Food and Drug Administration; Delegation of Authority, 49337-49338 [2021-18985]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Notices]
[Pages 49337-49338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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rescinded ``any prior delegation of rulemaking authority'' to the 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delegations to FDA rescinded by the September 15 Memorandum.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]
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