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225-17-0008

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 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 be 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.).  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 FDA Alumni Association (here after FDAAA) will contribute to FDA’s mission.

The FDAAA is a non-profit educational public service organization of former (voting) and current (non-voting)*  FDA employees, incorporated in the state of Maryland for the purposes of providing education and professional development regarding public health, sponsoring humanitarian outreach programs entailing training and technical assistance, and promoting public education concerning public health.  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. Domestic and International Professional Development seminars for FDA staff, e.g. FDA Commissioner’s Fellows program, FDA Alumni Advisor Program, training seminars, and other mentor programs.

2. Luncheons and brown bags on hot topics. 

3. Support 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. Supporting and working parallel with cross-center departments within FDA to accomplish efforts of mutual interest.

5. Agency Commemorations

FDA and FDAAA cosponsored Commemorations and Programs

6. FDAAA Associate Members*

Current FDA employees may request membership in FDAAA as Associate Members; as such, they are non-voting members and have no governance responsibilities in the organization.  With the concurrence of their supervisors, FDA employees may participate in meetings and activities related to this partnership and may work with FDAAA on collaborative efforts that are part of their official duties and are within the scope of the FDA’s mission.

IV. LIAISON OFFICERS

A. Food and Drug Administration
Heidi Marchand, PharmD. Assistant Commissioner
Office of Health and Constituent Affairs
Office of External Affairs
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20903
301-796-8457
Heidi.Marchand@fda.hhs.gov

B. Food and Drug Administration Alumni Association
Edward Steele
FDAAA President
 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.

V. RESOURCE OBLIGATIONS

This MOU represents the broad outline of the Parties’ intent to enter into specific agreements for collaborative efforts in intellectual 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.

VI. 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.

VII. APPROVAL AND ACCEPTANCE

FOR THE FOOD AND DRUG ADMINISTRATION ALUMNI ASSOCIATION

Nancy Bradish Myers
Chair Board of Directors

December 2, 2016

FOR THE FOOD AND DRUG ADMINISTRATION

Robert M. Califf, M.D.
Commissioner of Food and Drugs

December 2, 2016

 

Page Last Updated: 12/12/2016
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