[Federal Register Volume 61, Number 208 (Friday, October 25, 1996)]
[Notices]
[Pages 55306-55308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27489]
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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.
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:
Dermatologic and Ophthalmic Drugs Advisory Committee
Date, time, and place. November 7 and 8, 1996, 8:30 a.m., Quality
Suites, Main Ballroom, Three Research Ct., Rockville, MD.
Type of meeting and contact person. Closed presentation of data,
November 7, 1996, 8:30 a.m. to 11 a.m.; closed committee deliberations,
11 a.m. to 1 p.m.; open committee discussion, 1 p.m. to 5 p.m.; open
public hearing, November 8, 1996, 8:30 a.m. to 11:30 a.m., unless
public participation does not last that long; open committee
discussion, 11:30 a.m. to 5 p.m.; Tracy K. Riley or Danyiel A.
D'Antonio, Center for Drug Evaluation and Research (HFD-21), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
5455, or FDA Advisory Committee Information Hotline, 1-800-741-8138
(301-443-0572 in the Washington, DC area), Dermatologic and Ophthalmic
Drugs Advisory Committee, code 12534. Please call the hotline for
information concerning any possible changes.
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 dermatologic 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 1, 1996, 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.
Closed presentation of data. On November 7, 1996, the committee
will hear trade secret and/or confidential commercial information
relevant to pending investigational new drug applications (IND's) and/
or new drug applications (NDA's). This portion of the meeting will be
closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).
Closed committee deliberations. On November 7, 1996, the committee
will review trade secret and/or confidential commercial information
relevant to pending IND's and/or NDA's. This portion of the meeting
will be closed to permit discussion of this information (5 U.S.C.
552b(c)(4)).
Open committee discussion. On November 7, 1996, the committee will
hear presentations and discuss the potential for neurotoxicity of
thalidomide raised by the investigational use and possible eventual
approval of thalidomide for dermatologic and other indications. On
November 8, 1996, the committee will hear presentations and discuss the
teratogenicity of thalidomide and issues of pregnancy prevention raised
by the investigational use and possible eventual approval of
thalidomide for dermatologic and other indications.
FDA regrets that it was unable to publish this notice 15 days prior
to the Dermatologic and Ophthalmic Drugs Advisory Committee meeting.
Because the agency believes there is some urgency to bring these issues
to public discussion and qualified members of the Dermatologic and
Ophthalmic Drugs Advisory Committee were available at this time, the
Commissioner of Food and Drugs (the Commissioner) concluded that it was
in the public interest to hold this meeting even if there was not
sufficient time for the customary 15-day public notice.
Allergenic Products Advisory Committee
Date, time, and place. November 15, 1996, 2 p.m., Food and Drug
Administration, Bldg. 29, conference room 121, 8800 Rockville Pike,
Bethesda, MD.
[[Page 55307]]
Type of meeting and contact person. This meeting will be held by a
telephone conference call. A speaker telephone will be provided in the
conference room to allow public participation in the meeting. 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 3:30 p.m.; closed
committee deliberations, 3:30 p.m. to 5:30 p.m.; William Freas or
Sheila D. Langford, Center for Biologics Evaluation and Research (HFM-
21), Food and Drug Administration, 1401 Rockville Pike, Bethesda, MD
20852, 301-827-0314, or FDA Advisory Committee Information Hotline, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), Allergenic
Products Advisory Committee, code 12388. Please call the hotline for
information concerning any possible changes.
General function of the committee. The committee reviews and
evaluates data on the safety and effectiveness of allergenic biological
products intended for use in the diagnosis, prevention, or treatment 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 12, 1996, 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 the
indication of the approximate time to make their comments.
Open committee discussion. The committee will discuss the
intramural research program for the Laboratory of Immunoregulation in
the Division of Allergenic Products.
Closed committee deliberations. The committee will discuss trade
secret and/or confidential commercial information relevant to pending
IND's in the Center for Biologics Evaluation and Research. This portion
of the meeting will be closed to permit discussion of this information
(5 U.S.C. 552b(c)(4)). The committee will also discuss the intramural
scientific program. This portion of the meeting will be closed to
prevent disclosure of personal information concerning individuals
associated with the research program, disclosure of which would
constitute a clearly unwarranted invasion of personal privacy (5 U.S.C.
552b(c)(6)).
Anti-Infective Drugs Advisory Committee
Date, time, and place. November 20, 1996, 8 a.m., Holiday Inn--
Gaithersburg, The Ballroom, Two Montgomery Village Ave., Gaithersburg,
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; closed
committee deliberations, 9 a.m. to 12 m.; Ermona B. McGoodwin or
Danyiel A. D'Antonio, Center for Drug Evaluation and Research (HFD-21),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-443-5455, or FDA Advisory Committee Information Hotline, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), Anti-Infective Drugs
Advisory Committee, code 12530. Please call the hotline for information
concerning any possible changes.
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 infectious diseases and 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 15, 1996, 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.
Closed committee deliberations. The committee will hear trade
secret and/or confidential commercial information relevant to pending
IND's 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 the meeting(s) 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, 5600 Fishers Lane, rm. 12A-16, 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, 12420 Parklawn Dr., rm. 1-23,
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.
[[Page 55308]]
The Commissioner has determined for the reasons stated that those
portions of the advisory committee meetings so 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 (a)(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 21, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-27489 Filed 10-24-96; 8:45 am]
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