[Federal Register Volume 59, Number 105 (Thursday, June 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13330]
[[Page Unknown]]
[Federal Register: June 2, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: This notice announces a forthcoming meeting of a public
advisory committee of the Food and Drug Administration (FDA). This
notice also summarizes the procedures for the meeting and methods by
which interested persons may participate in open public hearings before
FDA's advisory committees.
MEETING: The following advisory committee meeting is announced:
Science Board to the Food and Drug Administration
Date, time, and place. June 28, 1994, 8:30 a.m., Parklawn Bldg.,
conference rm. D, 5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. Closed committee deliberations,
8:30 a.m. to 9:30 a.m.; open committee discussion, 9:30 a.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 6 p.m.; Neil Wilcox, Office of the Senior Advisor for Science
(HF-33), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-5839.
General function of the board. The board provides advice primarily
to the agency's Senior Science Advisor and, as needed, to the
Commissioner and other appropriate officials on specific complex and
technical issues as well as emerging issues within the scientific
community in industry and academia. Additionally, the board provides
advice to the agency on keeping pace with technical and scientific
evolutions in the fields of regulatory science; on formulating an
appropriate research agenda; and on upgrading its scientific and
research facilities to keep pace with these changes. It also provides a
means for critical review of agency sponsored intramural and extramural
scientific research programs.
Agenda--Open public hearing. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the board. Those desiring to make formal presentations must notify the
contact person before June 14, 1994, and submit a brief statement of
the general nature of the evidence or arguments they wish to present
and the names and addresses of proposed participants. Each presenter
will be limited in time and not all requests to speak may be able to be
accommodated. All written statements submitted in a timely fashion will
be provided to the board.
Open committee discussion. The board will discuss issues relevant
to toxicity testing and their potential impact on the scientific
effectiveness of the agency. The discussion is designed to give the
agency direction for future program development.
Closed committee deliberations. The board will discuss information
concerning nominations for the FDA award for scientific achievement,
that if discussed in public would disclose information of a personal
nature 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: May 25, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-13330 Filed 6-1-94; 8:45 am]
BILLING CODE 4160-01-F
