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

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

On January 30, 2017, the President issued Executive Order 13771, entitled “Reducing Regulation and Controlling Regulatory Costs.” Executive Order 13771 provides that “it is essential to manage the costs associated with the governmental imposition of private expenditures required to comply with Federal regulations.”  Toward that end, Executive Order 13771 directs that “for every one new regulation issued, at least two prior regulations be identified for elimination.” 

Consistent with these policy goals, on February 24, 2017, the President issued Executive Order 13777, entitled “Enforcing the Regulatory Reform Agenda.”  The purpose of the Executive Order is to alleviate unnecessary regulatory burdens placed on the American people. Executive Order 13777 builds upon other Administration regulatory reform efforts and, in particular, the policy announced by the President in Executive Order 13771. Executive Order 13777 directs each agency to establish a Regulatory Task Force to evaluate existing regulations and identify those that may merit repeal, replacement, or modification. Section 3(d) of the Order provides that, at a minimum, each task force must attempt to identify regulations that:

  1. Eliminate jobs, or inhibit job creation;
  2. Are outdated, unnecessary, or ineffective;
  3. Impose costs that exceed benefits;
  4. Create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
  5. Are inconsistent with the requirements of section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note), or the guidance issued pursuant to that provision, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
  6. Derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.

In accordance with Executive Orders 13771, “Reducing Regulation and Controlling Regulatory Costs,” 13777, “Enforcing the Regulatory Reform Agenda, and 13563 “ Improving Regulation and Regulatory Review,” and guidance provided by the Office of Management and Budget (OMB) and the Department of Health and Human Services (HHS), NIH is reviewing its 22 existing regulations to assess their compliance costs and regulatory burden, and identify potential deregulatory opportunities to repeal regulations that are old, outdated and no longer needed, and reduce compliance costs and regulatory burden. To accomplish this task, NIH has designated Deputy for Management, Dr. Alfred Johnson, as its Regulatory Reform Officer (RRO), and has established an NIH Regulatory Reform Task Force (RRTF) to oversee and support regulatory reform at NIH. The RRO serves as the chairperson for the RRTF. NIH has also developed an array of plans for actively seeking input and assistance from entities (i.e., stakeholders) significantly affected by the agency’s existing regulations. NIH seeks suggestions from stakeholders for specific existing regulations that may be outdated, ineffective, or excessively burdensome, and, therefore, warranting repeal, replacement, or modification.

The NIH Regulations Program, housed in the Division of Management Support, Office of Management Assessment, is partnering with NIH Institutes, Centers and Offices (ICOs) that historically have had primary responsibility for authoring maintaining one or more of the agency’s 22 regulations to plan and conduct comprehensive reviews and assessments of their respective regulations. These ICOs have responsibility for conducting the reviews, while the NIH Regulations Program and the Office of Management Assessment provide guidance and support.

NIH is committed to implementing regulatory reform and complying with all requirements of the President’s Regulatory Reform Agenda.

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

Division of Management Support

Director, Ekaterini 'Katy' Perry

National Institutes of Health,

Office of Management Assessment

6011 Executive Blvd., Suite 601, MSC 7669

Rockville, MD 20852

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

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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