[Federal Register Volume 87, Number 213 (Friday, November 4, 2022)]
[Notices]
[Page 66707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-24044]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Delegation of Authority Under Section 564A(e) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3a(e))

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services.

ACTION: Notice.

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SUMMARY: CDC has redelegated the authority under the Federal Food, 
Drug, and Cosmetic (FD&C) Act to create and issue amended emergency use 
instructions (EUI) to inform healthcare providers or individuals to 
whom an eligible product, as defined under the FD&C Act, is to be 
administered, concerning the product's approved, licensed, or cleared 
conditions of use that deviate from approved labeling, standard 
clinical practice, and/or standard medical modality (e.g., individual 
prescription within the patient-clinician relationship). This notice 
announces the redelegation of the above-mentioned authority, without 
the authority to redelegate, from the Director, CDC, to the Director, 
National Center for Immunizations and Respiratory Diseases (NCIRD).

DATES: This delegation was approved by the Director, CDC, and is 
effective October 28, 2022.

SUPPLEMENTARY INFORMATION: Only the Director, CDC, can issue original 
EUIs. The Director, NCIRD, may only issue amendments that are 
substantially within the scope of the original EUI and only for 
countermeasures within the scope of the NCIRD Director's official 
responsibilities. This authority shall be exercised under section 
564A(e) of the FD&C Act (21 U.S.C. 360bbb-3a(e)), and any related HHS 
policies. This delegation became effective on October 28, 2022. The 
Director, CDC, affirms and ratifies any actions taken that involve the 
exercise of the authority delegated herein prior to the effective date 
of this delegation.

Sherri A. Berger,
Chief of Staff, Centers for Disease Control and Prevention.
[FR Doc. 2022-24044 Filed 11-3-22; 8:45 am]
BILLING CODE 4163-18-P