2010-24905. Global Implementation of the Veterinary Medicinal Products Guidelines

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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: [phone], email: [e-mail].

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: [phone], email: [e-mail].

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: [phone], email: [e-mail].

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 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.