CFR Subpart D

CFR Subpart D
in effect

21 C.F.R. § 14.60 Minutes and reports of advisory committee meetings.

(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 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 reports 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 public who presented oral or written statements. (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 its activities and related matters informative 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.

21 C.F.R. § 14.61 Transcripts of advisory committee 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 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.

21 C.F.R. § 14.65 Public inquiries and requests for advisory committee records.

(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. (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 Federal Register notices published under § 14.20. (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 http://www.fda.gov) under § 20.40 and the related provisions of part 20.

21 C.F.R. § 14.70 Administrative record of a public hearing before an advisory committee.

(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.

21 C.F.R. § 14.75 Examination of administrative record and other advisory committee records.

(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 thereof is acted upon by the Commissioner, or upon a determination by the Commissioner that such minutes or portions thereof may be made available for public disclosure without undue interference with agency or advisory committee operations. (7) Formal advice or a report of the committee: After it has been acted upon, i.e., approved, disapproved, or rejected as inadequate, by the Commissioner, or upon a determination by the Commissioner that such formal advice or report may be made available for public disclosure without undue interference with agency or committee operations. Such formal advice or report may be retained as confidential while it is under active advisement. (8) Any other committee records relating 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 Commissioner, or upon a determination by the Commissioner that the records may be made available for public disclosure without undue interference with agency or committee operations. (b) The following information contained in the administrative record is not available for public examination or copying except as provided in § 12.32(g): (1) Material provided to the committee 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 presentation described in § 14.25(c) and which is prohibited from public disclosure under part 20 and the regulations referenced there. (c) The Dockets Management Staff (HFA-305) will maintain a file for each committee containing the following principal records for ready access by the public: (1) The committee charter. (2) A list of committee members and their curricula vitae. (3) The minutes of committee meetings. (4) Any formal advice or report of the committee.

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