TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

subpart d - RECORDS OF MEETINGS AND HEARINGS BEFORE ADVISORY COMMITTEES

14.60 - Minutes and reports of advisory committee meetings.

  (a) The executive secretary 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 chairman. 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 executive secretary 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.

[44 FR 22351, Apr. 13, 1979, as amended at 45 FR 85725, Dec. 30, 1980]