[Federal Register Volume 60, Number 33 (Friday, February 17, 1995)]
[Notices]
[Pages 9335-9338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4194]



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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:
Radiological Devices Panel of the Medical Devices Advisory Committee
    Date, time, and place. March 6, 1995, 8 a.m., Corporate Bldg., 
conference room 20G, 9200 Corporate Blvd., Rockville, MD. A limited 
number of overnight accommodations have been reserved at the 
Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Blvd., 
Gaithersburg, MD. Attendees requiring overnight accommodations may 
contact the hotel at 301-590-0044 and reference the FDA panel meeting 
block. Reservations will be confirmed at the group rate based on 
availability.
    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 4 p.m.; Robert A. Phillips, Center for 
Devices and Radiological Health (HFZ-470), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1212, or FDA Advisory Committee Information Hotline, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), Radiological Devices Panel, 
code 12526. If anyone who is planning to attend the meeting will need 
any special assistance as defined under the Americans with Disabilities 
Act, please communicate with the contact person.
    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 March 1, 1995, 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 clinical data 
requirements (experimental designs, protocols, quality assurance, etc.) 
for digital mammography submissions. Copies of a draft protocol are 
available from the contact person.
Blood Products Advisory Committee
    Date, time, and place. March 23 and 24, 1995, 8 a.m., Parklawn 
Bldg., conference rooms D and E, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open committee discussion, 
March 23, 1995, 8 a.m. to 9:30 a.m.; open public hearing, 9:30 a.m. to 
10 a.m., unless public participation does not last that long ; open 
committee discussion, 10 a.m. to 11:30 a.m.; open public hearing, 11:30 
a.m. to 12 m., unless public participation does not last that long; 
open committee discussion, 12 m. to 2:30 p.m.; open public hearing, 
2:30 p.m. to 3:30 p.m., unless public participation does not last that 
long; open committee discussion, 3:30 p.m. to 5:30 p.m.; open committee 
discussion, March 24, 1995, 8 a.m. to 9 a.m.; open public hearing, 9 
a.m. to 10:30 a.m., unless public participation does not last that 
long; open committee discussion, 10:30 a.m. to 5:30 p.m.; Linda A. 
Smallwood, Center for Biologics [[Page 9336]] Evaluation and Research 
(HFD-350), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-594-6700, or FDA Advisory Committee 
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), Blood Products Advisory Committee, code 12388.
    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 13, 1995, 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 the morning of March 23, 1995, the 
committee will discuss and provide recommendations for warnings in the 
labeling for blood products regarding potential transmission of viral 
agents. Additionally, the committee will discuss and provide 
recommendations for the format of blood container labeling. In the 
afternoon, the committee will discuss the practice of alanine 
aminotransferase (ALT) testing of blood and plasma donors, and they 
will provide recommendations. On the morning of March 24, 1995, the 
committee will discuss pool size for the manufacture of plasma products 
and, in the afternoon, the committee will participate in a workshop 
entitled, ``Human Tissue Intended for Transplantation and Human 
Reproductive Tissue: Donor Screening and Infectious Disease Testing.'' 
The issues to be discussed at the workshop are: (1) Recommendations for 
donor screening and infectious disease testing needed to clarify the 
interim rule for human tissue intended for transplantation (21 CFR 
1270) that published in the Federal Register of December 13, 1993 (58 
FR 65514), (2) draft recommendations for screening and testing donors 
of human reproductive tissue, and (3) the draft registration form. The 
agency is announcing the availability, before the meeting, of a draft 
document on the issues to be discussed at the workshop. Requests for 
single copies of the draft document may be made to the Division of 
Congressional, International, and Consumer Affairs, Center for 
Biologics Evaluation and Research (HFM-11), 1401 Rockville Pike, rm. 
200N, Rockville, MD 20857, 301-594-1800.
Joint Meeting of the Nonprescription Drugs and the Dermatologic and 
Ophthalmic Drugs Advisory Committees, Followed by a Session with 
Pulmonary-Allergy Drugs Committee Representation, and a Joint Meeting 
with the Arthritis Advisory Committee
    Date, time, and place. March 27 and 28, 1995, 8 a.m., Parklawn 
Bldg., conference rooms D and E, 5600 Fishers Lane, Rockville, MD. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
notice announcing a separate meeting of the Arthritis Advisory 
Committee to be held on March 27, 1995.
    Type of meeting and contact person. Open committee discussion, 
March 27, 1995, 8 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 3 p.m., open public hearing, 3 p.m. 
to 3:30 p.m., unless public participation does not last that long; open 
committee discussion, 3:30 p.m. to 5:30 p.m.; open committee 
discussion, March 28, 1995, 8 a.m. to 11:30 a.m.; open public hearing, 
11:30 a.m. to 12 m., unless public participation does not last that 
long; open committee discussion, 12 m. to 4 p.m.; Lee L. Zwanziger or 
Liz Ortuzar, Center for Drug Evaluation and Research (HFD-9), 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), Nonprescription Drugs 
Advisory Committee, code 12541.
    General function of the committees. The Nonprescription Drugs 
Advisory Committee reviews and evaluates available data concerning the 
safety and effectiveness of over-the-counter (OTC) (nonprescription) 
human drug products for use in the treatment of a broad spectrum of 
human symptoms and diseases. The Dermatologic and Ophthalmic Drugs 
Advisory Committee reviews and evaluates available data on the safety 
and effectiveness of marketed and investigational human drug products 
for use in the treatment of dermatologic and ophthalmic disorders. The 
Pulmonary-Allergy Drugs Advisory 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. The Arthritis Advisory 
Committee reviews and evaluates data on the safety and effectiveness of 
marketed and investigational human drugs for use in arthritic 
conditions.
    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 22, 1995, 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. During the morning of March 27, 1995, 
the Nonprescription Drugs Advisory Committee and the Dermatologic and 
Ophthalmic Drugs Advisory Committee will discuss data relevant to new 
drug application (NDA) 18-751 to switch econazole nitrate cream 1% 
(Spectazole, Johnson & Johnson Consumer Products, Inc.) from 
prescription to OTC status for the treatment of tinea pedis (athlete's 
foot). During the afternoon of March 27, 1995, the Nonprescription 
Drugs Advisory Committee and representatives of the Pulmonary-Allergy 
Drugs Advisory Committee will discuss data relevant to the efficacy and 
use of antihistamines for the treatment of the common cold. In the 
morning on March 28, 1995, the Nonprescription Drugs Advisory Committee 
and the Arthritis Drugs Advisory Committee will discuss data relevant 
to NDA 20-512 for ibuprofen suspension (Motrin, McNeil 
Consumer Products) for the treatment of fever and of pain in children 
between 2 and 12 years of age. During the afternoon, the committees 
will discuss recommendations regarding appropriate OTC indication(s) 
for muscle relaxants, OTC dose(s) and duration of use, safety profiles, 
abuse potential, and pharmacokinetic information.
Subcommittee Meeting of the Antiviral Drugs Advisory Committee on 
Immunosuppressive Drugs
    Date, time, and place. March 30 and 31, 1995, 8 a.m., Holiday Inn, 
Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
    Type of meeting and contact person. Open committee discussion, 
March 30, 1995, 8 a.m. to 11:30 a.m.; open public hearing, 11:30 a.m. 
to 12 m., unless public participation does not last that 
[[Page 9337]] long; open committee discussion, 12 m. to 6 p.m.; open 
committee discussion, March 31, 1995, 8 a.m. to 11:30 a.m.; open public 
hearing, 11:30 a.m. to 12 m., unless public participation does not last 
that long; open committee discussion, 12 m. to 2 p.m.; Lee L. Zwanziger 
or Liz Ortuzar, Center for Drug Evaluation and Research (HFD-9), 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 a contact person before March 22, 1995, 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 30, 1995, the subcommittee will 
discuss data relevant to NDA 20-513 (250 milligrams (mg) capsules) and 
NDA 20-514 (500 mg tablets), for mycophenolate mofetil 
(CellCept, Syntex Laboratories, Inc.), for use in the 
prophylaxis of organ rejection and treatment of refractory organ 
rejection in patients receiving allergenic renal transplants. On March 
31, 1995, the subcommittee will discuss data relevant to NDA 50-715 
(soft gelatin capsules) and NDA 50-716 (oral solution) for cyclosporine 
microemulsion (Neoral, Sandoz Pharmaceuticals Corp.) for 
prophylaxis of organ rejection in kidney, liver, and heart allergenic 
transplants.
Immunology Devices Panel of the Medical Devices Advisory Committee
    Date, time, and place. March 31, 1995, 9 a.m., Corporate Bldg., 
9200 Corporate Blvd., main conference room, Rockville, MD.
    Type of meeting and contact person. Open public hearing, 9 a.m. to 
10 a.m., unless public participation does not last that long; open 
committee discussion, 10 a.m. to 5 p.m.; Peter E. Maxim, Center for 
Devices and Radiological Health (HFZ-440), Food and Drug 
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1293, or 
FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Immunology Devices Panel, code 12516.
    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 March 15, 1995, 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 a premarket 
approval application for a software computer program to assist 
physicians and laboratory professionals in the data-base management, 
calculations, and reporting of results from quantitative measurements 
of alpha-fetoprotein as an aid in the detection of fetal open neural 
tube defects.
    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.

    [[Page 9338]] Dated: February 14, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-4194 Filed 2-16-95; 8:45 am]
BILLING CODE 4160-01-F