[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<Register> 
(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<Register> (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, 
Coreg<SUP>TM (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, Posicor<SUP>TM 
(mibefradil, Hoffmann La Roche), to be indicated for hypertension and 
angina; and (2) NDA 20-718, Integrilin<Register> (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