ICR Documents

Supporting Statement A Document Date Uploaded 0595 EUAs SSA Ext 2022.docx 07/22/2022 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded CDER Fact Sheet Healthcare Provider EUA Healthcare Provider Fact Sheet Template.pdf Supplementary Document 05/29/2024 CDER Fact Sheet Patient Caregiver and Parent EUA Patient Caregiver and Parent Fact Sheet CDER Template.pdf Supplementary Document 05/29/2024 Change for CDRH EUA Templates 0595 EUA change for CDRH templates SEPT 2022.docx Justification for No Material/Nonsubstantive Change 09/25/2022 MPOX Templates 83C 0595 EUA 83C for MPOX templates DEC 2022.docx Justification for No Material/Nonsubstantive Change 12/29/2022 CDER Fact Sheets Change for EUA Templates 0595 83-C CDER 5-29-2024.docx Justification for No Material/Nonsubstantive Change 05/29/2024 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received