[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,

[[Page 32830]]

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