[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 --