21 C.F.R. § 20.42

Current through October 31, 2024
Section 20.42 - Aggregation of certain requests

The Food and Drug Administration may aggregate certain requests by the same requester, or by a group of requesters acting in concert, if the requests involve clearly related matters and the agency reasonably believes that such requests actually constitute a single request which would otherwise satisfy the unusual circumstances specified in § 20.41(b)(3)(ii)(B) . FDA may extend the time for processing aggregated requests in accordance with the unusual circumstances provisions of § 20.41 .

21 C.F.R. §20.42

68 FR 25286 , May 12, 2003