[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR14.60]

[Page 156-157]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE--Table of Contents
 
 Subpart D--Records of Meetings and Hearings Before Advisory Committees
 
Sec. 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 Sec. 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 Sec. 14.25 (a) and (b), any closed 
portion during which a presentation is made under Sec. 14.25(c), and any 
closed deliberative portion under Sec. 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 
Sec. 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

[[Page 157]]

disclosure under Sec. 14.75(a)(6)(i), or (2) if under 
Sec. 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]