[Federal Register Volume 61, Number 37 (Friday, February 23, 1996)]
[Notices]
[Pages 7008-7011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4067]



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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 

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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:

General Hospital and Personal Use Devices Panel of the Medical 
Devices Advisory Committee

    Date, time, and place. March 11, 1996, 8 a.m., Holiday Inn--
Gaithersburg, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD. 
A limited number of overnight accommodations have been reserved at the 
hotel. Attendees requiring overnight accommodations may contact the 
hotel at 301-948-8900 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 Sociometrics, Inc., 301-608-2151. The availability of 
appropriate accommodations cannot be assured unless prior notification 
is received.
    Type of meeting and contact person. Closed committee deliberations, 
8 a.m. to 9 a.m.; open public hearing, 9 a.m. to 10 a.m., unless public 
participation does not last that long; open committee discussion, 10 
a.m. to 5 p.m.; Janet L. Scudiero, Center for Devices and Radiological 
Health (HFZ-420), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-1287, or FDA Advisory Committee 
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), General Hospital and Personal Use Devices Panel, code 12520.
    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 March 4, 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: (1) Discuss and make 
recommendations on the classification of two unclassified preamendments 
devices, percutaneously implanted long-term catheters, and implanted 
intravascular infusion ports; and (2) discuss a premarket notification 
submission for an antimicrobial coated latex examination glove.
    Closed committee deliberations. FDA staff will present to the 
committee trade secret and/or confidential commercial information 
regarding present and future FDA issues. This portion of the meeting 
will be closed to permit discussion of this information (5 U.S.C. 
552b(c)(4)).

Joint Meeting of the Antiviral Drugs Advisory Committee and the 
Dermatologic and Ophthalmic Drugs Advisory Committee (Ophthalmic 
Drugs Subcommittee)

    Date, time, and place. March 14, 1996, 1 p.m., and March 15, 1996, 
8:30 a.m., Holiday Inn--Gaithersburg, Whetstone and Goshen Rooms, Two 
Montgomery Village Ave., Gaithersburg, MD. -
    Type of meeting and contact person. Closed committee deliberations, 
March 14, 1996, 1 p.m. to 5 p.m.; open committee discussion, March 15, 
1996, 8:30 a.m. to 11 a.m.; open public hearing, 11 a.m. to 12 m., 
unless public participation does not last that long; open committee 
discussion, 12 m. to 4 p.m.; Ermona B. McGoodwin or Liz Ortuzar, 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), Antiviral Drugs Advisory Committee, 
code 12531. -
    General function of the committees. The Antiviral Drugs Advisory 
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. The Dermatologic and Ophthalmic Drugs Advisory Committee 
reviews and evaluates 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 March 8, 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. On March 14, 1996, the Antiviral 
Drugs Advisory Committee will discuss trade secret and/or confidential 
commercial information relevant to pending 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)). -
    Open committee discussion. On March 15, 1996, the Antiviral Drugs 
Advisory Committee and an ophthalmic drugs subcommittee of the 
Dermatologic and Ophthalmic Drugs Advisory Committee will meet jointly 
to discuss data relevant to NDA 20-638 VistideTM (cidofovir, 
intravenous, Gilead Sciences, Inc.) for treatment of cytomegalovirus 
(CMV) retinitis in patients with AIDS.

Blood Products Advisory Committee

    Date, time, and place. March 21 and 22, 1996, 8 a.m., Holiday Inn--
Bethesda, Versailles Ballrooms II and III, 8120 Wisconsin Ave., 
Bethesda, MD.
    Type of meeting and contact person. Open committee discussion, 
March 21, 1996, 8 a.m. to 9:10 a.m.; open public hearing, 9:10 a.m. to 
9:40 a.m., unless public participation does not last that long; open 
committee discussion, 9:40 a.m. to 11:15 a.m.; open public hearing, 
11:15 a.m. to 12:15 p.m., unless public participation does not last 
that long; open committee discussion, 12:15 p.m. to 3 p.m.; open public 
hearing, 3 p.m. to 4 p.m., unless public participation does not last 
that long; open committee discussion, 4 p.m. to 5 p.m.; open committee 
discussion, March 22, 1996, 8 a.m. to 11:30 a.m.; open public hearing, 
11:30 a.m. to 12:15 p.m., unless public participation does not last 
that long; open committee discussion, 12:15 p.m. to 2 p.m.; closed 
committee deliberations, 2 p.m. to 3 p.m.; Linda A. Smallwood, Center 
for Biologics Evaluation and Research (HFM-350), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-3514, 
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area) Blood Products Advisory Committee, 
code 12388.
    General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness, and appropriate use of 
blood products intended for use in the diagnosis, prevention, or 
treatment of human diseases.
    Agenda--Open public hearing. Interested persons may present data, 

[[Page 7010]]
    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 March 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.
    Open committee discussion. On March 21, 1996, the committee will 
hear agency updates on Creutzfeldt-Jakob Disease and blood safety, 
peripheral blood hematopoietic stem cell products intended for 
transfusion, and a summary of regulatory issues related to human 
reproductive tissue. Labeling issues regarding testing for antibody to 
hepatitis C virus antigen by an ``HCV 3.0'' assay will be reviewed and 
discussed in the morning and in the afternoon, there will also be a 
discussion of clinical claims for the Roche Amplicor HIV Monitoring 
TestTM. On March 22, 1996, the committee will review and discuss 
implications of non-lipid enveloped viruses in blood products.
    Closed committee deliberations. On March 22, 1996, the committee 
will review trade secret and/or confidential commercial information 
relevant to current and pending products. This portion of the meeting 
will be closed to permit discussion of this information (5 U.S.C. 
552b(c)(4)).

General and Plastic Surgery Devices Panel of the Medical Devices 
Advisory Committee

    Date, time, and place. March 25, 1996, 8:30 a.m., Holiday Inn--
Gaithersburg, Goshen Room, Two Montgomery Village Ave., Gaithersburg, 
MD. A limited number of overnight accommodations have been reserved at 
the hotel. Attendees requiring overnight accommodations may contact the 
hotel at 301-948-8900 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 John Sellman, Sociometrics, Inc., 301-608-2151. 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 3 p.m.; closed committee 
deliberations, 3 p.m. to 4:30 p.m.; Gail G. Gantt, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3090, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), General and Plastic Surgery Devices Panel, code 
12519.-
    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 March 18, 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 resorbable translucent membrane 
for use as an adjuvant in abdominopelvic surgery.
    Closed committee deliberations. FDA staff will present to the 
committee trade secret and/or confidential commercial information 
regarding present and future FDA issues. 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 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 

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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: February 15, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-4067 Filed 2-22-96; 8:45 am]
BILLING CODE 4160-01-F