MEMORANDUM OF UNDERSTANDING BETWEEN
THE FOOD AND DRUG ADMINISTRATION AND
THE FOOD AND DRUG ADMINISTRATION ALUMNI ASSOCIATION

I. PURPOSE

This Memorandum of Understanding (“MOU”) establishes a framework for a cooperative agreement within which the Food and Drug Administration (FDA) and the Food and Drug Administration Alumni Association (FDAAA), singularly (“Party”) and together (“Parties”), agree to partner on undertakings that are considered beneficial to both organizations and directly relate to the mission of FDA and within FDA’s statutory authorities.

II. BACKGROUND

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.) and related laws. In fulfilling its responsibilities under the Act, FDA promotes and protects the public health by assuring the safety, efficacy, and security of drugs, biologics, veterinary products, and medical devices, as well as the safety and security of foods, dietary supplements, cosmetics, and radiological products. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, FDA must stay abreast of the latest developments in medical research and communicate with stakeholders about complex scientific and public health issues. The collaborative professional development, training, educational and outreach partnerships with the FDAAA will contribute to FDA’s mission.

The FDAAA is a non-profit educational public service organization of former and current FDA employees, incorporated in the state of Maryland for the purposes of providing education and professional development regarding public health, sponsoring outreach programs entailing training and technical assistance, and promoting public education concerning public health, both domestically and globally. It is also an active alumni association. It is understood by the parties that FDAAA does not engage in lobbying activities at the federal, state or local level.

III. SCOPE OF COLLABORATION

It is understood that FDA and FDAAA may work together on selected activities and efforts. FDA and FDAAA will formalize such activities in specific agreements as permissible by law. FDA and FDAAA may collaborate by sharing expertise and support for a variety of domestic and international professional development, training, and outreach efforts. Opportunities for a collaborative working relationship between FDA and FDAAA include:

1. Develop and lead domestic and international professional development seminars for FDA staff, e.g., FDA Commissioner’s Fellows program, FDA Alumni Advisor Program, training seminars, and other mentoring programs.

2. Hold events of mutual interest, including luncheons, brown bag events on hot topics, and webinars.

3. Establish and foster a collaborative relationship with the FDA History Office in support of the educational and preservation efforts of both FDA and the FDA Alumni Association.

4. Support and work with individual centers or offices within FDA to accomplish goals of mutual interest.

5. Commemorate significant FDA milestones and achievements.

6. Engage current FDA employees, who may join FDAAA as Associate Members. FDA employees may participate in meetings and activities related to this partnership and may work with FDAAA on collaborative efforts as permitted by FDA.

IV. RESOURCE OBLIGATIONS

This MOU represents the broad outline of the Parties’ intent to enter into specific agreements for collaborative efforts in areas of mutual interest to FDA and FDAAA. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and FDAAA operate.

V. TERM, TERMINATION, AND MODIFICATION

This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years. It may be renewed by mutual written agreement of both Parties. This agreement may be terminated by either party by providing the other party with a 60-day written notice. At any time, the Parties may modify the MOU by mutual written consent.

IV. LIAISON OFFICERS

A. Food and Drug Administration

     Dayle Cristinzio and Beth Fritsch
     Office of External Affairs
     U.S. Food and Drug Administration
     10903 New Hampshire Avenue
     Silver Spring, Maryland 20903

B. Food and Drug Administration Alumni Association

     Denyse Baker
     Secretary, FDAAA
     mail@fdaaa.org

Each Party shall appoint a representative who shall act as the liaisons between such Party and the other Party's representative. A Party may update its representative upon written notice to the other Party.

VI. APPROVAL AND ACCEPTANCE

FOR THE FOOD AND DRUG ADMINISTRATION

/s/
Robert M. Califf, M.D.
Commissioner of Food and Drugs
Date: 5/23/2023

FOR THE FOOD AND DRUG ADMINISTRATION ALUMNI ASSOCIATION

/s/
Deborah M. Autor
Chair of the Board of Directors
Date: 5/23/2023