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or that the Board consists of a larger number of members.

(e) The members of a Board serve as consultants to the Commissioner and are special Government employees or Government employees. A Board functions as an administrative law tribunal in the proceeding and is not an advisory committee subject to the requirements of the Federal Advisory Committee Act or part 14.

(f) The Chairman of the Board has the authority of a presiding officer set out in $12.70.

[44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985)


Dockets Management Branch shall submit them to all persons entitled to submit a list of nominees.

(3) The lists of nominees and comments on them are to be held in confidence by the Dockets Management Branch as part of the administrative record of the proceeding and are not to be made available for public disclosure, and all persons who submit or receive them shall similarly hold them in confidence. This portion of the administrative record remains confidential but is available for judicial review in the event that it becomes relevant to any issue before a court.

(c) After reviewing the lists of nominees and any comments, the Commissioner will choose three qualified persons as members of a Board. One member will be from the lists of nominees submitted by the director of the center and by any person whose petition was granted and is the subject of the hearing. The second will be from the lists of nominees submitted by the other parties. The Commissioner may choose the third member from any source. That member is the Chairman of the Board.

(1) If the Commissioner is unable to find a qualified person with no conflict of interest from among a list of nominees or if additional information is needed, the Commissioner will request the submission of the required additional nominees or information.

(2) If a person fails to submit a list of nominees as required by paragraph (b) of this section, the Commissioner may choose a qualified member without further consultation with that person.

(3) The Commissioner will announce the members of a Board by filing a memorandum in the record of the proceeding and sending a copy to all participants.

(d) Instead of using the selection method in paragraphs (b) and (c) of this section, the director of the center, the other parties to the proceeding, and any person whose petition was granted and is the subject of the hearing, may, with the approval of the Commissioner, agree that a standing advisory committee listed in $14.80 constitutes the Board for a particular proceeding, or that another procedure is to be used for selection of the members of the Board,

§ 13.15 Separation of functions;

parte communications; administrative support. (a) The proceeding of a Board are subject to the provisions of $ 10.55 relating to separation of functions and ex parte communications. Representatives of the participants in any proceeding before a Board, including any members of the office of the Chief Counsel of FDA assigned to advise the center responsible for the matter, may have no contact with the members of the Board, except as participants in the proceeding, and may not participate in the deliberations of the Board.

(b) Administrative support for Board is to be provided only by the office of the Commissioner and the office of the Chief Counsel for FDA.


[44 FR 22348, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989)

Subpart B—Hearing Procedures

$ 13.20 Submissions to a Board.

(a) Submissions are to be filed with the Dockets Management Branch under § 10.20.

(b) The person making a submission shall serve copies of it on each participant in the proceeding, except as provided in $f 13.10(b)(2) and 13.45. Submissions of documentary data and information need not be sent to each participant, but any accompanying transmittal letter, summary, statement of position, certification under paragraph (d) of this section, or similar document must be.

(c) A submission must be mailed to the address shown in the notice of appearance or personally delivered.

(d) All submissions are to be accompanied by a certificate of service, or a statement that service is not required.

(e) No written submission or other portion of the administrative record may be held in confidence, except as provided in 88 13.10(b)(2) and 13.45.

(f) A participant who believes that compliance with the requirements of this section constitutes an unreasonable financial burden may submit to the Commissioner a petition to participate in forma pauperis in the form and manner specified in $ 12.82.

$ 13.25 Disclosure of data and informa

tion by the participants. (a) Before the notice of hearing is published under $13.5, the director of the center responsible for the matters involved in the hearing must submit to the Dockets Management Branch

(1) The relevant portions of the existing administrative record of the proceeding. Portions of the administrative record not relevant to the issues in the hearing are not part of the administrative record;

(2) A list of all persons whose views will be presented orally or in writing at the hearing;

(3) All documents in the director's files containing factual information, whether favorable or unfavorable to the director's position, which relate to the issues involved in the hearing Files means the principal files in the center in which documents relating to the issues in the hearing are ordinarily kept, e.g., the food additive master file and the food additive petition in the case of issues concerning a food additive, or the new drug application in the case of issues concerning a new drug. Internal memoranda reflecting the deliberative process, and attorney work product and material prepared specifically for use in connection with the hearing, are not required to be submitted;

(4) All other documentary information relied on; and

(5) A signed statement that, to the best of the director's knowledge and belief, the submission complies with this section.

(b) Within the time prescribed in the notice of hearing published under $13.5, each participant shall submit to the Dockets Management Branch all information specified in paragraph (a)(2) through (5) of this section and any objections that the administrative record filed under paragraph (a)(1) of this section is incomplete. With respect to the information specified in paragraph (a)(3) of this section, participants are to exercise reasonable diligence in identifying documents in files comparable to those described in that paragraph.

(c) The submissions required by paragraphs (a) and (b) of this section may be supplemented later in the proceeding, with the approval of the Board, on a showing that the views of the persons or the material contained in the supplement was not known or reasonably available when the initial submission was made or that the relevance of the views of the persons or the material contained in the supplement could not reasonably have been foreseen.

(d) The failure to comply substantially and in good faith with this section in the case of a participant constitutes a waiver of the right to participate further in the hearing and in the case of a party constitutes a waiver of the right to a hearing.

(e) The Chairman rules on questions relating to this section. Any participant dissatisfied with a ruling may petition the Commissioner for interlocutory review. [44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989)

§ 13.30 Proceedings of a Board.

(a) The purpose of a Board is to review medical, scientific, and technical issues fairly and expeditiously. The proceedings of a Board are conducted as a scientific inquiry rather than a legal trial.

(b) A Board may not hold its first hearing until after all participants have submitted the information required by 13.25.

(c) The Chairman calls the first hearing of the Board. Notice of the time and location of the first hearing is to be published at least 15 days in advance and the hearing will be open to the public. All participants will have an opportunity at the first hearing to make an oral presentation of the information and views which in their opinion are pertinent to the resolution of the issues being considered by a Board. A participant's presentation may be made by more than one person. The Chairman determines the order of the presentation. Participants may not interrupt a presentation, but members of the Board may ask questions. At the conclusion of a presentation, each of the other participants may briefly comment on the presentation and may request that the Board conduct further questioning on specified matters. Members of the Board may then ask further questions. Any other participant may be permitted to ask questions if the Chairman determines that it will help resolve the issues.

(d) The hearing is informal and the rules of evidence do not apply. No motions or objections relating to the admissibility of information and views may be made or considered, but other participants may comment upon or rebut all such information and views. No participant may interrupt the presentation of another participant for any reason.

(e) Within the time specified by the Board after its first hearing, participants may submit written rebuttal information and views in accordance with $13.20. The Chariman will then schedule a second hearing, if requested and justified by a participant. A second hearing, and any subsequent hearing, will be called only if the Chairman concludes that it is needed to fully and fairly present information that cannot otherwise adequately be considered and to properly resolve the issues. Notice of the time and location of any hearing is to be published at least 15 days in advance. The hearing is open to the public.

(f) A Board may consult with any person who it concludes may have information or views relevant to the issues.

(1) The consultation may occur only at an announced hearing of a Board. Participants have the right to suggest or, with the permission of the Chairman, ask questions of the consultant and present rebuttal information and

views, as provided in paragraphs (c) and (d) of this section except that written statements may be submitted to the Board with the consent of all participants.

(2) A participant may submit a request that the Board consult with a specific person who may have information or views relevant to the issues. The request will state why the person should be consulted and why the person's views cannot be furnished to the Board by means other than having FDA arrange for the person's appearance. The Board may, in its discretion, grant or deny the request.

(g) All hearings are to be transcribed. All hearings are open to the public, except that a hearing under $10.20()(3) is closed to all persons except those persons making and participating in the presentation and Federal Government executive branch employees and special Government employees. At least a majority of Board members are to be present at every hearing. The executive sessions of a Board, during which a Board deliberates on the issues, are to be closed and are not transcribed. All members of the Board shall vote on the report of the Board.

(h) All legal questions are to be referred to the Chief counsel for FDA for resolution. The Chief Counsel's advice on any matter of procedure or legal authority is to be transmitted in writing and made a part of the record or presented in open session and transcribed.

(i) At the conclusion of all public hearings the Board will announce that the record is closed to receiving information. The Board will provide an opportunity for participants to submit written statements of their positions, with proposed findings and conclusions, and may in its discretion, provide an opportunity for participants to summarize their positions orally.

(j) The Board will prepare a decision on all issues. The decision is to include specific findings and references supporting and explaining the Board's conclusions, and a detailed statement of the reasoning on which the conclusions are based. Any member of the Board may file a separate report stating additional or dissenting views.

Subpart C-Records of a Hearing

Before a Board



Subpart A-General Provisions.

Sec. 14.1 Scope. 14.5 Purpose of proceedings before an advi

sory committee. 14.7 Administrative remedies. 14.10 Applicability to Congress. 14.15 Committees working under a contract

with FDA.

$ 13.40 Administrative record of

Board. (a) The administrative record of a hearing before a Board consists of the following:

(1) All relevant FEDERAL REGISTER notices.

(2) All written submissions under § 13.20.

(3) The transcripts of all hearings of the Board.

(4) The initial decision of the Board.

(b) The record of the administrative proceeding is closed

(1) Relevant to receiving information and data, at the time specified in § 13.30(i); and

(2) Relevant to pleadings, at the time specified in $13.30(i) for filing a written statement of position with proposed findings and conclusions.

(c) The Board may, in its discretion, reopen the record to receive further evidence at any time before filing an initial decision.

Subpart B-Meeting Procedures 14.20 Notice of hearing before an advisory

committee. 14.22 Meetings of an advisory committee. 14.25 Portions of advisory committee meet

ings. 14.27 Determination to close portions of ad

visory committee meetings. 14.29 Conduct of a hearing before an advi

sory committee. 14.30 Chairman of an advisory committee. 14.31 Consultation by an advisory com

mittee with other persons. 14.33 Compilation of materials for members

of an advisory committee. 14.35 Written submissions to an advisory

committee. 14.39 Additional rules for a particular advi

sory committee.

Subpart C-Establishment of Advisory


14.40 Establishment and renewal of advisory

committees. 14.55 Termination of advisory committees.


§ 13.45 Examination of administrative

record. (a) The availability for public examination and copying of each document which is a part of the administrative record of the hearing is governed by § 10.20(j). Each document available for public examination copying is placed on public display in the office of the Dockets Management Branch promptly upon receipt in that office.

(b) Lists of nominees and comments submitted on them under $13.10(b)(3) are not subject to disclosure unless they become an issue in a court proceeding.

Subpart D-Records of Meetings and

Hearings Before Advisory Committees 14.60 Minutes and reports of advisory com

mittee meetings. 14.61 Transcripts of advisory Committee

meetings. 14.65 Public inquiries and requests for advi

sory committee records. 14.70 Administrative record of a public

hearing before an advisory committee. 14.75 Examination of administrative record

and other advisory committee records.

Subpart E–Members of Advisory


$ 13.50 Record for administrative deci.

sion. The administrative record of the hearing specified in $13.40(a) constitutes the exclusive record for decision.

14.80 Qualifications for members of standing

policy and technical advisory commit

tees. 14.82 Nominations of voting members of

standing advisory committees. 14.84 Nominations and selection of non

voting members of standing technical advisory committees.

14.86 Rights and responsibilities of non

voting members of advisory committees. 14.90 Ad hoc advisory committee members. 14.95 Compensation of advisory committee


Subpart F-Standing Advisory Committees

14.100 List of standing advisory committees.

Subpart G-Technical Electronic Products

Radiation Safety Standards Committee 14.120 Establishment of the Technical Elec

tronic Product Radiation Safety Stand

ards Committee (TEPRSSC). 14.122 Functions of TEPRSSC. 14.125 Procedures of TEPRSSC. 14.127 Membership of TEPRSSC. 14.130 Conduct of TEPRSSC meetings;

availability of TEPRSSC records.

Subpart H-Color Additive Advisory


14.140 Establishment of a color additive ad

visory committee. 14.142 Functions of a color additive advisory

committee. 14.145 Procedures of a color additive advi

sory committee. 14.147 Membership of a color additive advi

sory committee. 14.155 Fees and compensation pertaining to

a color additive advisory committee.

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(f) 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.

(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

listed in $14.100.

Subpart I-Advisory Committees for

Human Prescription Drugs 14.160 Establishment of standing technical

advisory committees for human prescrip

tion 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 writ

ing. AUTHORITY: 5 U.S.C. App. 2; 15 U.S.C. 14511461; 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264.

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


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