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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

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

Introduction

This is the first in a series of articles that will discuss some of the current and planned leveraging activities in the FDA's Center for Veterinary Medicine (CVM). The purpose of these articles is to stimulate an interest in and to inform Center stakeholders, our employees, and other interested parties about how to pursue leveraging opportunities within CVM.

The impact of Federal government downsizing, the changing economy, technological advances, and other factors, have prompted the Food and Drug Administration (FDA) to re-examine how it operates and to continuously seek out partnering opportunities to maximize the use of its resources.

What is Leveraging?

Over the last few years the FDA has emphasized the notion of collaborating or partnering with outside parties as a primary strategy to more effectively accomplish its mission of promoting and protecting the public health. This concept of collaboration and partnership in FDA is generally known as "leveraging." The President's Management Agenda (PMA) reinforces this concept through an emphasis on public-private partnerships and statements such as "We must have a Government that thinks differently . . . ." Through implementation of the PMA, the Agency will strive to increase leveraging opportunities with the private sector and others.

Why leverage?

It makes good business sense to engage in relationships where collaborators work synergistically to achieve goals that neither party could achieve on its own. Examples include joint workshops to assess particular public health challenges, co-sponsored training sessions, consensus standard setting, and mission-related research.

FDA/CVM has worked with outside groups for decades. In the early 1970's, under Commissioner Edwards, FDA expanded its use of outside advisory committees to harness the knowledge of experts outside the Agency to maximize the quality of certain product reviews. Although the FDA has a long history of collaborating with the external scientific community through cooperative agreements, interagency agreements, memorandums of understanding, and cooperative research and development agreements, it is now striving to make leveraging one of the core components of its operations. In fact, CVM believes so strongly in the benefits and value of collaboration that it has recently added leveraging as a core competency for all of its employees. As a result, leveraging has received increased emphasis and support by upper management, and training opportunities will be offered to all Center employees to develop the skills necessary for increasing leveraging partnerships in CVM.

How does FDA leverage?

All of the FDA/CVM partnerships have arisen from the initiative, creative thinking and ideas of our outside stakeholders, front-line employees, managers, and others. It is from these ideas that formal agreements and informal collaborative relationships have flourished. A number of factors will determine the formality of the agreement required including the collaborator, whether FDA funds are to be committed, and whether intellectual property rights may arise from the collaboration. Formal agreements may include:

  • COOPERATIVE AGREEMENT - This involves a collaborative effort between the FDA and the partner in which substantial technical expertise is anticipated between both parties and FDA will provide at least part of the funding for the project.
  • COST-SHARING CONTRACT - A cost-sharing contract is one under which the Federal Government contracts for goods or services and the contractor absorbs a portion of the total cost of the effort. These arrangements are usually appropriate when the contractor is able to apply or market the developed product for the benefit of their business.
  • COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT (CRADA) - CRADAs involve collaborative efforts between the FDA and one or more partners (academia, industry, not-for-profit, for-profit, State and local government organizations). From the FDA perspective, the CRADA is intended to help develop FDA technology, inventions, training programs, etc., that will facilitate achievement of mission-related goals. The CRADA partner, in return, receives some benefit from the establishment of this collaboration. The CRADA partner may provide funds to be used for the CRADA project. FDA and the partner may each contribute staff time and expertise, equipment, supplies, and facilities. Both parties are expected to make significant intellectual contributions to the objectives of the project.
  • INTER-AGENCY AGREEMENT (IAG) - The purpose of the collaboration is the sharing of knowledge, personnel or other resources to strengthen programs of mutual concern between two or more Federal agencies. It is also used as a mechanism for eliminating overlap or duplication of effort. Within the framework of the IAG, the parties may either contribute or receive funds, services, staff, property, facilities, equipment, or exchange information to forward the common project goal.
  • CO-SPONSORSHIP AGREEMENT - This can involve activities such as the joint development of a conference, seminar, symposium, educational program, or public information campaign that is related to the mission of the Agency. This kind of cooperative agreement involves the FDA and one or more non-Federal entities that share a mutual interest in the subject matter. As part of this cooperation, each party provides its own funding or staffing.

It is critical to emphasize the importance of bringing potential leveraging opportunities to the attention of FDA/CVM program personnel or CVM Leveraging Points of Contact (see information at end of article) for consideration. After the idea or concept is discussed and a decision made with respect to moving forward, the appropriate mechanism for implementing the collaboration can be determined.

Additional information on how the FDA/CVM leverages will be available in upcoming articles and is currently available in FDA's Leveraging Handbook, which is available on the FDA web site http://www.fda.gov/oc/leveraging/default.htm

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.