Notice2025-20771
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorization of Medical Products
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Published
November 24, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) 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 90 Issue 224 (Monday, November 24, 2025)</title>
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[Federal Register Volume 90, Number 224 (Monday, November 24, 2025)]
[Notices]
[Pages 52962-52965]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20771]
[[Page 52962]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1115]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Emergency Use
Authorization of Medical Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) 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 December 24, 2025.
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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#306062716344515656705654511e5858431e575f46"><span class="__cf_email__" data-cfemail="dc8c8e9d8fa8bdbaba9cbab8bdf2b4b4aff2bbb3aa">[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
OMB Control Number 0910-0595--Extension
This information collection helps support implementation of Agency
policies applicable to the authorization for medical products for use
in emergencies under sections 564, 564A, and 564B of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3, 360bbb-3a, and
360bbb-3b). For more information regarding emergency use authorization
(EUA), visit our website at <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a>. The FD&C Act permits the Commissioner of Food and Drugs
(the Commissioner) to authorize the use of unapproved medical products
for humans and animals, or unapproved uses of approved medical products
for humans and animals, during an emergency declared under section 564
of the FD&C Act. The data to support issuance of an EUA must
demonstrate that, based on the totality of the scientific evidence
available to the Commissioner, including data from adequate and well-
controlled clinical trials (if available), it is reasonable to believe
that the product may be effective in diagnosing, treating, or
preventing a serious or life-threatening disease or condition (21
U.S.C. 360bbb-3(c)).
Also, under section 564 of the FD&C Act, the Commissioner may
establish conditions on issuing an authorization that may be necessary
or appropriate to protect the public health. These conditions can
include: (1) requirements to disseminate or disclose information to
healthcare providers or authorized dispensers and product recipients;
(2) adverse event monitoring and reporting; (3) data collection and
analysis; (4) specific recordkeeping and records access; (5)
restrictions on product advertising, distribution, and administration;
and (6) limitations on good manufacturing practice requirements. As
governed by statute, some conditions are mandatory to the extent
practicable for authorizations of unapproved products, and
discretionary for authorizations of unapproved uses of approved
products. Some conditions may apply to manufacturers of an EUA product,
while other conditions may apply to any person who carries out an
activity for which the authorization is issued. Sections 564A and 564B
of the FD&C Act establish streamlined mechanisms intended to facilitate
preparedness and response activities involving certain FDA approved
products without requiring FDA to issue an EUA and set forth emergency
dispensing order and expiration date extension authority.
The guidance document entitled, ``Emergency Use Authorization of
Medical Products and Related Authorities'' (January 2017), available
for download from our website at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities</a>, discusses FDA issuance of
Emergency Use Authorizations (EUAs) under section 564 of the FD&C Act;
implementation of the emergency use authorities set forth in section
564A of the FD&C Act; reliance on the governmental pre-positioning
authority set forth in section 564B of the FD&C Act; and related FDA
regulations. As discussed in the guidance document, the specific type
and amount of data needed to support an EUA will vary depending on the
nature of the declared emergency and the nature of the candidate
product. The guidance document encourages early engagement with FDA,
explains mechanisms for communication, and makes content and format
recommendations on submitting information to the Agency. The guidance
document also recommends that a request for consideration for an EUA
include scientific evidence evaluating the product's safety and
effectiveness, including the adverse event profile for diagnosis,
treatment, or prevention of the serious or life-threatening disease or
condition, as well as data and other information on safety,
effectiveness, risks and benefits, and (to the extent available)
alternatives.
In accordance with 5 CFR 1320.8(d), we published a 60-day notice
soliciting public comment on information collection activities related
to emergency use authorization for medical products in the Federal
Register of July 14, 2025 (90 FR 31217). Under the 60-day notice, FDA
invited comments on the following topics: (1) whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
One comment was received. The comment did not discuss information
collection activities related to emergency use authorization for
medical products, was not responsive to the four information collection
topics solicited, and did not offer information that would enable FDA
to consider revising the information collection and/or burden
estimates. Instead, the comment raised policy concerns about FDA's
implementation of section 564 of
[[Page 52963]]
the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360bbb-3). Such
comments may be offered to FDA through alternative means, such as
directly to the FDA docket for the 2017 EUA guidance (which remains
continually open for submissions) (FDA-2016-D-1025) or through FDA's
citizen petition process (21 CFR 10.30). Therefore, the comment will
not be addressed in this document.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Information collection activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Requests for an EUA and/or a
substantive amendment to an
existing EUA:
Center for Biologics 1 4 4 45 180
Evaluation (CBER)..........
Center for Drug Evaluation 6 1 6 270
and Research (CDER)........
Center for Devices and 77 1.727 133 5,985
Radiological Health (CDRH).
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Total................... .............. .............. .............. .............. 6,435
Pre-EUA submissions or
amendments:
CBER........................ 2 2 4 34 136
CDER........................ 2 1 2 68
CDRH........................ 23 1.4 32 1,088
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Total................... .............. .............. .............. .............. 1,292
Submitting information required
under conditions of
authorization:
CBER........................ 4 3 12 8 96
CDER........................ 8 5 40 320
CDRH........................ 5 2.2 11 88
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Total................... .............. .............. .............. .............. 504
State and local public health 1 1 1 2 2
authority submissions required
under conditions of
authorization for unapproved
EUA product; CBER, CDER and
CDRH...........................
State and local public health 1 1 1 2 2
authority requests for
Emergency Dispensing Order;
CBER, CDER and CDRH............
State and local public health 1 1 1 20 20
authority requests for
expiration date extension; CDER
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Total....................... .............. .............. .............. .............. 56,651
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Although we have averaged burden across all respondents, we
categorize reporting activity by the type of EUA-related submission:
(1) those who file a request for FDA to issue an EUA and/or a
substantive amendment to an EUA that has previously been issued; (2)
those who submit a request for FDA to review information/data (i.e., a
pre-EUA package) for a candidate EUA product or a substantive amendment
to an existing pre-EUA package for preparedness purposes; (3) those who
must report on activities related to an unapproved EUA product (e.g.,
administering product, disseminating information) who must report to
FDA regarding such activity; (4) public health authorities (e.g.,
State, local) who must report on certain activities (e.g.,
administering product, disseminating information) related to an
unapproved EUA, and public health authorities who submit an expiration
date extension request for an approved product; (5) those who request
an emergency dispensing order under section 564A; and (6) those who
request expiry dating extensions under section 564A of the FDC&C Act.
We attribute greater burden to those requests for FDA to review pre-EUA
packages submitted by product sponsors than burden we attribute to
those submitted by Federal agencies (e.g., Centers for Disease Control
and Prevention, the Department of Defense), and have considered other
factors that contribute to variability in burden for reporting,
including the type of product and whether there is a previously
reviewed pre-EUA package or investigational application.
We also account for burden that may be attendant to the use of the
following agency EUA Templates and Fact Sheet Templates:
Table 2--EUA Templates and Fact Sheet Templates
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Template title Date Hyperlink
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CDRH COVID-19 Diagnostic Templates (Molecular and Antigen)
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Molecular Diagnostic EUA Cover 10/06/2021 https://www.fda.gov/
Sheet Template. media/152768/
download?attachment.
Molecular Diagnostic Template.. 10/06/2021 <a href="https://www.fda.gov/media/135900/download?attachment">https://www.fda.gov/media/135900/download?attachment</a>.
Molecular Diagnostic Home 10/06/2021 https://www.fda.gov/
Specimen Collection Template. media/138412/
download?attachment.
Antigen Diagnostic Template.... 10/06/2021 <a href="https://www.fda.gov/media/137907/download?attachment">https://www.fda.gov/media/137907/download?attachment</a>.
Molecular and Antigen Home Use 11/09/2021 https://www.fda.gov/
Test Template. media/140615/
download?attachment.
[[Page 52964]]
Supplemental Template for 10/25/2021 https://www.fda.gov/
Molecular and Antigen media/146695/
Diagnostic COVID-19 Tests for download?attachment.
Screening with Serial Testing.
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CDRH COVID-19 Serology/Antibody Templates
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Serology Template.............. 10/06/2021 <a href="https://www.fda.gov/media/137698/download?attachment">https://www.fda.gov/media/137698/download?attachment</a>.
Template for Serology Tests 10/06/2021 https://www.fda.gov/
that Detect or Correlate to media/146746/
Neutralizing Antibodies. download?attachment.
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CDRH COVID-19: Pooling and Serial Testing Amendment for Certain
Molecular Diagnostic Tests for SARS-CoV-2 Templates
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Appendix J--Sample Updated Fact 04/20/2021 https://www.fda.gov/
Sheet for Health Care media/147735/
Providers. download?attachment.
Appendix K--Sample Updated Fact 04/20/2021 https://www.fda.gov/
Sheet for Patients. media/147736/
download?attachment.
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CDRH COVID-19: Umbrella EUA for SARS-CoV-2 Molecular Diagnostic Tests
for Serial Testing Templates
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Appendix L--Fact Sheet for 11/15/2021 https://www.fda.gov/
Health Care Providers media/154112/
(Template). download?attachment.
Appendix M--Fact Sheet for 11/15/2021 https://www.fda.gov/
Patients (Template). media/154114/
download?attachment.
Appendix N--Test Summary 11/15/2021 https://www.fda.gov/
(Template). media/154113/
download?attachment.
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CDRH COVID-19: EUA for Molecular Diagnostic Tests for SARS-CoV-2
Developed And Performed By Laboratories Certified Under CLIA To Perform
High Complexity Tests Templates
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Fact Sheet for Healthcare 11/15/2021 https://www.fda.gov/
Providers. media/136599/
download?attachment.
Fact Sheet for Patients........ 11/15/2021 <a href="https://www.fda.gov/media/136600/download?attachment">https://www.fda.gov/media/136600/download?attachment</a>.
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CDRH Mpox Templates and EUA Summary Templates (Molecular and Antigen)
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EUA Summary Template for 09/07/2022 https://www.fda.gov/
Developers of Molecular media/161447/
Diagnostic Tests for Monkeypox. download?attachment.
EUA Template for Developers of 09/07/2022 https://www.fda.gov/
Molecular Diagnostic Tests for media/161448/
Monkeypox. download?attachment.
EUA Summary Template for 11/29/2022 https://www.fda.gov/
Developers of Antigen media/163530/
Diagnostic Tests for Monkeypox. download?attachment.
EUA Template for Developers of 11/29/2022 https://www.fda.gov/
Antigen Diagnostic Tests for media/163529/
Monkeypox. download?attachment.
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CDRH Other Devices Templates
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Ventilator EUA Interactive 04/21/2020 https://www.fda.gov/
Review Template. media/137172/
download?attachment.
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CDER Therapeutics Fact Sheet Templates
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Healthcare Provider Fact Sheet 11/26/2024 https://www.fda.gov/
Template. media/183876/
download?attachment.
Patient, Parent, and Caregiver 11/26/2024 https://www.fda.gov/
Fact Sheet Template. media/183875/
download?attachment.
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The CDRH templates are part of the Policy for Coronavirus Disease-
2019 Tests During the Public Health Emergency (Revised) and Policy for
Monkeypox [mpox] Tests to Address the Public Health Emergency guidance
documents, which also include additional policies specific to these
public health emergencies. The templates reflect the FDA's current
thinking on the data and information that developers should submit to
facilitate the EUA process. The templates provide information and
recommendations, and they are updated as appropriate as we learn more
about the COVID-19 and mpox diseases and gain experience with the EUA
process for the various types of tests. Developers who intend to use
alternative approaches should consider seeking the FDA's feedback or
recommendations to help them through the EUA process.
The CDER templates reflect the FDA's current thinking on the data
and information that developers should include in the fact sheets for
therapeutics. The templates provide general fact sheet information and
recommendations. and are not specific to COVID-19. Developers who
intend to use alternative approaches should consider seeking the FDA's
feedback or recommendations during the EUA process. Members of the
public can submit questions about the templates to <a href="/cdn-cgi/l/email-protection#6d2e29283f28382c2d0b090c4305051e430a021b"><span class="__cf_email__" data-cfemail="ce8d8a8b9c8b9b8f8ea8aaafe0a6a6bde0a9a1b8">[email protected]</span></a>.
Table 3--Estimated Annual Recordkeeping Burden \1\
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Number of Average burden
Records associated with Number of records per Total annual per Total hours
conditions of authorization recordkeepers recordkeeper records recordkeeping
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EUA Holders:
CBER........................ 8 4 32 25 800
[[Page 52965]]
CDER........................ 8 5 40 1,000
CDRH........................ 668 2 1,336 33,400
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Total................... .............. .............. .............. .............. 35,200
State and local Public Health 1 1 1 3 3
Authorities; CBER, CDER and
CDRH...........................
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Total....................... .............. .............. .............. .............. 59,403
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We provide a conservative estimate for respondent recordkeeping,
recognizing that the Federal Government performs much of this activity
in conjunction with submissions. We do not include burden for public
health authorities who may need to submit emergency dispensing orders
or expiration date extension requests, assuming covered entities
already maintain these records for the products they stockpile.
Table 4--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Information collection activity Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
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Dissemination of required information by EUA Holder or Authorized Stakeholder
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CBER............................ 8 4 32 5 160
CDER............................ 8 2 16 80
CDRH............................ 668 2 1,336 6,680
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Total....................... .............. .............. .............. .............. 6,920
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Our third-party disclosure estimate is based on the number of EUA
holders and authorized stakeholders disseminating information,
including fact sheets, advertising, and promotional materials.
Our estimated burden for the information collection reflects an
overall decrease of 7,087 hours and a corresponding decrease of 302,456
responses.
Lowell M. Zeta,
Acting, Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-20771 Filed 11-21-25; 8:45 am]
BILLING CODE 4164-01-P
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