[Federal Register Volume 60, Number 203 (Friday, October 20, 1995)]
[Notices]
[Pages 54235-54237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26151]
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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.
FDA has established an Advisory Committee Information Hotline (the
hotline) using a voice-mail telephone system. The hotline provides the
public with access to the most current information on FDA advisory
committee meetings. The advisory committee hotline, which will
disseminate current information and information updates, can be
accessed by dialing 1-800-741-8138 or 301-443-0572. Each advisory
committee is assigned a 5-digit number. This 5-digit number will appear
in each individual notice of meeting. The hotline will enable the
public to obtain information about a particular advisory committee by
using the committee's 5-digit number. Information in the hotline is
preliminary and may change before a meeting is actually held. The
hotline will be updated when such changes are made.
MEETINGS: The following advisory committee meetings are announced:
Antiviral Drugs Advisory Committee
Date, time, and place. November 6 and 7, 1995, 8:30 a.m., and
November 8, 1995, 8 a.m., Quality Hotel, Maryland Ballroom, 8727
Colesville Rd., Silver Spring, MD.
Type of meeting and contact person. Open committee discussion,
November 6, 1995, 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,
November 7, 1995, 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,
November 8, 1995, 8 a.m. to 10 a.m.; open public hearing, 10 a.m. to
10:30 a.m., unless public participation does not last that long; open
committee discussion, 10:30 a.m. to 12:30 p.m.; closed committee
deliberations, 12:30 p.m. to 4 p.m.; Lee L. Zwanziger or Liz Ortuzar,
Center for Drug Evaluation and Research (HFD-9), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4695,
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Antiviral Drugs Advisory Committee,
code 12531.
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 a contact person before October 31, 1995, 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. On November 6, 1995, the committee will
discuss data relevant to new drug applications (NDA's) 20-564 (tablets)
and 20-596 (oral solution) for lamivudine (EpivirTM, also known as
3TC), sponsored by Glaxo Wellcome. On November 7, 1995, the committee
will discuss data relevant to NDA 20-628 for saquinavir
(InviraseTM), sponsored by Hoffman-La Roche. On November 8, 1995,
the committee will discuss confirmatory trials of stavudine
(ZeritTM, also known as d4T), sponsored by Bristol-Myers Squibb.
All products listed above are for the treatment of human
immunodeficiency virus infection.
Closed committee deliberations. On November 8, 1995, the committee
will discuss trade secret and/or confidential commercial information
relevant to pending NDA's. This portion of the meeting will be closed
to permit discussion of this information (5 U.S.C. 552b(c)(4)).
Biological Response Modifiers Advisory Committee
Date, time, and place. November 13, 1995, 8 a.m., Parklawn Bldg.,
conference rooms D and E, 5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. Open public hearing, 8 a.m. to
9 a.m., unless public participation does not last
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that long; open committee discussion, 9 a.m. to 1 p.m.; open public
hearing, 1 p.m. to 1:15 p.m., unless public participation does not last
that long; open committee discussion, 1:15 p.m. to 4:15 p.m.; closed
committee deliberations, 4:15 p.m. to 6 p.m.; William Freas or Pearline
K. Muckelvene, Center for Biologics Evaluation and Research (HFM-21),
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852,
301-827-0314, or FDA Advisory Committee Information Hotline, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), Biological Response
Modifiers Advisory Committee, code 12388.
General function of the committee. The committee reviews and
evaluates data relating to the safety, effectiveness, and appropriate
use of biological response modifiers which are intended for use in the
prevention and treatment of a broad spectrum of human 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 5, 1995, 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: (1) Product
license application supplement, reference number 95-0100, for GM-CSF
Immunex Corp., for peripheral stem cell mobilization; and (2) product
license application supplement, reference number 95-0475, for G-CSF,
Amgen Inc., also for the same indication (peripheral stem cell
mobilization).
Closed committee deliberations. The committee will discuss trade
secret and/or confidential commercial information relevant to pending
investigational new drug applications. This portion of the meeting will
be closed to permit discussion of this information (5 U.S.C.
552b(c)(4)).
Pulmonary-Allergy Drugs Advisory Committee
Date, time, and place. November 17, 1995, 8 a.m., Parklawn Bldg.,
conference rooms G, H, I, and J, 5600 Fishers Lane, Rockville, 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 4 p.m.; closed committee deliberations,
4 p.m. to 5 p.m.; Leander B. Madoo, Center for Drug Evaluation and
Research (HFD-9), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-4695, or FDA Advisory Committee
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), Pulmonary-Allergy Drugs Advisory Committee, code 12545.
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 the treatment of pulmonary
disease and diseases with allergic and/or immunologic mechanisms.
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, 1995, 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 be briefed on the
Pediatric Labeling Rule and the data necessary to support pediatric
labeling of drugs. The committee will discuss NDA 20-114, Astelin nasal
spray (azelastine), for seasonal allergic rhinitis. The sponsor is
Carter-Wallace, Inc.
Closed committee deliberations. The committee will review trade
secret and/or confidential commercial information relevant to pending
investigational new drug applications and NDA's. This portion of the
meeting will be closed to permit discussion of this information (5
U.S.C. 552b (c)(4)).
Each public advisory committee meeting listed above 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. The dates and times reserved for the separate 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.
The Commissioner has determined for the reasons stated that those
portions of the advisory committee meetings so
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designated in this notice shall be closed. The Federal Advisory
Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed
advisory committee meetings in certain circumstances. Those portions of
a meeting designated as closed, however, shall be closed for the
shortest possible time, consistent with the intent of the cited
statutes.
The FACA, as amended, provides that a portion of a meeting may be
closed where the matter for discussion involves a trade secret;
commercial or financial information that is privileged or confidential;
information of a personal nature, disclosure of which would be a
clearly unwarranted invasion of personal privacy; investigatory files
compiled for law enforcement purposes; information the premature
disclosure of which would be likely to significantly frustrate
implementation of a proposed agency action; and information in certain
other instances not generally relevant to FDA matters.
Examples of portions of FDA advisory committee meetings that
ordinarily may be closed, where necessary and in accordance with FACA
criteria, include the review, discussion, and evaluation of drafts of
regulations or guidelines or similar preexisting internal agency
documents, but only if their premature disclosure is likely to
significantly frustrate implementation of proposed agency action;
review of trade secrets and confidential commercial or financial
information submitted to the agency; consideration of matters involving
investigatory files compiled for law enforcement purposes; and review
of matters, such as personnel records or individual patient records,
where disclosure would constitute a clearly unwarranted invasion of
personal privacy.
Examples of portions of FDA advisory committee meetings that
ordinarily shall not be closed include the review, discussion, and
evaluation of general preclinical and clinical test protocols and
procedures for a class of drugs or devices; consideration of labeling
requirements for a class of marketed drugs or devices; review of data
and information on specific investigational or marketed drugs and
devices that have previously been made public; presentation of any
other data or information that is not exempt from public disclosure
pursuant to the FACA, as amended; and, deliberation to formulate advice
and recommendations to the agency on matters that do not independently
justify closing.
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 17, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-26151 Filed 10-19-95; 8:45 am]
BILLING CODE 4160-01-F
