ICR Documents

Supporting Statement A Document Date Uploaded 0014 IND Regs SSA 2022 Rev.docx 02/18/2022 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 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received