MOU 225-24-007

MEMORANDUM OF UNDERSTANDING BETWEEN THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, THE FOOD AND DRUG ADMINISTRATION (FDA), THE CENTER FOR DRUG EVALUATION AND RESEARCH (CDER), THE OFFICE OF TRANSLATIONAL SCIENCES, AND THE UNIVERSITY OF CALIFORNIA, LOS ANGELES (UCLA)

This Memorandum of Understanding (MOU) is made and entered into by and between the Center for Drug Evaluation and Research, a center within the United States Food and Drug Administration (hereafter referred to as FDA) and the University of California, Los Angeles (UCLA) collectively referred to as the “Parties.”

WHEREAS the Parties wish to explore and establish a cooperative relationship through their mutual interest in the areas of education and research, the parties agree as follows:

I. Purpose

This Memorandum of Understanding (MOU) establishes the terms for collaborative engagement between FDA and UCLA, as well as describe activities which can be pursued through a variety of programs, including but not limited to: (a) joint research projects in fields of mutual interest; (b) exchange of academic publications and reports; (c) sharing of experiences in innovative teaching methods and course design; (d) organization of joint symposia, workshops, and conferences; (e) opportunities for faculty development and exchange; (f) opportunities for student exchange; and (g) opportunities for exchange of visiting research scholars.

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, among other things, directs its activities towards 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. Research, education and collaborative partnerships with UCLA will contribute to supporting FDA’s mission.

UCLA is a public land-grant research university in Los Angeles, California. Its academic roots were established in 1881 as a normal school then known as the southern branch of the California State Normal School. As a public research university, UCLA’s mission is the creation, dissemination, preservation, and application of knowledge for the betterment of our global society. The UCLA Department of Statistics was founded in 1998 and has become a leader in the development of statistical methodology that exploits the increasing availability of data and computing. The UCLA Statistical machine learning lab-Trustworthy AI lab envisions AI 2.0 as being driven by trustworthiness (beyond performance) and being built upon synthetic data (on top of raw data). Lab drives advancements in Generative AI for healthcare and finance sectors. Lab develops data-centric tools, such as artificially generated tables and conversations, which enables privacy-preserving data sharing and reliable scenario exploration.

III. Substance of Agreement

This MOU forms the basis for the development of scientific collaborations, outreach, educational initiatives, and intellectual partnerships between the FDA and UCLA. The types of initiatives expected to develop from this MOU may include:

A. Opportunities for students, post-doctoral trainees, and residents (e.g., fellows- PharmD, PhD, M.D.) from UCLA to apply, and will be subject to the availability of funding, for the Center for Drug Evaluation and Research (CDER) Oak Ridge Institute for Science and Education (ORISE) fellowship program to advance student education and increase matriculation into the health and biomedical science professions. Faculty sabbatical may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE Fellowship program mechanism, CDER and UCLA will adhere to the CDER ORISE Fellowship rules, which will be provided to UCLA upon commencement of the program. Fellows or faculty members entering the program must agree to adhere to the term of appointment which will be outlined in an offer of appointment letter. For more information about the CDER ORISE fellowship program visit: Information for Applicants | Research Participation Program at the U.S. Food and Drug Administration.

B. Opportunities for FDA staff to serve as UCLA adjunct faculty and/ or on UCLA advisory boards.

C. Opportunities to convene joint meetings for education and research; and

D. Research collaborations.

Under this MOU, joint efforts will be undertaken to support collaborative research and training as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources. Where applicable, these agreements shall incorporate by reference this MOU. FDA may enter into a contract, grant or cooperative agreement with UCLA to the extent authorized by law and available appropriations. The terms and conditions of any such awards or agreements will be in accordance with applicable federal law and regulations and shall be negotiated and executed by appropriate representatives of FDA and UCLA.

IV. Term, Termination, and Modification

This MOU shall remain in force for five (5) years from the date of the last signature. Either Party may terminate this MOU by providing ninety (90) days’ advance written notice to the other Party. The Parties may extend or renew this MOU by written amendment signed by each Party’s authorized signatory.

V. Additional Terms

No amendment of the terms of this MOU will be effective unless made in writing and signed by each Party’s authorized signatory. Each Party represents that the individuals signing this MOU have the authority to sign.

VI. General Provisions

Prior to initiating any specific activity or program, the Parties will negotiate and enter into an appropriate agreement, signed by each Party’s authorized signatory, describing the terms of the engagement, including but not limited to, financial commitments, academic freedom commitments, employment and compliance obligations and details of the exchange or collaborative relationship. This MOU is not intended to create any legally binding obligations on either institution but, rather, it is intended to facilitate discussions regarding general areas of cooperation.

A. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.

B. FDA and UCLA may decide to enter into Cooperative Research and Development Agreements (CRADAs) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.

C. The Parties will not, as a part of the activities covered by this MOU, share any non-public information, including (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7 (c) of the FOIA; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 USC 1905)), the Privacy Act (5 USC 552a), other Freedom of Information Act exemptions not mentioned above (5USC 552(v)), the Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191).

D. Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Either Party may restrict or limit access to its property and facilities at any time and for any reason. UCLA individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.

E. It is recognized that from time-to-time FDA and UCLA may share expenses. If research collaborations are developed, details regarding cost sharing will be agreed to in advance under other contractual mechanisms as appropriate and in compliance with all applicable federal requirements.

VII. Resource Obligations

This MOU represents the broad outline of the FDA and UCLA intent to collaborate in areas of mutual interest. All activities that may be undertaken by 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 agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU.

Liaison Officers:

A. For the University of California, Los Angeles (UCLA):

Representative for Technical and Programmatic Matters:

Individual's name: Dr. Guang Cheng
Organization: University of California, Los Angeles (UCLA)
Title: Professor of Statistics Univ of California, Los Angeles
Address: | 520 Portola Plaza 8125 Math Sciences Box 951554, Office: MS 8105H Los Angeles, CA 90095, Web site: http://statistics.ucla.edu
Telephone Number: 310-825-8430
Email: guangcheng@stat.ucla.edu

Representative for Contractual and Administrative Matters:

Individual Name: Yessenia Sarmiento
Organization: University of California, Los Angeles (UCLA)
Title: Contract & Grant Officer
Address: 10889 Wilshire Blvd., Suite 700 Los Angeles, CA 90095-1406
Telephone Number: 310-794-0393
Email: yessenia.sarmiento@research.ucla.edu

B. For the Food and Drug Administration:

Individual's name: Padmaja Mummaneni, PhD
Organization: Center for Drug Evaluation and Research, Office of Translational Sciences
Title: Senior Pharmacokineticist/Pharmacogenetisist, Contract Officer Representative (COR)
Address: 10903 New Hampshire Avenue White Oak Building 51, Room 2164 Silver Spring, MD 20993-0002
Telephone Number: 301-796-2027
Email: Padmaja.Mummaneni@fda.hhs.gov

Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing. If, at any time, 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.

VIII. 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 and UCLA, operate.

APPROVED AND ACCEPTED FOR US FOOD AND DRUG ADMINISTRATION

/s/
Dr. George Tidmarsh,
CDER Director, Center for Drug Evaluation and Research
Date: 10/20/2025

APPROVED AND ACCEPTED FOR THE UNIVERSITY OF CALIFORNIA, LOS ANGLES (UCLA)

/s/
Yessenia Sarmiento
Contract & Grant Officer
Date: 10/22/2025