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  1. Domestic MOUs

MOU 225-19-009

MEMORANDUM OF UNDERSTANDING
BETWEEN THE
AMERICAN ACADEMY OF PEDIATRICS‎
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 Academy of Pediatrics‎ ("AAP") (each a "Party" and collectively the "Parties") to collaborate on the mutual goal of developing and disseminating educational and outreach initiatives for the physician audience to help them interpret and understand the content of Nutrition Facts label.

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 also communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships with the AAP will greatly contribute to FDA's mission.

American Academy of Pediatrics

Since 1930, AAP has played an important role in addressing and attaining optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults. The AAP recognizes that sound nutrition education contributes to improved health outcomes and disease prevention and control. Understanding how to read and interpret the Nutrition facts label located on food and beverage packages is a critical step to improving a patient’s diet. Providing education to physicians on this topic is important, given their influence on patient health.

III. ROLES AND RESPONSIBILITIES

The FDA will:

  • Draft and revise the scripts for the Videos and solicit comments and edits from designated AAP staff;
  • Draft and revise the accompanying education materials ("Handout(s)"), which will be downloadable, as part of the CME Module, and solicit comments and edits from designated AAP staff;
  • Secure, pay for, and manage the Contractor tasked with project oversight and production of the Videos and development of the Handout(s), using the script and draft Handout(s) as approved by the Parties. The Videos will be shot at locations chosen by the FDA in the greater Washington, DC area, as approved by the Parties;
  • Obtain all needed permissions and consents for the Videos;
  • Designate a staff member to provide information and support for AAP’s CME application process, if requested;
  • Host the final version of the Videos, after review by FDA and the AAP, on the FDA's website; and
  • Promote the Videos and Handout(s) through FDA communication channels.

The AAP will:

  • Review the Video scripts and provide written feedback to the FDA, within two (2) weeks of receiving the draft of the Video scripts, as appropriate;
  • Review Handout(s) content and provide written feedback to the FDA, within two (2) weeks of receiving the draft content, and provide approval of the Video scripts, as appropriate;
  • As requested by FDA, and as AAP resources permit, serve as technical advisor to the FDA and/or its Contractor during the filming of the Videos and development of the Handout(s);
  • As requested by FDA, assist the Agency in securing a physician in the Washington, DC area to participate in the videos as a physician spokesperson;
  • Incorporate final version of the Videos and Handout(s), when both are approved by AAP and FDA, into a Web-based CME Module for physicians;
  • Manage the application and review process to obtain approval for the AAP to accredit the CME Module and offer AMA PRA Category 1 Credit(s)TM; and
  • Host the final version of the CME Module on AAP's Online Learning Center, and/or other section of AAP’s website offering AMA PRA Category 1 Credit(s)™ to physicians, subject to AAP's annual CME renewal process;
  • Promote the CME Module through AAP communication channels; and
  • Provide FDA with quarterly metrics about CME use and physician pre-and post-test scores (or other knowledge assessment data), per AAP’s practice.

The Parties acknowledge that the final Video scripts, the final downloadable Handout(s), and the final Videos are subject to the prior approval of both Parties, in a manner acceptable by both Parties.

Neither Party will be participating in the internal business affairs of the other Party's organization or agency.

The Parties agree that work will be completed according to a production schedule that will be developed as part of the Video Production Plan, which will be finalized after this MOU is signed, reviewed by both Parties, and commence when work begins on the project. The production schedule will include the basic steps as attached hereto as Exhibit A in addition to target completion dates.

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 law.

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

C. AAP will retain sole copyright in the CME Module, exclusive of the Videos and/or Handout(s). AAP commits to making the CME Module accessible to physicians 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 the Videos and Handout(s) by including both Parties' names and/or logos in the final Videos and Handout(s). Use of the AAP or FDA names, initials, logos, and any trademarked materials is prohibited without the advance express written approval by an authorized official of AAP and/or FDA, as applicable. Any reference or attribution to an AAP employee, if applicable, is subject to the prior written approval of the AAP and the AAP 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.

V. COSTS

All activities undertaken pursuant to this MOU are subject to the availability of personnel, resources, and funds. AAP is not being compensated by FDA for the activities conducted under this MOU. FDA will be responsible for all costs incurred for development, production, and promotion of the final version of the Videos through its communication channels and stakeholder organizations. AAP will be responsible for all costs incurred in connection with development of the CME Module from the final version of the Videos and promotion of the CME Modules through its communication channels and stakeholder organizations.

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 AAP operate.

VI. NEW DEVELOPMENT

In the event there is a development that may make the content of the Videos and/or CME Module and/or Handout(s) obsolete, and no later than three (3) years after the CME Module is initially offered on AAP’s website, the Parties will review the continued value of the content presented in the Videos, Handout(s) and CME Module to determine if it is desirable to continue use of these materials and/or re-apply for AMA PRA Category 1 Credit(s)™ for the CME Module.

In the event one Party believes the Videos, Handout(s), and/or CME Module 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 Videos, Handout(s), and/or CME Module 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 Ill of this MOU. In the event that the Parties agree that entirely new Videos, Handout(s), or CME Module is necessary to ensure the material reflects current requirements, and further agree to collaborate on creating new Videos, Handout(s), or CME Module, the Parties will engage in a new MOU or amend this MOU pursuant to Section XII to reflect that collaboration.

VII. USE OF NAMES, LOGOS, AND OTHER TRADEMARKS

The Parties intend to co-brand the Videos and Handout(s) by including both Parties' names and/or logos in the final Videos and Handout(s). Use of the AAP or FDA names, initials, logos, and any trademarked materials is prohibited without the advance express written approval by an authorized official of AAP and/or FDA, as applicable. Any reference or attribution to an AAP employee, if applicable, is subject to the prior written approval of the AAP and the AAP 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.

VIII. OWNERSHIP OF WORK PRODUCT

The Parties acknowledge the final version of the Videos, accompanying Handout(s), and any other content provided to AAP by FDA in connection with this MOU will be in the public domain, and as such, FDA and AAP shall have full rights to reuse such content for all FDA and AAP purposes, as applicable, and the right to share such content with other collaborators or requestors. AAP may chapterize or otherwise alter or add content to the Videos 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(s)™ to eligible physician viewers. Any modifications to the substantive content of the Videos shall be reviewed and approved by FDA. In addition to use in the CME Module contemplated in this MOU, AAP may use the Videos for other educational, non-commercial purposes.

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

IX. 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: Sharmi.Das@fda.hhs.gov

B. American Academy of Pediatrics‎

Debra Burrowes
Manager, Technical & Medical Services
Department of Primary and Subspecialty Pediatrics
American Academy of Pediatrics
345 Park Blvd.
Itasca, IL  60143
Phone: 630-626-6427
Email: dburrowes@aap.org

X. LIMITATION OF LIABILITY

In no event will either Party be liable 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 shall survive termination, cancellation, or expiration of this MOU or any reason whatsoever.

XI. ENTIRETY

This MOU represents the entire agreement of the Parties with respect to the subject matter hereof, and supersedes all prior and/or contemporaneous agreements or understandings, written or oral, with respect to the subject matter of this MOU.

XII. REVISIONS/AMENDMENTS

It is understood and agreed that the Parties may revise or modify this MOU by written amendment hereto, provided such revisions or modifications are mutually agreed upon.

XIII. DECISION MAKING AND DISPUTE RESOLUTION

The Parties through their authorized designees will make decisions based on mutual agreement. The Parties agree that every reasonable effort should be made to resolve any disputes that may arise. If the authorized personnel of the Parties are unable to resolve the dispute, the matter should be resolved by referral to designated key participants from each Party and, if resolution does not occur, to higher levels of management. If these steps do not resolve the dispute, this Agreement shall immediately terminate when one Party declares an impasse, in writing to the other Party. In such event of termination, the Parties shall resolve continued use of the Videos, and/or CME Module, and/or Handout(s) and in accordance with Section IV.

XIV. 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 AAP.  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 AAP operate.

XV. 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 5 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 Videos and/or Handout(s). The rights, obligations, and limitations established in Sections IV, VII, and VIII shall survive termination or expiration of the Agreement.

By signing below, the Parties accept the conditions that accurately represent the understanding reached between them.

APPROVED AND ACCEPTED FOR
AMERICAN ACADEMY OF PEDIATRICS‎  
/s/
By John J. Miller, CPA 

Title
Chief Financial Officer 

Date
11/30/18

APPROVED AND ACCEPTED FOR
U.S. FOOD AND DRUG ADMINISTRATION
/s/
By Conrad Choiniere

Title
Director, Office of Analytics and Outreach
FDA/CFSAN

Date
12/14/18
 

EXHIBIT A

SCHEDULE


The production schedule will include the basic steps listed below.

  • FDA to provide draft Video scripts to AAP for review and comment.
  • FDA to provide final Video scripts to AAP for review and approval.
  • Filming of Videos in accordance with approved script.
  • Video production and editing.
  • FDA to provide Video rough cuts and draft Handout(s) to AAP for review and comment.
  • FDA to provide final Videos and Handout(s) to AAP for review and approval.
  • AAP to provide FDA with CME assessment questions for review and comment.
  • AAP to obtain final approval for CME credit when Videos are complete and notify FDA.
  • AAP to post final CME module to the AAP Online Learning Center and FDA to post final Videos on FDA website.
  • AAP and FDA to review the CME Module to ensure it remains current and/or valid, annually through March 2025.
 
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