Authorization of Medical Products for Use Emergencies

ICR 202212-0910-015

OMB: 0910-0595

Federal Form Document

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0595 can be found here:

2024-05-30 - No material or nonsubstantive change to a currently approved collection

Forms and Documents

Document Name	Status
0595 EUA 83C for MPOX templates DEC 2022.docx Justification for No Material/Nonsubstantive Change	2022-12-29
0595 EUA 83C for MPOX templates DEC 2022.docx Justification for No Material/Nonsubstantive Change	2022-12-29
0595 EUA change for CDRH templates SEPT 2022.docx Justification for No Material/Nonsubstantive Change	2022-09-25
0595 EUA change for CDRH templates SEPT 2022.docx Justification for No Material/Nonsubstantive Change	2022-09-25
0595 EUAs SSA Ext 2022.docx Supporting Statement A	2022-07-22
0595 EUAs SSA Ext 2022.docx Supporting Statement A	2022-07-22

IC Document Collections

IC ID	Document Title	Status
43607	Requests for substantive amendment to an existing EUA Other-Guidance	Unchanged
254792	3rd PARTY DISCLOSURE: Dissemination of required information by EUA holder or authorized stakeholder Other-Statutory Authority	Unchanged
254791	RECORDKEEPING: EUA holders Other-Statutory Authority	Unchanged
236302	RECORDKEEPING: Public Health Authorities Other-Guidance	Unchanged
191144	Public Health Authorities; request for extension of expiration date Other-Guidance	Unchanged
191143	Public Health Authorities; request for EUA dispensing order Other-Guidance	Unchanged
191142	Public Health Authorities; unapproved EUA product Other-Guidance	Unchanged
191141	Submitting information required under conditions of aurhorization Other-Guidance	Unchanged
191140	Pre-EUA submissions or amendments Other-Guidance	Modified

ICR Details

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