eCFR Reference Browser

---

title: "21 CFR §12.1"

source: "https://www.ecfr.gov/current/title-21/section-12.1"

title_number: "21"

volume_number: "1"

chapter_number: "Unknown"

subchapter_code: "A"

subchapter_subject: "GENERAL"

part_code: "12"

part_subject: "FORMAL EVIDENTIARY PUBLIC HEARING"

subpart_code: "A"

subpart_subject: "General Provisions"

section_number: "12.1"

section_subject: "Scope."

cfr_reference: "21 CFR 12.1"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 1 to 99"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§12.1 - Scope.