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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.


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

NIH Institutes, Centers and Offices (ICOs) may occasionally identify a regulation document (e.g., an advanced notice of proposed rulemaking (ANPRM), notice of proposed rulemaking (NPRM), or final rule with request for comment that is of interest to NIH, published in the F ederal Register within which the authoring department or agency requests public comments. 

In the instances where such a regulation document was not previously reviewed by NIH ICOs as an outside regulation (OREG) via the normal Health and Human Services and NIH Regulations Program (NIHRP) review process, the NIHRP strongly recommends that the ICO interested in submitting comments contact and coordinate with the NIHRP to clear the ICO's comments with other appropriate NIH offices and as applicable, Senior NIH Leadership, before submitting the comments.

For additional information regarding this protocol and the OREG review process, contact Alycia Booth, Kelly Daughtridge​ ​or Daniel Hernandez

Contacting Regulations

Division of Compliance Management

NIH Regulations Officer, Daniel Hernandez

Office of Management Assessment

Office of Management

Office of the Director

6705 Rockledge Dr., Suite 601
Bethesda, MD 20892

Phone:(301) 496-4607


Last modified: 8/21/2023 2:57 PM