Biological Products; General records and postmarket adverse experience reporting

OMB 0910-0308

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.

OMB Details

Biological products; reporting under 21 CFR Part 600

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form 3500AMEDWATCHFillable Fileable SignableForm
Form VAERS-1Vaccine Adverse Event Reporting SystemFillable Fileable SignableForm and instruction

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


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