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

Each year, DCM and its NIHRP receive 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 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 impact public health.

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

Current Regulations

Most of the 23 Department of Health and Human Services (HHS) regulations that NIH has authored and/or maintains on behalf of the Secretary, HHS, i.e., regulations that comprise the “NIH Regulations Portfolio”, pertain to grant programs, loan repayment programs, and other financial assistance programs, as well as other regulations concerning such topics as: the conduct of persons and traffic on the NIH Federal enclave; standards of care for chimpanzees held in the federally supported sanctuary system; peer review; clinical trials registration and results submission; promoting objectivity in research; and the National Library of Medicine, among others; and HHS grant administration regulations all can be found in title 42 (Public Health) and title 45 (Public Welfare) of the Code of Federal Regulations (CFR). The regulations may be found by citation, keywords, or title and volume numbers searches at ecfr.gov.

Proposed Regulations

The Unified Agenda of Federal Regulatory and Deregulatory Actions (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.

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. Rulemaking often begins with the drafting of a notice of proposed rulemaking (NPRM) Before drafting an NPRM, agencies may decide to publish a Request for Information (RFI) in the Federal Register to solicit information from relevant organizations and institutions and the public.

Once a draft regulation has been reviewed internally within NIH, it is sent to HHS and circulated for review by other operating divisions and staff offices (OpDivs/Staff Divs) as needed, and if necessary then goes to the Office of Management and Budget of the White House. After questions and concerns from the reviewers have been addressed, the NPRM is published in the Federal Register for public review and comment. After comments are reviewed and addressed, a final version of the regulation i.e., final rule, is published in the Federal Register. Once the final rule is published any changes to the regulation requires initiating a new rulemaking action.

Twice each year, NIH and HHS publish a listing of regulatory actions that are planned and/or under development as part of the Unified Agenda. Additionally, in the Fall of each year, HHS publishes a Regulatory Plan consisting of its most significant planned regulatory actions as part of its Unified Agenda submission. Both the Unified Agenda and Regulatory Plan may be found at RegInfo.gov and lists regulations that 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?
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.