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U.S. Department of Health and Human Services

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MOU: 225-11-0011

 

MEMORANDUM OF UNDERSTANDING
BETWEEN
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVI CES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUA TION AND RESEARCH
OFFICE OF PHARMACEUTICAL SCIENCE
OFFICE OF PHARMACEUTICAL ASSESSMENT
AND
THE UNIVERSITY OF WASHINGTON
 
I.  Purpose
 
The United States Food and Drug Administration (FDA) and the University of Washington (UW), an institution of higher education and an agency of the State of Washington having its principal campus located in Seattle, Washington FDA and UW share interests in promoting scientific progress through exchange of scientific capital in Applied Physics Research in understanding continuous processing and control in micro reactors. Both institutions foresee benefits from the mutual exchange of training and research expertise in understanding of feasibility of using micro reactors for drug substance synthesis. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through various 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 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 was ranked 14th of the top 92 academic rankings of the world's universities in 2010.  The UW maintains an outstanding climate of support for the UW researchers by broadly enabling stellar research advances to achieve excellence by the research community through:
 
·         Partnering with the research community 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 the UW research;
·         Developing strong relations with sponsors;
·         Enhancing the ability to perform research in a global community, and
·         Supporting strong infrastructure for interdisciplinary research.
 
III.  Substance of Agreement:
 
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and the UW. The types of initiatives expected to develop from this MOU include:
 
a.  Advancing student education and matriculation into the health, biomedical and applied science professions.  One of the mechanisms to enroll students, post-doctoral trainees and residents from the UW 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, Center for Drug Evaluation and Research and the UW will adhere to the CDER ORISE Fellowship rules.  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. 
b.Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
c. Opportunities to convene joint meetings for education and research;
d. Research collaborations;
e. Cooperative international initiatives, and
f. Access to unique facilities and equipment 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 comply 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 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 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 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. The UW individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
 
It is recognized that occasionally FDA and institutions within the UW 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 compliant with all applicable federal requirements.
 
V. Resource Obligations:
 
This MOU represents the broad outline of the FDA and the UW intend to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to available 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:
 
David Morley
U. S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Pharmaceutical Science
Office of New Drug Quality Assessment
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Telephone: 301-796-1719
Fax: 301-796-9748
Email: David.Morley@fda.hhs.gov   
 
The individual to whom all technical inquiries to the UW should be addressed is:
 
Brian J. Marquardt Ph.D.
Research Professor and Senior Engineer
Applied Physics Laboratory
University of Washington
Seattle, Washington 98105
Phone: 1.206.685.0112
Fax: 1.206.616.3463
Email: marquardt@apl.uw.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
206-543-4043
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 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-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
Signed by: Peggy L. Hartman
Grant and Contract Administrator
Office of Sponsored Programs
Date: March 24, 2011
Approved and Accepted
for the Food and Drug Administration
Signed by: Janet Woodcock, MD
Director, CDER, FDA
Date: April 4, 2011