Memorandum of Understanding between
U.S. Department of Health and Human Services Food and Drug Administration
Center for Veterinary Medicine and
The Pennsylvania State University
The United States Food and Drug Administration (FDA) and The Pennsylvania State University, Animal Diagnostic Laboratory (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 public health and international trade.
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 Pennsylvania State University will greatly contribute to FDA’s mission.
The Pennsylvania State University is a State-related, land-grant, public research university and instrumentality of the Commonwealth of Pennsylvania that educates students from around the world and conducts interdisciplinary research and scholarship to promote human and economic development, global understanding, and advancement through the expansion of knowledge and its applications in sciences and arts and humanities.
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 the Veterinary Laboratory Investigation and Response Network (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.
FDA and Pennsylvania State University intend to seek opportunities to participate together to:
- Help CVM investigate potential problems with FDA regulated products, e.g., animal feed and animal drugs, and
- Promote human and animal health by collaborating with veterinary diagnostic laboratories to provide scientific information, build laboratory capacity for routine and emergency response, and train scientists.
Vet-LIRN conducts case investigations including: reviewing medical histories, completing necropsies with complete histopathology work up, toxicology testing, microbiology testing, and whole genome sequencing.
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 Pennsylvania State University and FDA. The Participants intend that, when applicable, these arrangements incorporate by reference this MOU.
IV. General Provisions
The Participants intend that:
- 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.
- The Pennsylvania State University and FDA 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.
- 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.
- It is recognized that from time to time, the FDA and The Pennsylvania State University may share expenses and may require compensation of one Participant by the other. It is agreed that as projects are developed, details of how expenses are to be shared will be agreed to in advance under contractual or other mechanisms, as appropriate and in compliance with all applicable legal requirements.
V. Information Sharing
- Due to The Pennsylvania State University’s legal status as a non-government entity, FDA is not able to enter into a formal information sharing agreement with The Pennsylvania State University pursuant to 21 CFR 20.88. As a result, FDA may not be able to share the same scope of information with The Pennsylvania State University as it does with other Vet-LIRN laboratories. However, this is not expected to impede the Participants’ ability to effectuate the public health objectives of this MOU.
- 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: names, addresses, and other personal identifying information in an adverse event report, and open case investigatory information and records such as medical records. FDA NPI does not include laboratory samples or sample results. FDA NPI must be redacted from any documents shared with The Pennsylvania State University under this agreement. For questions regarding whether certain information constitutes FDA NPI such that it must be redacted, consult CVM’s FOIA Office.
- In some instances, draft, pre-decisional and deliberative information may be shared by FDA with The Pennsylvania State University, 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 and 21 CFR 20.62.
- FDA will protect information received from The Pennsylvania State University 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 FDA and The Pennsylvania State University’s intent to collaborate in areas of mutual interest. All activities that may be undertaken under this 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 arrangements between the Participants and does not affect the ability of the Participants to enter other arrangements related to this MOU.
VII. Liaison Officers
A. For The Pennsylvania State University:
Suresh Varma Kuchipdui
Department of Veterinary & Biomedical Sciences
Animal Diagnostic Laboratory, University Park, PA 16802
B. For the Food and Drug Administration:
Dr. Regina Tan, Director, Office of Research
FDA/Center for Veterinary Medicine
8401 Muirkirk Road, Laurel, MD 20708
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.
IX. Statutes, Regulations, Rules, and Policies
This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA, The Pennsylvania State University, and the institutions within The Pennsylvania State University operate.
APPROVED AND ACCEPTED FOR
THE PENNSYLVANIA STATE UNIVERSITY
John W. Hanold
Associate Vice President for Research
APPROVED AND ACCEPTED FOR THE
FOOD AND DRUG ADMINISTRATION
Dr. Steven Solomon
Director, Center for Veterinary Medicine