Biological Products; General records and postmarket adverse experience reporting

ICR 202403-0910-011

OMB: 0910-0308

Federal Form Document

Forms and Documents

Document Name	Status
Form 3500A Biological products Reporting Form	Modified
Form 3500A Biological products; Recordkeeping Form	Modified
0308 Biologics AER including combo products SSA 2024.docx Supporting Statement A	2024-04-26
83-C for 0308 to add Combo Product AER disclosure MARCH 2023.docx Justification for No Material/Nonsubstantive Change	2023-03-20

IC Document Collections

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