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# Comments Sought on Special Protocol Assessment Guidance Extension
- URL: https://www.fdaweb.com/comments-sought-on-special-protocol-assessment-guidance-extension/
- Published: 2016-11-18T12:00:00.000Z
- Updated: 2026-09-14T21:49:12.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137381

*Federal Register* Notice: FDA is seeking comments on an information collection extension on its “Guidance for Industry on Special Protocol Assessment” that describes agency procedures to evaluate issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies. The guidance also describes procedures for sponsors to request special protocol assessment and for the agency to act on such requests. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-11-18/pdf/2016-27840.pdf?ref=fdaweb.com).