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
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All Historical Document Collections

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