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MOU 225-07-1001

Memorandum of Understanding

Yokahama City University 


The U.S. Food and Drug Administration Center for Biologics Evaluation and Research


I. Purpose:

The purpose of this MOU is to establish terms of collaboration between the Food and Drug Administration (FDA)'s Center for Biologics Evaluation and Research (CBER) and Yokohama City University in CBER's Collaborative Scientific Training Program (CSTP)

II. Overview:

Realizing the promise of innovative, complex biological medical products depends on moving new discoveries to the marketplace as safe and effective, quality products that provide preventative, therapeutic and diagnostic benefits to persons in need. The Critical Path Initiative of the U.S. Food and Drug Administration (FDA) targets development of scientific tools for evaluating products arising from established technologies and those arising from new biomedical discoveries and novel technologies. CBER established the CSTP to create collaborative scientific research and training partnerships and other associations that will help advance FDA's Critical Path Initiative and help realize the goal of turning new laboratory discoveries into safe, effective and affordable treatments.


The CBER CSTP recognizes the global nature of medical product innovation and manufacture and was developed to engage national and international institutions, experts and trainees in scientific collaborations with CBER scientists. CSTP partnerships will advance the scientific interests shared by each institution while pursuing each institution's individual and independent missions. Potential partners include academic institutions, international regulatory authorities, U.S. government agencies, non-profit organizations, and others. CSTP partners will create collaborative scientific interdisciplinary teams to focus on developing scientifically-based strategies that develop the scientific expertise needed to evaluate new biomedical products and that can remove or minimize hurdles to approving complex biological products. The Program will encourage the unrestricted dissemination of information that may aid product development and that will provide the scientific knowledge, expertise, and tools needed to evaluate and regulate new and existing biological medical products.


To engage the CSTP, CBER and a Collaborator Institution implement an inter-organizational memorandum of understanding (MOU) or similar documentation of intent to create a CSTP Partnership. Under the CSTP umbrella, projects or activities will be proposed and established using existing FDA mechanisms for implementing formal collaborations. Collaborations will be tailored to address specific CBER and Collaborator Institution needs and goals. Projects and activities could consist of scientific research or training; participation in planning meetings, presenting at conferences, workshops and symposia; advising consensus standard-setting groups; and other collaborative opportunities. Participating personnel may include recognized experts, established scientists, post-doctoral fellows, research trainees, and pre or post baccalaureate student interns.

Direct all CSTP inquiries to your CBER colleagues or to Dano B. Murphy, J.D., Telephone: 301-827-0801; email: dano.murphv@fda.hhs.gov.

III. Substance of the Agreement

Whereas, the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration has established the Collaborative Scientific Training Program (CSTP) to engage in collaborative scientific research and training that advances the Scientific interests shared by CBER and partner organizations while pursuing their individual and independent missions;

Whereas, CSTP Collaborations will promote the objectives of CBER to remain at the Forefront of biological product evaluation and regulation and further the pursuit of FDA's. Critical Path goals (http://www.fda.gov/oc/initiatives/criticalpath) to bring new Laboratory discoveries to market as safe, effective and affordable treatments;

Whereas, CBER and YOKOHAMA CITY UNIVERSITY wish to address important Public health and biological product issues by optimally employing their respective Strengths, expertise and resources by engaging in mutually beneficial collaborative Scientific research and training,

Whereas, CBER and YOKOHAMA CITY UNIVERSITY seek to create an Administrative structure for conducting anticipated collaborative scientific research and Training and for sharing the outcomes and knowledge of such collaborations,

Now, CBER and YOKOHAMA CITY UNIVERSITY agree to establish a Collaborative Scientific Training Program Partnership as described in the Program Description of the Collaborative Scientific Training Program (Version: DECEMBER2006),

Now, duly authorized representatives of CBER and YOKOHAMA CITY UNIVERSITY Indicate their agreement by signing below.

This Memorandum of Understanding (MOU) is entered into by the Center for Biologics Evaluation and Research (CBER), U.S. Food and Drug Administration (FDA), Bethesda, Maryland and the Collaborator Institution, YOKOHAMA CITY UNIVERSITY, Yokohama, Japan, to establish a Collaborative Scientific Training Program Partnership. Each collaborative scientific project pursued by the parties to this agreement will be Described in a Project and Activity Plan agreed to by CBER and YOKOHAMA CITY UNIVERSITY.


IV. Term of the Agreement:

This Memorandum of Understanding (MOU) shall become effective for a term of three (3) years beginning the date it is fully executed on the signature page below by Authorized representatives of CBER and Collaborator Institution. Thereafter, this MOU maybe renewed as desired by the parties unless CBER or Collaborator Institution provides written notice of intent to terminate. Between the time of giving of notice of termination and its effective date, the parties agree to work together to effect a harmonious disengagement of joint activities.


IN WITNESS WHEREOF, the parties have executed this Memorandum of Understanding as of the day and year last below written.

Approved and Accepted for Yokohama City University

Signed by: Bruce Stronach, Ph.D., President

Date: December 21, 2006

Approved and Accepted for the Food and Drug Administration

Signed by: Kathryn M. Carbone, M.D. Associate Director for Research

Date: December 21, 2006