ICR Documents

Supporting Statement A Document Date Uploaded 0167 Orphan Drugs Part 316 SSA 2023.docx 12/19/2023 Supporting Statement B Document Date Uploaded Supplementary Documents Title Document Document Type Date Uploaded 83C - Executive Order 14168 Compliance 83C_0167_Executive Order 14168_Form FDA 4035.docx Justification for No Material/Nonsubstantive Change 04/15/2025 Public Comments Author Name Comment Document Author Affiliation Sponsoring Org. Type Category Date of Comment Date Comment Received