MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
OFFICE OF COMMISSIONER
AND
REAGAN-UDALL FOUNDATION FOR THE FDA

I. Purpose

In the context of this COVID-19 declared public health emergency, FDA and the ReaganUdall Foundation for the FDA (the “Foundation”) declare a shared interest in COVID-19 research and data analyses. This Memorandum of Understanding (MOU) establishes the
framework for collaboration to promote these shared interests which can be pursued through various programs including collaborative research and exchange of scientific expertise between the Foundation and the Food and Drug Administration (“FDA” or the
“Agency”) to advance FDA’s response to COVID-19. Throughout this document, FDA and the Foundation are referred to individually as a "Party" and collectively as the "Parties."

II. Background

There is currently an outbreak of respiratory disease caused by a novel coronavirus. The virus has been named “severe acute respiratory syndrome coronavirus 2” (“SARS-CoV2”) and the disease it causes has been named “Coronavirus Disease 2019” (“COVID-19”). On January 31, 2020, the Department of Health and Human Services (“HHS”) issued a declaration of a public health emergency related to COVID-19. It mobilized the Operating Divisions of HHS, including FDA.

FDA’s response to the COVID-19 pandemic is multifaceted. It is being carried out in close collaboration with other federal, state, and local agencies. Data from a variety of sources are crucial to inform FDA’s COVID-19 response activities.

In addition, FDA recognizes the potential for many different real-world data sources to complement traditional clinical studies and speed the process of evaluating the impact of potential COVID-19 therapies. To meet that end, the Agency is advancing relationships with partners in the public and private sectors to rapidly collect and analyze information in areas such as illness patterns and treatment outcomes.

The Foundation’s research efforts in these areas can provide important leadership for the coordinated collection and analyses of data from different sources. FDA’s partnership with the Foundation will promote collaborative public-private research efforts related to COVID-19.

The Foundation is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”
The Foundation embodies FDA’s vision of collaborative innovation to address regulatory science challenges of the 21st Century and assist in the creation of new, applied scientific knowledge, tools, standards, and approaches the FDA needs to evaluate products more
effectively, predictably, and efficiently, and thereby enhance the FDA’s ability to protect and promote the health of the American public. The Foundation serves as a crucial conduit between FDA and the public, providing a means for FDA to interact directly with
stakeholders, including industry and consumers. The Foundation does not participate in regulatory decision-making or offer advice to FDA on policy matters.

III. Substance of Agreement

This MOU between FDA and the Foundation will expedite collaborative research and data collection efforts related to COVID-19. These collaborative research and data collection efforts will include:

• Developing a common set of core data elements to embed into data collection efforts;
• Identifying an initial set of immediate questions regarding therapeutic interventions; treatment settings, and associated outcomes that could be the initial focus of COVID19 data aggregation efforts; and
• Engaging in additional activities by the Foundation and FDA, where appropriate, to promote the collection and analysis of data related to COVID-19.

Under this MOU, FDA and the Foundation will seek opportunities to participate in collaborative research related to COVID-19 data collection. Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and, where appropriate, develop separate, written agreements of collaboration and sharing of resources. Where appropriate, these agreements shall incorporate by reference this MOU. FDA may enter into additional agreements with the Foundation to the extent authorized by law and available funding resources. The terms and conditions of any such agreements will comply with applicable federal law and regulations.

IV. General Provisions

1. Data Sharing Guideline: The Parties may enter into separate Confidential Disclosure Agreements (CDAs) pertaining to certain data and information shared in accordance with this MOU as needed. In accordance with applicable law and regulations, including, but not limited to, 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, 21 CFR 20.61 and 20.63, FDA will not share any confidential commercial information, trade secrets, or personal privacy information with the Foundation pursuant to this MOU.

V. Resource Obligations:

This MOU represents the broad outline of how FDA and the Foundation intend to collaborate in areas of interest to the FDA. It does not create binding, enforceable obligations against any Party. All activities that may be undertaken by this MOU are subject to available 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. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, by-laws and statutes under which FDA and the Foundation operate.

VI. Liaison Officers:

A. For Reagan-Udall Foundation:

Amar Bhat, Ph.D., or successor
Interim Executive Director
Reagan-Udall Foundation for the FDA
1900 L Street NW, Suite 835
Washington, DC 20036
Tel: 202-415-0385

B. For the Food and Drug Administration:
Joseph ranklin, J.D., Ph.D.
Policy Director for the Principal Deputy Commissioner
10903 New Hampshire Avenue, Bldg. 1
Silver Spring MD, 20993
Tel: 301-796-8583

Each Party may designate new liaisons by notifying the other Party's administrative liaison in writing. If an individual designated as a liaison under this Agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within 2-weeks
and notify the other Party through the designated administrative liaison.

VII. Term, Termination, and Modification:

This Agreement becomes effective upon acceptance by both Parties and will continue in effect for twelve (12) months. It may be modified or renewed by mutual written agreement of both Parties. It may be terminated by either Party upon 60-day advance written notice to the other.

VIII. Statutes, Regulations, Rules, and Policies

This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies.

Approved and Accepted for Reagan-Udall Foundation for the FDA
Signed by:

/s/
Amar Bhat, PhD.
Interim Executive Director

Approved and Accepted for the Food and Drug Administration
Signed by:

/s/
Amy Abernethy, MD, PhD
Principal Deputy Commissioner & Acting Chief Information

4/12/2020
Date

MOU 225‐20‐009 Amendment Number 1

MEMORANDUM OF UNDERSTANDING
BETWEEN 
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
U.S. FOOD AND DRUG ADMINISTRATION
OFFICE OF THE COMMISSIONER
AND
REAGAN‐UDALL FOUNDATION FOR THE FDA

This is amendment number one (1) to the Memorandum of Understanding (MOU) 225‐20‐009 between the U.S. Department of Health and Human Services, Food and Drug Administration, Office of the Commissioner, and Reagan‐Udall Foundation for the FDA (the “Parties”).

The purpose of this amendment is to extend the expiration date from April 13, 2021 to April 13, 2022. This is permissible under Section VII—Term, Termination, and Modification. Execution of this amendment provides continuity to promote collaboration and enhance knowledge and efficiency by providing for the sharing of information of mutual concern between the Parties.

This amendment, when accepted by the undersigned, will be effective from April 13, 2021 until April 13, 2022. All other content, terms, and conditions stated in MOU Number 225‐20‐009, executed on April 13, 2020, will remain unchanged.

APPROVED AND ACCEPTED BY:
U.S. FOOD AND DRUG ADMINISTRATION

/s/
RADM Denise M. Hinton
Chief Scientist

4/12/21
Date

APPROVED AND ACCEPTED BY:
REAGAN‐UDALL FOUNDATION FOR THE FDA

/s/
Susan C. Winckler, RPh, Esq.
Chief Executive Officer

4/12/21
Date