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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA LEVERAGING INITIATIVE IN LINE WITH PRESIDENT'S MANAGEMENT AGENDA: PART II - LEVERAGING ACTIVITIES IN CVM

by David Batson, Ph.D. and Melissa Starinsky
FDA Veterinarian Newsletter 2002 Volume XVI, No VI

Introduction

This is the second in a series of articles on leveraging in the Food and Drug Administration (FDA), in which we will discuss and give examples of specific leveraging projects in the Center for Veterinary Medicine (CVM). The first article, which appeared in the July/August 2002 edition, gave a brief overview of leveraging and why leveraging is important to CVM. This article will describe three specific CVM leveraging projects that involve a Cooperative Agreement, an Interagency Agreement, and a Cooperative Research and Development Agreement (CRADA), and how they impact the mission of the Center.

Cooperative Agreements

A cooperative agreement involves collaboration between two or more parties in which all of the parties contribute programmatic and/or funding resources. CVM has a long history with cooperative agreements and views these collaborations as mutually beneficial for all parties, with the ultimate beneficiary being the public health.

An example of a cooperative agreement in which CVM is currently involved is a project with the Fundacion Mexicana para la salud, International Hospital O'Horan, Yucatan, Mexico. Under this agreement, CVM is providing funding and scientific expertise and the Fundacion is providing scientific expertise, facilities, samples and equipment to work on the issue of antimicrobial resistance. It is anticipated that this project will contribute to the development of an international database that will utilize standardized microbial susceptibility testing methods and allow for an international monitoring system to flag the emergence of resistant microbial strains. The system will permit the examination of microbial susceptibility patterns across participating nations. Such a multinational surveillance program results in improved detection of epidemics and for earlier responses to the emergence of resistant pathogens. On an international scale, this provides greater public health protection against multi-drug resistant pathogens such as Salmonella enterica Typhimurium DT 104.

Interagency Agreements

Interagency agreements provide a mechanism for sharing of knowledge, personnel, or other resources to strengthen programs of mutual concern between two or more Federal agencies. The interagency agreement is also a mechanism for eliminating overlap or duplication of effort.

An example of an interagency agreement that is currently under way in CVM is a project between the U.S. Geological Survey (USGS) and the FDA. Under this agreement, the USGS is providing funding and scientific expertise while the FDA is contributing scientific expertise, facilities and equipment. The information generated will benefit the FDA in providing the required regulatory method for the confirmation of p-toluenesulfonamide (p-TSA) in fish. p-TSA is a metabolite and marker residue of chloramine-T which may be used in fish raised in public aquaculture. This method will be available to the laboratories of FDA's Office of Regulatory Affairs, to monitor the food supply for residues of p-TSA, and also to support a New Animal Drug Application for the use of chloramine-T to treat bacterial gill disease. Since so few drugs are approved for use in aquatic species, this method will benefit the FDA mission of promoting the availability of a safe and nutritious food supply.

Cooperative Research and Development Agreements (CRADAs)

CRADAs involve collaborative efforts between CVM and one or more partners (academia, industry, not-for-profit or, for-profit companies, and State and local governments). The CRADA is intended to help develop technology, inventions, training programs, etc., that will facilitate achievement of mission-related goals. The CRADA partner receives some benefit from the collaboration and may provide funds to be used on the project. A recent CVM CRADA with the Freshwater Institute of Shepherdstown, West Virginia, resulted in the gathering of information about the development of antimicrobial drug resistance in recirculating aquaculture systems. In this CRADA, CVM provided scientific expertise, equipment, supplies and facilities; the Freshwater Institute provided funding, study samples and scientific expertise in support of the effort. The proliferation of resistant microbial strains that can affect aquatic species is a national concern that is currently being addressed by the Center's Food Safety Program. This project also may provide useful information to the aquaculture industry by providing information regarding the safety of recirculating water systems.

In the next article in this series, two executed CRADAs will be discussed in detail. Subsequent articles will provide similar levels of detail on other types of agreements. We hope these discussions will stimulate interest in the development of new opportunities for enhancing FDA's scientific base through the use of leveraging.

If you have any questions on leveraging or if you have an interest in initiating a collaboration with FDA's Center for Veterinary Medicine please contact David Batson at (301) 827-8021 or Melissa Starinsky at (301) 827-5309.

Dr. Batson is a Health Scientist Administrator with CVM's Office of Research, and Ms. Starinsky is a Management and Program Analyst with CVM's Office of Management.