[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---