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  1. FDA Memoranda of Understanding

MOU 225-15-013 Amendment 1

MOU 225-15-013 Amendment 1

Memorandum of Understanding between the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology and the University of California, San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences

I. Purpose

The United States Food and Drug Administration (FDA) and University of California, San Diego, share interests in promoting scientific progress through knowledge exchange of scientific capital in pharmacology and translational research.  This Memorandum of Understanding (MOU) establishes the framework for collaboration to promote these shared interests, which can be pursued through a variety of programs, including collaborative education and research.

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, promotes and protects the public health by ensuring 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 also communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships with University of California, San Diego will greatly contribute to FDA’s mission.

University of California, San Diego is a non-profit, public research and teaching institution covering almost all scientific disciplines. University of California, San Diego has several research groups, one of which focuses on pediatric clinical pharmacology. University of California, San Diego is engaged in a series of research programs to expand knowledge of biological systems and their application to medicine.  FDA and University of California, San Diego have a mutual interest in collaborating and effectively translating research findings to the bedside to benefit the public health.  

III. Substance of Agreement

This MOU forms the basis for the development of scientific collaborations, outreach and educational initiatives, and intellectual partnerships between FDA and University of California, San Diego.  The types of initiatives expected to develop from this MOU include, but are not necessarily limited to, the following:

  1. Advancing student education and matriculation into the health and biomedical science professions.  One of the mechanisms to enroll students/post-doctoral trainees/residents from University of California, San Diego in the joint fellowship program at the FDA is through the Center for Drug Evaluation and Research’s (CDER) Oak Ridge Institute for Science and Education (ORISE) fellowship program.  Faculty sabbaticals may also be covered under ORISE.  If prospective fellows or faculty members enter the program through the ORISE mechanism, the Office of Clinical Pharmacology and University of California, San Diego intend to adhere to the CDER ORISE fellowship rules and regulations. Fellows or faculty members entering the program should be prepared to adhere to the term of appointment, which will be outlined in an offer of appointment letter. 
  2. Opportunities to convene joint meetings for education and research;
  3. Research collaboration;
  4. Cooperative international initiatives; and
  5. Access to unique facilities, patient populations and equipment for scientific endeavors.

Under this MOU, FDA and University of California, San Diego intends to seek opportunities to participate together in collaborative research and training, as permitted under appropriate statutory authority.  Before any specific collaboration is initiated or implemented, the Participants intend to identify priorities and topics of mutual interest and develop separate, written arrangements for collaboration and resource-sharing.   The Participants intend that, when applicable, these arrangements incorporate by 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 U.S. Government patent regulations and any other applicable statutes and regulations.
  2. University of California, San Diego and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) for specific collaborative projects.  The terms of such CRADAs will address Intellectual Property rights.
  3. Proprietary and/or nonpublic information may not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality and disclosure arrangements, or except to the extent that such disclosure is permitted by U.S. federal law.
  4. Each Participant will comply with the other Participant’s security procedures and policies regarding access to and use of facilities.  Either Participant may restrict or limit access to its property and facilities at any time and for any reason.  The Participants intend that individuals participating in activities under this MOU on FDA property comply with applicable U.S. federal law.
  5. It is recognized that from time to time, FDA and University of California, San Diego may share expenses and may request compensation to one Participant by the other.  The Participants intend that, as research projects are developed, details of how costs are to be shared shall be agreed to in advance under appropriate contractual mechanisms and in compliance with all applicable U.S. federal requirements.

V. Resource Obligations: 

This MOU represents the broad outline of the intent of FDA and University of California, San Diego to collaborate in areas of mutual interest.  It does not create binding, enforceable obligations against any Participant.  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 agreements or arrangements among the Participants and does not affect the ability of the Participants to enter other agreements or arrangements related to this MOU. 

VI. Liaison Officers:

A. For the University of California, San Diego

Gene Hasegawa
Associate Dean, UC San Diego Health Sciences
9500 Gilman Drive, MC 0602
La Jolla, CA  92093-0062

B. For the U.S. Food and Drug Administration

Yeruk (Lily) Mulugeta
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Tel: 301-796-3162|
yeruk.mulugeta@fda.hhs.gov

Each Participant may designate new liaisons 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, the Participant previously represented by that individual should name a new liaison within two (2) weeks and notify the other Participant through the designated administrative liaison.

VII. Term, Termination, and Modification

This MOU, when accepted by both Participants, will be effective for three (3) years starting on the date of the last signature.  It may be modified or terminated by mutual written consent of the Participants or may be terminated by either Participant upon 60-days written notice to the other.

VIII. Statutes, Regulations, Rules, and Policies

This MOU and all associated arrangements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and the institutions within University of California, San Diego operate.

Approved and Accepted for University of California, San Diego

/s/

Gene Hasegawa
June 30, 2015

Approved and Accepted for the Food and Drug Administration

/s/

Janet Woodcock, MD
Director, Center for Drugs and Evaluation Research
May 26, 2015

Amendment 1

This is an amendment to the Memorandum of Understanding MOU Number 225-15-013 dated June 30, 2015.  This modification is to extend the termination date to June 30, 2021. This amendment is permissible under Article VII. Term, Termination, and Modification of the MOU.

All other terms, conditions, and content of the MOU Number 225-15-013, executed on June 30, 2015, remain unchanged.

Approved and Accepted Food and Drug Administration

/s/
 
Janet Woodcock, Director   
Center for Drug Evaluation and Research

May 1, 2018

Approved and Accepted University Of California, San Diego Skaggs School Of Pharmacy And Pharmaceutical Sciences

/s/

Gene Hasegawa, Chief Operating Officer
University of California at San Diego, Health Sciences

May 8, 2018