[Federal Register Volume 60, Number 250 (Friday, December 29, 1995)]
[Notices]
[Pages 67359-67362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31461]
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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
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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:
Ophthalmic Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. January 22, 1996, 9:30 a.m., Holiday Inn--
Gaithersburg, 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 or 1-800-465-4329 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 Sociometrics, Inc., 8300 Colesville Rd.,
suite 550, Silver Spring, MD 20910, 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, 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 1:30 p.m.; closed presentation
of data, 1:30 p.m. to 5:30 p.m.; Sara M. Thornton, Center for Devices
and Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2053, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), Ophthalmic Devices Panel, code 12396.
-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 29, 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 review and recommend
the classification status for currently unclassified devices which may
include lacrimal system plugs, lacrimal system repair devices, and
scleral plugs. The Intraocular and Corneal Implants Branch will request
committee discussion on the clinical annex of the draft American
National Standards Institute (ANSI) standard for glaucoma drainage
devices.
-Closed committee deliberations. The committee will discuss trade
secret and/or confidential commercial information relevant to
investigational device exemption applications and premarket approval
applications for vitreo-retinal, surgical, and diagnostic devices,
intraocular and corneal implants, and contact lenses. This portion of
the meeting will be closed to permit discussion of this information (5
U.S.C. 552b(c)(4)).
Microbiology Devices Panel of the Medical Devices Advisory Committee
-Date, time, and place. January 25, 1996, 9:45 a.m., and January
26, 1996, 8:45 a.m., Gaithersburg Hilton, Grand Ballroom, 620 Perry
Pkwy., Gaithersburg, MD. A limited number of overnight accommodations
have been reserved at the Gaithersburg Hilton. Attendees requiring
overnight accommodations may contact the hotel at 301-977-8900 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 Sociometrics, Inc.,
8300 Colesville Rd., suite 550, Silver Spring, MD 20910, 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, January
25, 1996, 9:45 a.m. to 10:45 a.m., unless public participation does not
last that long; open committee discussion, 10:45 a.m. to 6:30 p.m.;
closed committee deliberations, January 26, 1996, 8:45 a.m. to 9:45
a.m.; open public hearing, 9:45 a.m. to 10:45 a.m., unless public
participation does not last that long; open committee discussion, 10:45
a.m. to 5 p.m.; Freddie M. Poole, Center for Devices and Radiological
Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd.,
Rockville, MD 20850, 30l-594-2096, or FDA Advisory Committee
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), Microbiology Devices Panel, code 12517.
-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 January 10, 1996, 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 January 25, 1996, the committee will
discuss a premarket approval application (PMA) for an in vitro
diagnostic, target-amplified nucleic acid device for the detection of
Mycobacterium tuberculosis complex in digested, decontaminated human
respiratory specimens. On January 26, 1996, the committee will discuss
issues concerning the accuracy of commercially available serological
kits for the detection of human anti-Toxoplasma IgM and anti-Borrelia
borgdorferi antibodies in relation to their indication for use.
-Closed committee deliberations. On January 26, 1996, FDA staff
will present to the committee 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)).
Science Advisory Board to the National Center for Toxicological
Research
-Date, time, and place. January 29, 1996, 1 p.m., and January 30,
1996, 9 a.m., Bldg. 12, conference room, National Center for
Toxicological Research, Jefferson, AR.
-Type of meeting and contact person. Open board discussion, January
29, 1996, 1 p.m. to 4:30 p.m.; open board
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discussion, January 30, 1996, 9 a.m. to 1 p.m.; open public hearing, 1
p.m. to 2 p.m., unless public participation does not last that long;
open board discussion, 2 p.m. to 3:30 p.m.; closed board deliberations,
3:30 p.m. to 4:30 p.m.; Ronald F. Coene, National Center for
Toxicological Research (HFT-10), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-3155, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), Science Advisory Board to the National Center for
Toxicological Research, code 12559.
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 January 15, 1996, 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 board discussion. The board will be given a progress report
on its recommendation that resulted from the board's Site Visit Team
Report on the Center's Analytical Methods Development Program. The
board will be presented and asked to review the Center's integration of
the eight programs it has site visited and made recommendations. The
presentation will include a discussion of the resource allocation to
these programs as well as their relationship to the Center's strategic
vision and goals. A final agenda will be available on January 22, 1996,
from the contact person.
-Closed board deliberations. The board will discuss personal
information concerning individuals associated with the research
programs at the Center, 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)).
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
[[Page 67362]]
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: December 19, 1995.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 95-31461 Filed 12-28-95; 8:45 am]
BILLING CODE 4160-01-F
