from the lists of nominees submitted by the director of the bureau responsible for the matter and by any person whose petition is the subject of the hearing. The second member shall be chosen from the lists of nominees submitted by the other parties. The Commissioner shall then choose the third member from any source, who shall be the Chairman of the Board. (1) If the Commissioner is unable to find a qualified person with no conflict of interest from among a list of nominees submitted, or if additional information is needed, the Commissioner shall request once from the party involved the submission of such additional nominees or information as is necessary to choose a qualified member of the Board nominated by that person. (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 person in lieu of a person nominated by that person without further consultation with that person. (3) The Commissioner shall announce the members of a Board by filing a memorandum in the record of the proceeding and sending a copy to each participant who has filed a notice of appearance. (d) In lieu of the procedure for selection of the members of a Board specified in paragraphs (b) and (c) of this section, the director of the bureau, the other party or parties to the proceeding, and any person whose petition is the subject of the hearing, may, with the approval of the Commissioner, agree that any standing advisory committee listed in § 14.80 of this chapter shall constitute the Board for a particular proceeding, or that another procedure shall be used for selection of the members of the Board, or that the Board shall consist of a larger number of members. (e) The members of a Board shall serve as consultants to the Commissioner and shall be special government employees or government employees. A Board shall function as an administrative law tribunal in the proceeding and is not an advisory committee subject to the requirements of the Feder al Advisory Committee Act or Part 14 of this chapter. (f) The chairman of a Board shall have the authority of a presiding officer set out in § 12.70 of this chapter. § 13.15 Separation of functions; ex parte communications; administrative sup port. (a) All proceedings of a Board shall be subject to the provisions of § 10.55 of this chapter, relating to separation of functions and ex parte communications. Representatives of the participants in any proceeding before a Board, including any members of the Office of the Chief Counsel of the Food and Drug Administration assigned to advise the bureau responsible for the matter, shall have no contact with the members of the Board, except as participants in such proceeding, and shall not participate in the deliberations of the Board. (b) Administrative support for a Board shall be provided only by the office of the Commissioner and the Office of the Chief Counsel for the Food and Drug Administration. Subpart B-Public Board of Inquiry Hearing Procedures § 13.20 Submissions to a Public Board of Inquiry. (a) All submissions relating to a hearing before a Board shall be filed with the Hearing Clerk pursuant to § 10.20 of this chapter. (b) A copy of any such submission shall be sent by the person making the submission to each participant in the proceeding, except as provided in §§ 13.10(b)(3) and 13.45 and except that submissions of documentary data and information may but are not required to be sent to each participant. Any transmittal letter, summary, statement of position, certification pursuant to paragraph (d) of this section, or similar document accompanying a submission of documentary data and information shall be sent to each participant pursuant to this paragraph. (c) Any such submission shall be sent as required by paragraph (b) of this section by mailing it to the address shown in the notice of appearance or by personal delivery. (d) All submissions pursuant to this section shall be accompanied by a signed certification stating the extent to which the submission has been served on each participant, or is exempt from such service, pursuant to paragraph (b) of this section. (e) No written submission or other portion of the administrative record shall be held in confidence, except as provided in §§ 13.10(b)(3) and 13.45. (f) Any participant who believes that compliance with the requirements of this section constitutes an unreasonable financial burden may submit to the Commissioner a petition to participate in forma pauperis. (1) Such petition shall be pursuant to § 10.30 of this chapter, except that the heading shall be "REQUEST TO PARTICIPATE IN FORMA PAUPERIS, DOCKET NO. — Pursuant to the guidelines established in § 20.43 (b) and (c) of this chapter, such petition shall demonstrate that either (i) the person is indigent and his participation has a strong public interest justification, or (ii) such participation is in the public interest because it can be considered primarily as benefiting the general public. (2) If the Commissioner grants such petition, the participant shall be permitted to file only one copy of each submission with the Hearing Clerk, and it shall be the responsibility of the Hearing Clerk to make sufficient additional copies for the administrative record and to serve a copy upon each other participant. § 13.25 Disclosure of data and information by the participants. (a) Before the notice of hearing is published pursuant to § 13.5, the director of the bureau responsible for the matters involved in the hearing shall submit to the Hearing Clerk: (1) The relevant portions of the existing administrative record of the proceeding. Those portions of the administrative record of the proceeding which are not relevant to the issues to be considered at the public hearing shall not be submitted to the Hearing Clerk or placed on public display and shall not be part of the administrative record of the proceeding. (2) A list of all persons whose views will be presented orally or in writing at the hearing. (3) All documents in his files containing factual data and information, whether favorable or unfavorable to his position, which relate to the issues involved in the hearing. (4) All other documentary data and information on which he relies. (5) A signed statement that, to the best of his knowledge and belief, the submission complies with the requirements of this section. (b) Within the time prescribed in the notice of hearing published pursuant to § 13.5, each participant shall submit to the Hearing Clerk all data and information specified in paragraph (a) (2) through (5) of this section, and any objections with respect to the completeness of the administrative record filed pursuant to paragraph (a)(1) of this section. (c) The submissions required by paragraphs (a) and (b) of this section may be supplemented later in the proceeding, with the approval of the Board, upon a showing that the views of the persons or the material contained in the supplement were not known or reasonably available when the initial submission was made or that the relevance of the views of the persons or the material contained in the supplement could not reasonably have been foreseen. (d) The failure to comply with the provisions of this section in the case of a participant shall constitute a waiver of the right to participate further in the hearing and in the case of a party shall constitute a waiver of the right to a hearing. (e) The Chairman of the Board shall rule on questions relating to this section. Any participant dissatisfied with any such ruling may petition the Commissioner for interlocutory review of that ruling. § 13.30 Proceedings of a Public Board of Inquiry. (a) The purpose of a Board is to review medical, scientific, and techni cal issues fairly and expeditiously in order to reach a reasonable decision that is sound from a medical, scientific, and technical standpoint. The proceedings of a Board shall be conducted in the manner of a scientific inquiry rather than as a legal trial. (b) Prior to the first hearing of a Board, all participants in the hearing shail have submitted to the Hearing Clerk the data and information required to be disclosed pursuant to § 13.25, subject to the sanctions specified in § 13.25(d). (c) The Chairman of a Board shall call the first hearing of the Board at a reasonable time subsequent to receipt of the data and information specified in paragraph (b) of this section. Notice of the time and location of such hearing shall be published in the FEDERAL REGISTER at least 15 days in advance and the hearing shall be open to the public. The director of the bureau responsible for the matter, the other parties, and all other participants shall have an opportunity at the first hearing to make an oral presentation of the data, information, and views which in their opinion are pertinent to resolution of the issues being considered by a Board. The Chairman shall determine the order in which these presentations shall be made. Each initial presentation shall be made without interruption from other participants, but members of the Board may ask any questions that they wish. At the conclusion of each presentation, each of the other participants may briefly state questions and criticism of the presentation and may request that the Board conduct further questioning with respect to specified matters. The Chairman and members of the Board may then ask further questions, and the Chairman may permit any other participant in the proceeding to ask questions if he determines this will facilitate resolution of the issues. (d) The hearing shall be informal in nature, and the rules of evidence shall not apply. No motions or objections relating to the admissibility of data, information, and views shall be made or considered, but other participants may comment upon or rebut all such data, information, and views. No participant may interrupt the presentation of another participant for any reason. (e) Within the time specified by a Board after its first hearing is concluded, each participant in the proceeding may submit in writing such rebuttal data, information, and views as he believes relevant to the issues, in accordance with the requirements of § 13.30. The Chairman of the Board shall thereafter schedule a second hearing if requested and justified by any participant. A second hearing, and any subsequent hearing, shall be called only if the Chairman concludes that it is necessary for the full and fair presentation of information that cannot otherwise adequately be considered and for the proper resolution of the issues involved. Notice of the time and location of any such subsequent hearings shall be published in the FEDERAL REGISTER at least 15 days in advance of the date of such hearing and the hearings shall be open to the public. (f) A Board may consult with any person who it concludes may have data, information, or views relevant to resolution of the issues involved. (1) Such consultation shall occur only at an announced hearing of a Board, and all participants shall have the right to be present and to suggest or, with the permission of the Chairman, conduct questioning of such consultant and to present rebuttal data, information, and views, as provided in paragraphs (c) and (d) of this section, except that written statements may be submitted to the Board with the consent of all participants. (2) Any participant may submit to the Board a request that it consult with a specific person who may have data, information, or views relevant to the resolution of the issues. Such requests shall state the reasons why the person named should be consulted and why the views of that person cannot reasonably be furnished to the Board by any means other than having the Food and Drug Administration arrange for his appearance at a hearing of the Board. The Board may, in its discretion, grant or deny such a request. (g) All hearings of a Board at which data, information, and views are pre |