[Federal Register Volume 90, Number 92 (Wednesday, May 14, 2025)]
[Rules and Regulations]
[Pages 20393-20394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08393]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
21 CFR Part 291
42 CFR Part 8
45 CFR Parts 86 and 92
Notification of HHS Documents Identified for Rescission
AGENCY: Department of Health and Human Services.
ACTION: Notification of rescissions.
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SUMMARY: The Department of Health and Human Services (HHS or the
Department) provides notice that it is rescinding four informal
guidance documents. This action will reduce the burdens on regulated
parties and allow HHS to refocus on its core mission to Make America
Healthy Again.
DATES: May 14, 2025.
FOR FURTHER INFORMATION CONTACT: Sean R. Keveney, Acting General
Counsel, Office of the General Counsel, HHS. 200 Independence Avenue
SW, Washington, DC 20201, 202-690-7741.
SUPPLEMENTARY INFORMATION: President Donald J. Trump has declared that
the policy of the executive branch is to ``alleviate unnecessary
regulatory burdens placed on the American people.'' Unleashing
Prosperity Through Deregulation, Executive Order 14192, 90 FR 9065,
9065 (Jan. 31, 2025). This burden does not come from formal regulations
alone, but also from ``rules, memoranda, administrative orders,
guidance documents, policy statements, and interagency agreements that
are not subject to the Administrative Procedure Act.'' Id. The
President has accordingly directed every agency to review and rescind
all such agency actions which are unlawful or impose greater burdens
than benefits. Ensuring Lawful Governance and Implementing the
President's ``Department of Government Efficiency'' Deregulatory
Initiative, Executive Order 14219, 90 FR 10583, 10583 (Feb. 19, 2025).
Independently, I have instructed HHS to launch the most sweeping
deregulatory initiative in the history of the Department. We are
eliminating bureaucratic red tape and refocusing on our core mission to
Make America
[[Page 20394]]
Healthy Again. Across the Department, we are aggressively deregulating
to return the freedoms eroded over decades by unnecessary and
burdensome regulations.
As part of this Department-wide initiative, I have determined that
the documents identified below have been superseded, are unduly
burdensome, no longer represent the considered legal judgment of HHS,
and/or are otherwise appropriate for rescission. To the extent one of
these documents should have been promulgated with notice and comment,
but was not, that provides another basis for rescission. Accordingly,
all documents identified below are hereby rescinded, effective
immediately.
Because HHS promulgated these documents without notice and comment,
HHS may rescind them in the same manner. Perez v. Mortg. Bankers Ass'n,
575 U.S. 92, 101 (2015). Any effect on reliance interests could only be
positive since these guidance documents have already largely been
superseded. Thus, formal rescission will reduce the burdens on
regulated parties. To the extent there are negative effects on reliance
interests, those interests are unreasonable or unwarranted. The
American public knew that these informal documents could be rescinded
at any time, especially following a change of administration now that
they are defunct.
This is the beginning of a new era for HHS and American health more
broadly. In this new era, patient choice and individual freedom will
predominate over burdensome federal regulations. In this document, we
are taking the first step towards making that a reality.
I hereby order that the following documents be rescinded, effective
immediately:
* Extension of Designation of Scarce Materials or Threatened
Materials Subject to COVID-19 Hoarding Prevention Measures; Extension
of Effective Date With Modifications, 86 FR 35810 (July 7, 2021).
* Opioid Drugs in Maintenance and Detoxification Treatment of
Opiate Addiction; Repeal of Current Regulations and Issuance of New
Regulations: Delay of Effective Date and Resultant Amendments to the
Final Rule, 66 FR 15347 (Mar. 19, 2001).
* Practice Guidelines for the Administration of Buprenorphine for
Treating Opioid Use Disorder, 86 FR 22439 (Apr. 28, 2021).
* Notification of Interpretation and Enforcement of Section 1557 of
the Affordable Care Act and Title IX of the Education Amendments of
1972, 86 FR 27984 (May 25, 2021).
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2025-08393 Filed 5-13-25; 8:45 am]
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