[Federal Register Volume 61, Number 189 (Friday, September 27, 1996)]
[Notices]
[Pages 50828-50830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24755]
[[Page 50828]]
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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:
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory
Committee
Date, time, and place. October 21, 1996, 8:30 a.m., Corporate
Bldg., conference room 020B, 9200 Corporate Blvd., Rockville, MD. A
limited number of overnight accommodations have been reserved at the
Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Blvd.,
Gaithersburg, MD. Attendees requiring overnight accommodations may
contact the hotel at 301-590-0044 or 800-228-9290 and reference the FDA
Panel meeting block. Reservations will be confirmed at the group rate
based on availability. Attendees with a disability requiring special
accommodations should contact Shirley Meeks, Conference Management,
301-594-1283, ext. 113. The availability of appropriate accommodations
cannot be assured unless prior written notification is received.
Type of meeting and contact person. Closed committee deliberations,
8:30 a.m. to 9:30 a.m.; open public hearing, 9:30 a.m. to 10:30 a.m.,
unless public participation does not last that long; open committee
discussion, 10:30 a.m. to 5 p.m.; Alfred W. Montgomery, Center for
Devices and Radiological Health (HFZ-470), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1180, or FDA Advisory Committee Information Hotline, 1-800-741-8138
(301-443-0572 in the Washington, DC area), Obstetrics and Gynecology
Devices Panel, code 12524. 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 marketed and
investigational devices and makes recommendations for their regulation.
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 October 11, 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.
Open committee discussion. The committee will discuss and vote on a
premarket approval application for a silicone barrier contraceptive
device.
Closed committee deliberations. FDA staff will present to the
committee trade secret and/or confidential commercial information
regarding medical devices used in obstetrics and gynecology that are
currently being evaluated by FDA. 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. October 21, 1996, 10 a.m., Holiday Inn--
Bethesda, Versailles Ballrooms I, II, and III, 8120 Wisconsin Ave.,
Bethesda, MD.
Type of meeting and contact person. Open public hearing, 10 a.m. to
10:40 a.m., unless public participation does not last that long; open
committee discussion, 10:40 a.m. to 1:30 p.m.; closed committee
deliberations, 1:30 p.m. to 2:30 p.m.; open committee discussion, 2:30
p.m. to 3 p.m.; closed committee deliberations, 3 p.m. to 5 p.m.; open
public hearing, 5 p.m. to 5:30 p.m., unless public participation does
not last that long; William Freas, Pearline K. Muckelvene, or Sheila D.
Langford, 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. Please call the hotline for
information concerning any possible changes.
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 October 14, 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.
Open committee discussion. The committee will discuss the: (1) FDA
oncology initiative; (2) standards for approval of therapies for non-
Hodgkin's Lymphoma; and (3) intramural research program for the
Laboratory of Cell Biology, Laboratory of Immunobiology, and the
Laboratory of Cell and Viral Regulation in the Office of Therapeutics
Research and Review of the Center for Biologics Evaluation and
Research.
Closed committee deliberations. On October 21, 1996, the committee
will discuss trade secret and/or confidential commercial information
relevant to pending investigational new drug applications (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)).
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Cardiovascular and Renal Drugs Advisory Committee
Date, time, and place. October 24, 1996, 9 a.m., Woodmont Building
II, conference room F, 5th floor, 1451 Rockville Pike, 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; closed
committee deliberations, 10 a.m. to 5:30 p.m.; Joan Standaert, Center
for Drug Evaluation and Research (HFD-110), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 419-259-6211,
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Cardiovascular and Renal Drugs
Advisory Committee, code 12533. 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 marketed and
investigational human drugs for use in cardiovascular and renal
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 October 10, 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 review trade
secret and/or confidential commercial information relevant to pending
IND's or new drug applications. This portion of the meeting will be
closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).
Vaccines and Related Biological Products Advisory Committee
Date, time, and place. October 29 and 30, l996, 8 a.m., Holiday
Inn--Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Ave.,
Bethesda, MD.
Type of meeting and contact person. Closed committee deliberations,
October 29, l996, 8 a.m. to 8:30 a.m.; open committee discussion, 8:30
a.m. to 5 p.m.; open committee discussion, October 30, l996, 8 a.m. to
1:30 p.m.; closed committee deliberations, 1:30 p.m. to 2:30 p.m.; open
public hearing, 2:30 p.m. to 3:30 p.m., unless public participation
does not last that long; open committee discussion, 3:30 p.m. to 5:15
p.m.; Nancy Cherry or Sandy Salins, 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), Vaccines and Related Biological 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 vaccines 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 October 22, 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.
Open committee discussion. On October 29, 1996, the committee will
review safety and efficacy data pertaining to diphtheria/tetanus/
acellular pertussis vaccines manufactured by Amvax, Inc., and Lederle
Laboratories. On October 30, 1996, the committee will review the
possibility of using animal challenge studies (and the design of such
studies), in addition to human neutralizing antibody data, to support
the efficacy of the botulinum toxoid vaccine. The committee will also
hear a briefing on a research program in the Division of Viral Products
and a briefing on a new Points to Consider document on Plasmid DNA
Vaccines for Preventive Infectious Disease Indications.
Closed committee deliberations. On October 29, l996, the committee
will review trade secret and/or confidential commercial information
relevant to pending IND's or product licensing applications. These
portions of the meeting will be closed to permit discussion of this
information (5 U.S.C. 552b(c)(4)). On October 30, l996, the committee
will also review data of a personal nature where disclosure would
constitute a clearly unwarranted invasion of personal privacy. This
portion of the meeting will be closed to permit discussion of this
information (5 U.S.C. 552b(c)(6)).
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, 5600 Fishers Lane, rm.
[[Page 50830]]
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.
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: September 19, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-24755 Filed 9-26-96; 8:45 am]
BILLING CODE 4160-01-F
