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  1. FDA Memoranda of Understanding

MOU 225-17-002

MOU 225-17-002

MEMORANDUM OF UNDERSTANDING
BETWEEN U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF TRANSLATIONAL SCIENCES
OFFICE OF CLINICAL PHARMACOLOGY AND
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
SAN FRANCISCO CAMPUS
DEPARTMENT OF BIOENGINEERING AND THEREAPEUTIC SCIENCES

 
I.  Purpose
 
The United States Food and Drug Administration (FDA) and The Regents of the University of California, on behalf of its San Francisco campus (UCSF) and UCSF’s, Department of Bioengineering and Therapeutic Sciences ( collectively, “the Parties”) share interests in promoting scientific progress through exchange of scientific capital in Clinical Pharmacology Training and Research Programs. Both institutions foresee benefits from the mutual exchange of training and research expertise in clinical pharmacology and translational science. This Memorandum of Understanding (MOU) establishes the terms 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). In fulfilling its responsibilities under the Act, FDA among other things, directs its activities toward promoting and protecting 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. 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. Increased development of research, education, and outreach collaborations with UCSF will greatly contribute to FDA's mission. UCSF's Department of Bioengineering and Therapeutic Sciences, housed within the School of Medicine and the School of Pharmacy, has been ranked as one of the top three world universities in the broad subject fields of clinical medicine and pharmacy in the 2010 Academic Ranking of World Universities (ARWU). Through its education, research, and service program, the School of Pharmacy focuses on organization, delivery, and financing by preparing regulatory scientists with the knowledge needed to improve drug development and drug regulatory systems. UCSF is one of the world's leading biomedical research institutions, producing a steady stream of scientific knowledge and clinical achievements. The creation of new knowledge and making such knowledge available in the world of health care (through education and technology transfer) are at the core of UCSF's mission. Through this training and research program, FDA will gain knowledge of top-notch bench science, and through mutual exchange of new knowledge and collaboration, we can effectively translate research findings to the bedside in order to benefit the public health.
 
III. Substance of Agreement
 
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and UCSF. The types of initiatives expected to develop from this MOU include:
  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 UCSF into the joint fellowship program at the FDA is through the CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbatical may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE fellowship program mechanism, the Office of Clinical Pharmacology and USCF will adhere to the CDER ORISE Fellowship rules and regulations. 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.
  2. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
  3. Opportunities to convene joint meetings for education and research;
  4. Research collaborations;
  5. Cooperative international initiatives; and
  6. Access to unique facilities and equipment for scientific endeavors.
Under this MOU, joint efforts to effectuate the above activities or to obtain grants and other extramural funds to support collaborative research and training will be in compliance with appropriate statutory authority and the policies and procedures of each Party.
 
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 UCSF to the extent authorized by law and available appropriations. The terms and conditions of any such awards will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within UCSF and FDA.
 
IV. General Provisions
  1. 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.
  2. Institutions within UCSF and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address intellectual property rights.
  3. Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.
  4. 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. UCSF individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations. FDA individuals participating in activities under this MOU on UCSF property will comply with all applicable laws, regulations and UCSF policy.
  5. It is recognized that from time to time FDA and institutions within UCSF will be sharing in expenses and may require compensation of either Party by the other. As research projects are developed, details of how costs are to be shared will be agreed to in advance under other contractual mechanisms, as appropriate, and in compliance with all applicable laws and regulations and UCSF policies and procedures. 
V. Resource Obligations
 
This MOU represents the broad outline of the FDA and UCSF's 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 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.
 
VI. Liaison Officers
 
FDA's Center for Drug Evaluation and Research (CDER) is the lead center for this MOU. The individual to whom all inquiries to FDA should be addressed is:
  • Padmaja Mummaneni, Project Specialist
    Food and Drug Administration
    10903 New Hampshire Avenue
    White Oak 51 Room 2164
    Silver Spring, MD 20993
    Tel: 301-796-2027 Fax: 301-847-8720
    Padmaja.Mummaneni@fda.hhs.gov
The individual to whom all inquiries to UCSF should be addressed is:
  • Kathy Giacomini, Ph.D.
    University of California, San Francisco
    Schools of Pharmacy and Medicine
    Department of Bioengineering and Therapeutic Sciences
    1550 4th Street, Room 584
    San Francisco, CA 94143
    Kathy.Giacomini@ucsf.edu
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.
 
VII. Term, Termination, and Modification
 
This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years. It may be renewed by mutual written agreement of both Parties. It may be modified at any time by mutual written agreement of both Parties. It may be terminated by either Party upon 60-days 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 under which FDA and UCSF operate.
 
Approved and Accepted for the Regents of the University of California,
San Francisco Campus, Office of Sponsored Research
Government and Business Contracts
 
September 21, 2016
 
Approved and Accepted for the University of California,
San Francisco School of Pharmacy
Dean's Office
 
 September 19, 2016
  
Approved and Accepted for the University of California,
San Francisco Department of Bioengineering and Therapeutic Sciences
 
 September 12, 2016
 
Approved and Accepted for the Food and Drug Administration
 
October   9, 2016