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I. Background

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This content was last updated on October 2002.

A partnership is a relationship between individuals or organizations in which the parties have close cooperation and share specified rights and responsibilities. It is not necessarily a legal, contractual relationship, but one anchored in common goals, responsibilities, and values. A partnership is a union of common purposes, where both parties benefit from the synergies of cooperation, and the fruits of success.

As used in this document, a partnership is defined as a "working relationship" characterized by mutual participation and joint interest. The partners could include federal/state/local government, educational institutions, trade associations, or other organizations. Each party has specific authorities, interests, and responsibilities that are mutually beneficial.

In FDA, the Office of Regulatory Affairs has used partnerships as a way of achieving goals and strengthening existing relationships with state agencies. Over the years, numerous creative approaches to our work have been born from this process. Together with our partners, we have furthered each other’s accomplishments and provided more consumer protection.

Our goal is to maximize the available resources in the most efficient and effective manner while achieving the highest level of consumer protection. The concept of "Partnership" development is a key mechanism in FDA's overall strategy to optimize consumer protection by building on the interest, skills, and talent of FDA and its partners.

The partnership and leveraging examples presented in this document are based on our experience with state government agencies. We have had a long tradition of such relationships with the state agencies. The ideas contained within may also be used to establish the framework for partnership initiatives with other entities. The ultimate goal is to utilize new or existing relationships with federal, state, or local agencies, industry associations, academia, or other organizations, in order to carry out the mission of consumer protection.

FDA faces continuing challenges in carrying out its mission because of constrained public resources, and profound scientific, technological and social changes. A more knowledgeable and diverse consumer population demands more information about the safety of FDA-regulated products and improved efficiency from all levels of government. In response to these factors, FDA joins its resources, talents and skills with those of our partners to optimize consumer protection.

FDA's field organization will strive to establish and continually improve federal-state partnerships in state jurisdictions. We desire to share responsibilities in those states with laws and regulations compatible with the Food, Drug, and Cosmetic Act and that also have equivalent surveillance and enforcement programs. Partnerships will be developed between local FDA managers, state managers, and local government managers. The resulting partnerships will be built on the strengths, abilities, skills and talents of the partners. Agreements will focus on the program interest of local FDA managers and their regulatory partners.

Type of Partnerships:

  1. Partnership Agreements are formal, written documents that are intended to clearly define specific goals, activities, and responsibilities of each partner. Partnership Agreements are developed to produce measurable outcomes that are related to programmatic objectives and/or operational needs. Such agreements may be negotiated at District, Regional or National levels. They are intended to accomplish a specific program objective between FDA and the partner organization. Partnership agreements should include:
    • Goals
    • Responsibilities
    • Priorities
    • Resources
    • Assessment & evaluation mechanisms
    • Time frames

    Each agreement must include a mechanism to monitor in-process activities (i.e. output measurement) and to conduct a final evaluation. Resulting benefits (i.e. ultimate outcomes), or lack thereof, should be fully described along with relevant and appropriate recommendations.

    Types of Partnership Agreements:

    1. Standard Partnership Agreements (click for an example) are limited to a significant goal or goals (anticipated outcomes) and related activities necessary to accomplish the goal(s) within a specific time frame (preferably the current FY). For example, a standard partnership agreement might cover an arrangement where FDA provides a state low acid canned food (LACF) inspectional training and equipment, and the state agrees to sample and analyze for FDA a specific number of LACF product samples during the state inspections.
    2. Integrated Partnership Agreements (click for an example) are all-inclusive arrangements that include all goals and activities between the parties. For example, an integrated partnership agreement between and state and FDA might include Planning and Operational Coordination, Food Recall Activities, Information Sharing, Food Sampling and Analysis, Emergency Response Plan, and Inspectional Activities - all within the single agreement.
  2. Partnership Activities are short term informal arrangements or other working relationships that are not contained in a written document. Partnership activities, though less formal than partnership agreements, are also reportable within the guidance provided by this document. Partnership activities do not require DFSR-assigned tracking numbers.
  3. Memorandum of Understandings (MOUs) are also formal, written documents that are general in scope, contain broad statements of cooperative relationships, and are usually not intended to produce measurable outcomes. A Field Management Directive covers the development of MOUs. These agreements were popular in the past but have largely been replaced by their more specific, outcome-oriented cousin, partnerships agreements.

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