Notice2021-18985
Food and Drug Administration; Delegation of Authority
Primary source
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Published
September 2, 2021
Issuing agencies
Health and Human Services Department
Full Text
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<title>Federal Register, Volume 86 Issue 168 (Thursday, September 2, 2021)</title>
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[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Notices]
[Pages 49337-49338]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18985]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration; Delegation of Authority
Notice is hereby given that I have delegated to the Food and Drug
Administration (FDA) Commissioner of Food and Drugs (Commissioner), the
authority vested in the Secretary to issue all regulations of the FDA.
This includes authority to issue regulations pursuant to the Federal
Food, Drug, and Cosmetic Act (FD&C Act), applicable portions of the
Public Health Service Act (PHS Act), and other authorities governing
functions of the FDA. This authority may be re-delegated by the
Commissioner.
On September 15, 2020, the Secretary of Health and Human Services
(HHS) issued a memorandum (``September 15 Memorandum'') to the HHS
Heads of Operating and Staff Divisions that reserved to the Secretary
``the authority to sign and issue any rule for which notice and comment
would normally be required, irrespective of whether notice and comment
is waived.'' The September 15 Memorandum further stated that it
rescinded ``any prior delegation of rulemaking authority'' to the
Operating Divisions, including FDA. This delegation revokes the
September 15 Memorandum as it applies to FDA and reinstates any
delegations to FDA rescinded by the September 15 Memorandum.
This delegation shall be exercised in accordance with the
Department's applicable policies, procedures, and guidelines. For
internal Department management purposes, this delegation is subject to
certain reservations of authority for the Secretary to approve FDA
regulations. Specifically, the Secretary reserves the authority to
approve regulations of FDA, except regulations to which sections 556
and 557 of Title 5 U.S.C. apply, which (1) establish procedural rules
applicable to a general class of foods, drugs, cosmetics, medical
devices, tobacco products, or other subjects of regulation; or (2)
present highly significant public issues involving the quality,
availability, marketability, or cost of one or more foods, drugs,
cosmetics, medical devices, tobacco products, or other subjects of
regulation. The delegation does not preclude the Secretary from
approving a regulation, or being notified in advance of an action, to
which section 556 and 557 of Title 5 U.S.C. apply, which meets one of
the above-referenced criteria. This reservation of authority is
intended only to improve the internal management of the Department of
Health and Human Services, and it is not intended to create any right
or benefit, substantive or procedural, enforceable at law by a party
against the United States, the Department of Health and Human Services,
the FDA, any Agency, officer, or employee of the United States, or any
person. Regulations issued by FDA without the approval of the Secretary
are to be conclusively viewed as falling outside the scope of this
reservation of authority.
This delegation became effective upon the date of signature. In
addition, I hereby affirm and ratify any actions
[[Page 49338]]
taken by the Commissioner or the Commissioner's subordinates which
involved the exercise of the authorities delegated herein, or
substantially similar authorities, prior to the effective date of the
delegation.
Dated: August 30, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-18985 Filed 9-1-21; 8:45 am]
BILLING CODE 4164-28-P
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