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Reasoning: Draft Proposal 2

When the Office of the Commissioner (OC) receives a request to reconsider a scientific decision of an FDA employee from an interested person outside the agency pursuant to 21 C.F.R. § 10.75, OC should inform the submitter within three weeks whether OC will review the request, and should inform the submitter when a decision or an update on the status of the review may be expected. 


FDA regulations set forth a basic process for an interested person outside of FDA to request internal agency review of a decision through the established channels of supervision or review.   In certain circumstances, this process may include a review by the Office of the Commissioner (OC).  While there are timeframes that govern the review of a decision through the established channels of supervision or review at the Center or Office level, there are not timeframes for any review that may be conducted by the Office of the Commissioner.

The Task Force concluded that OC should inform a requester when it has determined whether to review the request.  If OC has decided that review will occur, the requestor should be provided with information about when a decision may be expected.  Implementation of this proposal will support more consistent practices across the agency, while providing industry with more certainty regarding the regulatory process

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