[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