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.

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,

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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.

MEETING: The following advisory committee meeting is announced:

Veterinary Medicine Advisory Committee

Date, time, and place. May 29, 1996, 8:30 a.m., Holiday Inn--

Gaithersburg, Goshen Room, Two Montgomery Village Ave., Gaithersburg,

MD.

Type of meeting and contact person. Open committee discussion, 8:30

a.m. to 10:30 a.m.; open public hearing, 10:30 a.m. to 11:30 a.m.,

unless public participation does not last that long; open committee

discussion, 11:30 a.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; Joanne

M. Kla, Center for Veterinary Medicine (HFV-244), Food and Drug

Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1765,

or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-

0572 in the Washington, DC area), Veterinary Medicine Advisory

Committee, code 12546. Please call the hotline for information

concerning any possible changes.

General function of the committee. The committee reviews and

evaluates available data concerning safety and effectiveness of

marketed and investigational new animal drugs, feeds, and devices for

use in the treatment and prevention of animal disease and increased

animal production.

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 presentation should notify

the contact person before May 22, 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. FDA relies on States and the milk

industry for much of the routine drug residue monitoring, and in

conjunction with the National Conference on Interstate Milk Shipments

(NCIMS), uses its limited resources in the training of a wide range of

State and industry personnel, provides testing for the accreditation of

State laboratories, and conducts a limited number of assays. The

General Accounting Office (GAO) recently recommended that FDA develop a

comprehensive strategy to address animal drug residues in milk. The

first topic to be addressed by the committee will be a draft document

entitled ``FDA Strategy To Address Animal Drug Residues In Milk.''

During the afternoon, the committee will discuss the status of the

sometribove Post-Approval Monitoring Program (PAMP). FDA approved

sometribove, a recombinant bovine somatotropin (bST) on November 12,

1993 (58 FR 55946), and the product, Posilac, began

commercial distribution on February 4, 1994. Steps have been taken to

monitor sometribove in commercial use. The Monsanto Co. is conducting a

PAMP that includes the following elements:

A study of animal health effects including mastitis, animal

drug use and resulting loss of milk associated with bST use in a

minimum of 24 commercial dairy herds. The in-life portion of this study

were recently completed. The committee will hear a brief status report

on May 29, 1996, and will consider the report in detail during the fall

of 1996 after the quality assurance and statistical treatments of the

data are complete.

A 2-year tracking system of milk production and drug residues

in key dairy States that represent over 50 percent of the total U.S.

milk production to compare the amount of milk discarded due to drug

residues before and after bST approval.

A 12-month comparison of the proportion of milk discarded due

to possible drug residues between bST treated and untreated herds.

A reporting system to monitor bST use and reports of adverse

drug experiences.

The committee will also consider the 2-year tracking system to compare

mild discarded pre- versus post-bST approval and adverse experience

reports filed with FDA during the first 2 years of sometribove

commercial use.

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

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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: April 29, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96-11436 Filed 5-7-96; 8:45 am]

BILLING CODE 4160-01-F