§ 20.42 Aggregation of certain requests.

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Title 21 CFR: Food and Drugs › Chapter I › Part 20 › Subpart C › § 20.42: § 20.42 Aggregation of certain requests.

This text was captured on Aug 14, 2026. It is a snapshot, not a live feed, so check the official code before relying on it.

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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]

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