[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]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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,
[[Page 20832]]
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
[[Page 20833]]
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