Request for Samples and Protocols

OMB 0910-0206

OMB 0910-0206

This information collection supports FDA regulations regarding biologic samples and protocols. These samples and protocols are required by FDA to help ensure the safety, purity, and potency of products with the potential for lot-to-lot variability and produced from living organisms. The written protocols are reviewed by FDA scientists and samples to verify the manufacturer's test results.

The latest form for Request for Samples and Protocols expires 2021-09-30 and can be found here.

OMB Details

Release Requirements; Requests for samples and protocols; official release.

Federal Enterprise Architecture: Health - Consumer Health and Safety

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