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Agenda
Reg Review
ICR
ICR Documents
Supporting Statement A
Document
Date Uploaded
0014 INDs SSA AUG 2023 to add ICH Guidance REV.docx
08/08/2023
Supporting Statement B
Document
Date Uploaded
Supplementary Documents
Title
Document
Document Type
Date Uploaded
Request for Changes to PDUFA Forms
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx
Justification for No Material/Nonsubstantive Change
09/01/2022
83-C to add Special Protocol Assessments (SPAs)
83-C for 0014 to add SPAs MARCH 2023.docx
Justification for No Material/Nonsubstantive Change
03/13/2023
83-C to include DMC guidance burden (0581)
83-C for 0014 to add 0581 Guidance MARCH 2024.docx
Justification for No Material/Nonsubstantive Change
03/04/2024
Public Comments
Author Name
Comment Document
Author Affiliation
Sponsoring Org.
Type
Category
Date of Comment
Date Comment Received
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
An official website of the United States government
The .gov means it's official.
The site is secure.
