[Federal Register Volume 61, Number 156 (Monday, August 12, 1996)]
[Notices]
[Pages 41794-41795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20523]


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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

    Date, time, and place. August 27 and 28, 1996, 8:15 a.m., Marriott 
Hotel-Metro Center, Grand Ballroom Salons A, B, and C, 775 12th St. 
NW., Washington, DC.
    Type of meeting and contact person. Open committee discussion, 
August 27, 1996, 8:15 a.m. to 3 p.m.; open public hearing, 3 p.m. to 5 
p.m., unless participation does not last that long; open committee 
discussion, August 28, 1996, 8:15 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 (address above), 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. Please call the hotline for 
information concerning any possible changes.
    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 August 21, 1996, 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. The Food Advisory Committee and the 
Ephedra Working Group will discuss the actions and recommendations made 
by the working group during its October 11 and 12, 1995, meeting. 
Additional information that has become available to FDA since that time 
will also be presented during the meeting. The committee will be asked 
to consider the original working group's recommendations in light of 
this new information.
    -Under 21 CFR 14.20 and 14.35, interested persons may submit 
written information or views on the matter(s) before the committee. 
Voluminous data are to be accompanied by a summary. Submissions must be 
made to the Executive Secretary and not directly to any committee 
members. Substantive submissions received at least 3 weeks prior to a 
meeting may be included in members' briefing materials; submissions 
received later will be distributed at the committee meeting. All 
submissions that include copyrighted materials must be accompanied by 
documented permission for duplication and distribution at no copyright 
expense to FDA.
    -At least 50 copies of each submission must be provided; sufficient 
additional copies may be requested by the agency for distribution to 
the public at a meeting. Fewer copies of voluminous submissions will be 
required; only summaries of such submissions will be provided to 
committee members, with complete copies of submissions being made 
available for circulation among committee members and for viewing by 
the public at a meeting.
    -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 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

[[Page 41795]]

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, 5600 Fishers Lane, rm. 12A-16, 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, 12420 Parklawn Dr., rm. 1-23, 
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: August 6, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 96-20523 Filed 8-9-96; 8:45 am]
BILLING CODE 4160-01-F