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  1. For Federal, State, Local, Tribal, and Territorial Officials

Partnership Agreements

What are Partnership Agreements?

Partnership Agreements are formal, written documents that are intended to clearly define specific goals, activities and responsibilities of each partner. These agreements can be developed between FDA and international, state, territorial, tribal, local agencies, industry, academia or other organizations. They are non-funded agreements created to produce measurable outcomes that are related to programmatic objectives and/or operational needs. 

What are the benefits of a Partnership Agreement?

Partnership Agreements provide an opportunity to originate activities at the operational level. Consultation with the ORA Office, State Liaison (if applicable), the Division of Information Disclosure Policy (OSPOP/DIDP), the Office of Chief Counsel (OCC) and other applicable stakeholders provide participating partners with valuable guidance throughout the partnership development. A Partnership Agreement is not legally binding, confers no legal obligation on either partner, and may be revised or terminated at any time.

What is the duration of a Partnership Agreement?

Partnership Agreement duration is 12-36 months; agreements are effective upon signing and shall remain in effect until termination by any partner upon thirty-day advance written notice.

An annual review of activities provides partners an opportunity to revise strategic initiatives, identify new areas for development, update participant roles and responsibilities. Agreements maybe amended, modified or renewed by mutual consent of all parties.

Are Partnership Agreements legally binding?

The purpose of Partnership Agreements is to foster interaction, cooperation and coordination between the parties in the furtherance of the public health. Partnership Agreements are not legally binding and do not constitute a promise on the part of either party for performance. 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. Partnership Agreements impose no duty on either party to act or to refrain from acting.

What resources are available to help implement a Partnership Agreement?

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 allows 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.

Who do I contact for information about Partnership Agreements?

Specific questions on this program can be directed to the appropriate Office of Partnerships' contact within the Division of Partnership Investments and Agreements. Please visit the Office of Partnerships Contacts webpage to obtain a downloaded version of the staffing roster.

General questions can be directed to [email protected].

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