Advisory Committee; Notice of Meeting

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]

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