part_subject: "REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION"
subpart_code: "A"
subpart_subject: "General Provisions"
section_number: "16.1"
section_subject: "Scope."
cfr_reference: "21 CFR 16.1"
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"
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The procedures in this part apply when:
(a)The Commissioner is considering any regulatory action, including a refusal to act, and concludes, as a matter of discretion, on the Commissioner's initiative or at the suggestion of any person, to offer an opportunity for a regulatory hearing to obtain additional information before making a decision or taking action.
(b)The act or a regulation provides a person with an opportunity for a hearing on a regulatory action, including proposed action, and the act or a regulation either specifically provides an opportunity for a regulatory hearing under this part or provides an opportunity for a hearing for which no procedures are specified by regulation. Listed below are the statutory and regulatory provisions under which regulatory hearings are available:
§§ 112.201 through 112.213, (see part 112, subpart R of this chapter), relating to withdrawal of a qualified exemption.
For Federal Register citations affecting § 16.1, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.