Document ID: FDA-2010-N-0497-0001
Agency: fda
Document Type: Notice
Title: Global Implementation of the Veterinary Medicinal Products Guidelines,
Posted Date: 2010-10-05T04:00Z

[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61504-61505]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24905]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0497]

Global Implementation of the Veterinary Medicinal Products 
Guidelines

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces its intention 
to accept and consider a single source application for a cooperative 
agreement to the World Organization for Animal Health (OIE). The OIE is 
the intergovernmental organization responsible for improving animal 
health worldwide and is recognized by the World Trade Organization 
(WTO) as a reference for international sanitary rules, with 175 Member 
Countries and Territories. The purpose of this agreement is to continue 
outreach that began in fiscal year (FY) 2009 to expand capacity 
building to support OIE's services and activities that are needed to 
carry out OIE's Veterinary International Conference on Harmonization 
(VICH) Global Outreach to disseminate and implement VICH guidelines at 
the country level.

FOR FURTHER INFORMATION CONTACT:
    Program Contact: Merton V. Smith, Center for Veterinary Medicine 
(HFV-1), Food and Drug Administration, 7519 Standish Pl., rm. 177, 
Rockville, MD 20855, 240-276-9025, FAX: 240-276-9030, email: 
Merton.Smith@fda.hhs.gov.
    Management Contact: Katherine C. Bond, Office of the Commissioner, 
Food and Drug Administration, White Oak Bldg. 32, rm. 3300, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-8318, FAX: 301-595-
5058, email: Katherine.Bond@fda.hhs.gov.
    Grants Contact: Kimberly Pendleton, Division of Acquisition and 
Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, rm. 
2104, Rockville, MD 20857, 301-827-9363, FAX: 301-827-7101, email: 
kimberly.pendleton@fda.hhs.gov.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please contact Kimberly Pendleton.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

RFA-FD-10-010
Catalog of Federal Domestic Assistance Number(s): 93.103 https://www.cfda.gov

A. Background

    FDA announces its intention to accept and consider a single source 
application for award of a cooperative agreement to the OIE in support 
of international technical capacity building activities that help to 
assure that U.S. imports of veterinary medicinal products are safe, 
effective, and of high quality and that food from treated animals is 
safe and wholesome; to assist foreign regulators in developing and 
using rigorous safety standards; to develop and foster mutually 
beneficial regulatory partnerships; and to leverage resources for 
capacity building through appropriate training and other activities.

B. Research Objectives

     Promote and enhance in OIE Members good veterinary 
governance, which includes the compliance of Veterinary Services with 
OIE

[[Page 61505]]

international standards, as an instrumental and essential prerequisite 
to the establishment and effective implementation of adequate and 
appropriate legislation covering all aspects of products for veterinary 
use, including registration, quality control, distribution, monitoring 
of quantities and final use.
     Develop and improve international and regional cooperation 
in the establishment and enforcement of legislation to harmonize the 
regulatory framework between OIE Member States so as to assist 
countries in need to effectively institute and maintain such 
mechanisms.
     Encourage countries to allocate appropriate human and 
financial resources to veterinary services and laboratories to 
correctly implement the OIE standards and guidelines related to 
veterinary products and their control.
     Enhance capacities of national focal points for OIE on 
matters related to veterinary products according to the suggested terms 
of reference and encourage his/her participation in training sessions 
and appropriate international gatherings and meetings.
     Promote the responsible and prudent use of veterinary 
medicinal products, in particular of antimicrobials used in veterinary 
medicine, and the monitoring of the quantities used and potential 
existence or development of antimicrobial resistance in disease-causing 
organisms affecting both humans and animals.
     Actively encourage the recognition and application of the 
international recommendations, guidelines and tools developed by the 
OIE and adopted by the World Assembly of Delegates on veterinary 
products.

C. Eligibility Information

    The following organizations/institutions are eligible to apply: The 
OIE.

II. Award Information/Funds Available

A. Award Amount

    FDA anticipates providing one award of $565,000 (total costs 
including indirect costs) in fiscal year (FY) 2010 in support of this 
project. Subject to the availability of funds and successful 
performance, 1 additional year of support up to $565,000 per year will 
be available.

B. Length of Support

    The support will be 1 year with the possibility of an additional 
year of noncompetitive support. Continuation beyond the first year will 
be based on satisfactory performance during the preceding year, receipt 
of a non-competing continuation application and available Federal FY 
appropriations.

    Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24905 Filed 10-4-10; 8:45 am]
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