[Federal Register Volume 60, Number 74 (Tuesday, April 18, 1995)]
[Notices]
[Pages 19403-19405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9576]
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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 [[Page 19404]] will be updated when such changes are made.
MEETINGS: The following advisory committee meetings are announced:
Microbiology Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. May 1, 1995, 9:45 a.m., and May 2, 1995,
8:45 a.m., Holiday Inn--Gaithersburg, Walker and Whetstone Rooms, Two
Montgomery Village Ave., Gaithersburg, MD. A limited number of
overnight accommodations have been reserved at the Holiday Inn--
Gaithersburg. 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.
Type of meeting and contact person. Open public hearing, May 1,
1995, 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.;
open public hearing, May 2, 1995, 8:45 a.m. to 10 a.m., unless public
participation does not last that long; open committee discussion, 10
a.m. to 11:30 a.m.; closed presentation of data, 11:30 a.m. to 12:30
p.m.; open committee discussion, 12:30 p.m. to 6:30 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 April 25, 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 May 1, 1995, the committee will
discuss a premarket approval application (PMA) for an in vitro
diagnostic device intended for use in the determination of anti-
neoplastic resistance to tumor cells with specific chemotherapeutic
agents. On May 2, 1995, the committee will discuss a PMA for an in
vitro diagnostic, target-amplified nucleic acid device for the
detection of Mycobacterium tuberculosis complex in sediments prepared
from sputum (induced or expectorated), bronchial specimens, or tracheal
specimens.
Closed presentation of data. On May 2, 1995, the committee will
discuss trade secret and/or confidential commercial information
regarding the target-amplified nucleic acid device for the detection of
Mycobacterium tuberculosis complex. This portion of the meeting will be
closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).
FDA is giving less than 15 days public notice of the Microbiology
Devices Panel of the Medical Devices Advisory Committee meeting. The
agency decided that it is in the public interest to hold this meeting
May 1 and 2, 1995, even if there was not sufficient time for the
customary 15-day public notice.
Science Advisory Board to the National Center for Toxicological
Research
Date, time, and place. May 9, 1995, 8:30 a.m., Bldg. 12,
conference room, National Center for Toxicological Research, Jefferson,
AR.
Type of meeting and contact person. Open committee discussion,
8:30 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 committee
discussion, 2 p.m. to 4 p.m.; closed committee deliberations, 4 p.m. to
5 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. Any interested persons may present
data, information, or views, orally or in writing, on issues pending
before the committee. Those desiring to make a formal presentation
should notify the contact person before April 21, 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 requested to make their comments.
Open board discussion. The board will conduct a review of the
Science Advisory Board's (SAB's) Site Visit Team draft report on the
Analytical Methods Development Program, engage in discussions on this
report, and come to a final conclusion on the recommendations to be
made to the Director concerning this center program. The center will
provide progress reports on the recommendations of previously reviewed
research programs: (1) The Transgenics Program, and (2) Biochemical and
Molecular Markers of Cancer Program. The center will also provide a
review and examination of the process and the product of the Site Visit
Teams over the past 3 years, and develop a future agenda for the SAB. A
final agenda will be available on May 4, 1995, from the contact person.
Closed board deliberations. 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)).
The Commissioner approves the scheduling of meetings at locations
outside of the Washington, DC, area on the basis of the criteria of 21
CFR 14.22 of FDA's regulations relating to public advisory committees.
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 [[Page 19405]] 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: April 13, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-9576 Filed 4-13-95; 4:14 pm]
BILLING CODE 4160-01-F
