MEMORANDUM OF UNDERSTANDING
between The Food and Drug Administration
Department of Health and Human Services
and The American Nurses Association
This Memorandum of Understanding (MOU) establishes a framework for collaborative health professional training, outreach, and research initiatives between the Food and Drug Administration (FDA), Office of Health and Constituent Affairs and the American
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the FD&C Act). In fulfilling its responsibilities under the FD&C Act, FDA among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, and medical devices and the safety and security of foods, dietary supplements, cosmetics, and radiological products, as well as advancing the public health through regulation of tobacco products. To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, and outreach partnerships will greatly contribute to FDA's mission.
ANA is the only full-service professional organization representing the interests of the nation's 3.1 million registered nurses through its constituent and state nurses associations and its organizational affiliates. ANA advances the nursing profession by fostering high standards of nursing practice, promoting the rights of nurses in the workplace, projecting a positive and realistic view of nursing, and by advocating on health care issues affecting nurses and the public.
III. Substance of Agreement:
Opportunities for a collaborative working relationship between FDA and ANA may include:
- Extending FDA's capacity to provide training and public health information for America's nursing professions.
- Providing better and timely information and content about various public health and safety topics, including alerts of emerging safety issues and product recalls.
- Enhancing outreach capacity to reach hundreds of thousands of nurses by therapeutic area, practice and targeted specialties through continuing education activities, and opportunities to educate healthcare professionals about potential risks associated with consumption of regulated products;
- Developing FDA topical educational, training and outreach programs for nursing professionals in the public/private-sectorson medical product safety and efficacy issues, and
- Enhancing FDA's dialogue with U.S. and territory nursing professions through various forums such as face-to-face meetings, webinars and teleconferences, fellowships, research, and Health mobile technology.
IV. General Provisions
Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent, law permits such disclosure.
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 ANA. 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 does not create binding, enforceable obligations against any Party. This MOU and all associated
agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and ANA operate.
VI. Liaison Officers:
Each Party shall appoint a representative who shall act as the liaison between such party and the other party's representative. A party may update its representative upon written notice to the other party.
A. For the American Nurses Association
Holly Carpenter, BSN, RN, Senior Staff Specialist/ANA
Suzy Harrington, DNP, RN, MCHES, Director, HealthNurse/COEH/ANA
B. For the Food and Drug Administration:
Health Programs Coordinator
Office of Health and Constituent Affairs
VII. Term, Termination, and Modification:
This agreement will be effective when accepted by all participating parties.This agreement may be modified or terminated by mutual written consent by both parties or may be terminated by either party upon a 60-day advance written notice to the other.
VIII. SIGNATURES OF RESPONSIBLE PARTIES
APPROVED AND ACCEPTED FOR AMERICAN NURSES ASSOCIATION
Suzy Harrington, DNP, RN, MCHES,
May 17, 2013
APPROVED AND ACCEPTED FOR FOOD AND DRUG ADMINISTRATION
Heidi Marchand, Pharm.D.
Associate Commissioner,Office of Health and Constituent Affairs
May 17, 2013