[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
