[Federal Register Volume 61, Number 27 (Thursday, February 8, 1996)]
[Notices]
[Pages 4783-4785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2664]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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:
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory 
Committee
    -Date, time, and place. February 26, 1996, 8:30 a.m., Corporate 
Bldg., 9200 Corporate Blvd., rm. 020B, Rockville, MD. A limited number 
of overnight accommodations have been reserved at the Gaithersburg 
Marriott Washingtonian Center. Attendees requiring overnight 
accommodations may contact the hotel at 301-590-0044 and reference FDA 
Panel meeting block. Reservations will be confirmed at the group rate 
based on availability. Attendees with a disability requiring special 
accommodations should contact Sociometrics, Inc., 301-608-2151. The 
availability of appropriate accommodations cannot be assured unless 
prior written notification is received.
    -Type of meeting and contact person. Open public hearing, 8:30 a.m. 
to 9:30 a.m., unless public participation does not last that long; open 
committee discussion, 9:30 a.m. to 5 p.m.; Alfred W. Montgomery, Center 
for Devices and Radiological Health (HFZ-470), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1180, or FDA Advisory Committee Information Hotline, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), Obstetrics and Gynecology 
Devices Panel, code 12524.
    General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness of marketed and 
investigational devices and makes recommendations for their regulation.

[[Page 4784]]

    -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 February 10, 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.
    -Open committee discussion. The committee will discuss general 
issues relating to a premarket approval application for a tubal 
occlusion device for female sterilization. The committee will also be 
presented with data from the Centers for Disease Control on the U.S. 
Collaborative Review of Sterilization, ``CREST'' study.
Food Advisory Committee
    -Date, time, and place. February 28 and 29, 1996, 8 a.m., Holiday 
Inn--Alexandria (formerly the Old Colony Inn), Commonwealth Ballrooms C 
and D, 625 First St., Alexandria, VA.
    -Type of meeting and contact person. Open committee discussion, 
February 28, 1996, 8 a.m. to 3:45 p.m.; open public hearing, 3:45 p.m. 
to 5:15 p.m., unless public participation does not last that long; open 
committee discussion, February 29, 1996, 8 a.m. to 1:15 p.m.; open 
public hearing, 1:15 p.m. to 1:45 p.m., unless public participation 
does not last that long; open committee discussion, 1:45 p.m. to 5 
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 February 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. Comments may be limited to 5 minutes.
    -Open committee discussion. The committee will discuss the agency's 
responses to public comments on its 1992 policy for labeling, 
notification, testing, and allergenicity of foods derived from new 
plant varieties. The primary focus of the meeting will be a discussion 
of the status of labeling policies, both domestic and international, 
for foods derived using biotechnology. The committee will also discuss 
the actions and recommendations of its ephedra working group, which met 
on October 11 and 12, 1995. The recommendations of the working group, 
together with any amendatory comments from the committee, will be 
formally referred to FDA. If time permits, the committee will discuss 
FDA's concern about adverse health effects resulting from consumption 
of a fish known as escolar (also called oil fish, castor oil fish, or 
purgative fish), which is found in tropical or subtropical seas.
    -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 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 

[[Page 4785]]
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: February 2, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-2664 Filed 2-7-96; 8:45 am]
BILLING CODE 4160-01-F