Biological Products; General records and postmarket adverse experience reporting

ICR 202303-0910-016

OMB: 0910-0308

Federal Form Document

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0308 can be found here:

2024-04-26 - Extension without change of a currently approved collection

Forms and Documents

Document Name	Status
Form 3500A Biological products Reporting Form	Unchanged
Form 3500A Biological products Reporting Form	Unchanged
Form 3500A Biological products; Recordkeeping Form	Unchanged
Form 3500A Biological products; Recordkeeping Form	Unchanged
83-C for 0308 to add Combo Product AER disclosure MARCH 2023.docx Justification for No Material/Nonsubstantive Change	2023-03-20
83-C for 0308 to add Combo Product AER disclosure MARCH 2023.docx Justification for No Material/Nonsubstantive Change	2023-03-20
0308 BLAs VAERS SSA 2021 EXT.docx Supporting Statement A	2021-03-14
0308 BLAs VAERS SSA 2021 EXT.docx Supporting Statement A	2021-03-14

IC Document Collections

IC ID	Document Title	Status
5877	Biological products Reporting Form	Unchanged
5877	Biological products Reporting Form	Unchanged
259220	Postmarketing Safety Reporting for Combination Products	New
185787	Biological products; Recordkeeping Form	Unchanged
185787	Biological products; Recordkeeping Form	Unchanged

ICR Details

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