[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]
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