§10.50. Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing. — Inbound Citations

(f) If a petition filed under paragraph (c) of this section requests the Commissioner to issue, amend, or revoke a regulation, § 10.40 or § 10.50 also apply.

(1) This section applies to any regulation: (i) Not subject to § 10.50 and part 12, or (ii) if it is subject to § 10.50 and part 12, to the extent that those provisions make this section applicable.

(a) This section applies to court review of final administrative action taken by the Commissioner, including action taken under §§ 10.25 through 10.40 and § 16.1(b), except action subject to § 10.50 and part 12.

(d) If the Commissioner's review of the matter results in a proposed rule, the provisions of § 10.40 or § 10.50 also apply.

(f) In addition to the requirements of this section, the provisions of § 10.55 apply to the promulgation of a regulation subject to § 10.50 and part 12.

(a) FDA regulations are issued in the Federal Register under § 10.40 or § 10.50 and codified in the Code of Federal Regulations. Regulations may contain provisions that will be enforced as legal requirements, or which are intended only as guidance documents and recommendations, or both. The dissemination of draft notices and regulations is subject to § 10.80.

(a) A person has a right to an opportunity for a hearing under the laws specified in § 10.50; or

(a) This section applies to any matter subject by statute to an opportunity for a formal evidentiary public hearing, as listed in § 10.50(c), and any matter subject to a hearing before a Public Board of Inquiry under part 13.