[Federal Register Volume 61, Number 123 (Tuesday, June 25, 1996)]
[Notices]
[Pages 32829-32831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16174]
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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:
Vaccines and Related Biological Products Advisory Committee
Date, time, and place. July 10 and 11, 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,
July 10, l996, 8 a.m. to 10 a.m., open committee discussion, 10 a.m. to
3:45 p.m.; open public hearing, 3:45 p.m. to 4:30 p.m., unless public
participation does not last that long; closed committee deliberations,
July 11, 1996, 8 a.m. to 8:45 a.m.; open committee discussion, 8:45
a.m. to 12 m.; open public hearing, 12 m. to 12:30 p.m., unless public
participation does not last that long; open committee discussion, 12:30
p.m. to 2 p.m.; closed committee deliberations, 2 p.m. to 3:30 p.m.;
Nancy T. Cherry or Sandy M. 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 July 3, 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 July 10, 1996, the committee will
review safety and efficacy data pertaining to a diphtheria/tetanus/
acellular pertussis vaccine manufactured by SmithKline Beecham. On July
11, 1996, the committee will review safety and comparative
immunogenicity data pertaining to a liquid version of an Haemophilus b
conjugate vaccine manufactured by Merck & Co. The committee will also
hear a briefing on proposed changes in the polio vaccine
recommendations, and a briefing on a research program in the Division
of Viral Products.
Closed committee deliberations. On July 10 and 11, l996, the
committee will review trade secret and/or confidential commercial
information relevant to pending product licensing applications or
amendments. These portions of the meeting will be closed to permit
discussion of this information (5 U.S.C. 552b(c)(4)). On July 11, 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)).
Circulatory System Devices Panel of the Medical Devices Advisory
Committee
Date, time, and place. July 15, 1996, 7:30 a.m., Corporate Bldg.,
conference room 020B, 9200 Corporate Blvd., Rockville, MD. A limited
number of overnight accommodations have been reserved at the Courtyard
by Marriott, 2500 Research Blvd., Rockville, MD. Attendees requiring
overnight accommodations may contact the hotel at 301-670-6700, 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 notification
is received.
Type of meeting and contact person. Closed committee deliberations,
7:30 a.m. to 8:30 a.m.; open public hearing, 8:30 a.m. to 9:30 a.m.,
unless public participation does not last that long; open committee
discussion, 9:30 a.m. to 3:30 p.m.; Ramiah Subramanian, Center for
Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8320, or FDA Advisory Committee Information Hotline, 1-800-741-8138
(301-443-0572 in the Washington, DC area), Circulatory System Devices
Panel, code 12625. 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,
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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 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.
Open committee discussion. The committee will discuss and vote on a
premarket approval application (PMA) for a pacemaker lead. The
committee will also discuss issues related to the draft guidance for
Automatic Implantable Pacer Cardioverter Defibrillator (AIPCD)
submissions, primarily focusing on new suggested labeling changes.
Single copies of the draft guidance document are available from the
Division of Small Manufacturers Assistance, Center for Devices and
Radiological Health (HFZ-220), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 1-800-638-2041 or 301-443-6597.
Closed committee deliberations. FDA staff will present to the
committee trade secret and/or confidential commercial information
relevant to investigational device exemption applications and PMA's for
cardiovascular system devices. This portion of the meeting will be
closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).
Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee
-Date, time, and place. July 25, 1996, 8:30 a.m., Gaithersburg
Hilton, Ballroom, 620 Perry Pkwy., Gaithersburg, MD. A limited number
of overnight accommodations have been reserved at the hotel. Attendees
requiring overnight accommodations may contact the hotel at 301-977-
8900 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
notification is received.
-Type of meeting and contact person. Open public hearing, 8:30 a.m.
to 9:30 a.m., unless public participation does not last that long; open
committee discussion, 9:30 a.m. to 4 p.m.; closed committee
deliberations, 4 p.m. to 5 p.m.; Mary J. Cornelius, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd. Rockville, MD 20850, 301-594-2194, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), Gastroenterology and Urology Devices Panel, code
12523. 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 July 16, 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 general
issues related to a premarket approval application for a device
intended to manage female urinary incontinence.
-Closed committee deliberations. FDA staff will present to the
committee trade secret and/or confidential commercial information
regarding medical devices. This portion of the meeting will be closed
to permit discussion of this information (5 U.S.C. 552b(c)(4)).
Ophthalmic Devices Panel of the Medical Devices Advisory Committee
-Date, time, and place. July 26, 1996, 8:30 a.m., Gaithersburg
Hilton, Ballroom, 620 Perry Pkwy., Gaithersburg, MD. A limited number
of overnight accommodations have been reserved at the hotel. Attendees
requiring overnight accommodations may contact the hotel at 301-977-
8900 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 Joanne Choy,
Conference Management, 301-594-1283, ext. 105. The availability of
appropriate accommodations cannot be assured unless prior notification
is received.
-Type of meeting and contact person. Closed presentation of data,
8:30 a.m. to 9 a.m.; open committee discussion (first session), 9 a.m.
to 10:30 a.m.; open public hearing, 10:30 a.m. to 11:30 a.m., unless
public participation does not last that long; open committee discussion
(second session), 11:30 a.m. to 5 p.m.; Sara M. Thornton, Center for
Devices and Radiological Health (HFZ-460), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
2053, or FDA Advisory Committee Information Hotline, 1-800-741-8138
(301-443-0572 in the Washington, DC area), Ophthalmic Devices Panel,
code 12396. 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 July 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 an
indication of the approximate time required to make their comments.
-Open committee discussion. First Session--The Vitreoretinal and
Extraocular Devices Branch will present a summary report of public
comments received on the proposed rule that published in the Federal
Register of April 1, 1996 (61 FR 14277), for reclassification of
contact lens care products. The committee will review and recommend the
classification status for currently unclassified devices which may
include corneal storage media and external eyelid weights. Second
Session--FDA staff will present to the committee the regulatory status
of lasers for the correction of refractive error currently in use in
the United States and FDA's policies and regulations regarding those
lasers.
Closed presentation of data. FDA staff will present to the
committee trade secret and/or confidential commercial information
relevant to investigational device exemption applications and premarket
approval applications. 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
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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. 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: June 19, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-16174 Filed 6-24-96; 8:45 am]
BILLING CODE 4160-01-F
