[Federal Register Volume 60, Number 55 (Wednesday, March 22, 1995)]
[Notices]
[Pages 15147-15150]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7078]
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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:
Drug Abuse Advisory Committee
Date, time, and place. April 6 and 7, 1995, 8 a.m., Parklawn Bldg.,
conference rooms D and E, 5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. Closed committee deliberations,
April 6, 1995, 8 a.m. to 5 p.m.; open public hearing, April 7, 1995, 8
a.m. to 9 a.m., unless public participation does not last that long;
open committee discussion, 9 a.m. to 4 p.m.; Stephen P. Pollitt, 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), Drug Abuse Advisory Committee, code 12535.
General function of the committee. The 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, [[Page 15148]] efficacy, and abuse potential of drugs
and recommends actions to be taken on the marketing, investigation, and
control of such drugs.
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 23, 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.
Closed committee deliberations. On April 6, 1995, the committee
will review 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)).
Open committee discussion. On April 7, 1995, the committee will
discuss the 1995 Institute of Medicine Report on the Development of
Medications for the Treatment of Opiate and Cocaine Addiction.
Biological Response Modifiers Advisory Committee
Date, time, and place. April 10 and 11, 1995, 8 a.m., Parklawn
Bldg., conference rooms D and E, 5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. Open public hearing, April 10,
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 5:30 p.m.; open
public hearing, April 11, 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 1 p.m.; closed committee deliberations, 1 p.m. to 5 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 April 3, 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 April 10, 1995, the committee will
discuss: (1) Product license application supplement, reference number
94-0381, for Roferon A (Interferon-alpha-2a) Hoffman La Roche Inc., for
treatment of chronic phase, Philadelphia chromosome positive chronic
myelogenous leukemia; and (2) product license application supplements
94-0291 and 93-0287, for Sargramostim (GM-CSF), Immunex Corp., for
acceleration of neutrophil recovery following chemotherapy in acute
nonlymphoblastic leukemia and for chemotherapy-induced neutropenia
(this discussion will continue on the following morning). On the
morning of April 11, 1995, the committee will also discuss perspectives
on xenotransplantation. In the afternoon, the committee will discuss
the intramural scientific program of the Laboratory of Bone Marrow
Growth Factors and research programs of individuals in the Division of
Hematologic Products and Division of Cytokine Biology.
Closed committee deliberations. On April 11, 1995, the committee
will discuss the intramural scientific program. This portion of the
meeting will be closed to prevent disclosure of personal information
concerning individuals associated with the research program, disclosure
of which would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)).
Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee
Date, time, and place. April 21, 1995, 8 a.m., Corporate Bldg.,
Main Conference Room, 9200 Corporate Blvd., Rockville, MD. A limited
number of overnight accommodations have been reserved at the
Gaithersburg Marriott Washingtonian Center, 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.
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 5 p.m.; closed committee deliberations,
5 p.m. to 6 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.
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 April 14, 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 general
issues related to two premarket approval applications for devices
intended for the extracorporeal removal of low-density lipoprotein
(LDL) to lower LDL cholesterol in patients with familial
hypercholesterolemia.
Closed committee deliberations. The committee may discuss 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)).
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory
Committee
Date, time, and place. April 24, 1995, 8:30 a.m., Corporate Bldg.,
Main Conference Room, 9200 Corporate Blvd., Rockville, MD. A limited
number of overnight accommodations have been reserved at the
Gaithersburg Marriott Washingtonian Center, 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 [[Page 15149]] be confirmed at the group rate
based on availability.
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 2 p.m.; closed committee
deliberations, 2 p.m. to 4 p.m.; Colin M. Pollard, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1180, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), Obstetrics and Gynecology Devices Panel, code
12524.
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 April 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 general
issues regarding home uterine activity monitors (HUAM's), in light of
new published information on HUAM's.
Closed committee deliberations. The committee may discuss trade
secret and/or confidential commercial information regarding various
medical devices used in obstetrics and gynecology that are currently
being evaluated by FDA. 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 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 [[Page 15150]] FDA's
regulations (21 CFR part 14) on advisory committees.
Dated: March 16, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-7078 Filed 3-21-95; 8:45 am]
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