[Federal Register Volume 60, Number 162 (Tuesday, August 22, 1995)]
[Notices]
[Pages 43599-43602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20730]
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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:
Generic Drugs Advisory Committee
Date, time, and place. September 6 and 7, 1995, 8:30 a.m., Holiday
Inn--Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD.
Type of meeting and contact person. Open committee discussion,
September 6, 1995, 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 5 p.m.; open committee discussion,
September 7, 1995, 8:30 a.m. to 12 m.; closed committee deliberations,
12 m. to 5 p.m.; Kimberly L. Topper or Angie Whitacre, 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), Generic Drugs Advisory Committee, code 12539.
General function of the committee. The committee gives advice on
scientific and technical issues concerning the safety and effectiveness
of human generic drug products for use in the treatment of a broad
spectrum of human diseases and makes appropriate recommendations to the
Secretary of Health and Human Services, the Assistant Secretary for
Health, the Commissioner of Food and Drugs, and the Director of the
Center for Drug Evaluation and Research. The committee may also review
agency-sponsored intramural and extramural biomedical research programs
in support of FDA's generic drugs regulatory responsibilities.
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 August 22, 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 September 6 and 7, 1995, the
committee will review and advise on the status of Center for Drug
Evaluation and Research (CDER) quality and performance initiatives
related to formulation dissolution and bioequivalence. The committee
will also discuss its relationship to, and interaction with, CDER's new
Office of Pharmaceutical Sciences.
Closed committee deliberations. On September 7, 1995, the committee
will discuss trade secret and/or confidential commercial information
relevant to pending abbreviated new drug applications (ANDA's). This
portion of the meeting will be closed to permit discussion of this
information (5 U.S.C. 552b(c)(4)).
Radiological Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. September 11, 1995, 9:30 a.m., Corporate
Bldg., conference room 20B, 9200 Corporate Blvd., Rockville, MD. A
limited number of overnight accommodations have been reserved at the
Gaithersburg Marriott
[[Page 43600]]
Washingtonian Hotel, 9751 Washingtonian Blvd., Gaithersburg, MD.
Attendees requiring overnight accommodations may contact the hotel at
301-590-0044 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 cannot be assured unless prior written
notification is received.
Type of meeting and contact person. 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 12 m.; closed committee
deliberations, 12 m. to 1 p.m.; open committee discussion, 1 p.m. to 4
p.m.; John C. Monahan, Center for Devices and Radiological Health (HFZ-
470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 301-594-1212, or FDA Advisory Committee Information Hotline, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), Radiological
Devices Panel, code 12526. -
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 September 6, 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 draft
guidance document entitled ``Magnetic Resonance Imaging Guidance Update
for Rate of Change of Gradient Fields.'' Single copies of the draft
guidance are available from John C. Monahan (address above).
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)).
Neurological Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. September 15, 1995, 8 a.m., Corporate Bldg.,
ground floor conference room, 9200 Corporate Blvd., Rockville, MD. A
limited number of overnight accommodations have been reserved at the
Gaithersburg Marriott Washingtonian Hotel, 9751 Washingtonian Blvd.,
Gaithersburg, MD. Attendees requiring overnight accommodations may
contact the hotel at 301-590-0044 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. 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 1:30 p.m.; closed committee
deliberations, 1:30 p.m. to 4 p.m.; Jerilyn K. Glass, Center for
Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8517, or FDA Advisory Committee Information Hotline, 1-800-741-8138
(301-443-0572 in the Washington, DC area), Neurological Devices Panel,
code 12513.
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 September 4, 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 the following
topics: (1) Clinical perspectives on the use of balloon catheters,
coils, and liquid occlusive devices for the treatment of aneurysms,
arterio-venous malformations, or bleeding in the cerebrovascular
circulation; and (2) research considerations when designing studies to
evaluate these devices.
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)).
Immunology Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. September 21 and 22, 1995, 8 a.m., Holiday
Inn--Gaithersburg, Walker and Whetstone Ballrooms, 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 cannot be assured unless prior written notification is
received.
Type of meeting and contact person. Open public hearing, September
21, 1995, 8 a.m. to 9 a.m., unless public participation does not last
that long; open committee discussion, 9 a.m. to 1:30 p.m.; open public
hearing; 1:30 p.m. to 2:30 p.m., unless public participation does not
last that long; open committee discussion, 2:30 p.m. to 6 p.m.; closed
committee deliberations, September 22, 1995, 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.; Peter E.
Maxim, Center for Devices and Radiological Health (HFZ-440), Food and
Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-
1293, or FDA Advisory Committee Information Hotline, 1-800-741-8138
(301-443-0572 in the Washington, DC area), Immunology Devices Panel,
code 12516.
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 September 1, 1995, and submit a brief
statement of
[[Page 43601]]
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 relating to the review of three premarket approval applications
for: (1) An in situ hybridization assay to measure a prognostic marker
in breast tumor tissues; (2) a serum tumor marker to aid in the
detection of recurrence in Stage 2 and 3 breast cancer patients; and
(3) an assay to measure a urinary marker to aid in the detection of
recurrence in bladder cancer patients.
Closed committee deliberations. FDA staff will present to the
committee trade secret and/or confidential commercial information
regarding pending or future device submissions. This portion of the
meeting will be closed to permit discussion of this information (5
U.S.C. 552b(c)(4)).
Joint Meetings of Nonprescription Drugs Advisory Committee with
Endocrinologic and Metabolic Drugs Advisory Committee, Drug Abuse
Advisory Committee, and Gastrointestinal Drugs Advisory Committee
Date, time, and place. September 27 and 28, 1995, 8:30 a.m., and
September 29, 1995, 3 p.m., conference rms. D and E, Parklawn Bldg.,
5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. Open public hearing, September
27, 1995, 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 5 p.m.; closed
committee deliberations, 5 p.m. to 6 p.m.; open public hearing,
September 28, 1995, 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.; open public hearing, 4 p.m. to 4:30 p.m., unless public
participation does not last that long; open committee discussion, 4:30
p.m. to 6:30 p.m.; open committee discussion, September 29, 1995, 3
p.m. to 4 p.m.; Lee L. Zwanziger, Stephen Pollitt, 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 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 Endocrinologic and Metabolic Drugs Advisory Committee
reviews and evaluates data on the safety and effectiveness of marketed
and investigational human drugs for use in endocrine and metabolic
disorders. The Drug Abuse Advisory Committee advises on the scientific
and medical evaluation of information gathered by the Department of
Health and Human Services and the Department of Justice on the safety,
efficacy, and abuse potential of drugs and recommends actions to be
taken on the marketing, investigation, and control of such drugs. 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.
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 September 19, 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 September 27, 1995, the
Nonprescription Drugs Advisory Committee and some members of the
Endocrinologic and Metabolic Drugs Advisory Committee will discuss
public health issues relevant to cholesterol lowering regimens and data
relevant to new drug application (NDA) 16-640 for cholestyramine
(Questran powder) and NDA 19-669 for cholestyramine
(Questran Light with aspartame), sponsored by Bristol-Myers
Squibb to switch the products from prescription to over-the-counter
marketing status for use as adjunctive therapy to diet for the
reduction of elevated serum cholesterol in patients with primary
hypercholesterolemia (elevated low density lipoprotein (LDL)
cholesterol) who do not respond adequately to diet. On September 28,
1995, the Nonprescription Drugs Advisory Committee and the Drug Abuse
Advisory Committee will discuss data relevant to NDA 20-066
(Nicorette 4 milligrams (mg) and NDA 18-612
(Nicorette 2 mg) to switch nicotine polacrilex
(Nicorette, SmithKline Beecham Consumer Healthcare Products)
from prescription to over-the-counter status for use as an aid to
smoking cessation for the relief of nicotine withdrawal symptoms. Later
on September 28, 1995 the Nonprescription Drugs Advisory Committee and
some members of the Gastrointestinal Drugs Advisory Committee will
discuss data relevant to NDA 20-555 for nizatidine tablets, 75 mg,
sponsored by Whitehall-Robins Healthcare to switch the product from
prescription to over-the-counter status for the prevention of meal and
beverage induced heartburn. During the afternoon of September 29, 1995,
the Nonprescription Drugs Advisory Committee will discuss issues raised
during the Public Hearing before the Commissioner on Over-The-Counter
Drug Labeling held earlier during the same day.
Closed committee deliberations. On September 27, 1995, the
Nonprescription Drugs Advisory Committee will discuss trade secret and/
or confidential commercial information relevant to pending new drug
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 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
[[Page 43602]]
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 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: August 16, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-20730 Filed 8-21-95; 8:45 am]
BILLING CODE 4160-01-F
