Biological Products; General records and postmarket adverse experience reporting

OMB 0910-0308

This information collection supports Food and Drug Administration (FDA) regulations regarding certain general requirements and postmarket adverse experience reporting for biological products. Respondents to the collection are manufacturers of these products subject to the applicable regulations. The information collection enables FDA to implement public health protection provisions of the Federal Food, Drug, and Cosmetic Act.

The latest form for Biological Products; General records and postmarket adverse experience reporting expires 2021-04-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 3500A Biological products Reporting Form
Form 3500A Biological products; Recordkeeping Form
0308 Biologics AER including combo products SSA 2024.docx Supporting Statement A
83-C for 0308 to add Combo Product AER disclosure MARCH 2023.docx Justification for No Material/Nonsubstantive Change
Biological products Reporting Form
Postmarketing Safety Reporting for Combination Biological Products
Biological products; Recordkeeping Form

All Historical Document Collections

202403-0910-011	Extension without change of a currently approved collection	2024-04-26
202303-0910-016 Approved without change	No material or nonsubstantive change to a currently approved collection	2023-03-20
202102-0910-007 Approved without change	Extension without change of a currently approved collection	2021-03-15
201801-0910-009 Approved without change	Extension without change of a currently approved collection	2018-02-13
201410-0910-016 Approved with change	Extension without change of a currently approved collection	2014-11-10
201107-0910-007 Approved without change	Extension without change of a currently approved collection	2011-07-19
200807-0910-007 Approved without change	Extension without change of a currently approved collection	2008-07-21
200505-0910-001 Approved without change	Extension without change of a currently approved collection	2005-05-11
200303-0910-003 Approved without change	Extension without change of a currently approved collection	2003-03-14
200012-0910-005 Approved without change	Extension without change of a currently approved collection	2000-12-29
199903-0910-001 Approved without change	Reinstatement with change of a previously approved collection	1999-03-08
199503-0910-002 Approved without change	New collection (Request for a new OMB Control Number)	1995-03-24

OMB Details

Biological products; reporting under 21 CFR Part 600

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form 3500A	MEDWATCH	Fillable Fileable Signable	Form
Form VAERS-1	Vaccine Adverse Event Reporting System	Fillable Fileable Signable	Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.