[Federal Register Volume 59, Number 161 (Monday, August 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20510]


[[Page Unknown]]

[Federal Register: August 22, 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:
Antiviral Drugs Advisory Committee
    Date, time, and place. September 12 and 13, 1994, 8:30 a.m.; 
Holiday Inn, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
    Type of meeting and contact person. Open committee discussion, 
September 12, 1994, 8:30 a.m. to 11:30 a.m.; open public hearing, 11:30 
a.m. to 12 m., unless public participation does not last that long; 
open committee discussion, 12 m. to 5 p.m.; open committee discussion, 
September 13, 1994, 8:30 a.m. to 11:30 a.m.; open public hearing, 11:30 
a.m. to 12 m., unless public participation does not last that long; 
open committee discussion, 12 m. to 4 p.m.; Lee L. Zwanziger or Valerie 
Mealy, Center for Drug Evaluation and Research (HFD-9), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4695.
    General function of the committee. The committee reviews and 
evaluates available data concerning the safety and effectiveness of 
marketed and investigational human drug products for use in the 
treatment of acquired immune deficiency syndrome (AIDS), AIDS-related 
complex (ARC), and other viral, fungal, and mycobacterial infections.
    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 September 2, 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 scientific 
and medical issues relevant to the validation of surrogate markers for 
use as criteria in regulatory decisionmaking.
Anti-Infective Drugs Advisory Committee
    Date, time, and place. September 23, 1994, 8 a.m., Holiday Inn, 
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 11:30 a.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 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.
    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 September 16, 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 surrogate 
markers, such as pharmacokinetic parameters and microbiological 
inhibitory and cidal data, and whether these parameters can be used 
instead of clinical efficacy data to support an alternative dosing 
regimen for oral metronidazole in the treatment of Trichomonas 
vaginalis vaginitis.
Joint Meeting of the Dermatologic Drugs and Anti-Infective Drugs 
Advisory Committees
    Date, time, and place. September 23, 1994, 1 p.m., conference rms. 
D and E , Parklawn Bldg., 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. 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 5 p.m.; Ermona B. McGoodwin or Valerie 
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.
    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 September 16, 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 committees will discuss the 
potential for development of antibiotic resistance with over-the-
counter use of topical erythromycin in the treatment of acne.
Peripheral and Central Nervous System Drugs Advisory Committee
    Date, time, and place. September 26 and 27, 1994, 8:30 a.m., 
conference rms. D and E, Parklawn Bldg., 5600 Fishers Lane, Rockville, 
MD.
    Type of meeting and contact person. Open public hearing, September 
26, 1994, 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.; open 
public hearing, September 27, 1994, 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.; Michael A. Bernstein, Center for Drug 
Evaluation and Research (HFD-120), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2775.
    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 neurological 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 September 19, 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 discussions. On September 26, 1994, the committee 
will discuss the safety and effectiveness of Freedox 
(tirilazad mesylate), new drug application (NDA) 20-399, The Upjohn 
Co., for use in the treatment of subarachnoid hemorrhage. On September 
27, 1994, the committee will discuss the safety and effectiveness of 
Tegretol (carbamazepine), NDA 18-927, Basel Pharmaceuticals, 
for use as an anticonvulsant in children under 6 years old. 
Additionally, the committee will reconsider the relative risks and 
benefits of Felbatol (felbamate), NDA 20-189, Carter-Wallace, 
for use in the treatment of epilepsy.
National Mammography Quality Assurance Advisory Committee
    Date, time, and place. September 28, 1994, 10 a.m., and September 
29 and 30, 1994, 8:30 a.m., Gaithersburg Hilton Hotel, 620 Perry Pkwy., 
Gaithersburg, MD. A limited number of overnight accommodations have 
been reserved at the Gaithersburg Hilton Hotel. Attendees requiring 
overnight accommodations may contact the hotel at 301-977-8900 and 
reference the FDA committee meeting block. Reservations will be 
confirmed at the group rate based on availability.
    Type of meeting and contact person. Open public hearing, September 
28, 1994, 10 a.m. to 11 a.m., unless public participation does not last 
that long; open committee discussion, 11 a.m. to 5 p.m.; open committee 
discussion, September 29, 1994, 8:30 a.m. to 5 p.m.; open committee 
discussion, September 30, 1994, 8:30 a.m. to 5 p.m.; Charles K. 
Showalter, Center for Devices and Radiological Health (HFZ-240), Food 
and Drug Administration, 1901 Chapman Ave., Rockville, MD 20857, 301-
594-3311.
    General function of the committee. The committee advises on 
developing appropriate quality standards and regulations for the use of 
mammography facilities.
    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 September 23, 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 draft 
final standards for accreditation bodies and the draft final standards 
for facilities. Specific topics to be discussed include: States as 
certifying bodies, mobile units, breast implant imaging, consumer 
complaint mechanism, and equipment other than the x-ray unit.
    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: August 15, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-20510 Filed 8-19-94; 8:45 am]
BILLING CODE 4160-01-F