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  1. FDA Memoranda of Understanding

MOU 225-15-010

MEMORANDUM OF UNDERSTANDING
BETWEEN U.S. FOOD AND DRUG ADMINISTRATION
AND THE NATIONAL FORUM FOR HEART DISEASE
AND STROKE PREVENTION

 
I. PURPOSE
 
The U.S. Food and Drug Administration (FDA), Department of Health and Human Services, and the National Forum for Heart Disease and Stroke Prevention (NFHDSP) share common interests in reducing burdens of heart disease and stroke. This Memorandum of Understanding (MOU) establishes the framework on how FDA and NFHDSP may participate in a collective voice with a consortium of other organizations to formulate a strategy on ways to enhance therapeutic adherence, to protect and promote public health toward a heart-healthy and stroke-free society. This MOU sets forth principles and guidelines by which the parties intend to engage in a cooperative public education program. It is the parties’ intent to promote and increase the use of health knowledge, skills, and practices by the general population in its patterns of daily living.
 
II. BACKGROUND
 
Pursuant to sections 1701 -1704 and 399Y of the Public Health Service Act, 42 U.S.C. §§300u-300u-3, and 280h-2, the Secretary is mandated to support activities and programs that incorporate appropriate health education into our society; and is authorized to encourage others to support innovative programs in health promotion and health education; to make health information available to others who should be informed; to provide consultation and otherwise support the design and conduct of research concerning health promotion; to secure cooperation of others in activities designed to encourage health maintaining behaviors; and, to collaborate with others, e.g., national and community-based organizations, to educate the public concerning (1) the health risks associated with poor nutrition, and (2) the benefits of good nutrition and strategies to improve eating habits. 
 
NFHDSP is a 501(c)(3) nonprofit organization. NFHDSP leads collaborative policy and programmatic efforts, and builds the collective voice for heart disease and stroke prevention. NFHDSP is a catalyst to drive multi-sector action to prevent heart disease and stroke. NFHDSP members include more than 80 U.S. and international organizations representing public, private, health care, advocacy, academic, policy, and community sectors.
 
III. SUBSTANCE OF THE AGREEMENT
 
FDA and NFHDSP intend to collaborate with a consortium of public and private sector stakeholders to: 
 
A.      Discuss processes for the exploration, development, demonstration, and evaluation of innovative health promotion concepts.
 
B.      Foster cooperation in exchanging information and in research and scientific literature on cardiovascular surveillance, health equity, and nutrition, and to enhance patient therapeutic compliance.
 
C.      Identify and systematize current best practices in behavior modification education and research initiatives that demonstrate enhanced patient medication compliance.
 
D.     Develop concepts for community-based interventions to increase the percentage of patient medication compliance toward reducing health disparities in heart disease and stroke.
 
E.      Launch and support research and demonstrations involving health information, health promotion, preventive health services, and/or education in the appropriate use of health care
 
IV. GENERAL PROVISIONS
 
A.    This MOU does not grant exclusivity to either Party, nor does it restrict FDA or NFHDSP from participating in similar initiatives with other public or private agencies, organizations, or individuals.
 
B.     In no event will any party hereto be liable to the other under any theory of Liability, however arising, for any costs or cover or for indirect, special, incidental or consequential damages of any kind arising out of this MOU. This provision shall survive termination, cancellation, or expiration of this MOU for any reason whatsoever.
 
C.     This Agreement does not and is not intended to transfer to either Party any rights in any technology or intellectual property. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
 
D.    Proprietary and nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by separate appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by statute.  
 
VI. RESOURCE OBLIGATIONS
 
This MOU represents the broad outline of FDA’s and NFHDSP’s intent to collaborate in the aforementioned areas of mutual interest. This MOU does not create any binding, enforceable obligations against any Party, unless and until the Parties execute a mutually acceptable supplemental agreement. All activities that may be undertaken pursuant to this 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, and does not affect the ability of the Parties to enter into other agreements or arrangements related to this MOU. The activities to be engaged in by FDA and NFHDSP under this agreement shall be collaborative in nature and NFHDSP will not seek payment from FDA for such activities. Nothing in this MOU shall be construed to obligate either party to make payments to the other. Each party will be responsible for the costs of its performance.
 
VIII. LIAISON OFFICERS
 
U.S. Food and Drug Administration
 
Helene D. Clayton-Jeter, O.D.
Director, Cardiovascular & Endocrine Liaison Program
Office of Health & Constituent Affairs
Office of External Affairs
U.S. Food and Drug Administration
Tel: 301-796-8452 / Cell: 240-753-3939
helene.clayton-jeter@fda.hhs.gov
 
The National Forum for Heart Disease and Stroke Prevention
 
John Clymer
Executive Director
 
Sarah R. Lincoln
Project Director
1150 Connecticut Ave., NW, Suite 300
Washington, DC 20036
Phone: (866) 894-3500 ▪ Fax: (202) 330-5080
 
Each Party may designate new liaisons at any time by notifying the other Party’s liaison(s) in writing. If, at any time, an individual designated as a liaison under this MOU becomes unavailable or unable to fulfill those functions, then the relevant Party shall name a successor liaison within two weeks following any request to name a successor, and shall notify the other Party of the newly named successor liaison.
 
IX. TERM, TERMINATION, AND MODIFICATION
 
This MOU shall become effective upon acceptance of the Parties and will continue for    an initial term of five (5) years. This MOU may be modified at any time by mutual    agreement of the Parties.
 
X. STATUTES, REGULATIONS, RULES, AND POLICIES
                                                                                                                                 
This MOU and all associated agreements shall be subject to the applicable statutes, regulations, rules, and policies under which FDA and NF operate. 
  
IN WITNESS WHEREOF, the Parties by their undersigned representatives have caused      this MOU to be executed.
                                   
XI.       

Approved and Accepted for
U.S. Food and Drug Administration 
Heidi Marchand, Pharm.D.
Assistant Commissioner for Health and Constituent Affairs
Office of External Affairs 
March 26, 2015           
 
Approved and Accepted for
The National Forum 
John M. Clymer
Executive Director
March 29, 2015