21 CFR § 12.32 - Request for alternative form of hearing.

(a) A person with a right to request a hearing may waive that right and request one of the following alternatives:

(1) A hearing before a Public Board of Inquiry under part 13.

(2) A hearing before a public advisory committee under part 14.

(3) A hearing before the Commissioner under part 15.

(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

(ii) If submitted after or with a request for hearing, in the form of a waiver of the right to request a hearing conditioned on an alternative form of hearing. Upon acceptance by the Commissioner, the waiver becomes binding and may be withdrawn only by waiving any right to any form of hearing unless the Commissioner determines otherwise.

(c) When more than one person requests and justifies a hearing under this part, an alternative form of hearing may by used only if all the persons concur and waive their right to request a hearing under this part.

(d) The Commissioner will determine whether an alternative form of hearing should be used, and if so, which alternative is acceptable, after considering the requests submitted and the appropriateness of the alternatives for the issues raised in the objections. The Commissioner's acceptance is binding unless, for good cause, the Commissioner determines otherwise.

(e) The Commissioner will publish a notice of an alternative form of hearing setting forth the following information:

(1) The regulation or order that is the subject of the hearing.

(2) A statement specifying any part of the regulation or order that has been stayed by operation of law or in the Commissioner's discretion.

(3) The time, date, and place of the hearing, or a statment that such information will be contained in a later notice.

(4) The parties to the hearing.

(5) The issues at the hearing. The statement of issues determines the scope of the hearing.

(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 Dockets Management Staff before the notice is published. Additional copies of material already submitted under § 13.25 need not be included with any later submissions.

(f)

(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 Dockets Management Staff, 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.