[Federal Register Volume 59, Number 200 (Tuesday, October 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25945]
[[Page Unknown]]
[Federal Register: October 18, 1994]
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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.
MEETINGS: The following advisory committee meetings are announced:
Joint Meeting of the Food and Veterinary Medicine Advisory Committees
Date, time, and place. November 2 and 3, 1994, 8:30 a.m., Howard
Johnson Hotel-National Airport, Pentagon Ballroom, 2650 Jefferson Davis
Hwy., Arlington, VA.
Type of meeting and contact person. Open committee discussion,
November 2, 1994, 8:30 a.m. to 5:15 p.m.; open committee discussion,
November 3, 1994, 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 12:15 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.
General function of the committees. The Food Advisory Committee
provides advice on emerging food safety, food science, and nutrition
issues that FDA considers of primary importance in the next decade. The
Veterinary Medicine Advisory Committee reviews and evaluates available
data concerning safety and effectiveness of marketed and
investigational new animal drugs, feeds, and devices for use in the
treatment and prevention of animal disease and increased animal
production.
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 October 25, 1994, 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 joint committees will discuss
possible future initiatives that impact on science and regulation in
areas such as biotechnology, food safety and processing,
compositionally enhanced foods, and food production and agriculture
sustainability. The biotechnology discussion will focus on FDA's 1992
policy statement on foods derived from new plant varieties developed by
new biotechnology methods. Also, because FDA is considering proposing a
premarket notification program, the committees will be asked to discuss
procedures that FDA might use to become aware of a developer's
intention to introduce such foods into commercial distribution. The
agency will present examples of the applications for products currently
approaching commercialization. In addition, the committees will be
asked to consider proposed criteria that would identify concerns for
which FDA might seek advisory committee assistance.
Joint Meeting of the Dermatologic Drugs and Anti-Infective Drugs
Advisory Committees With Nonprescription Drugs Advisory Committee
Representation
Date, time, and place. November 16, 1994, 8 a.m., Bethesda Holiday
Inn, Versailles Ballroom, 8120 Wisconsin Ave., Bethesda, 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.; Ermona B. McGoodwin or Valerie
M. Mealy, Center for Drug Evaluation and Research (HFD-9), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
5455.
General function of the committees. The Dermatologic Drugs Advisory
Committee reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in the treatment of
dermatologic diseases. The Anti-Infective Drugs Advisory Committee
reviews and evaluates data relating to the safety and effectiveness of
marketed and investigational human drugs for use in infectious and
ophthalmic disorders. The Nonprescription Drugs Advisory Committee
reviews and evaluates available data concerning the safety and
effectiveness of over-the-counter (nonprescription) human drug products
for use in the treatment of a broad spectrum of human symptoms and
diseases.
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 November 9, 1994, 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 jointly discuss the
potential for development of antibiotic resistance with over-the-
counter use of topical erythromycin in the treatment of acne.
Anti-Infective Drugs Advisory Committee
Date, time, and place. November 17, 1994, 8:30 a.m., Bethesda
Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., Bethesda, MD.
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.; Ermona B. McGoodwin or Mary
Elizabeth Donahue, Center for Drug Evaluation and Research (HFD-9),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-443-5455.
General function of the committee. The committee reviews and
evaluates data relating to the safety and effectiveness of marketed and
investigational human drugs for use in infectious and ophthalmic
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 November 9, 1994, 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 the validity
of endoscopically-obtained maxillary sinus specimens versus antral
puncture for the microbiological diagnosis of sinusitis.
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 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 14, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-25945 Filed 10-17-94; 8:45 am]
BILLING CODE 4160-01-F
