21 C.F.R. § 20.42
Aggregation of certain requests.
Cite as 21 C.F.R. § 20.42 (2026)
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. [68 FR 25286, May 12, 2003]
- Cross-references to the CFR
- 20.4120.41.