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​​​​​​ 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.

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Regulations

Regulations Overview

Welcome to the Office of Management Assessment (OMA), Division of Compliance Management (DCM) Regulations SharePoint site.  DCM and its National Institutes of Health Regulations Program (NIHRP) are responsible for coordination of all NIH rulemaking activities and for the NIH review and clearance of certain regulations, guidance documents, and other regulatory documents developed by other Department of Health and Human Services (HHS) agencies and other departments, i.e., “outside regulations" or “OREGS."​

Outside Regulations

DCM and its NIHRP receive each year from the Department of Health and Human Services (HHS) for NIH review, clearance and comment, several hundred regulations, guidance documents, delegations of authority notices, and other notices for publication in the Federal Register that have been developed by other HHS organizational components and other departments and agencies, and that have relevance to NIH. These documents are referred to as “outside regulations" (or OREGS) assignments. The “OREGS" term itself is unique to NIH. 

The NIHRP's management of the OREGs clearance process is very important to the overall Federal rulemaking process, because the clearance process leverages the extraordinary reservoir of scientific and biomedical research knowledge and expertise that exists at NIH, and ensures that NIH's viewpoints are considered by other HHS organizational components, and other departments and agencies engaged in rulemaking that often significantly impacts public health.   

Protocol for Submitting NIH Comments
in Response to a Regulation Document Published in the Federal Register​

​​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.

Regulatory Reform at NIH​​​

On January 20, 2021, President Biden issued Executive Order 13992, Revocation of Certain Executive Orders Concerning Federal Regulation.  The new Executive Order 13992 revokes the two executive orders issued in 2017, which formed the basis for the Trump Administration's Regulatory Reform Agenda (RRA) initiative, the creation of the NIH Regulatory Reform Officer    (RRO) role, and the formation of the NIH Regulatory Reform Task Force (RRTF):

     •   Executive Order 13771, Reducing Regulation and Controlling Regulatory Costs
     •   Executive Order 13777, Enforcing the Regulatory Reform Agenda.

Executive Order 13992 abolishes “…any personnel positions, committees, task forces, or other entities established pursuant to the Executive Orders identified in section 2 of this order, including the regulatory reform officer positions and regulatory reform task forces established by sections 2 and 3 of Executive Order 13777"

Note: The OMA NIHRP will update this site with new regulatory information and guidance as it becomes available.

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 be​come 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 Regulations

Division of Compliance Management

Acting NIH Regulations Officer, Daniel Hernandez

Office of Management Assessment

Office of Management

Office of the Director

6705 Rockledge Dr.
6th Floor
Bethesda, MD 20892

Phone:(301) 496-4607

Email: dhernandez@mail.nih.gov