[Federal Register Volume 61, Number 90 (Wednesday, May 8, 1996)]
[Notices]
[Pages 20831-20833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-11436]



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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.

    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