[Federal Register Volume 61, Number 130 (Friday, July 5, 1996)]
[Notices]
[Pages 35229-35231]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17170]
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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
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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:
Medical Imaging Drugs Advisory Committee
-Date, time, and place. July 23, 1996, 8 a.m., Holiday Inn--
Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Ave., Bethesda,
MD.
-Type of meeting and contact person. Open committee discussion, 8
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 5 p.m.; Leander B. Madoo, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-4695, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), Medical Imaging Drugs Advisory Committee, code
12540. Please call the hotline for information concerning any possible
changes.
General function of the committee. The committee reviews and
evaluates data concerning the safety and effectiveness of marketed and
investigational human drug products for use in diagnostic and
therapeutic procedures using radioactive pharmaceuticals and contrast
media used in diagnostic radiology.
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 July 15, 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 continue discussion
and drafting a ``Points to Consider (PTC) Document for Developing
Medical Imaging Agents''. The agents encompassed will include
radiologic contrast media and nuclear medicine pharmaceuticals.
Food Advisory Committee
Date, time, and place. July 25 and 26, 1996, 8:15 a.m., Crystal
Gateway Marriott, Rooms F, G, and H, 1700 Jefferson Davis Hwy.,
Arlington, VA.
Type of meeting and contact person. Open committee discussion, July
25, 1996, 8:15 a.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, July 26, 1996, 8:15 a.m. to 1 p.m.; open public hearing, 1
p.m. to 2 p.m., unless public participation does not last that long;
open committee discussion, 2 p.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. 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 July 19, 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 committee will undertake a
discussion of the final report from the Keystone National Policy
Dialogue on Food, Nutrition, and Health. The focus of this report is on
both NLEA-authorized health claims and other nutrition messages in the
broad context of communicating diet and health information to
consumers. The committee may also consider current issues pertaining to
dietary supplements and the Dietary Supplement Health and Education
Act.
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)
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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, 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, 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: June 28, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-17170 Filed 7-3-96; 8:45 am]
BILLING CODE 4160-01-F
