[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]



-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Advisory Committees; Notice of Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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]
BILLING CODE 4160-01-F-------