[Federal Register Volume 60, Number 119 (Wednesday, June 21, 1995)]
[Notices]
[Pages 32330-32333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15147]
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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 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:
Biological Response Modifiers Advisory Committee
Date, time, and place. July 13 and 14, 1995, 8 a.m., Holiday Inn--
Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Ave., Bethesda,
MD.
Type of meeting and contact person. Open public hearing, July 13,
1995, 8 a.m. to 9 a.m., unless public participation does not last that
long; open committee discussion, 9 a.m. to 6 p.m.; open public hearing,
6 p.m. to 6:30 p.m., unless public participation does not last that
long; open public hearing, July 14, 1995, 8 a.m. to 8:30 a.m., unless
public participation does not last that long; open committee
discussion, 8:30 a.m. to 10:10 a.m.; closed committee deliberations,
10:10 a.m. to 10:30 a.m.; open committee discussion, 10:30 a.m. to 4:30
p.m.; William Freas or Pearline Muckelvene, 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.
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 July 5, 1995, 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 13, 1995, the committee will
discuss public health concerns in xenotransplantation. On the morning
of July 14, 1995, the committee will discuss data in support of the
safety of a proposed baboon bone marrow transplant in the treatment of
advanced human immunodeficiency virus, type 1, (HIV-1) disease, and a
discussion of the safety of clinical transplantation of nonhuman
primate tissue into human recipients. In the afternoon, the committee
will discuss extracorporeal liver assist devices for treatment of liver
failure, followed by a discussion of the utility of polymerase chain
reaction in the clinical trials of biologic therapies for hepatitis C.
Closed committee deliberations. On July 14, 1995, the committee
will discuss trade secret and/or confidential commercial information
relevant to pending investigational new drug applications (IND's). This
portion of the meeting will be closed to permit discussion of this
information (5 U.S.C. 552b(c)(4)).
Endocrinologic and Metabolic Drugs Advisory Committee
Date, time, and place. July 13 and 14, 1995, 8 a.m., Holiday--Inn
Silver Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
Type of meeting and contact person. Open public hearing, July 13,
1995, 8 a.m. to 8:30 a.m., unless public participation does not last
that long; open committee discussion, 8:30 a.m. to 5 p.m.; closed
presentation of data, July 14, 1995, 8 a.m. to 10 a.m.; open public
hearing, 10 a.m. to 10:30 a.m., unless public participation does not
last that long; open committee discussion, 10:30 a.m. to 4 p.m.;
Kathleen R. Reedy, Center for Drug Evaluation and Research (HFD-9),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-443-5455, FAX 301-443-0699, or FDA Advisory Committee Information
Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC area),
Endocrinologic and Metabolic Drugs Advisory Committee, 12536.
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 endocrine and metabolic
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 July 7, 1995, 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 13, 1995, the committee will
hear presentations and discuss data submitted regarding the safety and
efficacy of alendronate, new drug application (NDA) 20-560
(Fosamax, Merck), for an osteoporosis indication. On July 14,
1995, the committee will discuss guidance criteria for the development
of safe and effective medications for the treatment of obesity.
Closed presentation of data. On July 14, 1995, the committee will
hear trade secret and/or confidential commercial information relevant
to pending IND's. This portion of the meeting will be closed to permit
discussion of this information (5 U.S.C. 552b(c)(4)).
Joint Meeting of Nonprescription Drugs Advisory Committee With
Gastrointestinal Drugs Advisory Committee and With Arthritis Advisory
Committee
Date, time, and place. July 13 and 14, 1995, 8:30 a.m., conference
rooms D and E, Parklawn Bldg., 5600 Fishers Lane, Rockville,
MD. [[Page 32331]]
Type of meeting and contact person. Open public hearing, July 13,
1995, 8:30 a.m. to 9 a.m., unless public participation does not last
that long; open committee discussion, 9 a.m. to 5 p.m.; open committee
discussion, July 14, 1995, 8:30 a.m. to 11:30 a.m.; open public
hearing, 11:30 a.m. to 12 m., unless public participation does not last
that long; closed committee deliberations, 12 m. to 1 p.m.; open
committee discussion, 1 p.m. to 4 p.m.; Lee L. Zwanziger or Liz
Ortuzar, Center for Drug Evaluation and Research (HFD-9), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4695,
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Nonprescription Drugs Advisory
Committee, code 12541.
General functions of the committees. The Nonprescription Drugs
Advisory Committee reviews and evaluates available data concerning the
safety and effectiveness of over-the-counter (nonprescription) human
drug products for use in the treatment of a broad spectrum of human
symptoms and diseases. The Gastrointestinal Drugs Advisory Committee
reviews and evaluates data on the safety and effectiveness of marketed
and investigational human drugs for use in gastrointestinal diseases.
The Arthritis Advisory Committee reviews and evaluates data on the
safety and effectiveness of marketed and investigational human drugs
for use in arthritic conditions.
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 7, 1995, 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 13, 1995, the Nonprescription
Drugs Advisory Committee and the Gastrointestinal Drugs Advisory
Committee will discuss data relevant to NDA 20-520 to switch
Zantac 75 (ranitidine hydrochloride tablets) (Glaxo, Inc.)
from prescription to over-the-counter status for the treatment of
heartburn. On July 14, 1995, the Nonprescription Drugs Advisory
Committee and the Arthritis Advisory Committee will discuss data
relevant to NDA 20-499 (Bayer Corp.,) and NDA 20-429 (Whitehall-Robins
Healthcare). Both NDA's are to switch ketoprofen (12.5 milligrams
tablet/caplet) from prescription to over-the-counter status for the
temporary relief of minor aches and pains associated with the common
cold, toothache, muscular aches, backache, for the minor pain of
arthritis, for the pain of menstrual cramps, and for reduction of
fever.
Closed committee deliberations. On July 14, 1995, the committees
will discuss trade secret and/or confidential commercial information
relevant to pending IND's. This portion of the meeting will be closed
to permit discussion of this information (5 U.S.C. 552b(c)(4)).
General Hospital and Personal Use Devices Panel of the Medical Devices
Advisory Committee
Date, time, and place. July 17, 1995, 4:30 p.m., and July 18, 1995,
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 may be confirmed at the group
rate based on availability. Attendees with a disability requiring
special accommodations should contact Ed Rugenstein, 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,
July 17, 1995, 4:30 p.m. to 5:30 p.m.; open public hearing, July 18,
1995, 8 a.m. to 9:30 a.m., unless public participation does not last
that long; open committee discussion, 9:30 a.m. to 5 p.m.; Janet L.
Scudiero, Center for Devices and Radiological Health (HFZ-410), 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 July 10, 1995, 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 18, 1995, the committee will
discuss the classification of general purpose disinfectants and
sterilants, and as time permits, will discuss the classification of
Apgar timers, infusion stands, and lice detectors and removers.
-Closed committee deliberations. On July 17, 1995, 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)).
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee
Date, time, and place. July 19, 1995, 8 a.m., Holiday Inn--
Gaithersburg, Whetstone 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.
Type of meeting and contact person. Open public hearing, 8 a.m. to
10 a.m., unless public participation does not last that long; open
committee discussion, 10 a.m. to 3 p.m.; closed committee
deliberations, 3 p.m. to 5 p.m.; Daniel Schultz, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1307, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in
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 July 1, 1995, and submit a brief
statement of the general [[Page 32332]] 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 following
issues: (1) Implementation strategy for the draft guidance on medical
lasers; and (2) categorization and regulatory considerations for wound
dressing devices.
Closed committee deliberations. FDA staff will present to the
committee trade secret and/or confidential commercial information
regarding issues related to new technologies currently under review.
This portion of the meeting will be closed to permit discussion of this
information (5 U.S.C. 552b(c)(4)).
Anti-Infective Drugs Advisory Committee
Date, time, and place. July 20, 1995, 8 a.m., and July 21, 1995,
8:30 a.m., Holiday Inn--Silver Spring, Plaza Ballroom, 8777 Georgia
Ave., Silver Spring, MD.
Type of meeting and contact person. Open committee discussion, July
20, 1995, 8 a.m. to 1 p.m.; open public hearing, 1 p.m. to 2 p.m.,
unless public participation does not last that long; open committee
discussion, 2 p.m. to 5 p.m.; closed committee deliberations, July 21,
1995, 8:30 a.m. to 4:30 p.m.; Ermona B. McGoodwin or Mary Elizabeth
Donahue, Center for Drug Evaluation and Research (HFD-9), 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.
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 July 13, 1995, 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. During the morning of July 20, 1995, the
committee will discuss treatment goals of the short-term therapy of
cystitis, including safety and efficacy data for the fosfomycin
tromethamine NDA 50-717, Forest Laboratories, Inc./Zambon Corp. During
the afternoon, the committee will revisit the FDA/Infectious Diseases
Society of America guidelines for evaluating new treatment regimens for
urinary tract infections.
Closed committee deliberations. On July 21, 1995, the committee
will discuss 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)).
Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory
Committee
Date, time, and place. July 21, 1995, 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 Ed Rugenstein, Sociometrics, Inc., 301-608-2151. The
availability of appropriate accommodations can not be assured unless
prior written notification is received.
Type of meeting and contact person. Open public hearing, 8 a.m. to
9 a.m., unless public participation does not last that long; open
committee discussion, 9 a.m. to 12 m.; closed committee deliberations,
12 m. to 1 p.m.; open committee discussion, 1 p.m. to 6 p.m.; Marilyn
N. Flack, Center for Devices and Radiological Health (HFZ-470), Food
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,
301-594-2080, or FDA Advisory Committee Information Hotline, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), Ear, Nose, and Throat
Devices Panel, code 12522.
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 10, 1995, 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 a premarket
approval application that seeks to substantiate the safety and
effectiveness of a cochlear implant device for use in adults with
postlinguistically, profound, sensorineural hearing loss, who obtain
little benefit from conventional amplification.
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 [[Page 32333]] 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 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: June 15, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-15147 Filed 6-20-95; 8:45 am]
BILLING CODE 4160-01-F
