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Biologics License Applications; Procedures & Requirements
ICR 202302-0910-011
OMB: 0910-0338
Federal Form Document
OMB.report
HHS/FDA
OMB 0910-0338
ICR 202302-0910-011
( )
⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0338 can be found here:
2023-08-30 - Revision of a currently approved collection
Forms and Documents
Document
Name
Status
Form Form FDA 2253 Biologics; Licensing; General Biological Products Standards; and Additional Standards
Form and Instruction
Modified
Form 356h Notifications of suspensions
Form and Instruction
Unchanged
0338 BLAs Supporting Statement 2023 REV.docx
Supporting Statement A
2023-02-26
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx
Justification for No Material/Nonsubstantive Change
2022-09-01
IC Document Collections
IC ID
Document
Title
Status
5935
Biologics; Licensing; General Biological Products Standards; and Additional Standards
Form and Instruction
Modified
209328
Notifications of suspensions
Form and Instruction
Unchanged
ICR Details
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