MOU 225-25-007

Memorandum of Understanding
between
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Veterinary Medicine
and The Trustees of the University of Pennsylvania on behalf of the University of Pennsylvania School of Veterinary Medicine

I. Purpose

The United States Food and Drug Administration (FDA) and the Trustees of the University of Pennsylvania, on behalf of the University of Pennsylvania School of Veterinary Medicine (“Penn”), (collectively, the Participants), share interests in promoting scientific progress through collaborating in areas of common interest and developing a common approach to analytical methods in support of food safety in relation to the protection of human and animal health and international trade.

II. Background

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. §§ 301, et seq.). In fulfilling its responsibilities under the Act, FDA directs its activities toward, among other things, 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 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 communication with stakeholders about complex scientific public health issues. Increased development of research, education, and outreach partnerships with the of Pennsylvania School of Veterinary Medicine will greatly contribute to FDA’s mission.

The University of Pennsylvania School of Veterinary Medicine was founded in 1884 and has a long-standing tradition as a global leader in veterinary medicine education, research, and clinical care, with a tradition of compassionate clinical expertise, intellectual rigor and the pursuit of innovative thinking.  The University of Pennsylvania School of Veterinary Medicine falls within the Trustees of the University of Pennsylvania, which is a Pennsylvania nonprofit corporation with an address at the Office of Research Services, 3451 Walnut Street, 5th Floor, Philadelphia, PA 19104-6205. “Penn” is a member of the Veterinary Laboratory Investigational and Response Network (“Vet-LIRN”), which is supported by the FDA. Vet-LIRN is a network of veterinary diagnostic laboratories that supports the documentation, investigation, and diagnosis of animal feed or drug related illnesses. These efforts also contribute to overall food safety as animal feed events could signal potential issues in the human food system.

III. Substance of Understanding

FDA’s Center for Veterinary Medicine (CVM) coordinates facilities, equipment, and professional expertise of government and veterinary diagnostic laboratories to respond to high priority chemical and microbial feed/drug contamination events. CVM manages Vet-LIRN, a network to provide the means for rapid response to reports of animal injury and establishes protocols to facilitate veterinary diagnostic testing at network laboratories to help FDA investigate potential adverse events affecting the United States’ animal feed and drug supply by conducting testing of veterinary products, animal feeds, or diagnostic samples.  As a Vet-LIRN laboratory Network member, laboratories will maintain preparedness by optimizing and harmonizing testing methods, as well as conducting limited surveillance exercises and participating in network proficiency tests.

Vet-LIRN conducts follow-up related to consumer complaints including: reviewing medical histories, completing necropsies with complete histopathology work up, toxicology testing, microbiology testing, and whole genome sequencing.

The Participants intend to seek opportunities to participate together to:
• Investigate potential problems with FDA regulated products, e.g., animal feed and animal drugs, and 
• Collaborate with veterinary diagnostic laboratories to provide scientific information; build laboratory capacity for routine and emergency response, and train scientists.

The Participants have the option of entering into a contract, grant, or cooperative research agreement to the extent authorized by the law of each Participant’s institution and available appropriations. The Participants intend that the terms and conditions of any such arrangements will be in accordance with applicable law and regulations and will be negotiated and executed by appropriate representatives of institutions within of Pennsylvania School of Veterinary Medicine and FDA. The Participants intend that, when applicable, these arrangements reference this MOU.

IV. General Provisions:

The Participants intend that:

1. Rights to any inventions resulting from collaborative research will be determined by the separate written research arrangements governing the effort, based on current patent regulations and any other applicable statutes and regulations.
2. The Participants may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
3. Each Participant will comply with the other Participant’s security procedures and policies, as well as statutes and regulations, regarding access to and use of facilities. A Participant can either restrict or limit access to its property and facilities at any time and for any reason.
4. It is recognized that from time to time, the Participants may share expenses and may agree to compensation of one Participant by the other. As projects are developed, details of how expenses are to be shared, and whether any compensation will be made to one Participant by the other, will be agreed to in advance under contractual or other mechanisms, as appropriate and in compliance with all applicable legal requirements.

V. Information Sharing:

1. Due to Penn’s legal status as a non-government entity, FDA is not able to enter into a formal information sharing agreement with Penn pursuant to 21 CFR 20.88. As a result, FDA may not be able to share the same scope of information with Penn as it does with other Vet-LIRN laboratories. However, this is not expected to impede the Participants’ ability to effectuate the human and animal health objectives of this MOU.
2. This MOU does not authorize the sharing of FDA non-public information (NPI). The reference to “non-public information” covered by this agreement includes any information protected from public disclosure under federal law and regulations, including the Freedom of Information Act (FOIA) and 21 CFR part 20. See also 21 U.S.C. § 331(j), 21 U.S.C. § 360(j), 5 U.S.C. § 552a(i)(1), 18 U.S.C. § 1905. This may include confidential commercial information, trade secret information, personal privacy information, pre-decisional information, deliberative information, and law enforcement records.  Examples of documents that may contain FDA NPI include adverse event reports, open case investigatory information, and medical records. FDA NPI will be redacted from any documents shared with Penn under this agreement. For questions regarding whether certain information constitutes FDA NPI such that it must be redacted, consult CVM’s FOIA Office.
3. In some instances, draft, pre-decisional and deliberative information may be shared by FDA with Penn, provided that doing so is necessary to facilitate investigation of potential problems with FDA regulated products. FDA staff should be aware that disclosure of draft, pre-decisional, and deliberative information pursuant to this agreement will trigger uniform access under 21 CFR 20.21.  Pursuant to 21 CFR 20.21, any FDA record that is disclosed in an authorized manner to any member of the public is available for disclosure to all members of the public and is no longer exempt from disclosure under exemption (b)(5) of the FOIA “5 U.S.C. § 552” and 21 CFR 20.62.
4. FDA will protect information received from Penn pursuant to this agreement to the extent permitted by federal laws and regulations governing information disclosure, as cited above.

VI. Resource Obligations:

This MOU represents the broad outline of the intent the Participants to collaborate in areas of mutual interest.  This MOU is not intended to create binding or enforceable obligations against any Participants.  All activities that may be undertaken under this MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future arrangements between the Participants and does not affect the ability of the Participants to enter other arrangements.

VII. Liaison Officers:

A.   For Penn:
Attn: Associate Director, Office of Research Services/RIS# 83995
Trustees of the University of Pennsylvania
Office of Research Services
3451 Walnut Street, 5th Floor
Philadelphia, PA 19104-6205
Email: ORSContracts@pobox.upenn.edu
Phone: 215-898-7293

B. For the Food and Drug Administration:
Dr. Gregory Tyson, Director, Division of One Health Monitoring
FDA/Center for Veterinary Medicine
8401 Muirkirk Road, Laurel, MD 20708
240-402-5426

Each Participant can designate a new liaison at any time by notifying the other Participant’s administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, that Participant will name a new liaison within 2 weeks and notify the other Participant through its designated administrative liaison.

VIII. Term, Termination, and Modification

The Participants intend that this MOU become effective when accepted by both Participants and will have an effective period of performance of 5 years. It can be modified by mutual written consent by the Participants or can be terminated by either Participant(s) upon a 60-day advance written notice to the other.

APPROVED AND ACCEPTED FOR  
THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA

/s/
Meredith Krain
Associate Director, Research Services
Office of Research Services
Date: 06/26/2025

APPROVED AND ACCEPTED FOR THE
FOOD AND DRUG ADMINISTRATION

/s/
Timothy Schell, Ph.D.
Acting Director, Center for Veterinary Medicine
Date: 06/30/2025