Notice2025-13049
Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Use Authorization of Medical Products
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Published
July 14, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection activities related to emergency use authorization for medical products.
Full Text
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<title>Federal Register, Volume 90 Issue 132 (Monday, July 14, 2025)</title>
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[Federal Register Volume 90, Number 132 (Monday, July 14, 2025)]
[Notices]
[Pages 31217-31221]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13049]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1115]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection activities related
to emergency use authorization for medical products.
DATES: Either electronic or written comments on the collection of
information must be submitted by September 12, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 12, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
[FDA-2025-N-1115] for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Emergency Use Authorization of
Medical Products.'' Received comments, those filed in a timely manner
(see ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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#8adad8cbd9feebececcaeceeeba4e2e2f9a4ede5fc"><span class="__cf_email__" data-cfemail="5b0b091a082f3a3d3d1b3d3f3a75333328753c342d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these 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
[[Page 31218]]
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Total Average
Information collection activity Number of responses per annual burden per Total
respondents respondent responses response hours
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Requests for an EUA and/or a substantive
amendment to an existing EUA:
Center for Biologics Evaluation (CBER)..... 1 4 4 45 180
Center for Drug Evaluation and Research 6 1 6 270
(CDER)....................................
Center for Devices and Radiological Health 77 1.727 133 5,985
(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 authority 1 1 1 2 2
submissions required under conditions of
authorization for unapproved EUA product;
CBER, CDER and CDRH...........................
State and local public health authority 1 1 1 2 2
requests for Emergency Dispensing Order; CBER,
CDER and CDRH.................................
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State and local public health authority 1 1 1 20 20
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.
Supplemental Template for 10/25/2021 https://www.fda.gov/
Molecular and Antigen Diagnostic media/146695/
COVID-19 Tests for Screening download?attachment.
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 that 10/06/2021 https://www.fda.gov/
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 Providers. media/147735/
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 Health 11/15/2021 https://www.fda.gov/
Care Providers (Template). media/154112/
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.
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EUA Summary Template for 11/29/2022 https://www.fda.gov/
Developers of Antigen Diagnostic media/163530/
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 Review 04/21/2020 https://www.fda.gov/
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#a7e4e3e2f5e2f2e6e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="3271767760776773725456531c5a5a411c555d44">[email protected]</span></a>.
Table 3--Estimated Annual Recordkeeping Burden \1\
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Number of Total Average
Records associated with conditions of Number of records per annual burden per Total
authorization recordkeepers recordkeeper records recordkeeping hours
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EUA Holders:
CBER................................ 8 4 32 25 800
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 Total Average
Information collection activity Number of disclosures per annual burden per Total
respondents respondent disclosures disclosure hours
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Dissemination of required information by EUA
Holder or Authorized Stakeholder:
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.
[[Page 31221]]
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.
Dated: July 8, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-13049 Filed 7-11-25; 8:45 am]
BILLING CODE 4164-01-P
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