[Federal Register Volume 59, Number 38 (Friday, February 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4291]
[[Page Unknown]]
[Federal Register: February 25, 1994]
-----------------------------------------------------------------------
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.
MEETING: The following advisory committee meetings are announced:
Endocrinologic and Metabolic Drugs Advisory Committee
Date, time, and place. March 18, 1994, 8 a.m., conference rms. D
and E, Parklawn Bldg., 5600 Fishers Lane, Rockville, 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.; Igor Cerny, Center for Drug
Evaluation and Research (HFD-9), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5455.
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 endocrine and metabolic
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 March 3, 1994, 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 new drug
application (NDA) 20-357, metformin hydrochloride,
Glucophage, Lipha Pharmaceuticals, for use as an adjunct to
the diet to lower blood glucose in patients with noninsulin-dependent
diabetes mellitus whose hyperglycemia cannot be satisfactorily managed
by diet alone.
Blood Products Advisory Committee
Date, time, and place. March 24 and 25, 1994, 8:30 a.m., Holiday
Inn, Silver Spring Plaza, Plaza Ballroom, 8777 Georgia Ave., Silver
Spring, MD.
Type of meeting and contact person. Open committee discussion,
March 24, 1994, 8:30 a.m. to 10 a.m.; open public hearing, 10 a.m. to
10:30 a.m., unless public participation does not last that long; open
committee discussion, 10:30 a.m. to 1:30 p.m.; open public hearing,
1:30 p.m. to 2 p.m., unless public participation does not last that
long; open committee discussion, 2 p.m. to 4 p.m.; open public hearing,
4 p.m. to 4:30 p.m., unless public participation does not last that
long; open committee discussion, March 25, 1994, 8:30 a.m. to 10 a.m.;
open public hearing, 10 a.m. to 10:30 a.m., unless public participation
does not last that long; open committee discussion 10:30 a.m. to 2
p.m.; open public hearing, 2 p.m. to 2:30 p.m., unless public
participation does not last that long; Linda A. Smallwood, Center for
Biologics Evaluation and Research (HFM-300), Food and Drug
Administration, 1401 Rockville Pike, Bethesda, MD 20852-1448, 301-594-
6700.
General function of the committee. The committee reviews and
evaluates data on the safety and effectiveness, and appropriate use of
blood products 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 before March 14, 1994, 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 24, 1994, the committee will:
(1) Review and discuss issues relevant to the impact of use of virus
inactivated plasma; (2) hear a summary discussion on the workshop on
red cell substitutes; (3) discuss an addendum to the points to consider
document; and (4) hear presentations on the product license application
for Rho (D) Immune Globulin Intravenous (Human), WinRho, Winnipeg
Rh Institute, Inc. On March 25, 1994, the committee will hear a summary
discussion of the workshop on validation of blood establishment
computer systems and a followup review of the FDA contract on
increasing the safety of the blood supply by screening donors more
effectively.
Cardiovascular and Renal Drugs Advisory Committee
Date, time, and place. March 24 and 25, 1994, 8:30 a.m., conference
rms. D and E, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. Open public hearing, March 24,
1994, 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 p.m.; open
committee discussion, March 25, 1994, 8:30 a.m. to 5 p.m.; Joan C.
Standaert, Center for Drug Evaluation and Research (HFD-110), 419-259-
6211, or Valerie M. Mealy, Advisors and Consultants Staff (HFD-9), 301-
443-4695, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857.
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 March 15, 1994, 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 24, 1994, the committee will
discuss new drug application (NDA) 20-390 (vesnarinone),
Arkin, Otsuka America Pharmaceutical, for congestive heart
failure, and NDA 19-151/ S-002 (propafenone), Rythmol, Knoll
Pharmaceuticals, for prophylaxis of paroxysmal supraventricular
tachycardia and paroxysmal atrial fibrillation and flutter. On March
25, 1994, the committee will discuss product license application
(PLA)1048, supplement 93-0889 (alteplase recombinant),
Activase, Genentech, Inc., for a new accelerated dose
regimen.
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 17, 1994.
Jane E. Henney,
Deputy Commissioner for Operations.
[FR Doc. 94-4291 Filed 2-24-94; 8:45 am]
BILLING CODE 4160-01-F
