14.140 Establishment of a color additive advisory committee.

14.142 Functions of a color additive advisory committee.

14.145 Procedures of a color additive advisory committee.

14.147 Membership of a color additive advisory committee.

14.155 Fees and compensation pertaining to a color additive advisory committee. Subpart I—Advisory Committees for Human Prescription Drugs

14.160 Establishment of standing technical advisory committees for human prescription drugs.

14.171 Utilization of an advisory committee on the initiative of FDA.

14.172 Utilization of an advisory committee at the request of an interested person. 14.174 Advice and recommendations in writing.

AUTHORITY: 5 U.S.C. 5332 note; 15 U.S.C. 1451 et seq.; 21 U.S.C. 41 et seq.; 141 et seq., 321-371, 467f(b), 679(b), 821, 1031 et seq.; 42 U.S.C. 201 et seq.; 257a; 21 CFR 5.10.

SOURCE: 44 FR 22351, Apr. 13, 1979, unless otherwise noted.

Subpart A-General Provisions

§ 14.1 Scope.

(a) This part governors 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 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) Section 601.25 on review of the safety and effectiveness of biological drugs;

(vi) Part 860, on classification of devices;

(vii) Section 514(g)(5) of the act on establishment, amendment, or revocation of a device performance standard;

(viii) Section 515 of the act on review of device premarket approval applications and product development protocols; and

(ix) Section 520(1) of the 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.

(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 chairman 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:

(i) A group of persons convened on an ad hoc basis to discuss a matter of current interest to FDA, but which has no continuing function or organization and does not involve substantial special preparation.

(ii) A group of two or more FDA consultants meeting with the agency on an ad hoc basis.

(iii) A group of experts who are employed by a private company or a trade association which has been requested by FDA to provide its views on a regulatory matter pending before FDA.

(iv) A consulting firm hired by FDA to provide advice regarding a matter.

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(6) An advisory committee that is utilized by FDA is subject to this subpart even though it was not established by FDA. In general, a committee is "utilized" when FDA requests advice or recommendations from the committee on a specific matter in order to obtain an independent review and consideration of the matter, and not when FDA is merely seeking the comments of all interested persons or of persons who have a specific interest in the matter.

(i) A committee formed by an independent scientific or technical organization is utilized if FDA requests advice of that committee rather than of the parent organization, or if the circumstances show that the advice given is that of the committee and not of the parent organization. A committee formed by an independent scientific or technical organization is not utilized if FDA requests advice of the organization rather than of a committee and if the recommendations of any committee formed in response to the request are subject to substantial independent policy and factual review by the governing body of the parent organization.

(ii) A committee is not utilized by FDA if it provides only information, as contrasted with advice or opinions or recommendations.

(iii) FDA is charged with seeking out the views of all segments of the public on enforcement of the laws administered by the Commissioner. The fact that a group of individuals or a committee meets regularly with FDA, for example, a monthly meeting with consumer representatives, does not make that group or committee an advisory committee. Thus, this subpart does not apply to routine meetings, discussions, and other dealings, including exchanges of views, between FDA and any committee representing or advocating the particular interests of consumers, industry, professional organizations, or others.

(7) The inclusion of one or two FDA consultants who are special Government employees on an internal FDA committee does not make that committee an advisory committee.

(8) A Public Board of Inquiry established under Part 13, or other similar

group convened by agreement between the parties to a regulatory proceeding pending before FDA to review and prepare an initial decision on the issues in lieu of a formal evidentiary public hearing, is acting as an administrative law tribunal and is not an advisory committee.

(9) An open public conference or meeting conducted under § 10.65(b) is not an advisory committee meeting.

(10) An FDA committee that primarily has operational responsibility rather than that of providing advice and recommendations is not an advisory committee, for example, the Research Involving Human Subjects Committee (RIHSC).

(c) This part applies only when a committee convenes to conduct committee business. Site visits, social gatherings, informal discussions by telephone or during meals or while traveling or at other professional functions, or other similar activities do not constitute a meeting.

(d) An advisory committee that is utilized but not established by FDA is subject to this part only to the extent of such utilization, and not concerning any other activities of such committee.

(e) Any conference or meeting between an employee of FDA and a committee or group which is not an advisory committee shall be subject to § 10.65 or other provisions specifically applicable to the committee or group, for example, Part 13 for a Public Board of Inquiry.

(f) This part applies to all FDA advisory committees, except to the extent that specific statutes require otherwise for a particular committee, for example, TEPRSSC, the Board of Tea Experts, and advisory committees established under the Medical Device Amendments of 1976.

§ 14.5 Purpose of proceedings before an advisory committee.

(a) An advisory committee is utilized to conduct public hearings on matters of importance that come before FDA, to review the issues involved, and to provide advice and recommendations to the Commissioner.

(b) The Commissioner has sole discretion concerning action to be taken

and policy to be expressed on any matter considered by an advisory committee.

§ 14.7 Administrative remedies.

A person who alleges noncompliance by the Commissioner or an advisory committee with any provision of this part or the Federal Advisory Committee Act may pursue the following administrative remedies:

(a) If the person objects to any action, including a failure to act, other than denial of access to an advisory committee document, the person shall submit a petition in the form and in accordance with the requirements of § 10.30. The provisions of § 10.45 relating to exhaustion of administrative remedies are applicable.

(1) If the person objects to past action, the person shall submit the petition within 30 days after the action objected to. If the Commissioner determines that there was noncompliance with any provision of this subpart or of the Federal Advisory Committee Act, the Commissioner will grant any appropriate relief and take appropriate steps to prevent its future recurrence.

(2) If the person objects to proposed future action, the Commissioner will expedite the review of the petition and make a reasonable effort to render a decision before the action concerned in the petition.

(3) If the person objects to action that is imminent or occurring and which could not reasonably have been anticipated, e.g., the closing of a portion of a meeting which is made known for the first time on the day of the meeting, the matter may be handled by an oral petition in lieu of a written petition.

(b) If the person objects to a denial of access to an advisory committee document, administrative review is in accordance with the procedures established by the Department of Health and Human Services under 45 CFR 5.82.

§ 14.10 Applicability to Congress.

This part applies to Congress, individual Members of Congress, and other employees or representatives of Congress in the same way that they

apply to any other member of the public, except that disclosure of advisory committee records to Congress is governed by § 20.87.

§ 14.15 Committees working under a contract with FDA.

(a) FDA may enter into contracts with independent scientific or technical organizations to obtain advice and recommendations on particular matters, and these organizations may in turn undertake such work through existing or new committees. Whether a particular committee working under such a contract is an advisory committee subject to the Federal Advisory Committee Act and this subpart depends upon application of the criteria and principles in § 14.1(b).

(b) The following minimum standards apply to any committee of an independent scientific or technical organization which is working under a contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory committee:

(1) The committee shall give public notice of its meetings and agenda, and provide interested persons an opportunity to submit relevant information and views in writing at any time, and orally at specified times. The notice may be published in the FEDERAL REGISTER or disseminated by other reasonable means. It is in any event to be filed with the Dockets Management Branch not less than 15 days before the meeting. The time for oral presentations and the extent to which the committee meets in open session other than for such oral presentations is in the discretion of the committee.

(2) Minutes of open sessions are to be maintained, with all written submissions attached which were made to the committee in open session. After approval, the minutes are to be forwarded to the Dockets Management Branch and placed on public display. The extent to which the committee maintains minutes of closed sessions is in the discretion of the committee.

(3) In selecting the members of the committee, the organization involved is to apply the principles relating to conflicts of interest that FDA uses in establishing a public advisory commit

tee. Those principles are set out or cross-referenced in this part and in Part 19. Upon request, FDA will assist or provide guidance to any organization in meeting this requirement.

Subpart B-Meeting Procedures

§ 14.20 Notice of hearing before an advisory committee.

(a) Before the first of each month, and at least 15 days in advance of a meeting, the Commissioner will publish a notice in the FEDERAL REGISTER of all advisory committee meetings to be held during the month. Any advisory committee meetings for that month called after the publication of the general monthly notice are to be announced in the FEDERAL REGISTER On an individual basis at least 15 days in advance. The Commissioner may authorize an exception to these notice requirements in an emergency or for other reasons requiring an immediate meeting of an advisory committee, in which case public notice will be given at the earliest time and in the most accessible form feasible including, whenever possible, publication in the FEDERAL REGISTER.

(b) The FEDERAL REGISTER notice will include

(1) The name of the committee; (2) The date, time, and place of the meeting;

(3) The general function of the committee;

(4) A list of all agenda items, showing whether each will be discussed in an open or closed portion of the meeting;

(5) If any portion of the meeting is closed, a statement of the time of the open and closed portions;

(6) The nature of the subjects to be discussed during, and the reasons for closing, any closed portion of the meeting;

(7) The time set aside for oral statements and other public participation;

(8) The name, address, and telephone number of the advisory committee executive secretary and any other agency employee designated as responsible for the administrative support for the advisory committee;

(9) A statement that written submissions may be made to the advisory

committee through the executive secretary at any time, unless a cutoff date has been established under § 14.35(c)(2);

(10) When a notice is published in the FEDERAL REGISTER less than 15 days before a meeting, an explanation for the lateness of the notice; and

(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.

(d) A list of advisory committee meetings will be distributed to the press by the Associate Commissioner for Public Affairs.

(e) All advisory committee meetings are to be included on the public calendar described in § 10.100(a).

[44 FR 22351, Apr. 13, 1979, as amended at 47 FR 26375, June 1, 1982]

§ 14.22 Meetings of an advisory committee.

(a) No advisory committee may conduct a meeting except at the call or with the advance approval of, and with an agenda approved by, the designated Federal employee or alternate. No meeting may be held in the absence of the designated Federal employee.

(1) If any matter is added to the agenda after its publication in the FEDERAL REGISTER under § 14.5(b)(4), an attempt is to be made to inform persons known to be interested in the matter, and the change is to be announced at the beginning of the open portion of the meeting.

(2) The advisory committee meeting is to be conducted in accordance with the approved final agenda insofar as practical.

(b) Advisory committee meetings will be held at places that are reasonably accessible to the public. All advisory committee meetings will be held in Washington, DC, or Rockville, MD,