[Federal Register Volume 60, Number 200 (Tuesday, October 17, 1995)]
[Notices]
[Pages 53790-53791]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25766]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: This notice announces a forthcoming meeting of a public
advisory committee of the Food and Drug Administration (FDA). This
notice also summarizes the procedures for the meeting and methods by
which interested persons may participate in open public hearings before
FDA's advisory committees.
FDA has established an Advisory Committee Information Hotline (the
hotline) using a voice-mail telephone system. The hotline provides the
public with access to the most current information on FDA advisory
committee meetings. The advisory committee hotline, which will
disseminate current information and information updates, can be
accessed by dialing 1-800-741-8138 or 301-443-0572. Each advisory
committee is assigned a 5-digit number. This 5-digit number will appear
in each individual notice of meeting. The hotline will enable the
public to obtain information about a particular advisory committee by
using the committee's 5-digit number. Information in the hotline is
preliminary and may change before a meeting is actually held. The
hotline will be updated when such changes are made.
MEETING: The following advisory committee meeting is announced:
Food Advisory Committee and Working Group
Date, time, and place. November 14, 1995, 12:30 p.m., November 15
and 16, 1995, 8:15 a.m., and November 17, 1995, 8:30 a.m., Holiday Inn,
Eisenhower Metro Center, 2460 Eisenhower Ave., Alexandria, VA.
Type of meeting and contact person. Open working group committee
discussion, November 14, 1995, 12:30 p.m. to 5 p.m.; open public
hearing, 5 p.m. to 6 p.m., unless public participation does not last
that long; open working group committee discussion, November 15, 1995,
8:15 a.m. to 6 p.m.; open working group committee discussion, November
16, 1995, 8:15 a.m. to 6 p.m.; additional brief opportunities for
public hearings may be provided throughout the November 15 and 16,
1995, discussions; open committee discussion, November 17, 1995, 8:30
a.m. to 8:45 a.m.; open public hearing, 8:45 a.m. to 9:45 a.m., unless
public participation does not last that long; open committee
discussion, 9:45 a.m. to 4 p.m.; Lynn A. Larsen, Center for Food Safety
and Applied Nutrition (HFS-5), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, 202-205-4727, or Catherine M. DeRoever,
Advisory Committee Staff (HFS-22), 202-205-4251, FAX 202-205-4970, or
FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Food Advisory Committee, code 10564.
General function of the committee. The committee provides advice on
emerging food safety, food science, and nutrition issues that FDA
considers of primary importance in the next decade.
Agenda--Open public hearing. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. Those desiring to make formal presentations should
notify the contact person by close of business November 8, 1995, and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time required to
make their comments. If necessary, comments may be limited to 5
minutes.
Open committee discussion. A working group of the Food Advisory
Committee will undertake a scientific discussion of the safety review
that has been conducted for olestra for its intended use as a fat
replacer in savory snacks. Olestra is a sucrose polyester formed with
long chain fatty acids. The working group will be asked to comment on
whether all relevant issues associated with olestra have been
addressed. The discussion will cover all aspects of the safety review,
including nutrient effects and compensation, gastrointestinal tract
effects, and labeling. The Food Advisory Committee will discuss the
actions and recommendations of its ephedra and olestra working groups,
which met on October 11 and 12, 1995, and which are scheduled to meet
November 14 through 16, 1995, respectively. The recommendations of the
working groups, together with any amendatory comments from the
committee, will be formally referred to FDA. More detailed information
regarding the meeting agenda that may become available prior to the
meeting will be provided to the public via the 800 number given above.
FDA public advisory committee meetings may have as many as four
separable portions: (1) An open public hearing, (2) an open committee
discussion, (3) a closed presentation of data, and (4) a closed
committee deliberation. Every advisory committee meeting shall have an
open public hearing portion. Whether or not it also includes any of the
other three portions will depend upon the specific meeting involved.
There are no closed portions
[[Page 53791]]
for the meetings announced in this notice. The dates and times reserved
for the open portions of each committee meeting are listed above.
The open public hearing portion of each meeting shall be at least 1
hour long unless public participation does not last that long. It is
emphasized, however, that the 1 hour time limit for an open public
hearing represents a minimum rather than a maximum time for public
participation, and an open public hearing may last for whatever longer
period the committee chairperson determines will facilitate the
committee's work.
Public hearings are subject to FDA's guideline (subpart C of 21 CFR
part 10) concerning the policy and procedures for electronic media
coverage of FDA's public administrative proceedings, including hearings
before public advisory committees under 21 CFR part 14. Under 21 CFR
10.205, representatives of the electronic media may be permitted,
subject to certain limitations, to videotape, film, or otherwise record
FDA's public administrative proceedings, including presentations by
participants.
Meetings of advisory committees shall be conducted, insofar as is
practical, in accordance with the agenda published in this Federal
Register notice. Changes in the agenda will be announced at the
beginning of the open portion of a meeting.
Any interested person who wishes to be assured of the right to make
an oral presentation at the open public hearing portion of a meeting
shall inform the contact person listed above, either orally or in
writing, prior to the meeting. Any person attending the hearing who
does not in advance of the meeting request an opportunity to speak will
be allowed to make an oral presentation at the hearing's conclusion, if
time permits, at the chairperson's discretion.
The agenda, the questions to be addressed by the committee, and a
current list of committee members will be available at the meeting
location on the day of the meeting.
Transcripts of the open portion of the meeting may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857,
approximately 15 working days after the meeting, at a cost of 10 cents
per page. The transcript may be viewed at the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857, approximately 15 working days after the meeting,
between the hours of 9 a.m. and 4 p.m., Monday through Friday. Summary
minutes of the open portion of the meeting may be requested in writing
from the Freedom of Information Office (address above) beginning
approximately 90 days after the meeting.
This notice is issued under section 10(a)(1) and (2) of the Federal
Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR
part 14) on advisory committees.
Dated: October 12, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-25766 Filed 10-12-95; 4:41 pm]
BILLING CODE 4160-01-P --
