[Federal Register Volume 59, Number 143 (Wednesday, July 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18242]


[[Page Unknown]]

[Federal Register: July 27, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

 

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: This notice announces a forthcoming meeting of a public 
advisory committee of the Food and Drug Administration (FDA). This 
notice also summarizes the procedures for the meeting and methods by 
which interested persons may participate in open public hearings before 
FDA's advisory committees.

MEETING: The following advisory committee meeting is announced:
Generic Drugs Advisory Committee With Dermatologic Drugs Advisory 
Committee Representation
    Date, time, and place. September 12 and 13, 1994, 8:30 a.m., 
Parklawn Bldg., conference rms. G, H, I, and J, 5600 Fishers Lane, 
Rockville, MD.
    Type of meeting and contact person. Open committee discussion, 
September 12, 1994, 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, 
September 13, 1994, 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 4 p.m.; Kimberly L. Topper, 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 gives advice on 
scientific and technical issues concerning the safety and effectiveness 
of human generic drug products for use in the treatment of a broad 
spectrum of human diseases and makes appropriate recommendations to the 
Secretary of Health and Human Services, the Assistant Secretary for 
Health, the Commissioner of Food and Drugs, and the Director of the 
Center for Drug Evaluation and Research. The committee may also review 
agency sponsored intramural and extramural biomedical research programs 
in support of FDA's generic drugs regulatory responsibilities.
    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 September 1, 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. In April 1992, the Generic Drugs 
Advisory Committee met to consider methods for documenting the 
bioequivalence of topical corticosteroids. Subsequently, on July 1, 
1992, the Office of Generic Drugs issued a guidance document entitled 
``Interim Guidance for Topical Corticosteroids: In Vivo Bioequivalence 
and In Vitro Release Methods.'' The purpose of the September 1994 
meeting is to reexamine the 1992 interim guidance in light of new 
experimental data and methods of analysis. On September 12, 1994, the 
committee will discuss the pharmacodynamic (i.e., vasoconstrictor) 
measurement of bioequivalence. On September 13, 1994, this topic will 
be further discussed along with other issues related to the 
documentation of equivalence according to the interim guidance. 
Discussion will be limited to dermatologic products and will not 
include ophthalmic or inhaled corticosteroid products. Also, on 
September 13, 1994, there will be a review of the current status of 
topics discussed at previous Generic Drugs advisory committee meetings.
    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: July 21, 1994.
 Linda A. Suydam,
 Interim Deputy Commissioner for Operations.
[FR Doc. 94-18242 Filed 7-26-94; 8:45 am]
BILLING CODE 4160-01-F