Authorization of Medical Products for Use Emergencies

Forms and Documents

Document Name	Status
0910-0595_Supporting Statement A_2025.docx Supporting Statement A	2025-12-03
0910-0595_CDRH_Ventilator-EUA-Interactive-Review-Template.docx Supplementary Document	2025-12-03
0910-0595_CDRH_EUA-Antigen-Monkeypox-Template.docx Supplementary Document	2025-12-03
Summary-EUA-Antigen-Template-Monkeypox (1).docx Supplementary Document	2025-12-03
0910_0595_CDRH_EUA_Template_Monkeypox (2).docx Supplementary Document	2025-12-03
0910-0595_CDRH_Summary_EUA_Template_Monkeypox.docx Supplementary Document	2025-12-03
EUA-LDT-patients_0.pdf Supplementary Document	2025-12-03
0910-0595_CDRH_HCP Fact Sheet.pdf Supplementary Document	2025-12-03
0910-0595_CDRH_EUA-Molecular-Serial-Umbrella-Test-Summary-Template (2).docx Supplementary Document	2025-12-02
0910-0595_CDRH_EUA-Molecular-Serial-Umbrella-Patient-Fact-Sheet-Template.docx Supplementary Document	2025-12-02
0910-0595_CDRH_EUA-Molecular-Serial-Umbrella-HCP-Fact-Sheet-Template (1).docx Supplementary Document	2025-12-02
Pooling and Serial Testing Amendment - Appendix J - Sample Updated Fact Sheet for Health Care Providers.pdf Supplementary Document	2025-12-02
Pooling and Serial Testing Amendment - Appendix J - Sample Updated Fact Sheet for Health Care Providers.pdf Supplementary Document	2025-12-02
serology-neutralizing-template.docx Supplementary Document	2025-12-02
0910-0595_CDRH_serology-template.docx Supplementary Document	2025-12-02
0910-0595_CDRH_SupplementalTemplate-Molecular-Antigen-Diagnostic-COVID-19-Tests-Screening-Serial-Testing.docx Supplementary Document	2025-12-02
0910-0595_CDRH_Molecular-and-Antigen-Home-Use-Test-Template.docx Supplementary Document	2025-12-02
0910-0595_CDRH_antigen_template.docx Supplementary Document	2025-12-02
0910-0595_CDRH_molecular_homecollection_template2.docx Supplementary Document	2025-12-02
0910-0595_CDRH_molecular_template2.docx Supplementary Document	2025-12-02
0910-0595_CDRH_Molecular-Cover-Sheet.docx Supplementary Document	2025-12-02
0910-0595_CDER_eua_patient_parent_and_caregiver_fact_sheet_template.docx Supplementary Document	2025-12-02
0910-0595_CDER_eua_healthcare_provider_fact_sheet_template.docx Supplementary Document	2025-12-02

IC Document Collections

IC ID	Document Title	Status
43607	Requests for an EUA and/or a substantive amendment to an existing EUA Other-Guidance; Emergency Use Authorization of Medical Products	Modified
254792	3rd PARTY DISCLOSURE: Dissemination of required information by EUA holder or authorized stakeholder Other-Statutory Authority - Authorization for medical products f	Modified
254791	RECORDKEEPING: EUA holders Other-Statutory Authority - Authorization for medical products f	Modified
236302	RECORDKEEPING: State and local Public Health Authorities Other-Guidance; Emergency Use Authorization of Medical Products	Modified
191144	State and local public health authority requests for expiration date extension Other-Guidance; Emergency Use Authorization of Medical Products	Modified
191143	State and local public health authority requests for Emergency Dispensing Order Other-Guidance; Emergency Use Authorization of Medical Products	Modified
191142	State and local public health authority submissions required under conditions of authorization for unapproved EUA product Other-Guidance; Emergency Use Authorization of Medical Products	Modified
191141	Submitting information required under conditions of aurhorization Other-Guidance; Emergency Use Authorization of Medical Products	Modified
191140	Pre-EUA submissions or amendments Other-Guidance; Emergency Use Authorization of Medical Products	Modified

ICR Details

OMB Control No: 0910-0595	ICR Reference No: 202504-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202405-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CROSS CENTER
Title: Authorization of Medical Products for Use Emergencies
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/04/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	3,040	0
Time Burden (Hours)	50,378	0
Cost Burden (Dollars)	0	0

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Abstract: This Information Collection Request (ICR) collects information from manufacturers and public health authorities applicable to the authorization of the emergency use of certain medical products during a declared emergency. Respondents submit information as recommended in Food and Drug Administration (FDA or Agency) guidance, including a description of the medical product and the intended use, reports after administration of such a product, and requests for extension of the expiration date of eligible products.

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Authorizing Statute(s): US Code: 21 USC 360bbb-3 through 360bbb-3b Name of Law: FFDCA; Emergency Use of Medical Products
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 31217	07/14/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 52962	11/24/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
3rd PARTY DISCLOSURE: Dissemination of required information by EUA holder or authorized stakeholder
Pre-EUA submissions or amendments
RECORDKEEPING: EUA holders
RECORDKEEPING: State and local Public Health Authorities
Requests for an EUA and/or a substantive amendment to an existing EUA
State and local public health authority requests for Emergency Dispensing Order
State and local public health authority requests for expiration date extension
State and local public health authority submissions required under conditions of authorization for unapproved EUA product
Submitting information required under conditions of aurhorization

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	3,040	0	0	0	-7,087	10,127
Annual Time Burden (Hours)	50,378	0	0	0	-302,456	352,834
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Our estimated burden for the information collection reflects an overall decrease of 7,087 hours and a corresponding decrease of 302,456 responses. We have decreased our estimated burden to reflect a decrease in related submissions over the past 3 years

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Annual Cost to Federal Government: $2,545,092

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Yes

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 12/04/2025

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