Title 21 CFR reference

(a) This part governs the procedures when any of the following applies: advisory committeecommittee(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 ( or ) to hold a public hearing and to review and make recommendations on any matter before FDA and for interested persons to present information and views at an oral public hearing before the advisory committee. (2) Under specific provisions in the FD&C Act or other sections of this chapter, a matter is subject to a hearing before an advisory committee. The specific provisions are— (i) Section 14.120 on review of a performance standard for an electronic product by the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC); (ii) Section 14.140 on review of the safety of color additives; (iii) Section 14.160 on review of the safety and effectiveness of human prescription drugs; (iv) Section 330.10 on review of the safety and effectiveness of over-the-counter drugs; (v) [Reserved] (vi) Part 860, on classification of devices; (vii) Section 514(b)(5) of the FD&C Act on establishment, amendment, or…

This part applies to Congress, individual Members of Congress, and other employees or representatives of Congress in the same way that they apply to any other member of the public, except that disclosure of advisory committee records to Congress is governed by § 20.87.

Standing advisory committees and the dates of their establishment are as follows: Office of the Commissioner(a) — Board of Tea Experts.(1) (i) Date established: March 2, 1897. (ii) Function: Advises on establishment of uniform standards of purity, quality, and fitness for consumption of all tea imported into the United States under 21 U.S.C. 42. Science Board to the Food and Drug Administration.(2) (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 technical issues as well as emerging issues within the scientific community in industry and academia. Additionally, the board will provide advice to the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science; on formulating an appropriate research agenda; and on upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of agency sponsored intramural and extramural scientific research programs. Pediatric Advisory Committee.(3) (i) Date…

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]

(a) In performing its function of advising the Commissioner, TEPRSSC— (1) May propose electronic product radiation safety standards to the Commissioner for consideration; (2) Provides consultation to the Commissioner on all performance standards proposed for consideration under 21 U.S.C. 360kk; and (3) May make recommendations to the Commissioner on any other matters it deems necessary or appropriate in fulfilling the purposes of the act. (b) Responsibility for action on performance 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]

Federal Register04(a) When the Commissioner is considering promulgation of a performance standard for an electronic product, or an amendment of an existing standard, before issuing a proposed regulation in the the Commissioner will submit to TEPRSSC the proposed standard or amendment under consideration, together with other relevant 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 members are present from each group specified 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 Commissioner of the committee's consideration 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 inform the Director of the Center for Devices and Radiological Health in writing, in which case an additional 30 days will be allowed to make the report. (e) Sections 14.1…

(a) The Commissioner will appoint the members after consultation with public and private organizations concerned 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 radiation safety, as follows: (1) Five members selected from government agencies, including State and Federal Governments. (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 Chairperson's term as a member of TEPRSSC. If the Chairpersonship becomes vacant without adequate notice, the Designated Federal Officer may appoint a committee member as temporary Chairperson pending appointment of a new Chairperson by the Commissioner.…

(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 public 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]

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 additive advisory committee to review and make recommendations about the safety of a color additive on which important issues are pending before FDA and for interested persons to present information and views at an oral public hearing before a color additive advisory committee. (b) There is an issue arising under section 721(b)(5)(B) of the FD&C Act concerning the safety of a color additive, including its potential or actual carcinogenicity, that requires the exercise of scientific judgment and a person who would be adversely affected by the issuance, amendment, or repeal of a regulation listing a color additive requests that the matter, or the Commissioner as a matter of discretion determines that the matter should, be referred to a color additive advisory committee. (1) Paragraph (b) does not apply to any issue arising under the transitional provisions in section 203 of the Color Additive Amendments of 1960 relating to provisional listing of commercially established…

(a) A color additive advisory committee reviews all available information relating to the matter referred to it, including all information contained in any pertinent color additive petition and in FDA files. All information reviewed 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, following receipt of the administrative record by each of the committee members, 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 Chairperson of the committee shall certify to the Commissioner the report containing the recommendations of the committee, including any minority report. The report states the recommendations of the committee and the reasons or basis for them. The report includes copies of all material considered by the committee in addition to…

(a) A color additive advisory committee is subject to all the requirements of the Federal Advisory Committee Act and this part. (b) All interested persons have a right to consult with the color additive advisory committee reviewing a matter and to submit information and views to a color additive advisory committee, in accordance with the procedures in this part.

(a) The members of a color additive advisory committee are selected in the following manner: (1) If a color additive advisory committee is established for purposes that do not include review of an issue arising 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 (a)(2) of this section to select the members or may use an existing standing advisory committee listed in § 14.100, or may establish a new advisory committee under this subpart. Once the Commissioner has established a color additive advisory committee under this paragraph and has referred to it a matter relating to a color additive, no interested person may subsequently request that an additional or different color additive advisory committee be established to review and make recommendations about that color additive. (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 request of an interested person, it shall be established under the following requirements: (i) Except as provided in paragraph (a)(2) (ii) and (iii) of this…

(a) FDA may enter into contracts with independent scientific or technical organizations to obtain advice and recommendations on particular matters, and these organizations may in turn undertake such work through existing or new committees. Whether a particular committee working under such a contract is an advisory committee subject to the Federal Advisory Committee Act and this subpart depends upon application of the criteria and principles in § 14.1(b). (b) The following minimum standards apply to any committee of an independent scientific or technical organization which is working under a contract initially executed with FDA after July 1, 1975, but which is determined not to be an advisory committee: Federal Register04(1) The committee shall give public notice of its meetings and agenda, and provide interested persons an opportunity to submit relevant information and views in writing at any time, and orally at specified times. The notice may be published in the or disseminated by other reasonable means. It is in any event to be filed with the Division of Dockets Management not less than 15 days before the meeting. The time for oral presentations and the extent to which the…

(a) When a matter is referred to a color additive advisory committee, all related costs, including personal compensation of committee members, travel, materials, and other costs, are borne by the person requesting the referral, such costs to be assessed on the basis of actual cost to the government. The compensation of such costs includes personal compensation of committee members at a rate not to exceed $128.80 per member per day. (b) In the case of a request for referral to a color additive advisory committee, a special advance deposit is to be made in the amount of $2,500. Where required, further advances in increments of $2,500 each are to be made upon request of the Commissioner. All deposits for referrals to a color additive 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 Associate Commissioner for Management and Operations, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD…

The standing technical advisory committees for human prescription drugs are established to advise the Commissioner: (a) Generally on the safety and effectiveness, including the labeling and advertising, and regulatory control of the human prescription drugs falling within the pharmacologic class covered by the advisory committee and on the scientific standards appropriate for a determination 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 properly be conducted; (2) A particular drug meets the statutory standard for proof of safety and effectiveness necessary for approval or continued approval for marketing; or (3) A particular drug is properly classified as a new drug, an old drug, or a banned drug.

(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 periodic review by the appropriate standing technical advisory committee for human prescription drugs. The Commissioner's determinations on the agenda of the committee are based upon the priorities of the various matters 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 prescription 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 delivery system or formulation, or which are the subject of major scientific or public controversy, or which may be subject to special regulatory requirements such as a limitation…

Any interested person may request, under § 10.30, that a specific matter relating to a particular human prescription drug be submitted to an appropriate advisory committee for a hearing and review and recommendations. The request must demonstrate the importance of the matter and the reasons why it should be submitted for a hearing at that time. The Commissioner may grant or deny the request.

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 report. The report responds to the specific issues or questions which the Commissioner has addressed to the advisory committee, and states the basis of the advice and recommendations of the committee.

Federal Register04Federal Register04Federal Register.04(a) Before the first of each month, and at least 15 days in advance of a meeting, the Commissioner will publish a notice in the of all advisory committee meetings to be held during the month. Any advisory committee meetings for that month called after the publication of the general monthly notice are to be announced in the on an individual basis at least 15 days in advance. The Commissioner may authorize an exception to these notice requirements in an emergency or for other reasons requiring an immediate meeting of an advisory committee, in which case public notice will be given at the earliest time and in the most accessible form feasible including, whenever possible, publication in the Federal Register04(b) The notice will include— (1) The name of the committee; (2) The date, time, and place of the meeting; (3) The general function of the committee; (4) A list of all agenda items, showing whether each will be discussed in an open or closed portion of the meeting; (5) If any portion of the meeting is closed, a statement of the time of the open and closed portions; (6) The nature of the subjects to be discussed during,…

(a) No advisory committee may conduct a meeting except at the call or with the advance approval of, and with an agenda approved by, the designated Federal employee or alternate. No meeting may be held in the absence of the designated Federal employee. Federal Register04(1) If any matter is added to the agenda after its publication in the under § 14.20(b)(4), an attempt is to be made to inform persons known to be interested in the matter, and the change is to be announced at the beginning of the open portion of the meeting. (2) The advisory committee meeting is to be conducted in accordance with the approved final agenda insofar as practical. (b) Advisory committee meetings will be held at places that are reasonably accessible to the public. All advisory committee meetings will be held in Washington, DC, or Rockville, MD, or the immediate vicinity, unless the Commissioner receives and approves a written request from the advisory committee for a different location. A different 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 committee members will be at the…

An advisory committee meeting has the following portions: The open public hearing.(a) Every committee meeting includes an open portion, which constitutes a public hearing during which interested persons may present relevant information or views orally or in writing. The hearing is conducted in accordance with § 14.29. The open committee discussion.(b) A committee discusses any matter pending 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, consistent with the policy expressed in § 14.27, a committee conducts its discussion of pending matters in an open portion. No public participation is permissible during this portion of the meeting except with the consent of the committee Chairperson. The closed presentation of data.(c) Information prohibited from public disclosure under part 20 and the regulations 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 prohibited from public disclosure, the presentation is to be made in an open portion of a meeting. The closed committee deliberations.(d)…

(a) No committee meeting may be entirely closed. A portion of a meeting may be closed only in accordance with a written determination by the Commissioner under this section. Federal Register04(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 meeting. The reasons for closing a portion of a meeting will be announced in the notice of the meeting under § 14.20 in accordance with the following rules: (1) Any determination to close a portion 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 determines that the closing is permitted under 5 U.S.C. 552b(c), and that the closing is necessary. (3) Portions of meetings may ordinarily be closed if they concern the review, discussion, and evaluation of drafts or…

Federal Register04(a) For each meeting, the open portion 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 determines will facilitate the work of the committee. The notice published under § 14.20 will designate the time specifically reserved for the hearing, which is ordinarily the first portion of the meeting. Further public participation in any open portion of the meeting under § 14.25(b) is solely at the discretion of the Chairperson. (b) An interested person who wishes to be assured of the right to make an oral presentation at a meeting shall inform the Designated Federal Officer or other designated agency employee, orally or in writing, before the meeting. (1) The person shall state the general nature of the presentation and the approximate time desired. Whenever possible, all written information to be discussed by that person at the meeting should be furnished in advance to the Designated Federal Officer or other designated agency employee. This material may be distributed or mailed by FDA to the…

(a) The advisory committee Chairperson 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 interest, 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 hearing or meeting. designated Federal employee(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 who is assigned to the advisory committee. The designated Federal employee is also authorized to adjourn a hearing or meeting if the employee determines adjournment to be in the public interest.

(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 request. (c) A committee may confer with a person who is not a Federal Government 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 employee by the Commissioner as provided 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 matters 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 secrets (18 U.S.C. 208, 21 U.S.C. 331(j), 18 U.S.C. 1905),…

The Commissioner shall prepare and provide to all committee members a compilation of materials bearing upon 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 regulations relating to trade secrets and confidential commercial or financial information that may not be disclosed publicly and a summary of their principal provisions; (c) All applicable laws, regulations, and guidance documents relating to the subject matter covered by the advisory committee and a summary of their principal provisions; Federal Register04(d) All applicable laws, regulations, including the regulations in part 20 of this chapter, advisory committee charters, notices, curricula vitae, rules adopted by the advisory committee, and other material relating to the formation, composition, and operation of the advisory committee, and a summary of their principal 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,…

Federal Register04(a) Ten copies of written submissions to a committee are to be sent to the Designated Federal Officer unless an applicable notice or other regulations in this chapter specify 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. Federal Register04(b) At the request of a committee, or on the Commissioner's own initiative, the Commissioner may issue in the a notice requesting the submission to the committee of written information and views pertinent 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 request the applicant or sponsor of an application or petition about a specific product on which action is pending before FDA, and is being reviewed by an advisory committee, to present or discuss safety, effectiveness, or other data concerning the product during a regularly scheduled meeting of the committee. The request may be for an oral presentation or for a concise, well-organized written…

(a) In addition to these rules, an advisory committee may, with the concurrence of the designated Federal employee, adopt additional rules which are not inconsistent with this subpart or with other legal requirements. (b) Any additional rules will be included in the minutes of the meeting when adopted and in the materials compiled under § 14.33 and will be available for public disclosure under § 14.65(c).

(a) An advisory committee may be established or renewed whenever it is necessary or appropriate for the committee to hold a public hearing and to review and make recommendations on any matter pending before FDA. Except for committees established by statute, before a committee is established or renewed it must first be approved by the Department pursuant to 45 CFR part 11 and by the General Services Administration. Federal Register04(b) When an advisory committee is established or renewed, the Commissioner will issue a notice certifying that the establishment or renewal is in the public interest 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 notice 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 advisory…

(a) An advisory committee is utilized to conduct public hearings on matters of importance that come before FDA, to review the issues involved, and to provide advice and recommendations to the Commissioner. (b) The Commissioner has sole discretion concerning action to be taken and policy to be expressed on any matter considered by an advisory committee.

(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 period. A committee may be renewed for as many 2-year periods as the public interest requires. The requirements for establishment of a committee under § 14.40 also apply to its renewal. Federal Register04(b) FDA will issue a notice announcing the reasons for terminating a committee and, if it is a standing committee, amending § 14.100 to delete it from the list. (c) TEPRSSC is a permanent statutory advisory committee established by section 358(f)(1)(A) of the Public Health Service Act, as added by the Radiation Control for Health and Safety 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, except that a new charter is prepared and filed at the end of each 2-year period as provided in § 14.40(c). Also, the statutory medical device classification panels established under section 513(b)(1) of the FD&C Act (21 U.S.C. 360c(b)(1)) and part 860, and the…

(a) The Designated Federal Officer or other designated agency employee prepares 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 approved 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 following: (1) The time and place of the meeting. (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 written information made available for consideration by the committee at the proceedings. (4) A complete and accurate description of matters discussed and conclusions reached. A description is to be kept separately for the following portions of the meeting to facilitate their public disclosure: The open portions specified in § 14.25 (a) and (b), any closed portion during which a presentation is made under § 14.25(c), and any closed deliberative portion under § 14.25(d). The minutes of a closed deliberative…

(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 administrative record of the committee proceedings. 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 duplication, which will be, where applicable, 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 portion 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.…

(a) Public inquiries on general committee matters, except requests for records, are to be directed to the Committee Management Officer in the Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993. Federal Register04(b) Public inquiries on matters relating to a specific committee, except requests for records, are to be directed to the Designated Federal Officer or the designated agency employee listed in the notices published under § 14.20. http://www.fda.gov(c) Requests for public advisory committee records, including minutes, are to be made, to FDA's Division of Freedom of Information (the Freedom of Information Staff's address is available on the agency's web site at ) under § 20.40 and the related 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]

A person who alleges noncompliance by the Commissioner or an advisory committee with any provision of this part or the Federal Advisory Committee Act may pursue the following administrative remedies: (a) If the person objects to any action, including a failure to act, other than denial of access to an advisory committee document, the person shall submit a petition in the form and in accordance with the requirements of § 10.30. The provisions of § 10.45 relating to exhaustion of administrative remedies are applicable. (1) If the person objects to past action, the person shall submit the petition within 30 days after the action objected to. If the Commissioner determines that there was noncompliance with any provision of this subpart or of the Federal Advisory Committee Act, the Commissioner will grant any appropriate relief and take appropriate steps to prevent its future recurrence. (2) If the person objects to proposed future action, the Commissioner will expedite the review of the petition and make a reasonable effort to render a decision before the action concerned in the petition. (3) If the person objects to action that is imminent or occurring and which could not…

(a) Advice or recommendations of an advisory committee may be given only on matters covered in the administrative record of the committee's proceedings. 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 information considered by the committee. (4) All reports made by the committee. (5) Any reports prepared by a consultant under § 14.31(e). (b) The record of the proceeding is closed at the time the advisory committee renders its advice or recommendations or at any earlier time specified by the committee or in other sections in this chapter.

(a) The administrative record and other committee records are available for public disclosure under part 20, except as provided in paragraph (b) of this section, at the following times: (1) The written information for consideration 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 approved 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 approved by the committee and certified by the Chairperson; and (ii) For a matter directed to be maintained as confidential under § 14.22(i)(2): After the advice or report of the committee relevant to those minutes or portions…

(a) Members of a policy advisory committee— (1) Shall have diverse interests, education, training, and experience; specific technical expertise is not a requirement; (2) Are subject to the conflict of interest laws and regulations either as special Government employees or as members of the uniformed services, including the Commissioned Corps of the Public Health Service (the Commissioner has determined that, because members representing particular interests, e.g., a representative of labor, industry, consumers, or agriculture, are included on advisory committees specifically for the purpose of representing these interests, any financial interest covered by 18 U.S.C. 208(a) in the class which the member represents 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 inconsequential to affect the integrity of their services); and (3) Shall be voting members. Technical advisory committee.(b) (1) Voting members of technical advisory committees— (i) Shall have expertise in the subject matter with which the committee is concerned and have diverse professional education, training, and experience so…

Federal Register04(a) The Commissioner will publish one or more notices in the each year requesting nominations for voting members of all existing standing advisory committees. The notice will invite the submission of nominations for voting members from both individuals and organizations. (b) The notice announcing the establishment 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 include a complete curriculum vitae of the nominee. Nominations are to state that the nominee is aware of the nomination, 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 individuals and not as representatives of any group or organization which nominated them or with which they may be affiliated.

(a) This section applies when the Commissioner concludes that a technical advisory committee should include nonvoting members to represent and serve as a liaison with interested individuals and organizations. (b) Except when the Commissioner concludes otherwise, nonvoting members of a technical advisory committee are selected in accordance with paragraphs (c) and (d) of this section and are normally limited to one person selected by consumer groups and organizations and one person selected by industry groups and organizations. Federal Register04(c) To select a nonvoting member to represent consumer interests, except as provided in paragraph (c)(5) of this section, the Commissioner publishes a notice in the requesting nominations for each specific committee, or subcommittee, for which nonvoting members are to be appointed. (1) A period of 30 days will be permitted for submission of nominations for that committee or subcommittee. Interested persons may nominate one or more qualified persons to represent consumer interests. Although nominations from individuals will be accepted, individuals are encouraged to submit their nominations through consumer organizations as defined in…

(a) A nonvoting member of an advisory committee selected to represent and serve as a liaison with interested individuals, associations, and organizations has the same rights as any other committee member except that— (1) A nonvoting member may vote only on procedural matters such as additional rules adopted under § 14.39(a), approval of minutes under § 14.60(a), decisions on transcripts under § 14.61(b), and future meeting dates; (2) A nonvoting member who is a representative of industry interest may have access to data and information that constitute a trade secret or confidential commercial or financial information 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 advisory 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 nonvoting consumer and industry members of an advisory committee to represent the consumer and industry interests in all deliberations. (1) A nonvoting member does not represent any particular organization or group, but rather represents all interested persons within the class…

In selecting members of an ad hoc advisory committee, the Commissioner may use the procedures in §§ 14.82 and 14.84 or any other procedure deemed appropriate.

(a)(1) Except as provided in paragraphs (a) (2) and (3) of this section, all voting advisory committee members shall, and nonvoting members may, be appointed as special Government employees and receive a consultant fee and be reimbursed for travel expenses, including per diem in lieu of subsistence, unless such compensation and reimbursement are waived. (2) Members of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC) are not appointed as special Government employees. Any member of TEPRSSC who is not a Federal employee or member of the uniformed services, including 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 compensation 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 advisory committees as part of their assigned functions, are not appointed as special government employees, but are reimbursed by the Food and Drug Administration for…