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  1. FDA Memoranda of Understanding

MOU 225-17-005

MOU 225-17-005

MEMORANDUM OF UNDERSTANDING
BETWEEN THE AMERICAN MEDICAL ASSOCIATION
AND THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

 

I. Purpose

This Memorandum of Understanding ("MOU") establishes the framework for the U.S. Food and Drug Administration ("FDA") and the American Medical Association ("AMA")(each a "Party" and collectively the "Parties'} to collaborate on the mutual goal of developing and disseminating an educational and outreach initiatives for the physician audience to help them diagnose, treat, and report foodborne illnesses and educate patients on preventing foodborne illness.

II. Background

Food and Drug Administration

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, medical devices and radiological products and the safety and security of foods, dietary supplements and cosmetics, 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 also communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships with the AMA will greatly contribute to FDA's mission.

American Medical Association

Since 1847, the American Medical Association has played an important role in the development of medicine in the United States, promoting scientific advancement, improving public health, and investing in the doctor and patient relationship. The AMA recognizes that foodborne illness is a serious public health problem. Physicians and other health care providers play a critical role in the prevention and control of food-related disease outbreaks. Providing education to physicians on their role in recognizing suspicious symptoms, disease dusters, and etiologic agents, as well as reporting cases of   foodborne illness to public health authorities is important.

III. Substance of Agreement

The FDA and the AMA agree on the following framework for development and distribution of CME module videos.  Specific details on timing, developing training programs and materials, distribution methods will be determined and outlined in supplemental agreements. Examples of collaborative efforts include:

• Develop scripts for the CME Video modules;
• Draft and revise and agree on the accompanying downloadable education materials ("Handout(s)");
• Provide oversight for production of the CME Video Modules and production locations, using the scripts as approved by the Parties;
• Obtain all needed permissions and consents for the Video;
• Serve as technical advisors during the filming of Videos and development of the Handout(s);
• Participate in AMA's CME application planning committee;
• Host AMA-approved final versions of videos on the FDA's website;
• Promote Videos and Handout(s) through Parties communication channels and in Web-based CME Module for physicians;
• Manage the application and review process to obtain approval for the AMA to accredit the CME Module and offer AMA PRA Category 1 Credit™, and
• Host the final version of the CME Module on AMA's Online Learning Center, and/or other section of AMA's website offering AMA PRA Category  1Credit™ to physicians, subject to AMA's annual CME renewal process.

IV. General Provisions

A.  Data Sharing Guidelines

Proprietary or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by Jaw.

B. The Parties acknowledge the final version of the Video, accompanying Handout(s), and any other content provided to AMA by FDA in connection with this AGREEMENT will be in the public domain, and as such, FDA and AMA shall have full rights to reuse such content for all FDA and AMA purposes, as applicable, and the right to share such content with other collaborators or requesters. AMA may chapterize or otherwise alter or add content to the Video for the purposes of constructing the CME Module, including at a minimum
adding assessment questions to the module to meet the requirements for awarding AMA PRA Category 1 Credit™ to eligible physician viewers. In addition to use in the CME Module contemplated in this AGREEMENT, AMA may use the Video for other educational, non-commercial purposes.

C. AMA will retain sole copyright in the CME Module, exclusive of the Video and/or Handout(s). AMA commits to making the CME Module accessible to physicians free of charge.

D. All activities within the scope of this Agreement must comply with Section 508 of the Rehabilitation Act (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

E. The Parties intend to co-brand the Video and Handout(s) by including both Parties' names and/or logos in the final Video and Handout(s).Use of the AMA or FDA names, initials, logos, and any trade marked materials is prohibited without the advance express written approval by an authorized official of AMA and/or FDA, as applicable. Any reference or attribution to an AMA employee, if applicable, is subject to the prior written approval of the AMA and the AMA employee. Each specific use of a Party's name, initials and/or logo must be submitted for review 
at least five (5) to seven (7) business days in advance of the proposed use. The use of the Parties names and logos shall not imply any exclusive arrangement, or any endorsement.

F. All activities within the scope of this MU must comply with section 508 of the Rehabilitation Act (29 U.S.C. section 794d), as amended by the Workforce Investment Act of 1998, Pub. L. No. 105-220 Aug. 7, 1998, Investment Act of 1998, Pub. L. No. 105-220, Aug. 7, 1998.

V. Limitation of Liability

In no event will either Party be able to the other under any theory of liability, however arising, for any costs of cover or for indirect, special, incidental, or consequential damages of any kind arising out of this MOU. The provisions of this Section X shall survive termination, cancellation, or expiration of this MOU or any reason whatsoever.

VI. 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 AMA.  For example, the Parties may set forth their Roles and Responsibilities regarding particular CME videos in one or more Supplemental Agreements.  All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds.  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 hereunder. 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 AMA operate.

VII. Contacts

A. Food and Drug Administration Sharmi Das
 Director, Division of Education, Outreach and Information CFSAN/FDA
 240-402-3786
 Sharmi.Das@FDA. HHS.GOV

B. American Medical Association Andrea Garcia
 Sr. Policy Analyst, Science and Biotechnology
 American Medical Association Andrea.Garcia@ama-assn.org

VIII. Term, Termination, and Modification

This MOU becomes effective on the latest date of execution by both Parties. and will continue through the lifespan of the CME Module (a maximum of 3 years). This MOU may be modified in writing by mutual consent of authorized officials of each Party.

Either Party may terminate its participation in this MOU after providing the other Party sixty (60) days written notice of termination except as otherwise provided in Section XIII. In the event of termination, upon request either Party's name and/or logo shall be removed by the other Party from future use of the Video and/or Handout(s). The rights, obligations, and limitations established in Sections IV, VII, VIII, X and XIII shall survive
termination or expiration of the Agreement. 

APPROVED AND ACCEPTED FOR THE AMERICAN MEDICAL ASSOCIATION
Modena Wilson
SPV, Chief Health and Science Officer
November 2, 2016

APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Director
Office of Analytics and Outreach
Center for Food Safety and Applied Nutrition
Novemer 8, 2016