21 CFR 20.42
§ 20.42 Aggregation of certain requests.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 20.42, § 20.42 Aggregation of certain requests, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83318
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.