[Federal Register Volume 62, Number 20 (Thursday, January 30, 1997)]
[Notices]
[Pages 4535-4537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2297]
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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:
Arthritis Advisory Committee
Date, time, and place. February 4, 1997, 8:30 a.m., and February
5, 1997, 8 a.m., Gaithersburg Hilton, Ballroom, 620 Perry Pkwy.,
Gaithersburg, MD.
Type of meeting and contact person. Open public hearing, February
4, 1997, 8:30 a.m. to 9 a.m., unless public participation does not last
that long; open committee discussion, 9 a.m. to 5 p.m.; open public
hearing, February 5, 1997, 8 a.m. to 8:30 a.m., unless public
participation does not last that long; open committee discussion, 8:30
a.m. to 5 p.m.; Kathleen R. Reedy or LaNise S. Giles, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5455, FAX: 301-443-0699, or
FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Arthritis
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Advisory Committee, code 12532. 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 marketed and
investigational human drugs for use in arthritic conditions.
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 31, 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 February 4, 1997, the committee will
hear presentations and discuss data submitted regarding the safety and
efficacy of new drug application (NDA) 50-735, Neoral
(cyclosporine, Sandoz) soft gelatin capsules and oral solution for
microemulsion, for the treatment of severe rheumatoid arthritis. On
February 5, 1997, the committee will review, discuss, and critique the
draft document ``Guidance for Industry. Clinical Development Programs
for Drugs, Devices, and Biological Products for the Treatment of
Rheumatoid Arthritis (RA),'' including Juvenile Rheumatoid Arthritis
(JRA). This draft document is available for inspection in docket 96D-
0067 at the Dockets Management Branch (HFA-305), Food and Drug
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 301-
443-7542.
FDA regrets that it was unable to publish this notice 15 days prior
to the February 4, 1997, and February 5, 1997, Arthritis Advisory
Committee meeting. Because the agency believes there is some urgency to
bring this issue to public discussion and qualified members of the
Arthritis 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.
Cardiovascular and Renal Drugs Advisory Committee
Date, time, and place. February 27 and 28, 1997, 8:30 a.m.,
National Institutes of Health, Clinical Center, Bldg. 10, Jack Masur
Auditorium, 9000 Rockville Pike, Bethesda, MD. Parking in the Clinical
Center visitor area is reserved for Clinical Center patients and their
visitors. If you must drive, please use an outlying lot such as Lot
41B. Free shuttle bus service is provided from Lot 41B to the Clinical
Center every 8 minutes during rush hour and every 15 minutes at other
times.
Type of meeting and contact person. Open public hearing, February
27, 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 5:30 p.m.; open
committee discussion, February 28, 1997, 8:30 a.m. to 5:30 p.m.; Joan
C. Standaert, Center for Drug Evaluation and Research (HFD-110), 419-
259-6211, or Mae Brooks (HFD-21), 301-443-5455, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), Cardiovascular and Renal Drugs Advisory
Committee, code 12533. Please call the hotline for information
concerning any possible changes.
General function of committee. The committee reviews and evaluates
data on the safety and effectiveness of marketed and investigational
human drugs for use in cardiovascular and renal 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 13, 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 February 27, 1997, the committee will
discuss: (1) NDA 20-727, BiDil (hydralazine HCl/isosorbide
dinitrate tablets, Medco Research, Inc., to be indicated for treatment
of chronic congestive heart failure as an adjunct to standard therapy
in patients intolerant to or having contraindications to angiotensin
converting enzyme (ACE) inhibitor therapy; and (2) NDA 20-297,
CoregTM (carvedilol, SmithKline Beecham), to be indicated for the
treatment of moderate, chronic congestive heart failure. On February
28, 1997, the committee will discuss: (1) NDA 20-689, PosicorTM
(mibefradil, Hoffmann La Roche), to be indicated for hypertension and
angina; and (2) NDA 20-718, Integrilin (intrifiban, COR
Therapeutics, Inc.), to be indicated as adjunct therapy to aspirin and
heparin in patients undergoing percutaneous transluminal coronary
angioplasty for prevention of acute cardiac ischemic complications
related to abrupt closure of treated coronary vessels.
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
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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 (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: January 24, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-2297 Filed 1-29-97; 8:45 am]
BILLING CODE 4160-01-F
