[Federal Register Volume 60, Number 225 (Wednesday, November 22, 1995)]
[Notices]
[Pages 57873-57875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-28521]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committees; Notice of Meetings
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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. December 5, 1995, 1:30 p.m., Food and Drug
Administration, Bldg. 29, conference room 121, 8800 Rockville Pike,
Bethesda, MD.
Type of meeting and contact person. This meeting will be held by a
telephone conference call. A speaker telephone will be provided in the
conference room to allow public participation in the meeting. Closed
committee deliberations, 1:30 p.m. to 4 p.m.; open public hearing, 4
p.m. to 5 p.m., unless public participation does not last that long;
Nancy Cherry or Sandy 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.
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.
Closed committee deliberations. 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 USC 552b(c)(4)).
Radiological Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. December 11, 1995, 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 Gloria Williams, 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, 8:30 a.m.
to 9:45 a.m., unless public participation does not last that long; open
committee
[[Page 57874]]
discussion, 9:45 a.m. to 12:30 p.m.; closed committee deliberations,
12:30 p.m. to 1:30 p.m.; open committee discussion, 1:30 p.m. to 4:30
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 December 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 general
issues related to a premarket approval application for an ultrasound
imaging device indicated for use on the breast in women with
abnormalities based on prior mammography and/or physical examination.
This device will be used to further evaluate solid mass characteristics
in order to reduce the number of biopsies.
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)).
Anesthetic and Life Support Drugs Advisory Committee
Date, time, and place. December 11 and 12, 1995, 8:30 a.m., Holiday
Inn, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
Type of meeting and contact person. Open public hearing, December
11, 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.; open
committee discussion, December 12, 1995, 8:30 a.m. to 11 a.m.; closed
committee deliberations, 11 a.m. to 1 p.m.; Stephen P. Pollitt, 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), Anesthetic and Life Support Drugs
Advisory Committee, code 12529.
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 the field of anesthesiology and
surgery.
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 December 1, 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 new drug
application (NDA) 20-533, Naropin , Astra Laboratories, for
use as a local anesthetic and a report of the postmarket surveillance
of NDA 27-428, Oralet, Anesta.
-Closed committee deliberations. On December 12, 1995, the
committee will review trade secret and/or confidential commercial
information. This portion of the meeting will be closed to permit
discussion of this information (5 U.S.C. 552b(c)(4)).
Blood Products Advisory Committee
Date, time, and place. December 14 and 15, 1995, 8 a.m., Parklawn
Bldg., conference rooms D and E, 5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. Open committee discussion,
December 14, 1995, 8 a.m. to 8:40 a.m.; open public hearing, 8:40 a.m.
to 9:10 a.m., unless public participation does not last that long; open
committee discussion, 9:10 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; open committee discussion, 12 m. to 3:30 p.m.; open public
hearing, 3:30 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, December 15, 1995, 8 a.m. to 10:30 a.m.; open public
hearing, 10:30 a.m. to 11 a.m., unless public participation does not
last that long; open committee discussion, 11 a.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 20852-1448, 301-594-
6700, FAX 301-594-6764, 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,
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 December 8, 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 the morning of December 14, 1995, the
committee will hear agency updates on Creutzfeldt-Jakob Disease and
blood safety, and Human Immune Deficiency Virus, Type 1 (HIV-1) antigen
screening of donors; review the report of the FDA/Health Resources
Services Administration contract study of the Tissue Procurement and
Distribution System in the United States, and hear scientific
presentations on testing for Chagas disease (infection with Trypanosoma
cruzi) in blood donors. In the afternoon, the committee will hear a
summary of the Workshop on Cord Blood Derived Hematopoietic Stem Cells
and presentation on Peripheral Blood Derived Hematopoietic Stem Cell
Products Intended for Transfusion. A draft document for discussion
concerning the application of current statutory authorities to
peripheral blood hematopoietic stem cell products intended for
transfusion will be made available. On the morning of December 15,
1995, the committee will review and make recommendations on issues
related to respiratory syncytial virus immune globulin intravenous,
MedImmune. In the afternoon, the committee will review and discuss the
site visit reports of the Laboratories of Molecular Virology and
[[Page 57875]]
Immunochemistry, Division of Transfusion Transmitted Diseases.
Closed committee deliberations. 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)).
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 FDA's regulations (21 CFR
part 14) on advisory committees.
Dated: November 14, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-28521 Filed 11-21-95; 8:45 am]
BILLING CODE 4160-01-F
