Laws, Policies, and Memoranda

The primary laws, policies and memoranda that serve as drivers for the NIH Regulations Program include the

following:

Laws

Administrative Procedure ACT (APA) (5 U.S.C.) Subchapter II

Federal Register Act (44 U.S.C.1501-1511)

Regulatory Flexibility Act of 1980 (Pub. L. 96-354)

Paperwork Reduction Act of 1995 (Pub. L. 104-13) (5 U.S.C.350 et seq)

Unfunded Mandates Act of 1995 (Pub. L. 104-4)

Small Business Regulatory Enforcement Act (SBREFA) of 1996 (Pub. L. 104-121 [As amended by (Pub.L. 110-28), May 25, 2007]

Negotiated Rulemaking Act of 1996 (Pub. L. 104-320) (5 U.S.C. 561-570)

Congressional Review Act (Pub. L. 104-12) (5 U.S.C. Chapter 8)

E-Government Act of 2002 (Pub. L.107-347 (44 U.S.C. 3601-3606)

Plain Language Act of 2010 (Pub. L. 111-274)

Policies

E.O. 12866, Regulatory Planning and Review

E.O. 12372, Intergovernmental Review of Federal Programs

E.O. 13132, Federalism

E.O. 13211, Statement of Energy Effects

E.O. 13272, Proper Consideration of Small Entities

E.O. 13497, Revocation of Certain Executive Orders Concerning Regulatory Planning and Review

E.O. 13563, Improving Regulation and Regulatory Review

E.O. 13610, Identifying and Reducing Regulatory Burdens

OMB Circular A-4, Regulatory Analysis, September 17, 2003

Agency Checklist: Regulatory Impact Analysis, October 28, 2010

Regulatory Impact Analysis: Frequently Asked Questions, February 7, 2011

OIRA Document, Regulatory Impact Analysis: A Primer

Federal Register Document Drafting Handbook

Incorporation by Reference, 1 CFR 51

Memoranda

OMB Memorandum M-94-3, Guidance for Implementing E.O. 12866

OMB Memorandum M-00-02, Guidance for Implementing E.O. 1312, “Federalism”, October 28, 1999

OMB Memorandum M-03-18, Implementation Guidance for the E-Government Act of 2002, August 1, 2003

OMB Memorandum M-03-21, OMB Circular No.A-4 “Regulatory Analysis”, September 17. 2003

Presidential Memorandum of January 21, 2009, Transparency and Open Government

Presidential Memorandum of January 18, 2011, Regulatory Compliance

Presidential Memorandum of January 18, 2011, Regulatory Flexibility, Small Business, and job Creation

OMB Memorandum M-09-08, Implementation of Memorandum Concerning Regulatory Review, January 21, 2009

Presidential Memorandum of January 30, 2009 – Regulatory Review

OMB Memorandum M-09-13, Guidance for Regulatory Review, March 4, 2009

OMB Memorandum M-10-06, Open Government, December 8, 2009

OMB Memorandum of April 7, 2010, Information Collection under the Paperwork Reduction Act

OMB Memorandum of April 7, 2010, Increasing Openness in the Rulemaking Process – Use of Regulation Identifier Number

OMB Memorandum of May 28, 2010, Paperwork Reduction Act—Generic Clearances

OMB Memorandum of May 28, 2010, Increasing Openness in the Rulemaking Process-Improving E-Dockets

OMB Memorandum, June 18, 2010, Disclosure and Simplification of Regulatory Tools

OMB Memorandum M-11-05, Preliminary Guidance for the Plain Writing Act of 2010, November 22, 2010

OMB Memorandum M-11-07, Facilitating Scientific Research by Streamlining the Paperwork Reduction Act Process, December 9, 2010

Presidential Memorandum of January 18, 2011, Regulatory Compliance

OMB Memorandum M-11-10, Improving Regulations and Regulatory Review, February 2, 2011

OMB Memorandum M-11-15, Final Guidance on Implementing the Plain Writing Act of 2010

OMB Memorandum M-11-19, Retrospective Analysis of Existing Significant Regulations, April 25, 2011

OMB Memorandum M-11-25, Final Plans for Retrospective Review of Existing Rules, June 14, 2011

OMB Memorandum, Implementation of Retrospective Review Plans, October 26, 2011

OMB Memorandum of January 4, 2012, Clarifying Regulatory Requirements: Executive Summaries

QUICKLINKS

Contact Manual Chapters Find Forms Submit Allegations Print

Contacting DCM

Division of Compliance Management

Director, Anna Amar

anna.amar@nih.gov

Administrative Assistant, Raisa Sarwar

raisa.sarwar@nih.gov

Office of Management Assessment (OMA)

Office of Management (OM)

Office of the Director (OD)

6705 Rockledge Dr, Suite 601

Bethesda, MD 20892

Phone: (301) 496-4606

MSC = 7901