Public hearing before a public advisory committee (21 CFR 14.1-14.174)

196 21 CFR Ch. I (4–1–16 Edition) § 13.40 (h) All legal questions are to be re ferred to the Chief counsel for FDA for resolution. The Chief Counsel’s advice on any matter of procedure or legal au thority is to be transmitted in writing and made a part of the record or pre sented in open session and transcribed. (i) At the conclusion of all public hearings the Board will announce that the record is closed to receiving infor mation. The Board will provide an op portunity 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 summa rize their positions orally. (j) The Board will prepare a decision on all issues. The decision is to include specific findings and references sup porting and explaining the Board’s con clusions, and a detailed statement of the reasoning on which the conclusions are based. Any member of the Board may file a separate report stating addi tional or dissenting views. Subpart C—Records of a Hearing Before a Board § 13.40 Administrative record of a 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. § 13.45 Examination of administrative record. (a) The availability for public exam ination 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 or copying is placed on public display in the office of the Division of Dockets Management 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 pro ceeding. § 13.50 Record for administrative deci sion. The administrative record of the hearing specified in § 13.40(a) con stitutes the exclusive record for deci sion. PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE 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. 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 Chairperson 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. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00206 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 197 Food and Drug Administration, HHS § 14.1 Subpart C—Establishment of Advisory Committees 14.40 Establishment and renewal of advisory committees. 14.55 Termination of advisory committees. 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 Committees 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 ad visory 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 members. 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 Committees 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. 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. 1451– 1461, 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; Pub. L. 107–109; Pub. L. 108–155; Pub. L. 113–54. SOURCE: 44 FR 22351, Apr. 13, 1979, unless otherwise noted. Subpart A—General Provisions § 14.1 Scope. (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 com mittee) to hold a public hearing and to review and make recommendations on any matter before FDA and for inter ested persons to present information and views at an oral public hearing be fore the advisory committee. (2) Under specific provisions in the FD&C Act or other sections of this chapter, a matter is subject to a hear ing before an advisory committee. The specific provisions are— (i) Section 14.120 on review of a per formance 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 pre scription drugs; (iv) Section 330.10 on review of the safety and effectiveness of over-the counter drugs; (v) Section 601.25 on review of the safety and effectiveness of biological drugs; (vi) Part 860, on classification of de vices; VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00207 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 198 21 CFR Ch. I (4–1–16 Edition) § 14.1 (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 op portunity for a formal evidentiary pub lic 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 re quest. (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 tech nical advisory committee. A policy ad visory committee advises on broad and general matters. A technical advisory committee advises on specific tech nical or scientific issues, which may re late 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 sub group will be established as an advi sory committee separate from the par ent committee. (4) A committee composed entirely of full-time Federal Government employ ees is not an advisory committee. (5) An advisory committee ordinarily has a fixed membership, a defined pur pose of providing advice to the agency on a particular subject, regular or peri odic meetings, and an organizational structure, for example, a Chairperson and staff, and serves as a source of independent expertise and advice rath er than as a representative of or advo cate for any particular interest. The following groups are not advisory com mittees: (i) A group of persons convened on an ad hoc basis to discuss a matter of cur rent interest to FDA, but which has no continuing function or organization and does not involve substantial spe cial preparation. (ii) A group of two or more FDA con sultants meeting with the agency on an ad hoc basis. (iii) A group of experts who are em ployed by a private company or a trade association which has been requested by FDA to provide its views on a regu latory matter pending before FDA. (iv) A consulting firm hired by FDA to provide advice regarding a matter. (6) An advisory committee that is utilized by FDA is subject to this sub part even though it was not established by FDA. In general, a committee is uti lized when FDA requests advice or rec ommendations 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 in terested persons or of persons who have a specific interest in the matter. (i) A committee formed by an inde pendent scientific or technical organi zation is utilized if FDA requests ad vice of that committee rather than of the parent organization, or if the cir cumstances 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 organiza tion rather than of a committee and if the recommendations of any com mittee formed in response to the re quest are subject to substantial inde pendent policy and factual review by the governing body of the parent orga nization. (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 adminis tered by the Commissioner. The fact that a group of individuals or a com mittee meets regularly with FDA, for VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00208 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 199 Food and Drug Administration, HHS § 14.7 example, a monthly meeting with con sumer 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 ex changes of views, between FDA and any committee representing or advo cating the particular interests of con sumers, industry, professional organi zations, or others. (7) The inclusion of one or two FDA consultants who are special Govern ment employees on an internal FDA committee does not make that com mittee an advisory committee. (8) A Public Board of Inquiry estab lished under part 13, or other similar group convened by agreement between the parties to a regulatory proceeding pending before FDA to review and pre pare 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 pri marily has operational responsibility rather than that of providing advice and recommendations is not an advi sory committee, for example, the Re search Involving Human Subjects Com mittee (RIHSC). (c) This part applies only when a committee convenes to conduct com mittee business. Site visits, social gatherings, informal discussions by telephone or during meals or while traveling or at other professional func tions, 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 be tween an employee of FDA and a com mittee or group which is not an advi sory 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 advi sory committees, except to the extent that specific statutes require otherwise for a particular committee, for exam ple, TEPRSSC and advisory commit tees established under the Medical De vice Amendments of 1976. [44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 78 FR 17087, Mar. 20, 2013] § 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 discre tion 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 Com mittee Act may pursue the following administrative remedies: (a) If the person objects to any ac tion, 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 rem edies are applicable. (1) If the person objects to past ac tion, the person shall submit the peti tion within 30 days after the action ob jected to. If the Commissioner deter mines that there was noncompliance with any provision of this subpart or of the Federal Advisory Committee Act, the Commissioner will grant any ap propriate 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 por tion of a meeting which is made known VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00209 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 200 21 CFR Ch. I (4–1–16 Edition) § 14.10 for the first time on the day of the meeting, the matter may be handled by an oral petition in lieu of a written pe tition. (b) If the person objects to a denial of access to an advisory committee docu ment, administrative review is in ac cordance with the procedures estab lished by the Department of Health and Human Services under 45 CFR 5.34. [44 FR 22351, Apr. 13, 1979, as amended at 55 FR 1404, Jan. 16, 1990] § 14.10 Applicability to Congress. This part applies to Congress, indi vidual Members of Congress, and other employees or representatives of Con gress in the same way that they apply to any other member of the public, ex cept that disclosure of advisory com mittee 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 tech nical 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 com mittee subject to the Federal Advisory Committee Act and this subpart de pends upon application of the criteria and principles in § 14.1(b). (b) The following minimum standards apply to any committee of an inde pendent scientific or technical organi zation which is working under a con tract 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 oppor tunity to submit relevant information and views in writing at any time, and orally at specified times. The notice may be published in the FEDERAL REG ISTER or disseminated by other reason able means. It is in any event to be filed with the Division of Dockets Man agement not less than 15 days before the meeting. The time for oral presen tations 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 submis sions attached which were made to the committee in open session. After ap proval, the minutes are to be forwarded to the Division of Dockets Manage ment and placed on public display. The extent to which the committee main tains 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 com mittee. 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 organiza tion in meeting this requirement. Subpart B—Meeting Procedures § 14.20 Notice of hearing before an ad visory committee. (a) Before the first of each month, and at least 15 days in advance of a meeting, the Commissioner will pub lish a notice in the FEDERAL REGISTER of all advisory committee meetings to be held during the month. Any advi sory 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 au thorize an exception to these notice re quirements 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 ac cessible form feasible including, when ever possible, publication in the FED ERAL 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 com mittee; (4) A list of all agenda items, showing whether each will be discussed in an open or closed portion of the meeting; VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00210 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 201 Food and Drug Administration, HHS § 14.22 (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 meet ing; (7) The time set aside for oral state ments and other public participation; (8) The name, address, and telephone number of the advisory committee Des ignated Federal Officer and any other agency employee designated as respon sible for the administrative support for the advisory committee; (9) A statement that written submis sions may be made to the advisory committee through the Designated Federal Officer at any time, unless a cutoff date has been established under § 14.35(d)(2); (10) When a notice is published in the FEDERAL REGISTER less than 15 days be fore a meeting, an explanation for the lateness of the notice; and (c) If a public hearing before an advi sory committee is used in lieu of a for mal 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. [44 FR 22351, Apr. 13, 1979, as amended at 47 FR 26375, June 1, 1982; 54 FR 9035, Mar. 3, 1989; 66 FR 6469, Jan. 22, 2001; 66 FR 12850, Mar. 1, 2001] § 14.22 Meetings of an advisory com mittee. (a) No advisory committee may con duct 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 FED ERAL REGISTER under § 14.20(b)(4), an at tempt 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 reason ably accessible to the public. All advi sory committee meetings will be held in Washington, DC, or Rockville, MD, or the immediate vicinity, unless the Commissioner receives and approves a written request from the advisory com mittee for a different location. A dif ferent location may be approved when one or more of the following applies: (1) The total cost of the meeting to the Government will be reduced. (2) A substantial number of the com mittee members will be at the location at no expense to FDA for other reasons, e.g., for a meeting of a professional as sociation. (3) It is a central location more read ily accessible to committee members. (4) There is a need for increased par ticipation available at that location. (5) The committee wishes to review work or facilities in a specific location. (6) The committee is concerned with matters that functionally or histori cally occur in some other location, e.g., the Science Advisory Board of the Na tional Center for Toxicological Re search will generally hold meetings in the Little Rock, AR, vicinity. (c) Advisory committee members may, with the approval of FDA, con duct onsite visits relevant to their work. (d) Unless the committee charter pro vides otherwise, a quorum for an advi sory committee is a majority of the current voting members of the com mittee, except as provided in § 14.125(c) for TEPRSSC. Any matter before the advisory committee is to be decided by a majority vote of the voting members present at the time, except that the designated Federal official may require that any final report be voted upon by all current voting members of the com mittee. Any current voting member of the committee may file a separate re port with additional or minority views. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00211 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 202 21 CFR Ch. I (4–1–16 Edition) § 14.25 (e) If space is available, any inter ested person may attend any portion of any advisory committee meeting which is not closed. (f) Whenever feasible, meetings are to be held in government facilities or other facilities involving the least ex pense to the public. The size of the meeting room is to be reasonable, con sidering such factors as the size of the committee, the number of persons ex pected to attend a meeting, and the re sources and facilities available. (g) The Commissioner may authorize a meeting to be held by conference telephone call. For these meetings, a speaker phone will be provided in a conference room located in Wash ington, DC, or Rockville, MD, or the immediate vicinity, to permit public participation in open portions of the meetings, as provided in §§ 14.25 and 14.29. These meetings generally will be brief, and authorized— (1) For the purpose of taking final votes or otherwise confirming actions taken by the committee at other meet ings; or (2) Where time does not permit a meeting to be held at a central loca tion. (h) Any portion of a meeting will be closed by the committee Chairperson only when matters are to be discussed which the Commissioner has deter mined may be considered in closed ses sion under § 14.27(b). If a portion of the meeting is closed, the closed portion will be held after the conclusion of the open portion whenever practicable. (i) Any committee member may take notes during meetings and report and discuss committee deliberations after a meeting is completed and before offi cial minutes or a report are available, within the rules and regulations adopt ed by FDA and by the advisory com mittee with the concurrence of FDA, including all of the following: (1) There may be no attribution of in dividual views expressed in a closed session or revealing of numerical votes. (2) There may be no reporting or dis cussion of any particular matter if the committee or FDA specifically so di rects, e.g., where deliberations are in complete or involve a sensitive regu latory decision that requires prepara tion or implementation. (3) There may be no reporting or dis cussion of information prohibited from public disclosure under § 14.75. (4) Notes or minutes kept or reports prepared by a committee member have no status or effect unless adopted into the official minutes or report by the committee. [44 FR 22351, Apr. 13, 1979; 48 FR 40887, Sept. 12, 1983, as amended at 54 FR 9035, Mar. 3, 1989; 78 FR 17087, Mar. 20, 2013] § 14.25 Portions of advisory committee meetings. An advisory committee meeting has the following portions: (a) The open public hearing. Every committee meeting includes an open portion, which constitutes a public hearing during which interested per sons may present relevant information or views orally or in writing. The hear ing is conducted in accordance with § 14.29. (b) The open committee discussion. A committee discusses any matter pend ing before it in an open portion of its meeting unless the meeting has been closed for that matter under § 14.27. To the maximum extent feasible, con sistent with the policy expressed in § 14.27, a committee conducts its discus sion of pending matters in an open por tion. No public participation is permis sible during this portion of the meeting except with the consent of the com mittee Chairperson. (c) The closed presentation of data. In formation prohibited from public dis closure under part 20 and the regula tions referenced therein is presented to the committee in a closed portion of its meeting. However, if information is in the form of a summary that is not pro hibited from public disclosure, the presentation is to be made in an open portion of a meeting. (d) The closed committee deliberations. Deliberations about matters before an advisory committee may be held in a closed portion of a meeting only upon an appropriate determination by the Commissioner under § 14.27. § 14.27 Determination to close portions of advisory committee meetings. (a) No committee meeting may be en tirely closed. A portion of a meeting may be closed only in accordance with VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00212 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 203 Food and Drug Administration, HHS § 14.27 a written determination by the Com missioner under this section. (b) The Designated Federal Officer or other designated agency employee shall prepare the initial request for a determination to close a portion of a meeting, specifying the matter(s) to be discussed during the closed portion and the reasons why the portion should be closed. The Commissioner, based upon this request and with the concurrence of the Chief Counsel, will determine whether to close a portion of a meet ing. The reasons for closing a portion of a meeting will be announced in the FEDERAL REGISTER notice of the meet ing under § 14.20 in accordance with the following rules: (1) Any determination to close a por tion of a meeting restricts the closing to the shortest possible time consistent with the policy in this section. (2) A portion of a meeting may be closed only if the Commissioner deter mines that the closing is permitted under 5 U.S.C. 552b(c), and that the closing is necessary. (3) Portions of meetings may ordi narily be closed if they concern the re view, discussion, and evaluation of drafts or regulations, guidance docu ments or similar preexisting internal agency documents, but only if their premature disclosure would signifi cantly impede proposed agency action; review of trade secrets and confidential commercial or financial information; consideration of matters involving in vestigatory files compiled for law en forcement purposes; and review of mat ters, the disclosure of which would con stitute a clearly unwarranted invasion of personal privacy. (4) Portions of meetings ordinarily may not be closed if they concern re view, discussion, and evaluation of gen eral preclinical and clinical test proto cols and procedures for a class of drugs or devices; consideration of labeling re quirements for a class of marketed drugs and devices; review of informa tion on specific investigational or mar keted drugs and devices that have pre viously been made public; presentation of any other information not exempt from public disclosure under 5 U.S.C. 552b(c); the formulation of advice and recommendations to FDA on matters that do not independently justify clos ing. (5) No portion of a meeting devoted to matters other than those designated in paragraph (b) (1) through (3) of this section may be closed. (6) A matter which is properly con sidered in an open portion of a meeting may instead be considered in a closed portion only if it is so inextricably intertwined with matters to be dis cussed in a closed portion that it is not feasible to separate them or discussion of the matter in an open portion would compromise the matters to be dis cussed in the closed portion. (c) Attendance at a closed portion of a meeting is governed by the following rules: (1) A portion of a meeting closed for the presentation or discussion of infor mation that constitutes a trade secret or confidential commercial or financial information as defined in § 20.61 may be attended only by voting advisory com mittee members, nonvoting members representing consumer interests who are also special government employees as provided in § 14.80(b), the Designated Federal Officer of the advisory com mittee, a transcriber, consultants, and such other regular employees of FDA (including members of the Office of the Chief Counsel) as the Chairperson of the advisory committee may invite, and by those persons authorized to be present under § 14.25(c), for presen tation of information prohibited from public disclosure. A person making a presentation described in § 14.25(c) may be accompanied by a reasonable num ber of employees, consultants, or other persons in a commercial arrangement within the meaning of § 20.81(a). (2) A portion of a meeting that has been closed for consideration of exist ing internal agency documents falling within § 20.62 where premature disclo sure is likely to significantly impede proposed agency action; personnel, medical, and similar files, disclosure of which would be a clearly unwarranted invasion of personal privacy within the meaning of § 20.63; or investigatory records compiled for law enforcement purposes as defined in § 20.64 may be at tended only by committee members (voting and nonvoting), the Designated Federal Officer of the committee, a VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00213 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 204 21 CFR Ch. I (4–1–16 Edition) § 14.29 transcriber, and other regular employ ees of FDA (including members of the Office of the Chief Counsel) whom the Chairperson of the committee may in vite. Consultants, individuals per forming personal service contracts, employees of other Federal agencies, and the general public may not attend such portions. (3) If a person other than a person permitted to attend in accordance with paragraph (c) (1) and (2) of this section attempts to attend a closed portion of a meeting without the approval of the Designated Federal Officer and the Chairperson, and the matter is brought to their attention, the person will be required to leave the meeting imme diately. This inadvertent and unau thorized attendance does not enable other unauthorized persons to attend, nor does it, of itself, constitute grounds for release of transcripts of closed portions or any other documents otherwise exempt from disclosure under § 14.75 and part 20. (4) If a person other than a person permitted to attend in accordance with paragraphs (c) (1) and (2) of this section is allowed by the Designated Federal Officer and the Chairperson to attend a closed portion of a meeting, that por tion is open to attendance by any in terested person. [44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000] § 14.29 Conduct of a hearing before an advisory committee. (a) For each meeting, the open por tion for public participation, which constitutes a public hearing under § 14.25(a), will be at least 1 hour, unless public participation does not last that long, and may last for whatever longer time the committee Chairperson deter mines will facilitate the work of the committee. The FEDERAL REGISTER no tice published under § 14.20 will des ignate the time specifically reserved for the hearing, which is ordinarily the first portion of the meeting. Further public participation in any open por tion of the meeting under § 14.25(b) is solely at the discretion of the Chair person. (b) An interested person who wishes to be assured of the right to make an oral presentation at a meeting shall in form the Designated Federal Officer or other designated agency employee, orally or in writing, before the meet ing. (1) The person shall state the general nature of the presentation and the ap proximate time desired. Whenever pos sible, all written information to be dis cussed by that person at the meeting should be furnished in advance to the Designated Federal Officer or other designated agency employee. This ma terial may be distributed or mailed by FDA to the committee members in ad vance of the meeting if time permits, and otherwise will be distributed to the members when they arrive for the meeting. The mailing or distribution may be undertaken only by FDA unless FDA grants permission to a person to mail or distribute the material (2) Before the meeting, the Des ignated Federal Officer or other des ignated agency employee shall deter mine the amount of time allocated to each person for oral presentation and the time that the presentation is to begin. Each person will be so informed in writing, if time permits, or by tele phone. FDA may require persons with common interests to make joint pres entations. (c) The Chairperson of the committee shall preside at the meeting in accord ance with § 14.30 and be accompanied by other committee members, who serve as a panel in conducting the hearing portion of the meeting. (d) Each person may use the allotted time as desired, consistent with an or derly hearing. A person may be accom panied by additional persons, and may present any written information or views for inclusion in the record of the hearing, subject to the requirements of § 14.35(c). (e) If a person is absent at the time specified for that person’s presen tation, the persons following will ap pear in order. An attempt will be made to hear the person at the conclusion of the hearing. Interested persons attend ing the hearing who did not request an opportunity to make an oral presen tation may be given an opportunity to do so at the discretion of the Chair person. (f) The Chairperson and other mem bers may question a person concerning VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00214 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 205 Food and Drug Administration, HHS § 14.33 that person’s presentation. No other person, however, may question the per son. The Chairperson may allot addi tional time when it is in the public in terest, but may not reduce the time al lotted without consent of the person. (g) Participants may question a com mittee member only with that mem ber’s permission and only about mat ters before the committee. (h) The hearing is informal, and the rules of evidence do not apply. No mo tions or objections relating to the ad missibility of information and views may be made or considered, but other participants may comment upon or rebut matters presented. No partici pant may interrupt the presentation of another participant. § 14.30 Chairperson of an advisory committee. (a) The advisory committee Chair person has the authority to conduct hearings and meetings, including the authority to adjourn a hearing or meeting if the Chairperson determines that adjournment is in the public in terest, to discontinue discussion of a matter, to conclude the open portion of a meeting, or to take any other action to further a fair and expeditious hear ing or meeting. (b) If the Chairperson is not a full time employee of FDA, the Designated Federal Officer or other designated agency employee, or alternate, is to be the designated Federal employee who is assigned to the advisory committee. The designated Federal employee is also authorized to adjourn a hearing or meeting if the employee determines ad journment to be in the public interest. § 14.31 Consultation by an advisory committee with other persons. (a) A committee may confer with any person who may have information or views relevant to any matter pending before the committee. (b) An interested person may submit to the committee a written request that it confer with specific persons about any matter pending before the committee. The request is to contain adequate justification. The committee may, in its discretion, grant the re quest. (c) A committee may confer with a person who is not a Federal Govern ment executive branch employee only during the open portions of a meeting. The person may, however, submit views in writing to the committee as part of the administrative record under § 14.70. The person may participate at the closed portions of a meeting only if appointed as a special Government em ployee by the Commissioner as pro vided in paragraph (e) of this section. This paragraph (c) is not intended to bar the testimony of a person during a closed portion of a meeting about mat ters prohibited from public disclosure under §§ 14.25(c) and 14.27(c). (d) To prevent inadvertent violation of Federal conflict of interest laws and laws prohibiting disclosure of trade se crets (18 U.S.C. 208, 21 U.S.C. 331(j), 18 U.S.C. 1905), Federal executive branch employees who are not employees of the Department may not confer, tes tify, or otherwise participate (other than as observers) at any portion of an advisory committee meeting unless they are appointed as special Govern ment employees by the Commissioner under paragraph (e) of this section. this paragraph does not apply to Federal executive branch employees who are appointed as members of TEPRSSC, as provided in § 14.127. (e) The Commissioner may appoint persons as special Government employ ees to be consultants to an advisory committee. Consultants may be ap pointed to provide expertise, generally concerning a highly technical matter, not readily available from the mem bers of the committee. Consultants may be either from outside the Govern ment or from agencies other than the Food and Drug Administration. Re ports, data, information, and other written submissions made to a public advisory committee by a consultant are part of the administrative record itemized in § 14.70. [44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990] § 14.33 Compilation of materials for members of an advisory committee. The Commissioner shall prepare and provide to all committee members a compilation of materials bearing upon VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00215 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 206 21 CFR Ch. I (4–1–16 Edition) § 14.35 members’ duties and responsibilities, including— (a) All applicable conflict of interest laws and regulations and a summary of their principal provisions; (b) All applicable laws and regula tions relating to trade secrets and con fidential commercial or financial infor mation that may not be disclosed pub licly and a summary of their principal provisions; (c) All applicable laws, regulations, and guidance documents relating to the subject matter covered by the advi sory committee and a summary of their principal provisions; (d) All applicable laws, regulations, including the regulations in part 20 of this chapter, advisory committee char ters, FEDERAL REGISTER notices, cur ricula vitae, rules adopted by the advi sory committee, and other material re lating to the formation, composition, and operation of the advisory com mittee, and a summary of their prin cipal provisions; (e) Instructions on whom to contact when questions arise; and (f) Other material relating to FDA and the subject matter covered by the committee which may facilitate the work of the committee. [44 FR 22351, Apr. 13, 1979, as amended at 65 FR 56479, Sept. 19, 2000] § 14.35 Written submissions to an advi sory committee. (a) Ten copies of written submissions to a committee are to be sent to the Designated Federal Officer unless an applicable FEDERAL REGISTER notice or other regulations in this chapter speci fy otherwise. Submissions are subject to the provisions of § 10.20, except that it is not necessary to send copies to the Division of Dockets Management. (b) At the request of a committee, or on the Commissioner’s own initiative, the Commissioner may issue in the FEDERAL REGISTER a notice requesting the submission to the committee of written information and views perti nent to a matter being reviewed by the committee. The notice may specify the manner in which the submission should be made. (c) At the request of a committee, or on the Commissioner’s own initiative, the Commissioner may at any time re quest the applicant or sponsor of an ap plication or petition about a specific product on which action is pending be fore FDA, and is being reviewed by an advisory committee, to present or dis cuss safety, effectiveness, or other data concerning the product during a regu larly scheduled meeting of the com mittee. The request may be for an oral presentation or for a concise, well-or ganized written summary of pertinent information for review by the com mittee members before the meeting, or both. Unless specified otherwise, one copy of the written summary along with a proposed agenda outlining the topics to be covered and identifying the participating industry staff members or consultants that will present each topic is to be submitted to the Des ignated Federal Officer or other des ignated agency employee at least 3 weeks before the meeting. (d) An interested person may submit to a committee written information or views on any matter being reviewed. Voluminous data is to be accompanied by a summary. A submission is to be made to the Designated Federal Officer and not directly to a committee mem ber. (1) FDA will distribute submissions to each member, either by mail or at the next meeting. Submissions will be considered by the committee in its re view of the matter. (2) A committee may establish, and give public notice of, a cutoff date after which submissions about a mat ter will no longer be received or consid ered. (e) The Commissioner will provide the committee all information the Commissioner deems relevant. A mem ber will, upon request, also be provided any material available to FDA which the member believes appropriate for an independent judgment on the matter, e.g., raw data underlying a summary or report, or a briefing on the legal as pects of the matter. § 14.39 Additional rules for a par ticular advisory committee. (a) In addition to these rules, an ad visory committee may, with the con currence of the designated Federal em ployee, adopt additional rules which VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00216 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 207 Food and Drug Administration, HHS § 14.55 are not inconsistent with this subpart or with other legal requirements. (b) Any additional rules will be in cluded in the minutes of the meeting when adopted and in the materials compiled under § 14.33 and will be avail able for public disclosure under § 14.65(c). Subpart C—Establishment of Advisory Committees § 14.40 Establishment and renewal of advisory committees. (a) An advisory committee may be established or renewed whenever it is necessary or appropriate for the com mittee to hold a public hearing and to review and make recommendations on any matter pending before FDA. Ex cept for committees established by statute, before a committee is estab lished or renewed it must first be ap proved by the Department pursuant to 45 CFR part 11 and by the General Services Administration. (b) When an advisory committee is established or renewed, the Commis sioner will issue a FEDERAL REGISTER notice certifying that the establish ment or renewal is in the public inter est and stating the structure, function, and purposes of the committee and, if it is a standing advisory committee, shall amend § 14.100 to add it to the list of standing advisory committees. A no tice of establishment will be published at least 15 days before the filing of the advisory committee charter under paragraph (c) of this section. A notice of renewal does not require the 15-day notice. (c) No committee may meet or take action until its charter is prepared and filed as required by section 9(c) of the Federal Advisory Committee Act. This requirement is to be met by an advi sory committee utilized by FDA, even though it is not established by the agency, prior to utilization. (d) The regulations of the Depart ment cited in paragraph (a) of this sec tion provide that the charter of a par ent committee may incorporate infor mation concerning activities of a sub group. In such instances, a subgroup will not be established as a committee distinct from the parent committee. However, a subgroup will be estab lished as a separate committee when the charter of the parent committee does not incorporate the activities of the subgroup, or when the subgroup in cludes members who are not all drawn from the parent committee. (e) An advisory committee not re quired to be established by law will be established or utilized only if it is in the public interest and only if its func tions cannot reasonably be performed by other existing advisory committees or by FDA. (f) An advisory committee must meet the following standards: (1) Its purpose is clearly defined. (2) Its membership is balanced fairly in terms of the points of view rep resented in light of the functions to be performed. Although proportional rep resentation is not required, advisory committee members are selected with out regard to race, color, national ori gin, religion, age, or sex. (3) It is constituted and utilizes pro cedures designed to assure that its ad vice and recommendations are the re sult of the advisory committee’s inde pendent judgment. (4) Its staff is adequate. The Commis sioner designates an Designated Fed eral Officer and alternate for every ad visory committee, who are employees of FDA. The Designated Federal Officer is responsible for all staff support un less other agency employees are des ignated for this function. (5) Whenever feasible, or required by statute, it includes representatives of the public interest. [44 FR 22351, Apr. 13, 1979, as amended at 55 FR 42703, Oct. 23, 1990] § 14.55 Termination of advisory com mittees. (a) Except as provided in paragraph (c) of this section, a standing advisory committee is terminated when it is no longer needed, or not later than 2 years after its date of establishment unless it is renewed for an additional 2-year pe riod. A committee may be renewed for as many 2-year periods as the public in terest requires. The requirements for establishment of a committee under § 14.40 also apply to its renewal. (b) FDA will issue a FEDERAL REG ISTER notice announcing the reasons for terminating a committee and, if it VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00217 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 208 21 CFR Ch. I (4–1–16 Edition) § 14.60 is a standing committee, amending § 14.100 to delete it from the list. (c) TEPRSSC is a permanent statu tory advisory committee established by section 358(f)(1)(A) of the Public Health Service Act, as added by the Radiation Control for Health and Safe ty Act of 1968, transferred to the FD&C Act (21 U.S.C. 360kk(f)(1)(A)), and is not subject to termination and renewal under paragraph (a) of this section, ex cept that a new charter is prepared and filed at the end of each 2-year period as provided in § 14.40(c). Also, the statu tory medical device classification pan els established under section 513(b)(1) of the FD&C Act (21 U.S.C. 360c(b)(1)) and part 860, and the statutory medical device good manufacturing practice ad visory committees established under section 520(f)(3) of the FD&C Act (21 U.S.C. 360j(f)(3)), are specifically ex empted from the normal 2-year dura tion period. (d) Color additive advisory commit tees are required to be established under the circumstances specified in sections 721(b)(5)(C) and (D) of the FD&C Act (21 U.S.C. 379e(b)(5)(C) and (D)). A color additive advisory com mittee is subject to the termination and renewal requirements of the Fed eral Advisory Committee Act and of this part. (e) The Tobacco Products Scientific Advisory Committee is a permanent statutory advisory committee estab lished by section 917 of the Family Smoking Prevention and Tobacco Con trol Act (21 U.S.C. 387q) (Pub. L. 111–31) and is not subject to termination and renewal under paragraph (a) of this sec tion. [44 FR 22351, Apr. 13, 1979, as amended at 75 FR 73953, Nov. 30, 2010; 78 FR 17087, Mar. 20, 2013] Subpart D—Records of Meetings and Hearings Before Advisory Committees § 14.60 Minutes and reports of advi sory committee meetings. (a) The Designated Federal Officer or other designated agency employee pre pares detailed minutes of all advisory committee meetings, except that less detailed minutes may be prepared for open portions of meetings which under § 14.61, must be transcribed or recorded by the agency. Their accuracy is ap proved by the committee and certified by the Chairperson. The approval and certification may be accomplished by mail or by telephone. (b) The minutes include the fol lowing: (1) The time and place of the meet ing. (2) The members, committee staff, and agency employees present, and the names and affiliations or interests of public participants. (3) A copy of or reference to all writ ten information made available for consideration by the committee at the proceedings. (4) A complete and accurate descrip tion of matters discussed and conclu sions reached. A description is to be kept separately for the following por tions of the meeting to facilitate their public disclosure: The open portions specified in § 14.25 (a) and (b), any closed portion during which a presen tation is made under § 14.25(c), and any closed deliberative portion under § 14.25(d). The minutes of a closed delib erative portion of a meeting may not refer to members by name, except upon their request, or to data or information described in § 14.75(b). Any inadvertent references that occur are to be deleted before public disclosure. (5) A copy of or reference to all re ports received, issued, or approved by the committee. (6) The extent to which the meeting was open to the public. (7) The extent of public participation, including a list of members of the pub lic who presented oral or written state ments. (c) For a meeting that has a closed portion, either (1) the minutes of the closed portion are available for public disclosure under § 14.75(a)(6)(i), or (2) if under § 14.75(a)(6)(ii) they are not promptly available, the Designated Federal Officer or other designated agency employee shall prepare a brief summary of the matters considered in an informative manner to the public, consistent with 5 U.S.C. 552(b). (d) Where a significant portion of the meeting of a committee is closed, the committee will issue a report at least annually setting forth a summary of VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00218 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 209 Food and Drug Administration, HHS § 14.75 its activities and related matters in formative to the public consistent with 5 U.S.C. 552(b). This report is to be a compilation of or be prepared from the individual reports on closed portions of meeting prepared under paragraph (c) of this section. [44 FR 22351, Apr. 13, 1979, as amended at 45 FR 85725, Dec. 30, 1980] § 14.61 Transcripts of advisory com mittee meetings. (a) The agency will arrange for a transcript or recording to be made for each portion of a meeting. (b) A transcript or recording of an open portion of a meeting made by FDA is to be included in the record of the committee proceedings. (c) A transcript or recording of any closed portion of a meeting made by FDA will not be included in the admin istrative record of the committee pro ceedings. The transcript or recording will be retained as confidential by FDA, and will not be discarded or erased. (d) Any transcript or recording of a meeting or portion thereof which is publicly available under this section will be available at actual cost of du plication, which will be, where applica ble, the fees established in § 20.45. FDA may furnish the requested transcript or recording for copying to a private contractor who shall charge directly for the cost of copying under § 20.53. (e) A person attending any open por tion of a meeting may, consistent with the orderly conduct of the meeting, record or otherwise take a transcript of the meeting. This transcription will not be part of the administrative record. (f) Only FDA may make a transcript or recording of a closed portion of a meeting. [44 FR 22351, Apr. 13, 1979, as amended at 68 FR 25285, May 12, 2003] § 14.65 Public inquiries and requests for advisory committee records. (a) Public inquiries on general com mittee matters, except requests for records, are to be directed to the Com mittee Management Officer in the Ad visory Committee Oversight and Man agement Staff, Food and Drug Admin istration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993. (b) Public inquiries on matters relat ing to a specific committee, except re quests for records, are to be directed to the Designated Federal Officer or the designated agency employee listed in the FEDERAL REGISTER notices pub lished under § 14.20. (c) Requests for public advisory com mittee records, including minutes, are to be made, to FDA’s Division of Free dom of Information (the Freedom of In formation Staff’s address is available on the agency’s web site at http:// www.fda.gov) under § 20.40 and the re lated provisions of part 20. [44 FR 22351, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981; 76 FR 31469, June 1, 2011; 78 FR 17087, Mar. 20, 2013; 79 FR 68114, Nov. 14, 2014] § 14.70 Administrative record of a pub lic hearing before an advisory com mittee. (a) Advice or recommendations of an advisory committee may be given only on matters covered in the administra tive record of the committee’s pro ceedings. Except as specified in other FDA regulations, the administrative record consists of all the following items relating to the matter: (1) Any transcript or recording of an open portion of a meeting. (2) The minutes of all portions of all meetings, after any deletions under § 14.60(b)(4). (3) All written submissions to and in formation considered by the com mittee. (4) All reports made by the com mittee. (5) Any reports prepared by a con sultant under § 14.31(e). (b) The record of the proceeding is closed at the time the advisory com mittee renders its advice or rec ommendations or at any earlier time specified by the committee or in other sections in this chapter. § 14.75 Examination of administrative record and other advisory com mittee records. (a) The administrative record and other committee records are available VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00219 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 210 21 CFR Ch. I (4–1–16 Edition) § 14.80 for public disclosure under part 20, ex cept as provided in paragraph (b) of this section, at the following times: (1) The written information for con sideration by the committee at any meeting: at the same time it is made available to the committee. (2) The transcript or recording of any open portion of a meeting: as soon as it is available. (3) The minutes of any open portion of a meeting: after they have been ap proved by the committee and certified by the Chairperson. (4) The brief summary of any closed portion of a meeting prepared under § 14.60(c): as soon as it is available. (5) All written information or views submitted to the committee at an open portion of a meeting: as soon as they are submitted. (6) The minutes or portions thereof of a closed portion of a meeting— (i) For a matter not directed to be maintained as confidential under § 14.22(i)(2): After they have been ap proved by the committee and certified by the Chairperson; and (ii) For a matter directed to be main tained as confidential under § 14.22(i)(2): After the advice or report of the com mittee relevant to those minutes or portions thereof is acted upon by the Commissioner, or upon a determina tion by the Commissioner that such minutes or portions thereof may be made available for public disclosure without undue interference with agen cy or advisory committee operations. (7) Formal advice or a report of the committee: After it has been acted upon, i.e., approved, disapproved, or re jected as inadequate, by the Commis sioner, or upon a determination by the Commissioner that such formal advice or report may be made available for public disclosure without undue inter ference with agency or committee op erations. Such formal advice or report may be retained as confidential while it is under active advisement. (8) Any other committee records re lating to the matter, except transcripts and recordings of closed portions of meetings: After the advice or report of the committee relevant to those records is acted upon by the Commis sioner, or upon a determination by the Commissioner that the records may be made available for public disclosure without undue interference with agen cy or committee operations. (b) The following information con tained in the administrative record is not available for public examination or copying except as provided in § 12.32(g): (1) Material provided to the com mittee 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 pres entation described in § 14.25(c) and which is prohibited from public disclo sure under part 20 and the regulations referenced there. (c) The Division of Dockets Manage ment (HFA–305) will maintain a file for each committee containing the fol lowing principal records for ready ac cess by the public: (1) The committee charter. (2) A list of committee members and their curricula vitae. (3) The minutes of committee meet ings. (4) Any formal advice or report of the committee. [44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989] Subpart E—Members of Advisory Committees § 14.80 Qualifications for members of standing policy and technical advi sory committees. (a) Members of a policy advisory committee— (1) Shall have diverse interests, edu cation, training, and experience; spe cific technical expertise is not a re quirement; (2) Are subject to the conflict of in terest laws and regulations either as special Government employees or as members of the uniformed services, in cluding the Commissioned Corps of the Public Health Service (the Commis sioner has determined that, because members representing particular inter ests, e.g., a representative of labor, in dustry, consumers, or agriculture, are included on advisory committees spe cifically for the purpose of rep resenting these interests, any financial interest covered by 18 U.S.C. 208(a) in the class which the member represents VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00220 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 211 Food and Drug Administration, HHS § 14.82 is irrelevant to the services which the Government expects from them and thus is hereby exempted under 18 U.S.C. 208(b) as too remote and incon sequential to affect the integrity of their services); and (3) Shall be voting members. (b) Technical advisory committee. (1) Voting members of technical advisory committees— (i) Shall have expertise in the subject matter with which the committee is concerned and have diverse profes sional education, training, and experi ence so that the committee will reflect a balanced composition of sufficient scientific expertise to handle the prob lems that come before it; and (ii) Except for members of the Tech nical Electronic Product Radiation Safety Standards Committee (TEPRSSC), are subject to the conflict of interest laws and regulations either as special Government employees or as members of the uniformed services, in cluding the Commissioned Corps of the Public Health Service. (2) The Commissioner shall, when re quired by statute, and may when not required by statute, provide for non voting members of a technical advisory committee to serve as representatives of and liaison with interested organiza tions. Nonvoting members— (i) Shall be selected by the interested organizations, as provided in § 14.84; technical expertise in the subject mat ter with which the committee is in volved is not a requirement; and (ii) May be special Government em ployees subject to the conflict of inter est laws and regulations, except as pro vided in § 14.84(e). (c) A person may serve as a voting or nonvoting member on only one FDA advisory committee unless the Com missioner determines in writing that dual membership will aid the work of the committees involved and is in the public interest. (d) Members of FDA advisory com mittees, and the Chairperson, are ap pointed from among those nominated under §§ 14.82 and 14.84 and from any other sources by the Secretary, or, by delegation of authority, by the Assist ant Secretary for Health, or the Com missioner. (e) Members appointed to an advisory committee serve for the duration of the committee, or until their terms of ap pointment expire, they resign, or they are removed from membership by the Commissioner. (f) A committee member may be re moved from membership for good cause. Good cause includes excessive absenteeism from committee meetings, a demonstrated bias that interferes with the ability to render objective ad vice, failure to abide by the procedures established in this subpart, or violation of other applicable rules and regula tions, e.g., for nonvoting members, the provisions of § 14.86(c). (g) Consultants appointed under § 14.31(e) are not members of advisory committees. [44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988; 54 FR 9035, Mar. 3, 1989] § 14.82 Nominations of voting members of standing advisory committees. (a) The Commissioner will publish one or more notices in the FEDERAL REGISTER each year requesting nomi nations for voting members of all exist ing standing advisory committees. The notice will invite the submission of nominations for voting members from both individuals and organizations. (b) The notice announcing the estab lishment of a new committee under § 14.40(b) will invite the submission of nominations for voting members. (c) A person may nominate one or more qualified persons to an advisory committee. Nominations will specify the advisory committee for which the nominee is recommended and will in clude a complete curriculum vitae of the nominee. Nominations are to state that the nominee is aware of the nomi nation, is willing to serve as a member of the advisory committee, and appears to have no conflict of interest that would preclude membership. (d) Voting members serve as individ uals and not as representatives of any group or organization which nominated them or with which they may be affili ated. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00221 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 212 21 CFR Ch. I (4–1–16 Edition) § 14.84 § 14.84 Nominations and selection of nonvoting members of standing technical advisory committees. (a) This section applies when the Commissioner concludes that a tech nical advisory committee should in clude nonvoting members to represent and serve as a liaison with interested individuals and organizations. (b) Except when the Commissioner concludes otherwise, nonvoting mem bers of a technical advisory committee are selected in accordance with para graphs (c) and (d) of this section and are normally limited to one person se lected by consumer groups and organi zations and one person selected by in dustry groups and organizations. (c) To select a nonvoting member to represent consumer interests, except as provided in paragraph (c)(5) of this sec tion, the Commissioner publishes a no tice in the FEDERAL REGISTER request ing nominations for each specific com mittee, or subcommittee, for which nonvoting members are to be ap pointed. (1) A period of 30 days will be per mitted for submission of nominations for that committee or subcommittee. Interested persons may nominate one or more qualified persons to represent consumer interests. Although nomina tions from individuals will be accepted, individuals are encouraged to submit their nominations through consumer organizations as defined in paragraph (c)(3) of this section. Nominations of qualified persons for general consider ation as nonvoting members of unspec ified advisory committees or sub committees may be made at any time. All nominations are to be submitted in writing to Advisory Committee Over sight and Management Staff, Food and Drug Administration, 10903 New Hamp shire Ave., Bldg. 32, rm. 1503, Silver Spring, MD 20993. (2) A complete curriculum vitae of any nominee is to be included. Nomina tions must state that the nominee is aware of the nomination, is willing to serve as a member of an advisory com mittee, and appears to have no conflict of interest. The nomination must state whether a nominee is interested only in a particular advisory committee or subcommittee, or whether the nominee is interested in becoming a member of any advisory committee or sub committee. Nominations that do not comply with the requirements of this paragraph will not be considered. (3) The Advisory Committee Over sight and Management Staff will com pile a list of organizations whose objec tives are to promote, encourage, and contribute to the advancement of con sumer education and to the resolution of consumer problems. All organiza tions listed are entitled to vote upon the nominees. The list will include or ganizations representing the public in terest, consumer advocacy groups, and consumer/health branches of Federal, State, and local governments. Any or ganization that meets the criteria may be included on such list on request. (4) The executive secretary, or other designated agency employee, will re view the list of nominees and select three to five qualified nominees to be placed on a ballot. Names not selected will remain on a list of eligible nomi nees and be reviewed periodically by the Advisory Committee Oversight and Management Staff to determine con tinued interest. Upon selection of the nominees to be placed on the ballot, the curriculum vitae for each of the nominees will be sent to each of the or ganizations on the list complied under paragraph (c)(3) of this section, to gether with a ballot to be filled out and returned within 30 days. After the time for return of the ballots has expired, the ballots will be counted and the nominee who has received the highest number of votes will be selected as the nonvoting member representing con sumer interests for that particular ad visory committee or subcommittee. In the event of a tie, the Commissioner will select the winner by lot from among those tied for the highest num ber of votes (5) If a member representing con sumer interests resigns or is removed before termination of the committee on which the member is serving, the following procedures will be used to ap point a replacement to serve out the term of the former member: (i) The Commissioner will appoint the runner-up, in order of number of ballots received, on the original ballot submitted under paragraph (c)(4) of this section to fill the vacancy. If the VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00222 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 213 Food and Drug Administration, HHS § 14.86 runner-up is no longer willing to serve as a member, then the next runner-up will be appointed. (ii) If none of the nominees on the original ballot is willing to serve, or if there was only one nominee on the original ballot, the Advisory Com mittee Oversight and Management Staff will contact by telephone eligible individuals whose names have been submitted in the past as candidates for membership as representatives of con sumer interests. A list of persons who are interested in serving on an advi sory committee will then be prepared. The curricula vitae of these persons, together with a ballot, will be sent to a representative number of consumer organizations that have been deter mined to be eligible to vote for con sumer representatives in accordance with paragraph (c)(3) of this section. After 4 days have elapsed, the Advisory Committee Oversight and Management Staff will contact the consumer organi zations by telephone and elicit their votes. The candidate who has received the highest number of votes will be se lected. In the event of a tie, the Com missioner will select the winner by lot from among those tied for the highest number of votes. (d) To select a nonvoting member to represent industry interests, the Com missioner will publish, for each com mittee for which the Commissioner has determined to appoint a nonvoting member, a notice requesting that, within 30 days, any industry organiza tion interested in participating in the selection of an appropriate nonvoting member to represent industry interests send a letter stating that interest to the FDA employee designated in the notice. After 30 days, a letter will be sent to each organization that has ex pressed an interest, attaching a com plete list of all such organizations, and stating that it is their responsibility to consult with each other in selecting, within 60 days after receipt of the let ter, a single nonvoting member to rep resent industry interests for that com mittee. If no individual is selected within 60 days, the Commissioner will select the nonvoting member rep resenting industry interests. (e) The Commissioner has determined that, because nonvoting members rep resenting consumer and industry inter ests are included on advisory commit tees specifically for the purpose of rep resenting such interests and have no vote, any financial interest covered by 18 U.S.C. 208(a) in the class which the member represents is irrelevant to the services the Government expects from them and thus is hereby exempted under 18 U.S.C. 208(b) as too remote and inconsequential to affect the integ rity of their services. [44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 75 FR 15342, Mar. 29, 2010] § 14.86 Rights and responsibilities of nonvoting members of advisory committees. (a) A nonvoting member of an advi sory committee selected to represent and serve as a liaison with interested individuals, associations, and organiza tions has the same rights as any other committee member except that— (1) A nonvoting member may vote only on procedural matters such as ad ditional rules adopted under § 14.39(a), approval of minutes under § 14.60(a), de cisions on transcripts under § 14.61(b), and future meeting dates; (2) A nonvoting member who is a rep resentative of industry interest may have access to data and information that constitute a trade secret or con fidential commercial or financial infor mation as defined in § 20.61 only if the person has been appointed as a special Government employee under § 14.80(b). (b) A nonvoting member of an advi sory committee is subject to, and shall abide by, all rules and regulations adopted by FDA and the committee. (c) It is the responsibility of the non voting consumer and industry members of an advisory committee to represent the consumer and industry interests in all deliberations. (1) A nonvoting member does not rep resent any particular organization or group, but rather represents all inter ested persons within the class which the member is selected to represent. Accordingly, an interested person with in the class represented by that non voting member may, upon request, have access to all written statements or oral briefings concerning the com mittee prepared by the nonvoting VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00223 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 214 21 CFR Ch. I (4–1–16 Edition) § 14.90 member for distribution to any person outside the committee. When docu ments are prepared with non-Govern ment funds, persons desiring copies may be required to pay a reasonable fee to cover printing and similar costs. (2) The nonvoting member reviews all official committee minutes to assure their completeness and accuracy. (3) The nonvoting member acts as a liaison between the committee and the interested persons whom that member represents, and transmits requests for information from the committee and relevant information and views to the committee. The nonvoting member takes the initiative in contacting in terested persons whom the member represents to seek out relevant infor mation and views and to relate the progress of the advisory committee. (4) A nonvoting industry member rep resents all members of the industry, and not any particular association, company, product, or ingredient. If a matter comes before the committee that directly or indirectly affects the company employing the nonvoting in dustry member, the member shall so inform the committee but need not be absent during the discussion or decline to participate in the discussion. a non voting industry member may not dis cuss the company’s position as such, but may discuss any matter in general terms. All presentations and discus sions of scientific data and their inter pretation on behalf of a company will occur in open session, except as pro vided in § 14.25(c). (5) A nonvoting member of an advi sory committee may not make any presentation to that advisory com mittee during a hearing conducted by that committee. (6) Although a nonvoting member serves in a representative capacity, the nonvoting member shall exercise re straint in performing such functions and may not engage in unseemly advo cacy or attempt to exert undue influ ence over the other members of the committee. (d) A nonvoting member of an advi sory committee may be removed by the Commissioner for failure to comply with this section as well as § 14.80(f). § 14.90 Ad hoc advisory committee members. In selecting members of an ad hoc ad visory committee, the Commissioner may use the procedures in §§ 14.82 and 14.84 or any other procedure deemed ap propriate. § 14.95 Compensation of advisory com mittee members. (a)(1) Except as provided in para graphs (a) (2) and (3) of this section, all voting advisory committee members shall, and nonvoting members may, be appointed as special Government em ployees and receive a consultant fee and be reimbursed for travel expenses, including per diem in lieu of subsist ence, unless such compensation and re imbursement are waived. (2) Members of the Technical Elec tronic Product Radiation Safety Standards Committee (TEPRSSC) are not appointed as special Government employees. Any member of TEPRSSC who is not a Federal employee or mem ber of the uniformed services, includ ing the Commissioned Corps of the Public Health Service, shall receive a consultant fee and be reimbursed for travel expenses, including per diem in lieu of subsistence, unless such com pensation and reimbursement are waived. (3) Voting and nonvoting advisory committee members who are members of the uniformed services, including the Commissioned Corps of the Public Health Service, provide service on Food and Drug Administration advi sory committees as part of their as signed functions, are not appointed as special government employees, but are reimbursed by the Food and Drug Ad ministration for travel expenses. (b) Notwithstanding the member’s primary residence, an advisory com mittee member, while attending meet ings of the full committee or a sub committee, will be paid whether the meetings are held in the Washington, DC, area or elsewhere. (c) A committee member who partici pates in any agency-directed assign ment will be paid at an hourly rate when doing assigned work at home, a place of business, or in an FDA facility located within the member’s com muting area, and at a daily rate when VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00224 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 215 Food and Drug Administration, HHS § 14.100 required to travel outside of that com muting area to perform the assign ment. A committee member will not be paid for time spent on normal prepara tion for a committee meeting. (1) An agency-directed assignment is an assignment that meets the fol lowing criteria: (i) An activity that requires under taking a definitive study. The activity must produce a tangible end product, usually a written report. Examples are: (a) An analysis of the risks and bene fits of the use of a class of drugs or a report on a specific problem generated by an IND or NDA; (b) The performance of similar inves tigations or analysis of complex indus try submissions to support advisory committee deliberations other than normal meeting preparation; (c) The preparation of a statistical analysis leading to an estimate of toxicologically safe dose levels; and (d) The design or analysis of animal studies of toxicity, mutagenicity, teratogenicity, or carcinogenicity. (ii) The performance of an IND or NDA review or similar review. (2) A committee member who under takes a special assignment, the end product of which does not represent the end product of the advisory committee, but rather of the committee member’s own assignment, can be compensated. Should this preparatory work by mem bers collectively result in an end prod uct of the committee, this is to be con sidered normal meeting preparation and committee members are not to be compensated for this work. (d) Salary while in travel status is authorized when a committee mem ber’s ordinary pursuits are interrupted for the substantial portion of an addi tional day beyond the day or days spent in performing those services, and as a consequence the committee mem ber loses some regular compensation. This applies on weekends and holidays if the special Government employee loses income that would otherwise be earned on that day. For travel pur poses, a substantial portion of a day is defined as 50 percent of the working day, and the traveler will be paid at a daily rate. [44 FR 22351, Apr. 13, 1979, as amended at 53 FR 50949, Dec. 19, 1988] Subpart F—Standing Advisory Committees § 14.100 List of standing advisory com mittees. Standing advisory committees and the dates of their establishment are as follows: (a) Office of the Commissioner— (1) Board of Tea Experts. (i) Date established: March 2, 1897. (ii) Function: Advises on establish ment of uniform standards of purity, quality, and fitness for consumption of all tea imported into the United States under 21 U.S.C. 42. (2) Science Board to the Food and Drug Administration. (i) Date established: June 26, 1992. (ii) Function: The board shall provide advice primarily to the agency’s Senior Science Advisor and, as needed, to the Commissioner and other appropriate officials on specific complex and tech nical issues as well as emerging issues within the scientific community in in dustry and academia. Additionally, the board will provide advice to the agency on keeping pace with technical and sci entific evolutions in the fields of regu latory science; on formulating an ap propriate research agenda; and on up grading its scientific and research fa cilities to keep pace with these changes. It will also provide the means for critical review of agency sponsored intramural and extramural scientific research programs. (3) Pediatric Advisory Committee. (i) Date established: June 18, 2004. (ii) Function: Advises on pediatric therapeutics, pediatric research, and other matters involving pediatrics for which the Food and Drug Administra tion has regulatory responsibility. (4) Risk Communication Advisory Com mittee. (i) Date rechartered: July 9, 2009. (ii) Function: The committee reviews and evaluates strategies and programs designed to communicate with the pub lic about the risks and benefits of FDA regulated products so as to facilitate optimal use of these products. The committee also reviews and evaluates research relevant to such communica tion to the public by both FDA and VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00225 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 216 21 CFR Ch. I (4–1–16 Edition) § 14.100 other entities. It also facilitates inter actively sharing risk and benefit infor mation with the public to enable peo ple to make informed independent judgments about use of FDA-regulated products. (5) Tobacco Products Scientific Advisory Committee. (i) Date Established: August 12, 2009. (ii) Function: The committee reviews and evaluates safety, dependence, and health issues relating to tobacco prod ucts and provides appropriate advice, information, and recommendations to the Commissioner of Food and Drugs. Specifically, the committee will sub mit reports and recommendations on tobacco-related topics, including: The impact of the use of menthol in ciga rettes on the public health, including such use among children, African Americans, Hispanics and other racial and ethnic minorities; the nature and impact of the use of dissolvable to bacco products on the public health, in cluding such use on children; the ef fects of the alteration of nicotine yields from tobacco products and whether there is a threshold level below which nicotine yields do not produce dependence on the tobacco product involved; and any application submitted by a manufacturer for a modified risk tobacco product. The committee may provide recommenda tions to the Secretary of Health and Human Services regarding any regula tions to be issued under the Federal Food, Drug, and Cosmetic Act and may review any applications for new to bacco products or petitions for exemp tion under section 906(e) of the Family Smoking Prevention and Tobacco Con trol Act. The committee may consider and provide recommendations on any other matter as provided in the Family Smoking Prevention and Tobacco Con trol Act. (b) Center for Biologics Evaluation and Research— (1) Allergenic Products Advisory Com mittee. (i) Date established: July 9, 1984. (ii) Function: Reviews and evaluates data on the safety and effectiveness of allergenic biological products intended for use in the diagnosis, prevention, or treatment of human disease. (2) Cellular, Tissue and Gene Therapies Advisory Committee. (i) Date established: October 28, 1988. (ii) Function: Reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies and xenotransplantation products which are intended for transplantation, im plantation, infusion, and transfer in the prevention and treatment of a broad spectrum of human diseases and in the reconstruction, repair or re placement of tissues for various condi tions. The Committee also considers the quality and relevance of FDA’s re search program which provides sci entific support for the regulation of these products, and makes appropriate recommendations to the Commissioner of Food and Drugs. (3) Blood Products Advisory Committee. (i) Date established: May 13, 1980. (ii) Function: Reviews and evaluates data on the safety and effectiveness, and appropriate use of blood products intended for use in the diagnosis, pre vention, or treatment of human dis eases. (4) [Reserved] (5) Vaccines and Related Biological Products Advisory Committee— (i) Date established: December 31, 1979. (ii) Function: Reviews and evaluates data on the safety and effectiveness of vaccines intended for use in the diag nosis, prevention, or treatment of human diseases. (6) Transmissible Spongiform Encephalopathies Advisory Committee— (i) Date established: June 21, 1995. (ii) Function: Reviews and evaluates available scientific data concerning the safety of products which may be at risk for transmission of spngiform encephalopathies having an impact on the public health. (c) Center for Drug Evaluation and Re search— (1) Anesthetic and Analgesic Drug Products Advisory Committee. (i) Date established: May 1, 1978. (ii) Function: Reviews and evaluates data concerning the safety and effec tiveness of marketed and investiga tional human drug products including analgesics, e.g., abuse-deterrent VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00226 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 217 Food and Drug Administration, HHS § 14.100 opioids, novel analgesics, and issues re lated to opioid abuse, and those for use in anesthesiology. (2) Antimicrobial Drugs Advisory Com mittee. (i) Date established: October 7, 1980. (ii) Function: Reviews and evaluates available data concerning the safety and effectiveness of marketed and in vestigational human drug products for use in the treatment of infectious dis eases and disorders. (3) Arthritis Advisory Committee. (i) Date established: April 5, 1974. (ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in arthritic conditions. (4) Cardiovascular and Renal Drugs Ad visory Committee. (i) Date established: August 27, 1970. (ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in cardiovascular and renal disorders. (5) Dermatologic and Ophthalmic Drugs Advisory Committee. (i) Date established: October 7, 1980. (ii) Function: Reviews and evaluates available data concerning the safety and effectiveness of marketed and in vestigational human drug products for use in the treatment of dermatologic and ophthalmic disorders. (6) Drug Safety and Risk Management Advisory Committee. (i) Date established: May 31, 1978. (ii) Function: Reviews and evaluates data on risk management plans, pro vides active surveillance methodolo gies, trademark studies, methodologies for risk management communication, and related issues. (7) Endocrinologic and Metabolic Drugs Advisory Committee. (i) Date established: August 27, 1970. (ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in endocrine and meta bolic disorders. (8) Bone, Reproductive and Urologic Drugs Advisory Committee. (i) Date established: March 23, 1978. (ii) Function: Advises the Commis sioner or designee in discharging re sponsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which the Food and Drug Administration has regulatory respon sibility. (9) Gastrointestinal Drugs Advisory Committee. (i) Date established: March 3, 1978. (ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in gastrointestinal dis eases. (10) Oncologic Drugs Advisory Com mittee. (i) Date established: September 1, 1978. (ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in treatment of cancer. (11) Peripheral and Central Nervous System Drugs Advisory Committee. (i) Date established: June 4, 1974. (ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in neurological disease. (12) Psychopharmacologic Drugs Advi sory Committee. (i) Date established: June 4, 1974. (ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the practice of psychi atry and related fields. (13) Pulmonary-Allergy Drugs Advisory Committee. (i) Date established: February 17, 1972. (ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the treatment of pul monary disease and diseases with aller gic and/or immunologic mechanisms. (14) Medical Imaging Drugs Advisory Committee. (i) Date established: May 18, 2011. (ii) Function: Reviews and evaluates data concerning the safety and effec tiveness of marketed and investiga tional human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radi ology. (15) Pharmaceutical Science and Clin ical Pharmacology Advisory Committee. (i) Date established: January 22, 1990. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00227 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 218 21 CFR Ch. I (4–1–16 Edition) § 14.100 (ii) Function: The committee shall provide advice on scientific, clinical and technical issues related to safety and effectiveness of drug products for use in the treatment of a broad spec trum of human diseases, the quality characteristics which such drugs pur port or are represented to have and as required, any other product for which the Food and Drug Administration has regulatory responsibility, and make appropriate recommendations to the Commissioner of Food and Drugs. The Committee may also review agency sponsored intramural and extramural biomedical research programs in sup port of FDA’s drug regulatory respon sibilities and its critical path initia tives related to improving the efficacy and safety of drugs and improving the efficiency of drug development. (16) Nonprescription Drugs Advisory Committee. (i) Date established: August 27, 1991. (ii) Functions: The committee re views and evaluates available data con cerning the safety and effectiveness of over-the-counter (nonprescription) human drug products for use in the treatment of a broad spectrum of human symptoms and diseases. (17) Pharmacy Compounding Advisory Committee. (i) Date re-established: April 25, 2012. (ii) Function: Provides advice on sci entific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act and, as required, any other product for which the Food and Drug Administration has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs. (d) Center for Devices and Radiological Health— (1) Medical Devices Advisory Committee. (i) Date established: October 27, 1990. (ii) Function: Reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. (2) Device Good Manufacturing Practice Advisory Committee. (i) Date established: May 17, 1987. (ii) Function: Reviews proposed regu lations for good manufacturing prac tices governing the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of devices, and makes rec ommendations on the feasibility and reasonableness of the proposed regula tions. (3) Technical Electronic Product Radi ation Safety Standards Committee. (i) Date established: October 18, 1968. (ii) Function: Advises on technical feasibility, reasonableness, and prac ticability of performance standards for electronic products to control the emission of radiation under 42 U.S.C. 263f(f)(1)(A). (4) National Mammography Quality As surance Advisory Committee. (i) Date established: July 6, 1993. (ii) Function: Advises on developing appropriate quality standards and reg ulations for the use of mammography facilities. (5) Patient Engagement Advisory Com mittee. (i) Date Established: October 6, 2015. (ii) Function: Provides advice to the Commissioner on complex issues relat ing to medical devices, the regulation of devices, and their use by patients. Agency guidance and policies, clinical trial or registry design, patient pref erence study design, benefit-risk deter minations, device labeling, unmet clin ical needs, available alternatives, pa tient reported outcomes, and device-re lated quality of life or health status issues are among the topics that may be considered by the Committee. The Committee provides relevant skills and perspectives in order to improve com munication of benefits, risks, and clin ical outcomes, and increase integration of patient perspectives into the regu latory process for medical devices. It performs its duties by identifying new approaches, promoting innovation, rec ognizing unforeseen risks or barriers, and identifying unintended con sequences that could result from FDA policy. (e) National Center for Toxicological Research—Science Advisory Board. (1) Date established: June 2, 1973. (2) Function: Advises on establish ment and implementation of a research program that will assist the Commis sioner of Food and Drugs to fulfill reg ulatory responsibilities. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00228 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 219 Food and Drug Administration, HHS § 14.127 (f) Center for Food Safety and Applied Nutrition—Food Advisory Committee. (1) Date established: December 15, 1991. (2) Function: The committee provides advice on emerging food safety, food science, and nutrition issues that FDA considers of primary importance in the next decade. [54 FR 9036, Mar. 3, 1989] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 14.100, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov. Subpart G—Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Tech nical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC), consisting of 15 members, is established in accordance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360kk(f)(1)(A)) to provide consultation before the Commissioner prescribes any performance standard for an electronic product. [44 FR 22351, Apr. 13, 1979, as amended at 78 FR 17087, Mar. 20, 2013] § 14.122 Functions of TEPRSSC. (a) In performing its function of ad vising the Commissioner, TEPRSSC— (1) May propose electronic product radiation safety standards to the Com missioner for consideration; (2) Provides consultation to the Com missioner on all performance standards proposed for consideration under 21 U.S.C. 360kk; and (3) May make recommendations to the Commissioner on any other mat ters it deems necessary or appropriate in fulfilling the purposes of the act. (b) Responsibility for action on per formance standards under 21 U.S.C. 360kk rests with the Commissioner, after receiving the advice of TEPRSSC. [44 FR 22351, Apr. 13, 1979, as amended at 78 FR 17087, Mar. 20, 2013] § 14.125 Procedures of TEPRSSC. (a) When the Commissioner is consid ering promulgation of a performance standard for an electronic product, or an amendment of an existing standard, before issuing a proposed regulation in the FEDERAL REGISTER the Commis sioner will submit to TEPRSSC the proposed standard or amendment under consideration, together with other rel evant information to aid TEPRSSC in its deliberations. (b) The agenda and other material to be considered at any meeting will be sent to members whenever possible at least 2 weeks before the meeting. (c) Ten members constitute a quorum, provided at least three mem bers are present from each group speci fied in 21 U.S.C. 360kk(f)(1)(A) and in § 14.127(a), i.e., Government, industry, and the public. (d) The Chairperson of TEPRSSC will ordinarily submit a report to the Com missioner of the committee’s consider ation of any proposed performance standard for an electronic product within 60 days after consideration. If the Chairperson believes that more time is needed, the Chairperson will in form the Director of the Center for De vices and Radiological Health in writ ing, in which case an additional 30 days will be allowed to make the report. (e) Sections 14.1 through 14.7 apply to TEPRSSC, except where other provi sions are specifically included in §§ 14.120 through 14.130. [44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989; 78 FR 17087, Mar. 20, 2013] § 14.127 Membership of TEPRSSC. (a) The Commissioner will appoint the members after consultation with public and private organizations con cerned with the technical aspect of electronic product radiation safety. TEPRSSC consists of 15 members, each of whom is technically qualified by training and experienced in one or more fields of science or engineering applicable to electronic product radi ation safety, as follows: (1) Five members selected from gov ernment agencies, including State and Federal Governments. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00229 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 220 21 CFR Ch. I (4–1–16 Edition) § 14.130 (2) Five members selected from the affected industries after consultation with industry representatives. (3) Five members selected from the general public, of whom at least one shall be a representative of organized labor. (b) The Commissioner will appoint a committee member as Chairperson of TEPRSSC. (c) Appointments of members are for a term of 3 years or as specified by the Commissioner. (1) The Chairperson is appointed for a term concurrent with the Chair person’s term as a member of TEPRSSC. If the Chairpersonship be comes vacant without adequate notice, the Designated Federal Officer may ap point a committee member as tem porary Chairperson pending appoint ment of a new Chairperson by the Com missioner. (2) Members may not be reappointed for a second consecutive full term. (d) A person otherwise qualified for membership is not eligible for selection as a member of TEPRSSC from Gov ernment agencies or the general public if the Commissioner determines that the person does not meet the require ments of the conflict of interest laws and regulations. (e) Retention of membership is condi tioned upon the following: (1) Continued status as a member of the group from which the member was selected as specified in paragraph (a) of this section. (2) Absence of any conflict of interest during the term of membership as spec ified in paragraph (d) of this section. (3) Active participation in TEPRSSC activities. (f) Appointment as a member of TEPRSSC is conditioned on certifi cation that the prospective member: (1) Agrees to the procedures and cri teria specified in this subpart. (2) Has no conflict of interest as spec ified in paragraph (d) of this section. (3) Will notify the Designated Fed eral Officer of TEPRSSC before any change in representative status on TEPRSSC which may be contrary to the conditions of the appointment. (g) Members of TEPRSSC who are not full-time officers or employees of the United States receive compensa tion under § 14.95, in accordance with 42 U.S.C. 210(c). § 14.130 Conduct of TEPRSSC meeting; availability of TEPRSSC records. (a) In accordance with 21 U.S.C. 360kk(f)(1)(B), all proceedings of TEPRSSC are recorded, and the record of each proceeding is available for pub lic inspection. (b) All proceedings of TEPRSSC are open except when the Commissioner has determined, under § 14.27, that a portion of a meeting may be closed. [44 FR 22351, Apr. 13, 1979, as amended at 78 FR 17087, Mar. 20, 2013] Subpart H—Color Additive Advisory Committees § 14.140 Establishment of a color addi tive advisory committee. The Commissioner will establish a color additive advisory committee under the following circumstances: (a) The Commissioner concludes, as a matter of discretion, that it would be in the public interest for a color addi tive advisory committee to review and make recommendations about the safe ty of a color additive on which impor tant issues are pending before FDA and for interested persons to present infor mation and views at an oral public hearing before a color additive advi sory committee. (b) There is an issue arising under section 721(b)(5)(B) of the FD&C Act concerning the safety of a color addi tive, including its potential or actual carcinogenicity, that requires the exer cise of scientific judgment and a person who would be adversely affected by the issuance, amendment, or repeal of a regulation listing a color additive re quests that the matter, or the Commis sioner as a matter of discretion deter mines that the matter should, be re ferred to a color additive advisory com mittee. (1) Paragraph (b) does not apply to any issue arising under the transi tional provisions in section 203 of the Color Additive Amendments of 1960 re lating to provisional listing of com mercially established colors. A color VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00230 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 221 Food and Drug Administration, HHS § 14.147 additive advisory committee to con sider any such matter will be estab lished under paragraph (a) of this sec tion. (2) A request for establishment of a color additive advisory committee is to be made in accordance with § 10.30. The Commissioner may deny any petition if inadequate grounds are stated for es tablishing a color additive advisory committee. A request for establish ment of a color additive advisory com mittee may not rest on mere allega tions or denials, but must set forth spe cific facts showing that there is a gen uine and substantial issue of fact that requires scientific judgment and justi fies a hearing before a color additive advisory committee. When it conclu sively appears from the request for a color additive advisory committee that the matter is premature or that it does not involve an issue arising under sec tion 721(b)(5)(B) of the FD&C Act or that there is no genuine and substan tial issue of fact requiring scientific judgment, or for any other reason a color additive advisory committee is not justified, the Commissioner may deny the establishment of a color addi tive advisory committee. (3) Establishment of a color additive advisory committee on the request of an interested person is conditioned upon receipt of the application fee specified in § 14.155. (4) Any person adversely affected may request referral of the matter to a color additive advisory committee at any time before, or within 30 days after, publication of an order of the Commissioner acting upon a color ad ditive petition or proposal. § 14.142 Functions of a color additive advisory committee. (a) A color additive advisory com mittee reviews all available informa tion relating to the matter referred to it, including all information contained in any pertinent color additive petition and in FDA files. All information re viewed is placed on public display and is available for review at the office of the Division of Dockets Management. (b) The Commissioner specifies to the color additive advisory committee, in writing, the issues on which review and recommendations are requested. (c) The date of the first meeting of a color additive advisory committee, fol lowing receipt of the administrative record by each of the committee mem bers, is designated as the beginning of the period allowed for consideration of the matter by the committee. Within 60 days after the first meeting, unless the time is extended as provided in paragraph (d) of this section, the Chair person of the committee shall certify to the Commissioner the report con taining the recommendations of the committee, including any minority re port. The report states the rec ommendations of the committee and the reasons or basis for them. The re port includes copies of all material considered by the committee in addi tion to the administrative record fur nished to it. (d) If the Chairperson concludes that the color additive advisory committee needs additional time, the Chairperson shall so inform the Commissioner in writing and may certify the report of the committee to the Commissioner within 90 days instead of 60 days. (e) More than one matter may be handled concurrently by a color addi tive advisory committee. § 14.145 Procedures of a color additive advisory committee. (a) A color additive advisory com mittee is subject to all the require ments of the Federal Advisory Com mittee Act and this part. (b) All interested persons have a right to consult with the color additive advisory committee reviewing a mat ter and to submit information and views to a color additive advisory com mittee, in accordance with the proce dures in this part. § 14.147 Membership of a color addi tive advisory committee. (a) The members of a color additive advisory committee are selected in the following manner: (1) If a color additive advisory com mittee is established for purposes that do not include review of an issue aris ing under section 721(b)(5)(B) of the act, or is established on the initiative of the Commissioner, the Commissioner may use the procedure in paragraph VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00231 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 222 21 CFR Ch. I (4–1–16 Edition) § 14.155 (a)(2) of this section to select the mem bers or may use an existing standing advisory committee listed in § 14.100, or may establish a new advisory com mittee under this subpart. Once the Commissioner has established a color additive advisory committee under this paragraph and has referred to it a mat ter relating to a color additive, no in terested person may subsequently re quest that an additional or different color additive advisory committee be established to review and make rec ommendations about that color addi tive. (2) If the Commissioner established a color additive advisory committee to review an issue arising under section 721(b)(5)(B) of the FD&C Act on the re quest of an interested person, it shall be established under the following re quirements: (i) Except as provided in paragraph (a)(2) (ii) and (iii) of this section, the Commissioner will request the Na tional Academy of Sciences to select the members of a color additive advi sory committee from among experts qualified in the subject matter to be re viewed by the committee, and of ade quately diversified professional back grounds. The Commissioner will ap point one of the members as the Chair person. (ii) If the National Academy of Sciences is unable or refuses to select the members of a color additive advi sory committee, the Commissioner will select the members. (iii) If the Commissioner and the re questing party agree, section 721(b)(5)(D) of the FD&C Act may be waived and the matter may be referred to any standing advisory committee listed in § 14.100 or to any advisory committee established under any other procedure that is mutually agreeable. Once the Commissioner has established a color additive advisory committee and has referred to it a matter relating to a color additive, no interested per son may subsequently request that an additional or different color additive advisory committee be established to review and make recommendations about that color additive. (b) Members of a color additive advi sory committee are subject to the re quirements of the Federal Advisory Committee Act and this subpart, ex cept that no member of a color additive advisory committee may by reason of such membership alone be a special government employee or be subject to the conflict of interest laws and regula tions. § 14.155 Fees and compensation per taining to a color additive advisory committee. (a) When a matter is referred to a color additive advisory committee, all related costs, including personal com pensation of committee members, trav el, materials, and other costs, are borne by the person requesting the re ferral, such costs to be assessed on the basis of actual cost to the government. The compensation of such costs in cludes personal compensation of com mittee members at a rate not to exceed $128.80 per member per day. (b) In the case of a request for refer ral to a color additive advisory com mittee, a special advance deposit is to be made in the amount of $2,500. Where required, further advances in incre ments of $2,500 each are to be made upon request of the Commissioner. All deposits for referrals to a color addi tive advisory committee in excess of actual expenses will be refunded to the depositor. (c) All deposits and fees required by this section are to be paid by money order, bank draft, or certified check drawn to the order of the Food and Drug Administration, collectible at par in Washington, DC. All deposits and fees are to be forwarded to the Asso ciate Commissioner for Management and Operations, Food and Drug Admin istration, 5600 Fishers Lane, Rockville, MD 20857, and after appropriate record of them is made, they will be trans mitted to the Treasurer of the United States for deposit in the special ac count ‘‘Salaries and Expenses, Certifi cation, Inspection, and Other Services, Food and Drug Administration.’’ (d) The Commissioner may waive or refund such fees in whole or in part when, in the Commissioner’s judgment, such action will promote the public in terest. Any person who believes that payment of these fees will be a hard ship may petition the Commissioner VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00232 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 223 Food and Drug Administration, HHS § 14.171 under § 10.30 to waive or refund the fees. Subpart I—Advisory Committees for Human Prescription Drugs § 14.160 Establishment of standing technical advisory committees for human prescription drugs. The standing technical advisory com mittees for human prescription drugs are established to advise the Commis sioner: (a) Generally on the safety and effec tiveness, including the labeling and ad vertising, and regulatory control of the human prescription drugs falling with in the pharmacologic class covered by the advisory committee and on the sci entific standards appropriate for a de termination of safety and effectiveness in that class of drugs. (b) Specifically on any particular matter involving a human prescription drug pending before FDA, including whether the available information is adequate to support a determination that— (1) A particular IND study may prop erly be conducted; (2) A particular drug meets the statu tory standard for proof of safety and ef fectiveness necessary for approval or continued approval for marketing; or (3) A particular drug is properly clas sified as a new drug, an old drug, or a banned drug. § 14.171 Utilization of an advisory com mittee on the initiative of FDA. (a) Any matter involving a human prescription drug under review within the agency may, in the discretion of the Commissioner, be the subject of a public hearing and continuing or peri odic review by the appropriate stand ing technical advisory committee for human prescription drugs. The Com missioner’s determinations on the agenda of the committee are based upon the priorities of the various mat ters pending before the agency which fall within the pharmacologic class covered by that committee. (b) High priority for such hearing and review by the appropriate standing technical advisory committee for human prescription drugs are given to the following types of human prescrip tion drugs: (1) Investigational drugs which are potential therapeutic advances over currently marketed products from the standpoint of safety or effectiveness, or which pose significant safety hazards, or which present narrow benefit-risk considerations requiring a close judgmental decision on approval for marketing, or which have a novel de livery system or formulation, or which are the subject of major scientific or public controversy, or which may be subject to special regulatory require ments such as a limitation on clinical trials, a patient followup requirement, postmarketing Phase IV studies, dis tributional controls, or boxed warn ings. (2) Marketed drugs for which an im portant new use has been discovered or which pose newly discovered safety hazards, or which are the subject of major scientific or public controversy, or which may be subject to important regulatory actions such as withdrawal of approval for marketing, boxed warn ings, distributional controls, or newly required scientific studies. (c) The committee may request the Commissioner for an opportunity to hold a public hearing and to review any matter involving a human prescription drug which falls within the pharmaco logic class covered by the committee. The Commissioner may, after con sulting with the committee on such re quest, grant or deny the request in light of the priorities of the other mat ters pending before the committee. Whenever feasible, consistent with the other work of the committee, the re quest will be granted. (d) For a drug that meets any of the criteria established in paragraph (b) of this section, one or more members of or consultants to the appropriate advi sory committee may be selected for more detailed monitoring of the mat ter and consultation with FDA on be half of the committee. The member or consultant may be invited to attend appropriate meetings and shall assist the center in any briefing of the com mittee on that matter. (e) An advisory committee may ob tain advice and recommendations from other agency advisory committees, VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00233 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 224 21 CFR Ch. I (4–1–16 Edition) § 14.172 consultants, and experts which the ad visory committee and the center con clude would facilitate the work of the advisory committee. (f) Presentation of all relevant infor mation about the matter will be made in open session unless it relates to an IND the existence of which has not pre viously been disclosed to the public as defined in § 20.81 or is otherwise prohib ited from public disclosure under part 20 and the regulations referenced there in. Sections 314.430 and 601.51 deter mine whether, and the extent to which, relevant information may be made available for public disclosure, summa rized and discussed in open session but not otherwise made available for public disclosure, or not in any way discussed or disclosed in open session or other wise disclosed to the public. [44 FR 22351, Apr. 13, 1979, as amended at 54 FR 9037, Mar. 3, 1989] § 14.172 Utilization of an advisory com mittee at the request of an inter ested person. Any interested person may request, under § 10.30, that a specific matter re lating to a particular human prescrip tion drug be submitted to an appro priate advisory committee for a hear ing and review and recommendations. The request must demonstrate the im portance of the matter and the reasons why it should be submitted for a hear ing at that time. The Commissioner may grant or deny the request. § 14.174 Advice and recommendations in writing. Advice and recommendations given by a committee on a specific drug or a class of drugs are ordinarily in the form of a written report. The report may consist of the approved minutes of the meeting or a separate written re port. The report responds to the spe cific issues or questions which the Commissioner has addressed to the ad visory committee, and states the basis of the advice and recommendations of the committee. PART 15—PUBLIC HEARING BEFORE THE COMMISSIONER Subpart A—General Provisions Sec. 15.1 Scope. Subpart B—Procedures for Public Hearing Before the Commissioner 15.20 Notice of a public hearing before the Commissioner. 15.21 Notice of participation; schedule for hearing. 15.25 Written submissions. 15.30 Conduct of a public hearing before the Commissioner. Subpart C—Records of a Public Hearing Before the Commissioner 15.40 Administrative record. 15.45 Examination of administrative record. AUTHORITY: 5 U.S.C. 553; 15 U.S.C. 1451–1461; 21 U.S.C. 141–149, 321–393, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b–263n, 264. SOURCE: 44 FR 22366, Apr. 13, 1979, unless otherwise noted. Subpart A—General Provisions § 15.1 Scope. The procedures in this part apply when: (a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public hearing on any matter pending before the Food and Drug Administation. (b) The act or regulation specifically provides for a public hearing before the Commissioner on a matter, e.g., § 330.10(a)(8) relating to over-the counter drugs and sections 520 (b) and (f)(1)(B), and 521 of the act relating to proposals to allow persons to order cus tom devices, to proposed device good manufacturing practice regulations, and to proposed exemptions from pre emption of State and local device re quirements under § 808.25(e). (c) A person who has right to an op portunity for a formal evidentiary pub lic hearing under part 12 waives that opportunity and instead requests under § 12.32 a public hearing before the Com missioner, and the Commissioner, as a VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00234 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B