Public hearing before a public board of inquiry (21 CFR 13.1-13.50)

192 21 CFR Ch. I (4–1–16 Edition) § 12.159 § 12.159 Copies of petitions for judicial review. The Chief Counsel for FDA has been designated by the Secretary as the offi cer on whom copies of petitions of judi cial review are to be served. This offi cer is responsible for filing the record on which the final decision is based. The record of the proceeding is cer tified by the Commissioner. PART 13—PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY Subpart A—General Provisions Sec. 13.1 Scope. 13.5 Notice of a hearing before a Board. 13.10 Members of a Board. 13.15 Separation of functions; ex parte com munications; administrative support. Subpart B—Hearing Procedures 13.20 Submissions to a Board. 13.25 Disclosure of data and information by the participants. 13.30 Proceedings of a Board. Subpart C—Records of a Hearing Before a Board 13.40 Administrative record of a Board. 13.45 Examination of administrative record. 13.50 Record for administrative decision. AUTHORITY: 5 U.S.C. 551–558, 701–721; 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 22348, Apr. 13, 1979, unless otherwise noted. Subpart A—General Provisions § 13.1 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 hold a public hearing before a Public Board of Inquiry (Board) with respect to any matter be fore FDA; (b) Under specific sections of this chapter a matter before FDA is subject to a hearing before a Board; or (c) Under § 12.32, a person who has a right to an opportunity for a formal evidentiary public hearing waives that opportunity and requests that a Board act as an administrative law tribunal concerning the matters involved, and the Commissioner decides to accept this request. § 13.5 Notice of a hearing before a Board. If the Commissioner determines that a Board should be established to con duct a hearing on any matter, a notice of hearing will be published in the FED ERAL REGISTER setting forth the fol lowing information: (a) If the hearing is under § 13.1 (a) or (b), all applicable information de scribed in § 12.32(e). (1) Any written document that is to be the subject matter of the hearing will be published as a part of the no tice, or the notice will refer to it if the document has already been published in the FEDERAL REGISTER or state that the document is available from the Di vision of Dockets Management or an agency employee designated in the no tice. (2) For purposes of a hearing under § 13.1 (a) or (b), all participants who file a notice of participation under § 12.32(e)(6)(ii) are deemed to be parties and entitled to participate in selection of the Board under § 13.15(b). (b) If the hearing is in lieu of a for mal evidentiary hearing, as provided in § 13.1(c), all of the information de scribed in § 12.32(e). [44 FR 22348, Apr. 13, 1979, as amended at 47 FR 26375, June 18, 1982] § 13.10 Members of a Board. (a) All members of a Board are to have medical, technical, scientific, or other qualifications relevant to the issues to be considered, are subject to the conflict of interest rules applicable to special Government employees, and are to be free from bias or prejudice concerning the issues involved. A mem ber of a Board may be a full-time or part-time Federal Government em ployee or may serve on an FDA advi sory committee but, except with the agreement of all parties, may not cur rently be a full-time or part-time em ployee of FDA or otherwise act as a special Government employee of FDA. (b) Within 30 days of publication of the notice of hearing, the director of the center of FDA responsible for a VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00202 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 193 Food and Drug Administration, HHS § 13.15 matter before a Board, the other par ties to the proceeding, and any person whose petition was granted and is the subject of the hearing, shall each sub mit to the Division of Dockets Manage ment the names and full curricula vitae of five nominees for members of the Board. Nominations are to state that the nominee is aware of the nomi nation, is interested in becoming a member of the Board, and appears to have no conflict of interest. (1) Any two or more persons entitled to nominate members may agree upon a joint list of five qualified nominees. (2) The lists of nominees must be sub mitted to the persons entitled to sub mit a list of nominees under this para graph but not to all participants. With in 10 days of receipt of the lists of nominees, such persons may submit comments to the Division of Dockets Management on whether the nominees of the other persons meet the criteria established in paragraph (a) of this sec tion. A person submitting comments to the Division of Dockets Management shall submit them to all persons enti tled to submit a list of nominees. (3) The lists of nominees and com ments on them are to be held in con fidence by the Division of Dockets Management as part of the administra tive record of the proceeding and are not to be made available for public dis closure, and all persons who submit or receive them shall similarly hold them in confidence. This portion of the ad ministrative record remains confiden tial but is available for judicial review in the event that it becomes relevant to any issue before a court. (c) After reviewing the lists of nomi nees and any comments, the Commis sioner will choose three qualified per sons as members of a Board. One mem ber will be from the lists of nominees submitted by the director of the center and by any person whose petition was granted and is the subject of the hear ing. The second will be from the lists of nominees submitted by the other par ties. The Commissioner may choose the third member from any source. That member is the Chairman of the Board. (1) If the Commissioner is unable to find a qualified person with no conflict of interest from among a list of nomi nees or if additional information is needed, the Commissioner will request the submission of the required addi tional nominees or information. (2) If a person fails to submit a list of nominees as required by paragraph (b) of this section, the Commissioner may choose a qualified member without fur ther consultation with that person. (3) The Commissioner will announce the members of a Board by filing a memorandum in the record of the pro ceeding and sending a copy to all par ticipants. (d) Instead of using the selection method in paragraphs (b) and (c) of this section, the director of the center, the other parties to the proceeding, and any person whose petition was granted and is the subject of the hearing, may, with the approval of the Commissioner, agree that a standing advisory com mittee listed in § 14.80 constitutes the Board for a particular proceeding, or that another procedure is to be used for selection of the members of the Board, or that the Board consists of a larger number of members. (e) The members of a Board serve as consultants to the Commissioner and are special Government employees or Government employees. A Board func tions as an administrative law tribunal in the proceeding and is not an advi sory committee subject to the require ments of the Federal Advisory Com mittee Act or part 14. (f) The Chairman of the Board has the authority of a presiding officer set out in § 12.70. [44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985] § 13.15 Separation of functions; ex parte communications; administra tive support. (a) The proceeding of a Board are subject to the provisions of § 10.55 relat ing to separation of functions and ex parte communications. Representa tives of the participants in any pro ceeding before a Board, including any members of the office of the Chief Counsel of FDA assigned to advise the center responsible for the matter, may have no contact with the members of the Board, except as participants in the proceeding, and may not participate in the deliberations of the Board. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00203 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 194 21 CFR Ch. I (4–1–16 Edition) § 13.20 (b) Administrative support for a Board is to be provided only by the of fice of the Commissioner and the office of the Chief Counsel for FDA. [44 FR 22348, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989] Subpart B—Hearing Procedures § 13.20 Submissions to a Board. (a) Submissions are to be filed with the Division of Dockets Management under § 10.20. (b) The person making a submission shall serve copies of it on each partici pant in the proceeding, except as pro vided in §§ 13.10(b)(2) and 13.45. Submis sions of documentary data and infor mation need not be sent to each partic ipant, but any accompanying trans mittal letter, summary, statement of position, certification under paragraph (d) of this section, or similar document must be. (c) A submission must be mailed to the address shown in the notice of ap pearance or personally delivered. (d) All submissions are to be accom panied by a certificate of service, or a statement that service is not required. (e) No written submission or other portion of the administrative record may be held in confidence, except as provided in §§ 13.10(b)(2) and 13.45. (f) A participant who believes that compliance with the requirements of this section constitutes an unreason able financial burden may submit to the Commissioner a petition to partici pate in forma pauperis in the form and manner specified in § 12.82. § 13.25 Disclosure of data and informa tion by the participants. (a) Before the notice of hearing is published under § 13.5, the director of the center responsible for the matters involved in the hearing must submit to the Division of Dockets Management— (1) The relevant portions of the exist ing administrative record of the pro ceeding. Portions of the administrative record not relevant to the issues in the hearing are not part of the administra tive record; (2) A list of all persons whose views will be presented orally or in writing at the hearing; (3) All documents in the director’s files containing factual information, whether favorable or unfavorable to the director’s position, which relate to the issues involved in the hearing. Files means the principal files in the center in which documents relating to the issues in the hearing are ordinarily kept, e.g., the food additive master file and the food additive petition in the case of issues concerning a food addi tive, or the new drug application in the case of issues concerning a new drug. Internal memoranda reflecting the de liberative process, and attorney work product and material prepared specifi cally for use in connection with the hearing, are not required to be sub mitted; (4) All other documentary informa tion relied on; and (5) A signed statement that, to the best of the director’s knowledge and belief, the submission complies with this section. (b) Within the time prescribed in the notice of hearing published under § 13.5, each participant shall submit to the Division of Dockets Management all information specified in paragraph (a)(2) through (5) of this section and any objections that the administrative record filed under paragraph (a)(1) of this section is incomplete. With re spect to the information specified in paragraph (a)(3) of this section, partici pants are to exercise reasonable dili gence in identifying documents in files comparable to those described in that paragraph. (c) The submissions required by para graphs (a) and (b) of this section may be supplemented later in the pro ceeding, with the approval of the Board, on a showing that the views of the persons or the material contained in the supplement was not known or reasonably available when the initial submission was made or that the rel evance of the views of the persons or the material contained in the supple ment could not reasonably have been foreseen. (d) The failure to comply substan tially and in good faith with this sec tion in the case of a participant con stitutes a waiver of the right to par ticipate further in the hearing and in VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00204 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 195 Food and Drug Administration, HHS § 13.30 the case of a party constitutes a waiver of the right to a hearing. (e) The Chairman rules on questions relating to this section. Any partici pant dissatisfied with a ruling may pe tition the Commissioner for interlocu tory review. [44 FR 22348, Apr. 13, 1979, as amended at 50 FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989] § 13.30 Proceedings of a Board. (a) The purpose of a Board is to re view medical, scientific, and technical issues fairly and expeditiously. The proceedings of a Board are conducted as a scientific inquiry rather than a legal trial. (b) A Board may not hold its first hearing until after all participants have submitted the information re quired by § 13.25. (c) The Chairman calls the first hear ing of the Board. Notice of the time and location of the first hearing is to be published at least 15 days in advance and the hearing will be open to the public. All participants will have an opportunity at the first hearing to make an oral presentation of the infor mation and views which in their opin ion are pertinent to the resolution of the issues being considered by a Board. A participant’s presentation may be made by more than one person. The Chairman determines the order of the presentation. Participants may not in terrupt a presentation, but members of the Board may ask questions. At the conclusion of a presentation, each of the other participants may briefly comment on the presentation and may request that the Board conduct further questioning on specified matters. Mem bers of the Board may then ask further questions. Any other participant may be permitted to ask questions if the Chairman determines that it will help resolve the issues. (d) The hearing is informal and the rules of evidence do not apply. No 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 all such information and views. No participant may interrupt the pres entation of another participant for any reason. (e) Within the time specified by the Board after its first hearing, partici pants may submit written rebuttal in formation and views in accordance with § 13.20. The Chariman will then schedule a second hearing, if requested and justified by a participant. A second hearing, and any subsequent hearing, will be called only if the Chairman con cludes that it is needed to fully and fairly present information that cannot otherwise adequately be considered and to properly resolve the issues. Notice of the time and location of any hearing is to be published at least 15 days in ad vance. The hearing is open to the pub lic. (f) A Board may consult with any person who it concludes may have in formation or views relevant to the issues. (1) The consultation may occur only at an announced hearing of a Board. Participants have the right to suggest or, with the permission of the Chair man, ask questions of the consultant and present rebuttal information and views, as provided in paragraphs (c) and (d) of this section except that writ ten statements may be submitted to the Board with the consent of all par ticipants. (2) A participant may submit a re quest that the Board consult with a specific person who may have informa tion or views relevant to the issues. The request will state why the person should be consulted and why the per son’s views cannot be furnished to the Board by means other than having FDA arrange for the person’s appear ance. The Board may, in its discretion, grant or deny the request. (g) All hearings are to be transcribed. All hearings are open to the public, ex cept that a hearing under § 10.20(j)(3) is closed to all persons except those per sons making and participating in the presentation and Federal Government executive branch employees and spe cial Government employees. At least a majority of Board members are to be present at every hearing. The executive sessions of a Board, during which a Board deliberates on the issues, are to be closed and are not transcribed. All members of the Board shall vote on the report of the Board. VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00205 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 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