[Federal Register Volume 61, Number 80 (Wednesday, April 24, 1996)]
[Notices]
[Pages 18152-18153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10047]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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:
Cardiovascular and Renal Drugs Advisory Committee
Date, time, and place. May 2, 1996, 8:30 a.m., and May 3, 1996, 9
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, May 2,
1996, 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, May 3, 1996, 9 a.m. to 4:30 p.m.; Joan C.
Standaert, Center for Drug Evaluation and Research (HFD-110), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 419-259-
6211; or Valerie M. Mealy, Advisors and Consultants Staff (HFD-21),
301-443-4695, 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 the 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 April 19, 1996, 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 2, 1996, the committee will
discuss: (1) New drug application (NDA) 20-297, Supplement 1,
Coreg (carvedilol), SmithKline Beecham, to be indicated for
use in congestive heart failure; and (2) NDA 20-405, Lanoxin
(digoxin)
[[Page 18153]]
tablets, Glaxo-Wellcome, for congestive heart failure, and control of
ventricular rate in atrial fibrillation. On May 3, 1996, the committee
will discuss product license application 95-1167, reteplase, Boehringer
Mannheim, for management of acute myocardial infarction (AMI) in
adults, lysis of thrombi obstructing coronary arteries, improvement of
ventricular function following AMI, reduction of the incidence of
congestive heart failure, and reduction of mortality associated with
AMI.
FDA regrets that it was unable to publish this notice 15 days prior
to the May 2, 1996, Cardiovascular and Renal Drugs Advisory Committee
meeting. Because the agency feels that the issue needs to be brought to
public discussion urgently, and qualified members of the Cardiovascular
and Renal Drugs Advisory Committee were available at this time, the
agency decided 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.
Arthritis Advisory Committee
Date, time, and place. May 7, 1996, 8 a.m., Holiday Inn--
Gaithersburg, Whetstone and Walker Rooms, Two Montgomery Village Ave.,
Gaithersburg, MD.
Type of meeting and contact person. Open public hearing, 8 a.m. to
9 a.m., unless public participation does not last that long; open
committee discussion, 9 a.m. to 5 p.m.; Kathleen R. Reedy, 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 Advisory Committee, code
12532. 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 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 May 1, 1996, 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 hear presentations
and discuss data submitted regarding the safety and efficacy of NDA 20-
395, Enable (tenidap sodium), Pfizer, Inc., for use in the
treatment of rheumatoid arthritis and osteoarthritis.
FDA regrets that it was unable to publish this notice 15 days prior
to the May 7, 1996, Arthritis Advisory Committee meeting. Because the
agency feels that the issue needs to be brought to public discussion
urgently, and qualified members of the Arthritis Advisory Committee
were available at this time, the agency decided 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.
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: April 18, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-10047 Filed 4-23-96; 8:45 am]
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