Regulations

Regulations – The NIH Regulations Program manages the NIH rulemaking process, oversees clearance of outside regulations on behalf of NIH, and participates in OLPA-led legislative implementation planning and development of legislative proposals.

Regulations

Current Regulations

Most of NIH's regulations (pertaining to grant programs, loan repayment programs, other financial assistance programs, and the conduct of persons and traffic on the NIH Federal enclave) and Department of Health and Human Services (HHS) grant administration regulations can be found in title 42 (Public Health) and title 45 (Public Welfare) of the CFR.  The regulations may be found by citation, keywords, or title and volume numbers at ecfr.gov.

Proposed Regulations

The Unified Agenda lists NIH regulatory activities currently under development or review and can be found at RegInfo.gov.  Select the "Department of Health and Human Services" then search for NIH.  To submit a comment about a current NIH regulatory action, please visit regulations.gov and search for the NIH action in which you are interested.

Retrospective Review

Section 6 of Executive Order 13563 (January 2011) requires agencies to perform periodic review of existing significant regulations and consider whether they should be modified, streamlined, expanded or repealed.  In the effort, the public is invited to provide feedback on existing regulations at the Department of Health and Human Services website​.

For more information about the NIH Regulations Program please see the FAQs.

Frequently Asked Questions (FAQs)

Can I sign up for email alerts when a particular regulation is under review or development?
Once a regulation under development has been posted on regulations.gov, you may sign up and receive email alerts when a new comment has posted or when new documents have been added.  Directions are posted at http://www.regulations.gov/#%21help.

What is the general NIH Rulemaking process?
Government agencies initiate the rulemaking process for various reasons, such as changes in technology, new data, public concern, Congressional or Presidential mandates, lawsuit settlements, or staff recommendations.  Before drafting, agencies may decide to publish a Request for Information (RFI) in the Federal Register to solicit from industries and the public information needed to draft the proposed rule.

Once a draft has been reviewed internally within NIH and the Department of Health and Human Services (HHS), it is circulated for review by other agencies as needed, and then goes to the Office of Management and Budget of the White House.  After questions and concerns from the reviewers have been addressed, the draft is published in the Federal Register for public review and comment.  After comments are reviewed and addressed, a final version of the regulation is published again in the Federal Register.

Approximately twice each year, NIH and the HHS publish a Regulatory Plan as a part of the Unified Agenda.  Both the Plan and Agenda are found at RegInfo.gov and lists that regulations are under development and available for public comment currently or in the near future.

How long does it take for a proposed regulation to become final?
It depends, but usually the process is not a quick one.  The length of time depends upon the complexity of the regulation, the amount of analysis needed, the number of reviewers, and many other factors.  Previous NIH regulations have taken several years from the initial information​ gathering phase to final publication.

Additional Reference

How to Write a Rule (NIH Access Only)
NIH Rulemaking Process​ (NIH Access Only)
Regulations Laws, Policies, and Memoranda
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Contacting DMS

Regulations

Program Lead, Jerry Moore

National Institutes of Health,

Office of Management Assessment

6011 Executive Blvd., Suite 601, MSC 7669

Rockville, MD 20852

Phone: (301) 496-4606 or (301) 496-2832

Fax: (301) 402-0169

Want to know more about allegations?

DPI has the authority to conduct reviews using certain rules and acts.

Learn More About Allegations
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