OMB control number

Authorization of Medical Products for Use Emergencies

OMB 0910-0595 · HHS/FDA.

OMB 0910-0595

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.

The latest form for Authorization of Medical Products for Use Emergencies expires 2029-05-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0595 Comment from CPAC Foundations Center for Regulatory Freedom 2025.pdf (document unavailable) Public Comments
0910-0595_Supporting Statement A_2025.docx Supporting Statement A
0910-0595_CDRH_Ventilator-EUA-Interactive-Review-Template.docx Supplementary Document
0910-0595_CDRH_EUA-Antigen-Monkeypox-Template.docx Supplementary Document
Summary-EUA-Antigen-Template-Monkeypox (1).docx Supplementary Document
0910_0595_CDRH_EUA_Template_Monkeypox (2).docx Supplementary Document
0910-0595_CDRH_Summary_EUA_Template_Monkeypox.docx Supplementary Document
EUA-LDT-patients_0.pdf Supplementary Document
0910-0595_CDRH_HCP Fact Sheet.pdf Supplementary Document
0910-0595_CDRH_EUA-Molecular-Serial-Umbrella-Test-Summary-Template (2).docx Supplementary Document
0910-0595_CDRH_EUA-Molecular-Serial-Umbrella-Patient-Fact-Sheet-Template.docx Supplementary Document
0910-0595_CDRH_EUA-Molecular-Serial-Umbrella-HCP-Fact-Sheet-Template (1).docx Supplementary Document
Pooling and Serial Testing Amendment - Appendix J - Sample Updated Fact Sheet for Health Care Providers.pdf Supplementary Document
Pooling and Serial Testing Amendment - Appendix J - Sample Updated Fact Sheet for Health Care Providers.pdf Supplementary Document
serology-neutralizing-template.docx Supplementary Document
0910-0595_CDRH_serology-template.docx Supplementary Document
0910-0595_CDRH_SupplementalTemplate-Molecular-Antigen-Diagnostic-COVID-19-Tests-Screening-Serial-Testing.docx Supplementary Document
0910-0595_CDRH_Molecular-and-Antigen-Home-Use-Test-Template.docx Supplementary Document
0910-0595_CDRH_antigen_template.docx Supplementary Document
0910-0595_CDRH_molecular_homecollection_template2.docx Supplementary Document
0910-0595_CDRH_molecular_template2.docx Supplementary Document
0910-0595_CDRH_Molecular-Cover-Sheet.docx Supplementary Document
0910-0595_CDER_eua_patient_parent_and_caregiver_fact_sheet_template.docx Supplementary Document
0910-0595_CDER_eua_healthcare_provider_fact_sheet_template.docx Supplementary Document
Requests for an EUA and/or a substantive amendment to an existing EUA Other-Guidance; Emergency Use Authorization of Medical Products
3rd PARTY DISCLOSURE: Dissemination of required information by EUA holder or authorized stakeholder Other-Statutory Authority - Authorization for medical products f
RECORDKEEPING: EUA holders Other-Statutory Authority - Authorization for medical products f
RECORDKEEPING: State and local Public Health Authorities Other-Guidance; Emergency Use Authorization of Medical Products
State and local public health authority requests for expiration date extension Other-Guidance; Emergency Use Authorization of Medical Products
State and local public health authority requests for Emergency Dispensing Order Other-Guidance; Emergency Use Authorization of Medical Products
State and local public health authority submissions required under conditions of authorization for unapproved EUA product Other-Guidance; Emergency Use Authorization of Medical Products
Submitting information required under conditions of aurhorization Other-Guidance; Emergency Use Authorization of Medical Products
Pre-EUA submissions or amendments Other-Guidance; Emergency Use Authorization of Medical Products

All Historical Document Collections

202504-0910-001	Reinstatement without change of a previously approved collection	2025-12-04
202405-0910-004 Approved without change	No material or nonsubstantive change to a currently approved collection	2024-05-30
202212-0910-015 Approved without change	No material or nonsubstantive change to a currently approved collection	2022-12-29
202209-0910-008 Approved without change	No material or nonsubstantive change to a currently approved collection	2022-09-27
202207-0910-004 Approved without change	Revision of a currently approved collection	2022-07-22
201905-0910-009 Approved without change	Revision of a currently approved collection	2019-07-29
201603-0910-004 Approved without change	Extension without change of a currently approved collection	2016-03-21
201301-0910-003 Approved without change	Extension without change of a currently approved collection	2013-01-08
201212-0910-008 Approved without change	No material or nonsubstantive change to a currently approved collection	2012-12-13
201010-0910-001 Approved with change	No material or nonsubstantive change to a currently approved collection	2010-10-01
200910-0910-002 Approved without change	Extension without change of a currently approved collection	2009-10-27
200607-0910-003 Approved without change	New collection (Request for a new OMB Control Number)	2006-07-12

OMB Details

Requests for an EUA and/or a substantive amendment to an existing EUA

Federal Enterprise Architecture: Health - Consumer Health and Safety