§12.32. Request for alternative form of hearing. — Inbound Citations

(c) Under § 12.32, a person who has a right to an opportunity for a formal evidentiary public hearing waives that opportunity and requests that a Board act as an administrative law tribunal concerning the matters involved, and the Commissioner decides to accept this request.

(3) A person who has a right to an opportunity for a formal evidentiary public hearing under part 12 waives that opportunity and instead under § 12.32 requests a hearing before an advisory committee, and the Commissioner, as a matter of discretion, accepts the request.

(c) A person who has right to an opportunity for a formal evidentiary public hearing under part 12 waives that opportunity and instead requests under § 12.32 a public hearing before the Commissioner, and the Commissioner, as a matter of discretion, accepts the request.

(i) Material prohibited from public disclosure under § 20.63 (clearly unwarranted invasion of personal privacy) and, except as provided in paragraph (j)(3) of this section, material submitted with objections and requests for hearing filed under part 12, or at a hearing under part 12 or part 13, or an alternative form of public hearing before a public advisory committee or a hearing under § 12.32(a) (2) or (3), of the following types will not be on public display, will not be available for public examination, and will not be available for copying or any other form of verbatim transcription unless it is otherwise available for public disclosure under part 20:

(a) Safety and effectiveness information, which includes all studies and tests of an ingredient or product on animals and humans and all studies and tests on the ingredient or product for identity, stability, purity, potency, bioavailability, performance, and usefulness.

(b) A protocol for a test or study.

(c) Manufacturing methods or processes, including quality control procedures.

(d) Production, sales distribution, and similar information, except any compilation of information aggregated and prepared in a way that does not reveal confidential information.

(e) Quantitative or semiquantitative formulas.

(f) Information on product design or construction.

(iv) Material submitted at a hearing under § 12.32(a)(2) and parts 12, 13, and 15.

(a) If the hearing is under § 13.1 (a) or (b), all applicable information described in § 12.32(e).

(1) Any written document that is to be the subject matter of the hearing will be published as a part of the notice, or the notice will refer to it if the document has already been published in the Federal Register or state that the document is available from the Dockets Management Staff or an agency employee designated in the notice.

(2) For purposes of a hearing under § 13.1 (a) or (b), all participants who file a notice of participation under § 12.32(e)(6)(ii) are deemed to be parties and entitled to participate in selection of the Board under § 13.15(b).

(c) If a public hearing before an advisory committee is used in lieu of a formal evidentiary public hearing under § 14.1(a)(3), an initial notice of hearing is to be published separately in the Federal Register containing all the information described in § 12.32(e). This procedure may be used for any other hearing before an advisory committee when the Commissioner concludes, as a matter of discretion, that it would be informative to the public.

(2) If the hearing is in lieu of a formal evidentiary public hearing under § 15.1(c), all of the information described in § 12.32(e).

(2) If the applicant files a timely request for a hearing, the agency will publish a notice of hearing in the Federal Register in accordance with §§ 12.32(e) and 15.20 of this chapter.

(2) If the applicant files a timely request for a hearing, the agency will publish a notice of hearing in the Federal Register in accordance with §§ 12.32(e) and 15.20 of this chapter.

(2) If the applicant files a timely request for a hearing, the agency will publish a notice of hearing in the Federal Register in accordance with §§ 12.32(e) and 15.20 of this chapter.

(2) If the applicant files a timely request for a hearing, the agency will publish a notice of hearing in the Federal Register in accordance with §§ 12.32(e) and 15.20 of this chapter.

(2) For purposes of a hearing under § 13.1 (a) or (b), all participants who file a notice of participation under § 12.32(e)(6)(ii) are deemed to be parties and entitled to participate in selection of the Board under § 13.15(b).

(b) The following information contained in the administrative record is not available for public examination or copying except as provided in § 12.32(g):

(1) Material provided to the committee by FDA that is exempt from public disclosure under part 20 and the regulations referenced there.

(2) Material provided to the advisory committee by a person making a presentation described in § 14.25(c) and which is prohibited from public disclosure under part 20 and the regulations referenced there.