Source: https://www.law.cornell.edu/cfr/text/21/12.32
Timestamp: 2017-02-26 17:19:18
Document Index: 211497044

Matched Legal Cases: ['art 12', '§ 12', '§ 10', '§ 12', '§ 12', '§ 13', '§ 12', '§ 13', '§ 13', '§ 12', '§ 12', '§ 12', '§ 10', 'art 14', '§ 551', '§ 552', '§ 552', '§ 552', '§ 553', '§ 554', '§ 555', '§ 556', '§ 557', '§ 558', '§ 701', '§ 721']

21 CFR 12.32 - Request for alternative form of hearing. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter A › Part 12 › Subpart B › Section 12.32 21 CFR 12.32 - Request for alternative form of hearing.
§ 12.32 Request for alternative form of hearing.
(b) The request - (1) May be on the person's own initiative or at the suggestion of the Commissioner.
(2) Must be submitted in the form of a citizen petition under § 10.30 before publication of a notice of hearing under § 12.35 or a denial of hearing under § 12.28; and
(3) Must be - (i) In lieu of a request for a hearing under this part; or
(6) If the hearing will be conducted by a Public Board of Inquiry, the time within which - (i) The parties should submit nominees for the Board under § 13.10(b);
(ii) A notice of participation under § 12.45 should be filed; and
(iii) Participants should submit written information under § 13.25. The notice will list the contents of the portions of the administrative record relevant to the issues at the hearing before the Board. The portions listed will be placed on public display in the office of the Division of Dockets Management before the notice is published. Additional copies of material already submitted under § 13.25 need not be included with any later submissions.
(1) The decision of a hearing before a Public Board of Inquiry or a public advisory committee under this section has legal status of and will be handled as an initial decision under § 12.120.
(2) The decision of a public hearing before the Commissioner under this section will be issued as a final order. The final order will have the same content as an initial decision, as specified in § 12.120 (b) and (c).
(3) Thereafter, the participants in the proceeding may pursue the administrative and court remedies specified in §§ 12.120 through 12.159.
(g) If a hearing before a public advisory committee or a hearing before the Commissioner is used as an alternative form of hearing, all submissions will be made to the Division of Dockets Management, and § 10.20(j) governs their availability for public examination and copying.
(h) This section does not affect the right to an opportunity for a hearing before a public advisory committee under section 515(g)(2) of the act regarding device premarket approval applications and product development protocols. Advisory committee hearing procedures are found in part 14. This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeU.S. Code: Title 5 - GOVERNMENT ORGANIZATION AND EMPLOYEES§ 551 - Definitions§ 552 - Public information; agency rules, opinions, orders, records, and proceedings§ 552a - Records maintained on individuals§ 552b - Open meetings§ 553 - Rule making§ 554 - Adjudications§ 555 - Ancillary matters§ 556 - Hearings; presiding employees; powers and duties; burden of proof; evidence; record as basis of decision§ 557 - Initial decisions; conclusiveness; review by agency; submissions by parties; contents of decisions; record§ 558 - Imposition of sanctions; determination of applications for licenses; suspension, revocation, and expiration of licenses§ 701 - Application; definitions§ 721
21 CFR 14.75 — Examination of Administrative Record and Other Advisory Committee Records.
21 CFR 14.1 — Scope.
21 CFR 13.1 — Scope.
21 CFR 14.20 — Notice of Hearing Before an Advisory Committee.
21 CFR 15.20 — Notice of a Public Hearing Before the Commissioner.
21 CFR 13.5 — Notice of a Hearing Before a Board.