Document ID: FDA-2021-D-1149-0027
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Emergency Use Authorization of Medical Products and Related Authorities
Posted Date: 2023-07-12T04:00Z

[Federal Register Volume 88, Number 132 (Wednesday, July 12, 2023)]
[Notices]
[Pages 44369-44370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14714]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1149]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Emergency Use 
Authorization of Medical Products and Related Authorities

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by August 11, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0595. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Emergency Use Authorization of Medical Products and Related Authorities

OMB Control Number 0910-0595--Revision

    This information collection helps support FDA's implementation of 
sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb-3, 360bbb-3a, and 360bbb-3b), which govern the 
authorization of medical products for use in emergencies. The statutes 
authorize FDA to permit the introduction into interstate commerce a 
drug, device, or biological product intended for use in an actual or 
potential emergency. The purpose of these provisions is to sustain and 
strengthen national preparedness for public health, military, and 
domestic emergencies involving chemical, biological, radiological, and 
nuclear agents, including emerging infectious disease threats.
    We are revising the information collection to discuss the guidance 
document entitled, ``Transition Plan for Medical Devices Issued 
Emergency Use

[[Page 44370]]

Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19),'' 
announced in the Federal Register of March 27, 2023 (88 FR 18144). The 
guidance document describes a phased-in approach intended to help avoid 
disruption in device supply and help facilitate compliance with 
applicable legal requirements. The recommendations discussed in the 
guidance document result in the one-time collection of information 
intended to ensure an orderly and transparent transition from temporary 
policies established during the COVID-19 public health emergency to 
normal operations.
    In the Federal Register of December 23, 2021 (86 FR 72978), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. However, upon further review, we find the 
recommendations discussed in the guidance document apply to specific 
medical devices already issued EUAs and characterize the activity as 
non-standardized followup designed to clarify responses to approved 
collections of information, i.e., plans for continued compliance unique 
to that medical device issued an EUA. We therefore believe the activity 
constitutes the collection of non-identical and/or followup 
information, as defined under 5 CFR 1320.3. At the same time, we expect 
some degree of fluctuation in submissions under 21 CFR 814.20, as a 
result of implementation of the medical device transition plan. 
Information collection associated with 21 CFR part 814 is currently 
approved in OMB control number 0910-0231.

    Dated: July 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14714 Filed 7-11-23; 8:45 am]
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