[Federal Register Volume 59, Number 139 (Thursday, July 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17694]
[[Page Unknown]]
[Federal Register: July 21, 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:
Hematology and Pathology Devices Panel of the Medical Devices Advisory
Committee
Date, time, and place. August 5, 1994, 9 a.m., Holiday Inn Crowne
Plaza, Regency Room, 1750 Rockville Pike, Rockville, MD. A limited
number of overnight accommodations have been reserved at the Holiday
Inn Crowne Plaza. Attendees requiring overnight accommodations must
contact the hotel at 301-468-1100 and reference the FDA panel meeting
block. Reservations will be confirmed at the group rate on
availability.
Type of meeting and contact person. 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 4 p.m.; closed committee
deliberations, 4 p.m. to 5 p.m.; Larry J. Brindza, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-2096.
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 29, 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: (1) A
points-to-consider document for automated cervical cancer slide readers
and automated cervical cancer slide preparation instruments, (2) home
use prothrombin time tests, (3) standardization of coagulation assays
and reagents, (4) hematology replacement reagents, and (5) a briefing
on the FDA Immunohistochemistry Products Workshop held on June 28 and
29, 1994.
Closed committee deliberations. The committee will discuss trade
secret and/or confidential commercial information regarding cervical
cancer slide preparation devices. 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. August 19, 1994, 9 a.m., Parklawn Bldg.,
Conference rm. E, 5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. Closed committee deliberations,
9 a.m. to 12 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.; Peter E. Maxim, Center for Devices and Radiological
Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd.,
Rockville, MD 20850, 301-594-1293.
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 August 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 required to make their comments.
Open committee discussion. The committee will discuss draft
guidance documents on the following topics: (1) Anti-nuclear
antibodies, (2) anti-thyroid antibodies, and (3) alpha-fetoprotein for
neural tube defects. In addition, the committee will discuss points-to-
consider documents on immunohistochemical antibody products and tumor
markers (carcinoembryonic antigen, alpha-fetoprotein, and prostate
specific antigen) for monitoring.
Single copies of the draft guidance documents are available from
the Division of Small Manufacturers Assistance, Center for Devices and
Radiological Health (HFZ-220), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 800-638-2041, FAX 301-443-8818. The
points-to-consider documents will be available the day of the meeting.
Closed committee deliberations. The committee will discuss trade
secret and/or confidential commercial information regarding pending or
future device applications. This portion of the meeting will be closed
to permit discussion of this information (5 U.S.C. 552b(c)(4)).
Vaccines and Related Biological Products Advisory Committee
Date, time, and place. August 23, 1994, 12:30 p.m., and August 24,
1994, 8 a.m., Holiday Inn-Bethesda, Versailles Ballrooms I and II, 8120
Wisconsin Ave., Bethesda, MD.
Type of meeting and contact person. Closed committee deliberations,
August 23, 1994, 12:30 p.m to 6 p.m.; open committee discussion, August
24, 1994, 8 a.m. to 8:30 a.m.; 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 5 p.m.; Nancy Cherry or Stephanie
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 August 17, 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 hear reports from
committee members on liaison activities for the committee and consider
vaccine safety issues including: (1) Methodological approaches to
assessing vaccine safety, (2) general scientific considerations, (3)
the Vaccine Adverse Events Reporting System, and (4) recent reports
from the Institute of Medicine.
Closed committee deliberations. The committee will review trade
secret and/or confidential commercial information relevant to pending
investigational new drug 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)).
Radiological Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. August 29, 1994, 1 p.m., Parklawn Bldg.,
Conference rm. G, 5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. Closed committee deliberations,
1 p.m. to 2:30 p.m.; open public hearing, 2:30 p.m. to 3:30 p.m.,
unless public participation does not last that long; open committee
discussion, 3:30 p.m. to 5 p.m.; Robert A. Phillips, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 1390
Piccard Dr., Rockville, MD 20850, 301-594-1212.
If anyone who is planning to attend the meeting will need any
special assistance as defined under the Americans with Disabilities
Act, please notify the contact person listed under the ``Date, time,
and place'' portion above.
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 August 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.
Open committee discussion. The committee will discuss recommended
classification of picture archiving and communication devices.
Closed committee deliberations. The committee will discuss trade
secret and/or confidential commercial information regarding pending and
future device 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 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: July 15, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-17694 Filed 7-20-94; 8:45 am]
BILLING CODE 4160-01-F
