[Federal Register Volume 60, Number 94 (Tuesday, May 16, 1995)]
[Notices]
[Pages 26036-26038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12019]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committees; Notice of Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: This notice announces forthcoming meetings of public advisory 
committees of the Food and Drug Administration (FDA). This notice also 
summarizes the procedures for the meetings 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.
MEETINGS: The following advisory committee meetings are announced:
Endocrinologic and Metabolic Drugs Advisory Committee
     Date, time, and place. June 1, 1995, 8 a.m., Holiday Inn--Silver 
Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
     Type of meeting and contact person. Open public hearing, 8 a.m. to 
9 a.m., unless public participation does not last that long; open 
committee discussion, 9 a.m. to 5 p.m.; Kathleen R. Reedy, Center for 
Drug Evaluation and Research (HFD-9), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-443-5455, FAX 301-443-0699, 
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Endocrinologic and Metabolic Drugs 
Advisory Committee, code 12536.
     General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness of marketed and 
investigational human drugs for use in endocrine and metabolic 
disorders.
    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 before May 26, 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.
     Open committee discussion. The committee will hear presentations 
and discuss data submitted regarding the safety and efficacy of 
acarbose, new drug application 20-482, (Precose<Register>, Bayer 
Corp.), for a non-insulin dependent diabetes mellitus indication.
Working Group Meeting of the Food Advisory Committee
    Date, time, and place. June 7 and 8, 1995, 8:30 a.m., Days Inn--
Downtown Convention Center, 1201 K St. NW., Washington, DC.
     Type of meeting and contact person. Open working group discussion, 
June 7, 1995, 8:30 a.m. to 4 p.m.; open public hearing, 4 p.m. to 5:30 
p.m., unless public participation does not last that long; open working 
group discussion, June 8, 1995, 8:30 a.m. to 12 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 [[Page 26037]] 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 before May 31, 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 working group discussion. The working group will consider 
whether foods containing substances that may cause serious adverse 
gastrointestinal effects, such as laxation, present a significant 
concern such that consumer education or special labeling for these 
foods would be appropriate options for FDA to pursue. 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.
Food Advisory Committee
     Date, time, and place. June 8, 1995, 1 p.m., and June 9, 1995, 
8:30 a.m., Days Inn--Downtown Convention Center, 1201 K St. NW., 
Washington, DC.
    Type of meeting and contact person. Open committee discussion, June 
8, 1995, 1 p.m. to 4 p.m.; open public hearing, 4 p.m. to 5 p.m., 
unless public participation does not last that long; open committee 
discussion, June 9, 1995, 8:30 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 before May 31, 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. The committee will consider the actions 
and recommendations of two special working groups regarding: (1) An 
educational campaign on Vibrio vulnificus, and (2) certain food 
products that may cause unexpected gastrointestinal effects. The 
committee will also discuss with FDA staff, future food safety 
strategies for the agency. 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.
National Task Force on AIDS Drug Development
    Date, time, and place. June 29, 1995, 9 a.m., and June 30, 1995, 
8:30 a.m., Omni Shoreham Hotel, Diplomat Room, 250 Calvert St. NW., 
Washington, DC.
    Type of meeting and contact person. Open task force discussion, 
June 29, 1995, 9 a.m. to 4:30 p.m.; open public hearing, 4:30 p.m. to 
5:30 p.m., unless public participation does not last that long; open 
task force discussion, June 30, 1995, 8:30 a.m. to 11:30 a.m.; Heidi C. 
Marchand or Kimberley M. Miles, Office of AIDS and Special Health 
Issues (HF-12), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-0104, or the FDA Advisory Committee 
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), National Task Force on AIDS Drug Development, code 12602.
    General function of the task force. The task force shall identify 
any barriers and provide creative options for the rapid development and 
evaluation of treatments for human immunodeficiency virus (HIV) 
infection and its sequelae. It also advises on issues related to such 
barriers, and provides options for the elimination of these barriers.
    Open task force discussion. The task force will meet to discuss 
incentives and disincentives for private investment and collaboration 
in drug discovery and development for HIV/acquired immune deficiency 
syndrome (AIDS).
    Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the task force. Those desiring to make formal presentations should 
notify the contact person before June 5, 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.
    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 person attending the hearing who 
does [[Page 26038]] 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: May 10, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-12019 Filed 5-15-95; 8:45 am]
BILLING CODE 4160-01-F