# 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.
**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 *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:**
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, *[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**
**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 *https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.* 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 *https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities,* 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 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:
| Information collection activity | Number of | Number of | Total annual | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| 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 (CDER) | 6 | 1 | 6 | | 270 |
| Center for Devices and Radiological Health (CDRH) | 77 | 1.727 | 133 | | 5,985 |
| 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 |
| 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 |
| Total | | | | | 504 |
| State and local public health authority submissions required under conditions of authorization for unapproved EUA product; CBER, CDER and CDRH | 1 | 1 | 1 | 2 | 2 |
| State and local public health authority requests for Emergency Dispensing Order; CBER, CDER and CDRH | 1 | 1 | 1 | 2 | 2 |
| State and local public health authority requests for expiration date extension; CDER | 1 | 1 | 1 | 20 | 20 |
| Total | | | | | 56,651 |
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:
| Template title | Date | Hyperlink |
| --- | --- | --- |
| | | |
| Molecular Diagnostic EUA Cover Sheet Template | 10/06/2021 | . |
| Molecular Diagnostic Template | 10/06/2021 | . |
| Molecular Diagnostic Home Specimen Collection Template | 10/06/2021 | . |
| Antigen Diagnostic Template | 10/06/2021 | . |
| Molecular and Antigen Home Use Test Template | 11/09/2021 | . |
| Supplemental Template for Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing | 10/25/2021 | . |
| | | |
| Serology Template | 10/06/2021 | . |
| Template for Serology Tests that Detect or Correlate to Neutralizing Antibodies | 10/06/2021 | . |
| | | |
| Appendix J—Sample Updated Fact Sheet for Health Care Providers | 04/20/2021 | . |
| Appendix K—Sample Updated Fact Sheet for Patients | 04/20/2021 | . |
| | | |
| Appendix L—Fact Sheet for Health Care Providers (Template) | 11/15/2021 | . |
| Appendix M—Fact Sheet for Patients (Template) | 11/15/2021 | . |
| Appendix N—Test Summary (Template) | 11/15/2021 | . |
| | | |
| Fact Sheet for Healthcare Providers | 11/15/2021 | . |
| Fact Sheet for Patients | 11/15/2021 | . |
| | | |
| EUA Summary Template for Developers of Molecular Diagnostic Tests for Monkeypox | 09/07/2022 | . |
| EUA Template for Developers of Molecular Diagnostic Tests for Monkeypox | 09/07/2022 | . |
| EUA Summary Template for Developers of Antigen Diagnostic Tests for Monkeypox | 11/29/2022 | . |
| EUA Template for Developers of Antigen Diagnostic Tests for Monkeypox | 11/29/2022 | . |
| | | |
| Ventilator EUA Interactive Review Template | 04/21/2020 | . |
| | | |
| Healthcare Provider Fact Sheet Template | 11/26/2024 | . |
| Patient, Parent, and Caregiver Fact Sheet Template | 11/26/2024 | . |
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 *[email protected].*
| Records associated with conditions of authorization | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| EUA Holders: | | | | | |
| CBER | 8 | 4 | 32 | 25 | 800 |
| CDER | 8 | 5 | 40 | | 1,000 |
| CDRH | 668 | 2 | 1,336 | | 33,400 |
| Total | | | | | 35,200 |
| State and local Public Health Authorities; CBER, CDER and CDRH | 1 | 1 | 1 | 3 | 3 |
| Total | | | | | 59,403 |
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.
| Information collection activity | Number of | Number of | Total annual disclosures | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| | | | | | |
| CBER | 8 | 4 | 32 | 5 | 160 |
| CDER | 8 | 2 | 16 | | 80 |
| CDRH | 668 | 2 | 1,336 | | 6,680 |
| Total | | | | | 6,920 |
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.