- What are Partnership Agreements?
- What types of Partnership Agreements are currently being advanced?
- What are the benefits of a Partnership Agreement?
- What is the duration of a Partnership Agreement?
- Are Partnership Agreements legally binding?
- What are some of the outcomes from Partnership Agreements?
- Where can I learn more about the impacts of Partnership Agreements?
- What resources are available to help implement a Partnership Agreement?
- Who do I contact for information about Partnership Agreements?
What are Partnership Agreements?
Partnership Agreements are a specific type of Memorandum of Understanding (MOU) detailing a domestic mutual reliance relationship down to the activity level to carry out the mission of advancing public health. These agreements are non-funded but can support funding opportunities such as cooperative agreements.
Partnership Agreements are formal documents that clearly define goals, activities, and responsibilities of each partner. They are non-binding agreements anchored in common goals, responsibilities, and values to produce measurable outcomes related to programmatic objectives and/or operational needs. Individual Partnership Agreements can be found by searching the Domestic MOU webpage.
What types of Partnership Agreements are currently being advanced?
Three types of Partnership Agreements support domestic mutual reliance relationships:
- Established Partnership Agreements capture existing and new engagements focused on established collaborative activities in all areas of prevention, detection, and response.
- Developmental Partnership Agreements capture the initial development of a domestic mutual reliance collaborative relationship.
- Specialized Partnership Agreements focus on a specific collaborative activity.
To learn more about which states have active Partnership Agreements, please visit the Domestic Mutual Reliance webpage.
What are the benefits of a Partnership Agreement?
Partnership Agreements provide an opportunity to originate activities at the operational level. Consultation with subject matter experts including ORA Office/Division, State Liaison (if applicable), regulatory operations experts, disclosure, policy, legal and other applicable stakeholders provide participating partners with valuable guidance throughout the partnership development. The Partnership Agreement helps identify and define organizational communication streams between partners and better understand how partners coordinate and collaborate on implementing Domestic Mutual Reliance.
What is the duration of a Partnership Agreement?
A Partnership Agreement duration can be from 36-60 months; agreements are effective upon signing and remain in effect until termination by any partner upon a thirty-day advance written notice.
An annual review of activities provides partners an opportunity to revise strategic initiatives, identify new areas for development, and update participant roles and responsibilities. Agreements may be amended, modified, or renewed by mutual consent of all parties.
Are Partnership Agreements legally binding?
Partnership Agreements are intended to foster interaction, cooperation, and coordination between the parties to further public health. The agreement is not legally binding, confers no legal obligation on either partner, and may be revised or terminated at any time. Partnership Agreements do not create a legally enforceable contract, and the parties agree that no remedies at law or equity will be sought by either party for non-performance of this agreement. They impose no duty on either party to act or to refrain from acting.
What are some of the outcomes of Partnership Agreements?
Partnership Agreements provide the tools and resources that enable the FDA to work with regulatory partners to build systems that complement national uniformity of regulated products. The agreements capture engagements that work toward a seamless partnership that enables the FDA and states with comparable regulatory public health systems, as trusted partners, to fully rely on, coordinate with, and leverage one another’s work, data, and actions to achieve the public health goal of a safer national food supply.
Partnership Agreements bring together subject matter experts to achieve maximum protection of consumer safety without duplication of regulatory activities among the FDA and implementing partners. Meaningful metrics are tailored to each agreement, and partners come together annually to evaluate program outputs and outcomes to measure success.
Where can I learn more about the impacts of Partnership Agreements?
A partnership is a union of common purposes where both parties benefit from the synergies of cooperation. To learn more about ongoing cooperative activities resulting from our partnership agreements, and hear some success stories, visit the Domestic Mutual Reliance webpage.
What resources are available to help implement a Partnership Agreement?
The FDA recommends information sharing agreements for partners working with the Agency. Access to non-public information, where appropriate, shall be governed by separate Confidentiality Disclosure Agreements entered into under the authority of 21 C.F.R. § 20.88 and in which the Partners will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, 5 U.S.C. § 552(a), 21 C.F.R. Part 20 and other applicable laws and regulations governing the confidentiality of such information.
Information sharing agreements allow partners to share confidential information about open investigations, inspection records, draft rulemaking and guidance, and other non-public files. This helps expedite the information-sharing process and enables stakeholders to effectively fulfill their objectives.
No proprietary data, trade secrets, or personal privacy information shall be disclosed among the partners unless permitted by applicable law. For more information, please visit Information Sharing | FDA.
Who do I contact for information about Partnership Agreements?
General questions can be directed to OP.Feedback@fda.hhs.gov. More specific questions can be directed to the appropriate Office of Partnerships contact; please visit the Office of Partnerships Contacts webpage to obtain a downloaded version of the staffing roster.