Program for Consumer Products Other than Automobiles. EPCA directs DOE to conduct a rulemaking to establish energy conservation standards for battery chargers or determine that no energy conservation standard is technically feasible and economically justified (42 U.S.C. 6295 (u)(1)(E)(i)-(ii)and (w)(3)(D)).

In addition to the existing general definition of “external power supply,” EPCA defines a “Class A external power supply” (42 U.S.C. 6291(36)(C)) and sets efficiency standards for those products (42 U.S.C. 6295(u)(3)). EPCA directs DOE to publish a final rule to determine whether amended standards should be set for external power supplies or classes of external power supplies. If such determination is positive, DOE would include any amended or new standards as part of that final rule. DOE completed this determination in 2012. 75 FR 27170 (May 14, 2010)

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: DOE believes that the benefits to the Nation of the proposed energy standards for battery chargers and external power supplies (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 2.16 quads over 30 years and the benefit to the Nation will be between $6.68 billion and $12.44 billion.

Timetable: Start Printed Page 954

ActionDateFR Cite
Notice: Public Meeting, Framework Document Availability06/04/0974 FR 26816
Comment Period End07/20/09
Notice: Public Meeting, Data Availability09/15/1075 FR 56021
Comment Period End10/15/10
Final Rule (Technical Amendment)09/19/1176 FR 57897
NPRM03/27/1277 FR 18478
Final Rule: Technical Amendment04/16/1277 FR 22472
NPRM Comment Period End05/29/12
NPRM Comment Period Reopened06/29/1277 FR 38743
Reopened NPRM Comment Period End07/16/12
Request for Information03/26/1378 FR 18253
RFI Comment Period End05/28/13
Final Action12/00/13

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Local, State.

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

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

URL For More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​residential/​battery_​external.html.

URL For Public Comments: www.regulations.gov.

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.

Related RIN: Related to 1904-AB75.

RIN: 1904-AB57

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Statement of Regulatory Priorities for Fiscal Year 2014

As the lead federal agency responsible for protecting the health of all Americans and providing supportive services for vulnerable populations, the Department of Health and Human Services (HHS) implements programs that strengthen the health care system; advance scientific knowledge and innovation; improve the health, safety, and well-being of the American people; increase efficiency, transparency, and accountability of HHS programs; and strengthen the nation's health and human services infrastructure.

The Department's regulatory agenda for Fiscal Year 2014 advances this mission by issuing rules that will: Increase access to health care for all Americans and strengthen the Medicare program, the nation's largest insurance provider; support the President's commitment to implement strategies to reduce gun violence; build from previous experiences to safeguard the nation's food supply; promote children's health and well-being through programs that target those critical early years; arm consumers with information to help them make healthy choices; and marshal the best research and technology available to streamline and modernize the health care delivery and medical product availability systems. This overview highlights several regulations that best exemplify these priorities.

Expanding Coverage in the Private Health Care Market and Strengthening Medicare

The Department continues to implement Affordable Care Act provisions that expand health insurance coverage and promote health care security for all Americans. Millions of Americans—including women, families, seniors, and small business owners—are already benefitting from the Affordable Care Act. As the Department begins open enrollment in the Health Insurance Marketplaces, we will continue to provide guidance to states, providers, and insurers to enhance the experience of individuals and families accessing the Marketplaces. In addition, the Department plans to publish other rules that would enhance the protections of the Affordable Care Act.

For example, the Centers for Medicare and Medicaid Services (CMS) is preparing to monitor and update policies related to the Health Insurance Marketplaces based on experience with initial open enrollment to address emerging needs of states, health care providers, and insurers.[1]

CMS, along with the Departments of Labor and the Treasury, recently published a final rule to implement the Mental Health Parity and Addiction Equity Act (MHPAEA) of 2008, which 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 and health insurance coverage offered in connection with a group health plan. The Affordable Care Act builds on MHPAEA and requires coverage of mental health and substance use disorder services as one of ten essential health benefits categories. Under the essential health benefits rule, individual and small group health plans are required to comply with these parity regulations. This rule, in conjunction with the Affordable Care Act provisions will expand mental health and substance use disorder benefits and parity protections for 62 million Americans.[2]

CMS has also identified a number of opportunities to strengthen the Medicare program by updating rules related to health care payments and issuing rules to help root out potential waste, fraud, and abuse.

In one such rule, CMS will propose certain qualification standards regarding the types of prosthetic and orthotic devices billable to the Medicare program.[3] This rule continues the Department's efforts to identify and eliminate avenues for Medicare fraud and works to protect the Medicare Trust Fund.

In addition, CMS will update several Medicare provider payment rules to better reflect the state of practice and be responsive to feedback from providers.[4] These rules, which are published annually, provide predictability for health care providers so they can manage their finances appropriately.

Advancing Strategies To Reduce Gun Violence

On April 23, 2013, the Department published an Advance Notice of Proposed Rulemaking (ANPRM) requesting public input on issues Start Printed Page 955related to the HIPAA Privacy Rule and reporting to the National Instant Criminal Background Check System (NICS) the identities of individuals subject to a federal mental health prohibitor that disqualifies the individuals from possessing or receiving a firearm. The ANPRM also announced the Department's consideration of a proposal to modify the HIPAA Privacy Rule to expressly permit certain covered entities to disclose to NICS the identities of individuals subject to the federal mental health prohibitor. This NPRM will address public comments received in response to the ANPRM and includes proposals to help facilitate NICS reporting.

Safeguarding the Nation's Food Supply

FDA will continue its work to implement the Food Safety Modernization Act and other statutory authorities related to food safety, working with public and private partners to build a new system of food safety oversight. In the past year, FDA has issued significant proposed rules on preventive controls for human food and produce safety, as well as foreign supplier verification for importers and accreditation of third-party auditors. This year, FDA will continue its work to enhance its oversight of the nation's food supply, including publishing rules that will help curb the development of antimicrobial resistance in food products. For example:

FDA recently issued a proposed rule establishing preventive controls in the manufacture and distribution of animal feeds.[5] This regulation, as well as a companion piece related to human foods, constitute the heart of the 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.

In another proposed rule, FDA is codifying a provision in the Animal Drug User Fee Amendments of 2008 that requires sponsors of antimicrobial new animal drug products to annually report the amount of antimicrobial active ingredient in those drugs that are sold or distributed for use in food-producing animals, as well as outline other requirements for collecting additional drug distribution data. This rule will help FDA address the problem of antimicrobial resistance and will help ensure that FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals.[6]

Promoting Children's Health and Well-Being

The Administration for Children and Families' (ACF) regulatory portfolio includes rules that promote children's health and well-being by strengthening programs that serve children and their families. Specifically, ACF rules support the President's Early Learning Initiative: A series of new investments that will establish a continuum of high-quality early learning for a child—beginning at birth and continuing to age five.

For example, one final rule would provide the first comprehensive update of Child Care and Development Fund (CCDF) regulations since 1998.[7] 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 care for all families, including those who receive no direct assistance through CCDF. This final rule would make improvements in four key areas: (1) Health and safety; (2) child care quality; (3) family-friendly policies that promote continuity of care and support working families; and (4) program integrity. These changes reflect current research and knowledge about the early care and education sector, state innovations in policies and practices over the past decade, and increased recognition that high quality child care both supports work for low-income parents and promotes children's learning and healthy development.

Another final rule would amend Head Start program eligibility standards, as a component of an ongoing effort to strengthen the Head Start program and help ensure for children and families most in need access to this high-quality educational program.[8]

Empowering Americans To Make Healthy Choices in the Marketplace

As of 2010, more than one-third of U.S. adults [9] and 17% of all children and adolescents [10] in the United States are obese, representing a dramatic increase in the rise of this health status. Since 1980, the prevalence of obesity among children and adolescents has almost tripled.[11] 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 the First Lady's “Let's Move” initiative and the Secretary's leadership, HHS has marshaled the skills and expertise from across the Department to address this epidemic with research, public education, and public health strategies. Adding to this effort, FDA will issue several 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.[12]

One final rule will require restaurants and similar retail food establishments with 20 or more locations to list calorie content information for standard menu items on restaurant menus and menu boards, including drive-through menu boards.[13] Other nutrient information—total calories, fat, saturated fat, cholesterol, sodium, total carbohydrates, sugars, fiber, and total protein—would have to be made available in writing upon request.

A second final rule will require vending machine operators who own or operate 20 or more vending machines to disclose calorie content for some items.[14] The Department anticipates that such information will ensure that patrons of chain restaurants and vending machines have nutritional information about the food they are consuming.

A third proposed rule would revise 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 Start Printed Page 956on the label to help consumers maintain healthy dietary practices.[15]

Another proposed rule will focus on the serving sizes of foods that can reasonably consumed in one serving. This rule would provide consumers with nutrition information based on the amount of food that is typically eaten as a serving, which would assist consumers in maintaining healthy dietary practices.[16]

Reducing the Harms of Tobacco Use

In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act, which authorized FDA to regulate tobacco for the first time in history. Under the Tobacco Control Act, FDA has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and for reducing tobacco use by minors. In the coming year, FDA plans to issue a proposed rule that would clarify which products containing tobacco, in addition to cigarettes, are subject to FDA oversight.[17] This rule would also allow FDA to establish regulatory standards on the sale and distribution of tobacco products, such as age-related access restrictions and rules on advertising and promotion, as appropriate, to protect public health. This rule will help FDA target its efforts to identify and regulate tobacco products that are intended to entice children and youth.

Modernizing Medical Product Safety and Availability

In 2012, Congress gave FDA new authorities under the Food and Drug Administration Safety and Innovation Act to support its core mission of safeguarding the quality of medical products available to the public while ensuring the availability of innovative products to promote the public health. Similar to its work in the food safety, nutrition, and tobacco control spheres, FDA works diligently to implement regulations springing from this new statutory authority with a focus on enhancing FDA oversight and 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.

For example, a newly issued regulatory proposal would require manufacturers of certain drugs, such as drugs used for cancer treatments, anesthesia drugs, and other drugs that are critical to the treatment of serious diseases and life-threatening conditions, to report discontinuances or interruptions in the manufacturing of these products.[18] This rule would help FDA address and potentially prevent drug shortages and would help inform providers and public health officials earlier about potential drug shortages.

Another recent proposed rule would update FDA's regulations to reflect the increased use of generic drugs in the current marketplace and create parity between brand name and generic drug manufacturers with regards to the ability to update product labeling. In this rule, FDA would propose to allow generic drug manufacturers to independently update product labeling to reflect certain types of newly acquired safety information through submission of a “changes being effected” supplement, irrespective of whether the revised labeling differs from that of the corresponding brand name drug.[19] The rule would also propose the process by which information regarding a “changes being effected” labeling supplement would be made publicly available during FDA's review, so that the public can have timely access to this information.

Streamlining Regulations To Reduce Regulatory Burdens

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 industries by updating rules to align with emerging health and safety standards, eliminating outdated procedures, streamlining rules, and providing flexibility to use technology.

CMS continues its retrospective review efforts by proposing rules to update safety standards, eliminate redundancies, and reduce burden for patients and providers. For example, one proposed rule would amend the fire safety standards for hospitals, long-term care facilities, intermediate care facilities for the intellectually disabled (ICFs/ID), ambulatory surgery centers (ASCs), hospices which provide in-patient services, religious non-medical health care institutions, and Programs of All-Inclusive Care for the Elderly (PACE) facilities.[20] Further, this proposed rule would adopt the most recent edition of the Life Safety Code (LSC) and eliminate references in our regulations to all earlier editions.

In another rule, CMS, working with the Centers for Disease Control and Prevention and the Office for Civil Rights, will amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow laboratories to provide patients with direct access to completed test results at the patient's request.[21] This rule supports the Administration's transparency initiative by allowing consumers to make informed decisions about their care and treatment.

In a major undertaking, the Department and White House Office of Science and Technology Policy will propose revisions to the ethical rules governing research on human subjects, often referred to as the Common Rule.[22] The Common Rule governs institutions and researchers supported by HHS, and researchers throughout much of the federal government, in the conduct of research on humans. The proposed revisions will aim to better protect human subjects who are involved in research while facilitating research and reducing burden, delay, and ambiguity for investigators.

HHS—OFFICE FOR CIVIL RIGHTS (OCR)

Proposed Rule Stage

48. HIPAA Privacy Rule and the National Instant Criminal Background Check System (NICS)

Priority: Other Significant.

Legal Authority: Pub. L. 104-191; President's Gun Violence Reduction Executive Actions

CFR Citation: 45 CFR 164.

Legal Deadline: None.

Abstract: This proposed rule would modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to expressly permit certain HIPAA covered entities to disclose to Start Printed Page 957the National Instant Criminal Background Check System (NICS) the identities of individuals who are subject to a Federal “mental health prohibitor” that disqualifies them from possessing or receiving a firearm.

Statement of Need: This proposed rule is needed to ensure that entities that perform involuntary commitments or make adjudications causing individuals to be disqualified from possessing or receiving a firearm under the Federal mental health prohibitor can report to the NICS.

Summary of Legal Basis: On January 16, 2013, President Barack Obama announced 23 Executive actions aimed at curbing gun violence across the nation, including a specific commitment to address unnecessary legal barriers, particularly relating to the Health Insurance Portability and Accountability Act, which may prevent states from making information available to the NICS.

Anticipated Cost and Benefits: The rule does not establish any new requirements and is expected to be cost neutral. Possible unquantified benefits include increased flexibility for States and covered entities to report to the NICS, and increased public safety as a result of increased reporting to the NICS.

Risks: Not applicable.

Timetable:

ActionDateFR Cite
ANPRM04/23/1378 FR 23872
ANPRM Comment Period End06/07/13
NPRM12/00/13

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: State.

URL For More Information: www.hhs.gov/​ocr/​privacy.

Agency Contact: Andra Wicks, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW., Washington, DC 20201, Phone: 202 205-2292, Fax: 202 205-4786, Email: andra.wicks@hhs.gov.

RIN: 0945-AA05

HHS—FOOD AND DRUG ADMINISTRATION (FDA)

Proposed Rule Stage

49. 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 proposing to amend 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. If finalized, this rule will modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label.

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 in the last 18 years that can be used to update the content and appearance of information on the Nutrition Facts and Supplement Facts labels so that consumers can use the information more effectively 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: If finalized, 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 proposed changes would provide more current information to assist consumers in constructing a healthful diet. The potential benefit from the proposed 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 continue to 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 making food choices in the absence of necessary information.

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
NPRM12/00/13

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 EO 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 EO 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: 240 402-1450, Email: blakeley.fitzpatrick@fda.hhs.gov.

RIN: 0910-AF22

Start Printed Page 958

HHS—FDA

50. 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

CFR Citation: 21 CFR 101.9; 21 CFR 101.12.

Legal Deadline: None.

Abstract: FDA is proposing to amend its labeling regulations for foods to provide updated Reference Amounts Customarily Consumed (RACCs) for certain food categories. If finalized, 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 considering amending the definition of single-serving containers; amending the definition of serving size for breath mints; and providing for dual-column labeling, which would provide nutrition information per serving and per container, for certain containers.

Statement of Need: The regulations for serving sizes for nutrition labeling of foods have not been amended since mandatory nutrition labeling was first required in 1993. New scientific evidence, consumption data, and consumer research has become available in the last 18 years that can be used to update the serving size information on Nutrition Facts labels to reflect the amount of food customarily consumed. This will allow consumers to use the serving size information more effectively to select foods that will promote maintenance of healthy dietary practices.

Summary of Legal Basis: FDA's legal basis derived 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, if finalized, 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 economic burden on manufacturers.

Anticipated Cost and Benefits: If finalized, 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. Much of the information currently provided on the Nutrition Facts labels is based on old reference values and scientific information. The proposed changes would provide more current information to assist consumers in constructing a healthful diet.

Risks: If serving size information on the Nutrition Facts label is not updated, reference amounts customarily consumed that serve as the basis for serving sizes will continue to be based on old consumption data. Proposed updates to the serving size listed on the Nutrition Facts label will be based 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
NPRM12/00/13

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal, State.

Federalism: This action may have federalism implications as defined in EO 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: 202 402-1450, Fax: 301 436-1191, Email: cherisa.henderson@fda.hhs.gov.

RIN: 0910-AF23

HHS—FDA

51. Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

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

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 331; 21 U.S.C. 342; 21 U.S.C. 350c; 21 U.S.C. 350d note; 21 U.S.C. 350g; 21 U.S.C. 350g note; 21 U.S.C. 371; 21 U.S.C. 374; 42 U.S.C. 264; 42 U.S.C. 243; 42 U.S.C. 271; * * *

CFR Citation: 21 CFR 507.

Legal Deadline: NPRM, Statutory, October 2011, Final Rule to publish 9 months after close of comment period.

The legal deadline for FDA under the Food Safety Modernization Act to promulgate proposed regulations is October 2011 for certain requirements, with a final rule to publish 9 months after the close of the comment period. The Food Safety Modernization Act mandates that FDA promulgate final regulations for certain other provisions by July 2012. Finally, the FDA Amendments Act of 2007 directs FDA to publish final regulations for a subset of the proposed requirements by September 2009.

Abstract: FDA is proposing regulations for preventive controls for animal food, including ingredients and mixed animal feed. This action is intended to provide greater assurance that food marketed for all animals, including pets, is safe.

Statement of Need: Regulatory oversight of the animal food industry has traditionally been limited and focused on a few known safety issues, so there could be potential human and animal health problems that remain unaddressed. The massive pet food recall due to adulteration of pet food with melamine and cyanuric acid in 2007 is a prime example. The actions taken by two protein suppliers in China affected a large number of pet food suppliers in the United States and created a nationwide problem. By the time the cause of the problem was identified, melamine- and cyanuric acid-contaminated ingredients resulted in the adulteration of millions of individual servings of pet food. Congress passed FSMA, which the President signed into law on January 4, 2011 (Pub. L. 111-353). Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 418 (21 U.S.C. 350g) Hazard Analysis and Risk Based Preventive Controls. In enacting FSMA, Congress sought to improve the safety of food in the United States by taking a risk-based approach to food safety, emphasizing prevention. Section 418 of the FD&C Act requires owners, operators, or agents in charge of food facilities to develop and implement a written plan that describes and documents how their facility will implement the hazard analysis and preventive controls required by this section.

Summary of Legal Basis: FDA's authority for issuing this rule is provided in FSMA (Pub. L. 111-353), Start Printed Page 959which amended the FD&C Act by establishing section 418, which directed FDA to publish implementing regulations. FSMA also amended section 301 of the FD&C Act to add 301(uu) that states the operation of a facility that manufactures, processes, packs, or holds food for sale in the United States, if the owner, operator, or agent in charge of such facility is not in compliance with section 418 of the FD&C Act, is a prohibited act.

FDA is also issuing this rule under the certain provisions of section 402 of the FD&C Act (21 U.S.C. 342) regarding adulterated food.

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.

To the extent the regulations are related to communicable disease, FDA's legal authority also derives from sections 311, 361, and 368 of the Public Health Services Act (42 U.S.C. 243, 264 and 271). Finally, FDA is acting under the direction of section 1002(a) of title X of FDAAA of 2007 (21 U.S.C. 2102) which requires the Secretary to establish processing standards for pet food.

Alternatives: The Food Safety Modernization Act requires this rulemaking.

Anticipated Cost and Benefits: The benefits of the proposed rule would result from fewer cases of contaminated animal food ingredients or finished animal food products. Discovering contaminated food ingredients before they are used in a finished product would reduce the number of recalls of contaminated animal food products. Benefits would include reduced medical treatment costs for animals, reduced loss of market value of live animals, reduced loss of animal companionship, and reduced loss in value of animal food products. More stringent requirements for animal food manufacturing would maintain public confidence in the safety of animal foods and protect animal and human health. FDA lacks sufficient data to quantify the benefits of the proposed rule.

The compliance costs of the proposed rule would result from the additional labor and capital required to perform the hazard analyses, write and implement the preventive controls, monitor and verify the preventive controls, take corrective actions if preventive controls fail to prevent feeds from becoming contaminated, and implement requirements from the operations and practices section.

Risks: FDA is proposing this rule to provide greater assurance that food intended for animals is safe and will not cause illness or injury to animals. This rule would implement a risk-based, preventive controls food safety system intended to prevent animal food containing hazards, which may cause illness or injury to animals or humans, from entering into the food supply. The rule would apply to domestic and imported animal food (including raw materials and ingredients). Fewer cases of animal food contamination would reduce the risk of serious illness and death to animals.

Timetable:

ActionDateFR Cite
NPRM10/29/1378 FR 64736
NPRM Comment Period End02/26/14

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: Kim Young, Deputy Director, Division of Compliance, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, Room 106 (MPN-4, HFV-230), 7519 Standish Place, Rockville, MD 20855, Phone: 240 276-9207, Email: kim.young@fda.hhs.gov.

RIN: 0910-AG10

HHS—FDA

52. “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 proposed rule would deem 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 Family Smoking Prevention and Tobacco Control Act (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 Food Drug & Cosmetic Act (FD&C Act). This regulation is necessary to afford FDA the authority to regulate these products which include hookah, electronic cigarettes, cigars, pipe tobacco, other novel tobacco products, and future tobacco products.

Summary of Legal Basis: This should include a description of the legal basis for the action and whether any aspect of the action is required by statute or court order (section 4(c)(I)(C) of EO 12866).

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 be appropriate for the protection of the public health.

Alternatives: This should describe, to the extent possible, the alternatives the agency has considered or will consider for analysis (section 4(c)(1)(B) of EO 12866). Special consideration should be given to flexible approaches that “reduce burdens” and maintain “freedom of choice for the public” (section 4 of EO 13563).

In addition to the benefits and costs of the proposed rule, FDA has estimated the benefits and costs of several alternatives to the proposed rule: 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: This should include “preliminary estimates of the anticipated costs and benefits” of the regulatory action (section 4(c)(1)(B) of E.O. 12866). Under E.O. 13563, agencies must “use the best available Start Printed Page 960techniques to quantify anticipated present and future benefits and costs as accurately as possible.” Consistent with previous guidance we have provided concerning the implementation of E.O. 12866, the description of costs should include both capital (upfront) costs and annual (recurring) costs. If the benefits are difficult to quantify, we encourage you, to the extent possible, to use nominal units (for example, health effects or injuries avoided) for benefits. Avoid the misclassification of transfer payments as costs or benefits. You should appropriately discount both costs and benefits. To the extent that you cannot quantify costs and benefits, you should describe them in narrative form. (The Unified Agenda format does not permit the use of a columnar format for cost and benefit information. Please provide these data using a narrative format.)

The proposed rule has two parts: one part deems all tobacco products to be subject to the FD&C Act; the other part proposes additional provisions that would apply to newly-deemed products as well as to other covered tobacco products. The proposed deeming action differs from most public health regulations in that it is an enabling regulation. In other words, in addition to directly subjecting newly-deemed “tobacco products” to the substantive requirements of Chapter IX of the FD&C Act, it enables FDA to issue further public health regulations related to such products. Thus, almost all the potential benefits and most of the costs that flow from the proposed deeming action would be realized in stages over the long term. The proposed rule would generate some immediate quantifiable benefits by dissuading smokers of small and large cigars, thereby improving health and longevity; it would impose costs in the form of registration, submission, labeling, and other requirements.

Risks: This should include, if applicable, a description of “how the magnitude of the risk addressed by the action relates to other risks within the jurisdiction of the agency” (section 4(c)(1)(D) of E.O. 12866). You should include 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 reduction effort to other risks and risk reduction efforts within the agency's jurisdiction.

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 additional restrictions that FDA seeks to promulgate for the proposed deemed products would reduce initiation and increase cessation (particularly among youth). 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
NPRM12/00/13

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: May Nelson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, 9200 Corporate Boulevard, Rockville, MD 20850, Phone: 877 287-1373, Fax: 240 276-3904, Email: may.nelson@fda.hhs.gov

RIN: 0910-AG38

HHS—FDA

53. 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)(3)

CFR Citation: 21 CFR 514.80.

Legal Deadline: None.

Abstract: Section 105 of the Animal Drug User Fee Amendments of 2008 amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that the sponsor of each antimicrobial new animal drug product submit an annual report to the Food and Drug Administration 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 additional drug distribution data collection.

Statement of Need: Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA) amended section 512 of the FD&C Act to require that the sponsor of each new animal drug product that contains an antimicrobial active ingredient submit an annual report to the Food and Drug Administration (FDA, the 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 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 proposed 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 (110 Pub. L. 316; 122 Stat. 3509) amended section 512 of the FD&C Act (21 U.S.C. 360b) to require that sponsors of 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 is necessary to address potential problems concerning the safety and effectiveness of antimicrobial new animal drugs. Less Start Printed Page 961frequent 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 a current statutory requirement. There may be a minimal additional labor cost if any other reporting requirement is proposed. 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 Cong. Rec. H7534.

Timetable:

ActionDateFR Cite
ANPRM07/27/1277 FR 44177
ANPRM Comment Period End09/25/12
ANPRM Comment Period Extended11/26/1277 FR 59156
NPRM04/00/14

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Sharon Benz, Supervisory Animal Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, MPN-4, Room 2648, HFV-220, 7529 Standish Place, Rockville, MD 20855, Phone: 240 453-6864, Email: sharon.benz@fda.hhs.gov.

RIN: 0910-AG45

HHS—FDA

54. Revision of Postmarketing Reporting Requirements Discontinuance or Interruption in Supply of Certain Products (Drug Shortages)

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

Legal Authority: Secs 506C, 506C-1, 506D, and 506F of the FDA&C Act, as amended by title X (Drug Shortages) of FDASIA, Pub. L. 112-144, July 9, 2012

CFR Citation: 21 CFR 314.81; 21 CFR 314.91.

Legal Deadline: NPRM, Statutory, January 9, 2014, Not later than 18 months after the date of enactment of FDASIA, FDA must adopt the final regulation implementing section 506C as amended.

Section 1001 of FDASIA states that not later than 18 months after the date of enactment of FDASIA, the Secretary shall adopt a final regulation implementing section 506C as amended.

Abstract: FDASIA amends the FD&C Act to require manufacturers of certain drug products to report discontinuances or interruptions in the manufacturing of these products 6 months prior to the discontinuance or interruption, or if that is not possible, as soon as practicable. Manufacturers must notify FDA of a discontinuance or interruption in the manufacture of drugs that are life-supporting, life-sustaining or intended for use in the prevention or treatment of a debilitating disease or condition. The regulation may include biological products within the notification requirements if it would benefit public health.

Statement of Need: The Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law 112-144 (July 9, 2012), amends the FD&C Act to require manufacturers of certain drug products to report to FDA discontinuances or interruptions in the production of these products that are likely to meaningfully disrupt supply 6 months prior to the discontinuance or interruption, or if that is not possible, as soon as practicable. FDASIA also amends the FD&C Act to include other provisions related to drug shortages. Drug shortages have a significant impact on patient access to critical medications and the number of drug shortages has risen steadily since 2005 to a high of 251 shortages in 2011. Notification to FDA of a shortage or an issue that may lead to a shortage is critical—FDA was able to prevent more than 100 shortages in the first three quarters of 2012 due to early notification. This rule will implement the FDASIA drug shortages provisions, allowing FDA to more quickly and efficiently respond to shortages, thereby improving patient access to critical medications and promoting public health.

Summary of Legal Basis: Sections 506C, 506C-1, 506D, 506E, and 506F of the FD&C Act, as amended by title X (Drug Shortages) of FDASIA.

Alternatives: The principal alternatives assessed were to provide guidance on voluntary notification to FDA or to continue to rely on the requirements under the current interim final rule on notification. These alternatives would not meet the statutory requirement to issue the final regulation required by title X, section 1001 of FDASIA.

Anticipated Cost and Benefits: The rule would increase the modest reporting costs associated with notifying FDA of discontinuances or interruptions in the production of certain drug products. The rule would generate benefits in the form of the value of public health gains through more rapid and effective FDA responses to potential or actual drug shortages that otherwise would limit patient access to critical medications.

Risks: Drug shortages can significantly impede patient access to critical, sometimes life-saving, medications. Drug shortages, therefore, can pose a serious risk to public health and patient safety. This rule will require early notification of potential shortages, enabling FDA to more quickly and effectively respond to potential or actual drug shortages that otherwise would limit patient access to critical medications.

Timetable:

ActionDateFR Cite
NPRM11/04/1378 FR 65904
NPRM Comment Period End01/03/14

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Agency Contact: Valerie Jensen, Department of Health and Human Services, Food and Drug Administration, White Oak, Building 22, Room 6202, 10903 New Hampshire Avenue, Silver Spring, MD 20903, Phone: 301 796-0737.

RIN: 0910-AG88

HHS—FDA

55. 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 proposed 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 Start Printed Page 962drug to reflect certain types of newly acquired information in advance of FDA's review of such change. The proposed rule would describe the process by which information regarding a “changes being effected” (CBE) labeling supplement submitted by an NDA or ANDA holder would be made publicly available during FDA's review of the labeling change. The proposed rule also would clarify requirements for the NDA holder for the reference listed drug and all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA and/or ANDA holder's CBE labeling supplement. These proposed revisions to FDA's regulations would create parity between NDA holders and ANDA holders with respect to submission of CBE labeling supplements.

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 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. Allowing ANDA holders to update product labeling through CBE supplements in the same manner as NDA holders and BLA holders may improve communication of important, newly acquired drug safety information to prescribing healthcare providers and the public.

Summary of Legal Basis: The FD&C Act (21 U.S.C. 301 et seq.) and the PHS 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 the 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 considered several alternatives that would allow certain requirements of the proposed rule to vary, such as proposing a new category of supplements for certain labeling changes being effected in 30 days.

Anticipated Cost and Benefits: The economic benefits to the public health from adoption of the proposed rule are not quantified. By allowing all application holders to update labeling based on newly acquired information that meets the criteria for a CBE supplement, communication of important drug safety information to prescribing health care providers and the public could be improved. The primary estimate of the costs of the proposed rule includes costs to ANDA and NDA holders for submitting and reviewing CBE supplements.

Risks: This proposed 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 proposed 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 End01/13/14

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, WO 51, Room 6304, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Phone: 301 796-3601, Fax: 301 847-8440, Email: janice.weiner@fda.hhs.gov.

RIN: 0910-AG94

HHS—FDA

56. Veterinary Feed Directive

Priority: Other Significant.

Legal Authority: 21 U.S.C. 354; 21 U.S.C. 360b; 21 U.S.C. 360ccc; 21 U.S.C. 360ccc-1; 21 U.S.C. 371

CFR Citation: 21 CFR 514; 21 CFR 558.

Legal Deadline: None.

Abstract: The Animal Drug Availability Act created a new category of products called veterinary feed directive drugs (VFD drugs). This rulemaking is intended to provide for the increased efficiency of the VFD program.

Statement of Need: Before 1996, two options existed for regulating the distribution of animal drugs, including drugs in animal feed: (1) over-the-counter (OTC) and (2) prescription (Rx). In 1996 the Animal Drug Availability Act (ADAA) created a new category of products called veterinary feed directive (VFD) drugs. VFD drugs are new animal drugs intended for use in or on animal feed, which are limited to use under the professional supervision of a licensed veterinarian in the course of the veterinarian's professional practice. In order for animal feed containing a VFD drug to be used in animals, a licensed veterinarian must first issue an order, called a veterinary feed directive (or VFD), providing for such use. The Food and Drug Administration (FDA, the Agency) finalized its regulation to implement the VFD-related provisions of the ADAA in December 2000.

Since that time, FDA has received informal comments that the VFD process is overly burdensome. As a result, FDA began exploring ways to improve the VFD program's efficiency. To that end, FDA published an advanced notice of proposed rulemaking on March 29, 2010 (75 FR 15387), and draft text of a proposed regulation, which it published April 13, 2012 (77 FR 22247). The proposed revisions to the VFD process are also intended to support the Agency's initiative to transition certain new animal drug products containing medically important antimicrobial drugs from an OTC status to a status that requires veterinary oversight.

The proposed rule, if finalized, will make the following changes to the VFD Start Printed Page 963regulations at section 558.6 (21 CFR 558.6): 1) Reorganize the VFD regulations to make them more user-friendly. This proposal will replace the six subsections of the existing regulations with three subsections that better identify what is expected from each party involved in the VFD process; 2) Provide increased flexibility for licensed veterinarians and animal producers to align with the most recent practice standards, technological and medical advances, and practical considerations, to assure the safe and effective use of VFD drugs; 3) Provide for the continued availability through the current feed mill distribution system of those Category I drugs that move to VFD dispensing status. This will prevent potential shortages of antimicrobial drugs needed by food animal producers for judicious therapeutic uses on their farms and ranches; and 4) Lower the recordkeeping burden for all involved parties to align with other feed manufacturing recordkeeping requirements, thus eliminating the need for two separate filing systems.

Summary of Legal Basis: FDA's authority for issuing this rule is provided in the ADAA (Pub. L. 104-250), which amended the Federal Food, Drug, & Cosmetic Act (FD&C Act) by establishing section 504.

Alternatives: An alternative to the proposed rule that would ease the burden on VFD drug manufacturers would be to allow additional time to comply with the proposed labeling requirements for currently approved VFD drugs, for example, 1 or more years after the final rule becomes effective. This would not affect any new VFD drug approvals after the effective date of the final rule, and it could provide a transition period for current VFD manufacturers to coordinate the labeling changes to the specimen labeling, representative labeling, the VFD form itself, and advertising within the usual frequency of label changes.

Anticipated Cost and Benefits: The estimated one-time costs to industry from this proposed rule, if finalized, are the costs to review the rule and prepare a compliance plan. In addition FDA estimates that the government will incur costs associated with reviewing the VFD drug labeling supplements that are expected to be submitted by VFD drug manufacturers. The expected benefit of this proposal is a general improvement in the efficiency of the VFD process. Additionally, the reduction in veterinarian labor costs due to this rule is expected to result in an annual cost savings.

Risks: As FDA begins to implement the judicious use principles for medically important antimicrobial drugs based on the framework set forth in Guidance for Industry #209, which published April 13, 2012, it is critical that the Agency makes the VFD program as efficient as possible for stakeholders while maintaining adequate protection for human and animal health. The provisions included in this proposed rule are based on stakeholder input received in response to multiple opportunities for public comment, and represent FDA's best effort to strike the appropriate balance between protection of human and animal health and programmatic efficiency.

Timetable:

ActionDateFR Cite
ANPRM03/29/1075 FR 15387
ANPRM Comment Period End06/28/10
NPRM11/00/13

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Sharon Benz, Supervisory Animal Scientist, Department of Health and Human Services, Food and Drug Administration, Center for Veterinary Medicine, MPN-4, Room 2648, HFV-220, 7529 Standish Place, Rockville, MD 20855, Phone: 240 453-6864. Email: sharon.benz@fda.hhs.gov.

RIN: 0910-AG95

HHS—FDA

Final Rule Stage

57. Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines

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

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

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: FDA published a proposed rule to establish requirements for nutrition labeling of certain food items sold in certain vending machines. FDA also proposed the terms and conditions for vending machine operators registering to voluntarily be subject to the requirements. FDA is issuing a final rule, and taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act.

Statement of Need: This rulemaking was mandated by section 4205 of the Patient Protection and Affordable Care Act (Affordable Care Act).

Summary of Legal Basis: On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other things, creating new clause (H) to require that vending machine operators, who own or operate 20 or more machines, disclose calories for certain food items. FDA has the authority to issue this rule under sections 403(q)(5)(H) and 701(a) of the FD&C Act (21 U.S.C. 343(q)(5)(H), and 371(a)). Section 701(a) of the FD&C Act vests the Secretary of Health and Human Services, and, by delegation, the Food and Drug Administration (FDA) with the authority to issue regulations for the efficient enforcement of the FD&C Act.

Alternatives: Section 4205 of the Affordable Care Act requires the Secretary (and by delegation, the FDA) to establish by regulation requirements for calorie labeling of articles of food sold from covered vending machines. Therefore, there are no alternatives to rulemaking. FDA has analyzed alternatives that may reduce the burden of the rulemaking, including analyzing the benefits and costs of: Restricting the flexibility of the format for calorie disclosure, lengthening the compliance time, and extending the coverage of the rule to bulk vending machines without selection buttons.

Anticipated Cost and Benefits: Any vending machine operator operating fewer than 20 machines may voluntarily choose to be covered by the national standard. It is anticipated that vending machine operators that own or operate 20 or more vending machines will bear costs associated with adding calorie information to vending machines. FDA initially estimated that the total cost of complying with section 4205 of the Affordable Care Act and this rulemaking would be approximately $25.8 million initially, with a recurring cost of approximately $24 million.

Because comprehensive national data for the effects of vending machine labeling do not exist, FDA has not quantified the benefits associated with section 4205 of the Affordable Care Act and this rulemaking. Some studies have shown that some consumers consume fewer calories when calorie content information is displayed at the point of purchase. Consumers will benefit from having this important nutrition information to assist them in making healthier choices when consuming food away from home. Given the very high costs associated with obesity and its associated health risks, FDA estimates Start Printed Page 964that if 0.02 percent of the adult obese population reduces energy intake by at least 100 calories per week, then the benefits of section 4205 of the Affordable Care Act and this rulemaking would be at least as large as the costs.

Risks: Americans now consume an estimated one-third of their total calories from foods prepared outside the home and spend almost half of their food dollars on such foods. This rule will provide consumers with information about the nutritional content of food to enable them to make healthier food choices, and may help mitigate the trend of increasing obesity in America.

Timetable:

ActionDateFR Cite
NPRM04/06/1176 FR 19238
NPRM Comment Period End07/05/11
Final Action02/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, Local, State.

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

Agency Contact: Daniel Reese, Food Technologist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-820), 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2126, Email: daniel.reese@fda.hhs.gov.

RIN: 0910-AG56

HHS—FDA

58. Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments

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: Not Yet Determined.

Legal Deadline: None.

Abstract: FDA published a proposed rule in the Federal Register to establish requirements for nutrition labeling of standard menu items in chain restaurants and similar retail food establishments. FDA also proposed the terms and conditions for restaurants and similar retail food establishments registering to voluntarily be subject to the Federal requirements. FDA is issuing a final rule, and taking this action to carry out section 4205 of the Patient Protection and Affordable Care Act.

Statement of Need: This rulemaking was mandated by section 4205 of the Patient Protection and Affordable Care Act (Affordable Care Act).

Summary of Legal Basis: On March 23, 2010, the Affordable Care Act (Pub. L. 111-148) was signed into law. Section 4205 of the Affordable Care Act amended 403(q)(5) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by, among other things, creating new clause (H) to require that certain chain restaurants and similar retail food establishments with 20 or more locations disclose certain nutrient information for standard menu items. FDA has the authority to issue this rule under sections 403(a)(1), 403(q)(5)(H), and 701(a) of the FD&C Act (21 U.S.C. 343(a)(1), 343(q)(5)(H), and 371(a)). Section 701(a) of the FD&C Act vests the Secretary of Health and Human Services, and, by delegation, the Food and Drug Administration (FDA) with the authority to issue regulations for the efficient enforcement of the FD&C Act.

Alternatives: Section 4205 of the Affordable Care Act requires the Secretary, and by delegation the FDA, to establish by regulation requirements for nutrition labeling of standard menu items for covered restaurants and similar retail food establishments. Therefore, there are no alternatives to rulemaking. FDA has analyzed alternatives that may reduce the burden of this rulemaking, including analyzing the benefits and costs of expanding and contracting the set of establishments covered by this rule and shortening or lengthening the compliance time relative to the rulemaking.

Anticipated Cost and Benefits: Chain restaurants and similar retail food establishments covered by the Federal law operating in local jurisdictions that impose different nutrition labeling requirements will benefit from having a uniform national standard. Any restaurant or similar retail food establishment with fewer than 20 locations may voluntarily choose to be covered by the national standard. It is anticipated that chain restaurants with 20 or more locations will bear costs for adding nutrition information to menus and menu boards. FDA initially estimated that the total cost of section 4205 and this rulemaking would be approximately $80 million, annualized over 10 years, with a low annualized estimate of approximately $33 million and a high annualized estimate of approximately $125 million over 10 years. These costs (which are subject to change in the final rule) included an initial cost of approximately $320 million with an annually recurring cost of $45 million.

Because comprehensive national data for the effects of menu labeling do not exist, FDA has not quantified the benefits associated with section 4205 of the Affordable Care Act and this rulemaking. Some studies have shown that some consumers consume fewer calories when menus have information about calorie content displayed. Consumers will benefit from having important nutrition information for the approximately 30 percent of calories consumed away from home. Given the very high costs associated with obesity and its associated health risks, FDA estimates that if 0.6 percent of the adult obese population reduces energy intake by at least 100 calories per week, then the benefits of section 4205 of the Affordable Care Act and this rule will be at least as large as the costs.

Risks: Americans now consume an estimated one-third of their total calories on foods prepared outside the home and spend almost half of their food dollars on such foods. Unlike packaged foods that are labeled with nutrition information, foods in restaurants, for the most part, do not have nutrition information that is readily available when ordered. Dietary intake data have shown that obese Americans consume over 100 calories per meal more when eating food away from home rather than food at home. This rule will provide consumers information about the nutritional content of food to enable them to make healthier food choices and may help mitigate the trend of increasing obesity in America.

Timetable:

ActionDateFR Cite
NPRM04/06/1176 FR 19192
NPRM Comment Period End07/05/11
Final Action02/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, Local, State.

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

Agency Contact: Daniel Reese, Food Technologist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-820), 5100 Start Printed Page 965Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-2126, Email: daniel.reese@fda.hhs.gov.

RIN: 0910-AG57

HHS—CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)

Proposed Rule Stage

59. Fire Safety Requirements for Certain Health Care Facilities (CMS-3277-P)

Priority: Other Significant.

Legal Authority: 42 U.S.C. 1302; 42 U.S.C. 1395

CFR Citation: 42 CFR 403; 42 CFR 416; 42 CFR 418; 42 CFR 460; 42 CFR 482; 42 CFR 483; 42 CFR 485.

Legal Deadline: None.

Abstract: This proposed rule would amend the fire safety standards for hospitals; critical access hospital long-term care facilities; intermediate care facilities for the intellectually disabled; ambulatory surgery centers hospices, which provide in-patient services; religious non-medical health care institutions; and programs of all-inclusive care for the elderly facilities. Further, this proposed rule would adopt the 2012 edition of the Life Safety Code and eliminate references in our regulations to all earlier editions.

Statement of Need: By adopting the 2012 editions of the Life Safety Code (NFPA 101) and the Health Care Facilities Code (NFPA 99) we will bring CMS standards up-to-date with the most recent requirements. Currently, Medicare and Medicaid facilities are following the 2000 NFPA 101 Life Safety Code standards, and CMS regulations do not require compliance with NFPA 99.

Summary of Legal Basis: The rule would amend certain provisions of the Social Security Act in order to adopt fire safety standards for hospitals, critical access hospitals, long-term care facilities, intermediate care facilities for individuals with intellectual disabilities, ambulatory surgery centers, hospices which provide inpatient services, religious non-medical health care institutions, and programs of all-inclusive care for the elderly facilities.

Alternatives: None. A rule is needed to update requirements for Medicare and Medicaid facilities.

Anticipated Cost and Benefits: We estimate that the effect of this rule will not be economically significant and the cost for facilities to implement this rule will be minimal.

Risks: None. We expect the health care, fire safety, and building safety communities will support this rule.

Timetable:

ActionDateFR Cite
NPRM01/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Additional Information: Includes Retrospective Review under EO 13563.

Agency Contact: Kristin Shifflett, Health Insurance Specialist Clinical Standard Group, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, Mail Stop S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4133, Email: kristin.shifflett@cms.hhs.gov.

RIN: 0938-AR72

HHS—CMS

60. Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS): Special Payment Rules (CMS-6012-P)

Priority: Other Significant.

Legal Authority: 42 U.S.C. 1395m(h)(1); Pub. L. 106-554 (BIPA), sec 427

CFR Citation: 42 CFR 424.

Legal Deadline: None.

Abstract: This proposed rule would specify the qualification standards and the type of prosthetic and orthotic devices billable to the Medicare program. It also proposes the accreditation deadline for the entities billing orthotics and prosthetics and identifies the DMEPOS product categories exempt from accreditation requirements.

Statement of Need: CMS believes it is the intent of the Congress to strengthen DMEPOS supplier standards in order to protect beneficiaries and ensure the integrity of the Medicare program. Historically, there has been no Medicare requirement that a supplier of prosthetics and custom fabricated orthotics be certified or meet educational requirements other than what a state law may require. This proposed rule would provide a basis to improve the quality of orthotics and prosthetics furnished to Medicare beneficiaries by establishing minimum national supplier and practitioner qualifications and accreditation requirements for DMEPOS suppliers.

Summary of Legal Basis: Section 1834(h) of the Social Security Act (the Act) establishes the payment rules for orthotics and prosthetics that are described in section 1861(s)(9) of the Act and in our regulations.

Alternatives: None. A rule is necessary to implement the proposed provisions.

Anticipated Cost and Benefits: This proposed rule is expected to provide savings for the Medicare program by establishing stringent safeguards that would protect the Medicare Trust Fund. It would also provide a basis to improve the provision and the quality of prosthetics and custom fabricated orthotics to Medicare beneficiaries by establishing that DMEPOS suppliers have the qualifications, specialized education, training, licensure, and certification.

Risks: Not publishing this proposed rule puts Medicare beneficiaries at risk. Beneficiaries would be best served by establishing safeguards that would provide a basis to improve the provision of quality prosthetics and custom fabricated orthotics to Medicare beneficiaries by establishing practitioner qualifications and accreditation requirements for DMEPOS suppliers.

Timetable:

ActionDateFR Cite
NPRM05/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Agency Contact: Sandra Bastinelli, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3630, Email: sandra bastinelli@cms.hhs.gov.

RIN: 0938-AR84

HHS—CMS

61. • Eligibility, Enrollment, and Appeals Updates (CMS-9949-P)

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

Unfunded Mandates: Undetermined.

Legal Authority: Pub. L. 11-148 secs 1301 to 1304; secs 1311 to 1313; secs 1321 and 1322; secs 1331 and 1332; secs 1334 and 1402

CFR Citation: 45 CFR 155; 45 CFR 156.

Legal Deadline: None.

Abstract: This proposed rule would update policy based on experience with initial open enrollment.

Statement of Need: The Affordable Care Act establishes an initial open Start Printed Page 966enrollment period beginning October 1, 2013, and annual open enrollment periods in subsequent years. CMS expects that updates or revisions to existing policy may be necessary based on our experience with the initial open enrollment. These updates would be implemented before the second open enrollment period begins.

Summary of Legal Basis: This rule would address updates to provisions included in Title I of the Affordable Care Act.

Alternatives: None. Revisions made to the existing Exchange regulations would require rulemaking.

Anticipated Cost and Benefits: An estimate of costs or benefits will be completed once the necessary policy updates have been determined.

Risks: If this rule is not published, the Exchanges may not continue to function optimally.

Timetable:

ActionDateFR Cite
NPRM02/00/14

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, State.

Federalism: Undetermined.

Agency Contact: Manasse Spencer, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-1642, Email: spencer.manasse@cms.hhs.gov.

RIN: 0938-AS02

HHS—CMS

62. • Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (CMS-1607-P)

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

Unfunded Mandates: Undetermined.

Legal Authority: Sec. 1886(d) of the Social Security Act

CFR Citation: Not Yet Determined.

Legal Deadline: NPRM, Statutory, April 1, 2014. Final, Statutory, August 1, 2014.

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 proposed rule would implement changes arising from our continuing experience with these systems.

Statement of Need: 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 2015 IPPS and LTCHs at least 60 days before October 1, 2014.

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, 2014.

Alternatives: None. This implements a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for FY 2015.

Risks: If this regulation is not published timely, inpatient hospital and LTCH services will not be paid appropriately beginning October 1, 2014.

Timetable:

ActionDateFR Cite
NPRM04/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

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

Agency Contact: Roechel Kujawa, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-9111, Email: roechel.kujawa@cms.hhs.gov.

RIN: 0938-AS11

HHS—CMS

63. • CY 2015 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS-1612-P)

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

Unfunded Mandates: Undetermined.

Legal Authority: Social Security Act, secs 1102, 1871 and 1848

CFR Citation: Not Yet Determined.

Legal Deadline: Final, Statutory, November 1, 2014.

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, 2015.

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, 2014, and an implementation date of January 1, 2015.

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 a deadline of no later than November 1 for publication of the final rule or final physician fee schedule.

Alternatives: None. This implements a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for CY 2015.

Risks: If this regulation is not published timely, physician services will not be paid appropriately, beginning January 1, 2015.

Timetable:

ActionDateFR Cite
NPRM06/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Kathy Bryant, Deputy Director, Division of Practitioner Start Printed Page 967Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Mail Stop C4-01-27, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-3448, Email: kathy.bryant@cms.hhs.gov.

RIN: 0938-AS12

HHS—CMS

64. • CY 2015 Hospital Outpatient Prospective Payment System (PPS) Policy Changes and Payment Rates, and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS-1613-P)

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

Unfunded Mandates: Undetermined.

Legal Authority: sec 1833 of the Social Security Act

CFR Citation: Not Yet Determined.

Legal Deadline: Final, Statutory, November 1, 2014.

Abstract: This annual proposed rule would revise the Medicare hospital outpatient prospective payment system (PPS) to implement statutory requirements and changes arising from our continuing experience with this system. The proposed rule describes changes to the amounts and factors used to determine payment rates for services. In addition, the rule proposes changes to 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 Centers (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 2015 OPPS and ASC payment system at least 60 days before January 1, 2015.

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 system, 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, 2015.

Alternatives: None. This is a statutory requirement.

Anticipated Cost and Benefits: Total expenditures will be adjusted for CY 2015.

Risks: If this regulation is not published timely, outpatient hospital and ASC services will not be paid appropriately beginning January 1, 2015.

Timetable:

ActionDateFR Cite
NPRM06/00/14

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Federalism: Undetermined.

Agency Contact: Marjorie Baldo, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare Management, Mail Stop C4-03-06, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-4617, Email: marjorie.baldo@cms.hhs.gov.

RIN: 0938-AS15

HHS—CMS

Final Rule Stage

65. CLIA Programs And HIPAA Privacy Rule; Patients' Access to Test Reports (CMS-2319-F)

Priority: Other Significant.

Legal Authority: 42 U.S.C. 263a

CFR Citation: 42 CFR 493; 45 CFR 164.

Legal Deadline: None.

Abstract: This CMS-CDC-OCR rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to specify that, upon a patient's request, the laboratory may provide access to completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. Subject to conforming amendments, the rule retains the existing provisions that provide for release of test reports to authorized persons and, if applicable, the individuals (or their personal representative) responsible for using the test reports and, in the case of reference laboratories, the laboratory that initially requested the test. In addition, this rule also amends the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals the right to receive their test reports directly from laboratories by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information.

Statement of Need: The current CLIA regulations and related laws of the states and territories pose potential barriers to the laboratory exchange of test reports directly with the patient. This rule implements changes that support of the Secretary's efforts of achieving patient-centered and health IT-enabled health care and allow patients direct access to their test reports from a laboratory

Summary of Legal Basis: The final rule removes the exceptions to an individual's right of access related to CLIA and CLIA-exempt laboratories. HIPAA-covered laboratories will be required to provide an individual (or the individual's personal representative) with access, upon request, to the individual's completed test reports (and other information maintained in a designated record set) in accordance with the provisions of section 164.524 of the Privacy regulations.

Alternatives: Several alternatives were considered before selecting the approach in this final rule to provide access to laboratory test reports upon a patient's request. One alternative would have been to leave the regulations as written without making any changes. However, this option would leave in place the restrictions on patients' direct access to their laboratory test results and would therefore impede the goal of promoting patient-centered health care. Another alternative would have been to revise the definition of “authorized person” under CLIA to specifically include a patient as an authorized person. This alternative was not considered feasible because the definition of “authorized person” in the CLIA regulations also permits individuals to order tests, and it defers to state law for authorization. A last alternative considered would have been to require the laboratory to automatically provide each test report directly to each patient rather than the permissive approach to provide patients access to their reports upon request. However, this alternative would have Start Printed Page 968had the potential of significantly increasing the cost for laboratories since 100 percent of the 350 million to 703 million test reports issued annually would need to be provided to the patients.

Anticipated Cost and Benefits: We estimate that this rule will not have an economically significant impact on laboratories. It will facilitate the ability of patients to compare test results over time and to share this information with future physicians or multiple physicians. This improved information sharing is likely to improve health care, especially for patients and providers who do not have access to electronic health records in the near term.

Risks: None. This rule will allow laboratories to use existing processes for patient access or develop new procedures that are appropriate for their facility. It expands an individual's right of access to include receiving test reports directly from laboratories. This rule does not alter the role of the ordering or treating provider in reporting and explaining test results to patients.

Timetable:

ActionDateFR Cite
NPRM09/14/1176 FR 56712
NPRM Comment Period End11/14/11
Final Action11/00/13

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: State.

Additional Information: Includes Retrospective Review under EO 13563.

Agency Contact: Judith Yost, Director, Division of Laboratory Services, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244-1850, Phone: 410 786-3531, Email: judith.yost@cms.hhs.gov.

RIN: 0938-AQ38

HHS—ADMINISTRATION FOR CHILDREN AND FAMILIES (ACF)

Final Rule Stage

66. Head Start Eligibility Determination

Priority: Other Significant.

Legal Authority: 42 U.S.C. 9801 et seq.

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: This rule would amend Head Start program regulations to clarify and strengthen procedures for determining eligibility for Head Start program enrollment, including procedures to document and verify such eligibility. The intent is to reduce the risk of providing Head Start services to persons who are ineligible for those services.

Statement of Need: This final rule will amend Head Start program regulations to clarify and strengthen procedures for determining eligibility for Head Start program enrollment, including procedures to document and verify such eligibility. The intent is to reduce the risk of providing Head Start services to persons who are ineligible for those services. The final rule directly responds to the findings of an investigation by the Government Accountability Office (GAO) that the Head Start program is at risk of having over-income children enrolled while legitimate under-income and categorically eligible children are put on wait lists.

Summary of Legal Basis: This final rule is published under the authority granted to the Secretary of Health and Human Services by section 644(c) of the Head Start Act, as amended by the Improving Head Start for School Readiness Act of 2007, as well as sections 645(a)(1)(A) and 645A(c) of the Act.

Alternatives: Upon learning of GAO's investigation findings, the Administration for Children and Families (ACF) immediately took numerous actions within our statutory and regulatory authority to respond to GAO's findings and to bolster program integrity efforts across the Head Start and Early Head Start programs; prevent future fraud and mismanagement; and ensure that every slot is reserved for an eligible child. For example, ACF issued a Program Instruction on May 10, 2010, entitled, ”Income Eligibility for Enrollment” (ACF-PI-HS-10-01), which reminds grantees of their legal obligations to verify the eligibility of each child served and determine eligibility in accordance with the Head Start statute and regulations, as well as the serious consequences for falsifying eligibility determinations. However, we believe GAO's findings necessitate the implementation of new enrollment procedures, as contained in this final regulation, in order to reiterate and strengthen the requirements. Therefore, we are issuing this final regulation with requirements for Head Start and Early Head Start agency staff regarding verification, documentation, and certification of the information submitted by the applicants prior to determining if a pregnant woman or child is eligible for participation in a Head Start or Early Head Start program. This final regulation will ensure that taxpayer dollars are spent in conformance with the purpose and requirements of the Head Start Act and that the neediest children and families in our country benefit from the program's services.

Anticipated Cost and Benefits: There will not be a significant economic impact from this final rule. The estimated total cost of implementation of these rules for all grantees is approximately $132,188 annually.

Risks: Not applicable.

Timetable:

ActionDateFR Cite
NPRM03/18/1176 FR 14841
NPRM Comment Period End04/18/11
Final Action04/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Colleen Rathgeb, Division Director, Policy and Budget, HS, Department of Health and Human Services, Administration for Children and Families, 1250 Maryland Avenue SW., Washington, DC 20024, Phone: 202 205-7378, Email: colleen.rathgeb@acf.hhs.gov.

RIN: 0970-AC46

HHS—ACF

67. Child Care and Development Fund Reforms To Support Child Development and Working Families

Priority: Other Significant.

Legal Authority: Sec. 658E and other provisions of the Child Care and Development Block Grant Act of 1990, as amended

CFR Citation: 45 CFR 98.

Legal Deadline: None.

Abstract: This rule would provide the first comprehensive update of Child Care and Development Fund (CCDF) regulations since 1998. It would make changes in four key areas: (1) Improving health and safety; (2) improving the quality of child care; (3) establishing family-friendly policies; and (4) strengthening program integrity. The rule seeks to retain much of the flexibility afforded to States, territories, and tribes consistent with the nature of a block grant.

Statement of Need: The CCDF program has far-reaching implications for America's poorest children. It provides child care assistance to 1.6 Start Printed Page 969million children from nearly 1 million low-income working families and families who are attending school or job training. Half of the children served are living at or below poverty level. In addition, children who receive CCDF are cared for alongside children who do not receive CCDF, by approximately 570,000 participating child care providers, some of whom lack basic assurances needed to ensure children are safe, healthy, and learning. Since 1996, a body of research has demonstrated the importance of the early years on brain development and has shown that high-quality, consistent child care can positively impact later success in school and life. This is especially true for low-income children who face a school readiness and achievement gap and can benefit the most from high-quality early learning environments. In light of this research, many States, territories, and tribes, working collaboratively with the Federal Government, have taken important steps over the last 15 years to make the CCDF program more child-focused and family-friendly; however, implementation of these evidence-informed practices is uneven across the country and critical gaps remain. This regulatory action is needed in order to increase accountability in the CCDF program by ensuring that all children receiving federally funded child care assistance are in safe, quality programs that both support their parent's labor market participation, and help children develop the tools and skills they need to reach their full potential. A major focus of this final rule is to raise the bar on quality by establishing a floor of health and safety standards for child care paid for with Federal funds. National surveys have demonstrated that most parents logically assume that their child care providers have had a background check, have had training in child health and safety, and are regularly monitored. However, State policies surrounding the training and oversight of child care providers vary widely. In some States, many children receiving CCDF subsidies are cared for by providers that have little to no oversight with respect to compliance with basic standards designed to safeguard children's well-being, such as first-aid and safe sleep practices. This can leave children in unsafe conditions, even as their care is being funded with public dollars. In addition, the final rule empowers all parents who choose child care, regardless of whether they receive a Federal subsidy, with better information to make the best choices for their children. This includes providing parents with information about the quality of child care providers and making information about providers' compliance with health and safety regulations more transparent so that parents can be aware of the safety track record of providers when it's time to choose child care.

Summary of Legal Basis: This final regulation is being issued under the authority granted to the Secretary of Health and Human Services by the CCDBG Act (42 U.S.C. 9858 et seq.) and section 418 of the Social Security Act (42 U.S.C. 618).

Alternatives: The Administration for Children and Families considered a range of approaches to improve early childhood care and education, including administrative and regulatory action. ACF has taken administrative actions to recommend that States adopt stronger health and safety requirements and provided technical assistance to States. Despite these efforts to assist States in making voluntary reforms, unacceptable health and safety lapses remain. An alternative to this rule would be to take no regulatory action or to limit the nature of the required standards and the degree to which those standards are prescriptive. ACF believes this rulemaking is the preferable alternative to ensure children's health and safety and promote their learning and development.

Anticipated Cost and Benefits: Changes in this final rule directly benefit children and parents who use CCDF assistance to pay for child care. The 1.6 million children who are in child care funded by CCDF would have stronger protections for their health and safety, which addresses every parent's paramount concern. All children in the care of a participating CCDF provider will be safer because that provider is more knowledgeable about health and safety issues. In addition, the families of the 12 million children who are served in child care will benefit from having clear, accessible information about the safety compliance records and quality indicators of providers available to them as they make critical choices about where their children will be cared for while they work. Provisions also will benefit child care providers by encouraging States to invest in high quality child care providers and professional development and to take into account quality when they determine child care payment rates. A primary reason for revising the CCDF regulations is to better reflect current State and local practices to improve the quality of child care. Therefore, there are a significant number of States, territories, and tribes that have already implemented many of these policies. The cost of implementing the changes in this final rule will vary depending on a State's specific situation. ACF does not believe the costs of this final regulatory action would be economically significant and that the tremendous benefits to low-income children justify costs associated with this final rule.

Risks: Not applicable.

Timetable:

ActionDateFR Cite
NPRM05/20/1378 FR 29422
NPRM Comment Period End08/05/13
Final Action06/00/14

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: State, Tribal.

Agency Contact: Andrew Williams, Policy Division Director, Department of Health and Human Services, Administration for Children and Families, Office of Child Care, 370 L'Enfant Promenade SW., Washington, DC 20447, Phone: 202 401-4795, Fax: 202 690-5600, Email: andrew.williams@acf.hhs.gov.

RIN: 0970-AC53

DEPARTMENT OF HOMELAND SECURITY (DHS)

Fall 2013 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. Secur e and Manage Our Borders,

3. Enforce and Administer our Immigration Laws,

4. Safeguard and Secure Cyberspace,

5. Ensur e Resilience to Disasters, and

6. Mature and Strengthen DHS.

In achieving these goals, we are continually strengthening our partnerships with communities, first Start Printed Page 970responders, 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 2013 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 2008 (9/11 Act), Public Law 110-53 (Aug. 3, 2007); Public Law 109-295 (Oct. 4, 2006); the Consolidated Natural Resources Act of 2008 (CNRA), Public Law No. 110-220 (May 7, 2008); the Security and Accountability for Every Port Act of 2006 (SAFE Port Act), Public Law 109-347 (Oct. 13, 2006); the Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009, Public Law 110-329 (Sep. 30, 2008), and the Sandy Recovery Improvement Act (SRIA), Public Law 113-2 (Jan. 29, 2013).

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
1615-AB92Employment Authorization for Certain H-4 Spouses.
1615-AB95Immigration Benefits Business Transformation: Nonimmigrants; Student and Exchange Visitor Program.
1625-AA16Implementation of the 1995 Amendments to the International Convention on Standards of Training, Certification, and Watchkeeping (STCW) for Seafarers, 1978.
1625-AB38Update to Maritime Security.
1625-AB80Revision to Transportation Worker Identification Credential (TWIC) Requirements for Mariners.
1625-XXXXInland Waterways Navigation Regulations.
1651-AA96Definition of Form I-94 to Include Electronic Format.
1651-AA94Internet Publication of Administrative Seizure/Forfeiture Notices.
1651-XXXXPassenger List/Crew List I-418.
1652-AA43Modification of the Aviation Security Infrastructure Fee (ASIF) (Market Share).
1652-AA61Standardized Vetting, Adjudication, and Redress Services.
1653-AA44Amendment to Accommodate Process Changes with SEVIS II Implementation.
1660-AA75Debris Removal: Eligibility of Force Account Labor Straight-Time Costs Under the Public Assistance Program for Hurricane Sandy.
1660-AA77Change in Submission Requirements for State Mitigation Plans.

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.

RINRule
1625-AB38Updates to Maritime Security.
1651-AA70Importer Security Filing and Additional Carrier Requirements.