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.

Latest Forms, Documents, and Supporting Material
Document
Name
Supporting Statement A
All Historical Document Collections
Approved without change
 Extension without change of a currently approved collection 2021-08-27
Approved without change
 Extension without change of a currently approved collection 2018-08-20
Approved without change
 Extension without change of a currently approved collection 2015-09-24
Approved without change
 Extension without change of a currently approved collection 2012-07-17
Approved without change
 Extension without change of a currently approved collection 2009-08-05
Approved without change
 Extension without change of a currently approved collection 2006-07-05
Approved without change
 Extension without change of a currently approved collection 2003-05-29
Approved without change
 Extension without change of a currently approved collection 2000-06-29
Approved without change
 Reinstatement without change of a previously approved collection 1997-09-25
Approved without change
 No material or nonsubstantive change to a currently approved collection 1995-09-30
Approved without change
 Reinstatement with change of a previously approved collection 1992-10-13
Approved without change
 New collection (Request for a new OMB Control Number) 1984-12-12
OMB Details

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

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