Notice2023-14714
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorization of Medical Products and Related Authorities
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 132 (Wednesday, July 12, 2023)</title>
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[Federal Register Volume 88, Number 132 (Wednesday, July 12, 2023)]
[Notices]
[Pages 44369-44370]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#09595b485a7d686f6f496f6d682761617a276e667f"><span class="__cf_email__" data-cfemail="88d8dac9dbfce9eeeec8eeece9a6e0e0fba6efe7fe">[email protected]</span></a>.
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]
BILLING CODE P
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