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Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2018

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AGENCY:

Regulatory Information Service Center.

ACTION:

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

SUMMARY:

Publication of the Unified Agenda of Regulatory and Deregulatory Actions and the Regulatory Plan represent key components of the regulatory planning mechanism prescribed in Executive Order 12866, “Regulatory Planning and Review,” Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs,” January 30, 2017, and Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” February 24, 2017. The fall editions of the Unified Agenda include the agency regulatory plans required by E.O. 12866, which identify regulatory priorities and provide additional detail about the most important significant regulatory actions that agencies expect to take in the coming year.

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

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

The fall 2018 Unified Agenda publication appearing in the Federal Register includes the Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act.

The complete fall 2018 Unified Agenda contains the Regulatory Plans of 28 Federal agencies and 66 Federal agency regulatory agendas.

ADDRESSES:

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

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FOR FURTHER INFORMATION CONTACT:

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

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

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SUPPLEMENTARY INFORMATION:

Table of Contents

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

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

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

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

IV. What information appears for each entry?

V. Abbreviations

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

Introduction to the Fall 2018 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 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

Committee for Purchase From People Who Are Blind or Severely Disabled

Environmental Protection Agency

General Services Administration

National Aeronautics and Space Administration

Railroad Retirement Board

Small Business Administration

Joint Authority

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

Independent Regulatory Agencies

Commodity Futures Trading Commission

Consumer Financial Protection Bureau

Consumer Product Safety Commission

Federal Communications Commission

Federal Reserve System

National Labor Relations Board

Nuclear Regulatory Commission

Securities and Exchange Commission

Surface Transportation Board

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 2018 Regulatory Plan

Agency Regulatory Plans

Cabinet Departments

Department of Agriculture

Department of Commerce

Department of Defense

Department of EducationStart Printed Page 57805

Department of Energy

Department of Health and Human Services

Department of Homeland Security

Department of Housing and Urban Development

Department of Interior

Department of Justice

Department of Labor

Department of Transportation

Department of Treasury

Department of Veterans Affairs

Other Executive Agencies

Environmental Protection Agency

Equal Employment Opportunity Commission

General Services Administration

National Aeronautics and Space Administration

National Archives and Records Administration

Office of Personnel Management

Pension Benefit Guaranty Corporation

Small Business Administration

Social Security Administration

Federal Acquisition Regulation

Independent Regulatory Agencies

Consumer Product Safety Commission

Federal Trade Commission

National Indian Gaming Commission

Nuclear Regulatory Commission

Agency Regulatory Flexibility Agendas

Cabinet Departments

Department of Agriculture

Department of Commerce

Department of Energy

Department of Health and Human Services

Department of Homeland Security

Department of Interior

Department of Justice

Department of Labor

Department of Transportation

Department of Treasury

Other Executive Agencies

Architectural and Transportation Barriers Compliance Board

Committee for Purchase From the People Who Are Blind or Severely Disabled

Environmental Protection Agency

General Services Administration

National Aeronautics and Space Administration

Railroad Retirement Board

Small Business Administration

Federal Acquisition Regulation

Independent Agencies

Commodity Futures Trading Commission

Consumer Financial Protection Bureau

Consumer Product Safety Commission

Federal Communication Commission

Federal Reserve System

National Labor Relations Board

Nuclear Regulatory Commission

Securities and Exchange Commission

Surface Transportation Board

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

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

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

The Unified Agenda provides information about regulations that the Government is considering or reviewing. The Unified Agenda has appeared in the Federal Register twice each year since 1983 and has been available online since 1995. The complete Unified Agenda is available to the public at http://www.reginfo.gov. The online Unified Agenda offers flexible search tools and access to the historic Unified Agenda database to 1995. The complete online edition of the Unified Agenda includes regulatory agendas from 65 Federal agencies. Agencies of the United States Congress are not included.

The fall 2018 Unified Agenda publication appearing in the Federal Register consists of The Regulatory Plan and agency regulatory flexibility agendas, in accordance with the publication requirements of the Regulatory Flexibility Act. Agency regulatory flexibility agendas contain only those Agenda entries for rules that are likely to have a significant economic impact on a substantial number of small entities and entries that have been selected for periodic review under section 610 of the Regulatory Flexibility Act. Printed entries display only the fields required by the Regulatory Flexibility Act. Complete agenda information for those entries appears, in a uniform format, in the online Unified Agenda at http://www.reginfo.gov.

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

Cabinet Departments

Department of Defense *

Department of Education *

Department of Housing and Urban Development *

Department of State

Department of Veterans Affairs *

Other Executive Agencies

Agency for International Development

American Battle Monuments Commission

Commission on Civil Rights

Corporation for National and Community Service

Council on Environmental Quality

Court Services and Offender Supervision Agency for the District of Columbia

Equal Employment Opportunity Commission *

Federal Mediation Conciliation Service

Institute of Museum and Library Services

National Archives and Records Administration *

National Endowment for the Arts

National Endowment for the Humanities

National Mediation Board

Office of Government Ethics

Office of Management and Budget

Office of Personnel Management *

Peace Corps

Pension Benefit Guaranty Corporation *

Presidio Trust

Social Security Administration *

Tennessee Valley Authority

Independent Agencies

Council of the Inspectors General on Integrity and Efficiency

Farm Credit Administration

Federal Deposit Insurance Corporation

Federal Energy Regulatory Commission

Federal Housing Finance Agency

Federal Maritime Commission

Federal Trade Commission *

National Commission on Military, National, and Public Service

National Credit Union Administration

National Indian Gaming Commission *

National Transportation Safety Board

Postal Regulatory Commission

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

The activities included in the Agenda are, in general, those that will have a regulatory action within the next 12 months. Agencies may choose to include activities that will have a longer timeframe than 12 months. Agency agendas also show actions or reviews completed or withdrawn since the last Start Printed Page 57806Unified Agenda. Executive Order 12866 does not require agencies to include regulations concerning military or foreign affairs functions or regulations related to agency organization, management, or personnel matters.

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

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

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

Regulatory Flexibility Act

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

Executive Order 12866

Executive Order 12866, “Regulatory Planning and Review,” 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 13771

Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs,” January 30, 2017 (82 FR 9339) requires each agency to identify for elimination two prior regulations for every one new regulation issued, and the cost of planned regulations be prudently managed and controlled through a budgeting process.

Executive Order 13777

Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” February 24, 2017 (82 FR 12285) requires each agency to designate an agency official as its Regulatory Reform Officer (RRO). Each RRO shall oversee the implementation of regulatory reform initiatives and policies to ensure that agencies effectively carry out regulatory reforms, consistent with applicable law. The Executive Order also directs that each agency designate a regulatory Reform Task Force.

Executive Order 13563

Executive Order 13563, “Improving Regulation and Regulatory Review,” January 18, 2011 (76 FR 3821) supplements and reaffirms the principles, structures, and definitions governing contemporary regulatory review that were established in Executive Order 12866, which includes the general principles of regulation and public participation, and orders integration and innovation in coordination across agencies; flexible approaches where relevant, feasible, and consistent with regulatory approaches; scientific integrity in any scientific or technological information and processes used to support the agencies' regulatory actions; and retrospective analysis of existing regulations.

Executive Order 13132

Executive Order 13132, “Federalism,” 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 non-statutory unfunded substantial direct compliance costs on State and local governments, must consult with State and local officials early in the process of developing the regulation. In addition, the agency must provide to the Director of the Office of Management and Budget a federalism summary impact statement for such a regulation, which consists of a description of the extent of the agency's prior consultation with State and local officials, a summary of their concerns and the agency's position supporting the need to issue the regulation, and a statement of the extent to which those concerns have been met. As part of this effort, agencies include in their submissions for the Unified Agenda information on whether their regulatory actions may have an effect on the various levels of government and whether those actions have federalism implications.

Unfunded Mandates Reform Act of 1995

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

Executive Order 13211

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 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 Start Printed Page 57807 Federal Register. The Act specifies that a rule is “major” if it has resulted, or is likely to result, in an annual effect on the economy of $100 million or more or meets other criteria specified in that Act. The Act provides that the Administrator of OIRA will make the final determination as to whether a rule is major.

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

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

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

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

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

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

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

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

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

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

Long-Term Actions are rulemakings reported during the publication cycle that are outside of the required 12-month reporting period for which the Agenda was intended. Completed Actions in the publication cycle are rulemakings that are ending their lifecycle either by Withdrawal or completion of the rulemaking process. Therefore, the Long-Term and Completed RINs do not represent the ongoing, forward-looking nature intended for reporting developing rulemakings in the Agenda pursuant to Executive Order 12866, section 4(b) and 4(c). To further differentiate these two 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 Agenda have the flexibility to search for entries with any combination of desired characteristics. The online edition retains the Unified Agenda's subject index based on the Federal Register Thesaurus of Indexing Terms. In addition, online users have the option of searching Agenda text fields for words or phrases.

IV. What information appears for each entry?

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

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

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

(1) Economically Significant

As defined in Executive Order 12866, a rulemaking action that will have an annual effect on the economy of $100 million or more or will adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, Start Printed Page 57808public 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 12/00/19 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 2017.

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

Some agencies have provided the following optional information:

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

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

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

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

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

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

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

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

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

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

Anticipated Costs and Benefits—a description of preliminary estimates of the anticipated costs and benefits of the action.Start Printed Page 57809

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

V. Abbreviations

The following abbreviations appear throughout this publication:

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

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

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

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

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

  • NPRM—A Notice of Proposed Rulemaking is the document an agency issues and publishes in the Federal Register that describes and solicits public comments on a proposed regulatory action. Under the Administrative Procedure Act (5 U.S.C. 553), an NPRM must include, at a minimum: A statement of the time, place, and nature of the public rulemaking proceeding;
  • A reference to the legal authority under which the rule is proposed; and Either the terms or substance of the proposed rule or a description of the subjects and issues involved.

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, Public Law 112-4 is the fourth public law of the 112th Congress.

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

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

Seq. No.—The sequence number identifies the location of an entry in the printed edition of the Regulatory Plan and the Unified Agenda. Note that a specific regulatory action will have the same RIN throughout its development but will generally have different sequence numbers if it appears in 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 Plan and the Agenda?

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

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

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

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

Start Signature

Dated: October 15, 2018.

John C. Thomas,

Executive Director.

End Signature

Introduction to the Fall 2018 Regulatory Plan

Regulatory reform is a cornerstone of President Trump's agenda for economic growth. This Plan reaffirms the principles of individual liberty and limited government essential to reform. It also highlights the success of ongoing efforts, initiatives for improving accountability, and the promotion of good regulatory practices.

Across the Trump Administration, real regulatory reform is underway. As the agency examples throughout the Plan demonstrate, the benefits of a more rational regulatory system are felt far and wide and create opportunities for economic growth and development. Farmers can more productively use their land. Small businesses can hire more workers and provide more affordable healthcare. Innovators will be able to pursue advances in autonomous vehicles, drones, and commercial space exploration. Veterans enjoy expanded access to doctors through a telehealth program. Infrastructure can be improved more quickly with streamlined permitting requirements. These reforms and many others make life better for all Americans through lower consumer prices, more jobs, and, in the long run, improvements in well-being that result from the advance of innovative new products and services.

Private choices of individuals and businesses should generally prevail in a free society. Yet in modern times, the expansion of the administrative state has placed undue burdens on the public, impeding economic growth, technological innovation, and consumer choice. This Administration has spearheaded an unprecedented effort to Start Printed Page 57810restore appropriate checks on the regulatory state, ensuring that agencies act within the boundaries of the law and in a manner that yields the greatest benefits to the American people while imposing the fewest burdens. Our policies focus on restoring political accountability and protecting the constitutional values of due process and fair notice. Government should respect the private decisions of individuals and businesses unless a compelling need can be shown for intervention, a longstanding principle affirmed in Executive Order 12866 (“Regulatory Planning and Review,” September 30, 1993). We approach regulation with humility, trusting Americans to direct their energy and capital productively and to reap the benefits that result from a free exchange of goods and ideas.

The Administration's regulatory agenda involves structural reforms as well as the practical work of eliminating and revising regulations. Agencies continue to advance the health and safety mandates that Congress has entrusted to them and to revamp vital programs to increase their effectiveness. At the same time, agencies are revising or rescinding regulations that fail to address real-world problems, that are needlessly burdensome, and that prevent Americans from advancing innovative solutions. Our reform efforts emphasize the rule of law, respect for the Constitution's separation of powers, and the limits of agency authority.

Reducing Regulatory Burdens

At the outset, President Trump set forth a general mandate for regulatory reform across the Administration. Consistent with legal obligations, Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs,” January 30, 2017) directs a two-fold approach to reform: It requires that agencies eliminate two regulations for each new significant regulation and also requires that agencies offset any new regulatory costs. By requiring a reduction in the number of regulations, the order incentivizes agencies to identify regulations and guidance documents that do not provide sufficient benefits to the public. Agencies have reduced or eliminated unnecessary requirements large and small. For the first time in decades, Federal agencies have decreased new regulatory costs, while continuing to pursue important regulatory priorities.

Agencies have achieved historic and meaningful regulatory reform in the first two years.

  • For fiscal year 2018, agencies achieved $23 billion in net regulatory cost savings across the government.
  • Agencies issued 176 deregulatory actions (57 of which are significant deregulatory actions) and 14 significant regulatory actions.
  • These results expand and build upon the success of the Administration's first year, for a total regulatory cost reduction of $33 billion.

In addition to these impressive results, the agencies project $18 billion in regulatory cost savings for 2019. In addition, the “Safer Affordable Fuel-Efficient Vehicles Rule” revises the greenhouse gas standards and Corporate Average Fuel Economy standards for passenger cars and light trucks. The Department of Transportation and the Environmental Protection Agency have proposed a range of options that are projected to save between $120 and $340 billion in regulatory costs and anticipate completion of the rule in fiscal year 2019. The momentum for reform continues to accelerate as agencies complete substantial deregulatory actions.

Promoting the Rule of Law: Political Accountability, Guidance Documents, and Respecting Congress' Lawmaking Power

The Administration's regulatory reform is committed to the rule of law, understood as respect for the constitutional structure as well as the specific laws enacted by Congress. The Constitution establishes a relatively simple framework for regulation. Congress is vested with limited and enumerated legislative powers, which it may use to set regulatory policy and establish the authority of agencies to issue regulations. The President is vested with the executive power, which includes overseeing and directing administration of the laws. Within the framework and directions established by Congress, political accountability for regulatory policy depends on presidential responsibility and control. As Alexander Hamilton explained, “Energy in the executive is a leading character of good government. It is essential to the protection of the community against foreign attacks: It is not less essential to the steady administration of the laws.” The Federalist No. 70.

The annual Regulatory Plan has provided a longstanding form of presidential accountability for the regulatory policy of federal agencies as well as for the specific regulatory actions planned for the forthcoming year. Through the process of reviewing the Plan and Unified Agenda of Regulatory and Deregulatory Actions, OIRA helps agencies to direct administrative action consistent with presidential priorities. Agency heads explain their priorities through the narrative of the Regulatory Plan and list specific deregulatory and regulatory actions expected to be completed in the coming year. This process provides an important gatekeeping role to ensure agencies pursue only those actions consistent with law and that have the support of the heads of agencies and ultimately the President. Likewise, review of draft regulatory actions through Executive Order 12866 advances good regulatory policy consistent with legal requirements, sound analysis, and presidential priorities.

Faithful execution of the laws also includes respect for the lawmaking power of Congress. Although Congress often confers substantial discretion on agencies, OIRA works with agencies to limit expansive interpretations of executive authority and to regulate within the boundaries of the law. Carefully examining statutory authority and keeping agencies within the limits set by Congress protects against executive agencies exercising the legislative power. OIRA also works with agencies to ensure compliance with the Administrative Procedure Act. The requirements of public notice and opportunity for comment bolster the legitimacy of agency action and can provide refinements that improve the ultimate policy chosen by an agency.

Moreover, OIRA is looking closely at existing statutory requirements for limiting administrative excess across federal agencies, including within the historically independent agencies. Under the Paperwork Reduction Act, all federal agencies must comply with specific requirements before collecting information from the public. OIRA plays an important role in reviewing forms that collect information, verifying that they have practical utility and are as minimally burdensome as possible. Reduction of paperwork burdens plays an important role in eliminating unnecessary, duplicative, or conflicting regulatory requirements.

The Administration's commitment to the rule of law finds expression in other initiatives, such as restoring the proper use of guidance documents. While guidance documents may provide needed clarification of existing legal obligations, they have sometimes been stretched to impose new obligations. OIRA and the White House Counsel's Office have repeatedly affirmed the importance of due process and fair notice in regulatory policy and worked closely with agencies to prevent the misuse of guidance documents. Agencies should not surprise the public Start Printed Page 57811with new requirements through an informal memo, speech, or blog post. When agencies impose new regulatory obligations, they must follow the appropriate administrative procedures.

Through the review process for significant guidance documents, OIRA has identified proposed agency guidance that should be undertaken only through notice and comment rulemaking. Some agencies have withdrawn expansive guidance from the previous administration and are replacing it with rulemaking, rather than simply a revised guidance document. Rulemaking undoubtedly requires more agency time and resources; however, it also provides fair notice and allows input from the public, which ultimately results in more lawful and predictable regulatory policy.

Other agencies are also taking important steps. The Department of Justice clarified that guidance documents would not be used for enforcement purposes. Several agencies subsequently followed this principle, including a group of historically independent financial regulatory agencies. Other agencies are in the process of revising their guidance policies to promote greater accountability in the development, promulgation, and access to guidance documents.

Ensuring the proper use of guidance documents; eliminating outdated or stale guidance; requiring internal checks that enhance accountability for guidance; and providing greater transparency and online access to guidance documents are steps forward in promoting sound regulatory policy across the federal government. OIRA will continue to work with agencies to improve and refine their guidance practices.

Good Regulatory Practices: Transparency, Coordination, and Analysis

Regulatory reform in the Trump Administration includes the promotion and expansion of longstanding good regulatory practices such as transparency, coordination, and cost-benefit analysis. These practices improve regulatory outcomes irrespective of the policy preferences of an agency or administration.

Transparency in the regulatory process provides one of the most important checks on administrative agencies by allowing the public to have notice of regulatory actions and opportunities for comment in the administrative process. This Administration has taken specific steps to improve transparency.

For example, OIRA collaborates with agencies to make the Unified Agenda of Regulatory and Deregulatory Actions a more accurate reflection of what agencies plan to pursue in the coming year. Agencies must make every effort to include actions they plan to pursue, because if an item is not on the Agenda, under Executive Order 13771, an agency cannot move forward unless it obtains a waiver or the action is required by law. A clear and accurate Agenda helps avoid unfair surprise and achieves greater predictability of upcoming actions.

This Administration has also published the so-called “Inactive List,” a list of regulations contemplated by agencies, but previously not made public in the Agenda. Agencies continue to review these lists and remove actions they no longer plan to pursue. Publication of the list promotes agency accountability for all regulatory actions under consideration and a more accurate picture of regulations in the pipeline.

Furthermore, in the process of implementing the historic reforms of Executive Order 13771, OIRA published detailed information about the cost allowances, cost savings, and specific actions counted as regulatory and deregulatory. OIRA issued early guidance on how the Executive Order would be implemented. Drawing from the successful experience of similar deregulatory programs in the United Kingdom and Canada, the guidance explained that even small deregulatory actions would be counted in order to incentivize agencies to eliminate unnecessary regulatory burdens of all sizes. This transparency allows the public to understand the accounting methodology and the choices made to encourage the greatest possible reform efforts from the agencies.

Coordination is an important component of the OIRA regulatory review process. Coordination facilitates consistent application of presidential priorities, legal interpretation, and regulatory policy across different agencies. Centralized review allows the Administration to advance broader principles, such as concern for the rule of law, due process, and fair notice, as well as to reduce regulatory costs across the board.

Through the review process, agencies and senior officials within the Executive Office of the President have an opportunity to comment on draft regulations. These reviewers flag policy concerns or problems of duplication, inconsistency, and inefficiency. Such coordination allows for careful consideration of competing priorities and how they should be balanced across the Executive Branch. The review process also allows for coordination in other contexts, such as when one agency's rule implicates the programs or legal authorities of another. Interagency review can ameliorate problems arising from overlapping statutory mandates. Review can also strengthen the legal foundation and the supporting analysis of rules—bolstering their effectiveness and also their ability to survive legal challenge.

The historically independent agencies sometimes participate in the review process when a regulation raises issues that implicate their jurisdiction. Because these agencies are not generally subject to other White House coordination mechanisms, the review process provides an opportunity to ensure greater consistency across all agencies within the Executive Branch.

Finally, cost-benefit analysis must justify the need for regulation. As Executive Order 12866 recognizes, private choices of individuals and businesses are the baseline in the American system of government. To warrant departure from this baseline, regulatory actions must be consistent with statutory authority and should have benefits that substantially exceed costs.

Careful analysis that accurately captures both the benefits and costs of regulation is essential to achieving good regulatory policy. Consideration of alternatives and an assessment of their costs and benefits serves an important function by providing transparency for regulatory decisions and information that can inform public comment on the impact of regulatory alternatives before a rule is finalized. While anticipating and quantifying the costs and benefits of regulations pose challenges in some contexts, OIRA will continue to work closely with agencies to improve their analyses.

One of the practical consequences of Executive Order 13771 is that agencies have a new and meaningful incentive to engage in retrospective review of regulations, which President Obama called for in Executive Order 13563 (“Improving Regulation and Regulatory Review,” January 18, 2011). When issuing a rule, an agency can only predict the costs and benefits. Periodically reviewing the actual costs and benefits of regulations allows agencies to modify rules for greater effectiveness or to repeal rules that are unnecessary or counterproductive.Start Printed Page 57812

Review of Tax Regulations Under Executive Order 12866

Administration-wide regulatory reform efforts have been coupled with targeted reforms in specific high-burden areas. For example, the President issued Executive Order 13789 (“Identifying and Reducing Tax Regulatory Burdens,” April 21, 2017), directing the Department of the Treasury to identify and reduce tax regulatory burdens because America's “Federal tax system should be simple, fair, efficient, and pro-growth.” In addition to other measures, the President called for a review of whether tax regulations should go through the centralized OIRA regulatory review process. Tax regulations were previously exempt from this process, in part contributing to the problem of burdensome, complicated, and inefficient tax regulatory policy identified by Executive Order 13789.

After conducting this review, the Office of Management and Budget and the Department of the Treasury signed a Memorandum of Agreement (MOA), “Review of Tax Regulations under Executive Order 12866” (April 11, 2018). The MOA recognizes the importance of presidential oversight and accountability, particularly where tax regulations reflect the exercise of discretion, raise important legal or policy questions, or impose substantial costs on the public. Tax regulations uniquely impact all Americans and have significant consequences for investment, economic growth, and innovation. The OIRA review process provides an important check to ensure that tax regulations are consistent with the President's priorities for a “simple, fair, efficient, and pro-growth” tax system.

The historic reforms enacted in the Tax Cuts and Jobs Act (TCJA) require Treasury to issue a number of regulations. The MOA provides for the possibility of expedited review of TCJA regulations in order to provide timely guidance and information to the public. Over the past few months, Treasury and OIRA have worked closely together to improve tax regulations, ensuring that regulations are consistent with law, demonstrate benefits that exceed the costs, and impose the fewest possible burdens on the public. The review process encourages greater transparency of the impacts of the regulation, highlighting where the agency exercises discretion and the anticipated burdens placed on the public, including paperwork and other compliance burdens. When Treasury provides this information in a proposed rule, the public has a more informed basis from which to comment on the rule and share information about the consequences of particular regulatory choices. Moreover, the review process facilitates coordination with other agencies to avoid conflict with other administration priorities.

The improvement of tax regulations demonstrates a specific success in the Administration's regulatory reform agenda. It also reaffirms the value of the OIRA centralized review process for promoting presidential priorities and good regulatory practices such as transparency, coordination, and robust cost-benefit analysis.

Conclusion

Consistent with its longstanding commitment to the principles of good regulatory policy, OIRA works closely with agencies to advance regulatory policy that is consistent with law and the President's priorities and yields substantial net benefits for the public. The first two years of the Administration have produced unparalleled reform, and we project even more significant results in the coming year.

Start Signature

Neomi Rao,

Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget

End Signature

Department of Agriculture

Sequence No.TitleRegulation Identifier No.Rulemaking stage
1NOP; Strengthening Organic Enforcement0581-AD09Proposed Rule Stage.
2National Bioengineered Food Disclosure Standard0581-AD54Final Rule Stage.
3Animal Welfare; Amendments to Licensing Provisions and to Requirements for Dogs0579-AE35Proposed Rule Stage.
4Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms0579-AE47Proposed Rule Stage.
5Supplemental Nutrition Assistance Program: Requirements for Able-Bodied Adults Without Dependents0584-AE57Proposed Rule Stage.
6Providing Regulatory Flexibility for Retailers in the Supplemental Nutrition Assistance Program (SNAP)0584-AE61Proposed Rule Stage.
7Revision of Categorical Eligibility in the Supplemental Nutrition Assistance Program (SNAP)0584-AE62Proposed Rule Stage.
8Reform Provisions for the Supplemental Nutrition Assistance Program's Quality Control System0584-AE64Proposed Rule Stage.
9Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements0584-AE53Final Rule Stage.
10Egg Products Inspection Regulations0583-AC58Final Rule Stage.
11Modernization of Swine Slaughter Inspection0583-AD62Final Rule Stage.
12Update and Clarification of the Locatable Minerals Regulations0596-AD32Prerule Stage.
13Oil and Gas Resource Revision0596-AD33Prerule Stage.
14Servicing Regulation for the Rural Utilities Service (RUS) Telecommunications Programs0572-AC41Final Rule Stage.
15oneRD Guaranteed Loan Regulation0572-AC43Final Rule Stage.
Start Printed Page 57813

Department of Commerce

Sequence No.TitleRegulation Identifier No.Rulemaking stage
16Revisions to the Export Administration Regulations: Control of Firearms and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List0694-AF47Final Rule Stage.
17Magnuson-Stevens Act; Fishery Management Councils; Financial Disclosure and Recusal0648-BH73Proposed Rule Stage.
18Magnuson-Stevens Fisheries Conservation and Management Act; Traceability Information Program for Seafood0648-BH87Proposed Rule Stage.
19Taking and Importing Marine Mammals: Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico0648-BB38Final Rule Stage.
20Commerce Trusted Trader Program0648-BG51Final Rule Stage.
21Setting and Adjusting Patent Fees0651-AD31Proposed Rule Stage.

Department of Defense

Sequence No.TitleRegulation Identifier No.Rulemaking stage
22Contractor Purchasing System Review Threshold (DFARS Case 2017-D038)0750-AJ48Proposed Rule Stage.
23Brand Name or Equal (DFARS Case 2017-D040)0750-AJ50Proposed Rule Stage.
24Submission of Summary Subcontract Report (DFARS Case 2017-D005)0750-AJ42Final Rule Stage.
25Regulatory Program of the Army Corps of Engineers Tribal Consultation and National Historic Preservation Act compliance0710-AA75Prerule Stage.
26Natural Disaster Procedures: Preparedness, Response, and Recovery Activities of the Corps of Engineers0710-AA78Proposed Rule Stage.
27Definition of “Waters of the United States”0710-AA80Proposed Rule Stage.
28Compensatory Mitigation for Losses of Aquatic Resources—Review and Approval of Mitigation Banks and In-Lieu Fee Programs0710-AA83Proposed Rule Stage.
29Modification of Nationwide Permits0710-AA84Proposed Rule Stage.
30Policy for Domestic, Municipal, and Industrial Water Supply Uses of Reservoir Projects Operated by the Department of the Army, U.S. Army Corps of Engineers0710-AA72Final Rule Stage.
31Establishment of TRICARE Select and Other TRICARE Reforms0720-AB70Final Rule Stage.

Department of Education

Sequence No.TitleRegulation Identifier No.Rulemaking stage
32Nondiscrimination on the Basis of Sex in Education Programs or Activities Receiving Federal Financial Assistance1870-AA14Proposed Rule Stage.
33State Authorization and Related Issues1840-AD36Proposed Rule Stage.
34Accreditation and Related Issues1840-AD37Proposed Rule Stage.
35Ensuring Student Access to High Quality and Innovative Postsecondary Educational Programs1840-AD38Proposed Rule Stage.
36Eligibility of Faith-Based Entities and Activities-Title IV Programs1840-AD40Proposed Rule Stage.
37TEACH Grants1840-AD44Proposed Rule Stage.
38Institutional Accountability1840-AD26Final Rule Stage.
39Program Integrity; Gainful Employment1840-AD31Final Rule Stage.

Department of Energy

Sequence No.TitleRegulation Identifier No.Rulemaking stage
40Energy Conservation Standards for Residential Conventional Cooking Products1904-AD15Proposed Rule Stage.
41Procedures, Interpretations, and Policies for Consideration of New or Revised Energy Conservation Standards for Consumer Products1904-AD38Proposed Rule Stage.
42Energy Conservation Program: Definition for General Service Lamps1904-AE26Proposed Rule Stage.

Department of Health and Human Services

Sequence No.TitleRegulation Identifier No.Rulemaking stage
43HIPAA Privacy: Request for Information on Changes to Support, and Remove Barriers to, Coordinated Care0945-AA00Prerule Stage.
44HIPAA Privacy Rule: Presumption of Good Faith of Health Care Providers0945-AA09Proposed Rule Stage.
45Protecting Statutory Conscience Rights in Health Care; Delegations of Authority0945-AA10Final Rule Stage.
Start Printed Page 57814
46Revising Outdated Requirements for Opioid Treatment Providers (OTPS)0930-AA27Proposed Rule Stage.
47Coordinating Care and Information Sharing in the Treatment of Substance Use Disorders0930-AA32Proposed Rule Stage.
48Food Standards: General Principles and Food Standards Modernization (Reopening of Comment Period)0910-AC54Proposed Rule Stage.
49Mammography Quality Standards Act; Amendments to Part 900 Regulations0910-AH04Proposed Rule Stage.
50Medical Device De Novo Classification Process0910-AH53Proposed Rule Stage.
51Nonprescription Drug Product With an Additional Condition for Nonprescription Use0910-AH62Proposed Rule Stage.
52Format and Content of Reports Intended to Demonstrate Substantial Equivalence0910-AH89Proposed Rule Stage.
53Nutrient Content Claims, Definition of Term: Healthy0910-AI13Proposed Rule Stage.
54Compliance With Statutory Program Integrity Requirements0937-AA07Final Rule Stage.
55Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction (CMS-3347-P)0938-AT36Proposed Rule Stage.
56CY 2020 Notice of Benefit and Payment Parameters (CMS-9926-P)0938-AT37Proposed Rule Stage.
57Exchange Program Integrity (CMS-9922-P)0938-AT53Proposed Rule Stage.
58Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2020 (CMS-4185-P)0938-AT59Proposed Rule Stage.
59Modernizing and Clarifying the Physician Self-Referral Regulations (CMS-1720-P)0938-AT64Proposed Rule Stage.
60Adoption and Foster Care Analysis and Reporting System0970-AC72Proposed Rule Stage.

Department of Homeland Security

Sequence No.TitleRegulation Identifier No.Rulemaking stage
61EB-5 Immigrant Investor Program Realignment1615-AC26Prerule Stage.
62Inadmissibility on Public Charge Grounds1615-AA22Proposed Rule Stage.
63Registration Requirement for Petitioners Seeking To File H-1B Petitions on Behalf of Cap Subject Aliens1615-AB71Proposed Rule Stage.
64EB-5 Immigrant Investor Regional Center Program1615-AC11Proposed Rule Stage.
65Strengthening the H-1B Nonimmigrant Visa Classification Program1615-AC13Proposed Rule Stage.
66U.S. Citizenship and Immigration Services Biometrics Collection for Consistent, Efficient, and Effective Operations1615-AC14Proposed Rule Stage.
67Removing H-4 Dependent Spouses from the Class of Aliens Eligible for Employment Authorization1615-AC15Proposed Rule Stage.
68Electronic Processing of Immigration Benefit Requests1615-AC20Proposed Rule Stage.
69Updating Adjustment of Status Procedures for More Efficient Processing and Immigrant Visa Usage1615-AC22Proposed Rule Stage.
70Improvements to the Medical Certification for Disability Exceptions Processing1615-AC23Proposed Rule Stage.
71Credible Fear Reform1615-AC24Proposed Rule Stage.
72Employment Authorization Documents for Asylum Applicants1615-AC27Proposed Rule Stage.
73EB-5 Immigrant Investor Program Modernization1615-AC07Final Rule Stage.
74Removal of Certain International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as Amended (STCW) Training Requirements1625-AC48Proposed Rule Stage.
75TWIC Reader Requirements; Delay of Effective Date1625-AC47Final Rule Stage.
76Collection of Biometric Data From Aliens Upon Entry To and Exit From the United States1651-AB12Final Rule Stage.
77Implementation of the Electronic System for Travel Authorization (ESTA) at U.S. Land Borders—Automation of CBP Form I-94W1651-AB14Final Rule Stage.
78Vetting of Certain Surface Transportation Employees1652-AA69Proposed Rule Stage.
79Amending Vetting Requirements for Employees With Access to a Security Identification Display Area (SIDA)1652-AA70Proposed Rule Stage.
80Protection of Sensitive Security Information1652-AA08Final Rule Stage.
81Flight Training for Aliens and Other Designated Individuals; Security Awareness Training for Flight School Employees1652-AA35Final Rule Stage.
82Security Training for Surface Transportation Employees1652-AA55Final Rule Stage.
83Apprehension, Processing, Care and Custody of Alien Minors and Unaccompanied Alien Children1653-AA75Proposed Rule Stage.
84Establishing a Maximum Period of Authorized Stay for F-1 and Other Nonimmigrants1653-AA78Proposed Rule Stage.
85Adjusting Program Fees for the Student and Exchange Visitor Program1653-AA74Final Rule Stage.
86Factors Considered When Evaluating a Governor's Request for Individual Assistance for a Major Disaster1660-AA83Final Rule Stage.
87Update to FEMA's Regulations on Rulemaking Procedures1660-AA91Final Rule Stage.
Start Printed Page 57815

Department of Housing and Urban Development

Sequence No.TitleRegulation Identifier No.Rulemaking stage
88Enhancing and Streamlining the Implementation of “Section 3” Requirements for Creating Economic Opportunities for Low- and Very Low-Income Persons and Eligible Businesses2501-AD87Proposed Rule Stage.
89Project Approval for Single Family Condominium (FR-5715)2502-AJ30Final Rule Stage.
90Affirmatively Furthering Fair Housing Streamlining and Enhancement (FR-6123)2529-AA97Prerule Stage.

Department of the Interior

Sequence No.TitleRegulation Identifier No.Rulemaking stage.
91Revisions to the Requirements for Exploratory Drilling on the Arctic Outer Continental Shelf1082-AA01Proposed Rule Stage

Department of Justice

Sequence No.TitleRegulation Identifier No.Rulemaking stage
92Bump-Stock-Type Devices1140-AA52Final Rule Stage.
93Implementation of the Provision of the Comprehensive Addiction and Recovery Act of 2016 Relating to the Partial Filling of Prescriptions for Schedule II Controlled Substances1117-AB45Proposed Rule Stage.
94Procedures for Asylum1125-AA87Proposed Rule Stage.

Department of Labor

Sequence No.TitleRegulation Identifier No.Rulemaking stage
95Defining and Delimiting the Exemptions for Executive, Administrative, Professional, Outside Sales and Computer Employees1235-AA20Proposed Rule Stage.
96Regular and Basic Rates Under the Fair Labor Standards Act1235-AA24Proposed Rule Stage.
97Joint Employment Under the Fair Labor Standards Act1235-AA26Proposed Rule Stage.
98Labor Certification Process for Temporary Agricultural Employment in the United States (H-2A workers)1205-AB89Proposed Rule Stage.
99Health Reimbursement Arrangements and Other Account-Based Group Health Plans1210-AB87Proposed Rule Stage.
100Definition of an “Employer” Under Section 3(5) of ERISA—Association Retirement Plans and Other Multiple Employer Plans1210-AB88Proposed Rule Stage.
101Standards Improvement Project IV1218-AC67Final Rule Stage.
102Tracking of Workplace Injuries and Illnesses1218-AD17Final Rule Stage.
103Occupational Exposure to Beryllium and Beryllium Compounds in Construction and Shipyard Sectors1218-AD21Final Rule Stage.

Department of Transportation

Sequence No.TitleRegulation Identifier No.Rulemaking stage
104Processing Buy America Waivers Based on Non availability2105-AE79Proposed Rule Stage.
105Registration and Marking Requirements for Small Unmanned Aircraft2120-AK82Final Rule Stage.
106Removing Regulatory Barriers for Automated Driving Systems2127-AM00Prerule Stage.
107The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks2127-AL76Proposed Rule Stage.
108Passenger Equipment Safety Standards Amendments2130-AC46Final Rule Stage.
109Pipeline Safety: Class Location Requirements2137-AF29Prerule Stage.
110Hazardous Materials: Enhanced Safety Provisions for Lithium Batteries Transported by Aircraft2137-AF20Proposed Rule Stage.
111Pipeline Safety: Safety of Hazardous Liquid Pipelines2137-AE66Final Rule Stage.
112Pipeline Safety: Safety of Gas Transmission Pipelines, MAOP Reconfirmation, Expansion of Assessment Requirements and Other Related Amendments2137-AE72Final Rule Stage.
113Hazardous Materials: Oil Spill Response Plans and Information Sharing for High-Hazard Flammable Trains (FAST Act)2137-AF08Final Rule Stage.
Start Printed Page 57816

Department of Veterans Affairs

Sequence No.TitleRegulation Identifier No.Rulemaking stage
114Veterans Community Walk-in Care2900-AQ47Proposed Rule Stage.
115Economic Growth, Regulatory Relief, and Consumer Protection Act (the Act), Public Law 115-174, 132 Stat. 12962900-AQ42Final Rule Stage.
116Veterans Health Administration Benefits Claims, Appeals, and Due Process2900-AQ44Final Rule Stage.
117Veterans Care Agreements2900-AQ45Final Rule Stage.
118Veterans Community Care Program2900-AQ46Final Rule Stage.

Environmental Protection Agency

Sequence No.TitleRegulation Identifier No.Rulemaking stage
119Reclassification of Major Sources as Area Sources Under Section 112 of the Clean Air Act2060-AM75Proposed Rule Stage.
120Emission Guidelines for Greenhouse Gas Emissions From Existing Electric Utility Generating Units; Revisions to Emission Guideline Implementing Regulations; Revisions to New Source Review Program2060-AT67Proposed Rule Stage.
121Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NSR): Project Emissions Accounting2060-AT89Proposed Rule Stage.
122Oil and Natural Gas Sector: Emission Standards for New, Reconstructed, and Modified Sources Review2060-AT90Proposed Rule Stage.
123Mercury and Air Toxics Standards for Power Plants Residual Risk and Technology Review and Cost Review2060-AT99Proposed Rule Stage.
124The Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule for Model Years 2021-2026 Passenger Cars and Light Trucks2060-AU09Proposed Rule Stage.
125Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h)2070-AK34Proposed Rule Stage.
126Pesticides; Certification of Pesticide Applicators Rule; Reconsideration of the Minimum Age Requirements2070-AK37Proposed Rule Stage.
127Pesticides; Agricultural Worker Protection Standard; Reconsideration of Several Requirements2070-AK43Proposed Rule Stage.
128Increasing Consistency and Transparency in Considering Costs and Benefits in the Rulemaking Process2010-AA12Proposed Rule Stage.
129Hazardous and Solid Waste Management System: Disposal of Coal Combustion Residues From Electric Utilities: Amendments to the National Minimum Criteria (Phase 2)2050-AG98Proposed Rule Stage.
130National Primary Drinking Water Regulations for Lead and Copper: Regulatory Revisions2040-AF15Proposed Rule Stage.
131National Primary Drinking Water Regulations: Regulation of Perchlorate2040-AF28Proposed Rule Stage.
132Revised Definition of “Waters of the United States”2040-AF75Proposed Rule Stage.
133Effluent Limitations Guidelines and Standards for the Steam Electric Power Generating Point Source Category2040-AF77Proposed Rule Stage.
134Peak Flows Management2040-AF81Proposed Rule Stage.
135Clean Water Act Section 404(c) Regulatory Revision2040-AF88Proposed Rule Stage.
136Review of the Primary National Ambient Air Quality Standards for Sulfur Oxides2060-AT68Final Rule Stage.
137Renewable Fuel Volume Standards for 2019 and Biomass-Based Diesel (BBD) Volume for 20202060-AT93Final Rule Stage.
138Review of Dust-Lead Hazard Standards and the Definition of Lead-Based Paint2070-AJ82Final Rule Stage.
139Service Fees for the Administration of the Toxic Substances Control Act2070-AK27Final Rule Stage.
140Clean Water Act Hazardous Substances Spill Prevention2050-AG87Final Rule Stage.
141Accidental Release Prevention Requirements: Risk Management Programs Under the Clean Air Act; Reconsideration of Amendments2050-AG95Final Rule Stage.
142Hazardous and Solid Waste Management System: Disposal of Coal Combustion Residues From Electric Utilities: Amendments to the National Minimum Criteria (Phase 1, Part 2)2050-AH01Final Rule Stage.
143Definition of “Waters of the United States”—Recodification of Preexisting Rule2040-AF74Final Rule Stage.

Equal Employment Opportunity Commission

Sequence No.TitleRegulation Identifier No.Rulemaking stage
144Amendments to Regulations Under the Americans With Disabilities Act3046-AB10Proposed Rule Stage.
145Amendments to Regulations Under the Genetic Information Nondiscrimination Act of 20083046-AB11Proposed Rule Stage.
Start Printed Page 57817

General Services Administration

Sequence No.TitleRegulation Identifier No.Rulemaking stage
146General Services Administration Acquisition Regulation (GSAR); GSAR Case 2015-G506, Adoption of Construction Project Delivery Method Involving Early Industry Engagement3090-AJ64Proposed Rule Stage.
147General Services Acquisition Regulation (GSAR); GSAR Case 2016-G511, Contract Requirements for GSA Information Systems3090-AJ84Proposed Rule Stage.
148General Services Administration Acquisition Regulation (GSAR); GSAR Case 2016-G515, Cyber Incident Reporting3090-AJ85Proposed Rule Stage.
149Federal Permitting Improvement Steering Council (FPISC); FPISC Case 2018-001; Fees for Governance, Oversight, and Processing of Environmental Reviews and Authorizations3090-AJ88Proposed Rule Stage.
150GSAR Case 2008-G517, Cooperative Purchasing—Acquisition of Security and Law Enforcement Related Goods and Services (Schedule 84) by State and Local Governments Through Federal Supply Schedules3090-AI68Final Rule Stage.
151General Services Administration Acquisition Regulation (GSAR); GSAR Case 2013-G502, Federal Supply Schedule Contract Administration3090-AJ41Final Rule Stage.
152General Services Administration Acquisition Regulation (GSAR); GSAR Case 2019-G501, Ordering Procedures for Commercial e-Commerce Portals3090-AK03Final Rule Stage.

National Aeronautics and Space Administration

Sequence No.TitleRegulation Identifier No.Rulemaking stage
153Detection and Avoidance of Counterfeit Parts2700-AE38Proposed Rule Stage.

Office of Personnel Management

Sequence No.TitleRegulation Identifier No.Rulemaking stage
154Freedom of Information Act (FOIA) Regulations3206-AK53Proposed Rule Stage.
155Direct-Hire Authority for Agency Chief Information Officers3206-AN65Proposed Rule Stage.
156Administrative Law Judges3206-AN72Final Rule Stage.

Small Business Administration

Sequence No.TitleRegulation Identifier No.Rulemaking stage
157Small Business HUBZone Program and Government Contracting Programs3245-AG38Proposed Rule Stage.
158Women-Owned Small Business and Economically Disadvantaged Women-Owned Small Business—Certification3245-AG75Proposed Rule Stage.
159Implementation of the Small Business 7(a) Lending Oversight Reform Act of 20183245-AH05Proposed Rule Stage.

Social Security Administration

Sequence No.TitleRegulation Identifier No.Rulemaking stage
160Revised Medical Criteria for Evaluating Digestive Disorders, Cardiovascular Disorders, and Skin Disorders0960-AG65Proposed Rule Stage.
161Removing Inability to Communicate in English as an Education Category0960-AH86Proposed Rule Stage.
162Newer and Stronger Penalties (Conforming Changes)0960-AH91Proposed Rule Stage.
163Privacy Act Exemption: Personnel Security and Suitability Program Files0960-AH97Proposed Rule Stage.
164References to Social Security and Medicare in Electronic Communications0960-AI04Proposed Rule Stage.
165Availability of Information and Records to the Public0960-AI07Proposed Rule Stage.
166Setting the Manner for the Appearance of Parties and Witnesses at a Hearing0960-AI09Proposed Rule Stage.
167Redeterminations When There Is a Reason To Believe Fraud or Similar Fault Was Involved in an Individual's Application for Benefits0960-AI10Proposed Rule Stage.
168Hearings Held by Administrative Appeals Judges of the Appeals Council0960-AI25Proposed Rule Stage.
169Rules Regarding the Frequency and Notice of Continuing Disability Reviews0960-AI27Proposed Rule Stage.
170Privacy and Disclosure of Official Records and Information0960-AI38Proposed Rule Stage.
171Revised Medical Criteria for Evaluating Musculoskeletal Disorders (3318P)0960-AG38Final Rule Stage.
172Privacy Act Exemption: Social Security Administration Violence Evaluation and Reporting System (SSAvers)0960-AI08Final Rule Stage.
Start Printed Page 57818

Consumer Product Safety Commission

Sequence No.TitleRegulation Identifier No.Rulemaking stage
173Regulatory Options for Table Saws3041-AC31Final Rule Stage.
174Portable Generators3041-AC36Final Rule Stage.

Nuclear Regulatory Commission

Sequence No.TitleRegulation Identifier No.Rulemaking stage
175Low-Level Radioactive Waste Disposal [NRC-2011-0012]3150-AI92Proposed Rule Stage.
176Regulatory Improvements for Production and Utilization Facilities Transitioning to Decommissioning [NRC-2015-0070]3150-AJ59Proposed Rule Stage.
177Cyber Security at Fuel Cycle Facilities [NRC-2015-0179]3150-AJ64Proposed Rule Stage.
178American Society of Mechanical Engineers 2015-2017 Code Editions Incorporation by Reference [NRC-2016-0082]3150-AJ74Proposed Rule Stage.
179Approval of American Society of Mechanical Engineers Code Cases, Revision 38 [NRC-2017-0024]3150-AJ93Proposed Rule Stage.
180Revision of Fee Schedules: Fee Recovery for FY 2019 [NRC-2017-0032]3150-AJ99Proposed Rule Stage.
181Mitigation of Beyond Design Basis Events (MBDBE) [NRC-2014-0240]3150-AJ49Final Rule Stage.
182Advanced Power Reactor 1400 (APR-1400) Design Certification [NRC-2015-0224]3150-AJ67Final Rule Stage.

[FR Doc. ??-????? Filed ??-??-??; 8:45 am]

U.S. DEPARTMENT OF AGRICULTURE

Fall 2018 Statement of Regulatory Priorities

The Department of Agriculture's (USDA) ongoing regulatory reform strategy remains one of the cornerstones for creating a culture of consistent, efficient service to our customers, while reducing burdens and improving efficiency. Accordingly, USDA's fall 2018 Regulatory Agenda reflects these priorities, including those administrative efficiencies such as streamlining and one-stop shopping. Moreover, these USDA regulatory reform efforts, combined with other reform efforts, will make it easier to invest, produce, and build in rural America, which will lead to the creation of jobs and enhanced economic prosperity. To achieve results, USDA is guided by the following comprehensive set of priorities through which the Department, its employees, and external partners will work to identify and eliminate regulatory and administrative barriers and improve business processes to enhance program delivery and reduce burdens on program participants. These priorities include:

Regulatory Reform Task Force (RRTF): In response to Executive Order 13777—Enforcing the Regulatory Reform Agenda and Executive Order 13771—Reducing Regulation and Controlling Regulatory Costs, which set forth expectations for reducing the regulatory burden on the public, the Department has established an internal RRTF to identify outdated regulations for elimination and administrative processes for streamlining. The USDA RRTF is comprised of senior agency managers representing all the major missions of the Department. USDA is also soliciting public comments on recommended reforms through July 2019.

Organizational Reform: To ensure that USDA's programs, agencies, and offices best serve the Department's customers, USDA is implementing organizational changes that are targeted at improving customer service like seeking direct public feedback through our Tell Sonny initiative. Through these reforms, USDA is breaking down organizational barriers that have impeded the Department's ability to most effectively and efficiently support its customers across the Nation. Moreover, reforms like the consolidation of administrative functions at the mission area level eliminate inefficiencies and allow the Department to best support the needs of our customers. Through the implementation of these improvements, USDA will be better positioned to remove obstacles, and give agricultural producers every opportunity to prosper and feed a growing world population. These improvements support the accomplishment of USDA's mission to provide leadership on agriculture, food, natural resources, rural prosperity, nutrition, and related issues through fact-based, data-driven, and customer-focused decisions.

Farm Bill Implementation: Legislation covering major commodity support programs and crop insurance, trade, conservation, rural development, nutrition assistance and other programs (the Farm Bill) expires at the end of fiscal year 2018. Plans for implementation to any new or modified programs reauthorized in the new Farm Bill will be considered upon enactment and regulatory agenda priorities adjusted accordingly. USDA notes that Farm Bill implementation will allow us the opportunity to modify existing regulations while introducing program reforms to ease the burden on our customers and improve program outcomes.

Executive Order 13777—Enforcing the Regulatory Reform Agenda

Executive Order 13777 establishes a Federal policy to lower regulatory burdens on the American people by implementing and enforcing regulatory reform. The RRTF reviewed proposed, pending and existing regulations to determine the deregulatory and regulatory actions to include in the 2018 fall Regulatory Agenda. These actions were further evaluated to determine which rules should be made a priority based on the impact of their proposals and the Department's ability to finalize the action in FY 2019. Executive Order 13777 also directed the Department to seek input from entities significantly affected by Federal regulations. To satisfy this requirement, the Department published a Request for Information (RFI) in the Federal Register on July 17, 2017, seeking public input on identifying regulatory reform initiatives Start Printed Page 57819(82 FR 32649). The RFI asked the public to identify regulations, guidance documents, or any other policy documents or administrative processes that need reform, as well as ideas on how to modify, streamline, expand, or repeal such items. Through the end of June 2018, USDA had received and reviewed over 4,000 public comments on recommended reforms, including requests from stakeholders to extend the public comment period past its one-year time period. Accordingly, USDA has extended the public comment period through July 18, 2019. While comments to the notice do not bind USDA to any further actions, all submissions are reviewed and inform actions to repeal, replace, or modify existing regulations.

Executive Order 13771—Reducing Regulation and Controlling Regulatory Costs

Executive Order 13771 directs agencies to eliminate two existing regulations for every new regulation while limiting the total costs associated with an agency's regulations. Specifically, it requires a regulatory two-for-one wherein an agency must propose the elimination of two existing regulations for every new regulation it publishes. Moreover, the costs associated with the new regulation must be completely offset by cost savings brought about by deregulation.

The Department's 2018 fall Regulatory Agenda reflects the Department's commitment to regulatory reform and continues USDA's rigorous implementation of Executive Order 13771. The Regulatory Agenda identifies 72 rules, of which 34 rules are not subject to the offsetting or deregulatory requirements of Executive Order 13771. Of the remaining 38 rules, 32 are deregulatory and six are regulatory. Of the 32 deregulatory actions, USDA has identified 16 final rules that will be completed in FY 2019 resulting in either a cost savings or meeting the direction that an agency issue twice as many Executive Order 13771 deregulatory actions as Executive Order 13771 regulatory actions.

USDA's 2018 fall Statement of Regulatory Priorities was developed to lower regulatory burdens on the American people by implementing and enforcing regulatory reform. These regulatory priorities will contribute to the mission of the Department, and the achievement of the long-term goals the Department aims to accomplish. Highlights of how the Department's regulatory reform efforts contribute to the accomplishment of the Department's strategic goals include the following:

The Department will promote American agricultural products and exports that benefit and grow the U.S. agricultural economy and rural America: To achieve this, USDA will expand international marketing opportunities through promotion activities, development of international standards, removal of trade barriers to U.S. exports, and negotiation of new trade agreements. USDA will also partner with developing countries to assist them with movement along the agricultural market continuum from developing economies to developed economies with promising demand potential.

Agricultural Trade Promotion Program: This action will assist U.S. agricultural industries to conduct market promotion activities that promote U.S. agricultural commodities in foreign markets, including activities that address existing or potential non-tariff barriers to trade. For more information about this rule, see RIN 0551-AA92.

The Department will ensure that programs are delivered efficiently, effectively, with integrity, and a focus on customer service: To achieve this, USDA is working to leverage the strength and talent of USDA employees with continued dedication to data-driven enterprise solutions through collaborative governance and human capital management strategies centered on accountability and professional development. USDA will reduce regulatory and administrative burdens hindering agencies from reaching the greatest number of stakeholders. Improved customer service and employee engagement within USDA will create a more effective and accessible organization for all stakeholders.

Implement the National Bioengineered Food Disclosure Standard: This action was mandated by the National Bioengineered Food Disclosure Standard (Law), which required USDA to develop a national standard and the procedures for its implementation within two years of the Law's enactment. Pursuant to the law, AMS has proposed requirements that, if finalized, will serve as a national mandatory bioengineered food disclosure standard for bioengineered food and food that may be bioengineered. The proposed rule published on May 4, 2018, and the deadline for public comment was July 3, 2018. AMS reviewed over 14,000 comments that will be analyzed and addressed in the final rule. For more information about this rule, see RIN 0581-AD54.

Improve effectiveness and efficiency of helping individuals move into work: The Food and Nutrition Act of 2008 (FNA) establishes a time limit for participation in SNAP of three months in three years for able-bodied adults without children who are not working. FNA allows states to waive the time limit under certain circumstances. The proposed action would modify SNAP requirements and services for able-bodied adults without children in response to public input provided through an advance notice of proposed rulemaking published on February 23, 2018. For more information about this rule, see RIN 0584-AE57.

Revision of categorical eligibility in the Supplemental Nutrition Assistance Program (SNAP): The Food and Nutrition Act of 2008 allows households in which all members receiving benefits under a State program funded by the Temporary Assistance for Needy Families (TANF) program are categorically eligible to participate in SNAP. States have the option of adopting a policy in which households may become categorically eligible for SNAP because they receive a non-cash or in-kind benefit or service funded by TANF. FNS will issue a proposed rule to amend the regulations pertaining to categorically eligible TANF households by limiting categorical eligibility to households that received cash TANF or other substantial assistance from TANF. For more information about this rule, see RIN 0584-AE62.

Reform provisions for the Supplemental Nutrition Assistance Program's Quality Control System: FNS will propose revisions to reform and strengthen its SNAP Quality Control system based on stakeholder input received from its June 1, 2018, request for State government and stakeholder input as to how to best proceed with reforming the SNAP Quality Control system. For more information about this rule, see RIN 0584-AE64.

Simplifying Rural Development's Guaranteed Loan Regulations Combining Rural Development Guaranteed Loan Regulations into a single regulation: Rural Development proposes to combine its four existing guaranteed loan regulations: (1) Water and Waste Disposal; (2) Community Facilities; (3) Business and Industry; and (4) Rural Energy for America, into a single regulation. The proposed action will enable Rural Development to simplify, improve, and enhance the delivery of these four guaranteed loan programs, and better manage the risks inherent with making and servicing guaranteed loans and will result in an improved customer experience for Start Printed Page 57820lenders trying to access these programs. For more information about this rule, see RIN 0572-AC43.

Servicing Regulation for the Rural Utilities Service (RUS) Telecommunications Programs: The RUS Telecommunications Programs provide loan funding to build and expand broadband service into unserved and underserved rural communities, along with limited funding to support the costs to acquire equipment to provide distance learning and telemedicine service. RUS will propose to modify the program to give RUS greater authority to address servicing actions associated with distressed loans employing only limited coordination with the Department of Justice. This will streamline and expedite servicing actions, improve the government's recovery on such loans, and improve overall customer service. For more information about this rule, see RIN 0572-AC41.

Amendments to Rural Development (RD) environmental reviews for rural infrastructure projects: USDA's RD programs provide loans, grants and loan guarantees to support investment in rural infrastructure to spur economic development, create jobs, improve the quality of life, and address the health and safety needs of rural residents. The current regulation requires that the environmental review under the National Environmental Policy Act (NEPA) be completed prior to the completion of the obligation of funds. The proposal will allow RD some flexibility with the authority to move forward with the obligation of funds conditioned upon the completion of environmental review for infrastructure projects. For more information about this rule, see RIN 0572-AC44.

Animal Welfare; Amendments to Licensing Provisions and to Requirements for Dogs: The Animal and Plant Health Inspection Service (APHIS) will issue a proposal that would amend the regulations governing the issuance and renewal of licenses under the Animal Welfare Act (AWA) to better promote sustained compliance under the AWA by (1) reducing licensing fees and (2) strengthening existing safeguards that prevent an individual whose license has been suspended or revoked, or who has a history of noncompliance, from obtaining a license or working with regulated animals. This rulemaking would also strengthen the veterinary care and watering standards for regulated dogs to better align the regulations with the humane care and treatment standards set by the Animal Welfare Act. The proposal follows an advance notice of proposed rulemaking published on August 24, 2017, that solicited comment from the public to aid in the development of these revisions. APHIS received and analyzed approximately 47,000 public comments. For more information about this rule, see RIN 0579-AE35.

The Department is making it a priority to maximize the ability of American agricultural producers to prosper by feeding and clothing the world: A strong and prosperous agricultural sector is essential to the well-being of the overall U.S. economy. America's farmers and ranchers ensure a safe and reliable food and fuel supply and support job growth and economic development. To maintain a strong agricultural economy, USDA will support farmers in starting and maintaining profitable farm and ranch businesses, as well as offer support to producers affected by natural disasters. The Department will continue to work to create new markets and support a competitive agricultural system by reducing barriers that inhibit agricultural opportunities and economic growth.

Seed Cotton Changes to Agriculture Risk Coverage (ARC) and Price Loss Coverage (PLC) Programs: This final action, as authorized by the Bipartisan Budget Act of 2018, will revise the ARC and PLC Programs to add seed cotton to the list of covered commodities and establish a loan rate for the purposes of calculating an ARC or PLC payment. For more information about this rule, see RIN 560-AI40.

Market Facilitation Program: This action will assist agricultural producers with respect to commodities, livestock, or livestock products that have been significantly impacted by actions of foreign governments resulting in the loss of traditional exports. For more information about this rule, see RIN 0560-AI42.

Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms (Part 340): APHIS is proposing to revise its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms in order to update the regulations in response to advances in genetic engineering and APHIS' understanding of the plant health risk posed by genetically engineered organisms, thereby reducing burden for regulated entities whose organisms pose no plant health risks. For more information about this rule, see RIN 0579-AE47.

National Organic Program; Strengthening Organic Enforcement: The Agricultural Marketing Service will propose changes to the USDA organic regulations to strengthen the oversight of organic products, improve enforcement of organic standards, and protect organic integrity. The proposal will address gaps in the organic standards to deter fraud, and enhance enforcement. In addition, this proposal will support consumer trust and continued industry growth. For more information about this rule, see RIN 0581-AD09.

Establishing a performance standard for authorizing the importation and interstate movement of fruits and vegetables: APHIS would broaden the existing performance standard to provide for consideration of all new fruits and vegetables for importation into the United States using a notice-based process rather than through proposed and final rules. Likewise, APHIS would propose an equivalent revision of the performance standard 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 action will allow APHIS to consider requests to authorize the importation or interstate movement of new fruits and vegetables in a manner that is more flexible and responsive to evolving pest situations in both the United States and exporting countries, while maintaining the science-based process for making risk evaluations. For more information about this rule, see RIN 0579-AD71.

Providing all Americans access to a safe, nutritious, and secure food supply is USDA's most important responsibility, and it is one undertaken with great seriousness. USDA has critical roles in preventing foodborne illness and protecting public health, while ensuring Americans have access to food and healthful diet. The Department will continue to prevent contamination and limit foodborne illness by expanding its modernization of food inspection systems, and USDA's research, education, and extension programs will continue to provide information, tools, and technologies about the causes of foodborne illness and its prevention. USDA will continue to develop partnerships that support best practices in implementing effective nutrition assistance programs that ensure eligible populations have access to programs that support their food needs.Start Printed Page 57821

Increase flexibilities provided to school lunch program operators in meeting nutrition requirements: The Food and Nutrition Service (FNS) plans to issue a final rule that provides flexibilities to Program operators participating in the Child Nutrition Programs effective School Year 2019-2020. For more information about this rule, see RIN 0584-AE53.

Provide regulatory flexibility for retailers in the Supplemental Nutrition Assistance Program (SNAP): FNS will issue a proposed rule to provide retailers with more flexibility in meeting the enhanced SNAP eligibility requirements of the 2016 final rule and meet the requirements expressed in the Consolidated Appropriation Act of 2017. For more information about this rule, see RIN 0584-AE61.

Modernize swine slaughter inspection: The Food Safety and Inspection Service (FSIS) plans to finalize a proposal published on February 1, 2018, to establish a voluntary New Swine Inspection System (NSIS) for market-hog slaughter establishments, and mandatory provisions for all swine slaughtering establishments. NSIS will provide for increased offline inspection activities that are more directly related to food safety resulting in greater compliance with sanitation and Hazard Analysis and Critical Control Point (HACCP) regulations and reduce the risk of foodborne illness. FSIS received over 83,500 comments. Many of the comments requested that FSIS withdraw the proposal to remove limits on line speeds due to the negative effect on animal welfare and worker safety. These comments will be analyzed and further addressed in the final rule. For more information about this rule, see RIN 0583-AD62.

The Department will ensure productive and sustainable use of our National Forest System Lands: To ensure that America's forests and grasslands are healthy and sustainable, USDA manages approximately 193 million acres of public land, much of it rural and remote. Land management activities can influence rural economies, and USDA can help enable economic growth and recovery.

Update and Clarification of the Locatable Mineral Regulations: The Forest Service plans to seek public input as it evaluates its management of the activities associated with mining “locatable minerals” that have an impact on the surface resources including expediting Forest Service review and approval of certain proposed mineral operations on National Forest System (NFS) lands. The Forest Service plans to seek public input to determine whether its assessment of the need for these changes is shared by the public. For more information about this rule, see RIN 0596-AD32.

Oil and Gas Resource Revisions: The Forest Service plans to seek public input as it evaluates its regulations concerning its responsibility for authorizing and regulating access to federal oil and natural gas resources. Updating the regulations will afford an opportunity to modernize and streamline analytical and procedural requirements, reduce the paperwork burden on industry, reduce permitting times for leasing NFS lands, and help provide a more consistent approach to oil and gas management across the NFS. In addition, USDA recommended revising the regulation as part of the USDA Final Report Pursuant to Executive Order 13783 on Promoting Energy Independence and Economic Growth. The regulation revision will also make updates in response to legislative actions such as the Energy Policy Act of 2005. For more information about this rule, see RIN 0596-AD33.

USDA—AGRICULTURAL MARKETING SERVICE (AMS)

Proposed Rule Stage

1. NOP; Strengthening Organic Enforcement

Priority: Other Significant.

E.O. 13771 Designation: Regulatory.

Legal Authority: 7 U.S.C. 6501

CFR Citation: 7 CFR 205.

Legal Deadline: None.

Abstract: The rule supports a broader strategy to strengthen oversight of organic imports and the organic supply chain. AMS intends this rule to deter fraud, enhance enforcement and protect organic integrity.

Statement of Need: The March 2010 Office of Inspector General (OIG) audit of the National Organic Program (NOP) raised issues related to the program's progress for imposing enforcement actions. One concern was that organic producers and handlers facing revocation or suspension of their certification are able to market their products as organic during what can be a lengthy appeals process. As a result, AMS expects to publish a proposed rule to revise language in section 205.681 of the NOP regulations, which pertains to adverse action appeals. It is expected that this rule will streamline the NOP appeals process such that appeals are reviewed and responded to in a more timely manner.

Summary of Legal Basis: The Organic Foods Production Act of 1990 (OFPA), 7 U.S.C. 6501 et seq., requires that the Secretary establish an expedited administrative appeals procedure for appealing an action of the Secretary or certifying agent (section 6520). The NOP regulations describe how appeals of proposed adverse action concerning certification and accreditation are initiated and further contested (sections 205.680, 205.681).

Alternatives: The program considered maintaining the status quo and hiring additional support for the NOP appeals team. This rulemaking was determined to be preferable because it will reduce redundancy in the appeals process, where an appellant can more quickly appeal the administrator's decision to an administrative law judge.

Anticipated Cost and Benefits: This action will affect certified operations and accredited certifying agents. The primary impact is expected to be expedited enforcement action, which may benefit the organic community through deterrence and increased consumer confidence in the organic label. It is not expected to have a significant cost burden upon affected entities beyond any monetary penalty or suspension or revocation of certification or accreditation, to which these entities are already subject to under current regulations.

Risks: No risks have been identified.

Timetable:

ActionDateFR Cite
NPRM03/00/19

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Jennifer Tucker, Deputy Administrator, USDA National Organic Program, Department of Agriculture, Agricultural Marketing Service, 1400 Independence Avenue SW, Washington, DC 20250, Phone: 202 260-8077.

RIN: 0581-AD09

USDA—AMS

Final Rule Stage

2. National Bioengineered Food Disclosure Standard

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

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

E.O. 13771 Designation: Other.

Legal Authority: Pub. L. 114-216; 7 U.S.C. 1621 to 1627Start Printed Page 57822

CFR Citation: 7 CFR 1285.

Legal Deadline: Final, Statutory, July 29, 2018.

Abstract: Abstract: On July 29, 2016, the Agricultural Marketing Act of 1946 was amended to establish a National Bioengineered Food Disclosure Standard (Law) (Pub. L. 114-216). The provisions of this rule, pursuant to the law, will serve as a national mandatory bioengineered food disclosure standard for bioengineered food and food that may be bioengineered.

Statement of Need: This rule would establish a single, national standard to supersede a patchwork of similar standards implemented or planned by individual States. The rule may be considered a regulatory reduction in that affected entities would be regulated by a uniform standard recognized in both interstate commerce and international trade. Consumers would benefit from a single standard for consistent messaging about bioengineered food in the market.

Summary of Legal Basis: The authority for this action is provided by the Agricultural Marketing Act of 1946 as amended by Pub. L. 114-216.

Alternatives: The proposed rule evaluated alternative thresholds for which disclosure would be required and alternative definitions for the term “very small food manufacturer.”

Anticipated Cost and Benefits: Implementation of the standard is intended to coincide with that of the Food and Drug Administration's updated food labeling requirements. Such coordination would reduce expenses for affected food manufactures, who would otherwise bear twice the cost of changing food labels to comply with each regulation.

Risks: No risks have been identified at this time.

Timetable:

ActionDateFR Cite
NPRM05/04/1883 FR 19860
Comment Period End07/03/18
Final Action11/00/18

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

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

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

Agency Contact: Arthur Neal, Deputy Administrator, Transportation and Marketing, Department of Agriculture, Agricultural Marketing Service, Washington, DC 20250, Phone: 202 692-1300.

RIN: 0581-AD54

USDA—ANIMAL AND PLANT HEALTH INSPECTION SERVICE (APHIS)

Proposed Rule Stage

3. Animal Welfare; Amendments to Licensing Provisions and to Requirements for Dogs

Priority: Other Significant.

E.O. 13771 Designation: Other.

Legal Authority: 7 U.S.C. 2131 to 2159

CFR Citation: 9 CFR 1 to 3.

Legal Deadline: None.

Abstract: This rulemaking would amend the licensing requirements under the Animal Welfare Act regulations to promote compliance, reduce licensing fees, and strengthen existing safeguards that prevent individuals and businesses who have a history of noncompliance from obtaining a license or working with regulated animals. This action would reduce regulatory burden with respect to licensing and more efficiently ensure licensees' sustained compliance with the Act. This rulemaking would also strengthen the veterinary care and watering standards for regulated dogs to better align the regulations with the humane care and treatment standards set by the Animal Welfare Act.

Statement of Need: Although an applicant for a license renewal must also certify that he or she is in compliance with all regulations, the current regulations do not require the applicant to show compliance before APHIS renews his or her license. As a result, licensees can currently renew their licenses indefinitely without undergoing a thorough compliance inspection. This proposal would require persons to seek a new license every three years and demonstrate compliance with the AWA regulations as part of the application process. Further, the current regulations do not require a licensee to show compliance when the licensee makes any subsequent changes to his or her animals or facilities, including noteworthy changes in the number or type of animals used in regulated activity. Based on our experience with enforcing the AWA and regulations, we are concerned that many licensees struggle to achieve and maintain compliance after making such changes to their animals used in regulated activity.

Summary of Legal Basis: Under the Animal Welfare Act (AWA or the Act, 7 U.S.C. 2131 et seq.), the Secretary of Agriculture is authorized to promulgate standards and other requirements governing the humane handling, care, treatment, and transportation of certain animals by dealers, exhibitors, operators of auction sales, research facilities, and carriers and intermediate handlers. Definitions, regulations, and standards established under the AWA are contained in the Code of Federal Regulations (CFR) in 9 CFR parts 1, 2, and 3 (referred to below as the regulations). Part 2 provides administrative requirements and sets forth institutional responsibilities for regulated parties, including licensing requirements for dealers, exhibitors, and operators of auction sales.

Alternatives: APHIS considered several alternatives in developing various aspects of the proposed rule. Regarding the types of animals that would trigger the need for a new license, APHIS considered requiring a new license for all exotic or wild animal changes, but rejected this in favor of requiring a new license for types of animals that are dangerous and have unique regulatory and care needs. With respect to license termination following two or more attempted inspections during the period of licensure, APHIS considered requiring immediate termination but decided in favor of allowing the licensee the opportunity to first present evidence in defense. APHIS also considered different time frames for the fixed-term license (e.g., four or five years) and settled on three years based on our experience administering the AWA.

Anticipated Cost and Benefits: This rule would result in cost savings for both APHIS and licensees by simplifying the licensing process and reducing fees, while enhancing the protection of covered animals. Total cost reductions for affected entities are expected to range between $600,000 and $2.1 million per year. In accordance with guidance on complying with E.O. 13771, the single primary estimate of cost savings for this proposed rule is $1.37 million, the midpoint estimate of savings annualized in perpetuity using a 7 percent discount rate.

Risks: This proposed rule would address two existing areas of concern. As noted, it is possible for licensees to renew their licenses without undergoing a thorough compliance inspection and for licensees to make noteworthy changes in the number or type of animals used in regulated activity. This rulemaking would address those concerns by requiring licensees to affirmatively demonstrate compliance with the AWA regulations and standards and to obtain a new license Start Printed Page 57823when making noteworthy changes subsequent to the issuance of a license in regard to the number, type, or location of animals used in regulated activities.

Timetable:

ActionDateFR Cite
ANPRM08/24/1782 FR 40077
ANPRM Comment Period End10/23/17
ANPRM Comment Period Extended10/23/1782 FR 48938
ANPRM Comment Period Extended End11/02/17
NPRM11/00/18

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal, Local, State.

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

Agency Contact: Christine Jones, Chief of Staff, Animal Care, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 84, Riverdale, MD 20737-1231, Phone: 301 851-3730.

RIN: 0579-AE35

USDA—APHIS

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

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

Legal Authority: 7 U.S.C. 7701 to 7772; 7 U.S.C. 7781-to 786

CFR Citation: 7 CFR 340.

Legal Deadline: None.

Abstract: APHIS is proposing to revise its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms in order to update the regulations in response to advances in genetic engineering and APHIS' understanding of the plant health risk posed by genetically engineered organisms, thereby reducing the burden for regulated entities whose organisms pose no plant health risks.

Statement of Need: This rule is necessary in order to respond to advances in genetic engineering and APHIS' understanding of the pest risks posed by genetically engineered (GE) organisms, to assess such organisms for plant pest risks in light of those advances and establish a process to determine whether APHIS has jurisdiction under the Plant Protection Act to regulate specific GE organisms under Part 340, and to respond to two Office of Inspector General audits regarding APHIS' regulation of genetically engineered organisms, as well as the requirements of the 2008 Farm Bill.

Summary of Legal Basis: The Plant Protection Act, as amended (7 U.S.C. 7701 et seq.).

Alternatives: Alternatives that we considered were (1) to leave the regulations unchanged and (2) to regulate all GE organisms as presenting a possible plant pest or noxious weed risk, without exception, and with no means of granting nonregulated status.

Anticipated Cost and Benefits: Not yet determined.

Risks: Unless we issue this proposal, we will not be able to respond to the products of future technologies and not be able to provide appropriate oversight of GE organisms that pose a plant pest risk. Additionally, as noted above, the current regulations do not incorporate recommendations of two OIG audits, and do not respond to the requirements of the 2008 Farm Bill, particularly regarding APHIS oversight of field trials and environmental releases of genetically engineered organisms.

Timetable:

ActionDateFR Cite
NPRM04/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal, State.

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

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

Agency Contact: Gwendolyn Burnett, Agriculturalist, BRS, Department of Agriculture, Animal and Plant Health Inspection Service, 4700 River Road, Unit 147, Riverdale, MD 20737-1236, Phone: 301 851-3893.

RIN: 0579-AE47

USDA—FOOD AND NUTRITION SERVICE (FNS)

Proposed Rule Stage

5. Supplemental Nutrition Assistance Program: Requirements for Able-Bodied Adults Without Dependents

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

E.O. 13771 Designation: Regulatory.

Legal Authority: Sec. 6(o)(4) of the Food and Nutrition Act of 2008, as amended, 7 U.S.C. 2011 to 2036

CFR Citation: 7 CFR 273.24(f).

Legal Deadline: None.

Abstract: The Food and Nutrition Act of 2008, as amended (the Act), establishes a time limit for SNAP participation of three months in three years for able-bodied adults without dependents (ABAWDs) who are not working. The Act provides State flexibility by allowing State agencies to request to waive the time limit if an area that an individual resides in has an unemployment rate of over 10 percent or does not have a sufficient number of jobs to provide employment for individuals. This rule will propose modifications to the Supplemental Nutrition Assistance Program (SNAP) requirements and services for Able-Bodied Adults Without Dependents (ABAWDs) in response to public input provided through the advanced notice of proposed rulemaking (ANPRM).

Statement of Need: SNAP offers nutrition assistance to millions of eligible, low-income individuals and families; this nutrition assistance also provides economic benefits to communities. It is important that SNAP support self-sufficiency and reduce the need for government assistance for its program participants. The Department recognizes that a well-paying job provides the best path to self-sufficiency for those who are able to work. To that end, the Department aims to create conditions that incentivize SNAP program participants to find employment.

Summary of Legal Basis: Currently unavailable.

Alternatives: Currently unavailable.

Anticipated Cost and Benefits: Currently unavailable.

Risks: Currently unavailable.

Timetable:

ActionDateFR Cite
ANPRM02/23/1883 FR 8013
NPRM10/00/18

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: Local, State.Start Printed Page 57824

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

RIN: 0584-AE57

USDA—FNS

6. Providing Regulatory Flexibility for Retailers in the Supplemental Nutrition Assistance Program (SNAP)

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

Legal Authority: Pub. L. 113-79; 7 U.S.C. 2011 to 2036

CFR Citation: 7 CFR 271.2; 7 CFR 278.1.

Legal Deadline: None.

Abstract: The Agricultural Act of 2014 amended the Food and Nutrition Act of 2008 to increase the requirement that certain Supplemental Nutrition Assistance Program (SNAP) authorized retail food stores have available on a continuous basis at least three varieties of items in each of four staple food categories, to a mandatory minimum of seven varieties. The Food and Nutrition Service (FNS) codified these mandatory requirements. This change will provide some retailers participating in SNAP as authorized food stores with more flexibility in meeting the enhanced SNAP eligibility requirements.

Statement of Need: The United States Department of Agriculture (USDA, or the Department) Food and Nutrition Service (FNS, or the Agency) is proposing changes to regulations in Sections 271 and 278 which modify the definition of variety as it pertains to the stocking requirements that certain retail food stores must meet to be eligible to participate in the Supplemental Nutrition Assistance Program (SNAP). On December 15, 2016, FNS published a final rule that amended SNAP regulations at 7 CFR parts 271 and 278 to clarify and enhance current SNAP regulations governing the eligibility of certain firms to participate in SNAP. On May 5, 2017, appropriations legislation (the Consolidated Appropriation Act of 2017, or the Omnibus) suspended implementation of two provisions in the 2016 final rule: (1) The Definition of ‘Staple Food’ Acceptable Varieties in the Four Staple Food Categories provision and (2) the Definition of ‘Retail Food Store’ Breadth of Stock provision (known as the Definition of “Variety” provision and the Breadth of Stock provision, respectively). In order to move forward with implementing these provisions of the 2016 final rule, the Omnibus required USDA to first amend the Definition of Variety provision so that the number of qualifying food varieties in each staple food category increased.

Summary of Legal Basis: On May 5, 2017, the Consolidated Appropriation Act of 2017 (the Omnibus) was signed into law. Section 765 of the Omnibus prohibited the USDA from implementing the Definition of “Staple Food” Acceptable Varieties in the Four Staple Food Categories provision (7 CFR 271.2 and 7 CFR 278.1(b)(1)(ii)(C)) and variety as applied in the definition of the term staple food as defined at 7 CFR 271.2 to increase the number of items that qualify as acceptable varieties in each staple food category from the number of items that qualified as acceptable varieties under the 2016 final rule.

Alternatives: Currently unavailable.

Anticipated Cost and Benefits: The Department has estimated that the proposed rule will save approximately $16.1 million in fiscal year (FY) 2018 and approximately $22.5 million over five years, FY 2018 through FY 2022. Under the 2016 final rule, the cost to currently authorized small retailers was estimated to average approximately $245 per store in the first year and about $620 over five years (including ongoing costs of less than $100 per year for years after the first). The proposed rule would reduce those costs to about $160 per store in the first year and $500 over five years.

Risks: NA.

Timetable:

ActionDateFR Cite
NPRM11/00/18

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

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.

Related RIN: Related to 0584-AE27

RIN: 0584-AE61

USDA—FNS

7. Revision of Categorical Eligibility in the Supplemental Nutrition Assistance Program (SNAP)

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

E.O. 13771 Designation: Regulatory.

Legal Authority: 42 U.S.C. 601; Pub. L. 113-79

CFR Citation: 7 CFR 273.2(j)(2).

Legal Deadline: None.

Abstract: Under section 5(a) of the Food and Nutrition Act of 2008, households in which all members receive benefits under a State program funded by the Temporary Assistance to Needy Families (TANF) program are categorically eligible to participate in the Supplemental Nutrition Assistance Program (SNAP). This proposal would change the regulations at 7 CFR 273.2(j)(2) pertaining to categorically eligible TANF households by limiting categorical eligibility to households that receive cash TANF or other substantial assistance from TANF. Categorical eligibility conferred by any non-cash assistance would be limited to substantial ongoing assistance or services, such as child care, that have an eligibility determination process similar to cash TANF. This rule would not alter categorical eligibility for Supplemental Security Income (SSI) households or General Assistance (GA) households.

Statement of Need: This proposal would change current regulations by limiting categorical eligibility to households that receive cash assistance or other ongoing or substantial assistance from TANF, such as child care, and that have an eligibility determination process similar to cash TANF. These stricter requirements would ensure that categorical eligibility is appropriately targeted toward low-income households most in need while maintaining administrative streamlining across Federal benefits programs.

Summary of Legal Basis: Currently unavailable.

Alternatives: Currently unavailable.

Anticipated Cost and Benefits: Currently unavailable.

Risks: Currently unavailable.

Timetable:

ActionDateFR Cite
NPRM01/00/19

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Governmental Jurisdictions.

Government Levels Affected: Federal, Local, State.

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

RIN: 0584-AE62

Start Printed Page 57825

USDA—FNS

8. • Reform Provisions for the Supplemental Nutrition Assistance Program's Quality Control System

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Other.

Legal Authority: 7 U.S.C. 2011 to 2036

CFR Citation: 7 CFR 275.

Legal Deadline: None.

Abstract: The Department proposes to revise its regulations for various Quality Control (QC) provisions in subpart C of 7 CFR part 275 to reflect numerous changes to the Supplemental Nutrition Assistance Program's (SNAP) Quality Control system. There have been concerns about the SNAP QC process by not only its stakeholders, but FNS as well, primarily due to questions regarding the integrity of State collected error rate data that is used to develop SNAP's national error rates. SNAP has been working diligently for several years to address these concerns and plans to move forward to reform components of its QC process to ensure the integrity of state-reported error rates.

Statement of Need: The Department proposes to revise regulations for Quality Control (QC) provisions in subpart C of 7 CFR part 275 to reflect numerous changes to the Supplemental Nutrition Assistance Program (SNAP) QC system to improve QC integrity. OIG highlighted need for changes to SNAP QC procedures in a recent audit. These changes can only be made through regulation, not just policy. SNAP has issued an RFI to gather ideas from stakeholders on potential regulation changes to improve integrity and improper payment management.

Summary of Legal Basis: FNA Section 16(c).

Alternatives: None. Regulations needed to make significant change to SNAP quality control procedures.

Anticipated Cost and Benefits: Costs: Currently unavailable. Benefits: Improved integrity and accuracy of SNAP improper payment measurement.

Risks: NA.

Timetable:

ActionDateFR Cite
NPRM03/00/19

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

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

RIN: 0584-AE64

USDA—FNS

Final Rule Stage

9. Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

Legal Authority: 42 U.S.C. 1758; 42 U.S.C. 1766; 42 U.S.C. 1772; 42 U.S.C. 1773; 42 U.S.C. 1779

CFR Citation: 7 CFR 210.10; 7 CFR 210.11; 7 CFR 215.7a; 7 CFR 220.8; 7 CFR 226.20

Legal Deadline: None.

Abstract: This final rule will increase flexibility in the Child Nutrition Program requirements related to milk, grains, and sodium effective School Year (SY) 2019-2020, which begins July 1, 2019. This rule is the culmination of an efficient rulemaking process initiated by the Department of Agriculture (USDA) following the Secretary's May 1, 2017, Proclamation affirming USDA's commitment to assist schools in overcoming operational challenges related to the school meals regulations implemented in 2012.

Statement of Need: This final rule will codify, with some modifications, three menu planning flexibilities established by the interim final rule of the same title published November 30, 2017. By codifying these changes, USDA acknowledges the persistent menu planning challenges experienced by some schools, and affirms its commitment to give schools more control over the food service decisions and greater ability to offer wholesome and appealing meals that reflect local preferences.

Summary of Legal Basis: The authority for this action is provided by the Richard B. Russell National School Lunch Act, 42 U.S.C. 1758(a)(4), requiring that school meals reflect the latest Dietary Guidelines for Americans.

Alternatives: NA.

Anticipated Cost and Benefits: Currently unavailable.

Risks: NA.

Timetable:

ActionDateFR Cite
Interim Final Rule11/30/1782 FR 56703
Interim Final Rule Comment Period End01/29/18
Interim Final Rule Effective07/01/18
Final Action12/00/18

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Additional Information: School Lunch—NSLA Section 9(a)(1)—42 U.S.C. 1758(a)(1). Child and Adult Care Food Program—NSLA Section 17(g)—42 U.S.C. 1766(g) Special Milk Program—Child Nutrition Act Section 3(a)(1)—42 U.S.C. 1772(a)(1). School Breakfast Program—Child Nutrition Act Section 4(e)(1)(A)—42 U.S.C. 1773(e)(1)(A). Smart Snacks in Schools—Child Nutrition Act Section 10(b)—42 U.S.C. 1779(b).

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

RIN: 0584-AE53

USDA—FOOD SAFETY AND INSPECTION SERVICE (FSIS)

Final Rule Stage

10. Egg Product Inspection Regulations

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

Legal Authority: 21 U.S.C. 1031 et seq.

CFR Citation: 9 CFR 590.570; 9 CFR 590.575; 9 CFR 590.146; 9 CFR 590.10; 9 CFR 590.411; 9 CFR 590.502; 9 CFR 590.504; 9 CFR 590.580; 9 CFR 591.

Legal Deadline: None.

Abstract: The Food Safety and Inspection Service (FSIS) is proposing to require official egg products plants to develop and implement Hazard Analysis and Critical Control Point (HACCP) Systems and Sanitation Standard Operating Procedures (SOPs), consistent with HACCP and Sanitation SOP requirements in the meat and poultry products inspection regulations. FSIS also is proposing to require egg products plants to produce egg products using a process that will eliminate detectable pathogens from the finished product. Plants would be expected to develop HACCP systems that ensure that pathogens cannot be detected in finished egg products.

In addition, FSIS is proposing to amend the egg products inspection regulations by removing the current requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment prior to Start Printed Page 57826their use in official plants; providing for the generic labeling of egg products; requiring safe handling labels on shell eggs and egg products; and changing the Agency's interpretation of the requirement for continuous inspection in official plants.

Statement of Need: The actions being proposed are part of FSIS's regulatory reform effort to better define the roles of Government and the regulated industry, encourage innovations that will improve food safety, remove unnecessary regulatory burdens on inspected egg products plants, and make the egg products regulations as consistent as possible with the Agency's meat and poultry products regulations.

Summary of Legal Basis: The authority for this action is provided by the Egg Product Inspection Act (21 U.S.C. 1031 et seq.).

Alternatives: The Agency considered the following regulatory alternatives for the implementation of government standards (HACCP) and related requirements for the egg products industry: (1) Status quo; (2) Intensify present inspection; (3) Voluntary HACCP regulatory program; (4) Mandatory HACCP regulation with exemption for small businesses; (5) Modified HACCP recording deviations and responses only; (6) Mandatory HACCP, Sanitation SOPs, and lethality performance standards adoption; and implementation of the sixth of these regulatory alternatives, mandatory HACCP, Sanitation SOPS, and lethality performance standards, should achieve immediate reductions in, and an eventual minimization of, foodborne hazards.

Anticipated Cost and Benefits: Costs to the egg products industry come from the development of Sanitation SOPs and HACCP plans and compliance with the proposed HACCP requirements. FSIS will incur costs to train egg products inspectors (EPIs) to ensure that they can competently perform inspection duties associated with HACCP and Sanitation SOPs at the 77 federally-inspected egg products plants. While EPIs are in training, FSIS will also incur costs to pay for replacement inspectors so that egg products plants can continue to operate.

Potential industry cost reductions from the proposed rule come from generic labeling, and the elimination of certain regulations, waivers, and no objection letters. Under generic labeling, plants do not have to submit certain labels to FSIS for small changes, allowing plants to avoid a 60-day approval process and documentation of submissions for the approval of new labels. In addition, plants receive cost savings from the elimination of outdated regulations. The regulatory requirements in the current system may inefficiently use industry resources. HACCP gives egg products plants the flexibility to decide how they wish to produce product in the manner that is most efficient to them, so that no detectable pathogens remain in the finished product.

Under the current command-and-control based system, FSIS personnel must approve waivers and no objection letters for certain plant activities outside the current regulations and inspection program, personnel assume responsibility for “approving” production-associated decisions. Under HACCP, industry would assume full responsibility for production decisions and execution. FSIS would monitor plants' compliance with the requirement that finished egg products not contain detectable pathogens and within HACCP requirements. This allows industry and the Agency to reduce costs for approving activities and allows for better use of resources.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM02/13/1883 FR 6314
NPRM Comment Period End06/13/18
Final Action05/00/19

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Matthew Michael, Director, Issuances Staff, Department of Agriculture, Food Safety and Inspection Service, Office of Policy and Program Development, 1400 Independence Avenue SW, Washington, DC 20250-3700, Phone: 202 720-0345, Fax: 202 690-0486, Email: matthew.michael@fsis.usda.gov.

RIN: 0583-AC58

USDA—FSIS

11. Modernization of Swine Slaughter Inspection

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

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

CFR Citation: 9 CFR 301; 9 CFR 309; 9 CFR 310; 9 CFR 314.

Legal Deadline: None.

Abstract: The Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat inspection regulations to establish a new inspection system for swine slaughter establishments demonstrated to provide greater public health protection than the existing inspection system. The Agency is also proposing several changes to the regulations that would affect all establishments that slaughter swine, regardless of the inspection system under which they operate.

Statement of Need: The proposed action is necessary to improve food safety, improve compliance with the Humane Methods of Slaughter Act, improve the effectiveness of market hog slaughter inspection, make better use of the Agency's resources, and remove unnecessary regulatory obstacles to innovation.

Summary of Legal Basis: The authority for this action is provided by the Federal Meat Inspection Act (21 U.S.C. 601 et seq.).

Alternatives: The Agency is considering alternatives such as: (1) A mandatory New Swine Slaughter Inspection System (NSIS) for market hog slaughter establishments and (2) a voluntary NSIS for market hog establishments, under which FSIS would conduct the same offline inspection activities as traditional inspection.

Anticipated Cost and Benefits: The proposed regulations are expected to benefit establishments by removing unnecessary regulatory obstacles to innovation and allowing establishments more flexibility in line configuration. The proposed changes are also expected to reduce establishments' sampling costs. Additionally, the proposed regulations are expected to improve the effectiveness of market hog slaughter inspection, leading to a reduction in the number of human illnesses attributed to products derived from market hogs. The proposed actions make better use of the Agency's resources, which is expected to reduce the Agency's personnel and training budgetary requirements. Establishments are expected to incur increased labor and recordkeeping costs.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM02/01/1883 FR 4780
NPRM Comment Period End04/02/18
Final Rule04/00/19

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Matthew Michael, Director, Issuances Staff, Department of Agriculture, Food Safety and Inspection Service, Office of Policy and Program Start Printed Page 57827Development, 1400 Independence Avenue SW, Washington, DC 20250-3700, Phone: 202 720-0345, Fax: 202 690-0486, Email: matthew.michael@fsis.usda.gov.

RIN: 0583-AD62

USDA—FOREST SERVICE (FS)

Prerule Stage

12. Update and Clarification of the Locatable Minerals Regulations

Priority: Other Significant.

E.O. 13771 Designation: Other.

Legal Authority: 30 U.S.C. 612

CFR Citation: 36 CFR 228(A).

Legal Deadline: None.

Abstract: The Forest Service proposes the amendment of its locatable mineral regulations that better reflect the needs of both the Forest Service and mining industry. By addressing recent issues and remedying existing weakness in current regulations that have been identified, the Forest Service will be in a better position to better implement its mining regulations. The goals of the regulatory revision are (1) to expedite Forest Service review and approval of certain proposed mineral operations authorized by the United States mining laws; (2) to increase consistency with the United States Department of the Interior, Bureau of Land Management (BLM) surface management regulations governing operations authorized by the United States mining laws to assist those who conduct these operations on lands managed by each agency; and (3) to increase the Forest Service's nationwide consistency in regulating mineral operations authorized by the United States mining laws.

Statement of Need: The Forest Service proposes the amendment of its locatable mineral regulations to better reflect the needs of both the Forest Service and mining industry. By addressing recent issues and remedying existing weakness in current regulations that have been identified, the Forest Service will be in a better position to implement its mining regulations, thus reducing processing timelines and redundancies.

Summary of Legal Basis: The Mining Law of 1872, as amended, confers a statutory right to enter upon certain National Forest System lands to search for locatable minerals. These rules govern prospecting, exploration, development, mining, and processing operations conducted on National Forest System lands.

Alternatives: A no action alternative would leave the regulations unchanged, thus maintaining the status-quo.

Anticipated Cost and Benefits: Not applicable.

Risks: Not applicable.

Timetable:

ActionDateFR Cite
ANPRM09/13/1883 FR 46451
ANPRM Comment Period End10/15/18

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal.

Agency Contact: Ann Goode, Department of Agriculture, Forest Service, 1400 Independence Avenue SW, Washington, DC 20250, Phone: 202 720-7123, Email: aegoode@fs.fed.us.

RIN: 0596-AD32

USDA—FS

13. Oil and Gas Resource Revision

Priority: Other Significant.

E.O. 13771 Designation: Other.

Legal Authority: 30 U.S.C. 612; 30 U.S.C. 181; 30 U.S.C. 351; 30 U.S.C. 21

CFR Citation: 36 CFR 228(E).

Legal Deadline: None.

Abstract: The Forest Service plays a role in the leasing and development of Federally owned oil and natural gas found on National Forest System lands in partnership with the Bureau of Land Management. Updating the regulations will afford an opportunity to modernize and streamline analytical and procedural requirements and help provide a more consist approach to oil and gas management across the National Forest System. The potential changes to the existing regulation permitting sections include eliminating language that is redundant with the NEPA process, removing confusing options, and ensuring better alignment with the BLM regulations. The intent of these potential changes would be to decrease permitting times by removing regulatory burdens that unnecessarily encumber energy production across the National Forest System.

Statement of Need: The Forest Service plays a role in the leasing and development of federally owned oil and natural gas found on National Forest System lands in partnership with the Bureau of Land Management. Updating the regulations will afford an opportunity to modernize and streamline analytical and procedural requirements and help provide a more consist approach to oil and gas management across the National Forest System.

Summary of Legal Basis: Forest Service 36 CFR 228(e) regulations are done as a result of the Onshore Oil and Gas Leasing Reform Act of 1987.

Alternatives: Forest Service 36 CFR 228(e) regulations are done as a result of Onshore Oil and Gas Leasing Reform Act of 1987.

Anticipated Cost and Benefits: Not applicable.

Risks: Not applicable.

Timetable:

ActionDateFR Cite
ANPRM09/13/1883 FR 46458
ANPRM Comment Period End10/15/18

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal.

Agency Contact: Nicholas Diprofio, Department of Agriculture, Forest Service, 1400 Independence Avenue SW, Washington, DC 20250, Phone: 202 205-1082, Email: ndiprofio@fs.fed.us.

RIN: 0596-AD33

USDA—RURAL UTILITIES SERVICE (RUS)

Final Rule Stage

14. Servicing Regulation for the Rural Utilities Service (RUS) Telecommunications Programs

Priority: Other Significant.

E.O. 13771 Designation: Fully or Partially Exempt.

Legal Authority: 5 U.S.C. 301; 7 U.S.C. 1981; 16 U.S.C. 1005

CFR Citation: 7 CFR 1782.

Legal Deadline: None.

Abstract: The regulation will cover servicing actions associated with the Telecommunications Infrastructure Loan Program, Broadband Access Loan and Loan Guarantee Program, Distance Learning and Telemedicine Program, and Broadband Initiatives Program (hereinafter collectively referred to as the “RUS Telecommunications Programs”).

Statement of Need: The RUS Telecommunications Programs provide loan funding to build and expand broadband service into unserved and underserved rural communities, along with very limited funding to support the costs to acquire equipment to provide distance learning and telemedicine service. This action will provide servicing actions available for the loan portofolio and will enable the Agency to quickly and consistently address servicing actions and improve customer service.

Summary of Legal Basis: This action is required by statute, the Agricultural Start Printed Page 57828Act of 2014 amendment to section 601 of the Rural Electrification Act of 1936 (7 U.S.C. 950bb). This section requires the Secretary to establish written procedures for all broadband programs to recover funds from loan defaults.

Alternatives: The agency considered using other existing RD agency regulations and decided upon combining Telecommunications servicing requirements with the Water Programs servicing regulation. These types of RUS loans are more similar than other RD loan programs.

Anticipated Cost and Benefits: There are no anticipated costs. The rule will ensure recipients comply with the established objectives and requirements for loans, repaying loans on schedule and acting in accordance with any necessary agreements, ensure serving actions are handled consistently, and protect the financial interest of the Agency.

Risks: N/A.

Timetable:

ActionDateFR Cite
Final Rule06/00/19

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Thomas P. Dickson, Department of Agriculture, Rural Utilities Service, 1400 Independence Avenue SW, Washington, DC 20250, Phone: 202 690-4492, Email: thomas.dickson@wdc.usda.gov.

RIN: 0572-AC41

USDA—RUS

15. • OnerD Guaranteed Loan Regulation

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

E.O. 13771 Designation: Fully or Partially Exempt.

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: Rural Development proposes to combine into a single regulation its four guaranteed loan programs: (1) Water and Waste Disposal, (2) Community Facilities, (3) Business and Industry, and (4) Rural Energy for America. The new regulation will encompass the policies and procedures for guaranteed loan making and servicing, lender reporting, and program monitoring. The proposed action will enable Rural Development to simplify, improve, and enhance the delivery of these four guaranteed loan programs, and better manage the risks inherent with making and servicing guaranteed loans and will result in an improved customer experience for lenders trying to access these programs. This new structure will also make it more efficient and faster to promulgate regulations associated with amending existing programs or incorporating newly authorized programs in the future.

Statement of Need: Rural Development is combining its four guaranteed loan programs: (1) Water and Waste Disposal; (2) Community Facilities; (3) Business and Industry; and (4) Rural Energy for America into a single regulation. The new regulation will encompass the policies and procedures for guaranteed loan making and servicing, lender reporting, and program monitoring. The proposed action is expected to involve a few substantive policy changes in order to achieve consistency across the included programs and better customer experience for lenders trying to access these programs.

Summary of Legal Basis: This regulatory action is not required by statute or court order; however, the underlying statutes authorizing these policies are the Consolidated Farm and Rural Development Act, 7 U.S.C. 1921 Establishing a Performance Standard for Authorizing the Importation and Interstate Movement of Fruits and Vegetables (0579-AD71); Concluded 8/24/2018 and 9007 of the 2002 Farm Bill as amended, 7 U.S.C. 8107.

Alternatives: The alternative is to continue operating under the current existing four regulations for these programs.

Anticipated Cost and Benefits: At this time an estimated cost is not known. The proposed action is expected to reflect current program policy and produce the same policy results, but in a more effective manner. Anticipated benefits include:

  • Improve quality customer experience by streamlining and consolidating similar guaranteed loan programs into a client-driven consolidated regulation.
  • Advance economic development and access to capital by reducing regulatory complexities and redundancies.
  • Improve operational efficiencies and cross-program coordination (oneRD) by enabling staff to learn all RD guaranteed loan programs using one regulation
  • Enable RD to integrate innovation in the delivery of loan guarantees and align with industry lending practices
  • Create a regulation that paves the way for modern processing and servicing to improve portfolio management

Risks: N/A.

Timetable:

ActionDateFR Cite
Final Rule05/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Agency Contact: Thomas P. Dickson, Department of Agriculture, Rural Utilities Service, 1400 Independence Avenue SW, Washington, DC 20250, Phone: 202 690-4492, Email: thomas.dickson@wdc.usda.gov.

RIN: 0572-AC43

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 Start Printed Page 57829nanotechnology, 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, as well as new efforts by the Department to remove unnecessary regulatory burdens on external stakeholders.

Responding to the Administration's Regulatory Philosophy and Principles

The vast majority of Commerce's programs and activities do not involve regulation. Of Commerce's 12 primary operating units, only three bureaus will be planning actions that are considered the “most important” significant pre-regulatory or regulatory actions for FY 2019. During the next year, the National Oceanic and Atmospheric Administration (NOAA) plans to publish five rulemaking actions that are designated as Regulatory Plan actions. The Bureau of Industry and Security (BIS) and the United States Patent and Trademark Office will each publish one rulemaking action 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.

Commerce has implemented Executive Order 13771 working through its Regulatory Reform Task Force established under Executive Order 13777 to identify and prioritize deregulatory actions that each bureau within the Department can take to reduce and remove regulatory burdens on stakeholders.

In Fiscal Year 2019, Commerce expects to publish [7] regulatory actions and [59] deregulatory actions, far exceeding the requirement under Executive Order 13771 to publish two deregulatory actions for every one regulatory action. To that end, Commerce may have other deregulatory actions to implement that do not currently appear in the agenda.

National Oceanic and Atmospheric Administration

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.

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 Satellite, Data, and Information Service (NESDIS), exercise regulatory authority.

NMFS oversees the management and conservation of the Nation's marine fisheries; protects marine mammals and Endangered Species Act-listed marine and anadromous species; 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.

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; conserving, protecting, and recovering marine mammals and Endangered Species Act-listed marine and anadromous species 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 the impacts of a changing climate 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 Start Printed Page 57830(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 2019, a number of the regulatory and deregulatory 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.

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.

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.

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 intentional take of marine mammals. The MMPA allows, upon request, the incidental take of marine mammals by U.S. citizens who engage in a specified activity (e.g., oil and gas development, pile driving) within a specified geographic region. NMFS authorizes incidental take under the MMPA if we find that the taking would be of small numbers, have no more than a “negligible impact” on those marine mammal species or stock, and would not have an “unmitigable adverse impact” on the availability of the species or stock for “subsistence” uses. NMFS also initiates rulemakings under the MMPA to establish a management regime to reduce marine mammal mortalities and injuries as a result of interactions with fisheries. In addition, 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, and 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 ESA. NMFS manages marine and “anadromous” species, and FWS manages land and freshwater species. Together, NMFS and FWS work to protect critically imperiled species from extinction. Of the approximately 720 listed species found in part or entirely in the United States and its waters, NMFS has jurisdiction over nearly 100 species. NMFS' rulemaking actions are focused on determining whether any species under its responsibility is an endangered or threatened species and whether those species must be added to the list of protected species. NMFS is also responsible for designating, reviewing, and revising critical habitat for any listed species. In addition, under the ESA, Federal agencies consult with NMFS on any proposed action authorized, funded, or carried out by that agency that may affect listed species or designated critical habitat, or that may affect proposed species or critical habitat. These interagency consultations are designed to assist Federal agencies in fulfilling their duty to ensure Federal actions do not jeopardize the continued existence of a species or destroy or adversely modify critical habitat, while still allowing Federal agencies to fulfill their respective missions (e.g., permitting infrastructure projects or oil and gas exploration, conducting military readiness activities).

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 five actions that rise to the level of “most important” of Commerce's significant regulatory actions and thus are included in this year's regulatory plan. A description of the five regulatory plan actions is provided below.

Additionally, NMFS is undertaking a series of rulemakings that are considered deregulatory, as defined by Executive Order 13771. Such actions directly benefit the regulated community by increasing access, providing more economic opportunity, reducing costs, and/or increasing flexibility. Specific examples of such actions are the Commerce Trusted Trader Program and modifications to the Fisheries Finance Program, as described below. Other examples include rulemakings implementing regional Fishery Management Council actions that alleviate or reduce previous requirements.

1. Commerce Trusted Trader Program (0648-BG51): Under the Magnuson-Stevens Fishery Conservation and Management Act, importation of fish products taken in violation of foreign law and regulation is prohibited. To enforce this prohibition, NMFS has implemented the Seafood Import Monitoring Program (81 FR 88975, Start Printed Page 57831December 9, 2016) which requires U.S. importers to report on the origin of fish products and to keep supply chain records. The Commerce Trusted Trader Program will establish a voluntary program for certified seafood importers that provides benefits such as reduced targeting and inspections, and enhanced streamlined entry into the United States. The program will require that a Commerce Trusted Trader establish a secure supply chain and maintain the records necessary to verify the legality of all designated product entering into U.S. commerce, but it will excuse the Commerce Trusted Trader from entering that data into the International Trade Data System prior to entry, as required by Seafood Import Monitoring Program. This program is deregulatory in nature because it reduces reporting costs at entry and reduces recordkeeping costs due to flexibility in archiving.

2. Magnuson-Stevens Fisheries Conservation and Management Act; Traceability Information Program for Seafood (0648-BH87): Section 539 of the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2018 (2018 Appropriations Act) directed the Secretary of Commerce to “. . . establish a traceability program for United States inland, coastal, and marine aquaculture of shrimp and abalone . . .” and by December 31, 2018 to “. . . promulgate such regulations as are necessary and appropriate to establish and implement the program.” The proposed Traceability Information Program for Seafood (TIPS) would establish registration, reporting and recordkeeping requirements for domestic, commercial aquaculture producers of shrimp and abalone species and products containing those species from the point of production to entry into U.S. commerce. TIPS would close the domestic reporting and recordkeeping gap and enable NOAA to add imported shrimp and abalone to the Seafood Import Monitoring Program (SIMP), which was mandated under the 2018 Appropriations Act and finalized under 50 CFR 300.324 in a Final Rule (0648-BH89; 83 FR 17762) published April 24, 2018.

3. Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico (0648-BB38): The Marine Mammal Protection Act (MMPA) prohibits the “take” (e.g., behavioral harassment, injury, or mortality) of marine mammals with certain exceptions, including through the issuance of incidental take authorizations. Where there is a reasonable likelihood of an activity resulting in the take of marine mammals—as is the case for certain methods of geophysical exploration, including the use of airgun arrays (i.e., “seismic surveys”)—action proponents must ensure that take occurs in a lawful manner. However, there has not previously been any analysis of industry survey activities in the Gulf of Mexico conducted pursuant to requirements of MMPA, and industry operators have been, and currently are, conducting their work without MMPA incidental take authorizations. In support of the oil and gas industry, the Bureau of Ocean Energy Management has requested 5-year incidental take regulations, which would provide a regulatory framework under which individual companies could apply for project-specific Letters of Authorization. Providing for industry compliance with the MMPA through the requested regulatory framework, versus companies pursuing individual authorizations, would be the most efficient way to achieve such compliance for both industry and for NMFS, and would provide regulatory certainty for industry operators.

4. Modify the Fisheries Financing Program To Allow the Financing of New Replacement Fishing Vessel Construction in Limited Access Fisheries (0648-BH82): In 2016, Congress passed section 302 of the Coast Guard Authorization Act of 2015 which included specific authority for the Fisheries Finance Program to finance the construction of fishing vessels in a fishery that is federally managed under a limited access system. Replacement of aged fishing vessels in managed fisheries will result in more efficient use of fisheries, promote safety at sea, and improve environmental operations of the fishing industry. This rule will provide a source of funding to recapitalize and modernize an aged fishing fleet that will help ensure the continuation of the economic benefits provided by the nation's commercial fishing fleet.

5. Magnuson-Stevens Act; Fishery Management Councils; Financial Disclosure and Recusal (0648-BH73): NMFS received input from regional Fishery Management Councils calling for further guidance and clarification of financial disclosure requirements of Council members and the regulatory procedures to make determinations on voting recusals of Council members. This rule proposes changes to the regulations that address disclosure of financial interests by, and voting recusal of, Council members appointed by the Secretary of Commerce. The regulatory changes are needed to provide the guidance for (1) consistency and transparency in the calculation of a Council member's financial interests; (2) determining whether a close causal link exists between a Council decision and a benefit to a Council member's financial interest; and (3) establishing regional procedures for preparing and issuing recusal determinations. This proposed rule is intended to improve regulations implementing the statutory requirements governing disclosure of financial interests and voting recusal at section 302(j) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

Bureau of Industry and Security

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

Major Programs and Activities

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

BIS also has an enforcement component with nine offices covering the United States. BIS export control officers are also stationed at several U.S. embassies and consulates abroad. BIS works with other U.S. Government agencies to promote coordinated U.S. Government efforts in export controls and other programs. BIS participates in U.S. Government efforts to strengthen multilateral export control regimes and Start Printed Page 57832to promote effective export controls through cooperation with other Governments

BIS' Regulatory Plan Action

BIS maintains the EAR, including the Commerce Control List (CCL). The CCL describes commodities, software, and technology that are subject to licensing requirements for specific reasons for control. The Department of State, Directorate of Defense Trade Controls (DDTC), maintains the International Traffic in Arms Regulations (ITAR), including the United States Munitions List (USML), which describes defense articles subject to State's licensing jurisdiction.

In Fiscal Year 2019, BIS plans to publish a final rule describing how articles the President has determined no longer warrant control under USML Category I (Firearms, Close Assault Weapons and Combat Shotguns), Category II (Guns and Armament), and Category III (Ammunition/Ordnance) would be controlled on the CCL and by the EAR. This final rule will be published in conjunction with a DDTC final rule that would amend the list of articles controlled by those USML Categories to describe more precisely items warranting continued control on that list.

The changes described in these final rules will be based on a review of those categories by the Department of Defense, which worked with the Departments of State and Commerce in preparing the amendments. As with the proposed rules that were published in Fiscal Year 2018, the review for the final rule will be focused on ensuring that the agencies have identified the types of articles that are now controlled on the USML that are either (i) inherently military and otherwise warrant control on the USML or (ii) if of a type common to non-military firearms applications, possess parameters or characteristics that provide a critical military or intelligence advantage to the United States, and are almost exclusively available from the United States. If an article satisfies one or both of those criteria, the article will remain on the USML. If an article does not satisfy either criterion, it will be identified in the new Export Control Classification Numbers (ECCNs) included in the BIS proposed rule. Thus, the scope of the items that will be described in the final rule will essentially be commercial items widely available in retail outlets and less sensitive military items.

The firearms and other items described in the proposed rule are widely used for sporting applications, and BIS will not “de-control” these items in the final rule. BIS would require licenses to export or reexport to any country a firearm or other weapon that would be added to the CCL. Rather than decontrolling firearms and other items, BIS, working with the Departments of Defense and State, is trying to reduce the procedural burdens and costs of export compliance on the U.S. firearms industry while allowing the U.S. Government to control firearms appropriately and to make better use of its export control resources.

United States Patent Trademark Office

The United States Patent and Trademark Office's (USPTO) mission is to foster innovation, competitiveness and economic growth, domestically and abroad by delivering high quality and timely examination of patent and trademark applications, guiding domestic and international intellectual property policy, and delivering intellectual property information and education worldwide.

Major Programs and Activities

USPTO is the Federal agency for granting U.S. patents and registering trademarks. In doing this, the USPTO fulfills the mandate of Article I, Section 8, Clause 8, of the Constitution that the legislative branch “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” The USPTO registers trademarks based on the commerce clause of the Constitution (Article I, Section 8, Clause 3). Under this system of protection, American industry has flourished. New products have been invented, new uses for old ones discovered, and employment opportunities created for millions of Americans. The strength and vitality of the U.S. economy depends directly on effective mechanisms that protect new ideas and investments in innovation and creativity. The continued demand for patents and trademarks underscores the ingenuity of American inventors and entrepreneurs. The USPTO is at the cutting edge of the nation's technological progress and achievement.

The USPTO advises the President of the United States, the Secretary of Commerce, and U.S. government agencies on intellectual property (IP) policy, protection, and enforcement; and promotes the stronger and more effective IP protection around the world. The USPTO furthers effective IP protection for U.S. innovators and entrepreneurs worldwide by working with other agencies to secure strong IP provisions in free trade and other international agreements. It also provides training, education, and capacity building programs designed to foster respect for IP and encourage the development of strong IP enforcement regimes by U.S. trading partners. USPTO administers regulations located at title 37 of the Code of Federal Regulations concerning its patent and trademark services, and the other functions it performs.

USPTO's Regulatory Plan Action

NPRM: Setting and Adjusting Patent Fees (RIN 0651-AD31): The Leahy-Smith America Invents Act (AIA), enacted in 2011, provided USPTO with the authority to set and adjust its fees for patent and trademark services. Since then, USPTO has conducted an internal biennial fee review, in which it undertook internal consideration of the current fee structure, and considered ways that the structure might be improved, including rulemaking pursuant to the USPTO's fee setting authority. This fee review process involves public outreach, including, as required by the Act, public hearings held by the USPTO's Public Advisory Committees, as well as public comment and other outreach to the user community and public in general. In 2019, the USPTO anticipates publishing an NPRM proposing the setting and adjusting of patent fees. The USPTO will set and adjust Patent fee amounts to provide the Office with a sufficient amount of aggregate revenue to recover its aggregate cost of operations while helping the Office maintain a sustainable funding model, reduce the current patent application backlog, decrease patent pendency, improve quality, and upgrade the Office's business information technology capability and infrastructure.

DOC—BUREAU OF INDUSTRY AND SECURITY (BIS)

Final Rule Stage

16. Revisions to the Export Administration Regulations: Control of Firearms and Related Articles the President Determines No Longer Warrant Control Under the United States Munitions List

Priority: Other Significant.

E.O. 13771 Designation: Other.

Legal Authority: 10 U.S.C. 7420; 10 U.S.C. 7430(e); 15 U.S.C. 1824a; 22 U.S.C. 2151 note; 22 U.S.C. 287c; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 22 U.S.C. 7201 et seq.; 22 U.S.C. 7210; 30 U.S.C. 185(s); 30 U.S.C. 185(u); 42 U.S.C. 2139a; 42 U.S.C. 6212; 43 U.S.C. Start Printed Page 578331354; 50 U.S.C. 1701 et seq.; 50 U.S.C. 4601 et seq.; 50 U.S.C. app 2401 et seq.; 50 U.S.C. app 5; E.O. 12058; E.O. 12851; E.O. 12854; E.O. 12918; E.O. 12938; E.O. 12947; E.O. 13020; E.O. 13026; E.O. 13099; E.O. 13222; E.O. 13224; E.O. 13338; E.O. 13637; Pub. L. 108-11

CFR Citation: 15 CFR 740; 15 CFR 742; 15 CFR 774; 15 CFR 736; 15 CFR 743; 15 CFR 744; 15 CFR 746; 15 CFR 748; 15 CFR 758; 15 CFR 762; 15 CFR 772.

Legal Deadline: None.

Abstract: This rule describes how articles the President determines no longer warrant control under United States Munitions List (USML) Category I-Firearms, Close Assault Weapons and Combat Shotguns; Category II-Guns and Armament; and Category III-Ammunition/Ordnance would be controlled on the Commerce Control List (CCL). This rule will be published simultaneously with a proposed rule by the Department of State that would revise Categories I, II, and III of the USML to describe more precisely the articles warranting continued control on that list. This rule also would reorganize and renumber entries currently on the CCL that control shotguns and certain firearms related items to place all firearms related entries close to each other that list.

Statement of Need: This final rule is needed to ensure appropriate controls would be in place on firearms and related items determined to no longer warrant control under the United States Munitions List that would be moved to the Commerce Control List (CCL). This final rule describes how articles the President determines no longer warrant control under United States Munitions List (USML) Category I Firearms, Close Assault Weapons and Combat Shotguns; Category II Guns and Armament; and Category III Ammunition/Ordnance, would be controlled on the Commerce Control List (CCL) and by the Export Administration Regulations (EAR). This rule is being published in conjunction with a proposed rule from the Department of State, Directorate of Defense Trade Controls, which would amend the list of articles controlled by USML Category I (Firearms, Close Assault Weapons and Combat Shotguns), Category II (Guns and Armament), and Category III (Ammunition/Ordnance) of the USML to describe more precisely items warranting continued control on that list.

The changes described in this rule and in the State Department's companion rule on Categories I, II, and III of the USML are based on a review of those categories by the Department of Defense, which worked with the Departments of State and Commerce in preparing the amendments. The review was focused on identifying the types of articles that are now controlled on the USML that are either (i) inherently military and otherwise warrant control on the USML or (ii) if of a type common to non-military firearms applications, possess parameters or characteristics that provide a critical military or intelligence advantage to the United States, and are almost exclusively available from the United States. If an article satisfies one or both of those criteria, the article remains on the USML. If an article does not satisfy either criterion, it has been identified in the new Export Control Classification Numbers (ECCNs) included in this proposed rule. Thus, the scope of the items described in this proposed rule is essentially commercial items widely available in retail outlets and less sensitive military items.

Summary of Legal Basis: This action is taken pursuant to BIS' authority under the Export Administration Regulations (EAR), which regulate exports and reexports to protect national security, foreign policy, and short supply interests. BIS maintains the EAR, which includes the Commerce Control List (CCL), which describes commodities, software, and technology that are subject to licensing requirements for specific reasons for control.

Alternatives: Take no action in order to maintain the status quo by not revising USML Categories I, II, and III and not making the needed conforming changes under the EAR. This alternative was mentioned by some of the public commenters in response to the proposed rule published by BIS on May 24, 2018 (83 FR 24166). BIS will evaluate this (take no action) alternative suggested by some of the commenters, as well as all other comments received on the May 24 proposed rule, when drafting the final rule. The rationale provided in the May 24 proposed rule already addressed why maintaining the status quo was not warranted, but BIS will further address these comments in the final rule. BIS will also address the comments that were supportive of the May 24 proposed rule that agreed with the Departments of Commerce and State that the items described in the two rules reflected what items should be retained on the USML and what items should be moved to the CCL.

Anticipated Cost and Benefits: This final rule involves four collections currently approved by OMB under these BIS collections and control numbers: Simplified Network Application Processing System (control number 0694-0088), which includes, among other things, license applications; License Exceptions and Exclusions (control number 0694-0137); Import Certificates and End-User Certificates (control number 0694-0093); Five Year Records Retention Period (control number 0694-0096); and the U.S. Census Bureau collection for the Automated Export System (AES) Program (control number 0607-0152). This final rule would affect the information collection, under control number 0694-0088, associated with the multi-purpose application for export licenses. This collection carries a burden estimate of 43.8 minutes for a manual or electronic submission for a burden of 31,833 hours. BIS believes that the combined effect of all rules to be published adding items removed from the ITAR to the EAR that would increase the number of license applications to be submitted by approximately 30,000 annually, resulting in an increase in burden hours of 21,900 (30,000 transactions at 43.8 minutes each) under this control number. For those items in USML Categories I, II and III that would move by this rule to the CCL, the State Department estimates that 10,000 applicants annually will move from the USML to the CCL. BIS estimates that 6,000 of the 10,000 applicants would require licenses under the EAR, resulting in a burden of 4,380 hours under this control number. Those companies are currently using the State Department's forms associated with OMB Control No. 1405-0003 for which the burden estimate is 1 hour per submission, which for 10,000 applications results in a burden of 10,000 hours. Thus, subtracting the BIS burden hours of 4,380 from the State Department burden hours of 10,000, the burden would be reduced by 5,620 hours. For purposes of E.O. 13771 of January 30, 2017 (82 FR 9339), the Department of State and Department of Commerce final rules are expected to be net deregulatory actions. The Departments of State and Commerce for purposes of E.O. 13771 have agreed to equally share the cost burden reductions that would result from the publication of these two integral regulatory actions. The Department of State would receive 50% and the Department of Commerce would receive 50% for purposes of calculating the deregulatory benefit of these two integral regulatory actions. For purposes of the Department of Commerce, the net deregulatory actions would result in a permanent and recurring cost savings of $1,250,000 per Start Printed Page 57834year, and a reduction in burden hours by 2,810 hours. The reduction in burden hours by 2,810 would result in an additional cost savings of $126,281 to the exporting public. Therefore, the total dollar cost savings would be $1,376,281 for purposes of E.O. 13771 for the Department of Commerce.

Risks: This final rule must be published concurrently with the Department of State final rule that would revise USML Categories I, II, and II, to provide for appropriate controls on firearms and related items determined to no longer warrant control under the United States Munitions List (USML) that would be moved to the Commerce Control List (CCL) under the Export Administration Regulations (EAR). If this rule were not published, entities would not benefit from simpler license application procedures and reduced (or eliminated) registration fees based on the transfer of jurisdiction of the items described in the rule. Thus, entities would not benefit from reduced administrative costs associated with EAR jurisdiction.

Timetable:

ActionDateFR Cite
NPRM05/24/1883 FR 24166
NPRM Comment Period End07/09/1883 FR 24166
Final Action04/00/19

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Timothy Mooney, Export Policy Analyst, Department of Commerce, Bureau of Industry and Security, 14th Street and Pennsylvania Avenue NW, Washington, DC 20230, Phone: 202 482-3371, Fax: 202 482-3355, Email: timothy.mooney@bis.doc.gov.

Related RIN: Related to 0694-AF17, Merged with 0694-AF48, Merged with 0694-AF49

RIN: 0694-AF47

DOC—NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION (NOAA)

Proposed Rule Stage

17. Magnuson-Stevens Act; Fishery Management Councils; Financial Disclosure and Recusal

Priority: Other Significant.

E.O. 13771 Designation: Other.

Legal Authority: 16 U.S.C. 1801 et seq.

CFR Citation: 50 CFR 600.

Legal Deadline: None.

Abstract: Current regulations require that fishery management council members disclose any financial interest in harvesting, processing, lobbying, advocacy, or marketing activity that is being, or will be, undertaken within any fishery over which the Fishery Management Council (Council) concerned has jurisdiction. Furthermore, current implementing regulations also require the voting recusal of an appointed Council member when a Council decision would have a significant and predictable effect on the member's financial interests. NMFS received input from the Fishery Management Council Coordination Committee, the North Pacific Fishery Management Council, the Western Pacific Fishery Management Council, and the New England Fishery Management Council all calling for further guidance and clarification of financial disclosure requirements of Council members and the regulatory procedures to make determinations on voting recusals of Council members. This proposed action would articulate the guidance necessary to: Provide consistency and transparency in the calculation of a Council member's financial interests; provide clarity consistent with statutory language to ensure that any recusal is based on a close causal link between a Council decision and a benefit to a Council member's financial interest; and establish regional procedures for preparing and issuing recusal determinations.

Statement of Need: NMFS received input from regional Fishery Management Councils calling for further guidance and clarification of financial disclosure requirements of Council members and the regulatory procedures to make determinations on voting recusals of Council members. This proposed rule makes changes to the regulations that address disclosure of financial interests by, and voting recusal of, Council members appointed by the Secretary of Commerce. The regulatory changes are needed to provide the guidance for (1) consistency and transparency in the calculation of a Council member's financial interests; (2) determining whether a close causal link exists between a Council decision and a benefit to a Council members financial interest; and (3) establishing regional procedures for preparing and issuing recusal determinations. This proposed rule is intended to improve regulations implementing the statutory requirements governing disclosure of financial interests and voting recusal at section 302(j) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

Summary of Legal Basis: Magnuson-Stevens Fishery Conservation and Management Act.

Alternatives: The alternatives are (1) the status quo (keep the regulatory scheme as it currently is) and (2) update the regulations to provide consistency, transparency, and clarity in the regulations and to establish regional procedures for preparing and issuing recusal determinations.

Anticipated Cost and Benefits: This rule is administrative in nature. It does not directly regulate a particular fishery. Instead, it provides guidance and improved clarity about implementing existing requirements. Because the proposed rule will not directly alter the behavior of any entities that operate in federally managed fisheries, no direct economic effects are expected to result from this action. This action may indirectly result in positive net economic benefits in the long-term by improving transparency and providing increased predictability about the voting procedures of the Councils. This increased transparency provides a net benefit to the nation.

Risks: Because the regulations lack guidance on several key aspects of reaching a recusal determination, and provide little guidance on the procedures to be followed when preparing and issuing a recusal determination, designated officials have developed differing practices over time to fill in these regulatory gaps and to address new factual circumstances that have arisen. The risk in not updating the regulations would be a continuation of the lack of clarity and consistency in the implementation of the current regulations.

Timetable:

ActionDateFR Cite
NPRM10/00/18

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal.

Agency Contact: Alan Risenhoover, Director, Office of Sustainable Fisheries, Department of Commerce, National Oceanic and Atmospheric Administration, 1315 East-West Highway, Room 13362, Silver Spring, MD 20910, Phone: 301 713-2334, Fax: 301 713-0596, Email: alan.risenhoover@noaa.gov.

RIN: 0648-BH73

Start Printed Page 57835

DOC—NOAA

18. Magnuson-Stevens Fisheries Conservation and Management Act; Traceability Information Program for Seafood

Priority: Other Significant.

E.O. 13771 Designation: Other.

Legal Authority: 16 U.S.C. 1801 et seq.; Pub. L. 115-141

CFR Citation: 50 CFR 698.

Legal Deadline: Final, Statutory, December 31, 2018, Sec 539 of H.R. 1625—Consolidated Appropriations Act, 2018.

Abstract: On December 9, 2016, NMFS issued a final rule that established a risk-based traceability program to track seafood from harvest to entry into U.S. commerce. The final rule included, for designated priority fish species, import permitting and reporting requirements to provide for traceability of seafood products offered for entry into the U.S. supply chain, and to ensure that these products were lawfully acquired and are properly represented. Shrimp and abalone products were included in the final rule to implement the Seafood Import Monitoring Program, but compliance with Seafood Import Monitoring Program requirements for those species was stayed indefinitely due to the disparity between Federal reporting programs for domestic aquaculture of shrimp and abalone products relative to the requirements that would apply to imports under Seafood Import Monitoring Program. In Section 539 of the Consolidated Appropriations Act, 2018, Congress mandated lifting the stay on inclusion of shrimp and abalone in Seafood Import Monitoring Program and authorized the Secretary of Commerce to require comparable reporting and recordkeeping requirements for domestic aquaculture of shrimp and abalone. This rulemaking would establish permitting, reporting and recordkeeping requirements for domestic producers of shrimp and abalone from the point of production to entry into commerce.

Statement of Need: Section 539 of the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2018 (2018 Appropriations Act) directed the Secretary of Commerce to “establish a traceability program for United States inland, coastal, and marine aquaculture of shrimp and abalone” and by December 31, 2018 to “promulgate such regulations as are necessary and appropriate to establish and implement the program.” The proposed Traceability Information Program for Seafood (TIPS) would establish registration, reporting and recordkeeping requirements for domestic, commercial aquaculture producers of shrimp and abalone species and products containing those species from the point of production to entry into U.S. commerce. TIPS would close the domestic reporting and recordkeeping gap and enable NOAA to add imported shrimp and abalone to the Seafood Import Monitoring Program (SIMP), which was mandated under the 2018 Appropriations Act and finalized under 50 CFR 300.324 in a final rule (0648-BH89; 83 FR 17762) published April 24, 2018.

Summary of Legal Basis: Magnuson-Stevens Fishery Conservation and Management Act; Commerce, Justice, Science, and Related Agencies Appropriations Act, 2018.

Alternatives: Coextensive with the scope of SIMP, the Traceability Information Program for Seafood would establish a domestic traceability program for aquaculture shrimp and abalone traces fish and fish products from production to entry into U.S. commerce. NMFS will solicit public input on alternatives to the registration, reporting and recordkeeping requirements for U.S. shrimp and abalone aquaculture producers in the proposed rule.

Anticipated Cost and Benefits: The costs of the Traceability Information Program for Seafood, as proposed, would include a small registration fee and labor associated with reporting harvest information to NMFS as well as compliance with any requests for audit or inspection. The Traceability Information Program for Seafood would enable NMFS to determine the origin of the domestic aquaculture shrimp and abalone products and confirm that they were lawfully produced. The Traceability Information Program for Seafood will close the domestic reporting and recordkeeping gap and enable NMFS to add imported shrimp and abalone to the Seafood Import Monitoring Program, which will prevent illegally harvested or misrepresented seafood products from entering U.S. commerce, thereby leveling the playing field for law abiding shrimp and abalone producers in the U.S. and around the world.

Risks: Failure to implement the Traceability Information Program for Seafood would violate Section 539 of the 2018 Appropriations Act and likely provoke challenges to the Seafood Import Monitoring Program in international trade fora.

Timetable:

ActionDateFR Cite
NPRM10/00/18

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.

Agency Contact: John Henderschedt, Director, Office for International Affairs and Seafood Inspection, Department of Commerce, National Oceanic and Atmospheric Administration, 1315 East-West Highway, Room 10362, Silver Spring, MD 20910, Phone: 301 427-8314, Email: john.henderschedt@noaa.gov.

Related RIN: Related to 0648-BF09

RIN: 0648-BH87

DOC—NOAA

Final Rule Stage

19. Taking and Importing Marine Mammals: Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico

Priority: Other Significant.

E.O. 13771 Designation: Regulatory.

Legal Authority: 16 U.S.C. 1361 et seq.

CFR Citation: 50 CFR 217.

Legal Deadline: None.

Abstract: The National Marine Fisheries Service is taking this action in response to an October 17, 2016 petition from the U.S. Department of Interior (DOI), Bureau of Ocean Energy Management (BOEM), to promulgate regulations governing the authorization of take of marine mammals incidental to oil and gas industry geophysical surveys conducted in support of hydrocarbon exploration and development on the Outer Continental Shelf in the Gulf of Mexico from approximately 2018 through 2023.

Statement of Need: The Marine Mammal Protection Act (MMPA) prohibits the “take” (e.g., behavioral harassment, injury, or mortality) of marine mammals with certain exceptions, including through the issuance of incidental take authorizations. Where there is a reasonable likelihood of an activity resulting in the take of marine mammals—as is the case for certain methods of geophysical exploration, including the use of airgun arrays (i.e., “seismic surveys”)—action proponents must ensure that take occurs in a lawful Start Printed Page 57836manner. However, there has not previously been any analysis of industry survey activities in the Gulf of Mexico conducted pursuant to requirements of MMPA, and industry operators have been, and currently are, conducting their work without MMPA incidental take authorizations. In support of the oil and gas industry, the Bureau of Ocean Energy Management has requested 5-year incidental take regulations, which would provide a regulatory framework under which individual companies could apply for project-specific Letters of Authorization. Providing for industry compliance with the MMPA through the requested regulatory framework, versus companies pursuing individual authorizations, would be the most efficient way to achieve such compliance for both industry and for NMFS, and would provide regulatory certainty for industry operators.

Summary of Legal Basis: Marine Mammal Protection Act.

Alternatives: The regulatory impact analysis considers several alternatives with varying amounts of required mitigation by industry authorization-holders. The proposed rule seeks comment on the extent to which certain areas should be closed to geophysical activity, the distance at which operators must shut down upon detection of specified species of whales, and the mitigation requirements concerning large dolphins.

Anticipated Cost and Benefits: The rule would include mitigation, monitoring, and reporting requirements, as required by the MMPA. The rule analyzes the impacts against two baselines—the current mitigation requirements as stipulated in a settlement agreement currently in effect until November 1, 2018, and the requirements prior to the settlement agreement. Compared to the settlement agreement, the annualized impacts of the proposed rule are estimated to achieve a cost savings of $11 million to $147 million. Compared to the pre-settlement agreement baseline the annualized costs are estimated to range from $49 million to $182 million. The rule would also result in certain non-monetized benefits. The lessened risk of harm to marine mammals afforded by this rule (pursuant to the requirements of the MMPA) would benefit the regional economic value of marine mammals via tourism and recreation to some extent, as mitigation measures applied to geophysical survey activities in the Gulf of Mexico (GOM) region are expected to benefit the marine mammal populations that support this economic activity in the GOM. The rule would also afford significant benefit to the regulated industry by providing an efficient framework within which compliance with the MMPA, and the attendant regulatory certainty, may be achieved. Cost savings may be generated in particular by the reduced administrative effort required to obtain an LOA under the framework established by a rule compared to what would be required to obtain an incidental harassment authorization (IHA) under section 101(a)(5)(D) of the MMPA. Absent the rule, survey operators in the GOM would likely be required to apply for an IHA. Although not monetized, NMFSs analysis indicates that the upfront work associated with the rule (e.g., analyses, modeling, process for obtaining LOA) would likely save significant time and money for operators.

Risks: Absent the rule, oil and gas industry operators would face a highly uncertain regulatory environment due to the imminent threat of litigation. BOEM currently issues permits under a stay of ongoing litigation; in the absence of the rule, the litigation would continue. The IHA application process that would be available to companies would be more expensive and time-consuming.

Timetable:

ActionDateFR Cite
NPRM06/22/1883 FR 29212
NPRM Comment Period End08/21/18
Final Action02/00/19

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Energy Effects: Statement of Energy Effects planned as required by Executive Order 13211.

Agency Contact: Donna Wieting, Director, Office of Protected Resources, Department of Commerce, National Oceanic and Atmospheric Administration, National Marine Fisheries Service, 1315 East-West Highway, Silver Spring, MD 20910, Phone: 301 427-8400.

RIN: 0648-BB38

DOC—NOAA

20. Commerce Trusted Trader Program

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

Legal Authority: 16 U.S.C. 1801 et seq.

CFR Citation: 50 CFR 300.

Legal Deadline: None.

Abstract: This rule will establish a voluntary Commerce Trusted Trader Program for importers, aiming to provide benefits such as reduced targeting and inspections and enhanced streamlined entry into the United States for certified importers. Specifically, this rule would establish the criteria required of a Commerce Trusted Trader, and identify specifically how the program will be monitored and by whom. It will require that a Commerce Trusted Trader establish a secure supply chain and maintain the records necessary to verify the legality of all designated product entering into U.S. commerce, but will excuse the Commerce Trusted Trader from entering that data into the International Trade Data System prior to entry, as required by Seafood Import Monitoring Program (finalized on December 9, 2016). The rule will identify the benefits available to a Commerce Trusted Trader, detail the application process, and specify how the Commerce Trusted Trader will be audited by third-party entities while the overall program will be monitored by the National Marine Fisheries Service.

Statement of Need: Under the Magnuson-Stevens Fishery Conservation and Management Act, importation of fish products taken in violation of foreign law and regulation is prohibited. To enforce this prohibition, NMFS has implemented the Seafood Import Monitoring Program (SIMP) (81 FR 88975, December 9, 2016) which requires U.S. importers to report on the origin of fish products and to keep supply chain records. The Commerce Trusted Trader Program was recommended by an interagency working group to reduce the burden of SIMP compliance for importers with secure supply chains by reducing reporting requirements for entry into U.S. commerce and allowing more flexible approaches to retaining supply chain records.

Summary of Legal Basis: Magnuson-Stevens Fishery Conservation and Management Act.

Alternatives: SIMP is aimed at preventing the infiltration of illegal fish products into the U.S. market. Alternatives to reduce the reporting and recordkeeping burden for U.S. importers were considered during the course of that rulemaking. Collecting less information at import about the origin of products would increase the likelihood of illegal products entering the supply chain. However, working with individual traders to secure the supply chain will be an economical approach to ensure that illegal products are precluded and records will be kept as needed for post-entry audits. The Commerce Trusted Trader Program is designed to allow those entities who Start Printed Page 57837demonstrate a robust traceability and internal control system, and submit to annual third-party audits of their system, to benefit from reduced reporting requirements of SIMP species at the time of entry as well as flexibility in how they maintain the complete chain of custody records within their secure supply chain.

Anticipated Cost and Benefits: The Commerce Trusted Trader Program, as proposed, will result in an estimated industry-wide savings between $0.50 and $1.21 million annually. Anticipated costs are minimal and include a one-time application fee of $30.00 and associated labor costs of developing application materials. Commerce Trusted Traders will benefit from the reduced reporting costs at entry and reduced recordkeeping costs due to flexibility in archiving chain of custody records, but incur costs to perform an annual third-party audit of adherence to their Compliance Plan.

Risks: While there is no risk of not implementing a Commerce Trusted Trader Program, not doing so would deprive industry of potentially significant cost savings for an existing regulatory program.

Timetable:

ActionDateFR Cite
NPRM01/17/1883 FR 2412
NPRM Comment Period End03/19/18
Final Action11/00/18

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: John Henderschedt, Director, Office for International Affairs and Seafood Inspection, Department of Commerce, National Oceanic and Atmospheric Administration, 1315 East-West Highway, Room 10362, Silver Spring, MD 20910, Phone: 301 427-8314, Email: john.henderschedt@noaa.gov.

Related RIN: Related to 0648-BF09

RIN: 0648-BG51

DOC—PATENT AND TRADEMARK OFFICE (PTO)

Proposed Rule Stage

21. Setting and Adjusting Patent Fees

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

E.O. 13771 Designation: Fully or Partially Exempt.

Legal Authority: Pub. L. 112-29

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: The USPTO operates like a business in that it fulfills requests for intellectual property products and services that are paid for by users of those services. The USPTO takes this action to set and adjusts patent fee amounts to provide sufficient aggregate revenue to cover aggregate cost of operations.

Statement of Need: The purpose of this rule is to set and adjust patent fee amounts to provide sufficient aggregate revenue to cover the agency's aggregate cost of operations. To this end, this rule creates new or changes existing fees for patent services, and does so without imposing any new costs.

Summary of Legal Basis: The Leahy-Smith America Invents Act (AIA), enacted in 2011, provided USPTO with the authority to set and adjust its fees for patent and trademark services. Since then, USPTO has conducted an internal biennial fee review, in which it undertook internal consideration of the current fee structure, and considered ways that the structure might be improved, including rulemaking pursuant to the USPTO's fee setting authority. This fee review process involves public outreach, including, as required by the Act, public hearings held by the USPTO's Public Advisory Committees, as well as public comment and other outreach to the user community and public in general.

Alternatives: This rulemaking action is currently in development and alternatives have not yet been determined.

Anticipated Cost and Benefits: This rulemaking action is currently in development and aggregate annual economic impacts have not yet been determined. It is anticipated that the final rule would become effective with the new fee schedule in 2020.

Risks: The USPTO will set and adjust Patent fee amounts to provide the Office with a sufficient amount of aggregate revenue to recover its aggregate cost of operations while helping the Office maintain a sustainable funding model, reduce the current patent application backlog, decrease patent pendency, improve quality, and upgrade the Office's business information technology capability and infrastructure. Therefore, one risk of taking no action could be that USPTO might not be able to recover its aggregate costs of operations in the long run.

Timetable:

ActionDateFR Cite
NPRM09/00/19
NPRM Comment Period End11/00/19
Final Action08/00/20
Final Action Effective10/00/20

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Agency Contact: Brendan Hourigan, Director, Office of Planning and Budget, Department of Commerce, Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450, Phone: 571 272-8966, Fax: 571 273-8966, Email: brendan.hourigan@uspto.gov.

RIN: 0651-AD31

DEPARTMENT OF DEFENSE

Statement of Regulatory Priorities

Background

The Department of Defense (DoD) is the largest Federal department, employing over 1.3 million military personnel and 742,000 civilians with operations all over the world. DoD's enduring mission is to provide combat-credible military forces needed to deter war and protect the security of our nation. In support of this mission, DoD adheres to a strategy where a more lethal force, strong alliances and partnerships, American technological innovation, and a culture of performance will generate a decisive and sustained United States military advantage. Because of this expansive and diversified mission and reach, DoD regulations can address a broad range of matters and have an impact on varied members of the public, as well as a multitude of other federal agencies.

The regulatory and deregulatory actions identified in this Regulatory Plan embody the core of DoD's regulatory priorities for Fiscal Year (FY) 2019 and help support or impact the Secretary's three lines of efforts to: (1) Build a more lethal force; (2) strengthen alliances and attract new partners; and (3) reform the Department for greater performance and affordability. These actions originate within three of DoD's Start Printed Page 57838main regulatory components—the Office of the Under Secretary of Defense for Acquisition and Sustainment (OUSD(A&S)), which is responsible for contracting and procurement policy, the Office of the Under Secretary of Defense for Personnel and Readiness (OUSD(P&R)), which supports troop readiness and health affairs, and the Department of the Army through the United States Army Corps of Engineers (USACE), which provides engineering services to support the national interest. The missions of these offices are discussed more fully below.

DoD's Regulatory Philosophy and Principles

The Department's regulatory program strives to be responsive, efficient, and transparent. DoD adheres to the general principles set forth in Executive Order (E.O.) 12866, “Regulatory Planning and Review,” dated October 4, 1993, by promulgating only those regulations that are required by law, necessary to interpret the law, or are made necessary by compelling public need. By following this regulatory philosophy, the Department's regulatory program also compliments and advances the Secretary's third line of effort—to reform the Department for greater performance and affordability.

The Department is also fully committed to implementing and sustaining regulatory reform in accordance with Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs,” dated January 30, 2017, and Executive Order 13777, “Enforcing the Regulatory Reform Agenda,” dated February 24, 2017. These reform efforts support DoD's goals to eliminate outdated, unnecessary, or ineffective regulations; account for the currency and legitimacy of each of the Department's regulations; and ultimately reduce regulatory burden and costs placed on the American people. Specifically in support of DoD's reform efforts, DoD appointed a Regulatory Reform Officer to oversee the implementation of regulatory reform initiatives and policies. DoD also established a Regulatory Reform Task Force (Task Force) to review and evaluate existing regulations and make recommendations to the Agency head regarding their repeal, replacement, or modification, consistent with applicable law.

DoD is implementing its reform efforts in three general phases:

  • Phase I: Utilizing the Task Force, assess all 716 existing, codified DoD regulations to include 350 solicitation provisions and contract clauses contained in the Defense Federal Acquisition Regulation Supplement (DFARS). The Task Force will present recommendations for the repeal, replacement, or modification to the Secretary of Defense on a quarterly basis through the end of December 2018.
  • Phase II: Implementing the approved recommendations. Implementation requires drafting, internal coordination, review by the Office of Management and Budget, and providing for notice and comment, as required by law.
  • Phase III: Incorporating into its policies a requirement for components to sustain review of both new regulatory actions and existing regulations.

In FY 2019, based primarily on the ongoing work of the Task Force, DoD expects to publish more deregulatory actions than regulatory actions. Exact figures are not yet available as the regulations reported in this edition of the Unified Agenda are still under evaluation for classification under Executive Order 13771. Additionally, the Task Force will continue working to execute directives under Executive Orders 13783 and 13807 to streamline its regulatory process and permitting reviews.

In addition to reform efforts, DoD is also mindful of the importance of international regulatory cooperation, consistent with domestic law and trade policy, as described in Executive Order 13609, “Promoting International Regulatory Cooperation” (May 1, 2012). For example, DoD, along with the Departments of State and Commerce, engages with other countries in the Wassenaar Arrangement, Nuclear Suppliers Group, Australia Group, and Missile Technology Control Regime through which the international community develops a common list of items that should be subject to export controls. DoD has been a key participant in the Administration's Export Control Reform effort that resulted in a complete overhaul of the U.S. Munitions List and fundamental changes to the Commerce Control List. New controls have facilitated transfers of goods and technologies to allies and partners while helping prevent transfers to countries of national security and proliferation concern. In this context, DoD will continue to assess new and emerging technologies to ensure items that provide critical military and intelligence capabilities are properly controlled on international export control regime lists.

DoD Priority Regulatory Actions

As stated above, OUSD (A&S), OUSD (P&R), and the Department of the Army will be planning actions that are considered the most important significant DoD regulatory actions for FY 2019. During the next year, these DoD Components plan to publish 15 rulemaking actions that are designated as significant actions. Further information on these actions is provided below.

OUSD (A&S)/Defense Pricing and Contracting (DPC)

DPC is responsible for all contracting and procurement policy matters in the Department and uses the Defense Acquisition Regulations System (DARS) to develop and maintain acquisition rules and to facilitate the acquisition workforce as they acquire goods and services. For this component, DoD is highlighting the following rules:

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

Rulemakings that promote Open Government and use disclosure as a regulatory tool.

Brand Name or Equal (DFARS Case 2017-D040). RIN: 0750-AJ50

This rule proposes to amend the DFARS to implement section 888 of the NDAA for FY 2017. Section 888 requires DoD to justify when a solicitation includes “brand name or equal” specifications, which could limit competition by unnecessarily restricting offerors to a limited set of specifications. Currently, if the Government intends to procure specific “brand name” products, the contracting officer must prepare a justification and obtain the appropriate approval based on the estimated dollar value of the contracts. However, a justification is not required to use “brand name or equal” descriptions in a solicitation. To implement section 888, this rule proposes to amend the DFARS to require contracting officers to obtain an approval of a justification for use of “brand name or equal” descriptions, which would then be posted with the covered solicitation. It is expected that this rule will both promote transparency with industry by disclosing the basis for the Government's decision to limit competition and, in turn, present an opportunity to increase competition.

Rulemakings that streamline regulations and reduce unjustified burdens.

Contractor Purchasing System Review Threshold (DFARS Case 2017-D038). RIN: 0750-AJ48

This rule proposes to amend the DFARS to raise the threshold for determining when a contractor purchasing system review (CPSR) is required. The Government will conduct Start Printed Page 57839a CPRS in order to evaluate the efficiency and effectiveness with which a prime contractor spends Government funds and complies with Government policy when subcontracting. Currently, if a prime contractor's sales to the Government are expected to exceed $25 million during the next 12 months, then the administrative contracting officer (ACO) will determine whether there is a need for a CPSR. This rule proposes to amend the DFARS to raise the dollar threshold at which an ACO makes the determination to conduct a CPSR to $50 million for DoD contracts. It is expected that this rule may reduce the number of CPSRs conducted by DoD and, in turn, alleviate the burden on contractors associated with participating in the CPSR.

Rules modifying, streamlining, expanding, or repealing regulations making DoD's regulatory program more effective or less burdensome in achieving regulatory objectives.

Submission of Summary Subcontract Reports (DFARS Case 2017-D005). RIN: 0750-AJ42

This rule proposes to amend the DFARS to clarify the entity to which contractors submit Summary Subcontract Reports in the Electronic Subcontracting Reporting System (eSRS) and to clarify the entity that acknowledges receipt of, or rejects, the reports in eSRS. This rule streamlines the submission and review of Summary Subcontract Reports (SSRs) for DoD contractors and brings the DFARS into compliance with changes in the Federal Acquisition Regulation. Instead of submitting multiple SSRs to various departments and agencies within DoD, contractors with individual subcontracting plans will submit a single, consolidated SSR in eSRS at the DoD level. The consolidated SSR will be acknowledged or rejected in eSRS at the DoD level.

OUSD (P&R)/Assistance Secretary of Defense for Health Affairs

The mission of DoD's health program is to enhance the Department of Defense and our Nation's security by providing health support for the full range of military operations and sustaining the health of all those entrusted to our care by creating a world-class health care system that supports the military mission by fostering, protecting, sustaining and restoring health.

TRICARE is the health care program for uniformed service members including active duty and retired members of the U.S. Army, U.S. Air Force, U.S. Navy, U.S. Marine Corps, U.S. Coast Guard, the Commissioned Corps of the U.S. Public Health Service and the Commissioned Corps of the National Oceanic and Atmospheric Association and their families around the world. It serves 9.5 million individuals worldwide. It continues to offer an increasingly integrated and comprehensive health care plan, refining and enhancing both benefits and programs in a manner consistent with the law, industry standard of care, and best practices, to meet the changing needs of its beneficiaries. The program's goal is to increase access to health care services, improve health care quality, and control health care costs.

For this component, DoD is highlighting the following rule:

Establishment of TRICARE Select and Other TRICARE Reforms. RIN: 0720-AB70

This final rule implements the primary features of section 701 and partially implements several other sections of the National Defense Authorization Act for Fiscal Year 2017 (NDAA-17). The rule makes significant changes to the TRICARE program, especially to the health maintenance organization (HMO)-like health plan known as TRICARE Prime; to the preferred provider organization (PPO) health plan previously known as TRICARE Extra and replaced by TRICARE Select; and to the third health care option known as TRICARE Standard, which was terminated December 31, 2017, and is also replaced by TRICARE Select.

The statute also adopts a new health plan enrollment system under TRICARE and new provisions for access to care, high value services, preventive care, and healthy lifestyles. In implementing section 701 and partially implementing several other sections of NDAA-17, this rule advances all four components of the Military Health System's quadruple aim of improved readiness, better care, better health, and lower cost. The aim of improved readiness is served by reinforcing the vital role of the TRICARE Prime health plan to refer patients, particularly those needing specialty care, to military medical treatment facilities (MTFs) in order to ensure that military health care providers maintain clinical currency and proficiency in their professional fields.

The objective of better care is enhanced by a number of improvements in beneficiary access to health care services, including increased geographical coverage for the TRICARE Select provider network, reduced administrative hurdles for TRICARE Prime enrollees to obtain urgent care services and specialty care referrals, and promotion of high value services and medications. The goal of better health is advanced by expanding TRICARE coverage of preventive care services, treatment of obesity, high-value care, and telehealth. Finally, the aim of lower cost is furthered by refining cost-benefit assessments for TRICARE plan specifications that remain under DoD's discretion and adding flexibilities to incentivize high-value health care services.

USACE

The United States Army Corps of Engineers (USACE), is a major Army command made up of some 37,000 civilian and military personnel, making it one of the world's largest public engineering, design, and construction management agencies. Although generally associated with flood and coastal storm damage reduction, commercial navigation, and aquatic ecosystem restoration in the United States, USACE is involved in a wide range of public works throughout the world.

The USACE's mission is to “Deliver vital public and military engineering services; partnering in peace and war to strengthen our Nation's security, energize the economy and reduce risks from disasters.” The most visible missions include:

  • Water resources development activities including flood risk management, navigation, aquatic ecosystem restoration, recreation, emergency response, and environmental stewardship
  • Design and construction management of military facilities for the Army, Air Force, Army Reserve and Air Force Reserve and other Defense and Federal agencies.

For this component, DoD is highlighting the following rules.

Waters of the United States. RINs: 0710-AA79, 0710-AA80

In 2015, the Environmental Protection Agency and the Department of the Army (“the agencies”) published the “Clean Water Rule: Definition of `Waters of the United States' ” (80 FR 37054, June 29, 2015). On October 9, 2015, the U.S. Court of Appeals for the Sixth Circuit stayed the 2015 rule nationwide pending further action of the court. On February 28, 2017, the President signed Executive Order 13778, “Restoring the Rule of Law, Federalism, and Economic Growth by Reviewing the `Waters of the United States' Rule” which instructed the agencies to review the 2015 rule and rescind or replace it as appropriate and consistent with law. On July 27, 2017, Start Printed Page 57840the agencies published a Federal Register notice proposing to repeal (STEP 1 of a comprehensive 2-STEP process) the 2015 Clean Water Rule (2015 Rule) and recodify the pre-existing regulations; the initial 30-day comment period was extended an additional 30 days to September 28, 2017. The agencies signed a supplemental notice of proposed rulemaking on June 29, 2018, clarifying and seeking additional comment on the proposal.

In Step 2 (Revised Definition of `Waters of the United States'), the agencies plan to propose a new definition that would replace the prior regulations and the approach in the CWR2015 Rule. In determining the possible new approach, the agencies are considering defining “navigable waters” in a manner consistent with the plurality opinion of Justice Antonin Scalia in the Rapanos decision, as instructed by Executive Order 13778, “Restoring the Rule of Law, Federalism, and Economic Growth by Reviewing the `Waters of the United States' Rule.”

On February 6, 2018, the agencies issued a final rule adding an applicability date to the CWR2015 Rule of February 6, 2020, to provide continuity and certainty for regulated entities, the States and Tribes, and the public while the agencies conduct STEP 2 of the rulemaking. Until the new definition is finalized, the agencies will continue to implement the regulatory definition in place prior to the CWR consistent with Supreme Court decisions and practice, and as informed by applicable agency guidance documents.

Regulatory Program of the Army Corps of Engineers Tribal Consultation and National Historic Preservation Act Compliance. RIN: 0710-AA75

The USACE recognizes the sovereign status of Indian tribes (as defined by Executive Order 13175) and our obligation for pre-decisional government-to-government consultation, as established through and confirmed by the U.S. Constitution, treaties, statutes, executive orders, judicial decisions, and Presidential documents and policies, on proposed regulatory actions (e.g., individual permit decisions and general permit verifications). The USACE Regulatory Program's regulations for considering the effects of its actions on historic properties as required under Section 106 of the National Historic Preservation Act (NHPA) are outlined at 33 CFR 325 Appendix C. Since these regulations were promulgated in 1990, there have been amendments to the NHPA and revisions to Advisory Council on Historic Preservation's (ACHP) regulations at 36 CFR part 800 subpart B, addressing, among other things, tribal consultation requirements. In response, the USACE issued interim guidance until rulemaking could be completed in order to ensure full compliance with the NHPA and ACHP's regulations. The USACE seeks to revise its regulations to conform to these requirements.

Policy for Domestic, Municipal, and Industrial Water Supply Uses of Reservoir Projects Operated by the Department of the Army, U.S. Army Corps of Engineers. RIN: 0710-AA72

The USACE is updating and clarifying its policies governing the use of its reservoir projects for domestic, municipal and industrial water supply pursuant to Section 6 of the Flood Control Act of 1944 and the Water Supply Act of 1958 (WSA). The USACE intends through this rulemaking to explain and improve its interpretations and practices under these statutes. The rule is intended to enhance the USACE's ability to cooperate with State and local interests in the development of water supplies in connection with the operation of its reservoirs for federal purposes as authorized by Congress, to facilitate water supply uses of USACE reservoirs by others as contemplated under applicable law, and to avoid interfering with lawful uses of water by any entity when the USACE exercises its discretionary authority under either section 6 or the WSA. The rule would apply only to reservoir projects operated by the USACE, not to projects operated by other federal or non-federal entities, and it would not impose requirements on any other entity, alter existing contractual arrangements at USACE reservoirs, or require operational changes at any Corps reservoir.

Natural Disaster Procedures: Preparedness, Response, and Recovery Activities of the Corps of Engineers. RIN: 0710-AA78

The USACE is proposing to update its regulations for USACE's natural disaster procedures pursuant to Section 5 of the Flood Control Act of 1941, as amended (33 U.S.C. 701n), commonly referred to as Public Law 84-99. The revisions are necessary to incorporate elements of the Water Resources and Reform Development Act of 2014 (WRRDA 2014), and update procedures concerning USACE authority to address disaster preparedness, response, and recovery activities. The revisions relating to WRRDA 2014 include the authority to implement modifications to Flood Control Works (FCW) and Coastal Storm Risk Management Projects (formerly referred to as Hurricane and Shore Protection Projects); and the authority to implement nonstructural alternatives to rehabilitation, if requested by the non-federal sponsor. Other significant changes under consideration include revisions to the eligibility criteria for rehabilitation assistance for FCW, an increase to the minimum repair cost for FCW projects, revised policies to address endangered species and vegetation management during rehabilitation, and a change in the cost share for emergency measures constructed using permanent construction standards.

Compensatory Mitigation for Losses of Aquatic Resources—Review and Approval of Mitigation Banks and In-Lieu Fee Programs. RIN: 0710-AA83

This rule proposes to amend the regulations governing the review and approval process for mitigation banks and in-lieu fee programs, which are used to provide compensatory mitigation that offsets losses of jurisdictional waters and wetlands authorized by Department of the Army permits. Those regulations also include time frames for certain steps in the mitigation bank and in-lieu fee program review and approval process. The review and approval process for mitigation banks and in-lieu fee programs includes an opportunity for public and agency review and comment, as well as a second review by an interagency review team. The interagency review team consists of federal, tribal, state, and local agencies that review documentation and provide the United States Army Corps of Engineers (USACE) with advice on the establishment and management of mitigation banks and in-lieu fee programs. The USACE is reviewing the review and approval process and the interagency review team process in particular to determine whether and how it can enhance the efficiency of those processes. An increase in efficiency could result in savings to the public if it results in similar or improved outcomes with shorter review times and thereby reduce risk and uncertainty for mitigation bank and in-lieu fee program sponsors and the costs they incur in obtaining mitigation banking or in-lieu fee program instruments. An increase in review efficiency could also decrease the resources other federal, tribal, state, and local agencies expend in reviewing these activities, attending meetings, participating in site visits, and Start Printed Page 57841providing their comments to the USACE.

Modification of Nationwide Permits. RIN: 0710-AA84

The USACE issues nationwide permits to authorize specific categories of activities in jurisdictional waters and wetlands that have no more than minimal individual and cumulative adverse environmental effects. The issuance and reissuance of nationwide permits must be done every five years to continue the Nationwide Permit Program. The nationwide permits were last issued on December 21, 2016, and expire on March 18, 2022. On October 25, 2017, the USACE issued a report to meet the requirements of Executive Order 13783, Promoting Energy Independence and Economic Growth. In that report, the USACE recommended changes to nine nationwide permits that authorize activities related to domestic energy production and use, including oil, natural gas, coal, and nuclear energy sources, as well as renewable energy sources such as flowing water, wind, and solar energy. This rulemaking action would seek to review and, if appropriate, modify those nine nationwide permits in accordance with the opportunities identified in the report in order to reduce burdens on the public. In addition, the Corps is considering modifying an additional 23 nationwide permits to allow federal agencies to select and use nationwide permits without additional USACE review. This rulemaking action would help simplify the nationwide permit authorization process.

DOD—DEFENSE ACQUISITION REGULATIONS COUNCIL (DARC)

Proposed Rule Stage

22. Contractor Purchasing System Review Threshold (DFARS CASE 2017-D038)

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

Legal Authority: 41 U.S.C. 1303

CFR Citation: 48 CFR 244.

Legal Deadline: None.

Abstract: DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement to establish a higher dollar threshold for conducting contractor purchasing system reviews. This rule proposes, in lieu of the threshold at Federal Acquisition Regulation 44.302(a) of $25 million, the administrative contracting officer shall determine the need for a contractors purchasing system review if a contractor's sales to the Government are expected to exceed $50 million during the next 12 months.

Statement of Need: There is a need to increase the threshold for a contractor purchasing system review from $25 to $50 million to reduce the administrative burden on contractors and the Government for maintaining and reviewing an approved contractor purchasing system.

Summary of Legal Basis: This rule is proposed under the authority at 41 U.S.C. 1303, Functions and authority, which provides the authority to issue and maintain the Federal Acquisition Regulation and executive agency implementing regulations.

Alternatives: No alternatives to this action are being considered at this time.

Anticipated Cost and Benefits: Implementing this rule provides a net annualized savings of approximately $12 million. This estimate is based on data available in the Federal Procurement Data System (FPDS) data for fiscal year 2016, which indicates that 958 unique vendors received awards valued at $25 million or more, but less than $50 million, that were subject to the purchasing system review. Removing this requirement would relieve these contractors from the time and cost burden required to establish, maintain, audit, document, and train for an approved purchasing system.

Risks: If this rule is not finalized, the public will continue to experience additional costs to comply with this rule at the current threshold.

Timetable:

ActionDateFR Cite
NPRM01/00/19

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal.

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

RIN: 0750-AJ48

DOD—DARC

23. Brand Name or Equal (DFARS CASE 2017-D040)

Priority: Other Significant.

E.O. 13771 Designation: Other.

Legal Authority: 41 U.S.C. 1303; Pub. L. 113-291, sec. 888; 10 U.S.C. 2304(f)

CFR Citation: 48 CFR 206; 48 CFR 211.

Legal Deadline: Final, Statutory, December 23, 2016, Effective upon enactment.

Abstract: DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement to implement section 888 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017, which requires that competition not be limited through the use of specifying brand names or brand name or equivalent descriptions, or proprietary specifications and standards, unless a justification for such specifications is provided and approved in accordance with 10 U.S.C. 2304(f).

Statement of Need: This case is necessary to ensure contracting officers comply with section 888 of the NDAA for FY 2015 (Pub. L. 113-291). Specifically, it will ensure contracting officers properly justify for the use of brand name and brand name or equivalent descriptions, or proprietary specifications or standards.

Summary of Legal Basis: This rule is proposed under the authority at 41 U.S.C. 1303, Functions and authority, which provides the authority to issue and maintain the Federal Acquisition Regulation and executive agency implementing regulations. In addition, this rule is necessary to implement the statutory amendments made by section 888 of the NDAA for FY 2017.

Alternatives: There are no viable alternatives that are consistent with the stated objectives of the statute.

Anticipated Cost and Benefits: The Department does not expect this proposed rule to have any cost impact on contractors or offerors. Rather, preparing a justification for the use of brand name descriptions or specifications provides increased transparency into the acquisition planning and source selection strategy process for department goods and services.

Risks: If this rule is not finalized, the department will not be in compliance with section 888 of the NDAA for FY 2017, therefore losing an opportunity to increase competition, expand the defense industrial base and secure reduced pricing.

Timetable:

ActionDateFR Cite
NPRM10/00/18

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal.

Agency Contact: Jennifer Hawes, Defense Acquisition Regulations System, Department of Defense, 3060 Defense Pentagon, Room 3B941, Start Printed Page 57842Washington, DC 20301-3060, Phone: 571 372-6115, Email: jennifer.l.hawes2.civ@mail.mil.

RIN: 0750-AJ50

DOD—DARC

Final Rule Stage

24. Submission of Summary Subcontract Report (DFARS CASE 2017-D005)

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

Legal Authority: 41 U.S.C. 1303

CFR Citation: 48 CFR 252.

Legal Deadline: None.

Abstract: DoD is issuing a final rule to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to clarify the entity to which Summary Subcontract Reports (SSRs) are to be submitted and the entity that acknowledges receipt of, or rejects, SSRs in the Electronic Subcontracting Reporting System (eSRS). The SSR is used to collect prime contractors' and subcontractors' subcontract award data for a specific Federal Government agency when the prime or subcontractor: (a) Holds one or more contracts over $700,000 (over $1,500,000 for construction of a public facility); and (b) is required to report subcontracts awarded to various types of small business under an individual subcontracting plan with the Federal Government. Currently, the contractors submit the SSR to the various individual DoD components (i.e., departments and agencies within DoD) with which they have contracts. As a result of this rule, contractors with individual subcontracting plans will submit a single, consolidated SSR in eSRS at the DoD-level, which will be acknowledged or rejected in eSRS at the DoD-level. These revisions will bring DFARS into compliance with the requirement for a consolidated SSR in the clause at Federal Acquisition Regulation 52.219-9, Small Business Subcontracting Plan. This rule will also have a positive impact on contractors, because they will be able to submit a single consolidated SSR to DoD, instead of multiple SSRs to DoD components.

Statement of Need: The purpose of the rule change is to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a policy that streamlines the submission and review of Summary Subcontract Reports (SSRs) for DoD contractors. Instead of the current practice of submitting multiple SSRs to various departments or agencies within DoD, contractors with individual subcontracting plans will submit one consolidated SSR at the DoD level in the Electronic Subcontracting Reporting System (eSRS). The consolidated SSR will be acknowledged or rejected in eSRS at the DoD level. Large business contractors currently submit SSRs to the department or agency within DoD that administers the majority of the contractor's individual subcontracting plans, and these contractors frequently must submit SSRs to each department or agency within DoD with which they have contracts. This results in extra work for the contractors and creates problems with duplicate subcontracting data. By requiring submission and review of SSRs at the DoD level, this rule identifies a solution for these issues.

Summary of Legal Basis: This rule is issued under the authority at 41 U.S.C. 1303, functions and authority, which provides the authority to issue and maintain the Federal Acquisition Regulation and executive agency implementing regulations.

Alternatives: There are no known alternatives that would achieve the efficiencies expected from this rule. The current submission requirements result in extra work for contractors and create problems with duplicate subcontracting data being reported.

Anticipated Cost and Benefits: By requiring submission and review of SSRs at the DoD level, this rule solves these issues. The following is a summary of the estimated anticipated public cost savings calculated in 2016 dollars at a 7-percent discount rate and in perpetuity:

Annualized Cost Savings: −$25,514.

Present Value Cost Savings: −$364,492.

Risks: There are no identified risks associated with this rule. The rule should serve to eliminate the potential for duplicative reporting of subcontracting data to DoD.

Timetable:

ActionDateFR Cite
NPRM06/29/1883 FR 30666
NPRM Comment Period End08/28/18
Final Action12/00/18
Final Action Effective12/00/18

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal.

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

RIN: 0750-AJ42

DOD—U.S. ARMY CORPS OF ENGINEERS (COE)

Prerule Stage

25. Regulatory Program of the Army Corps of Engineers Tribal Consultation and National Historic Preservation Act Compliance

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Other.

Legal Authority: 33 U.S.C. 1344; 33 U.S.C. 401; 33 U.S.C. 403; 33 U.S.C. 1413

CFR Citation: 33 CFR 325.

Legal Deadline: None.

Abstract: The U.S. Army Corps of Engineers (USACE) recognizes the sovereign status of Indian tribes (as defined by Executive Order 13175) and our obligation for pre-decisional government-to-government consultation, as established through and confirmed by the U.S. Constitution, treaties, statutes, executive orders, judicial decisions, and Presidential documents and policies, on proposed regulatory actions (e.g., individual permit decisions and general permit verifications). In addition, the USACE must also consider the effects of its actions on historic properties pursuant to section 106 of the National Historic Preservation Act. The USACE Regulatory Program's regulations for complying with the NHPA are outlined at 33 CFR 325 appendix C. Since these regulations were promulgated in 1990, there have been amendments to the NHPA and revisions to the Advisory Council on Historic Preservation's (ACHP) regulations at 36 CFR part 800 subpart B, addressing, among other things, tribal consultation requirements. In response, the USACE issued interim guidance until rulemaking could be completed in order to ensure full compliance with the NHPA and ACHP's regulations. The USACE seeks to revise its regulations to conform to these requirements. Consequently, the USACE intends to publish an advance notice of proposed rulemaking to solicit the public's input and inform its drafting of any future rulemaking.

Statement of Need: Since the USACE Regulatory Program's regulations for section 106 of the National Historic Preservation Act (NHPA) were promulgated in 1990, there have been amendments to the NHPA and revisions Start Printed Page 57843to Advisory Council on Historic Preservation's (ACHP) regulations at 36 CFR part 800 subpart B. The ACHP's regulations address, among other things, tribal consultation requirements. The Corps seeks to revise its regulations to conform to these requirements, and to develop regulations governing consultation with Indian tribes.

Summary of Legal Basis: For historic properties: Section 106 of the National Historic Preservation Act. The USACE's obligations to consult with Indian tribes are derived from the U.S. Constitution, treaties, statutes, executive orders, judicial decisions, and Presidential documents and policies.

Alternatives: Various alternatives are expected to be developed from the input received from the advance notice of proposed rulemaking, and further explored during the development of the proposed and final rules.

Anticipated Cost and Benefits: Anticipated costs and benefits will be estimated as rule options are developed after comments received in response to the advance notice of proposed rulemaking are evaluated.

Risks: The regulation is expected to reduce risks to the environment, specifically historic properties, properties of traditional religious and cultural importance to tribes, and natural resources that are subject to tribal treaty rights. Other potential risks will likely be identified through the advance notice of proposed rulemaking and those risks will be evaluated during the rulemaking process.

Timetable:

ActionDateFR Cite
ANPRM02/00/19
ANPRM Comment Period End05/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Amy Klein, Regulatory Program Manager, Department of Defense, U.S. Army Corps of Engineers, 441 G Street NW, Washington, DC 20314, Phone: 202 761-4559, Email: amy.s.klein@usace.army.mil.

RIN: 0710-AA75

DOD—COE

Proposed Rule Stage

26. Natural Disaster Procedures: Preparedness, Response, and Recovery Activities of the Corps of Engineers

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

E.O. 13771 Designation: Other.

Legal Authority: 33 U.S.C. 701n

CFR Citation: 33 CFR 203.

Legal Deadline: None.

Abstract: The Corps is proposing to update the Federal regulation for its natural disaster procedures currently promulgated in 33 CFR part 203. This proposed rule continues the rulemaking process to revise 33 CFR part 203, which implements section 5 of the Flood Control Act of 1941, as amended, (33 U.S.C. 701n), commonly referred to as Public Law 84-99. The Corps initiated this process through advanced notice of proposed rulemaking (ANPR) on February 13, 2015. The revisions under consideration would respond to the comments to the ANPR. The revisions address statutory changes to the program enacted in section 3011 and 3029 of the Water Resources and Reform Development Act of 2014 (WRRDA 2014) regarding the System Wide Improvement Framework (SWIF), modifications to Flood Control Works (FCW) and Coastal Storm Risk Management Projects (formerly referred to as Hurricane and Shore Protection Projects); and nonstructural alternatives to rehabilitation, if requested by the non-Federal sponsor. Additional revisions address statutory changes from section 1176 of the Water Resources Development Act of 2016 (WRDA) which provided an express definition of nonstructural alternatives,” as that term is used in Public Law 84-99, and authorized the Chief of Engineers, under certain circumstances, to increase the level of protection of flood control or hurricane or shore protection works when conducting repair or restoration activities to such works under Public Law 84-99. Other significant changes under consideration include revisions to the eligibility criteria for rehabilitation assistance for flood control works (FCW), an increase to the minimum repair cost for FCW projects, revised policies to address endangered species and vegetation management during rehabilitation, and a change in the cost share for emergency measures constructed using permanent construction standards.

Statement of Need: Since the last revision in 2003, significant disasters, including Hurricane Katrina (2005), Hurricane Sandy (2012), flooding on the Mississippi and Missouri Rivers (2008, 2011, and 2013), and Hurricanes Harvey, Irma and Maria (2017) have provided a more detailed understanding of the nature and severity of risk associated with flood control projects. Additionally, the maturation of risk-informed decision making approaches and technological advancements have influenced the outlook on how Public Law 84-99 activities should be implemented, with a shift towards better alignment with Corps Levee Safety and National Flood Risk Management Programs, as well as the National Preparedness and Response Frameworks. Through these programs, the Corps works with non-federal sponsors and stakeholders to assess, communicate, and manage the risks to people, property, and the environment associated with levee systems and flood risks. Revisions to part 203 are necessary to implement statutes that amended or otherwise affected Public Law 84-99, as explained in the next section.

Summary of Legal Basis: Public Law 84-99 authorizes an emergency fund to be expended at the discretion of the Chief of Engineers for preparation for natural disasters, flood fighting, rescue operations, repairing or restoring flood control works, emergency protection of federally authorized hurricane or shore protection projects, and the repair and restoration of federally authorized hurricane and shore protection projects damaged or destroyed by wind, wave, or water of other than ordinary nature.

1. Subsection 3029(a) of the Water Resources Reform and Development Act of 2014 (WRRDA) (Pub. L. 113-121) granted the Chief of Engineers authority, under certain circumstances, to make modifications to flood control and hurricane or shore protections works damaged during flood or coastal storms events, as well as the authority to implement nonstructural alternatives in the repair and restoration of hurricane or shore protection works.

2. Subsection 3029(b) of WRRDA 2014 directed the Secretary of the Army to undertake a review of implementation of Public Law 84-99 to ensure the safety of affected communities to future flooding and storm events; the resiliency of water resources development projects to future flooding and storm events; the long-term cost-effectiveness of water resources development projects that provide flood control and hurricane and storm damage reduction benefits; and the policy goals and objectives that were outlined by the President as a response to recent Start Printed Page 57844extreme weather events at that time are met.

3. Section 3011 of WRRDA 2014 mandated that a levee system shall remain eligible for rehabilitation assistance under Public Law 84-99 as long as the system sponsor continues to make satisfactory progress, as determined by the Secretary of the Army, on an approved system wide improvement framework or letter of intent.

4. Section 1176 of the Water Resources Development Act of 2016 (WRDA) (Pub. L. 114-322, title I) provided an express definition of nonstructural alternatives, as that term is used in Public Law 84-99, and authorized the Chief of Engineers, under certain circumstances, to increase the level of protection of flood control or hurricane or shore protection works when conducting repair or restoration activities to such works under Public Law 84-99.

Alternatives:

1. No rule update: Implement all changes through agency discretion. Alternative not selected because the Public Law 84-99 amendments are very prescriptive and it is inappropriate for those conflicts to exist.

2. Modify: Evaluate required changes and determine which require implementation via agency discretion and those requiring an update to the rule, thereby only updating the rule where necessary. Alternative not selected because of inconsistencies resulting from a lack of comprehensive consideration and a mix of policies. It would result in misunderstandings of program activities and inhibit transparency.

3. Repeal and replace (Selected Alternative): Incorporate and integrate the current state of the practice of flood risk management principles and concepts through the provision of agency policy codified in a federal rule. The intended benefit is to encourage broader community flood risk management activities, as enacted by non-federal project sponsors. The rule alternative also consolidates recent Public Law 84-99 amendments into one comprehensive rule, ensuring the Public has a clear understanding of the responsibilities and requirements.

Anticipated Cost and Benefits: Overall, the changes to this regulation provide greater flexibility to the federal government and non-Federal sponsors and improve the effectiveness of federal and local investments in riverine and coastal projects. These proposed changes take advantage of our increased understanding of project risks, moving from an assessment of how the project is expected to perform to a focus on a broader set of actions to reduce risk to life, including operations, maintenance, planning, and execution actions to improve emergency warning and evacuation and other activities to improve the ability of communities and individuals to understand and manage project-related risks. Informed by more detailed understanding of risk for levee projects, the federal government and non-federal sponsors are able to apply limited resources to the risk management activities that most effectively reduce riverine flood risk and avoid expenditures that have little risk reduction benefit.

Risks: The rule will is expected to reduce risks to public health and safety by improving the Corps' ability to prepare for national response framework missions that contribute to the restoration of critical lifelines that are necessary for life sustaining activities and economic recovery. The rule is also expected to encourage broader community flood risk management activities, as enacted by non-federal project sponsors.

Timetable:

ActionDateFR Cite
ANPRM02/13/1580 FR 8014
ANPRM Comment Period End04/14/15
NPRM12/00/18
NPRM Comment Period End02/00/19

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Willem Helms, Department of Defense, U.S. Army Corps of Engineers, 441 G Street NW, Washington, DC 20314, Phone: 202 761-5909.

RIN: 0710-AA78

DOD—COE

27. Definition of “Waters of the United States”

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Deregulatory.

Legal Authority: 33 U.S.C. 1251 et seq.

CFR Citation: 33 CFR 328.

Legal Deadline: None.

Abstract: In 2015, the Environmental Protection Agency and the Department of the Army (the agencies) published the “Clean Water Rule: Definition of Waters of the United States” (80 FR 37054, June 29, 2015). On October 9, 2015, the U.S. Court of Appeals for the Sixth Circuit stayed the 2015 rule nationwide pending further action of the court. On February 28, 2017, the President signed Executive Order 13778, “Restoring the Rule of Law, Federalism, and Economic Growth by Reviewing the ‘Waters of the United States Rule’,” which instructed the agencies to review the 2015 Rule and rescind or replace it as appropriate and consistent with law. The agencies are publishing this proposed rule to follow the first step, which sought to recodify the definition of “waters of the United States” that existed prior to the 2015 Rule. In this second step, the agencies are conducting a substantive reevaluation and revision of the definition of “waters of the United States” in accordance with the Executive order.

Statement of Need: Please see EPA's statement of need for RIN 2040-AF75, because EPA is the lead for this rulemaking action.

Summary of Legal Basis: The Clean Water Act (33 U.S.C. 1251 et seq.).

Alternatives: Please see EPA's alternatives for RIN 2040-AF75, because EPA is the lead for this rulemaking action.

Anticipated Cost and Benefits: Please see EPA's statement of anticipated costs and benefits for RIN 2040-AF75, because EPA is the lead for this rulemaking action.

Risks: Please see EPA's statement of risks for RIN 2040-AF75, because EPA is the lead for this rulemaking action.

Timetable:

ActionDateFR Cite
NPRM12/00/18

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Stacey Jensen, Department of Defense, U.S. Army Corps of Engineers, 441 G Street NW, Washington, DC 20314, Phone: 202 761-5856.

Related RIN: Related to 2040-AF75

RIN: 0710-AA80

DOD—COE

28. Compensatory Mitigation for Losses of Aquatic Resources—Review and Approval of Mitigation Banks and In-Lieu Fee Programs

Priority: Other Significant. Major status under 5 U.S.C. 801 is undetermined.Start Printed Page 57845

E.O. 13771 Designation: Deregulatory.

Legal Authority: 33 U.S.C. 1344; 33 U.S.C. 403; 33 U.S.C. 1413

CFR Citation: 33 CFR 332.

Legal Deadline: None.

Abstract: In 2008, the U.S. Army Corps of Engineers (Corps) issued a final rule governing compensatory mitigation for losses of aquatic resources (73 FR 19593). The regulation prescribes a review and approval process for the establishment and management of mitigation banks and in-lieu fee programs. The regulation also includes time frames for certain steps in the mitigation bank and in-lieu fee program review and approval process. The review and approval process for mitigation banks and in-lieu fee programs includes an opportunity for public and agency review and comment, as well as a second review by an interagency review team. The interagency review team consists of Federal, Tribal, State, and local agencies that review documentation and provide the USACE with advice on the establishment and management of mitigation banks and in-lieu fee programs. The Corps is reviewing the review and approval process and the interagency review team process in particular to enhance the efficiency of the mitigation bank and in-lieu fee program approval time frames. An increase in efficiency would likely result in savings to the public because it is expected to result in shorter review times for proposed mitigation banks, in-lieu fee programs, and instrument modifications, as well as credit release requests, and decreases in the resources other federal, state, and local agencies expend in reviewing these activities, attending meetings, participating in site visits, and providing their comments to the Corps.

Statement of Need: This proposed rule would propose executing execute of one of the legislative principles in the Administration's framework for rebuilding infrastructure in the United States, by removing duplication in the review process for mitigation banks and in-lieu fee programs that offset losses of jurisdictional waters and wetlands authorized by Department of the Army permits issued under section 404 of the Clean Water Act and section 10 of the Rivers and Harbors Act of 1899. It could reduce duplication, increase efficiency, and lower costs by providing one review process for proposed mitigation banks and in-lieu fee programs, instead of two processes. Depending on the outcome of this rulemaking, Federal, tribal, state, and local agencies could end up using a different approach to provide input into the mitigation bank and in-lieu fee program review process by participating in the public notice and comment process along with the general public.

Summary of Legal Basis: The Corps' legal authority for conducting this rulemaking is section 404 of the Clean Water Act (33 U.S.C. 1344) and section 10 of the Rivers and Harbors Act of 1899 (33 U.S.C. 403).

Alternatives: Alternatives that may be considered during the rulemaking process might include, but are not limited to, conducting the rulemaking to remove the interagency review team process from the regulation, using other approaches to increase efficiency in the mitigation bank and in-lieu fee program review and approval process, or making no changes to the regulation.

Anticipated Cost and Benefits: The proposed rule change is anticipated to reduce costs for sponsors of mitigation banks and in-lieu fee programs, by reducing the amount of time it takes to review and approve their mitigation banks and in-lieu fee programs, and oversee their operation. The proposed rule change is also anticipated to reduce costs to the Corps and other Federal, Tribal, State, and local government agencies by eliminating costs associated with the current interagency review team processes, including staff time for review of documentation for mitigation banks and in-lieu fee programs, site visits, travel, and participation in meetings. A regulatory impact analysis will be prepared for the proposed rule, to fully evaluate anticipated costs and benefits.

Risks: The proposed rule is not anticipated to increase risks to public health, safety, or the environment because the Corps would retain its authority to review and approve mitigation banks and in-lieu fee programs, as well as modification of mitigation banking instruments and in-lieu fee program instruments. It might only alter how Federal, Tribal, State, and local government agencies provide their views on proposed mitigation banks and in-lieu fee programs, and modifications to approved mitigation banks and in-lieu fee programs. Mitigation banks and in-lieu fee programs would continue to be required to provide ecologically successful aquatic resource compensatory mitigation projects to offset permitted impacts to jurisdictional waters and wetlands.

Timetable:

ActionDateFR Cite
NPRM03/00/19
NPRM Comment Period End05/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Agency Contact: David B. Olson, Regulatory Program Manager, Department of Defense, U.S. Army Corps of Engineers, 441 G Street NW, CECW-CO, Washington, DC 20314-1000, Phone: 202 761-4922, Email: david.b.olson@usace.army.mil.

RIN: 0710-AA83

DOD—COE

29. Modification of Nationwide Permits

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

E.O. 13771 Designation: Deregulatory.

Legal Authority: 33 U.S.C. 1344(e); 33 U.S.C. 403

CFR Citation: None.

Legal Deadline: None.

Abstract: The U.S. Army Corps of Engineers (Corps) issues nationwide permits to authorize specific categories of activities in jurisdictional waters and wetlands that have no more than minimal individual and cumulative adverse environmental effects. This action would be a deregulatory action because it proposes to remove specific terms of nationwide permits that impose costs on prospective permittees, and it would help simplify the nationwide permit authorization process. Since the submission and review of such nationwide permits can take significantly less time than individual permits, any changes to the program that increase the conditions under which the nationwide permits can be used could result in significant cost savings for the public. The issuance and reissuance of nationwide permits must be done every five years to continue the Nationwide Permit Program. The nationwide permits were last issued on December 21, 2016, and expire on March 18, 2022. On October 25, 2017, the Corps issued a report to meet the requirements of Executive Order 13783, Promoting Energy Independence and Economic Growth. In that report, the Corps recommended changes to nine nationwide permits that authorize activities related to domestic energy production and use, including oil, natural gas, coal, and nuclear energy sources, as well as renewable energy sources such as flowing water, wind, and solar energy. This rulemaking action would seek to review and, if appropriate, modify those nine nationwide permits in accordance with the opportunities identified in the Start Printed Page 57846report in order to reduce burden on the public. In addition, the Corps is considering modifying an additional 23 nationwide permits to allow federal agencies to select and use nationwide permits without additional Corps review. This rulemaking action would help simplify the nationwide permit authorization process.

Statement of Need: This proposed rule would propose executing the recommendations the Corps made in the report dated October 25, 2017, that it wrote in response to Executive Order 13783, Promoting Energy Independence and Economic Growth, as well as one of the legislative principles in the Administration's framework for rebuilding infrastructure in the United States. For Executive Order 13783, the Corps may propose to modify 9 nationwide permits that authorize activities association with energy production and distribution. For the framework for rebuilding infrastructure in the United States, the Corps may propose to modify an additional 23 nationwide permits so that federal agencies that want to use these nationwide permits do not have to submit pre-construction notifications.

Summary of Legal Basis: The Corps has authority to issue nationwide permits under the following statutes: Section 404 of the Clean Water Act (33 U.S.C. 1344) and Section 10 of the Rivers and Harbors Act of 1899 (33 U.S.C. 403).

Alternatives: Potential alternatives consist of: (1) Conducting the rulemaking necessary to make the proposed modifications or other modifications to these 32 nationwide permits prior to the expiration of the current nationwide permits, (2) conducting rulemaking to modify a smaller number of the current nationwide permits prior to the expiration of the current nationwide permits, and (3) taking no action until the next scheduled rulemaking. The current nationwide permits went into effect on March 19, 2017, and expire on March 18, 2022. If the nationwide permits are not reissued before March 18, 2022, the nationwide permits will automatically expire and project proponents would be required to obtain individual permits to conduct regulated activities under section 404 of the Clean Water Act and/or Section 10 of the Rivers and Harbors Act of 1899, unless the applicable Corps district has regional general permits available to authorize similar categories of activities.

Anticipated Cost and Benefits: The proposed changes to these 32 nationwide permits would reduce compliance costs for regulated entities by removing or changing certain terms of those nationwide permits to make them easier to use. According to the regulatory impact analysis prepared for the 2017 nationwide permits, a typical nationwide permit verification costs $4,308 to $14,358 to obtain, whereas a typical individual permit costs $17,230 to $34,460 to obtain. A more detailed cost/benefit analysis will be prepared when the proposed rule is developed.

Risks: The nationwide permits reduce risks to public health, safety, and the environment by providing streamlined authorization for categories of activities that require Department of the Army authorization and result in no more than minimal individual and cumulative adverse environmental effects. The nationwide permits authorize the construction and maintenance of infrastructure that supports public health and safety. The streamlined authorization process provided by the nationwide permits reduces risks to the environment by giving incentives to project proponents to design their projects to reduce adverse environmental effects so that they are no more than minimal. Many of the nationwide permits have acreage and other terms that help regulated entities design their projects to qualify for nationwide permit authorization.

Timetable:

ActionDateFR Cite
NPRM06/00/19
NPRM Comment Period End08/00/19

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: David B. Olson, Regulatory Program Manager, Department of Defense, U.S. Army Corps of Engineers, 441 G Street NW, CECW-CO, Washington, DC 20314-1000, Phone: 202 761-4922, Email: david.b.olson@usace.army.mil.

RIN: 0710-AA84

DOD—COE

Final Rule Stage

30. Policy for Domestic, Municipal, and Industrial Water Supply Uses of Reservoir Projects Operated by the Department of the Army, U.S. Army Corps of Engineers

Priority: Other Significant.

E.O. 13771 Designation: Other.

Legal Authority: 33 U.S.C. 708; 43 U.S.C. 390b

CFR Citation: 33 CFR 209.

Legal Deadline: None.

Abstract: The Department of the Army, U.S. Army Corps of Engineers (Corps) is updating and clarifying the policies governing the use of its reservoir projects for domestic, municipal, and industrial water supply pursuant to the Flood Control Act of 1944 section 6, 33 U.S.C. 708 (section 6), and the Water Supply Act of 1958, 43 U.S.C. 390(b) (WSA). The proposed rules for the use of storage space in Corps reservoir projects for water supply are being developed to implement section 6 of the Flood Control Act of 1944 and the Water Supply Act of 1958.

Statement of Need: The Corps is updating and clarifying its policies governing the use of its reservoir projects for domestic, municipal and industrial water supply pursuant to Section 6 of the Flood Control Act of 1944 and the Water Supply Act of 1958. The Corps intends through this rulemaking to explain and improve its interpretations and practices under these statutes. The rule is intended to enhance the Corps' ability to cooperate with state and local interests in the development of water supplies in connection with the operation of its reservoirs for federal purposes as authorized by Congress, to facilitate water supply uses of Corps reservoirs by others as contemplated under applicable law, and to avoid interfering with lawful uses of water by any entity when the Corps exercises its discretionary authority under either Section 6 or the Water Supply Act.

Summary of Legal Basis: Section 6 of the Flood Control Act of 1944 authorizes the Secretary of the Army to make contracts with states, municipalities, private concerns, or individuals, at such prices and on such terms as [the Secretary] may deem reasonable, for domestic and industrial uses for surplus water that may be available at any reservoir under the control of the [Department of the Army]. 33 U.S.C. 708. The Water Supply Act provides that storage may be included in any reservoir project surveyed, planned, constructed or to be planned, surveyed and/or constructed by the Corps to impound water for present or anticipated future demand or need for municipal or industrial water, 43 U.S.C. 390b(b).

Alternatives: The Army anticipates considering two alternatives: (1) A no action alternative and (2) revising the Corps' policies implementing section 6 and the Water Supply Act.

Anticipated Cost and Benefits: The proposed rule is not expected to have a significant economic impact. It would Start Printed Page 57847not change the methodology by which the cost of Water Supply Act storage agreements is determined. It would establish a new pricing methodology for surplus water contracts, under which users would be charged only for costs, if any, incurred by the Corps in making surplus water available. The costs incurred by the Government and the costs charged to users for surplus water withdrawals are not expected to be significant.

Risks: This rule is expected to reduce risks to public health and the environment by facilitating water supply uses of Corps reservoirs by others as contemplated under applicable law, and to avoid interfering with lawful uses of water by any entity. This rule is also expected to reduce risk by clarifying existing policies of non-interference with water rights issued by the states or other permitting authorities.

Timetable:

ActionDateFR Cite
NPRM12/16/1681 FR 91556
NPRM Comment Period End11/16/17
Final Action08/00/19
Final Action Effective10/00/19

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Joseph Redican, Deputy Chief, Planning and Policy Division, Department of Defense, U.S. Army Corps of Engineers, 441 G Street NW, Washington, DC 20314, Phone: 202 761-4523, Email: joseph.h.redican@usace.army.mil.

RIN: 0710-AA72

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

Final Rule Stage

31. Establishment of Tricare Select and Other Tricare Reforms

Priority: Other Significant.

E.O. 13771 Designation: Other.

Legal Authority: 10 U.S.C. ch. 55; NDAA-17 sec. 701; NDAA-17 sec. 706; NDAA-17 sec. 715; NDAA-17 sec. 718; NDAA-17 sec. 729

CFR Citation: 32 CFR 199.

Legal Deadline: Other, Statutory, June 23, 2017, NDAA 17 section 718. Other, Statutory, January 1, 2018, NDAA 17 section 729.

Abstract: This final rule implements the primary features of section 701 and partially implements several other sections of the National Defense Authorization Act for Fiscal Year 2017 (NDAA-17). The law makes significant changes to the TRICARE program, especially to the health maintenance organization (HMO) like health plan, known as TRICARE Prime; to the preferred provider organization health plan, previously called TRICARE Extra and now to be called TRICARE Select; and to the third health care option, known as TRICARE Standard, which was terminated as of December 31, 2017, and replaced by TRICARE Select. The statute also adopts a new health plan enrollment system under TRICARE and new provisions for access to care, high value services, preventive care, and healthy lifestyles. In implementing the statutory changes, this finalizes a number of improvements to TRICARE. Specifically, this rule will enhance beneficiary access to health care services, including increased geographic coverage for the TRICARE Select provider network, reduced administrative hurdles for TRICARE Prime enrollees to obtain urgent care services and specialty care referrals, and promotes high value services and medications and telehealth services. It also expanded TRICARE coverage of preventive care services and prevention and treatment of obesity and refining cost-benefit assessments for TRICARE plan specifications that remain under DoD's discretion.

Statement of Need: This rule implements the primary features of section 701 and partially implements several other sections of the National Defense Authorization Act for Fiscal Year 2017 (NDAA-17). The law makes significant changes to the TRICARE program, especially to the health maintenance organization (HMO)-like health plan, known as TRICARE Prime; to the preferred provider organization health plan, previously called TRICARE Extra and now to be called TRICARE Select; and to the third health care option, known as TRICARE Standard, which will be terminated as of December 31, 2017, and replaced by TRICARE Select. The statute also adopts a new health plan enrollment system under TRICARE and new provisions for access to care, high-value services, preventive care, and healthy lifestyles. In implementing the statutory changes, this rule makes a number of improvements to TRICARE.

In implementing section 701 and partially implementing several other sections of NDAA-17, this interim final rule advances all four components of the Military Health System's quadruple aim of stronger readiness, better care, healthier people, and smarter spending. The aim of stronger readiness is served by reinforcing the vital role of the TRICARE Prime health plan to refer patients, particularly those needing specialty care, to military medical treatment facilities in order to ensure that military health care providers maintain clinical currency and proficiency in their professional fields. The objective of better care is enhanced by a number of improvements in beneficiary access to health care services, including geographical coverage for the TRICARE Select provider network, reduced administrative hurdles for TRICARE Prime enrollees to obtain urgent care services and specialty care referrals, and promotion of high-value services and medications and telehealth services. The goal of healthier people is advanced by expanding TRICARE coverage of preventive care services and prevention and treatment of obesity. And the aim of smarter spending is furthered by sharpening cost-benefit assessments for TRICARE plan specifications that remain under the DoD's discretion.

Summary of Legal Basis: This rule is required to implement or partially implement several sections of NDAA-17, including 701, 706, 715, 718, and 729. The legal authority for this rule also includes chapter 55 of title 10, United States Code.

Alternatives: None.

Anticipated Cost and Benefits: This rule is not anticipated to have an annual effect on the economy of $100M or more, thus it is not an economically significant rule under the Executive Order and the Congressional Review Act. The rule includes estimated program costs associated with implementation that include administrative startup costs ($11M) information systems changes ($10M). Executive Order 13771, Reducing Regulation and Controlling Regulatory Costs, seeks to control costs associated with the government imposition of private expenditures required to comply with Federal regulations and to reduce regulations that impose such costs. Consistent with the analysis of transfer payments under OMB Circular A-4, this rule does not involve regulatory costs subject to Executive Order 13771.

Risks: The rule does not impose any risks. The risks lie in not implementing statutorily required changes.

Timetable:

ActionDateFR Cite
Interim Final Rule09/29/1782 FR 45438
Interim Final Rule Comment Period End11/28/17
Start Printed Page 57848
Final Action01/00/19

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Mark Ellis, Department of Defense, Office of Assistant Secretary for Health Affairs, 5111 Leesburg Pike, Suite 810A, Falls Church, VA 22041, Phone: 703 681-0039.

RIN: 0720-AB70

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

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

Overall, the laws, regulations, and programs that the Department administers will affect nearly every American during his or her life. Indeed, in the 2018-19 school year, about 57 million students will attend an estimated 133,000 elementary and secondary schools in approximately 13,600 districts, and about 20 million students will enroll in degree-granting postsecondary schools. All of these students may benefit from some degree of financial assistance or support from the Department.

In developing and implementing regulations, guidance, technical assistance, evaluations, data gathering and reporting, and monitoring related to our programs, we are committed to working closely with affected persons and groups. We know that improving education starts with allowing greater decision-making authority at the State and local levels while also recognizing that the ultimate form of local control occurs when parents and students are empowered to choose their own educational paths forward. Our core mission includes this empowerment of local education, serving the most vulnerable, and facilitating equal access for all, to ensure all students receive a high-quality education, and complete it with a well-considered and attainable path to a sustainable career.

Toward these ends, we work with a broad range of interested parties and the general public, including families, students, and educators; State, local, and Tribal governments; other Federal agencies; and neighborhood groups, community-based early learning programs, elementary and secondary schools, colleges, rehabilitation service providers, adult education providers, professional associations, advocacy organizations, businesses, and labor organizations.

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

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

We are committed to reducing burden with regard to regulations, guidance, and information collections, reducing the burden on information providers involved in our programs, and making information easily accessible to the public. To that end and consistent with Executive Order 13777 (“Enforcing the Regulatory Reform Agenda”), we are in the process of reviewing all of our regulations and guidance to modify and rescind items that: (1) Eliminate jobs, or inhibit job creation; (2) are outdated, unnecessary, or ineffective; (3) impose costs that exceed benefits; (4) create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies; (5) are inconsistent with the requirements of section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note), or the guidance issued pursuant to that provision, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or (6) derive from or implement Executive orders or other Presidential directives that have been subsequently rescinded or substantially modified.

II. Regulatory and Deregulatory Priorities

Proposed Rulemakings

The following are the key regulatory and deregulatory rulemaking actions the Department is planning for the coming year. We provide below information about the potential costs and benefits for several of these rulemaking actions, including whether they would be considered regulatory or deregulatory actions under Executive Order 13771. For rulemakings that we are just beginning now, we have limited information about their potential costs and benefits and cannot estimate at this time whether they would be considered regulatory or deregulatory actions.

Postsecondary Education/Federal Student Aid

The Department will continue its work to complete two rulemakings in the area of higher education and Federal Student Aid under the Higher Education Act of 1965, as amended (HEA). The Department has completed negotiated rulemaking for these two rulemakings, described below, and we are revisiting these regulations with the goals of alleviating unnecessary regulatory burdens and ensuring appropriate protections for students, institutions, Start Printed Page 57849taxpayers, and the Federal government. Through the use of the negotiated rulemaking process, we have received input from a diverse range of interests and affected parties.

The Department recently published new proposed regulations that would govern the William D. Ford Federal Direct Loan (Direct Loan) Program regarding the standard and the process for determining whether a borrower has a defense to repayment on a loan based on an act or omission of a school. We also have proposed to amend other sections of the Direct Loan Program regulations, including those that codify our current policy regarding the impact that discharges have on the 150 percent Direct Subsidized Loan Limit and the Student Assistance General Provisions regulations providing the financial responsibility standards and disclosure requirements for schools. In addition, we proposed to amend the discharge provisions in the Federal Perkins Loan, Direct Loan, and Federal Family Education Loan programs. These proposed regulations would replace those promulgated by the Department in 2016.

The Department recently proposed regulations that would rescind the Gainful Employment (GE) regulations and remove them from subparts Q and R of the Student Assistance and General Provisions in 34 CFR part 668. Under the proposed rescission, the Department would remove the provisions providing for a debt-to-earnings (D/E) rates measure to determine a gainful employment program's continuing eligibility for participation in the programs authorized by title IV of the HEA as well as certain disclosure and reporting requirements.

Additionally, the Secretary plans to initiate a new rulemaking to revise regulations related to the Secretary's recognition of accrediting agencies, including specific topics such as: The requirements of accrediting agencies in their oversight of member institutions; requirements for accrediting agencies to honor institutional mission; criteria used by the Secretary to recognize accrediting agencies, emphasizing criteria that focus on educational quality; developing a single definition for purposes of measuring and reporting job placement rates; and simplifying the process for recognition and review of accrediting agencies. The rulemaking will also cover issues such as: State authorization, to address the requirements related to programs offered through distance education or correspondence courses, including disclosures about such programs to enrolled and prospective students, and other State authorization issues; the definitions of a number of terms in the regulations governing institutional and programmatic eligibility; requirements of the Teacher Education Assistance for College and Higher Education Grant (TEACH Grant) program, in an effort to minimize inadvertent grant-to-loan conversions and improve outcomes for TEACH Grant recipients; direct assessment programs and competency-based education; and regulations regarding the eligibility of faith-based entities to participate in the Title IV, HEA programs.

Civil Rights/Title IX

The Secretary is planning a new rulemaking to address issues under Title IX of the Education Amendments of 1972, as amended. In this action, we seek to clarify schools' obligations in redressing sex discrimination, including complaints of sexual misconduct, and the procedures by which they must do so.

Special Education

The Department will continue its work to complete its rulemaking in the area of significant disproportionality under section 618(d) of the Individuals with Disabilities Education Act (IDEA). In July 2018, the Department published a final rule extending the compliance date for States until July 1, 2020. We are revisiting the significant disproportionality regulations with the goal of better serving children with disabilities.

Deregulatory Actions

The Department anticipates issuing a number of deregulatory actions in the upcoming fiscal year. We have thus far been focusing our deregulatory efforts on eliminating outdated regulations. In many instances, our deregulatory actions are being taken because legislation has superseded our regulations. For example, we are planning to rescind a number of sections from our Office of Career, Technical, and Adult Education regulations to remove outdated, superseded regulations for programs no longer administered by the Department. This deregulatory action will clarify for our stakeholders and the general public which of our regulations are still in effect. The unified agenda identifies other deregulatory actions that will provide cost savings and clarity.

Additionally, during the course of its Executive Order 13777 review, the Department's Regulatory Reform Task Force has identified a number of information collections (ICRs) as being outdated, unnecessary, or ineffective. We are currently working to discontinue these.

III. Regulatory Review

As stated previously, the Department is continuing its comprehensive regulatory reform efforts pursuant to Executive Order 13777, focusing on rescinding and modifying all outdated, unnecessary, or ineffective regulations, guidance, and information collections. Section 3(e) of the Executive order requires the Department, as part of this effort, to “seek input and other assistance, as permitted by law, from entities significantly affected by Federal regulations, including State, local, and tribal governments, small businesses, consumers, non-governmental organizations, and trade associations” on regulations that meet some or all of the criteria above. The Department will continue to consider public input and feedback as part of these efforts.

IV. Principles for Regulating

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

In deciding when to regulate, we consider the following:

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

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

  • Regulate no more than necessary.
  • Minimize burden to the extent possible, and promote multiple approaches to meeting statutory requirements if possible.
  • Encourage coordination of federally funded activities with State and local reform activities.Start Printed Page 57850
  • Ensure that the benefits justify the costs of regulating.
  • To the extent possible, establish performance objectives rather than specify the behavior or manner of compliance a regulated entity must adopt.
  • Encourage flexibility, to the extent possible and as needed to enable institutional forces to achieve desired results.

ED—OFFICE FOR CIVIL RIGHTS (OCR)

Proposed Rule Stage

32. Nondiscrimination on the Basis of Sex in Education Programs or Activities Receiving Federal Financial Assistance

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Other.

Legal Authority: 20 U.S.C. 1681 et seq.

CFR Citation: 34 CFR 106.

Legal Deadline: None.

Abstract: The Secretary plans to issue a notice of proposed rulemaking to clarify the obligations of recipients of Federal financial assistance in redressing sex discrimination, including complaints of sexual misconduct, and the procedures by which they must do so.

Statement of Need: Based on its extensive review of the critical issues addressed in this rulemaking, the Department has determined that current regulations and subregulatory guidance do not provide a sufficiently clear definition of what conduct constitutes sexual harassment or sufficiently clear standards for how recipients must respond to incidents of sexual harassment. To address this concern, we propose this regulatory action to address sexual harassment under Title IX for the central purpose of ensuring that Federal financial recipients understand their legal obligations under title IX.

Summary of Legal Basis: We are issuing a notice of proposed rulemaking, and subsequently final regulations, to implement Title IX.

Alternatives: This will be discussed in the notice of proposed rulemaking (NPRM) and final regulations.

Anticipated Cost and Benefits: This will be discussed in the notice of proposed rulemaking (NPRM) and final regulations.

Risks: This will be discussed in the notice of proposed rulemaking (NPRM) and final regulations.

Timetable:

ActionDateFR Cite
NPRM11/00/18

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

URL For Public Comments: www.regulations.gov.

Agency Contact: Alejandro Reyes, Department of Education, Office for Civil Rights, 400 Maryland Avenue SW, Room 4E213, Washington, DC 20202, Phone: 202 453-7100, Email: t9ocrcomments@ed.gov.

RIN: 1870-AA14

ED—OFFICE OF POSTSECONDARY EDUCATION (OPE)

Proposed Rule Stage

33. State Authorization and Related Issues

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Other.

Legal Authority: 20 U.S.C. 3474; 20 U.S.C. 1221e-3; 20 U.S.C. 1011 et seq.

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: The Department is proposing to amend, through negotiated rulemaking, the regulations governing the legal authorization of institutions by States. The Department is also proposing to amend regulations for the State authorization of distance education providers and correspondence education providers as a component of institutional eligibility for participation in Federal student financial aid under title IV of the Higher Education Act of 1965, as amended.

Statement of Need: As required by Executive Order 13771 and 13777, the Department must identify regulations that are among other things outdated, unnecessary, or ineffective and create a serious inconsistency or otherwise interfere with regulatory reform initiative and policies.

Update and revision to the regulations on State Authorization is necessary so that the Department does not inhibit innovation and competition in postsecondary education. Institutions need the regulatory flexibility to innovate and the Department is committed to ensuring program integrity with appropriate guardrails to protect students and taxpayer dollars. The focus of this rulemaking is on breaking down barriers to innovation and reducing regulatory burden while protecting students and taxpayers from unreasonable risk.

Summary of Legal Basis: The Department has the authority to establish a negotiated rulemaking committee with the purpose of creating, amending or rescinding regulations in the Code of Federal Regulations.

Alternatives: One alternative is not to negotiate on the proposed topic and instead work on sub-regulatory guidance to ease burden and clarify current regulations for postsecondary institutions and accreditors.

Note that, the intent to establish a negotiated rulemaking committee has already been published; the topics proposed for negotiation have been added to the Agency Agenda Report/Unified Agenda. Further, the Department has already conducted one of three public hearings inviting comment on our Federal Register notice outlining our intent to negotiate. After reviewing feedback from comments received, the Department may choose to modify the topics proposed for negotiation and at that time we can more thoughtfully provide alternatives.

Anticipated Cost and Benefits: We have limited information about the potential cost and benefits and cannot estimate at this time.

Risks: By negotiating on a wide range of topics in one negotiated rulemaking panel there is an increased risk on not reaching consensus. To account for this, the Department will provide draft language prior to the first session of three sessions (each session is three days long) of negotiated rulemaking. Historically, the first session has been used as a listening session to get feedback from the rulemaking committee and the Department provides more specific proposals to the rulemaking committee between the first and second session.

Further, there is no prohibition in the rulemaking process for the main committee to break-off before, during or after a session to discussion topics within their areas of expertise to propose language to the main committee.

Timetable:

ActionDateFR Cite
Notice of Intention to Commence Negotiated Rulemaking07/31/1883 FR 36814
NPRM06/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.Start Printed Page 57851

Federalism: Undetermined.

Agency Contact: Lynn Mahaffie, Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Washington, DC 20202, Phone: 202 453-6914.

RIN: 1840-AD36

ED—OPE

34. Accreditation and Related Issues

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Other.

Legal Authority: 20 U.S.C. 3474; 20 U.S.C. 1221e-3; 20 U.S.C. 1011 et seq.

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: The Department is proposing to amend, through negotiated rulemaking, the regulations relating to the Secretary's recognition of accrediting agencies and accreditation procedures as a component of institutional eligibility for participation in Federal student financial aid under title IV of the Higher Education Act of 1965, as amended.

Statement of Need: As required by Executive Order 13771 and 13777, the Department must identify regulations that are among other things outdated, unnecessary, or ineffective and create a serious inconsistency or otherwise interfere with regulatory reform initiative and policies.

We believe that a revision to the accreditation regulations is necessary to restore the separation of duties in responsibilities in the triad: The State Authorization, Accreditation, and the U.S. Department of Education. We believe that the accreditation regulations may contain redundancy, unnecessary duplication of oversight, and pose broad Federal overreach in measuring program quality. We also want to ensure that accreditors while measuring institutional quality do not infringe on autonomy of institutions in their missions.

Summary of Legal Basis: The Department has the authority to establish a negotiated rulemaking committee with the purpose of creating, amending or rescinding regulations in the Code of Federal Regulations.

Alternatives: One alternative is not to negotiate on the proposed topic and instead work on sub-regulatory guidance to ease burden and clarify current regulations for postsecondary institutions and accreditors.

Note that, the intent to establish a negotiated rulemaking committee has already been published; the topics proposed for negotiation have been added to the Agency Agenda Report/Unified Agenda. Further, the Department has already conducted one of three public hearings inviting comment on our Federal Register notice outlining our intent to negotiate. After reviewing feedback from comments received, the Department may choose to modify the topics proposed for negotiation and at that time we can more thoughtfully provide alternatives.

Anticipated Cost and Benefits: We have limited information about the potential cost and benefits and cannot estimate at this time.

Risks: By negotiating on a wide range of topics in one negotiated rulemaking panel there is an increased risk on not reaching consensus. To account for this, the Department will provide draft language prior to the first session of three sessions (each session is three days long) of negotiated rulemaking. Historically, the first session has been used as a listening session to get feedback from the rulemaking committee and the Department provides more specific proposals to the rulemaking committee between the first and second session.

Timetable:

ActionDateFR Cite
Notice of Intention to Commence Negotiated Rulemaking07/31/1883 FR 36814
NPRM06/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Lynn Mahaffie, Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Washington, DC 20202, Phone: 202 453-6914.

RIN: 1840-AD37

ED—OPE

35. Ensuring Student Access to High Quality and Innovative Postsecondary Educational Programs

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

E.O. 13771 Designation: Other.

Legal Authority: 20 U.S.C. 3474; 20 U.S.C. 1221e-3; 20 U.S.C. 1011 et seq.

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: The Department proposes to create and amend, through negotiated rulemaking, regulations relating to institutional eligibility and operations for participation in Federal student financial aid under title IV of the Higher Education Act of 1965, as amended, including those relating to credit hour, competency-based education, direct assessment programs, and regular and substantive interaction between faculty and students in the delivery of distance education programs, in order to promote greater access for students to high-quality, innovative programs of postsecondary education.

Statement of Need: As required by Executive Order 13771 and 13777, the Department must identify regulations that are among other things outdated, unnecessary, or ineffective and create a serious inconsistency or otherwise interfere with regulatory reform initiative and policies.

Update and revision to the outlined regulations is necessary so that the Department does not inhibit innovation and competition in postsecondary education. For example, regulations implemented regarding the credit-hour, regular and substantive interaction and institutional partnerships in instructional programs may limit innovation and inhibit student completion and graduation in the rapidly evolving postsecondary education landscape. Institutions need the regulatory flexibility to innovate and the Department is committed to ensuring program integrity with appropriate guardrails to protect students and taxpayer dollars. The focus of this rulemaking is on breaking down barriers to innovation and reducing regulatory burden while protecting students and taxpayers from unreasonable risk.

Summary of Legal Basis: The Department has the authority to establish a negotiated rulemaking committee with the purpose of creating, amending or rescinding regulations in the Code of Federal Regulations.

Alternatives: One alternative is not to negotiate on the proposed topics and instead work on sub-regulatory guidance to ease burden and clarify current regulations for postsecondary institutions and accreditors. Another alternative is to only negotiate on one or a smaller number of the topics the Department has proposed.

Note that, the intent to establish a negotiated rulemaking committee has already been published; the topics proposed for negotiation have been added to the Agency Agenda Report/Unified Agenda. Further, the Department has already conducted one of three public hearings inviting comment on our FR Notice outlining Start Printed Page 57852our intent to negotiate. After reviewing feedback from comments received, the Department may choose to modify the topics proposed for negotiation and at that time we can more thoughtfully provide alternatives.

Anticipated Cost and Benefits: We have limited information about the potential cost and benefits and cannot estimate at this time.

Risks: By negotiating on a wide range of topics in one negotiated rulemaking panel there is an increased risk on not reaching consensus. To account for this, the Department will provide draft language prior to the first session of three sessions (each session is three days long) of negotiated rulemaking. Historically, the first session has been used as a listening session to get feedback from the rulemaking committee and the Department provides more specific proposals to the rulemaking committee between the first and second session.

Also, by negotiating a wide range of topics the Department risks not having the expertise necessary on the rulemaking committee to fully explore the nuances of each of the proposed topics. To account for this the Department will form two subcommittees, one directly related to direct assessment programs and competency-based education. These committees will report back to the main rulemaking committee with their reports.

Further, there is no prohibition in the rulemaking process for the main committee to break-off before, during or after a session to discussion topics within their areas of expertise to propose language to the main committee.

Timetable:

ActionDateFR Cite
Notice of Intention to Commence Negotiated Rulemaking07/31/1883 FR 36814
NPRM06/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Lynn Mahaffie, Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Washington, DC 20202, Phone: 202 453-6914.

RIN: 1840-AD38

ED—OPE

36. Eligibility of Faith-Based Entities and Activities—Title IV Programs

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

E.O. 13771 Designation: Other.

Legal Authority: 20 U.S.C. 1001 and 1002; 20 U.S.C. 1099b; 20 U.S.C. 1087aa, 1087dd, and 1091

CFR Citation: 34 CFR 600.9; 34 CFR 600.11; 34 CFR 674.9.

Legal Deadline: None.

Abstract: Various provisions of the Department's regulations regarding the eligibility of faith-based entities to participate in the Department's higher education and student aid programs, and the eligibility of students to participate in student aid programs and obtain certain benefits under those programs, unnecessarily restrict participation by religious entities. For example, some provisions may be overly broad in their prohibition of activities or services that relate to sectarian instruction or religious worship. Other provisions may be overly broad in prohibiting the benefits a borrower may receive based on faith-based activity. The Department is proposing to review and amend, through negotiated rulemaking, such regulations in order to be consistent with current law, and to reduce or eliminate unnecessary burdens and restrictions on religious entities and activities.

Statement of Need: Rulemaking is necessary in light of the recent United States Supreme Court decision in Trinity Lutheran Church of Columbia, Inc. v. Comer, 137 S. Ct. 2012 (2017), and the October 6, 2017, Memorandum for All Executive Agencies issued by the Attorney General of the United States pursuant to Executive Order No. 13798.

Summary of Legal Basis: The Department has the authority to establish a negotiated rulemaking committee with the purpose of creating, amending or rescinding regulations in the Code of Federal Regulations.

Alternatives: One alternative is not to negotiate on the proposed topic and instead work on sub-regulatory guidance to ease burden and clarify current regulations for postsecondary institutions and accreditors.

Note that, the intent to establish a negotiated rulemaking committee has already been published; the topics proposed for negotiation have been added to the Agency Agenda Report/Unified Agenda. Further, the Department has already conducted one of three public hearings inviting comment on our Federal Register notice outlining our intent to negotiate. After reviewing feedback from comments received, the Department may choose to modify the topics proposed for negotiation and at that time we can more thoughtfully provide alternatives.

Anticipated Cost and Benefits: We have limited information about the potential cost and benefits and cannot estimate at this time.

Risks: By negotiating on a wide range of topics in one negotiated rulemaking panel there is an increased risk on not reaching consensus. To account for this the Department will provide draft language prior to the first session of three sessions (each session is three days long) of negotiated rulemaking. Historically, the first session has been used as a listening session to get feedback from the rulemaking committee and the Department provides more specific proposals to the rulemaking committee between the first and second session.

Also, the Department will form two subcommittees, one specifically for faith-based entities. These committees will report back to the main rulemaking committee with their reports.

Timetable:

ActionDateFR Cite
Notice of Intention to Commence Negotiated Rulemaking07/31/1883 FR 36814
NPRM06/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal, Local, State.

Federalism: Undetermined.

URL For More Information: www.regulations.gov.

URL For Public Comments: www.regulations.gov.

Agency Contact: Lynn Mahaffie, Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Washington, DC 20202, Phone: 202 453-6914.

RIN: 1840-AD40

ED—OPE

37. • Teach Grants

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Other.

Legal Authority: 20 U.S.C. 1070g, et seq.

CFR Citation: 34 CFR 686.

Legal Deadline: None.

Abstract: The Department is proposing to amend, through negotiated Start Printed Page 57853rulemaking, the regulations relating to the Teacher Education Assistance for College and Higher Education (TEACH) Grant. Our goal is to simplify and clarify program requirements, minimize inadvertent grant-to-loan conversions, and improve outcomes for TEACH Grant recipients.

Statement of Need: As required by Executive Order 13771 and 13777, the Department must identify regulations that are among other things outdated, unnecessary, or ineffective and create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies. Our goal is to simplify and clarify program requirements, minimize inadvertent grant-to-loan conversions, and improve outcomes for TEACH Grant recipients.

Summary of Legal Basis: The Department has the authority to establish a negotiated rulemaking committee with the purpose of creating, amending or rescinding regulations in the Code of Federal Regulations.

Alternatives: One alternative is not to negotiate on the proposed topic and instead work on sub-regulatory guidance to ease burden and clarify current regulations to the loan servicer that overseas TEACH grant servicing.

Note that, the intent to establish a negotiated rulemaking committee has already been published; the topics proposed for negotiation have been added to the Agency Agenda Report/Unified Agenda. Further, the Department has already conducted one of three public hearings inviting comment on our Federal Register notice outlining our intent to negotiate. After reviewing feedback from comments received, the Department may choose to modify the topics proposed for negotiation and at that time we can more thoughtfully provide alternatives.

Anticipated Cost and Benefits: We have limited information about the potential cost and benefits and cannot estimate at this time.

Risks: By negotiating on a wide range of topics in one negotiated rulemaking panel there is an increased risk on not reaching consensus. To account for this, the Department will provide draft language prior to the first session of three sessions (each session is three days long) of negotiated rulemaking. Historically, the first session has been used as a listening session to get feedback from the rulemaking committee and the Department provides more specific proposals to the rulemaking committee between the first and second session.

Further, there is no prohibition in the rulemaking process for the main committee to break-off before, during or after a session to discussion topics within their areas of expertise to propose language to the main committee.

Timetable:

ActionDateFR Cite
Notice of Intention to Commence Negotiated Rulemaking07/31/1883 FR 36814
NPRM06/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Federal, Local, State.

Federalism: Undetermined.

URL For More Information: www.regulations.gov.

URL For Public Comments: www.regulations.gov.

Agency Contact: Sophia McArdle, Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Washington, DC 20202, Phone: 202 453-6318.

RIN: 1840-AD44

ED—OPE

Final Rule Stage

38. Institutional Accountability

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

E.O. 13771 Designation: Other.

Legal Authority: 20 U.S.C. 1082(a)(5), (a)(6); 20 U.S.C. 1087(a); 20 U.S.C. 1087e(h); 20 U.S.C. 1221e-3; 20 U.S.C. 1226a-1; 20 U.S.C. 1234(a); 31 U.S.C. 3711

CFR Citation: 34 CFR 668; 34 CFR 674; 34 CFR 682; 34 CFR 685; and other sections as applicable.

Legal Deadline: None.

Abstract: The Secretary plans to establish new regulations governing the William D. Ford Federal Direct Loan (Direct Loan) Program regarding the standard and the process for determining whether a borrower has a defense to repayment on a loan based on an act or omission of a school. We also may amend other sections of the Direct Loan Program regulations, including those that codify our current policy regarding the impact that discharges have on the 150 percent Direct Subsidized Loan Limit; and the Student Assistance General Provisions regulations providing the financial responsibility standards and disclosure requirements for schools. In addition, we may amend the discharge provisions in the Federal Perkins Loan, Direct Loan and Federal Family Education Loan program regulations.

Statement of Need: The Secretary initiated negotiated rulemaking to revise current regulations governing borrower defenses to loan repayment.

Summary of Legal Basis: Section 492 of the HEA requires that, before publishing any proposed regulations to implement programs authorized under title IV of the HEA, the Secretary obtain public involvement in the development of the proposed regulations. After obtaining advice and recommendations from the public, the Secretary conducts negotiated rulemaking to develop the proposed regulations. Section 431 of the Department of Education Organization Act provides authority to the Secretary, in relevant part, to inform the public regarding federally supported education programs; and collect data and information on applicable programs for the purpose of obtaining objective measurements of the effectiveness of such programs in achieving the intended purposes of such programs. 20 U.S.C. 1231a.

Alternatives: These are identified through the negotiated rulemaking process and presented in the Notice of Proposed Rulemaking.

Anticipated Cost and Benefits: These are identified through the negotiated rulemaking process and presented in the Notice of Proposed Rulemaking.

Risks: These are identified through the negotiated rulemaking process and presented in the Notice of Proposed Rulemaking.

Timetable:

ActionDateFR Cite
Notice of Intention to Commence Negotiated Rulemaking06/16/1782 FR 27640
NPRM07/31/1883 FR 37242
NPRM Comment Period End08/30/18
Final Action01/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, Local, State.

URL For More Information: www.regulations.gov.

URL For Public Comments: www.regulations.gov.

Agency Contact: Annmarie Weisman, Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Room 287-25, Washington, DC 20202, Phone: 202 453-6712, Email: annmarie.weisman@ed.gov.

RIN: 1840-AD26

Start Printed Page 57854

ED—OPE

39. Program Integrity; Gainful Employment

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

E.O. 13771 Designation: Other.

Legal Authority: 20 U.S.C. 3474; 20 U.S.C. 1221e-3

CFR Citation: 34 CFR 668.

Legal Deadline: None.

Abstract: The Secretary plans to amend regulations on institutional eligibility under the Higher Education Act of 1965, as amended (HEA), and the Student Assistance General Provisions, including the regulations governing whether certain postsecondary educational programs prepare students for gainful employment in a recognized occupation, and the conditions under which these educational programs remain eligible under the Federal Student Aid programs authorized under title IV of the HEA.

Statement of Need: The Secretary initiated negotiated rulemaking to revise the gainful employment regulations published by the Department on October 31, 2014 (79 FR 64889). The negotiated rulemaking committee did not reach consensus and the Department proposed new regulations to rescind the gainful employment regulations.

Summary of Legal Basis: Section 492 of the HEA requires that, before publishing any proposed regulations to implement programs authorized under title IV of the HEA, the Secretary obtain public involvement in the development of the proposed regulations. After obtaining advice and recommendations from the public, the Secretary conducts negotiated rulemaking to develop the proposed regulations. Section 431 of the Department of Education Organization Act provides authority to the Secretary, in relevant part, to inform the public regarding federally supported education programs; and collect data and information on applicable programs for the purpose of obtaining objective measurements of the effectiveness of such programs in achieving the intended purposes of such programs. 20 U.S.C. 1231a.

Alternatives: These are identified through the negotiated rulemaking process and presented in the Notice of Proposed Rulemaking.

Anticipated Cost and Benefits: These are identified through the negotiated rulemaking process and presented in the Notice of Proposed Rulemaking.

Risks: These are identified through the negotiated rulemaking process and presented in the Notice of Proposed Rulemaking.

Timetable:

ActionDateFR Cite
Notice of Intention to Commence Negotiated Rulemaking06/16/1782 FR 27640
NPRM08/14/1883 FR 40167
NPRM Comment Period End09/13/18
Final Action12/00/18

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses, Governmental Jurisdictions.

Government Levels Affected: Federal, Local, State.

URL For Public Comments: www.regulations.gov.

Agency Contact: Annmarie Weisman, Department of Education, Office of Postsecondary Education, 400 Maryland Avenue SW, Room 287-25, Washington, DC 20202, Phone: 202 453-6712, Email: annmarie.weisman@ed.gov.

RIN: 1840-AD31

DEPARTMENT OF ENERGY

Statement of Regulatory and Deregulatory Priorities

The Department of Energy (DOE or the Department) 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 ensure America's security and prosperity by addressing its energy, environmental, and nuclear challenges through transformative science and technology solutions.

Through its regulatory and deregulatory activities, the Department works to ensure it both achieves its critical mission, and implements the administration's initiative to reduce regulation and control regulatory costs as outlined in Executive Order (E.O.) 13771, “Reducing Regulation and Controlling Regulatory Costs.” As such, the Department strives to act in a prudent and financially responsible manner in the expenditure of funds, from both public and private sources, and manages appropriately the costs associated with private expenditures required for compliance with DOE regulations. Ultimately, DOE aims to promote meaningful regulatory burden reduction, while also achieving its regulatory objectives and meeting its statutory obligations.

Regulatory and Deregulatory Priorities

DOE's regulatory and deregulatory priorities reflect the Department's efforts to achieve meaningful burden reduction while continuing to achieve the Department's statutory obligations.

DOE is engaged in a number of deregulatory activities aimed at reducing regulatory costs and burdens. These activities include amending regulations to expedite the preparation of and simplify the content of Notices of Sale for the price competitive sale of petroleum from the Strategic Petroleum Reserve (SPR), which in turn will reduce the administrative burden placed on prospective bidders. Another important deregulatory action concerns modernizing the procedures for establishing energy conservation standards and test procedures as part of DOE's Appliance Program. Also, DOE published a final rule that will provide for faster approval of applications for small-scale exports of natural gas, including liquefied natural gas (LNG), from U.S. export facilities.

Retrospective Analyses of Existing Rules

On January 30, 2017, the President issued E.O. 13771, “Reducing Regulation and Controlling Regulatory Costs.” That Order stated the policy of the executive branch is to be prudent and financially responsible in the expenditure of funds, from both public and private sources. The Order stated it is essential to manage the costs associated with the governmental imposition of private expenditures required to comply with Federal regulations. Toward that end, E.O. 13771 requires, among other things, that whenever an agency proposes for notice and comment or otherwise promulgates a new regulation, the agency must identify at least two existing regulations to be repealed. E.O. 13771 also provides for the establishment of agency regulatory cost budgets, as identified by the Office of Management and Budget.

Additionally, on February 24, 2017, the President issued E.O. 13777, “Enforcing the Regulatory Reform Agenda.” That Order required that the head of each agency designate an agency official as its Regulatory Reform Officer (RRO). Each RRO oversees the implementation of regulatory reform initiatives and policies to ensure that agencies effectively carry out regulatory reforms, consistent with applicable law. Further, E.O. 13777 required the establishment of a regulatory reform task force at each agency. The regulatory reform task force makes recommendations to the agency head regarding the repeal, replacement, or Start Printed Page 57855modification of existing regulations, consistent with applicable law.

In implementation of both Orders, on May 30, 2017, DOE published in the Federal Register a Request for Information (RFI), seeking input and other assistance from entities significantly affected by regulations of the DOE, including State, local, and Tribal governments, small businesses, consumers, non-governmental organizations, and manufacturers and their trade associations. DOE's goal in publishing the RFI was to “create a systematic method for identifying those existing DOE rules that are obsolete, unnecessary, unjustified, or simply no longer make sense.” DOE solicited views on: (a) How DOE could best conduct its analysis of existing agency actions, and (b) insights on specific rules or Department-imposed obligations that should be altered or eliminated. DOE received 132 separate public comments from decision-makers, stakeholders, and the public on rules promulgated by DOE and the burdens some of those rules have imposed.

In response to the May 30, 2017, RFI, DOE received many comments recommending that DOE update and modernize its procedures for establishing energy conservation standards and test procedures for the DOE Appliance Program, otherwise known as the “Process Rule.” The current Process Rule can be found in Appendix A to Subpart C of part 430 of the Code of Federal Regulations, published on July 15, 1996. In response to stakeholder input, DOE published a RFI on December 18, 2017 (82 FR 59992), seeking comments and information from interested parties to assist DOE in identifying potential modifications to its “Process Rule.” DOE conducted a public meeting and webinar on January 9, 2018, that was widely attended by a broad spectrum of stakeholders. DOE is currently preparing a Notice of Proposed Rulemaking (NOPR), taking into account the many suggestions from stakeholders, and is including this proposed rule as part of its 2018 Regulatory Plan. DOE has characterized this action as deregulatory.

The second deregulatory action that is part of DOE's 2018 Regulatory Plan is a rule that proposes to withdraw the revised definitions of general service lamps (GSL) and general service incandescent lamps (GSIL) that would otherwise take effect on January 1, 2020. This proposal would maintain the existing statutory definitions of GSL and GSIL currently found in the Department's regulations.

Lastly, DOE is placing one action in its Regulatory Plan: Energy Conservation Standards for Residential Conventional Cooking Products (1904-AD15), even though it does not meet the Regulatory Plan criterion of “most important significant regulatory actions” of the agency. DOE has included this regulatory action for the purpose of transparency and due to the non-trivial costs of the proposed action. At the 7% and 3% discount rate the primary annualized cost of this rule could be as much as 42.6 million and 42.3 million dollars, respectively. The primary annualized benefits at the 7% and 3% discount rate have been projected to be 126 million and 178 million dollars, respectively.

DOE—ENERGY EFFICIENCY AND RENEWABLE ENERGY (EE)

Proposed Rule Stage

40. Energy Conservation Standards for Residential Conventional Cooking Products

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

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

E.O. 13771 Designation: Regulatory.

Legal Authority: 42 U.S.C. 6295(m)(1); 42 U.S.C. 6292(a)(10); 42 U.S.C. 6295(h).

CFR Citation: 10 CFR 429; 10 CFR 430.

Legal Deadline: Other, Statutory, Subject to 6-year-look-back at 6295(m).

Abstract: EPCA, as amended by EISA 2007, requires the Secretary to determine whether updating the statutory energy conservation standards for residential conventional cooking products would yield a significant savings in energy use and is technically feasible and economically justified. DOE is reviewing to make such determination.

Statement of Need: The Energy Policy and Conservation Act of 1975 (EPCA), as amended, prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including residential conventional cooking products. EPCA also requires the U.S. Department of Energy (DOE) to determine whether more-stringent, amended standards would be technologically feasible and economically justified, and would save a significant amount of energy. DOE is proposing new and amended energy conservation standards for residential conventional cooking products, specifically conventional cooking tops and conventional ovens.

Summary of Legal Basis: EPCA provides that not later than 6 years after issuance of any final rule establishing or amending a standard, DOE must publish either a notice of determination that standards for the product do not need to be amended, or a notice of proposed rulemaking including new proposed energy conservation standards (42 U.S.C. 6295(m)(1)).

Alternatives: Additional compliance flexibilities may be available through other means. EPCA provides that a manufacturer whose annual gross revenue from all of its operations does not exceed $8 million may apply for an exemption from all or part of an energy conservation standard for a period not longer than 24 months after the effective date of a final rule establishing the standard (42 U.S.C. 6295(t)). Additionally, section 504 of the Department of Energy Organization Act, 42 U.S.C. 7194, provides authority for the Secretary to adjust a rule issued under EPCA in order to prevent special hardship, inequity, or unfair distribution of burdens that may be imposed on that manufacturer.

Anticipated Cost and Benefits: Using a 7-percent discount rate for benefits and costs, the estimated cost of the proposed standards for consumer conventional cooking products is $42.6 million per year in increased equipment costs, while the estimated annual benefits are $120.3 million in reduced equipment operating costs.

Using a 3-percent discount rate for all benefits and costs, the estimated cost of the proposed standards for consumer conventional cooking products is $42.3 million per year in increased equipment costs, while the estimated annual benefits are $163.3 million in reduced operating costs.

In determining whether a standard is economically justified, DOE must consider whether the benefits of the standard exceed the burdens by, to the greatest extent practicable, considering 7 enumerated factors, including the economic impact of the standard on manufacturers. DOE uses industry net present value (INPV) is the sum of the discounted cash flows to the industry from the reference year through the end of the analysis period (2017 to 2049), to determine manufacturer impact. Using a real discount rate of 9.1 percent, DOE estimates that the INPV for manufacturers of consumer conventional cooking products is $1,241.6 million in 2016 dollars. Under the proposed standards, DOE expects that manufacturers may experience a reduction of up to 4.7 percent of their Start Printed Page 57856INPV, which is approximately $58.4 million in 2016.

The cumulative net present value (NPV) of total consumer benefits of the standards for consumer conventional cooking products ranges from $1.08 billion (at a 7-percent discount rate) to $2.63 billion (at a 3-percent discount rate). This NPV expresses the estimated total value of future operating-cost savings minus the estimated increased product costs for consumer conventional cooking products purchased in 2020-2049.

Risks:

Timetable:

ActionDateFR Cite
Request for Information (RFI)02/12/1479 FR 8337
RFI Comment Period End03/14/14
RFI Comment Period Extended03/03/1479 FR 11714
RFI Comment Period Extended End04/14/14
NPRM and Public Meeting06/10/1580 FR 33030
NPRM Comment Period Extended07/30/1580 FR 45452
NPRM Comment Period Extended End09/09/15
Supplemental NPRM09/02/1681 FR 60784
SNPRM Comment Period Extended09/30/1681 FR 67219
SNPRM Comment Period Extended End11/02/16
Supplemental NPRM02/00/19

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

URL For More Information: www1.eere.energy.gov/​buildings/​appliance_​standards/​rulemaking.aspx?​ruleid=​85.

URL For Public Comments: www.regulations.gov/​#!docketDetail;​D=​EERE-2014-BT-STD-0005.

Agency Contact: Stephanie Johnson, General Engineer, Department of Energy, Energy Efficiency and Renewable Energy, 1000 Independence Avenue SW, Building Technologies Office, EE5B, Washington, DC 20002, Phone: 202 287-1943, Email: stephanie.johnson@ee.doe.gov.

RIN: 1904-AD15

DOE—EE

41. Procedures, Interpretations, and Policies for Consideration of New or Revised Energy Conservation Standards for Consumer Products

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Deregulatory.

Legal Authority: 5 U.S.C. 553(d)

CFR Citation: 10 CFR 430.

Legal Deadline: None.

Abstract: DOE is considering a notice-and-comment rulemaking to amend its Process Improvement Rule (“Process Rule”) to reflect statutory changes as well as innovative, collaborative approaches that DOE has been using to reflect more efficient appliance standards rulemaking.

Statement of Need: DOE is proposing to update and modernize its procedures for establishing energy conservation standards and test procedures for the DOE Appliance Program, otherwise known as the “Process Rule.” This proposed rule would reduce burdens on all stakeholders when engaging in the rulemaking process.

Summary of Legal Basis: On July 15, 1996, DOE published a final rule titled, “Procedures, Interpretations and Policies for Consideration of New or Revised Energy Conservation Standards for Consumer Products.” This document was codified at 10 CFR part 430, subpart C, appendix A. As explained in the final rule for the Process Rule, this rule came within the scope of the Administrative Procedure Act's exemption from notice-and-comment rulemaking for procedural rules at 5 U.S.C. 553(b)(A). Although DOE's current rulemaking to consider potential revisions to the Process Rule might similarly warrant exemption from notice-and-comment requirements, DOE nonetheless seeks input from interested parties regarding potential avenues to improve DOE's procedures.

Alternatives:

Anticipated Cost and Benefits:

Risks:

Timetable:

ActionDateFR Cite
Request for Information (RFI)10/31/1479 FR 64705
RFI Comment Period End12/30/14
Request for Information (RFI) and Notice of Public Meeting12/18/1782 FR 59992
RFI Comment Period Extended02/07/1883 FR 5374
RFI Comment Period Extended End03/02/18
NPRM10/00/18

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

URL For More Information: energy.gov/eere/buildings/standards-and-test-procedures.

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

RIN: 1904-AD38

DOE—EE

42. • Energy Conservation Program: Definition for General Service Lamps

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

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

CFR Citation: 10 CFR 430.

Legal Deadline: None.

Abstract: The Department proposes to withdraw the revised definitions of general service lamp (GSL) and general service incandescent lamp (GSIL) that take effect on January 1, 2020. This proposal would maintain the existing statutory definitions of GSL and GSIL currently found in the Department's regulations.

Statement of Need: DOE is proposing to withdraw the revised definitions of General Service Lamps (GSL) and general service incandescent lamps (GSIL) that would otherwise take effect on January 1, 2020, to reduce the regulatory burdens on stakeholders.

Summary of Legal Basis: On August 15, 2017, DOE published a notice of data availability and request for information (NODA) seeking data for GSILs and other incandescent lamps. The purpose of this NODA was to assist DOE in making a determination regarding amending standards for GSILs. Comments submitted in response to the NODA lead DOE to re-consider the decisions it had already made with respect to the definitions for GSLs and GSILs.

Alternatives:

Anticipated Cost and Benefits:

Risks:

Timetable:

ActionDateFR Cite
NPRM10/00/18

Regulatory Flexibility Analysis Required: No.Start Printed Page 57857

Government Levels Affected: None.

Agency Contact: Celia Sher, Attorney-Advisor, Department of Energy, 1000 Independence Avenue SW, Washington, DC 20002, Phone: 202 287-6122.

RIN: 1904-AE26

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Statement of Regulatory Priorities for Fiscal Year 2019

The Department of Health and Human Services (HHS) carries out a wide array of activities in order to fulfill its mission of protecting and promoting the health and well-being of the American people. From supporting cutting-edge research and disease surveillance, to regulating products and facilities, to administering programs that help our citizens most in need of access to healthcare and social services, HHS's work has a clear impact on the daily life of all Americans. As the federal agency most deeply involved in more than one-sixth of the US economy, it is imperative that HHS be attentive to the costs of over-regulation. Building on the progress that HHS has made in Fiscal Year 2018, the Department will continue to find ways to clarify its regulations to ease the burden of public compliance, or to remove them where feasible to avoid unnecessarily diverting resources from the private sector while simultaneously ensuring the integrity of HHS programs.

HHS is committed to a regulatory agenda that is focused on better meeting the needs of the individuals served by its programs, informed by an understanding that excess and unclear federal regulation not only imposes serious burdens on job creation and the economy as a whole, but also that the opportunity costs from overregulation dampen provider productivity and medical product innovation, which undermines HHS's own ultimate core mission. Through its rulemakings in the coming fiscal year, HHS will take concrete steps towards reducing and streamlining its regulations and improving the transparency, flexibility, and accountability of its regulatory processes.

I. Advancing Secretary Azar's Priorities Through Rulemaking

Since his confirmation as the twenty-fourth Secretary of Health and Human Services in January 2018, Secretary Alex Azar has focused the Department's efforts on four priorities. These initiatives—combatting the opioid crisis; increasing the affordability and accessibility of individual health insurance; tackling the high cost of prescription drugs; and moving to a value-based healthcare system—renew the substantial efforts made by the Department in these areas over the past year and a half and have the potential to deliver lasting change across America's healthcare system.

Combatting the Opioid Crisis

One of the most pressing public health problems of our time, the opioid crisis has steadily grown over the past several decades and is now impacting communities across the country. In addition to providing unprecedented levels of support for states, local governments, and community organizations working to combat this crisis, HHS is exploring ways to enhance our nation's response through critically examining its regulations. To reduce opioid misuse without restricting access to legitimate services, Medicaid programs can utilize several medical management techniques, including quantity limits of short-acting and long-acting opioids. The President's FY 2019 Budget includes a proposal that would establish minimum standards for Medicaid Drug Utilization Review programs. Currently, CMS does not set minimum requirements for these programs, and there is substantial variation in how states approach this issue. Establishing minimum standards would not only help increase oversight of opioid prescriptions and dispensing in Medicaid, but would save the program an estimated $245 million over 10 years.

Additionally, the Substance Abuse and Mental Health Services Administration (SAMHSA) is considering updating its regulations governing medication-assisted treatment for opioid use disorders (OUD) by deleting outdated provisions and revising reporting requirements for providers with waivers to treat up to 275 patients with OUD. SAMHSA will also provide guidance and consider additional changes to 42 CFR part 2 that can foster further alignment with the Health Insurance Portability and Accountability Act (HIPAA). Furthermore, although many covered entities believe that the HIPAA Privacy Rule precludes such disclosures, the Office for Civil Rights (OCR) plans to propose a rule clarifying the Privacy Rule provisions most applicable to information sharing with family members or others when patients are incapacitated. This would reduce uncertainties about the ability of covered entities to disclose patient information to family members, friends, or others best positioned to help individuals suffering with a substance use disorder or serious mental illness.

Strengthening Individual Health Insurance Programs

In addition, strengthening program integrity with respect to subsidy payments in the individual markets is a top priority of this Administration. In furtherance of that goal, the Centers for Medicare & Medicaid Services (CMS) will publish an Exchange Program Integrity rule focusing on ensuring that eligible enrollees receive the correct advanced payments of the premium tax credit, conducting effective and efficient oversight of State-Based Exchanges, and protecting the interests of taxpayers, consumers, and the financial integrity of Federally Facilitated Exchanges. CMS, through its annual Payment Notice for the Exchanges, will also emphasize deregulation and increasing flexibility for states and issuers. CMS will continue to work with the Tri-Departments to explore allowing more flexibility in the availability of health plans in the individual and small group markets, as well as carrying out the instructions in the President's October 12, 2017, Executive Order to consider expanding the use of health reimbursement arrangements (HRAs).

HHS' forthcoming report on promoting competition and choice will also inform HHS' efforts in this area and help drive positive change.

These initiatives will help restore market forces to ensure consumers have plans to choose from that meet their needs.

Tackling the High Cost of Prescription Drugs

In May 2018, Secretary Azar unveiled the President's blueprint to tackle the high cost of prescription drugs, American Patients First. HHS is aggressively working on actions the President may direct HHS to take immediately as well as the consideration of actions on which feedback was solicited in the blueprint. As a part of this ongoing effort, the Food and Drug Administration (FDA) plans to propose regulations to facilitate access to more treatments for common conditions and potentially some chronic conditions by using innovative approaches, including new technologies, to assist consumers in self-selection and use of drug products that have previously been available only by prescription. If finalized, FDA believes this rule will improve public health and lower costs by increasing the number and types of medications that are available without a prescription. Start Printed Page 57858Changes CMS plans to make in its annual Part C and D rules, and potentially other mechanisms, are likewise seeking to improve health and lower costs for American patients.

Transforming Our Healthcare System Into One That Pays for Value

Over the years, it has become increasingly apparent that the United States' fee-for-service payment system does not incentivize innovative therapies and intelligent treatment plans for patients. Previous Congresses and administrations have attempted to alleviate these problems through patchwork attempts at introducing innovative payment models. Now, under Secretary Azar's leadership, HHS will undertake efforts to comprehensively address this issue and attempt to rebuild our healthcare system into one that truly incentivizes effective, efficient patient care by paying for value. As an early step in this effort, CMS plans to propose regulatory revisions to address the impact of the physician self-referral (commonly known as “Stark”) law and encourage coordinated care. Additionally, OCR will be examining the HIPAA rules for obstacles that may limit or discourage coordinated care or otherwise impose regulatory burdens that may impede the transformation to value-based healthcare, without providing commensurate privacy or security protections for patients' protected health information (PHI). HHS' forthcoming report on promoting competition and choice will also inform HHS' efforts in this area and help drive positive change.

II. Empowering the American People Through Reducing Regulatory Burden and Clarifying Regulation

In addition to these four priorities, HHS has been comprehensively reviewing its regulations to find ways to reduce burdens on states, grantees, industries, and individuals. Regulatory burden can result from a variety of sources, including reporting requirements, outdated restrictions, requirements and/or conditions not required by the authorizing statutes, and a lack of clear regulatory guidelines. HHS is committed to streamlining and clarifying its regulations to reduce unnecessary burden while continuing to protect the public health and to meet the human services needs of the American people.

Minimizing Duplicative Requirements and Eliminating Obsolete Regulations

The Department recognizes the burden that requirements for many of its programs place on states, territories, tribes, local governments, industry, providers and facilities, caseworkers, grant recipients, and individuals. HHS plans to actively engage stakeholders in transparent, deliberative processes to ensure that the Department reduces burden while continuing to administer high-quality programs. For example, the Administration for Children and Families (ACF) plans to issue a Notice of Proposed Rulemaking seeking public comment on its proposal to streamline the Adoption and Foster Care Analysis and Reporting System (AFCARS), which doubled reporting requirements for states and tribes. Through careful consideration of all comments submitted by the public to its Advanced Notice of Proposed Rulemaking issued in March 2018, ACF believes it can streamline the 2016 Rule so that state and tribal IV-E agencies are able to devote less time and fewer resources to administrative work and to redirect those efforts to the children they serve.

In addition to minimizing regulatory burden, HHS realizes that many of its regulations may contain provisions that are outdated, obsolete, or otherwise not applicable to the current environment. HHS has resolved to reform its processes so that those providing care and other services to Americans are able to thrive within the state and federal regulatory environment. As an early step in this broader effort, CMS plans to issue a proposed rule that will remove unnecessary and outdated requirements from the conditions of participation for the Medicare and Medicaid programs for Long-Term Care facilities. Currently, these requirements often impede the delivery of quality care and divert resources away from facility residents.

Providing Necessary Regulatory Clarity to Industry Stakeholders

As part of efforts to streamline regulation, in some cases, regulation is necessary in order to make HHS's processes transparent and predictable. This year, FDA plans to continue work on needed implementing regulations for its tobacco program. Rulemaking is needed to clarify for industry the submission and review processes for various review pathways as part of a comprehensive framework to regulate nicotine and tobacco and advance the public health. In addition, FDA is updating important rules for medical device applications so the rules reflect risk-based and least burdensome pathways to market for devices, including new and innovative devices. These rules will fill gaps to ensure that manufacturers in these sectors know how to bring innovative products to market that may save lives or reduce health risks. FDA intends to continue rulemaking this fiscal year to fill these regulatory gaps so that these processes become more fair, efficient, and predictable.

Protecting the Exercise of Conscience Rights

Religious and faith-based organizations and individuals have historically played an important role in providing needed health care and human services. However, regulatory and other burdens on religious freedom and conscience that discourage such organizations and individuals from participating in HHS programs have been often overlooked in recent years. HHS has taken a number of steps to rectify the situation in the past year and plans to continue work to ensure that HHS's programs respect religious liberty and conscience—and to relieve burden on the exercise of religion and conscience. In order to adequately protect these First Amendment and statutory rights, HHS plans to complete a rulemaking to implement and enforce a number of HHS-specific conscience laws and protections, in order to help ensure that individuals participating in HHS-funded health programs are aware of their conscience rights, that recipients of HHS funds comply with their obligations to respect such rights, and that there are enforcement procedures for such conscience protections that are comparable to other civil rights. Additionally, in finalizing its update to the Title X family planning regulations, HHS plans to ensure that the conscience rights of Title X providers are respected.

III. Harnessing Regulatory Reform To Encourage Innovation

In addition to reducing burden, an important outcome of regulatory reform efforts is the proliferation of innovative solutions and programs structured to suit the needs of unique problems and populations. HHS is committed to promoting innovation through a variety of mechanisms, including deregulatory actions.

Promoting Flexibility for States, Grantees, and Regulated Entities

HHS intends to enhance regulatory flexibility so that its state and community partners are able to better tailor their programs to meet the needs of the people they serve. Over the past year and a half, the Department has been looking seriously at its programs to see how it can maximize the number of people reached through amending its regulations to remove or change Start Printed Page 57859regulatory limitations on grantees and regulated entities. For example, ACF plans to consider revising minimum service duration requirements for Head Start center-based programs to allow these programs to serve more children or better meet the needs and daily schedules of local families. Rulemaking carried out in 2016 nearly doubled the current minimum.

Keeping Pace With 21st Century Science

In order to best respond to the needs of patients, it is crucial that HHS regulations and programs reflect current science. HHS is fulfilling this need by updating regulations so that the Department can utilize the full spectrum of current scientific thinking when carrying out program activities. Specifically, HRSA plans to revise the Vaccine Injury Table to include vaccines that the Centers for Disease Control and Prevention (CDC) recommends for administration to pregnant women. This revision will allow injuries related to these vaccines to be eligible for the National Vaccine Injury Compensation Program. Additionally, FDA intends to propose a new rule that will modernize mammography quality by recognizing new technologies, making improvements in facility processes, and updating reporting requirements. FDA believes that these changes will improve the delivery of mammography services and allow for more informed decision-making by strengthening the communication of health care information.

FDA is also taking action to facilitate food innovations that can give consumers more choices and enable better nutrition. Diet is a powerful tool for reducing chronic disease and its impact on the healthcare system. Modernizing the outdated framework for food standards will allow industry flexibility for innovation to produce more healthful foods while maintaining the basic nature and nutritional integrity of key food products. FDA will reopen the comment period on its earlier proposed rule soliciting updated information to guide development of a modern approach to regulating food standards and related labeling.

Summary

In the coming fiscal year, HHS plans to consider a number of deregulatory actions, accompanied by regulatory changes intended to make its processes more flexible, efficient, and transparent. In order to fully realize the potential of these efforts, HHS recognizes the need for a collaborative rulemaking process where the concerns of patients, providers, States, tribes, faith-based and community organizations, and other stakeholders are appropriately considered. By working with its partners in bringing better healthcare and human services to the American people, and understanding the challenges that they face under HHS's current regulatory structures, the Department will continue to modernize its role in this critical sector of the national economy, assuring its vitality and the increased wellbeing of those it serves.

HHS—OFFICE FOR CIVIL RIGHTS (OCR)

Prerule Stage

43. HIPAA Privacy: Request for Information on Changes To Support, and Remove Barriers To, Coordinated Care

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Other.

Legal Authority: Pub. L. 115-5, sec. 13405(c)

CFR Citation: 45 CFR 164.

Legal Deadline: Final, Statutory, June 1, 2010, The statutory deadline to issue a rule on accounting of disclosures was 06/01/2010.

Required by the HITECH Act. Statutory deadline contingent on further regulatory action.

Abstract: This Request for Information (RFI) would solicit the public's views on whether there are provisions of the HIPAA Rules which present barriers that limit or discourage coordinated care and case management among hospitals, physicians (and other providers), payors, and patients, or otherwise impose regulatory burdens that may impede the transformation to value-based health care without providing commensurate privacy or security protections for patients' protected health information and while maintaining patients' ability to control the use or disclosure of their PHI and to access PHI. In addition to a general request for information, the RFI would specifically seek comment on a number of particular issues, including: (1) Methods of accounting of all disclosures of a patient's protected health information; (2) patients' acknowledgment of receipt of a providers' notice of privacy practices; (3) creation of a safeharbor for good faith disclosures of PHI for purposes of care coordination or case management; (4) disclosures of protected health information without a patient's authorization for treatment, payment, and health care operations; (5) the minimum necessary standard/requirement. This RFI would subsume the previous 0945-AA08 entry in the Regulatory Agenda.

Statement of Need: The HHS Deputy Secretary recently launched an initiative called the Regulatory Sprint to Coordinated Care. The goal of the Regulatory Sprint is to remove regulatory barriers that impede coordinated, value-based health care. This RFI is being produced to support the Regulatory Sprint.

Summary of Legal Basis: The HIPAA statute and its amendments.

Alternatives: None were considered as this RFI is intended to solicit various policies for improving HIPAA.

Anticipated Cost and Benefits: No anticipated costs as this is not regulatory. Benefits include receiving public feedback on potential policies to pursue in rulemaking.

Risks: None known.

Timetable:

ActionDateFR Cite
NPRM05/31/1176 FR 31426
NPRM Comment Period End08/01/11
NPRM Withdrawal11/00/18
RFI11/00/18

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

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

Agency Contact: Andra Wicks, Health Information Privacy Specialist, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 202 774-3081, TDD Phone: 800 537-7697, Email: andra.wicks@hhs.gov.

RIN: 0945-AA00

HHS—OCR

Proposed Rule Stage

44. HIPAA Privacy Rule: Presumption of Good Faith of Health Care Providers

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

Legal Authority: Health Insurance Portability and Accountability (HIPAA) Act of 1996, Pub. L. 104-191

CFR Citation: 45 CFR 164.510.

Legal Deadline: None.

Abstract: In an effort to address the opioid epidemic, the proposed rule would make a number of changes to Start Printed Page 57860provisions of the HIPAA Privacy Rule regarding uses and disclosures of protected health information to ease the burden on and potential risks to covered entities that may want to disclose PHI in such circumstances.

Statement of Need: With over 60,000 individuals dying of opioid overdoses in 2016 and others suffering from addiction to the opiates, HHS issued a declaration of emergency to recognize a nationwide opioid epidemic. HIPAA permits providers and other covered entities to disclose protected health information about an individual to families, caregivers and other relevant parties in circumstances related to opioid overdose and addiction. Despite this permission and HHS guidance clarifying HIPAA, HHS continues to receive anecdotal evidence that providers and other covered entities are reluctant to share an opioid patient's health information with family or other caregivers.This proposal seeks to encourage covered entities to share protected health information with family members, caregivers, and others in a position to avert threats of harm to health and safety when necessary to promote the health and recovery of those struggling with opioid addiction.

Summary of Legal Basis: OCR has broad authority under the HIPAA statute to make modifications to the Privacy Rule, within the statutory constraints of HIPAA, the HITECH Act, and other applicable law (e.g., the Administrative Procedures Act). OCR, by delegation from the Secretary, has broad authority under HIPAA to make modifications to the Privacy Rule, as provided by section 264 of HIPAA (codified at 42 U.S.C. 1320d-2(note)).

Alternatives: OCR may issue additional guidance as an alternative to the proposed rule. However, HIPAA continues to be cited as a barrier to sharing protected health information in crisis situations, despite extensive existing guidance and outreach efforts. Without regulatory changes, it is not clear that additional guidance would be effective in clarifying the ability to share protected health information in such situations. Revising the Privacy Rule would be a more effective and permanent vehicle for achieving the desired policy, and would provide additional Good Samaritan safe harbor protections to health care providers who share protected health information when trying to help patients.

Anticipated Cost and Benefits: The proposed rule will not create any new requirements or costs for regulated entities or the public. It will benefit patients and families by helping to ensure that family members and others involved in the patients' care can get the information they need to help their loved ones obtain appropriate care and support. It will also provide additional protections to health care providers exercising their professional judgment when making disclosures of protected health information to further the interests of patients.

Risks: While we do not anticipate significant risks to privacy associated with this proposal, the NPRM requests public input on whether the impact of these amendments, taken together, could be expected to discourage individuals from seeking care based on concerns that their PHI may be disclosed against their wishes.

Timetable:

ActionDateFR Cite
NPRM01/00/19

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

Agency Contact: Andra Wicks, Health Information Privacy Specialist, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 202 774-3081, TDD Phone: 800 537-7697, Email: andra.wicks@hhs.gov.

RIN: 0945-AA09

HHS—OCR

Final Rule Stage

45. Protecting Statutory Conscience Rights in Health Care; Delegations of Authority

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

E.O. 13771 Designation: Regulatory.

Legal Authority: Pub. L. 115-31; 22 U.S.C. 7631(d); 26 U.S.C. 5000A(d)(2); 29 U.S.C. 669(a)(5); 42 U.S.C. 300a-7; 42 U.S.C. 238n; secs. 1553, 280g-1(d), 290bb-36(f), 1320a-1, 1320c-11, 1395cc(f), 1395i-5, 1395w-22(j)(3)(B), 1395x(e), 1395x(y)(1); 1396a(a), 1396a(w)(3), 1396f, 1396s(c)(2)(B)(ii), 1396u-2(b)(3)(B), 1397j-1(b), 1553, 5106i(a); 18113s, 18023(c)(2)(A)(i)-(iii), 18023(b)(1)(A), 18023(b)(4), 18113; . . .

CFR Citation: 45 CFR 88.

Legal Deadline: None.

Abstract: This final rule would provide for the implementation and enforcement of the Federal health care conscience and associated anti-discrimination laws.

Statement of Need: Revision of the current conscience rule is necessary to provide proper enforcement tools to address unlawful discrimination, coercion and hostility, which has been the subject of a rising number of complaints before OCR and in Federal courts and raised questions from Congressional oversight. Clarity about existing conscience protections is needed to reduce confusion about the law. Furthermore, the Department lacks strategic coordination across its components and enforcement tools that are available to remedy invidious discrimination under other protected bases.

Summary of Legal Basis: The rule would enforce and implement health care conscience and associated anti-discrimination statutes that protect health care providers and patients in these areas as prescribed by Congress: (1) Conscience protections related to abortion, sterilization, and certain other health services to participants in programs and their personnel funded by the Department; (2) conscience protections for health care entities related to abortion provision or training, referral for such abortion or training, or accreditation standards related to abortion; (3) protections from discrimination for health care entities and individuals who object to furthering or participating in abortion under programs funded by the Department's yearly appropriations acts; (4) conscience protections under the Patient Protection and Affordable Care Act related to assisted suicide, individual mandate, and other matters of conscience; (5) conscience protections for objections to counseling and referral for certain services in Medicaid or Medicare Advantage; (6) conscience protections related to the performance of advanced directives; (7) conscience protections related to Global Health Programs to the extent administered by the Secretary; (8) exemptions from compulsory health care or services generally and under specific programs for hearing screenings, occupational illness testing, vaccination, and mental health treatment; and (9) protections for religious nonmedical health care.

Alternatives: Maintaining the status quo by enforcing 45 CFR part 88 as it currently exists creates a significant risk of unaddressed violations of conscience laws, and leaves few remedies available due to OCR's administrative enforcement scheme and court decisions holding that Congress did not incorporate into its conscience statutes for parties to file private rights of action in the courts.

Anticipated Cost and Benefits: Protection of religious beliefs and moral convictions is a broad qualitative benefit Start Printed Page 57861that serves individual rights and society as a whole, and protection of conscience reduces barriers to entry, combats attrition, and increases diversity of providers in the health care field. Costs of $311 million in the first year and $124.6 million per year in years 2 through 5 are estimated to be incurred for familiarization with the law, preparation of notices and assurances of compliance, compliance procedures and voluntary remedial efforts. Costs for OCR enforcement are $1 million in the first year and $1 million per year in years 2 through 5.

Risks: Enforcement of these conscience laws could risk reduction in access to health care services in low provider populated areas.

Timetable:

ActionDateFR Cite
NPRM01/26/1883 FR 3880
NPRM Comment Period End03/27/18
Final Action11/00/18

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Federal, Local, State.

Agency Contact: Sarah Bayko-Albrecht, Supervisory Analyst, Department of Health and Human Services, Office for Civil Rights, 200 Independence Avenue SW, Washington, DC 20201, Phone: 800 368-1019, TDD Phone: 800 537-7697, Email: ocrmail@hhs.gov.

RIN: 0945-AA10

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

Proposed Rule Stage

46. Revising Outdated Requirements for Opioid Treatment Providers (OTPS)

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

E.O. 13771 Designation: Deregulatory.

Legal Authority: sec. 303(g) of the Controlled Substances Act (CSA); 21 U.S.C. 823(g)

CFR Citation: 42 CFR 8.

Legal Deadline: None.

Abstract: This planned deregulatory action would revise 42 CFR part 8 to reduce outmoded requirements. First, SAMSHA may streamline the regulation by deleting now outdated requirements pertaining to transitional certification for opioid treatment programs (OTPs). This change will help make the regulation less confusing by removing a provision that no longer applies.

Second, SAMSHA may alter requirements pertaining to interim maintenance treatment program approval.

Statement of Need: SAMHSA plans to promulgate a rule to remove the transitional certification provisions that are now outdated. Additionally, updating language to permit private, for-profit entities to serve as opioid treatment programs could improve patient access to this treatment.

This planned deregulatory action would revise 42 CFR part 8 to reduce outmoded requirements. First, SAMSHA may streamline the regulation by deleting now outdated requirements pertaining to transitional certification for opioid treatment programs (OTPs). This change will help make the regulation less confusing by removing a provision that no longer applies.

Second, SAMSHA may alter requirements pertaining to interim maintenance treatment program approval.

Summary of Legal Basis: Section 303(g) of the Controlled Substances Act (CSA) (21 U.S.C. 823(g) establishes procedures for determining whether a healthcare practitioner can dispense opioid drugs for the purpose of treating opioid use disorders. HHS has adopted regulations at 42 CFR part 8 to provide additional details. These regulations were most recently substantively revised in July 2016 (81 FR 44712).

Alternatives: The alternatives include not making these changes or making only one of the above changes rather than both.

Anticipated Cost and Benefits: Eliminating outmoded transition regulations will make the regulations less confusing. In addition, permitting private, for-profit entities to qualify for certification potentially will broaden access to opioid treatment programs. SAMHSA is unsure how to quantify costs and benefits for these changes.

Risks: The transition provisions are outdated and no longer apply. SAMSHA anticipates most stakeholders will support permitting private, for-profit entities to serve as OTPs but some may be skeptical of these entities as compared to nonprofits. Rescinding the reporting requirements for providers treating up to 275 patients should hold minimal risk since these providers still are bound by other certification requirements such as recordkeeping, etc. These reporting requirements initially were added in July 2016 (81 FR 66191).

Timetable:

ActionDateFR Cite
NPRM09/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Local, State, Tribal.

Agency Contact: Chris Carroll, Director of Health Care Financing and Systems Integration, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Rockville, MD 20857, Phone: 240 276-1765, Email: christopher.carroll@samhsa.hhs.gov.

RIN: 0930-AA27

HHS—SAMHSA

47. • Coordinating Care and Information Sharing in the Treatment of Substance Use Disorders

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

E.O. 13771 Designation: Deregulatory.

Legal Authority: 42 U.S.C. 290dd-2

CFR Citation: 42 CFR 2.

Legal Deadline: None.

Abstract: SAMHSA is proposing broad changes to Confidentiality of Alcohol and Drug Abuse Patient Records, 42 Code of Federal Regulations (CFR) 2, also known as 42 CFR part 2 to remove barriers to coordinated care and permit additional sharing of information among providers and part 2 programs assisting patients with substance use disorders (SUDs).

Statement of Need: SAMHSA is proposing broad changes to Confidentiality of Alcohol and Drug Abuse Patient Records, 42 Code of Federal Regulations (CFR) 2, also known as 42 CFR part 2 to remove barriers to coordinated care and permit additional sharing of information among providers and part 2 programs assisting patients with substance use disorders (SUDs).

Summary of Legal Basis: To be determined.

Alternatives: The alternatives include not making these changes or making changes to part 2 more limited in scope (i.e., only in one or two sections).

Anticipated Cost and Benefits: The rule is not expected to be economically significant. As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.

Risks: SAMHSA believes the many stakeholders will support efforts to make it easier for patients and providers to share information under part 2. However, some commenters may Start Printed Page 57862believe these changes will further undermine privacy protection under part 2 and lead individuals who may seek treatment to not seek treatment for fear of disclosure of their SUD.

Timetable:

ActionDateFR Cite
NPRM03/00/19

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Local, State, Tribal.

Agency Contact: Chris Carroll, Director of Health Care Financing and Systems Integration, Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Rockville, MD 20857, Phone: 240 276-1765, Email: christopher.carroll@samhsa.hhs.gov.

RIN: 0930-AA32

HHS—FOOD AND DRUG ADMINISTRATION (FDA)

Proposed Rule Stage

48. Food Standards: General Principles and Food Standards Modernization (Reopening of Comment Period)

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 336; 21 U.S.C. 341; 21 U.S.C. 343; 21 U.S.C. 371

CFR Citation: 21 CFR 130.5.

Legal Deadline: None.

Abstract: FDA is reopening the comment period on a proposed rule, issued jointly with USDA/FSIS in 2005, that proposed to establish general principles that would be the first step in modernizing and updating the framework for food standards (also known as standards of identity). We are reopening the comment period because of the time that has elapsed since the publication of the proposed rule during which time there have been additional technological advances and other changes in the food industry which could help inform the development of a modernized food standards framework.

Statement of Need: Standards of identity for foods are regulations Congress authorized FDA to issue to promote honesty and fair dealing in the interest of consumers. FDA's standards of identity have proved valuable in assuring that food products are consistent across different manufacturers. They are important for international trade as well as domestic trade and are critical to government expenditures on food for the military, for WIC (women, infants, and children) programs, and in school feeding programs. However, questions have been raised about whether the regulations concerning standards of identity should be revised in light of changing consumer expectations and subsequent developments in food technology, and global trade. In 1996, FDA and USDA established a task force to discuss the current and future role of food standards. The task force determined there were several regulatory options including making no change to the food standards, eliminating all food standards, or using resources to review and revise the food standards to protect consumers without inhibiting technological advances in food preparation and marketing. FDA and FSIS ultimately decided to propose amending the petition process so the standards of identity would be more internally consistent, flexible for manufacturers, and easier to administer while ensuring product quality and uniformity to consumers, and did so in 2005.

Summary of Legal Basis: FDA has established over 280 food standards of identity, in addition to standards of quality and fill of container, under the authority set forth in section 401 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 341). This section provides in part:

Whenever in the judgment of the Secretary (of Health and Human Services) such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing for any food, under its common or usual name so far as practicable, a reasonable definition and standard of identity, a reasonable standard of quality, or reasonable standards of fill of container.

The standards of identity, quality, and fill of container for foods regulated by FDA are codified in title 21, parts 130 to 169 (21 CFR parts 130 to 169). FDA food standards are established under the common or usual name of a food and often specify the content of the food, generally in terms of the types of ingredients that it must contain (i.e., mandatory ingredients), and that it may contain (i.e., optional ingredients). FDA food standards may specify minimum and maximum levels of constituents. They also may describe the manufacturing process when that process has a bearing on the identity of the finished food. Finally, FDA food standards may also include provisions related to label declaration of ingredients and nomenclature of the food depending on the form, packing medium, and optional ingredients used.

Alternatives: FDA is proposing to reopen the comment period on the 2005 proposal, to allow for us to update the record and inform decisionmaking on standards of identity. The only alternative would be to open a docket and request comments and data on the issue generally, which would be a step backward. FDA does not believe it is in a position to develop a new proposed rule without affording stakeholders and the public a chance to comment and provide new data and information. After we have reviewed this information, we will be in a position to either publish a new proposed rule or to issue a final rule based on the full record.

Anticipated Cost and Benefits: There is no cost/benefit analysis associated with reopening a proposed rule to solicit updated comments and information. The preliminary regulatory impact analysis in the proposed rule evaluated various options and concluded that taking the action covered in the proposed rule will generate net social benefits, and concluded that the social costs of taking the proposed action are likely to be small. The analysis found that most of the other options were likely to have lower net benefits because they had lower benefits, higher costs, or both.

Risks:

Timetable:

ActionDateFR Cite
ANPRM12/29/9560 FR 67492
ANPRM Comment Period End04/29/96
NPRM05/20/0570 FR 29214
NPRM Comment Period End08/18/05
NPRM Comment Period Reopened06/00/19

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: Undetermined.

Agency Contact: Andrea Krause, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, College Park, MD 20740, Phone: 240 402-2371, Fax: 301 436-2636, Email: andrea.krause@fda.hhs.gov.

Related RIN: Related to 0583-AC72

RIN: 0910-AC54

Start Printed Page 57863

HHS—FDA

49. Mammography Quality Standards Act; Amendments to Part 900 Regulations

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

E.O. 13771 Designation: Regulatory.

Legal Authority: 21 U.S.C. 360i; 21 U.S.C. 360nn; 21 U.S.C. 374(e); 42 U.S.C. 263b

CFR Citation: 21 CFR 900.

Legal Deadline: None.

Abstract: FDA is proposing to amend its regulations governing mammography. The amendments would update the regulations issued under the Mammography Quality Standards Act of 1992 (MQSA). FDA is taking this action to address changes in mammography technology and mammography processes that have occurred since the regulations were published in 1997 and to address breast density reporting to patient and health care providers.

Statement of Need: FDA is proposing to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is taking this action to address changes in mammography technology and mammography processes.

FDA is also proposing updates to modernize the regulations by incorporating current science and mammography best practices, including addressing breast density reporting to patients and health care providers. These updates are intended to improve the delivery of mammography services.

Summary of Legal Basis: Mammography is an X-ray imaging examination device that is regulated under the authority of the FD&C Act. FDA is proposing these amendments to the mammography regulations (set forth in 21 CFR part 900) under section 354 of the Public Health Service Act (42 U.S.C. 263b), and sections 519, 537, and 704(e) of the FD&C Act (21 U.S.C. 360i, 360nn, and 374(e)).

Alternatives: The Agency will consider different options so that the health benefits to patients are maximized and the economic burdens to mammography facilities are minimized.

Anticipated Cost and Benefits: The primary public health benefits of the rule will come from the potential for earlier breast cancer detection, improved morbidity and mortality, resulting in reductions in cancer treatment costs. The primary costs of the rule will come from industry labor costs and costs associated with supplemental testing and biopsies.

Risks:

Timetable:

ActionDateFR Cite
NPRM11/00/18

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Erica Payne, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5522, Silver Spring, MD 20993, Phone: 301 796-3999, Fax: 301 847-8145, Email: erica.payne@fda.hhs.gov.

RIN: 0910-AH04

HHS—FDA

50. Medical Device De Novo Classification Process

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

E.O. 13771 Designation: Other.

Legal Authority: 21 U.S.C. 321(h); 21 U.S.C. 360c, 360i-360j; 21 U.S.C. 371; 21 U.S.C. 374

CFR Citation: 21 CFR 860.

Legal Deadline: None.

Abstract: De novo classification decreases regulatory burdens because manufacturers can use a less burdensome application pathway under the FD&C Act to market their devices. The proposed rule would establish procedures and criteria for the de novo process and would make it more transparent and predictable for manufacturers.

Statement of Need: FDA is taking this action to implement amendments to the De Novo classification process in the FD&C Act that were enacted by the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), and the 21st Century Cures Act of 2016 (Cures).

Summary of Legal Basis: The FD&C Act (21 U.S.C. 301 et seq.), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act established three categories (classes) of medical devices based on the regulatory controls sufficient to provide reasonable assurance of safety and effectiveness of the device. In 1997, Congress enacted section 513()(2) to include a De Novo classification process for some devices for which reasonable assurance of safety and effectiveness could be established through the De Novo process. FDASIA and cures expanded and modified this process.

Alternatives: The De Novo classification process is based on authority from the FD&C Act. The De Novo classification program must continue because it is required by statute. If the proposed rule is not finalized, then procedures and details about the application process and handling of De Novo applications might be unclear to potential applicants, and the program may not be as efficient as it might be.

Anticipated Cost and Benefits: By clarifying the requirements for the De Novo classification process. FDA expects that the rule would reduce the time and costs associated with preparing and reviewing De Novo requests, and would generate net benefits in the form of cost savings for both private and government sectors.

Risks:

Timetable:

ActionDateFR Cite
NPRM10/00/18

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Jean M. Olson, Regulatory Counsel, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 66, Room 5508, Silver Spring, MD 20993, Phone: 301 796-6579, Email: jean.olson@fda.hhs.gov.

RIN: 0910-AH53

HHS—FDA

51. Nonprescription Drug Product With an Additional Condition for Nonprescription Use

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Deregulatory.

Legal Authority: 21 U.S.C. 321; 21 U.S.C. 352; 21 U.S.C. 355; 21 U.S.C. 371; 42 U.S.C. 262; 42 U.S.C. 264; . . .

CFR Citation: 21 CFR 314.56; 21 CFR 201.67.

Legal Deadline: None.

Abstract: The proposed rule is intended to increase access to nonprescription drug products. The proposed rule would establish requirements for a drug product that Start Printed Page 57864could be marketed as a nonprescription drug product with an additional condition that an applicant must implement to ensure appropriate self-selection, appropriate actual use, or both by consumers.

Statement of Need: Nonprescription products have traditionally been limited to drugs that can be labeled with information for consumers to safely and appropriately self-select and use the drug product without supervision of a health care provider. There are certain prescription medications that may have comparable risk-benefit profiles to over-the-counter medications in selected populations. However, appropriate consumer selection and use may be difficult to achieve in the nonprescription setting based solely on information included in labeling. FDA is proposing regulations that would establish the requirement for a drug product could be marketed as a nonprescription drug product with an additional condition that an applicant must implement to ensure appropriate self-selection or appropriate actual use or both for consumers.

Summary of Legal Basis: FDA's proposed revisions to the regulations regarding labeling and applications for nonprescription drug products labeling are authorized by the FD&C Act (21 U.S.C. 321 et seq.) and by the Public Health Service Act (42 U.S.C. 262 and 264).

Alternatives: FDA evaluated various requirements for new drug applications to assess flexibility of nonprescription drug product design through drug labeling for appropriate self-selection and appropriate use.

Anticipated Cost and Benefits: The benefits of the proposed rule would include increased consumer access to drug products which could translate to a reduction in under treatment of certain diseases and conditions. Benefits to industry would arise from the flexibility in drug product approval. The proposed rule would impose costs arising from the development of an innovative approach to assist consumers with nonprescription drug product self-selection or use.

Risks: None.

Timetable:

ActionDateFR Cite
NPRM08/00/19

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Agency Contact: Chris Wheeler, Supervisory Project Manager, Department of Health and Human Services, Food and Drug Administration, 10903 New Hampshire Avenue, Building 51, Room 3330, Silver Spring, MD 20993, Phone: 301 796-0151, Email: chris.wheeler@fda.hhs.gov.

RIN: 0910-AH62

HHS—FDA

52. Format and Content of Reports Intended To Demonstrate Substantial Equivalence

Priority: Other Significant.

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Deregulatory.

Legal Authority: 21 U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 387; 42 U.S.C. 4332

CFR Citation: 21 CFR 1107.

Legal Deadline: None.

Abstract: This proposed rule would establish the format and content of reports intended to demonstrate substantial equivalence (SE) in tobacco products and would provide information as to how the Agency will review and act on these submissions.

Statement of Need: The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), requires premarket submissions for new tobacco products. Substantial equivalence reports are one type of premarket submission that manufacturers of new tobacco products may use to obtain marketing authorization for a new tobacco product. This regulation is necessary to provide information to manufacturers to aid them in preparing and submitting substantial equivalence reports.

Summary of Legal Basis: Section 905(j) of the FD&C Act, as amended by the Tobacco Control Act, provides for the submission of substantial equivalence reports and authorizes FDA to prescribe the form and manner of these reports. Section 910 of the FD&C Act mandates the premarket review of new tobacco products, establishes definitions of substantial equivalence and characteristics, and requires health information as part of a submission under section 905(j) of the FD&C Act. Section 909 establishes record and report requirements for tobacco products. Sections 701 and 704 of the FD&C Act authorize the promulgation of regulations to implement the FD&C Act and inspections.

Alternatives: In addition to the benefits and costs of the proposed rule, FDA assessed the benefits and costs of several alternatives to the proposed rule: (1) Extending the effective date of the rule, (2) allowing for more deficiency letters and review cycles, and (3) allowing for only one review cycle.

Anticipated Cost and Benefits: The costs of the rule are compliance costs on affected entities, e.g., to read and understand the rule, to revise internal procedures, and fill out a form for substantial equivalence reports. The quantified benefits of the proposed rule are cost-savings resulting from shorter FDA review times and fewer staff to review substantial equivalence reports. The cost savings to the government is expected to be larger than the compliance cost for industry and the net result is an overall net positive benefit from this proposed rule. The qualitative benefits of the rule include additional clarity to industry about the requirements for the content and format of substantial equivalence reports, as well as the establishment of procedures for substantial equivalence report review and communication with applicants. These changes make the substantial equivalence marketing pathway clearer for both FDA and applicants.

Risks: Premarket submissions for new tobacco products are required by the FD&C Act. But to prepare premarket submissions such as substantial equivalence reports intended to meet those requirements, manufacturers need more information about content and format requirements. This rule provides more information on content and format requirements and describes possible FDA actions on the substantial equivalence report.

Timetable:

ActionDateFR Cite
NPRM11/00/18

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: None.

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

RIN: 0910-AH89

Start Printed Page 57865

HHS—FDA

53. • Nutrient Content Claims, Definition of Term: Healthy

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Regulatory.

Legal Authority: 21 U.S.C. 321, 331, 343, and 371

CFR Citation: 10 CFR 101.65 (revision).

Legal Deadline: None.

Abstract: The proposed rule would update the definition for the implied nutrient content claim “healthy” to be consistent with current nutrition science and federal dietary guidelines. The proposed rule would revise the requirements for when the claim “healthy” can be voluntarily used in the labeling of human food products so that the claim reflects current science and dietary guidelines and help consumers maintain healthy dietary practices.

Statement of Need: FDA is proposing to redefine healthy to make it more consistent with current public health recommendations, including those captured in recent changes to the Nutrition Facts label. The existing definition for healthy is based on nutrition recommendations regarding intake of fat, saturated fat, and cholesterol, and specific nutrients Americans were not getting enough of in the early 1990s. Nutrition recommendations have evolved since that time; recommended diets now focus on dietary patterns, which includes getting enough of certain food groups such as fruits, vegetables, low-fat dairy, and whole grains. Chronic diseases, such as heart disease, cancer, and stroke, are the leading causes of death and disability in the United States and diet is a contributing factor to these diseases. Claims on food packages such as healthy can provide quick signals to consumers about the healthfulness of a food or beverage, thereby making it easier for busy consumers to make healthy choices.

FDA is proposing to update the existing nutrient content claim definition of Healthy based on the food groups recommended by the Dietary Guidelines for Americans and also include nutrients to limit to ensure that foods bearing the claim can help consumers build more healthful diets to reduce their risk of diet-related chronic diseases.

Summary of Legal Basis: FDA is issuing this proposed rule under sections 201(n), 301(a), 403(a), 403(r), and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(n), 331(a), 343(a), 343(r), and 371(a)). These sections authorize the agency to adopt regulations that prohibit labeling that bears claims that characterize the level of a nutrient which is of a type required to be declared in nutrition labeling unless the claim is made in accordance with a regulatory definition established by FDA. Pursuant to this authority, FDA issued a regulation defining the healthy implied nutrient content claim, which is codified at 21 CFR 101.65. This proposed rule would update the existing definition to be consistent with current federal dietary guidance.

Alternatives: Alternative 1: Codify the policy in the current enforcement discretion guidance.

In 2016, FDA published Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry. This guidance was intended to advise food manufacturers of FDA's intent to exercise enforcement discretion relative to foods that use the implied nutrient content claim healthy on their labels which: (1) Are not low in total fat, but have a fat profile makeup of predominantly mono and polyunsaturated fats; or (2) contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.

One alternative is to codify the policy in the current enforcement discretion. Although guidance is non-binding, we assume that most packaged food manufacturers are aware of the guidance and, over the past 2 years, have already made any adjustments to their products or product packaging. Therefore, we assume that this alternative would have no costs to industry and no benefits to consumers.

Alternative 2: Extend the compliance date by 1 year.

Extending the anticipated proposed compliance date on the rule updating the definition by 1 year would reduce costs to industry as they would have more time to change products that may be affected by the rule or potentially coordinate label changes with already scheduled label changes. On the other hand, a longer compliance date runs the risk of confusing consumers that may not understand whether a packaged food product labeled healthy follows the old definition or the updated one.

Anticipated Cost and Benefits: Food products bearing the healthy claim currently make up a small percentage (5%) of total packaged foods. Relabeling and reformulating costs can range from about $2,000/UPC to relabel, $800,000/formula to reformulate. We currently anticipate that total cost to industry will be about $15 million, annualized at 7% in perpetuity.

Updating the definition of healthy to align with current dietary recommendations help consumers build more healthful diets to reduce their risk of diet-related chronic diseases. We currently anticipate the monetized benefits to be around $100 million, annualized at 7% in perpetuity.

There are no cost savings.

Risks:

Timetable:

ActionDateFR Cite
NPRM03/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Vincent De Jesus, Nutritionist, Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition, (HFS-830), Room 3D-031, 5100 Paint Branch Parkway, College Park, MD 20740, Phone: 240 402-1774, Fax: 301 436-1191, Email: vincent.dejesus@fda.hhs.gov.

RIN: 0910-AI13

HHS—OFFICE OF ASSISTANT SECRETARY FOR HEALTH (OASH)

Final Rule Stage

54. • Compliance With Statutory Program Integrity Requirements

Priority: Other Significant.

E.O. 13771 Designation: Other.

Legal Authority: 42 U.S.C. 300-300a-6

CFR Citation: Not Yet Determined.

Legal Deadline: None.

Abstract: This action would finalize revisions to the Title X regulations to ensure compliance with, and enhance the implementation of, various statutory program integrity requirements, including the statutory requirement that none of the funds appropriated for Title X may be used in programs where abortion is a method of family planning.

Statement of Need: This action should enhance compliance with the statutory program integrity requirements applicable to, and purpose and goals of, the Title X program (especially those related to section 1008), the appropriations provisos and riders addressing the Title X program, and other obligations and requirements established under other Federal law. The action should also enhance Start Printed Page 57866programmatic transparency regarding the provision of Title X services (with respect to both the identity of the providers and the services being provided by such entities).

Summary of Legal Basis: The Department has legal authority to issue and amend regulations to implement Title X of the Public Health Service (PHS) Act (42 U.S.C. 300 300a-6), in order to establish the requirements applicable to projects for family planning services, pursuant to section 1006 of the Public Health Service Act, 42 U.S.C. 300a-4; section 1006 also provides priority for low-income families. Section 1001 of the PHS Act establishes certain parameters for voluntary Title X family planning projects/programs, including the offering of a broad range of acceptable and effective family planning methods and services (including natural family planning methods, infertility services, and services for adolescents) and the encouragement, to the extent practical, of family participation. Section 1008 of the PHS Act, 42 U.S.C. 300a-6, establishes the prohibition on the use of the funds appropriated for Title X “in programs where abortion is a method of family planning.”

In addition, the annual Labor-HHS appropriations act imposes, on an annual basis, certain additional requirements with respect to the Title X program, including that all pregnancy counseling be nondirective; that Title X funds not be expended for any activity that in any way tends to promote public support or opposition to any legislative proposal or candidate for public office; that Title X grant applicants certify to the Secretary that they encourage family participation in the decision of minors to seek family planning services and provide counseling to minors on how to resist attempts to coerce them into engaging in sexual activities; and that Title X providers comply with State laws requiring notification or the reporting of child abuse, child molestation, sexual abuse, rape, or incest. See, e.g., Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, 207-208, Title II, 132 Stat. 348, 716-17.

Finally, the action would ensure that the Title X program and Title X providers comply with laws that protect the conscience rights of individuals and entities who decline to perform, participate in, or refer for abortions, including the Church Amendments (42 U.S.C. 300a-7), the Coats-Snowe Amendment (42 U.S.C. 238n), and the Weldon Amendment, see, e.g., Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, 507(d), 132 Stat. 348, 764 (2018).

The Department has legal authority to issue and amend regulations to implement Title X of the Public Health Service (PHS) Act (42 U.S.C. 300 300a-6), in order to establish the requirements applicable to projects for family planning services, pursuant to section 1006 of the Public Health Service Act, 42 U.S.C. 300a-4; section 1006 also provides priority for low-income families. Section 1001 of the PHS Act establishes certain parameters for voluntary Title X family planning projects/programs, including the offering of a broad range of acceptable and effective family planning methods and services (including natural family planning methods, infertility services, and services for adolescents) and the encouragement, to the extent practical, of family participation. Section 1008 of the PHS Act, 42 U.S.C. 300a-6, establishes the prohibition on the use of the funds appropriated for Title X “in programs where abortion is a method of family planning.”

In addition, the annual Labor-HHS appropriations act imposes, on an annual basis, certain additional requirements with respect to the Title X program, including that all pregnancy counseling be nondirective; that Title X funds not be expended for any activity that in any way tends to promote public support or opposition to any legislative proposal or candidate for public office; that Title X grant applicants certify to the Secretary that they encourage family participation in the decision of minors to seek family planning services and provide counseling to minors on how to resist attempts to coerce them into engaging in sexual activities; and that Title X providers comply with State laws requiring notification or the reporting of child abuse, child molestation, sexual abuse, rape, or incest. See, e.g., Consolidated Appropriations Act, 2018, Pub. L. 115-141, Div. H, 207-208, Title II, 132 Stat. 348, 716-17.

Finally, the action would ensure that the Title X program and Title X providers comply with laws that protect the conscience rights of individuals and entities who decline to perform, participate in, or refer for abortions, including the Church Amendments (42 U.S.C. 300a-7), the Coats-Snowe Amendment (42 U.S.C. 238n), and the Weldon Amendment, see, e.g., Consolidated Appropriations Act, 2018, Public Law 115-141, Div. H, 507(d), 132 Stat. 348, 764 (2018).

Alternatives: The Department continues to consider alternative approaches that would ensure (1) sufficient compliance with the statutory program integrity requirements and purpose and goals of the Title X program, the appropriations provisos and riders addressing the Title X program, and other obligations and requirements established under other Federal law, and (2) transparency regarding the provision of services (with respect to both the identity of the providers and the services being provided by such entities).

Anticipated Cost and Benefits: The changes proposed will improve the integrity of Title X program, especially with respect to ensuring that projects and providers do not fund, support, or promote abortion as a method of family planning, and enhance compliance with statutory requirements and appropriations riders and provisos. In addition, it is expected that the changes will facilitate the ability of an expanded number of entities to participate in Title X, including by removal of abortion counseling and referral requirements that potentially violate Federal health care conscience protections; this should serve to expand and enhance patient service and care. The proposed rule estimated $13.6 million in annualized costs at a 7% discount rate.

Risks: None known.

Timetable:

ActionDateFR Cite
NPRM06/01/1883 FR 25502
NPRM Comment Period End07/31/18
Final Action10/00/18

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Agency Contact: Valerie Huber, Senior Policy Advisor, Department of Health and Human Services, Office of Assistant Secretary for Health, 200 Independence Avenue SW, Washington, DC 20201, Phone: 202 690-7694, Fax: 202 401-8034, Email: valerie.huber@hhs.gov.

Related RIN: Related to 0937-ZA00

RIN: 0937-AA07

HHS—CENTERS FOR MEDICARE & MEDICAID SERVICES (CMS)

Proposed Rule Stage

55. Requirements for Long-Term Care Facilities: Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (CMS-3347-P) (Section 610 Review)

Priority: Economically Significant. Major under 5 U.S.C. 801.Start Printed Page 57867

E.O. 13771 Designation: Deregulatory.

Legal Authority: Secs. 1819 and 1919 of the Social Security Act; sec. 1819(d)(4)(B) and 1919(d)(4)(B) of the Social Security Act; sec. 1819(b)(1)(A) and 1919(b)(1)(A) of the Social Security Act

CFR Citation: 42 CFR 483; 42 CFR 488.

Legal Deadline: None.

Abstract: This proposed rule would reform the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs, that CMS has identified as unnecessary, obsolete, or excessively burdensome on facilities. This rule would increase the ability of healthcare professionals to devote resources to improving resident care by eliminating or reducing requirements that impede quality care or that divert resources away from providing high quality care.

Statement of Need: CMS is committed to transforming the healthcare delivery system, and the Medicare program, by putting an additional focus on patient-centered care and working with providers, physicians, and patients to improve outcomes. We seek to reduce burdens for long-term care facilities; healthcare professionals and residents; improve the quality of care; decrease costs; and, ensure that residents and their providers are making the best healthcare choices possible.

We are therefore proposing revisions to the requirements that long-term care facilities must meet to participate in the Medicare and Medicaid programs that would increase the ability of healthcare professionals to devote resources to improving resident care by eliminating or reducing requirements that impede quality care or that divert resources away from providing high quality care.

Summary of Legal Basis: The Secretary has statutory authority to issue these rules under the Nursing Home Reform Act, (part of the Omnibus Budget Reconciliation Act of 1987 (OBRA '87), Pub. L. 100-203, 101 Stat. 1330 (1987)), which added sections 1819 and 1919 to the Act; those provisions authorize the Secretary to promulgate regulations that are “adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.” (Sections 1819(f)(1) and 1919(f)(1) of the Act). In addition, the Act authorizes the Secretary to impose “such other requirements relating to the health and safety [and well-being] of residents as [he] may find necessary.” (Sections 1819(d)(4)(B), 1919(d)(4)(B) of the Act). Under Sections 1819(c)(1)(A)(xi) and 1919 (c)(1)(A)(xi) of the Act, the Secretary may also establish “other right[s]” for residents, in addition to those expressly set forth in the statutes and regulations, to “protect and promote the rights of each resident.”

Alternatives: For all of the proposed provisions, we considered not making these changes. Specifically, we considered the impact that any revisions would have on the health and safety of residents in long-term care facilities and if such revisions would realistically be burden reducing for facilities. Ultimately, we believe that the proposed revisions will be burden reducing and do not impede on the health and safety of residents.

Anticipated Cost and Benefits: This proposed rule would create ongoing cost savings to long-term care facilities in many areas. In addition, various proposals would clarify existing policy and relieve some administrative burdens.

Risks:

Timetable:

ActionDateFR Cite
NPRM11/00/18

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: Federal.

Agency Contact: Ronisha Blackstone, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality, MS: S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-6882, Email: ronisha.blackstone@cms.hhs.gov.

RIN: 0938-AT36

HHS—CMS

56. CY 2020 Notice of Benefit and Payment Parameters (CMS-9926-P)

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

E.O. 13771 Designation: Other.

Legal Authority: Pub. L. 111-148, title I

CFR Citation: 45 CFR 149; 45 CFR 153; 45 CFR 155; 45 CFR 156.

Legal Deadline: None.

Abstract: This annual proposed rule would set forth payment parameters and provisions related to the risk adjustment programs; cost-sharing parameters; and user fees for issuers offering plans on Federally-facilitated Exchanges and State-based Exchanges using the Federal platform. It would also provide additional standards for several other Affordable Care Act programs.

Statement of Need: This rule will propose standards related to the risk adjustment program for the 2020 benefit year, as well as certain modifications that will promote state flexibility and control over their insurance markets, reduce burden on stakeholders, and improve program integrity.

Summary of Legal Basis: This rule addresses multiple sections of the Patient Protection and Affordable Care Act (Pub. L. 111148) and the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111152), which amended and revised several provisions of the Patient Protection and Affordable Care Act.

Alternatives: We considered slight variants of the proposed policies related to the risk adjustment program and standards related to the Exchanges.

Anticipated Cost and Benefits: We anticipate that the proposed changes will include some initial costs on stakeholders, but generate savings over the long term. As we move toward publication, estimates of the cost and benefits of these provisions will be included in the rule.

Risks: If this regulation is not published timely, issuers in the individual and small group market will not have important information for rate setting for the 2020 plan year, and changes applicable to qualified health plans will not be in place in time for the 2020 plan year.

Timetable:

ActionDateFR Cite
NPRM10/00/18

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

Agency Contact: Lindsey Murtagh, Senior Policy Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4106, Email: lindsey.murtagh@cms.hhs.gov.

RIN: 0938-AT37

HHS—CMS

57. Exchange Program Integrity (CMS-9922-P)

Priority: Other Significant.

E.O. 13771 Designation: Regulatory.

Legal Authority: Pub. L. 111-148

CFR Citation: 45 CFR 155; 45 CFR 156.Start Printed Page 57868

Legal Deadline: None.

Abstract: This rule proposes improvements to Exchange program integrity, ensuring that eligible enrollees receive the correct advanced payments of the premium tax credit, and conducting effective and efficient oversight of State-Based Exchanges.

Statement of Need: This proposed rule would propose changes to strengthen program integrity related to oversight of State Exchanges, and the operation of Exchanges.

Summary of Legal Basis: This rule addresses multiple sections of the Patient Protection and Affordable Care Act (Pub. L. 111148) and the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111152), which amended and revised several provisions of the Patient Protection and Affordable Care Act.

Alternatives: The proposed policies are important for program integrity reasons. We considered variations on the proposed policies.

Anticipated Cost and Benefits: We do not anticipate the proposed rule to be a significant regulatory action, but do anticipate it would generate costs on stakeholders. We believe these costs will be offset by improvements in program integrity.

Risks: If this regulation is not published timely, important program integrity improvements will be delayed.

Timetable:

ActionDateFR Cite
NPRM10/00/18

Regulatory Flexibility Analysis Required: No.

Government Levels Affected: Federal, State.

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

Agency Contact: Jeff Wu, Health Insurance Specialist, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Consumer Information and Insurance Oversight, MS: 733H.02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 301 492-4305, Email: jeff.wu@cms.hhs.gov.

RIN: 0938-AT53

HHS—CMS

58. Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2020 (CMS-4185-P)

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

E.O. 13771 Designation: Deregulatory.

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

CFR Citation: 42 CFR 417; 42 CFR 422; 42 CFR 423.

Legal Deadline: None.

Abstract: This proposed rule would set forth programmatic and operational changes to the Medicare Advantage (MA) and prescription drug benefit programs for contract year 2020.

Statement of Need: This rule is necessary to make revisions to the Medicare Advantage (MA) and Prescription Drug Benefit programs to implement applicable provisions of the Bipartisan Budget Act of 2018 and based on our continued experience in the administration of the programs.

Summary of Legal Basis: This rule addresses multiple sections of the Social Security Act. It also implements sections 50323, 50311, and 50354 of the Bipartisan Budget Act of 2018.

Alternatives: This rule implements provisions that require public notice and comment and are necessary for the upcoming contract year. We will continue to explore additional alternatives as we develop the rule.

Anticipated Cost and Benefits: Preliminary estimates of the anticipated costs and benefits of this proposed rule indicate savings and burden reduction for the government, MA organizations, prescription drug plan sponsors, and providers. We expect some savings will also be passed onto beneficiaries in the form of increased benefit offerings and reduced premiums or cost sharing. Numerical estimates are pending and as we move toward publication, estimates of costs and benefits will be included in the proposed rule.

Risks:

Timetable:

ActionDateFR Cite
NPRM10/00/18

Regulatory Flexibility Analysis Required: Undetermined.

Small Entities Affected: Businesses, Governmental Jurisdictions, Organizations.

Government Levels Affected: Federal.

Agency Contact: Michael Dibella, Director, Division of Policy, Analysis, and Planning, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-22-18, 7500 Security Blvd., Baltimore, MD 21244, Phone: 410 786-4480, Email: michael.dibella@cms.hhs.gov.

RIN: 0938-AT59

HHS—CMS

59. • Modernizing and Clarifying the Physician Self-Referral Regulations (CMS-1720-P)

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

Legal Authority: 42 U.S.C. 1395nn

CFR Citation: 42 CFR 411.

Legal Deadline: None.

Abstract: This rule proposes to address any undue regulatory impact and burden of the physician self-referral law.

Statement of Need: This rule is necessary to facilitate the successful transition from volume-based to value-based payment for health care services and promote care coordination among health care providers and suppliers who furnish care to Medicare beneficiaries and other patients. This rule is also necessary to bring needed clarity and flexibility for parties subject to the physician self-referral law's prohibitions on referrals and Medicare claims submission.

Summary of Legal Basis: This rule interprets section 1877 of the Social Security Act.

Alternatives: We will continue to explore alternatives as we develop the rule.

Anticipated Cost and Benefits: We believe that this rule could have a positive impact on health outcomes of beneficiaries and other American patients because providers, suppliers and physicians will be able to better coordinate patient care without running afoul of the physician self-referral law's referral and Medicare claims submission prohibitions. We also believe the proposed regulatory reforms may make compliance with the physician self-referral law more straightforward.

Risks:

Timetable:

ActionDateFR Cite
RFI Notice With Comment Period06/25/1883 FR 29524
RFI Comment Period End08/28/18
NPRM12/00/18

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: None.

Agency Contact: Lisa Wilson, Technical Advisor, Department of Health and Human Services, Centers for Medicare & Medicaid Services, Center for Medicare, MS: C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244, Phone: 410 786-8852, Email: lisa.wilson2@cms.hhs.gov.

RIN: 0938-AT64

Start Printed Page 57869

HHS—ADMINISTRATION FOR CHILDREN AND FAMILIES (ACF)

Proposed Rule Stage

60. Adoption and Foster Care Analysis and Reporting System

Priority: Other Significant.

E.O. 13771 Designation: Deregulatory.

Legal Authority: Secs. 474(f), 479 and 1102 of the Social Security Act

CFR Citation: 45 CFR 1355.

Legal Deadline: None.

Abstract: This notice of proposed rulemaking (NPRM) seeks public suggestions in particular from State and Tribal title IV-E agencies and Indian tribes, Tribal organizations and consortiums, for streamlining the Adoption and Foster Care Analysis and Reporting System (AFCARS) data elements and removing any undue burden related to reporting AFCARS.

Statement of Need: The reporting requirements for the Adoption and Foster Care Analysis and Reporting System (AFCARS) have doubled in the past year. In an effort to ensure that an appropriate balance is achieved between reporting burden and administering high-quality programs that provide services to children and families. By engaging in this rulemaking process, the public and stakeholders will be afforded an opportunity to provide input on what data collections are most useful to the administration of child welfare programs.

Summary of Legal Basis: Section 479 of the Social Security Act requires HHS regulate a national data collection system which provides comprehensive information on adopted and foster children and their parents.

Alternatives: None. This rule implements statutory requirements.

Anticipated Cost and Benefits: An estimate of costs to States to modify their existing data systems is not available at this time.

Risks: None.

Timetable:

ActionDateFR Cite
ANPRM03/15/1883 FR 11449
ANPRM Comment Period End06/13/18
NPRM05/00/19

Regulatory Flexibility Analysis Required: No.

Small Entities Affected: No.

Government Levels Affected: None.

Agency Contact: Kathleen McHugh, ACYF/Children's Bureau, Department of Health and Human Services, Administration for Children and Families, 330 C Street SW, Washington, DC 20201, Phone: 202 401-5789, Email: kathleen.mchugh@acf.hhs.gov.

RIN: 0970-AC72

DEPARTMENT OF HOMELAND SECURITY (DHS)

Fall 2018 Statement of Regulatory Priorities

The Department of Homeland Security (DHS or Department) was established in 2003 pursuant to the Homeland Security Act of 2002, Public Law 107-296. The DHS mission statement provides the following: “With honor and integrity, we will safeguard the American people, our homeland, and our values.”

Fulfilling that mission requires the dedication of more than 240,000 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.

Leading a unified national effort, DHS has five core missions: (1) Prevent terrorism and enhance security; (2) secure and manage our borders; (3) enforce and administer our immigration laws; (4) safeguard and secure cyberspace; and (5) ensure resilience to disasters. In addition, we must specifically focus on maturing and strengthening the homeland security enterprise itself.

In achieving those goals, we are continually strengthening our partnerships with communities, first responders, law enforcement, and Government agencies—at the Federal, State, local, tribal, 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 mission, see the DHS website at http://www.dhs.gov/​our-mission.

The regulations we have summarized below in the Department's Fall 2018 regulatory plan and agenda support the Department's authorities. These regulations will improve the Department's ability to accomplish its mission. Also, the regulations we have identified in this year's regulatory plan continue to address legislative initiatives such as the Implementing Recommendations of the 9/11 Commission Act of 2007 (9/11 Act), Public Law 110-53 (Aug. 3, 2007).

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 in order 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.

Executive Order 13771 Requirements

In fiscal year 2019, DHS plans to finalize the following actions:

We provide further information about those actions in the DHS Regulatory Plan and Unified Agenda.

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 is particularly concerned with the impact its regulations have on small businesses. DHS and its components continue to emphasize the use of plain language in our regulatory documents to promote a better understanding of regulations and to promote increased public participation in the Department's regulations.Start Printed Page 57870

The Fall 2018 regulatory plan for DHS includes regulations from several DHS components, including U.S. Citizenship and Immigration Services (USCIS), the U.S. Coast Guard (the Coast Guard), U.S. Customs and Border Protection (CBP), the U.S. Immigration and Customs Enforcement (ICE), the Federal Emergency Management Agency (FEMA), and the Transportation Security Administration (TSA). Below is a discussion of the regulations that comprise the DHS fall 2018 regulatory plan.

United States Citizenship and Immigration Services

USCIS is the government agency that administers the nation's lawful immigration system, safeguarding its integrity and promise by efficiently and fairly adjudicating requests for immigration benefits while protecting Americans, securing the homeland, and honoring our values. In the coming year, USCIS will promulgate several regulatory actions to support that mission.

Removing H-4 Dependent Spouses from the Class of Aliens Eligible for Employment Authorization. USCIS will propose to rescind the final rule published in the Federal Register on February 25, 2015. The 2015 final rule amended DHS regulations by extending eligibility for employment authorization to certain H-4 dependent spouses of H-1B nonimmigrants who are seeking employment-based lawful permanent resident status.

H-1B Nonimmigrant Program and Petitioning Process Regulations. In order to improve U.S. worker protections as well as to address the requirements of Executive Order 13788, Buy American and Hire American, USCIS will propose to issue regulations with the focus of improving the H-1B nonimmigrant program and petitioning process. Such initiatives will include a proposed rule that would establish an electronic registration program for H-1B petitions subject to annual numerical limitations and would improve the H-1B numerical limitation allocation process (Registration Requirement for Petitioners Seeking to File H-1B Petitions on Behalf of Aliens Subject to Numerical Limitations); and a proposed rule that would revise the definition of specialty occupation to increase focus on truly obtaining the best and brightest foreign nationals via the H-1B program and would revise the definition of employment and employer-employee relationship to help better protect U.S. workers and wages. (Strengthening the H-1B Nonimmigrant Visa Classification Program).

Heightened Screening and Vetting of Immigration Program Regulations. USCIS will propose regulations guiding the inadmissibility determination whether an alien is likely at any time to become a public charge under section 212(a)(4) of the Immigration and Nationality Act. (Inadmissibility on Public Charge Grounds). Additionally, USCIS will propose to update its biometrics regulations to eliminate multiple references to specific biometric types, and to allow for the expansion of the types of biometrics required to establish and verify an identity. The goal of this proposal will be to establish consistent identity enrollment and verification policies and processes, and to provide clear proposals on how biometrics will be used in the immigration process. (USCIS Biometrics Collection for Collection for Consistent, Efficient and Effective Operations).

Employment Creation Immigrant Regulations. USCIS will amend its regulations modernizing the employment-based, fifth preference (EB-5) immigrant investor category based on current economic realities and to reflect statutory changes made to the program. (EB-5 Immigrant Investor Program Modernization). USCIS will also propose to update its regulations for the EB-5 Immigrant Investor Regional Center Program to better reflect realities for regional centers and EB-5 immigrant investors, to increase predictability and transparency in the adjudication process, to improve operational efficiency, and to enhance program integrity. (EB-5 Immigrant Investor Regional Center Program). Lastly, USCIS will publish an advanced notice of proposed rulemaking to solicit public input on proposals that would increase monitoring and oversight of EB-5 projects, and encourage investment in rural areas. (EB-5 Immigrant Investor Program Realignment.)

Asylum Reforms. USCIS will propose regulations aimed at deterring the fraudulent filing of asylum applications for the purpose of obtaining Employment Authorization Documents. (Employment Authorization Documents for Asylum Applicants). USCIS will also propose to amend its regulations to streamline credible fear screening determinations in response to the Southwest Border crises. (Credible Fear Reform Regulation).

Adjustment of Status Process Improvements. USCIS will propose to update regulatory provisions to improve the efficiency in the processing of adjustment of status applications, to reduce processing times, to improve data quality provided to partner agencies, to reduce the potential for visa retrogression, to promote efficient usage of available immigrant visas, and to discourage fraudulent and frivolous filings. (Updating Adjustment of Status Procedures for More Efficient Processing and Immigrant Visa Usage). USCIS will also propose updates to its regulations to improve the efficiency of USCIS processing of the Medical Certification for Disability Exceptions. (Improvements to the Medical Certification for Disability Exceptions).

Electronic Processing of Immigration Benefit Requests. USCIS will propose to amend its regulations to mandate electronic submission for all immigration benefit requests, explain the requirements associated with electronic processing, and allow end-to-end digital processing. This proposal would enhance efficiency and efficacy in USCIS operations, and improve the experience for those applying for immigration benefits.

United States Coast Guard

Coast Guard is a military, multi-mission, maritime service of the United States and the only military organization within DHS. It is the principal Federal agency responsible for the $4.5 trillion maritime transportation system, including maritime safety, security, and stewardship. The Coast Guard delivers daily value to the nation through multi-mission resources, authorities, and capabilities.

Effective governance in the maritime domain hinges upon an integrated approach to safety, security, and stewardship. The Coast Guard's policies and capabilities are integrated and interdependent, delivering results through a network of enduring partnerships with maritime stakeholders. Consistent standards of universal application and enforcement, which encourage safe, efficient, and responsible maritime commerce, are vital to the success of the maritime industry. The Coast Guard's ability to field versatile capabilities and highly-trained personnel is one of the U.S. Government's most significant and important strengths in the maritime environment.

America is a maritime nation, and our security, resilience, and economic prosperity are intrinsically linked to the oceans. Safety, efficient waterways, and freedom of transit on the high seas are essential to our well-being. The Coast Guard is leaning forward, poised to meet the demands of the modern maritime environment. The Coast Guard creates value for the public through solid prevention and response efforts. Activities involving oversight and Start Printed Page 57871regulation, enforcement, maritime presence, and public and private partnership foster increased maritime safety, security, and stewardship.

The statutory responsibilities of the Coast Guard include ensuring marine safety and security, preserving maritime mobility, protecting the marine environment, enforcing U.S. laws and international treaties, and performing search and rescue. The Coast Guard supports the Department's overarching goals of mobilizing and organizing our Nation to secure the homeland from terrorist attacks, natural disasters, and other emergencies.

In fiscal year 2019, the Coast Guard plans to finalize 0 regulatory actions and 11 deregulatory actions. The Coast Guard is highlighting the following Executive Order 13771 deregulatory actions:

Amendments to the Marine Radar Observer Refresher Training Regulations. The Coast Guard will propose removing obsolete portions of the radar observer endorsement requirements and harmonizing the endorsement with the merchant mariner credential. Active mariners with radar observer endorsements having one year of relevant sea service within the previous five years and having served in a position using radar for navigation and collision avoidance purposes on board a radar-equipped vessel, or who have met certain instructor requirements, would be able to renew their radar observer endorsement without completing a radar course. This proposed rule would eliminate the requirement for mariners to carry a certificate of training if the radar observer endorsement is on the MMC, and would allow the endorsement and MMC to expire at the same time. Elimination of the requirement to take a radar refresher or re-certification course every five years would reduce burden on affected mariners without affecting safety. (Note: There is no associated Regulatory Plan entry for this rule because this rule is non-significant under Executive Order 12866. There is an entry, however, in the Unified Agenda.)

TWIC Reader Requirements; Delay of Effective Date. The Coast Guard has proposed to partially delay the effective date of the final rule entitled “Transportation Worker Identification Credential (TWIC) Reader Requirements,” published in the Federal Register on August 23, 2016. The rule would delay the requirements for facilities that handle bulk CDC, but do not transfer it to or from vessels, as well as facilities that receive vessels that carry CDC, but do not transfer it to the facility. The Coast Guard is considering this delay to allow time to re-evaluate the “asset categorization” methodology used to determine which facilities were considered high risk. Currently, the rule is scheduled to be implemented after the Department of Homeland Security submits the report to Congress on the effectiveness of the TWIC program, required by the Transportation Worker Identification Credential Security Card Program Improvements and Assessment Act (Pub. L. 114-278). This rule would delay the effective date for the affected facilities until August 23, 2021.

Removal of Certain International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as Amended (STCW) Training Requirements. The Coast Guard will propose to remove three Coast Guard merchant mariner training requirements related to STCW officer and rating endorsements from its regulations in 46 CFR parts 11 and 12. The Coast Guard has determined these training requirements exceed current international certification and training standards of the STCW and cause a misalignment between the training of U.S. mariners and the mariners of other countries. The proposed rule would remove the following training requirements: Leadership and managerial skills training to qualify as master of vessels of less than 500 gross tons limited to near-coastal waters; bridge resource management training to qualify as officer in charge of a navigational watch on vessels of less than 500 gross tons limited to near-coastal waters; and computer systems and maintenance training to qualify as electro-technical rating on vessels powered by main propulsion machinery of 750 kW/1,000 HP or more. Removal of these training requirements would reduce the burden on affected mariners without affecting safety.

Person in Charge of Fuel Transfers. The Coast Guard will propose an alternative to the existing regulatory requirement that a person in charge (PIC) of a fuel transfer on an inspected vessel hold a Merchant Mariner Credential with either an officer endorsement or Tankerman-PIC endorsement. The proposed rule would add the option of designating the PIC using a letter of designation (LOD), which is currently an option for uninspected vessels but not inspected vessels. The LOD designates the holder as a PIC of the transfer of fuel oil and states that the holder has received sufficient formal instruction from the operator or agent of the vessel to ensure his or her ability to safely and adequately carry out the duties and responsibilities of the PIC. Our decades of experience with LODs on uninspected vessels indicates we can safely provide this option to persons on inspected vessels. Allowing the PIC to hold an LOD instead of an Merchant Mariner Credential would relieve certain personnel from the burden of obtaining and renewing an Merchant Mariner Credential every 5 years, and would create flexibility as to who may serve as a PIC of fuel transfers on inspected vessels. This option would be available only for transfers of fuel; the PIC requirements for vessels transferring cargo would remain unchanged. (Note: There is no associated Regulatory Plan entry for this rule because this rule is non-significant under Executive Order 12866. There is an entry, however, in the Unified Agenda.)

United States Customs and Border Protection

CBP is the Federal agency principally responsible for the security of our Nation's borders, both at and between the ports of entry into the United States. CBP must accomplish its border security and enforcement mission without stifling the flow of legitimate trade and travel. The primary mission of CBP is its homeland security mission, that is, to prevent terrorists and terrorist weapons from entering the United States. An important aspect of this priority mission involves improving security at our borders and ports of entry, but it also means extending our zone of security beyond our physical borders.

CBP is also responsible for administering laws concerning the importation into the United States of goods, and enforcing the laws concerning the entry of persons into the United States. This includes regulating and facilitating international trade; collecting import duties; enforcing U.S. trade, immigration and other laws of the United States at our borders; inspecting imports, overseeing the activities of persons and businesses engaged in importing; enforcing the laws concerning smuggling and trafficking in contraband; apprehending individuals attempting to enter the United States illegally; protecting our agriculture and economic interests from harmful pests and diseases; servicing all people, vehicles, and cargo entering the United States; maintaining export controls; and protecting U.S. businesses from theft of their intellectual property.

In carrying out its mission, CBP's goal is to facilitate the processing of legitimate trade and people efficiently without compromising security. Consistent with its primary mission of homeland security, CBP intends to issue several regulations during the next fiscal Start Printed Page 57872year that are intended to improve security at our borders and ports of entry. During the upcoming year, CBP will also be working on various projects to streamline CBP processing, reduce duplicative processes, reduce various burdens on the public, and automate various paper forms. Below are descriptions of CBP's planned regulatory and deregulatory actions for fiscal year 2019.

Collection of Biometric Data from Aliens Upon Entry to and Departure from the United States. DHS is required by statute to develop and implement an integrated, automated entry and exit data system to match records, including biographic data and biometric identifiers, of aliens entering and departing the United States. In addition, Executive Order 13780, Protecting the Nation from Foreign Terrorist Entry into the United States, states that DHS is to expedite the completion and implementation of a biometric entry-exit tracking system. Although the current regulations provide that DHS may require certain aliens to provide biometrics when entering and departing the United States, they only authorize DHS to collect biometrics from certain aliens upon departure under pilot programs at land ports and at up to 15 airports and seaports. In order to provide the legal framework for DHS to begin a seamless biometric entry-exit system, DHS intends to issue an interim final rule to amend the regulations to remove the references to pilot programs and the port limitation. In addition, to enable CBP to make the process for verifying the identity of alien's more efficient, accurate, and secure by using facial recognition technology, this rule would also provide that alien travelers may be required to provide photographs upon entry and/or departure.

Implementation of the Electronic System for Travel Authorization (ESTA) at U.S. Land Borders—Automation of CBP Form I-94W. CBP intends to amend DHS regulations to implement the ESTA requirements under section 711 of the Implementing Recommendations of the 9/11 Commission Act of 2007, for aliens who intend to enter the United States under the Visa Waiver Program (VWP) at land ports of entry. Currently, aliens from VWP countries must provide certain biographic information to U.S. CBP officers at land ports of entry on a paper I-94W Nonimmigrant Visa Waiver Arrival/Departure Record (Form I-94W). Under this rule, these VWP travelers would instead provide this information to CBP electronically through ESTA prior to application for admission to the United States.

Technical Corrections to Reflect the Consolidation of Vessel Repair Unit Locations. CBP intends to issue a final rule to update provisions relating to the declaration, entry and dutiable status of repair expenditures made abroad for certain vessels to reflect the port of New Orleans, Louisiana as the only Vessel Repair Unit (VRU) location. The amendment will improve the efficiency of vessel repair entry processing, ensure the proper assessment and collection of duties, and make the regulations more transparent. This rule is a deregulatory action under Executive Order 13771. (Note: There is no associated Regulatory Plan entry for this rule because this rule is non-significant under Executive Order 12866. There is an entry, however, in the Unified Agenda.)

Modernization of the Customs Brokers Regulations. CBP intends to issue a proposed rule to amend the requirements for customs brokers. Specifically, CBP will propose to expand the scope of the national permit authority to allow national permit holders to conduct any type of customs business throughout the customs territory of the United States. To accomplish this, CBP will propose to eliminate broker districts and district permits, which also eliminates the need for district permit waivers and for brokers to maintain district offices. Additionally, CBP will propose to update the responsible supervision and control oversight framework to better reflect the modern business environment. This rule is a deregulatory action under Executive Order 13771. (Note: There is no associated Regulatory Plan entry for this rule because this rule is non-significant under Executive Order 12866. There is an entry, however, in the Unified Agenda.)

Automation of CBP Form I-418 for Vessels. CBP intends to issue a rule amending the regulations regarding the submission of Form I-418, Passenger List—Crew List. Currently, the master or agent of every commercial vessel arriving in the United States, with limited exceptions, must submit a paper Form I-418, along with certain information regarding longshore work, to CBP at the port where immigration inspection is performed. Most commercial vessel operators are also required to submit a paper Form I-418 to CBP at the final U.S. port prior to departing for a foreign port. Under this rule, most vessel operators would be required to electronically submit the data elements on Form I-418 to CBP through the National Vessel Movement Center in lieu of submitting a paper form. This rule would eliminate the need to file the paper Form I-418 in most cases. This rule is a deregulatory action under Executive Order 13771. (Note: There is no associated Regulatory Plan entry for this rule, because this rule is not significant under Executive Order 12866. There is an entry, however, in the Unified Agenda.)

In addition to the regulations that CBP issues to promote DHS's mission, CBP also issues regulations related to the mission of the Department of the Treasury. Under section 403(1) of the Homeland Security Act of 2002, the former-U.S. Customs Service, including functions of the Secretary of the Treasury relating thereto, transferred to the Secretary of Homeland Security. As part of the initial organization of DHS, the Customs Service inspection and trade functions were combined with the immigration and agricultural inspection functions and the Border Patrol and transferred into CBP. The Department of the Treasury retained certain regulatory authority of the U.S. Customs Service relating to customs revenue function. In addition to its plans to continue issuing regulations to enhance border security, in the coming year, CBP expects to continue to issue regulatory documents that will facilitate legitimate trade and implement trade benefit programs. For a discussion of CBP regulations regarding the customs revenue function, see the regulatory plan of the Department of the Treasury.

Federal Emergency Management Agency

FEMA's mission is helping people before, during, and after disasters.

FEMA is working on a deregulatory action titled Update to FEMA's Regulations on Rulemaking Procedures. That rule would revise FEMA regulations pertaining to rulemaking by removing sections that are outdated or do not affect the public and update provisions that affect the public's participation in the rulemaking process.

FEMA is also working on a regulatory action titled Factors Considered When Evaluating a Governor's Request for Individual Assistance for a Major Disaster. This regulation would address the Sandy Recovery Improvement Act of 2013's requirement that FEMA review, update, and revise through rulemaking the individual assistance factors FEMA uses to measure the severity, magnitude, and impact of a disaster. FEMA published a proposed rule on November 12, 2015, and now plans to issue a final rule.

Federal Law Enforcement Training Center

The Federal Law Enforcement Training Center (FLETC) does not have Start Printed Page 57873any significant regulations planned for fiscal year 2019.

United States Immigration and Customs Enforcement

ICE is the principal criminal investigative arm of DHS and one of the three Department components charged with the criminal and civil enforcement of the Nation's immigration laws. Its primary mission is to protect national security, public safety, and the integrity of our borders through the criminal and civil enforcement of Federal law governing border control, customs, trade, and immigration. During fiscal year 2019, ICE will focus rulemaking efforts on three priority regulations: (1) A final rule to address the detention, processing, and release of alien children; (2) a final rule to increase the fees paid to the Student and Exchange Visitor Program (SEVP) to recover costs for services; and (3) a proposed rule to replace “duration of status” with a maximum period of stay for certain classes of nonimmigrants.

Below are ICE's significant regulatory actions for the coming fiscal year:

Apprehension, Processing, Care, and Custody of Alien Minors and Unaccompanied Alien Children. ICE, in concert with CBP and the Department of Health and Human Services, will finalize a rule related to the detention, processing, and release of alien children. In 1985, a class-action suit challenged the policies of the former Immigration and Naturalization Service (INS) relating to the detention, processing, and release of alien children; the case eventually reached the U.S. Supreme Court. The Court upheld the constitutionality of the challenged INS regulations on their face and remanded the case for further proceedings consistent with its opinion. In January 1997, the parties reached a comprehensive settlement agreement, referred to as the Flores Settlement Agreement (FSA). The FSA was to terminate five years after the date of final court approval; however, the termination provisions were modified in 2001, such that the FSA does not terminate until forty-five days after publication of regulations implementing the agreement. Since 1997, intervening statutory changes, including passage of the Homeland Security Act and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA), have significantly changed the applicability of certain provisions of the FSA. The proposed rule will codify the relevant and substantive terms of the FSA and enable the U.S. Government to seek termination of the FSA and the litigation concerning its enforcement. Through this rule, DHS will create a pathway to ensure the humane detention of family units while satisfying the goals of the FSA. The rule will also implement related provisions of the TVPRA.

Adjusting Program Fees for the Student and Exchange Visitor Program. ICE will finalize a rule to adjust the fees that the Student and Exchange Visitor Program (SEVP) charges individuals and organizations. In 2016, SEVP conducted a comprehensive fee study and determined that current fees do not recover the full costs of the services provided. ICE has determined that adjusting fees is necessary to fully recover the increased costs of SEVP operations, program requirements, and to provide the necessary funding to sustain initiatives critical to supporting national security. The rule will adjust DHS's fees for individuals and organizations. The SEVP fee schedule was last adjusted in a rule published on September 26, 2008.

Establishing a Maximum Period of Authorized Stay for F-1 and Other Nonimmigrants. ICE will publish a proposed rule that modifies the period of authorized stay for certain categories of nonimmigrants traveling to the United States. The rule would change the authorized stay from “duration of status” and replace it with a maximum period of authorized stay, and options for extensions, for each applicable visa category. This change will help eliminate confusion over the length of authorized period of stay for nonimmigrants to lawfully remain in the United States and will assist efforts to reduce overstay rates.

National Protection and Programs Directorate

The National Protection and Programs Directorate's (NPPD) vision is a safe, secure, and resilient infrastructure where the American way of life can thrive. NPPD leads the national effort to protect and enhance the resilience of the Nation's physical and cyber infrastructure. Although NPPD does not plan to finalize any significant regulations within the next fiscal year, NPPD will undertake reviews of its existing regulations in accordance with Executive Order 13771. NPPD is also working on several future rulemaking projects, as reflected in the Unified Agenda.

Transportation Security Administration

The Transportation Security Administration (TSA) protects the Nation's transportation systems to ensure freedom of movement for people and commerce. TSA applies an intelligence-driven, risk-based approach to all aspects of TSA's mission. This approach results in layers of security to mitigate risks effectively and efficiently. TSA uses established processes, working with stakeholders, to review programs, requirements, and procedures for appropriate modifications based upon changes in the environment, whether those changes result from an evolving threat or enhancements available through new technologies.

For the coming fiscal year, TSA is prioritizing deregulatory actions and regulatory actions that are required to meet statutory mandates and that are necessary for national security. Below are planned TSA actions for fiscal year (FY) 2019.

Security Training for Surface Transportation Employees. TSA will finalize a rule requiring higher-risk public transportation agencies (including rail mass transit and bus systems), railroad carriers (freight and passenger), and over-the-road bus owner/operators to conduct security training for frontline employees. This regulation will implement mandates of the Implementing Regulations of the 9/11 Commission Act of 2007, (9/11 Act), which addressed recommendations of the 9/11 Commission for enhancing the nation's security based upon vulnerabilities identified in the aftermath of September 11, 2001. In compliance with the definition of frontline employees in pertinent provisions of the 9/11 Act, the rule will include identification of which employees are required to receive security training and the content of that training. The final rule will also propose definitions for transportation security-sensitive materials, as required by section 1501 of the 9/11 Act.

Vetting of Certain Surface Transportation Employees. TSA will propose a rule requiring security threat assessments for security coordinators and other frontline employees of certain public transportation agencies (including rail mass transit and bus systems), railroads (freight and passenger), and over-the-road bus owner/operators. The NPRM will also propose provisions to implement TSA's statutory requirement to recover its cost of vetting through user fees. While many stakeholders conduct background checks on their employees, their actions are limited based upon the data they can access. Through this rule, TSA will be able to conduct a more thorough check against terrorist watch-lists of individuals in security-sensitive positions.

Amending Vetting Requirements for Employees with Access to a Security Start Printed Page 57874Identification Display Area. The FAA Extension, Safety, and Security Act of 2016 mandates that TSA consider modifications to the list of disqualifying criminal offenses and criteria, develop a waiver process for approving the issuance of credentials for unescorted access, and propose an extension of the look back period for disqualifying crimes. Based on these requirements, and current intelligence pertaining to the “insider threat,” TSA will propose revisions that enhance the eligibility requirements and disqualifying criminal offenses for individuals seeking or having unescorted access to any Security Identification Display Area of an airport.

Protection of Sensitive Security Information. Through a joint rulemaking with the Department of Transportation (DOT), TSA will streamline existing requirements to protect sensitive security information. This action finalizes an Interim Final Rule for a statutorily-required regulation related to national security. The rule amends TSA's and DOT's regulations to provide three options for the sensitive security information distribution statement, one significantly abbreviated, to address comments on the IFR that the current marking requirements are unduly burdensome. TSA is considering further deregulatory actions, including aligning the requirement for the handling of Federal Flight Deck Officer names consistent with the handling of Federal Air Marshal names (two names listed together would be sensitive security information, not a single Federal Flight Deck Officer name).

Flight Training for Aliens and Other Designated Individuals; Security Awareness Training for Flight School Employees. This rule will streamline regulations and reduce burden for the alien flight student program. This action finalizes an IFR for rule that implements a statutory requirement, as well as addresses comments received in response to a reopening of the comment period on the IFR. The alien flight student program requires security threat assessments for aliens seeking flight training in the United States and imposes additional security measures on the flight schools training these individuals. In response to recommendations from industry through the Aviation Security Advisory Committee, TSA is considering revising these requirements to reduce costs and industry burden. For example, reporting and recordkeeping requirements for the program are estimated to be overly burdensome due to the requirement for paper records. TSA is considering an electronic recordkeeping platform where all flight providers would upload required student information to a TSA-managed website. Also at industry's request, TSA is considering changing the interval for security threat assessments of alien flight students, eliminating the requirement for a new security threat assessment for each “training event.” A related change to the current information collection request pertaining to the alien flight student program will be part of this deregulatory action.

United States Secret Service

The United States Secret Service does not have any significant regulations planned for fiscal year 2019.

DHS Regulatory Plan for Fiscal Year 2019

A more detailed description of the priority regulations that comprise the DHS Fall 2018 regulatory plan follows.

DHS—U.S. CITIZENSHIP AND IMMIGRATION SERVICES (USCIS)

Prerule Stage

61. • EB-5 Immigrant Investor Program Realignment

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Other.

Legal Authority: 8 U.S.C. 1153(b)(5); 8 U.S.C. 1186(a); 8 U.S.C. 1153

CFR Citation: 8 CFR 204.6; 8 CFR 216.6.

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) plans to publish an advanced notice of proposed rulemaking to solicit public input on proposals that would increase monitoring and oversight of the EB-5 program as well as encourage investment in rural areas. DHS would solicit feedback on proposals associated with redefining components of the job creation requirement, and defining conditions for regional center designations and operations.

Statement of Need: DHS will solicit public input on proposals that would increase monitoring and oversight, encourage investment in rural areas, redefine components of the job creation requirement, and define conditions for regional center designations and operations.

Summary of Legal Basis: This rule is based on the authority of DHS to designate regional centers and to permit investors to establish reasonable methodologies to demonstrate job creation under 8 U.S.C. 1153 note (Public Law 102-395, sec. 610 (as amended)), for admission to the United States as lawful permanent residents on a conditional basis. In addition, 8 U.S.C. 1153(b)(5) provides eligibility to aliens who invest in new commercial enterprises which will create jobs and 8 U.S.C. 1186a provides requirements for removal of conditions on permanent resident status, the administration and interpretation of which is left to DHS.

Alternatives:

Anticipated Cost and Benefits: DHS is currently considering the specific cost and benefit impacts of the proposed provisions.

Risks:

Timetable:

ActionDateFR Cite
ANPRM09/00/19

Regulatory Flexibility Analysis Required: Undetermined.

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

Agency Contact: Kevin Cummings, Chief, Business and Foreign Workers Division, Office of Policy and Strategy, Department of Homeland Security, U.S. Citizenship and Immigration Services, 20 Massachusetts Avenue NW, Suite 1200, Washington, DC 20529-2200, Phone: 202 272-8377, Fax: 202 272-1480, Email: kevin.j.cummings@uscis.dhs.gov.

RIN: 1615-AC26

DHS—USCIS

Proposed Rule Stage

62. Inadmissibility on Public Charge Grounds

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

E.O. 13771 Designation: Other.

Legal Authority: 8 U.S.C. 1101 to 1103; 8 U.S.C. 1182 and 1183; . . .

CFR Citation: 8 CFR 103; 8 CFR 212 to 214; 8 CFR 248.

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) will propose regulatory provisions guiding the inadmissibility determination on whether an alien is likely at any time to become a public charge under section 212(a)(4) of the Immigration and Nationality Act (INA), 8 U.S.C. 1182(a)(4). DHS proposes to add a regulatory provision, which would define the term public charge and would outline DHS's public charge considerations.

Statement of Need: To ensure that foreign nationals coming to the United Start Printed Page 57875States or adjusting status to permanent residence, either temporarily or permanently, have adequate means of support while in the United States, and that foreign nationals do not become dependent on public benefits for support.

Summary of Legal Basis: INA 212(a)(4).

Alternatives:

Anticipated Cost and Benefits: DHS is currently considering the specific cost and benefit impacts of the proposed provisions. In general, DHS anticipates that by clarifying the meaning of public charge some stakeholders would incur costs in terms of potentially not being able to adjust status. Other anticipated costs to individuals requesting immigration benefits are associated with the opportunity cost of time to complete and file required forms and documentation, possible costs associated with any additional background checks, and unintended and indirect costs associated with the loss of public assistance due to disenrollment or foregone enrollment in public benefits programs for those who are otherwise eligible. DHS anticipates there will be benefits associated with ensuring that foreign nationals coming to the United States have adequate means of support and do not become dependent on public assistance.

Risks:

Timetable:

ActionDateFR Cite
NPRM05/26/9964 FR 28676
NPRM Comment Period End07/26/99
NPRM10/10/1883 FR 51114
NPRM Comment Period End12/10/18

Regulatory Flexibility Analysis Required: Undetermined.

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

Additional Information: CIS No. 2499-10, Transferred from RIN 1115-AF45.

URL For More Information: www.regulations.gov.

URL For Public Comments: www.regulations.gov.

Agency Contact: Mark Phillips, Chief, Residence and Naturalization Division, Department of Homeland Security, U.S. Citizenship and Immigration Services, Office of Policy and Strategy, 20 Massachusetts Avenue NW, Washington, DC 20529, Phone: 202 272-8377, Email: mark.phillips@uscis.dhs.gov.

RIN: 1615-AA22

DHS—USCIS

63. Registration Requirement for Petitioners Seeking to File H-1B Petitions on Behalf of Cap Subject Aliens

Priority: Other Significant.

E.O. 13771 Designation: Other.

Legal Authority: 8 U.S.C. 1184(g)

CFR Citation: 8 CFR 214.

Legal Deadline: None.

Abstract: The Department of Homeland Security proposes to amend its regulations governing petitions filed on behalf of H-1B beneficiaries who may be counted under section 214(g)(1)(A) of the Immigration and Nationality Act (INA) (“H-1B regular cap”) or under section 214(g)(5)(C) of the INA (“H-1B master's cap”). This rule proposes to establish an electronic registration program for petitions subject to numerical limitations for the H-1B nonimmigrant classification. This action is being considered because the demand for H-1B specialty occupation workers by U.S. employers has often exceeded the numerical limitation. This rule is intended to allow U.S. Citizenship and Immigration Services (USCIS) to more efficiently manage the intake and selection process for these H-1B petitions. The Department published a proposed rule on this topic in 2011. The Department intends to publish an additional proposed rule in 2018. The proposal may include a modified selection process, as outlined in section 5(b) of Executive Order 13788, Buy American and Hire American.

Statement of Need: Consistent with the Buy American and Hire American, E.O. 13788's direction to suggest reforms to help ensure that H-1B visas are awarded to the most-skilled or highest-paid petition beneficiaries, this regulation would help to streamline the process for administering the H-1B cap and increase the probability of the total number of petitions selected under the cap filed for H-1B beneficiaries who possess a master's or higher degree from a U.S. institution of higher education each fiscal year.

Summary of Legal Basis: The Secretary of Homeland Security's authority for these proposed regulatory amendments is found in various sections of the INA, 8 U.S.C. 1101 et seq., and the Homeland Security Act of 2002 (HSA), Public Law 107-296, 116 Stat. 2135, 6 U.S.C. 101 et seq. General authority for issuing the proposed rule is found in section 103(a) of the INA, 8 U.S.C. 1103(a), which authorizes the Secretary to administer and enforce the immigration and nationality laws, as well as section 102 of the HSA, 6 U.S.C. 112, which vests all of the functions of DHS in the Secretary and authorizes the Secretary to issue regulations. Further authority for the regulatory amendments in the proposed rule is found in section 214(a)(1) of the INA, 8 U.S.C. 1184(a)(1), which authorizes the Secretary to prescribe by regulation the terms and conditions of the admission of nonimmigrants; section 214(c) of the INA, 8 U.S.C. 1184(c), which authorizes the Secretary to prescribe how an importing employer may petition for an H-1B nonimmigrant worker, and the information that an importing employer must provide in the petition; and section 214(g) of the INA, 8 U.S.C. 1184(g), which provides the H-1B numerical limitations and various exceptions to those limitations.

Alternatives:

Anticipated Cost and Benefits: The proposed rule would aim to result in better resource management and predictability for both USCIS and petitioning H-1B employers. An electronic registration process could benefit most of the regulated public by potentially reducing the overall cost and time involved in petitioning for H-1B nonimmigrant workers. However, some additional costs may be incurred from the electronic registration process to some petitioners.

Risks:

Timetable:

ActionDateFR Cite
NPRM03/03/1176 FR 11686
NPRM Comment Period End05/02/11
NPRM10/00/18

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

Additional Information: USCIS 2443-08. Includes Retrospective Review under E.O. 13563.

URL For More Information: www.regulations.gov.

URL For Public Comments: www.regulations.gov.

Agency Contact: Kevin Cummings, Chief, Business and Foreign Workers Division, Office of Policy and Strategy, Department of Homeland Security, U.S. Citizenship and Immigration Services, 20 Massachusetts Avenue NW, Suite 1200, Washington, DC 20529-2200, Phone: 202 272-8377, Fax: 202 272-1480, Email: kevin.j.cummings@uscis.dhs.gov.

RIN: 1615-AB71

Start Printed Page 57876

DHS—USCIS

64. EB-5 Immigrant Investor Regional Center Program

Priority: Other Significant.

E.O. 13771 Designation: Other.

Legal Authority: 8 U.S.C. 1153(b)(5); Pub. L. 102-395, secs. 610 and 601(a); Pub. L. 107-273, sec. 11037; Pub. L. 101-649, sec. 121(a); Pub. L. 105-119, sec. 116; Pub. L. 106-396, sec. 402; Pub. L. 108-156, sec. 4; Pub. L. 112-176, sec. 1; Pub. L. 114-113, sec. 575; Pub. L. 114-53, sec. 131; Pub. L. 107-273

CFR Citation: 8 CFR 204; 8 CFR 216.

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) is considering making regulatory changes to the EB-5 Immigrant Investor Regional Center Program. DHS issued an Advance Notice of Proposed Rulemaking (ANPRM) to seek comment from all interested stakeholders on several topics, including: (1) The process for initially designating entities as regional centers, (2) a potential requirement for regional centers to utilize an exemplar filing process, (3) continued participation requirements for maintaining regional center designation, and (4) the process for terminating regional center designation. While DHS has gathered some information related to these topics, the ANPRM sought additional information that can help the Department make operational and security updates to the Regional Center Program while minimizing the impact of such changes on regional center operations and EB-5 investors.

Statement of Need: Based on decades of experience operating the program, DHS has determined that program changes are needed to better reflect business realities for regional centers and EB-5 immigrant investors, to increase predictability and transparency in the adjudication process for stakeholders, to improve operational efficiency for the agency, and to enhance program integrity.

Summary of Legal Basis: The Immigration and Nationality Act (INA) authorizes the Secretary of Homeland Security (Secretary) to administer and enforce the immigration and nationality laws including establishing regulations deemed necessary to carry out his authority, and section 102 of the Homeland Security Act, 6 U.S.C. 112, authorizes the Secretary to issue regulations. 8 U.S.C. 1103(a), INA section 103(a). INA section 203(b)(5), 8 U.S.C. 1153(b)(5), also provides the Secretary with authority to make visas available to immigrants seeking to engage in a new commercial enterprise in which the immigrant has invested and which will benefit the United States economy and create full-time employment for not fewer than 10 U.S. workers. Further, section 610 of Public Law 102-395 (8 U.S.C. 1153 note) created the Immigrant Investor Pilot Program and authorized the Secretary to set aside visas for individuals who invest in regional centers created for the purpose of concentrating pooled investment in defined economic zones, and was last amended by Public Law 107-296.

Alternatives:

Anticipated Cost and Benefits: DHS is still in the process of reviewing potential changes it would propose to the regional center process. DHS may propose to implement an exemplar filing requirement for all designated regional centers that would require regional centers to file exemplar project requests. An exemplar filing requirement could cause some projects to not go forward, but DHS is still in the process of assessing the impacts on the number of projects that may be affected. DHS anticipates that any proposed changes to the regional center program would increase overall program efficiency, transparency, and predictability for both USCIS and EB-5 stakeholders.

Risks:

Timetable:

ActionDateFR Cite
ANPRM01/11/1782 FR 3211
ANPRM Comment Period End04/11/17
NPRM03/00/19

Regulatory Flexibility Analysis Required: Yes.

Small Entities Affected: Businesses.

Government Levels Affected: None.

URL For More Information: www.regulations.gov.

URL For Public Comments: www.regulations.gov.

Agency Contact: Kevin Cummings, Chief, Business and Foreign Workers Division, Office of Policy and Strategy, Department of Homeland Security, U.S. Citizenship and Immigration Services, 20 Massachusetts Avenue NW, Suite 1200, Washington, DC 20529-2200, Phone: 202 272-8377, Fax: 202 272-1480, Email: kevin.j.cummings@uscis.dhs.gov.

RIN: 1615-AC11

DHS—USCIS

65. Strengthening the H-1B Nonimmigrant Visa Classification Program

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Other.

Legal Authority: 8 U.S.C. 1184

CFR Citation: 8 CFR 214.2(h)(4).

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) will propose to revise the definition of specialty occupation to increase focus on obtaining the best and the brightest foreign nationals via the H-1B program, and revise the definition of employment and employer-employee relationship to better protect U.S. workers and wages. In addition, DHS will propose additional requirements designed to ensure employers pay appropriate wages to H-1B visa holders.

Statement of Need: The purpose of these changes is to ensure that H-1B visas are awarded only to individuals who will be working in a job which meets the statutory definition of specialty occupation. In addition, these changes are intended to ensure that the H-1B program supplements the U.S. workforce and strengthens U.S. worker protections.

Summary of Legal Basis: The Homeland Security Act of 2002, Public Law 107-296, section 102, 116 Stat. 2135 (Nov. 25, 2002), 6 U.S.C. 112, and the Immigration and Nationality Act of 1952 (INA), charge the Secretary of Homeland Security (Secretary) with administration and enforcement of the immigration and nationality laws. See INA section 103, 8 U.S.C. 1103. This rule will significantly enhance the ability of USCIS to effectively manage and monitor the H-1B program.

Alternatives:

Anticipated Cost and Benefits: DHS is still considering the cost and benefit impacts of the proposed provisions.

Risks:

Timetable:

ActionDateFR Cite
NPRM08/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

URL For More Information: www.regulations.gov.

URL For Public Comments: www.regulations.gov. Start Printed Page 57877

Agency Contact: Kevin Cummings, Chief, Business and Foreign Workers Division, Office of Policy and Strategy, Department of Homeland Security, U.S. Citizenship and Immigration Services, 20 Massachusetts Avenue NW, Suite 1200, Washington, DC 20529-2200, Phone: 202 272-8377, Fax: 202 272-1480, Email: kevin.j.cummings@uscis.dhs.gov.

RIN: 1615-AC13

DHS—USCIS

66. U.S. Citizenship and Immigration Services Biometrics Collection for Consistent, Efficient, and Effective Operations

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

Unfunded Mandates: Undetermined.

E.O. 13771 Designation: Other.

Legal Authority: 8 U.S.C. 1103(a); 8. U.S.C. 1444 and 1446; 8 U.S.C. 1365a and 1365b; 8 U.S.C. 1304(a); Pub. L. 107-56; Pub. L. 107-173; Pub. L. 109-248, sec. 402(a) and 402(b)

CFR Citation: 8 CFR 103.2(b)(9); 8 CFR 103.7(b)(1)(i)(C); 8 CFR 103.16; 8 CFR 204.2(d)(2)(vi); 8 CFR 204.3(c)(3); 8 CFR 204.5(p)(4); 8 CFR 208.10; 8 CFR 210.2(c)(2)(i); 8 CFR 210.5(b)(2); 8 CFR 214.1(f); 8 CFR 214.11(a); 8 CFR 214.11(m)(2); 8 CFR 236.5; 8 CFR 240.68(b); 8 CFR 245.21(b); 8 CFR 245a.2(d); 8 CFR 245a.4(b)(4); 8 CFR 214.2(w)(15); 8 CFR 215.8; 8 CFR 244.17; 8 CFR 245a.12(d); 8 CFR 264.1(g); 8 CFR 264.2(d); 8 CFR 333.1(a) to (b); 8 CFR 316.4(a).

Legal Deadline: None.

Abstract: The Department of Homeland Security (DHS) will propose to update its regulations to eliminate multiple references to specific biometric types, and to allow for the expansion of the types of biometrics required to establish and verify an identity. DHS will also propose to modify age restrictions where they exist to detect, deter, or prevent human trafficking of children; establish consistent identity enrollment and verification policies and processes; and align U.S. Citizenship and Immigration Services (USCIS) biometric collection with other immigration operations. The DHS proposal will provide a definition to the public on the term biometric and how biometrics will be used in the immigration process.

Statement of Need: As DHS seeks to better secure the immigration process by confirming the identity of individuals encountered, the use of biometrics needs to be expanded to account for different methods of biometric collection beyond fingerprints and to remove age restrictions.

Summary of Legal Basis:

Alternatives:

Anticipated Cost and Benefits: DHS is still considering the exact cost and benefit impacts of the proposed provisions. In general, DHS anticipates that stakeholders will incur costs due to the increased collection of biometrics and the expansion of the types of biometrics required to establish and verify an identity. The anticipated costs to individuals submitting biometrics are associated with biometric fees and travel costs, and the opportunity cost of time in completing and filing required forms and the time associated with travel. DHS anticipates benefits of those individuals seeking immigration benefits and to the government.

Risks:

Timetable:

ActionDateFR Cite
NPRM02/00/19

Regulatory Flexibility Analysis Required: Undetermined.

Government Levels Affected: Undetermined.

Federalism: Undetermined.

URL For More Information: www.regulations.gov.

URL For Public Comments: www.regulations.gov.

Agency Contact: Lee Bowes, Deputy Associate Director, Immigration Records and Identity Services Directorate, Department of Homeland Security, U.S. Citizenship and Immigration Services, 20 Massachusetts Avenue NW, Washington, DC 20529, Phone: 202 272-8377, Email: lee.f.bowes@uscis.dhs.gov.

RIN: 1615-AC14

DHS—USCIS

67. Removing H-4 Dependent Spouses From the Class of Aliens Eligible for Employment Authorization

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

Unfunded Mandates: This action may affect the private sector under Public Law 104-4.

E.O. 13771 Designation: Other.

Legal Authority: