Memorandum of Understanding

This Memorandum is for the purpose of documenting an understanding between the Food and Drug Administration (FDA), Department of Health and Human Services (DHHS), and the Food and Drug Administration Alumni Association, Inc. (FDAAA). FDA and FDAAA agree to partner on future specific undertakings that are considered beneficial to both organizations, are directly related to the mission of FDA, and are within FDA's statutory authorities.

The FDAAA is a non-profit educational public service organization of former (voting) and current FDA (non-voting)1 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 understood by the parties that the FDAAA does not engage in lobbying activities at the Federal, State or local level.

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. FDA will use appropriate legal mechanisms to enter into such agreements. Such agreements will be based on current authorities, which could include the Federal Acquisition Regulation and the Grants, and Cooperative Agreements Act of 1977, Chapter 63 of Title 31 of the United States Code, entitled Using Procurement Contracts and Grants and Cooperative Agreements, 31 U.S.C. §6301-6308. To the extent that FDA will be getting advice and recommendations from either FDAAA or its members, such will be done consistent with the Federal Advisory Committee Act, 5 USC Appendix II. For any collaborative research projects, the parties may decide to enter into a Cooperative Research and Development Agreement (CRADA) under 15 U.S.C. § 3710a, "Cooperative Research and Development Agreements." Under Title 42, United States Code, 209(f), the FDA may employ individuals as Experts and Consultants in scientific occupations with or without compensation. Under the terms of such agreements, FDAAA and FDA may collaborate using the experience and training of alumni that are of value to FDA in accomplishing its public health mission. It is also understood that such agreements must be within the scope of FDA's appropriations, authorities, and governing regulations.

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 mission.

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.

Memorandum of Understanding between FDA and FDAAA

This agreement may be terminated by either party by providing the other party with 5 working days' advance written notice of such termination.

Signatures

Accepted for the FDA Accepted for the FDAAA

/s/ /s/

 

Mark B. McClellan, M.D., Ph.D. John C. Villforth

Commissioner of Food and Drugs Chairman, Board of Directors

Food and Drug Administration Alumni Association, Inc.

3/3/03