[Federal Register Volume 59, Number 121 (Friday, June 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15435]


[[Page Unknown]]

[Federal Register: June 24, 1994]


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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.
MEETINGS: The following advisory committee meetings are announced:
National Mammography Quality Assurance Advisory Committee
    Date, time, and place. July 12, 1994, 1:30 p.m., and July 13, 14, 
and 15, 1994, 9 a.m., Gaithersburg Holiday Inn, Grand Ballroom, Two 
Montgomery Village Ave., Gaithersburg, MD. A limited number of 
overnight accommodations have been reserved at the Gaithersburg Holiday 
Inn. Attendees requiring overnight accommodations must contact the 
hotel at 301-948-8900 and reference the FDA Panel meeting block. 
Reservations will be confirmed at the group rate based on availability.
    Type of meeting and contact person. Open public hearing, July 12, 
1994, 1:30 p.m. to 2:30 p.m., unless public participation does not last 
that long; open committee discussion, 2:30 p.m. to 5:30 p.m.; open 
committee discussion, July 13 and 14, 1994, 9 a.m. to 5 p.m.; open 
committee discussion, July 15, 1994, 9 a.m. to 3:30 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 July 8, 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 interim 
final standards for accreditation bodies and the interim final 
standards for facilities. Specific topics to be discussed include: 
Sanctions, suspensions, revocations and injunction procedures, quality 
control and quality assurance standards, x-ray equipment standards, and 
accreditation bodies standards.
National Task Force on AIDS Drug Development
     Date, time, and place. July 18 and 19, 1994, 8:30 a.m., Sheraton 
National Hotel, South Ballroom, 900 South Orme St., Arlington, VA.
    Type of meeting and contact person. Open task force discussion, 
July 18, 1994, 8:30 a.m. to 4:30 p.m.; open public hearing, 4:30 p.m. 
to 5:30 p.m., unless public participation does not last that long; open 
task force discussion, July 19, 1994, 8:30 a.m. to 11:30 a.m.; Jean H. 
McKay, Office of AIDS and Special Health Issues (HF-12), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-0104.
    General function of the task force. The National Task Force on AIDS 
Drug Development shall identify any barriers and provide creative 
options for the rapid development and evaluation of treatments for 
human immunodeficiency virus (HIV) infection and its sequelae. It also 
advises on issues related to such barriers and provides options for the 
elimination of these barriers.
    Open task force discussion. The task force will present, hear, and 
discuss issues on the barriers to acquired immune deficiency syndrome 
(AIDS) drug discovery from the perspective of task force members, 
members of the Federal Government, and the public. The task force will 
determine how to proceed with overcoming the barriers to AIDS drug 
discovery.
    Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the task force. Those desiring to make formal presentations should 
notify the contact person before July 8, 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.
Nonprescription Drugs Advisory Committee
    Date, time, and place. July 27, 1994, 2 p.m., Parklawn Bldg., 
conference rms. D and E, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open public hearing, 2 p.m. to 
3 p.m., unless public participation does not last that long; open 
committee discussion, 3 p.m. to 6 p.m.; Mae Brooks or Lee L. Zwanziger, 
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 
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 July 20, 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 new drug 
application (NDA) 19-501, The Upjohn Co., to switch Rogaine 
(minoxidil 2% topical solution) for use as a hair growth stimulant for 
persons with androgenetic alopecia, from prescription to over-the-
counter marketing status.
Antiviral Drugs Advisory Committee
    Date, time, and place. July 29, 1994, 8 a.m., Parklawn Bldg., 
conference rms. G, H, I, and J, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open committee discussion, 8 
a.m. to 11 a.m.; open public hearing, 11 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 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 a contact person before July 20, 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 data 
submitted in support of supplementary new drug applications (NDA's) 19-
655 (supplement 023), 19-910 (supplement 011), and 19-951 (supplement 
003) for zidovudine (Retrovir, Burroughs Welcome) for use as 
prophylaxis against maternal to fetal transmission of HIV infection.
Joint Meeting of the Gastrointestinal Drugs and the Nonprescription 
Drugs Advisory Committees
    Date, time, and place. July 29, 1994, 9 a.m., Parklawn Bldg., 
conference rms. D and E, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open public hearing, 9 a.m. to 
10 a.m., unless public participation does not last that long; open 
committee discussion, 10 a.m. to 3 p.m.; Joan C. Standaert, Center for 
Drug Evaluation and Research (HFD-180), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 419-259-6211, or Lee Zwanziger 
or Valerie M. Mealy, 301-443-4695.
    General function of the committees. The Gastrointestinal Drugs 
Advisory Committee reviews and evaluates data on the safety and 
effectiveness of marketed and investigational human drugs for use in 
gastrointestinal diseases. 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 committees. Those desiring to make formal presentations should 
notify the contact person before July 15, 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 committees discussion. The committees will discuss NDA 20-325, 
Pepcid (famotidine), Merck and Co., for treatment and prevention of 
episodic heartburn.
    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: June 20, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-15435 Filed 6-23-94; 8:45 am]
BILLING CODE 4160-01-F