Authorization of Medical Products for Use Emergencies

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 2022-08-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
EUA Patient Caregiver and Parent Fact Sheet CDER Template.pdf Supplementary Document
EUA Patient Caregiver and Parent Fact Sheet CDER Template.pdf Supplementary Document
EUA Healthcare Provider Fact Sheet Template.pdf Supplementary Document
EUA Healthcare Provider Fact Sheet Template.pdf Supplementary Document
0595 83-C CDER 5-29-2024.docx Justification for No Material/Nonsubstantive Change
0595 83-C CDER 5-29-2024.docx Justification for No Material/Nonsubstantive Change
0595 EUA 83C for MPOX templates DEC 2022.docx Justification for No Material/Nonsubstantive Change
0595 EUA 83C for MPOX templates DEC 2022.docx Justification for No Material/Nonsubstantive Change
0595 EUA change for CDRH templates SEPT 2022.docx Justification for No Material/Nonsubstantive Change
0595 EUA change for CDRH templates SEPT 2022.docx Justification for No Material/Nonsubstantive Change
0595 EUAs SSA Ext 2022.docx Supporting Statement A
0595 EUAs SSA Ext 2022.docx Supporting Statement A
Requests for substantive amendment to an existing EUA Other-Guidance
3rd PARTY DISCLOSURE: Dissemination of required information by EUA holder or authorized stakeholder Other-Statutory Authority
RECORDKEEPING: EUA holders Other-Statutory Authority
RECORDKEEPING: Public Health Authorities Other-Guidance
Public Health Authorities; request for extension of expiration date Other-Guidance
Public Health Authorities; request for EUA dispensing order Other-Guidance
Public Health Authorities; unapproved EUA product Other-Guidance
Submitting information required under conditions of aurhorization Other-Guidance
Pre-EUA submissions or amendments Other-Guidance

All Historical Document Collections

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 to Issue an EUA or a Substantive Amendment to an Existing EUA

Federal Enterprise Architecture: Health - Consumer Health and Safety