Advisory Committees; Notice of Meetings

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]

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