HHS - 21 CFR PART 14
PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
|Publication Date:||1 April 2018|
(a) This part governs the procedures when any of the following applies:
(1) The Commissioner concludes, as a matter of discretion, that it is in the public interest for a standing or ad hoc policy or technical public advisory committee (advisory committee or committee) to hold a public hearing and to review and make recommendations on any matter before FDA and for interested persons to present information and views at an oral public hearing before the advisory committee.
(2) Under specific provisions in the FD&C Act or other sections of this chapter, a matter is subject to a hearing before an advisory committee. The specific provisions are-
(i) Section 14.120 on review of a performance standard for an electronic product by the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC);
(ii) Section 14.140 on review of the safety of color additives;
(iii) Section 14.160 on review of the safety and effectiveness of human prescription drugs;
(iv) Section 330.10 on review of the safety and effectiveness of over-thecounter drugs;
(v) [Reserved] (vi) Part 860, on classification of devices;
(vii) Section 514(b)(5) of the FD&C Act on establishment, amendment, or
revocation of a device performance standard;
(viii) Section 515 of the FD&C Act on review of device premarket approval applications and product development protocols; and
(ix) Section 520(f) of the FD&C Act on review of device good manufacturing practice regulations.
(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. (b) In determining whether a group is a public advisory committee as defined in § 10.3(a) and thus subject to this part and to the Federal advisory Committee Act, the following guidelines will be used:
(1) An advisory committee may be a standing advisory committee or an ad hoc advisory committee. All standing advisory committees are listed in § 14.100.
(2) An advisory committee may be a policy advisory committee or a technical advisory committee. A policy advisory committee advises on broad and general matters. A technical advisory committee advises on specific technical or scientific issues, which may relate to regulatory decisions before FDA.
(3) An advisory committee includes any of its subgroups when the subgroup is working on behalf of the committee. Section 14.40(d) describes when a subgroup will be established as an advisory committee separate from the parent committee.
(4) A committee composed entirely of full-time Federal Government employees is not an advisory committee.
(5) An advisory committee ordinarily has a fixed membership, a defined purpose of providing advice to the agency on a particular subject, regular or periodic meetings, and an organizational structure, for example, a Chairperson and staff, and serves as a source of independent expertise and advice rather than as a representative of or advocate for any particular interest. The following groups are not advisory committees: