[Federal Register Volume 61, Number 21 (Wednesday, January 31, 1996)]
[Notices]
[Pages 3427-3430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-2045]
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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:
Medical Imaging Drugs Advisory Committee
-Date, time, and place. February 15, 1996, 8:30 a.m., Holiday Inn--
Silver Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
-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 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), Medical Imaging Drugs Advisory Committee, code
12540.
-General function of the committee. The committee reviews and
evaluates data concerning the safety and effectiveness of marketed and
investigational human drug products for use in diagnostic and
therapeutic procedures using radioactive pharmaceuticals and contrast
media used in diagnostic radiology.
-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 9, 1996, and submit a brief
statement of the general nature of the evidence or the 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 and begin
drafting ``Points to Consider (PTC) for Developing Medical Imaging
Agents.'' The purpose of the meeting is to provide the committee
opportunity to work together on this draft and not primarily to hear
presentations. The agents encompassed will include radiologic contrast
media and nuclear medicine pharmaceuticals. Written comments will be
accepted until April 15, 1996, and will be available in the Dockets
Management Branch for public inspection under docket number 95N-0414
(Dockets Management Branch, HFA-305, Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857).
Medical Imaging Drugs Advisory Committee
-Date, time, and place. February 16, 1996, 8:30 a.m., Holiday Inn--
Silver Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
-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 3 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 William Freas,
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), Medical Imaging Drugs Advisory
Committee, code 12540.
-General function of the committee. The committee reviews and
evaluates data concerning the safety and effectiveness of marketed and
investigational human drug products for use in diagnostic and
therapeutic procedures using radioactive pharmaceuticals and contrast
media used in diagnostic radiology.
-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 9, 1996, and submit a brief
statement of the general nature of the evidence or the arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time required to make their comments.
[[Page 3428]]
-Open committee discussion. The committee will discuss product
license application (PLA) 91-0209, from Immunomedics, for Immu-4, a
murine monoclonal antibody fragment directed against the
carcinoembryonic antigen (CEA).
Gastrointestinal Drugs Advisory Committee
Date, time, and place. February 22 and 23, 1996, 9 a.m.,
Washingtonian Center Marriott, 9752 Washington Blvd., Gaithersburg, MD.
-Type of meeting and contact person. Open public hearing, February
22, 1996, 9 a.m. to 10 a.m., unless public participation does not last
that long; open committee discussion, 10 a.m. to 4:30 p.m.; open
committee discussion, February 23, 1996, 9 a.m. to 4:30 p.m.; Joan C.
Standaert (HFD-180), 419-259-6211, or Valerie M. Mealy (HFD-21), 301-
443-4695, Center for Drug Evaluation and Research, 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), Gastrointestinal Drugs Advisory Committee, code
12538.
-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 gastrointestinal 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 February 13, 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 February 22, 1996, the committee
will discuss new drug application (NDA) 20-580, Cotazyme, and NDA 20-
581, Cotazyme S and Zymase (pancreatic lipase, Organon), indicated for
exocrine pancreatic insufficiency. On February 23, 1996, the committee
will discuss NDA 20-617, C-14 Urea Breath Test (Trimed Specialties
Inc.), for diagnosis of Helicobacter pylori .
-Biological Response Modifiers Advisory Committee-
Date, time, and place. February 28 and 29, 1996, 8:30 a.m., Holiday
Inn--Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Ave.,
Bethesda, MD.
Type of meeting and contact person. Open public hearing, February
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, February 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 2 p.m.; William Freas or Pearline Muckelvene, 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), Biological Response Modifiers
Advisory Committee, code 12388.
General function of the committee. The committee reviews and
evaluates data relating to the safety, effectiveness, and appropriate
use of biological response modifiers which are intended for use in the
prevention and treatment of a broad spectrum 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 February 12, 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 February 28, 1996, the committee
will: (1) Discuss premarket approval application (PMA) 94-001, for
CEPRATE SC Device (CellPro), for selection of CD34+ progenitor/stem
cells, and (2) then receive an update on stem cell policy. On February
29, 1996, the committee will discuss: (1) Clinical trials in in utero
stem cell transplantation: Issues in early clinical trial development,
and (2) the draft document ``Addendum on Gene Therapy to the 1991
Points to Consider (PTC) on Human Somatic Cell and Gene Therapy.'' The
draft document will be available at the meeting and is also available
through the CBER FAX Information System at 301-594-1939 from a touch
tone phone.
-Antiviral Drugs Advisory Committee
Date, time, and place. February 28 and 29, and March 1, 1996.
February 28 and 29, 1996, 8:30 a.m., Holiday Inn--Gaithersburg, Grand
Ballroom, Two Montgomery Village Ave., Gaithersburg, MD; March 1, 1996,
8:30 a.m., Holiday Inn--Silver Spring, Plaza Ballroom, 8777 Georgia
Ave., Silver Spring, MD.
Type of meeting and contact person. Open committee discussion,
February 28, 1996, 8:30 a.m. to 1 p.m.; open public hearing, 1 p.m. to
2 p.m., unless public participation does not last that long; open
committee discussion, 2 p.m. to 5 p.m.; open committee discussion,
February 29, 1996, 8:30 a.m. to 11 a.m.; open public hearing, 11 a.m.
to 12 m., unless public participation does not last that long; open
committee discussion, 12 m. to 5 p.m.; open committee discussion, March
1, 1996, 8:30 a.m. to 11 a.m.; open public hearing, 11 a.m. to 12 m.,
unless public participation does not last that long; open committee
discussion, 12 m. to 5 p.m.; Ermona B. McGoodwin or Liz Ortuzar, Center
for Drug Evaluation and Research (HFD-21), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455,
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Antiviral Drugs Advisory Committee,
code 12531.
General function of the committee. The committee reviews and
evaluates available data concerning the safety and effectiveness of
marketed and investigational human drug products for use in the
treatment of acquired immune deficiency syndrome (AIDS), AIDS-related
complex (ARC), and other viral, fungal, and mycobacterial infections.
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 23, 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 February 28, 1996, the committee will
discuss recent studies with nucleoside analogues for the treatment of
human immunodeficiency virus (HIV) infection. The discussion will
include data from AIDS Clinical Trial Group (ACTG) Study 175, the Delta
studies, and other relevant studies. Data pertinent to the following
NDA's will be included in the discussion: Bristol Myers Squibb NDA's
20-154, 20-155, and 20-156 for Videx (didanosine) chewable
tablets, buffered powder for oral solution, and pediatric powder for
[[Page 3429]]
oral solution; Glaxo Wellcome NDA's 19-665 and 19-910 for
Retrovir (zidovudine) capsules and syrup; Roche Laboratories'
NDA 20-199 for HIVID (zalcitabine) tablets. On February 29,
1996, the committee will discuss data relevant to NDA's 20-659 and 20-
680 ritonavir (liquid and capsules, Abbott Laboratories) for treatment
of HIV infection. On March 1, 1996, the committee will discuss data
relevant to NDA 20-685 CrixivanTM (indinavir capsules, Merck and
Co., Inc.) for treatment of HIV infection.
-Endocrinologic and Metabolic Drugs Advisory Committee
Date, time, and place. February 29, 1996, 8 a.m., Holiday Inn--
Gaithersburg, Goshen Room, 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), Endocrinologic and Metabolic
Drugs Advisory Committee, code 12536.
-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 February 21, 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-
563, Humalog , (insulin lispro [rDNA origin], Eli Lilly) for
treatment of insulin dependent diabetes mellitis.
-Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory
Committee and the Antiviral Drugs Advisory Committee
-Date, time, and place. March 1, 1996, 8 a.m., Holiday Inn--
Gaithersburg, Grand Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
-Type of meeting and contact person. Open committee discussion, 8
a.m. to 1 p.m.; open public hearing, 1 p.m. to 2 p.m., unless public
participation does not last that long; open committee discussion, 2
p.m. to 5 p.m.; Kathleen R. Reedy, Ermona McGoodwin, or Angie Whitacre,
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), Endocrinologic
and Metabolic Drugs Advisory Committee, code 12536. -
-General functions of the committees. The Endocrinologic and
Metabolic Drugs Advisory Committee reviews and evaluates data on the
safety and effectiveness of marketed and investigational human drugs
for use in endocrine and metabolic disorders. The Antiviral Drugs
Advisory Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of acquired immune deficiency
syndrome (AIDS), AIDS-related complex (ARC), and other viral, fungal,
and mycobacterial infections.
-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 21, 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-
604, Serostim, (somatropin [rDNA], Serono Laboratories, Inc.)
for treatment of AIDS-wasting associated with catabolism, weight loss
or cachexia.
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.
[[Page 3430]]
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: January 26, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-2045 Filed 1-30-96; 8:45 am]
BILLING CODE 4160-01-F---