[Federal Register Volume 61, Number 38 (Monday, February 26, 1996)]
[Notices]
[Pages 7116-7117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4288]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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 will be updated when such changes are made.
MEETING: The following advisory committee meeting is announced:
[[Page 7117]]
Science Board to the Food and Drug Administration
Date, time, and place. March 28 and 29, 1996, 8:30 a.m., Sheraton
National Hotel, North Ballroom, 900 South Orme St. (Columbia Pike and
Washington Blvd.), Arlington, VA.
Type of meeting and contact person. Open committee discussion,
March 28, 1996, 8:30 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 5 p.m.; open committee discussion,
March 29, 1996, 8:30 a.m. to 10:30 a.m.; open public hearing 10:30 a.m.
to 11:30 a.m., unless public participation does not last that long;
open committee discussion, 11:30 a.m. to 1:30 p.m. For the March 28,
1996, agenda contact Susan Homire, Office of Science (HF-33), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857, 301-827-
3340; for the March 29, 1996, agenda contact Mary Gross, Office of
External Affairs (HF-24), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD, 20857, 301-827-3440; or, FDA Advisory Committee
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), Science Board to the Food and Drug Administration, code 12603.
General function of the board. The board shall provide 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 will
provide 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
will also provide the 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 March 14, 1996, 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 board discussion. On March 28, 1996, the board will discuss
issues related to the safety in the testing of biomaterials used in
products regulated by FDA; including strategies by which the agency can
prepare for new developments in biomaterials science and the use of
novel materials in device and medical implant products. On March 29,
1996, the board will discuss financial disclosure by clinical
investigators. For further information on the agenda of this meeting
see a document entitled ``Financial Disclosure by Clinical
Investigators; Reopening of the Comment Period and Notice of Meeting,''
published elsewhere in this issue of the Federal Register.
FDA public advisory committee meetings 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.
There are no closed portions for the meetings announced in this notice.
The dates and times reserved for the open 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.
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: February 16, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-4288 Filed 2-23-96; 8:45 am]
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