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Non-Binding Agreements with the FDA Office of Regulatory Affairs

In FDA, the Office of Regulatory Affairs (ORA) has utilized partnerships for more than four decades as a way of advancing public health goals and strengthening existing relationships with partnering agencies. FDA’s goal is to leverage available resources in the most efficient and effective manner by building on the knowledge, skills, and abilities of FDA and its partners.

What is a Non-Binding Agreement? 

Non-binding agreements are between an ORA office and any federal, state, local, territorial, or tribal (SLTT) agencies, associations, academia, or other entities.  The term “agreement” in this training is collectively used to identify any non-binding agreement unless specifically noted. The term “partnership” is a general term to describe the relationship between entities.  The term “Partnership Agreements” (PAs) are a specific type of Memorandum of Understanding detailing a domestic mutual reliance relationship down to the activity level to carry out the mission of advancing public health. PA’s can be used to support funding opportunities such as cooperative agreements or grants. 

When is a Non-Binding Agreement Appropriate? 

Non-Binding Agreements are appropriate when FDA and the partner organization agree to demonstrate mutual commitment to shared goals and objectives with no obligation of fiscal resources (which are required in contracts, grants, and cooperative agreements).

What is a Memorandum of Understanding? 

A Memorandum of Understanding (MOU) is a formal agreement between the Food and Drug Administration (FDA) and federal, state, or local government agencies; academic institutions; and other entities (e.g., non-profit organizations). The MOU constitutes an understanding between the parties but is a non-binding agreement. It is FDA's policy to enter into MOUs with other entities whenever there is a need to define lines of authority or responsibility or to clarify cooperative procedures. The intent of the MOU is to improve consumer protection through more effective use of collective resources and to eliminate duplication of activities.

What is the difference between a Memorandum of Agreement and a Memorandum of Understanding?

The difference between a Memorandum of Understanding (MOU) and a Memorandum of Agreement (MOA) is that an MOU is used for simple common-cause agreements which are not legally binding. An MOA, on the other hand, establishes common legal terms that establish a “conditional agreement” where the transfer of funds for services is anticipated. As such the term MOA shall NOT be used in place of an MOU or Partnership Agreement.

Where can I find existing Memorandums of Understanding?

A curated list of agency wide memorandums of understanding for academic institutions, domestic organizations and agencies, as well as non-profit entities can be found at:
FDA Memoranda of Understanding | FDA

Who can I contact to learn more? 

General questions may be directed to the Office of Partnerships' general mailbox: op.feedback@fda.hhs.gov.

 
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