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MOU 225–20–018

MEMORANDUM OF UNDERSTANDING BETWEEN THE ACADEMY OF NUTRITION AND DIETETICS AND THE FOOD AND DRUG ADMINISTRATION U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

I. PURPOSE

This Memorandum of Understanding ("MOU") establishes the framework for a collaboration between the U.S. Food and Drug Administration ("FDA") and the Academy of Nutrition and Dietetics ("ACADEMY") (each a "Party" and collectively the "Parties") that will help facilitate a common goal of increasing awareness and understanding on topics of nutrition, agricultural biotechnology, and food safety, including disseminating educational and outreach materials on these topics. 

II. BACKGROUND

Food and Drug Administration

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended (21 U.S.C. 301 et seq.). 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. 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 research and communicate with stakeholders about complex scientific and public health issues. Collaborating with ACADEMY to help develop and disseminate food safety, agricultural biotechnology, and nutrition education resources and information to dietitians, health educators, practitioners, and consumers will further support FDA's mission.

Academy of Nutrition and Dietetics

Founded in 1917, ACADEMY is the world's largest organization of food and nutrition professionals. ACADEMY has over 100,000 credentialed practitioners – registered dietitian nutritionists, dietetic technicians, students, and registered, and other dietetics professionals holding undergraduate and advanced degrees in nutrition and dietetics – and is committed to improving the nation's health and advancing the profession of dietetics through research, education, and advocacy.

Members of ACADEMY play a key role in shaping the public's food choices, thereby improving its nutritional status, and in treating persons with illnesses or injuries. Members offer preventive and medical nutrition therapy services in a variety of settings.

Dietetics practitioners work in health care systems, home health care, foodservice, business, and research and educational organizations, as well as in private practice. Community-based dietetics practitioners provide health promotion, disease prevention, and wellness services.

Partnering with ACADEMY to develop materials to ensure its practitioners have access to FDA’s resources to understand nutrition, agricultural biotechnology, and food safety would increase the reach of FDA’s education efforts and advance FDA and ACADEMY’s public health missions.

III. ROLES AND RESPONSIBILITIES

FDA intends to:

  • Develop an education learning series to educate ACADEMY members and other health professionals about agricultural biotechnology, nutrition, or food safety.
  • Draft, revise, and finalize the educational learning series webcast on agricultural biotechnology that will be equivalent to up 1.5 hours of coursework/Continuing Professional Education (CPE) credit.
    • Engage FDA Subject Matter Experts (SMEs) to review the draft modules for scientific and regulatory accuracy.
    • Solicit comments and edits from designated ACADEMY staff, SMEs, and assigned reviewers.
    • Obtain all required FDA clearances for the materials.
    • Provide graphic design services to produce all final modules.
    • Create all final modules in 508-compliant formats, including collateral materials as PDF documents for posting on the Web.
  • Host the final version of the agricultural biotechnology education learning series webcast on FDA's website. CPEs will be available via the ACADEMY’s website.
  • Promote the education learning series modules through FDA communication channels.
  • Acknowledge that the ACADEMY will also publicize and host the developed education learning series on its website to provide CPE.
  • Designate a staff member to provide information for ACADEMY’s Continuing Professional Education (CPE) application process, if requested.

ACADEMY intends to:

  • Assign an ACADEMY staff member, SME, and content expert reviewer to review the education learning series webcast and provide written feedback to FDA within the timeframes set in the production schedule.
  • Manage ACADEMY’s development and review process to obtain approval to provide CPE for the agricultural biotechnology education learning series.
  • Host the education learning series webcast on ACADEMY’s website.
  • Offer the CPE credits for Registered Dietitians (RDs) and Nutrition Dietetics Technicians Registered (NDTRs), at no cost, to ACADEMY members and non-members seeking them.
    • Award CPE credits to RDs and NDTRs who complete the modules.
    • Make CPE credits available for up to 3 years from the launch of the education learning series webcast.
  • Promote the education learning series webcast through ACADEMY communication channels, such as its website, social media platforms, member communications, and conferences.
  • Provide FDA with quarterly metrics about the number of individuals completing the education learning modules, accessed through ACADEMY’s website, and pre- and post-test assessment scores.
  • Identify ACADEMY staff, SMEs, or members to participate in educational activities, such as, videos, interviews, or blogs, to increase the awareness of health professionals about agricultural biotechnology, nutrition, or food safety.

The Parties agree that work will be completed according to a production schedule that will be developed for the agricultural biotechnology education learning series, which will be finalized after this MOU is signed, reviewed by both Parties, and commence when work begins on each project.

IV. GENERAL PROVISIONS

A. Data Sharing Guidelines

The parties intend to share only publicly available information.

B. The Parties acknowledge that the final version of any education materials, including any modules on agricultural biotechnology, nutrition, food safety, or related subjects provided to ACADEMY by FDA in connection with this MOU, will be in the public domain, and as such, FDA and ACADEMY shall have full rights to reuse such content for all FDA and ACADEMY purposes, as applicable, and the right to share such content with other collaborators or requestors.

C. ACADEMY will retain sole copyright in the CPE materials; ACADEMY commits to making the CPE Webcast accessible to its members and non-members free of charge.

D. All activities within the scope of this MOU 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 all education materials by including both Parties' names and/or logos in the final education materials. Apart from the co-branded educational materials, ACADEMY agrees not to use the name of FDA except in factual publicity regarding the activities covered by this MOU.  Such factual publicity shall not imply that the involvement of FDA serves as an endorsement of the general policies, activities, or products of ACADEMY; where confusion could result, publicity will be accompanied by a disclaimer to the effect that no endorsement is intended. ACADEMY will clear all publicity materials related to activities covered by this MOU with FDA to ensure compliance with this paragraph.

F. This MOU does not affect or supersede any existing or future agreements or arrangements between the Parties. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and ACADEMY operate.

V.  NEW DEVELOPMENT

In the event there is a development that may make the content of the agricultural biotechnology modules obsolete, the Parties will review the continued value of the content presented in the modules to determine if it is desirable to continue use of these materials.

In the event one Party believes that any education series modules should no longer be used, but the other Party wishes to continue use, the Party continuing use will remove the name, initials, logo, and attribution to the other Party upon the other Party's request.

In the event that the Parties agree that the education series modules may continue to be used but require edits or other changes in order to ensure the material reflects current regulatory requirements, the Parties will collaborate in the manner outlined in Section III of this MOU.

VI. CONTACTS

A. Food and Drug Administration

Sharmi Das
Director, Division of Education, Outreach, and Information
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
5001 Campus Drive
College Park, MD 20740
Phone: 240-402-3786
Email: [email protected]

B. Academy of Nutrition and Dietetics

Diane Enos
Chief Learning Officer
Academy of Nutrition of Dietetics
120 S. Riverside Plaza, Ste 2190
Chicago, IL 60606
Phone: 312-899-1767
Email: [email protected]

VII. 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 ACADEMY. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against any Party. 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 ACADEMY operate.

VIII. TERM, TERMINATION, AND MODIFICATION

This MOU will be effective for five years when accepted by both FDA and the ACADEMY and will have an effective date from that date of the latest signature by the later Party to sign this MOU. 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. 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 education materials.

Approved and Accepted For U.S. Food and Drug Administration

/S/
Sharmi Das
Director, Division of Education, Outreach, and Information
September 4, 2020

Approved and Accepted For Academy of Nutrition and Dietetics

/S/
Diane Enos
Chief Learning Officer, Academy of Nutrition of Dietetics
September 4, 2020

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