[Federal Register Volume 61, Number 38 (Monday, February 26, 1996)]
[Notices]
[Pages 7115-7116]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4189]



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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:
Circulatory System Devices Panel of the Medical Devices Advisory 
Committee
    Date, time, and place.- March 4, 1996, 8:30 a.m., Gaithersburg 
Hilton, Salons D and E, 620 Perry Pkwy., Gaithersburg, MD. A limited 
number of overnight accommodations have been reserved at the 
Gaithersburg Hilton. Attendees requiring overnight accommodations may 
contact the hotel at 301-977-8900 and reference the FDA Panel meeting 
block. Reservations will be confirmed at the group rate based on 
availability. Attendees with a disability requiring special 
accommodations should contact Sociometrics, Inc., 301-608-2151. The 
availability of appropriate accommodations cannot be assured unless 
prior notification is received.
    Type of meeting and contact person. Open public hearing, 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 4:30 p.m.; Ramiah Subramanian, 
Center for Devices and Radiological Health (HFZ-450), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8320, or FDA Advisory Committee Information Hotline, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), Circulatory Systems Devices 
Panel of the Medical Devices Advisory Committee, code 12625. -
    General function of the committee. The committee reviews and 
evaluates data on the safety and effectiveness of marketed and 
investigational devices and makes recommendations for their 
regulation.-
    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 26, 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 discuss general 
issues related to two premarket approval applications: (1) A stent for 
a peripheral vascular use, and (2) an angioplasty balloon. -
    FDA regrets that it was unable to publish this notice 15 days prior 
to the March 4, 1996, Circulatory System Devices Panel of the Medical 
Devices Advisory Committee meeting. Because the agency feels that the 
issue needs to be brought to public discussion urgently, and qualified 
members of the Circulatory System Devices Panel of the Medical Devices 
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.
Vaccines and Related Biological Products Advisory Committee
    Date, time, and place. March 7, l996, 3 p.m., Food and Drug 
Administration, 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, 3 p.m. to 4:30 p.m.; open public hearing, 4:30 
p.m. to 5:30 p.m., unless public participation does not last that long; 
Nancy T. Cherry or Sandy Salins, 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.
    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.-
    Open committee discussion. The committee will discuss the influenza 
virus vaccine formulation for 1996 and 1997.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the March 7, 1996, Vaccines and Related Biological Products Advisory 
Committee meeting. Because the agency feels that the issue needs to be 
brought to public discussion urgently, and qualified members of the 
Vaccines and Related Biological Products 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. 

[[Page 7116]]

Pulmonary-Allergy Drugs Advisory Committee
    Date, time, and place. March 28 and 29, 1996, 8:30 a.m., Quality 
Hotel, Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD.
    Type of meeting and contact person. Open public hearing, March 28, 
1996, 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, March 29, 1996, 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.; Leander B. Madoo, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-4695, or FDA Advisory Committee 
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), Pulmonary-Allergy Drugs Advisory Committee, code 12545.-
    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 the treatment of pulmonary 
disease and diseases with allergic and/or immunologic mechanisms.-
    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 March 15, 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 March 28, 1996, the committee will 
discuss Zeneca Pharmaceuticals' new drug application (NDA) 20-547 for 
Accolate (zafirlukast) tablets. The proposed indication for 
Accolate is as an oral anti-inflammatory agent for use in the 
prophylaxis and chronic treatment of asthma and as a first-line 
maintenance therapy in patients with asthma who are not adequately 
controlled by PRN 2-agonist alone. On March 29, 1996, the 
committee will discuss 3M Pharmaceuticals' NDA 20-503 for EpaqTM, 
an albuterol metered-dose inhaler which is the first to utilize a 
hydrofluoroalkane propellent. The proposed indication is for treatment 
or prevention of bronchospasm in patients with reversible obstructive 
airway disease.
    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: February 16, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-4189 Filed 2-23-96; 8:45 am]
BILLING CODE 4160-01-F