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21 CFR 12.1

§ 12.1 Scope.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 12.1, § 12.1 Scope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83095
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Full text

The procedures in this part apply when— (a) A person has a right to an opportunity for a hearing under the laws specified in § 10.50; or (b) The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.