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