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  1. FDA Memoranda of Understanding

MOU 225-17-024

MOU 225-17-024

MEMORANDUM OF UNDERSTANDING BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH AND
THE UNIVERSITY OF WASHINGTON SCHOOL OF PHARMACY

I. Purpose

The United States Food and Drug Administration (FDA) and the University of Washington (UW) School of Pharmacy (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) and the collaborative framework it provides will facilitate existing and new mutually agreed upon programs and activities and 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, et seq.). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward 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. 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 partnerships within the UW will contribute to FDA's mission.

The UW's vision is to be the global leader in pharmacy education, research and service, and is committed to providing a transformative learning experience in a collaborative and diverse environment focused on improving the health and well-being of the communities it serves, through

  • Partnering with the local and national research communities to create a culture of high achievement;
  • Promoting shared responsibility, the ethical conduct of research, and compliance; Enhancing researchers' abilities to obtain and manage grants;
  • Investing strategically in promising research and researchers;
  • Creating integrated services, transparent research administration, infrastructure, and streamlined processes;
  • Advocating for the needs of the UW research community;
  • Broadening awareness of the value of UW research;
  • Developing strong relations with research sponsors;
  • Enhancing the ability to perform research in a global community, and
  • Supporting strong infrastructure for interdisciplinary research.

Ill. Substance of Agreement:

This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and UW. The types of activities expected to be pursued under t his MOU may include, but are not limited to the following:

1. Opportunities to apply for fellowship programs at the FDA to advance UW student and faculty education and matriculation into the health and biomedical sciences. The Oak Ridge Institute for Science and Education (ORISE) fellowship program is one of the mechanisms that can be used by CDER to bring student s/ post -doctoral candidates/faculty from UW to the FDA.
a. Fellows or faculty members entering the program must agree to adhere to the ORISE terms of appointment which will be outlined in an ORISE offer of appointment letter;
b. Faculty sabbatical may be covered under ORISE if applicable. If prospective fellows or faculty members enter through the ORISE fellowship program, the FDA and UW will adhere to the CDER ORISE Fellowship requirements as well as any agency-wide ORISE requirements.

2. Personnel exchanges between university y faculty, staff, and FDA's scientist s and staff as permitted by the Intergovernmental Personnel Act;

3. Opportunities for both Parties to convene joint meetings for education and research;

4. Research collaborations; and

5. Access for each Party to unique facilities and equipment of either Party for scientific endeavors.

Under this MOU, joint efforts will be undertaken to obtain extramural funds 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 a contract, grant or cooperative agreement with the UW 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 the UW and FDA.

IV. General Provisions:

1. Rights to any invention s resulting from collaborative research will be determined by the separate written research agreements governing the effort, and will comply with current U.S. Government patent regulations and any other applicable statutes and regulations.

2. Institutions within the UW and FDA may decide to enter 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 permitted by law and is governed by appropriate confidentiality disclosure agreements.

4. Each Party will comply with the other Part y'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. UW individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.

5. It is recognized that from time to time FDA and institutions within UW will be sharing in expenses and may require compensation of either Party by the other. As research project s are developed, details of how costs are to be shared will be agreed to in advance under other mechanisms as appropriate and in compliance with all applicable federal requirements.

6. As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.

V. Resource Obligations:

This MOU represents the broad outline of the FDA and the UW 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.

VI. Liaison Officers:

A. FDA's Office of Clinical Pharmacology, Offices of Translational Sciences in the Center for Drug Evaluation and Research (CDER) is the sponsoring office for t his MOU. The individual to whom all inquiries to FDA should be addressed is:

Individual's name: Padmaja Mummaneni, PhD
Organization: Center for Drug Evaluation and Research, Office of Translational Sciences, Office of Clinical Pharmacology
Title: Consumer Safety Officer, Regulator y Health Project Manager, 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

B. The individual to whom all technical inquiries to the UW should be addressed is: Individual's name: Andy Stergachis, Ph. D., BPharm
Professor of Pharmacy & Global Health
Associate Dean, School of Pharmacy
 

Director, Global Medicines Program
University of Washington, H-362B Box 357631 Seattle, Washington 98195-7631
Telephone Number: 1.206.221.0703
Fax: 1.206.685.9297
Email: st ergach@u w.edu

The office for all administrative inquiries to the UW is: Office of Sponsored Programs
4333 Brooklyn Ave NE, Box 359472
Seattle, WA 98195-9472
Telephone Number: 206-543-4043 Email: osp@uw.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, when accepted by all Parties, will have an effective period of performance from the date of the latest signature and continuing for a period of five years and may be modified or terminated by mutual written consent of the parties or may be terminated by either Partner(s) upon a 60-day 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, the UW and the institutions within the UW operate.

Approved and Accepted for the University of Washington  
/s/
Signed by: Chrishalodebany Jackson Grant and Contract Administrator
Office of Sponsored Programs
Date: September 19, 2017

Approved and Accepted for the Food and Drug Administration
/s/
Signed by: Janet Woodcock, M.D. Director, CDER, FDA
Date: September 26, 2017