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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 12.1: Scope.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER A—GENERAL
  4. PART 12—FORMAL EVIDENTIARY PUBLIC HEARING
  5. Subpart A—General Provisions

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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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