[Federal Register Volume 59, Number 98 (Monday, May 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12493]
[[Page Unknown]]
[Federal Register: May 23, 1994]
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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.
MEETINGS: The following advisory committee meetings are announced:
Vaccines and Related Biological Products Advisory Committee
Date, time, and place. June 7, 1994, 8 a.m., Holiday Inn--Silver
Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
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 p.m.; closed committee deliberations,
1 p.m. to 6 p.m.; Nancy T. Cherry or Stephanie A. Milwit, Scientific
Advisors and Consultants Staff (HFM-21), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852, 301-594-1054.
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 before May 31, 1994, 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 participate in a
general discussion of the clinical development of, and trial design
issues for, vaccines for the prevention of Lyme disease.
Closed committee deliberations. The committee will review trade
secret and/or confidential commercial information relevant to pending
investigational new drug (IND) applications or product licensing
applications. 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. June 9, 1994, 8:30 a.m., and June 10, 1994,
8 a.m., conference rms. D and E, Parklawn Bldg., 5600 Fishers Lane,
Rockville, MD.
Type of meeting and contact person. Open public hearing, June 9,
1994, 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, June 10, 1994, 8 a.m. to 9 a.m.; closed committee
deliberations, 9 a.m. to 5 p.m.; Isaac F. Roubein, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-3741.
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 May 31, 1994, 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 June 9, 1994, the committee will
discuss: (1) The labeling of succinylcholine chloride injection
(neuromuscular blocking agent) new drug applications (NDA's) 8-453,
Burroughs Wellcome and Co.; 8-845, Abbott Laboratories; 8-847, Bristol-
Myers Squibb Co.; and 80-997, Organon, Inc.; and (2) adverse experience
associated with the administration of 5 percent lidocaine for spinal
anesthesia, NDA 20-098/S-04, Astra Pharmaceutical Products, Inc. On
June 10, 1994, the committee will hear a progress report on the
metabolism of lidocaine by human liver tissues.
Closed committee deliberations. The committee will review trade
secret and/or confidential commercial information relevant to NDA 19-
627 and IND 40,069. This portion of the meeting will be closed to
permit discussion of this information (5 U.S.C. 552b(c)(4)).
Science Advisory Board to the National Center for Toxicological
Research
Date, time, and place. June 14, 1994, 1 p.m., and June 15, 1994, 9
a.m., Bldg. 12, conference rm., National Center for Toxicological
Research (NCTR), Jefferson, AR.
Type of meeting and contact person. Open committee discussion, June
14, 1994, 1 p.m. to 5 p.m.; open board discussion, June 15, 1994, 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; closed board
deliberations, 2:30 p.m. to 3:30 p.m.; Ronald F. Coene, NCTR (HFT-10),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-443-3155.
General function of the board. The board advises on establishment
and implementation of a research program that will assist the
Commissioner of Food and Drugs to fulfill 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 June 1, 1994, 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 requested to make their comments.
Open board discussion. The board will conduct a review of the
Science Advisory Board's Site Visit Team draft reports on two research
programs of the center: (1) Biochemical and Molecular Markers Program,
and (2) Transgenics Program. The board will engage in discussions on
these reports and come to a final conclusion on the recommendations to
be made to the Director concerning these center programs. The center
will also provide progress reports on the recommendations of two
previously reviewed research programs: (1) The Nutritional Modulation
of Risk and Toxicity Program, and (2) the Applied and Environmental
Microbiology Program. A final agenda will be available beginning June
7, 1994, from the contact person.
Closed board deliberations. On June 14, 1994, the board will
discuss personal information concerning individuals associated with
these review programs, disclosure of which would constitute a clearly
unwarranted invasion of personal privacy. This portion of the meeting
will be closed to permit discussion of this information (5 U.S.C.
552b(c)(6)).
Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory
Committee
Date, time, and place. June 27, 1994, 9:30 a.m., and June 28, 1994,
8 a.m., Holiday Inn--Silver Spring, Plaza Ballroom, 8777 Georgia Ave.,
Silver Spring, MD.
A limited number of overnight accommodations have been reserved at
the Holiday Inn. Attendees requiring overnight accommodations must
contact the hotel at 301-589-0800 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, June 27,
1994, 9:30 a.m. to 3 p.m., unless public participation does not last
that long; open committee discussion, 3 p.m. to 4:30 p.m.; closed
committee deliberations, June 28, 1994, 8 a.m. to 10 a.m.; open public
hearing, 10 a.m. to 11 a.m., unless public participation does not last
that long; open committee discussion, 11 a.m. to 4:30 p.m.; Harry R.
Sauberman, Center for Devices and Radiological Health (HFZ-470), Food
and Drug Administration, 1390 Piccard Dr., Rockville, MD 20850, 301-
594-2080. If anyone who is planning to attend the meeting will need any
special assistance, as defined under the American with Disabilities
Act, please notify the contact person.
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 June 5, 1994, 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 proposed
protocol for performing scientific and clinical evaluations of hearing
aids for the purpose of substantiating manufacturer performance claims.
Closed committee deliberations. The committee will discuss 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)).
Dental Products Panel of the Medical Devices Advisory Committee
Date, time, and place. June 28, 1994, 10:30 a.m., and June 29,
1994, 8 a.m., Quality Hotel, Maryland Ballroom, 8727 Colesville Rd.,
Silver Spring, MD.
A limited number of overnight accommodations have been reserved.
Attendees requiring overnight accommodations must contact the hotel at
301-589-5200 and reference the FDA Panel meeting block. Reservations
will be confirmed at the group rate based on availability.
Type of meeting and contact person. Closed committee deliberations,
June 28, 1994, 10:30 a.m. to 4:30 p.m.; open public hearing, June 29,
1994, 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.; Carolyn A. Tylenda,
Center for Devices and Radiological Health (HFZ-410), Food and Drug
Administration, 1390 Piccard Dr., Rockville, MD, 301-594-3090.
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 June 15, 1994, 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. The committee will discuss trade
secret and/or confidential commercial information regarding pending and
future device submissions. This portion of the meeting will be closed
to permit discussion of this information (5 U.S.C. 552b(c)(4)).
Open committee discussion. The committee will discuss
classification of bone filling and augmentation materials, and
classification of dental amalgam filling material and dental product
ingredient labeling.
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: May 17, 1994.
Linda Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-12493 Filed 5-20-94; 8:45 am]
BILLING CODE 4160-01-F
