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Orphan Drugs
ICR 202504-0910-005
OMB: 0910-0167
Federal Form Document
OMB.report
HHS/FDA
OMB 0910-0167
ICR 202504-0910-005
( )
Forms and Documents
Document
Name
Status
83C_0167_Executive Order 14168_Form FDA 4035.docx
Justification for No Material/Nonsubstantive Change
2025-04-15
0167 Orphan Drugs Part 316 SSA 2023.docx
Supporting Statement A
2023-12-19
IC Document Collections
IC ID
Document
Title
Status
5770
Orphan Drug Requirements
Other-Guidance
Modified
ICR Details
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