[Federal Register Volume 62, Number 34 (Thursday, February 20, 1997)]
[Notices]
[Pages 7789-7790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4305]
[[Page 7789]]
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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 will be updated when such changes are made.
MEETINGS: The following advisory committee meetings are announced:
Anti-Infective Drugs Advisory Committee
Date, time, and place. March 5, 1997, 8:30 a.m., Bethesda Ramada,
Embassy Ballroom, 8400 Wisconsin Ave., Bethesda, MD, and March 6 and 7,
1997, 8:30 a.m., Holiday Inn--Bethesda, Versailles Ballrooms I and III,
8210 Wisconsin Ave., Bethesda, MD. The hotels are in close proximity
and have parking available. In addition, there is a public parking
garage nearby at 8216 Woodmont Ave.
Type of meeting and contact person. Open public hearing, March 5,
1997, 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.; open
committee discussion, March 6, 1997, 8:30 a.m. to 5 p.m.; open
committee discussion, March 7, 1997, 8:30 a.m. to 2 p.m.; Ermona B.
McGoodwin or Danyiel D'Antonio, Center for Drug Evaluation and Research
(HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857, 301-443-5455, or FDA Advisory Committee Information Hotline,
1-800-741-8138 (301-443-0572 in the Washington, DC area), Anti-
Infective Drugs Advisory Committee, code 12530. Please call the hotline
for information concerning any possible changes.
General function of the committee. The committee reviews and
evaluates available data concerning the safety and effectiveness of
marketed and investigational human drug products for use in the
treatment of infectious diseases and disorders.
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 February 28, 1997, 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 the morning of March 5, 1997, the
committee will discuss supplemental new drug application (NDA) 50-679/
S002 Maxipime for Injection (cefepime hydrochloride, Bristol-
Myers Squibb), in the treatment of febrile episodes in neutropenic
patients. In the afternoon of March 5, 1997, and on March 6 and 7,
1997, the committee will discuss the draft guidance document entitled
``Evaluating Clinical Studies of Antimicrobials in the Division of
Anti-Infective Drug Products,'' which is currently in the Draft-Not for
Implementation stage. Copies of this draft guidance document can be
obtained 2 weeks before the meeting from the Drug Information Branch,
Division of Communications Management (HFD-210), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-4573, FAX: 301-827-4577. An
electronic version of this draft guidance document will be available 2
weeks before the meeting via the World Wide Web. To access the draft
guidance document on the Internet, connect to CDER's home page at
http://www.fda.gov/cder/guidance.htm.
FDA regrets that it was unable to publish this notice 15 days prior
to the March 5, 6, and 7, 1997, Anti-Infective Drugs Advisory Committee
meeting. Because the agency believes there is some urgency to bring
these issues to public discussion and qualified members of the Anti-
Infective Drugs Advisory Committee were available at this time, the
Commissioner concluded that it was in the public interest to hold this
meeting even if there was not sufficient time for the customary 15-day
public notice.
Science Board to the Food and Drug Administration
Date, time, and place. March 13, 1997, 9 a.m. to 3 p.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, 9
a.m. to 11 a.m.; open public hearing, 11 a.m. to 12 m., unless public
participation does not last that long; open committee discussion, 12 m.
to 3 p.m.; Susan A. Homire, Office of Science (HF-33), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340,
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. Please call the hotline for information
concerning any possible changes.
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 should notify
the contact person before March 3, 1997, 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
accommodated. All written statements submitted in a timely fashion will
be provided to the board.
Open board discussion. The Science Board Subcommittee on
Toxicology, which has been established to address
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issues related to toxicological testing methods, will provide an update
on its activities. The Science Board Subcommittee on FDA Research will
present a report to the board on a strategy for optimizing the quality
and mission relevance of agency research programs.
Vaccines and Related Biological Products Advisory Committee
Date, time, and place. March 14, 1997, 12:30 p.m., National
Institutes of Health, Bldg. 29, conference room 121, 8800 Rockville
Pike, Bethesda, MD.
Type of meeting and contact person. This meeting will be held by a
telephone conference call. A speaker telephone will be provided in the
conference room to allow public participation in the meeting. Open
committee discussion, 12:30 p.m. to 2 p.m.; open public hearing, 2 p.m.
to 3 p.m., unless public participation does not last that long; Nancy
T. Cherry or Denise A. Royster, Center for Biologics Evaluation and
Research (HFM-21), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), Vaccines and Related Biological Products Advisory Committee,
code 12388. Please call the hotline for information concerning any
possible changes.
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 by March 1, 1997, 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 the
influenza virus vaccine's formulation for 1997 and 1998.
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 the meeting(s) 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, 12420 Parklawn Dr., rm. 1-23,
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 (a)(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 12, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-4305 Filed 2-18-97; 11:00 am]
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