[Federal Register Volume 59, Number 18 (Thursday, January 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-1702]


[[Page Unknown]]

[Federal Register: January 27, 1994]


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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.

MEETINGS: The following advisory committee meetings are announced:

Dermatologic Drugs Advisory Committee

    Date, time, and place. February 16, 1994, 8 a.m., conference rms. G 
through J, 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 12 m.; Ermona B. McGoodwin or Valerie 
M. Mealy, 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 the treatment of dermatologic 
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 11, 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 19-821, Soriatane (acitretin), Roche 
Dermatologics, for treatment of psoriasis.

Joint Meeting of the Dermatologic Drugs and Nonprescription Drugs 
Advisory Committees

    Date, time, and place. February 16, 1994, 1 p.m., conference rms. G 
through J, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. 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.; Ermona B. McGoodwin or Lee L. 
Zwanziger, 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 committees. The Dermatologic Drugs Advisory 
Committee reviews and evaluates data on the safety and effectiveness of 
marketed and investigational human drugs for use in the treatment of 
dermatologic diseases. The Nonprescription Drugs Advisory Committee 
reviews and evaluates available data concerning the safety and 
effectiveness of over-the-counter (nonprescription) human drug products 
for use in the treatment of a broad spectrum of human symptoms and 
diseases.
    Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committees. Those desiring to make formal presentations should 
notify the contact person before February 11, 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 committees will discuss new drug 
application NDA 20-310, ketoconazole 1% shampoo, Johnson and Johnson 
Consumer Products, for treatment of dandruff.

National Mammography Quality Assurance Advisory Committee

    Date, time, and place. February 17 and 18, 1994, 8:30 a.m., 
Ballroom, Holiday Inn Metro Center, 775 12th St. NW., Washington, DC.
    Type of meeting and contact person. Open public hearing, February 
17, 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, February 18, 1994, 8:30 a.m. to 5 p.m.; Charles 
K. Showalter, Center for Devices and Radiological Health (HFZ-240), 
Food and Drug Administration, 1901 Chapman Ave., Rockville, MD 20857, 
301-594-3311.
    General function of the committee. The committee advises on 
developing appropriate quality standards and regulations for 
mammography facilities.
    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 January 31, 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: (1) Discuss the 
interim final standards for accreditation bodies and for facilities, 
(2) receive status reports from FDA on activities related to 
implementation of the Mammography Quality Standards Act of 1992 (Pub. 
L. 102-539), and (3) discuss priorities for future standards.

Board of Tea Experts

    Date, time, and place. February 24 and 25, 1994, 10 a.m., New York 
Regional Laboratory, rm. 700, 850 Third Ave., Brooklyn, NY.
    Type of meeting and contact person. Open public hearing, February 
24, 1994, 10 a.m. to 11 a.m., unless public participation does not last 
that long; open committee discussion, 11 a.m. to 4:30 p.m.; open 
committee discussion, February 25, 1994, 10 a.m. to 4:30 p.m.; Robert 
H. Dick, New York Regional Laboratory, Food and Drug Administration, 
850 Third Ave., Brooklyn, NY 11232, 718-965-5730.
    General function of the committee. The committee advises on 
establishment of uniform standards of purity, quality, and fitness for 
consumption of all tea imported into the United States under 21 U.S.C. 
42.
    Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee.
    Open committee discussion. The committee will discuss and select 
tea standards.
    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: January 21, 1994.
 Jane E. Henney,
 Deputy Commissioner for Operations.
[FR Doc. 94-1702 Filed 1-26-94; 8:45 am]
BILLING CODE 4160-01-F