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MOU 225-07-8405

Memorandum of Understanding

Between
U.S. Department of Health and Human Services
The Food and Drug Administration
Office of the Chief Scientist 

And

The University System of Maryland

 

I. Purpose

The United States Food and Drug Administration (FDA) and the University System of Maryland (USM) (the Parties) have a shared interest in scientific progress in the diverse disciplines that directly and indirectly affect human and animal health and medicine. The Parties also endorse scientific training for faculty, students and staff to foster a well-grounded foundation in interdisciplinary fields in which academia and government share mutual interest. 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 research, public outreach, extension activities, cooperative international initiatives, disciplinary training, and exchange of scientists and staff, including sabbaticals, postdoctoral fellowships, and student internships.  

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, and medical devices and the safety and security of foods, dietary supplements, cosmetics, and radiological products. 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 communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships with USM will greatly contribute to FDA’s mission. FDA’s Centers and Offices are described in Appendix A.

USM is one of Maryland’s most valuable assets and adds immeasurably to the quality of life in the state and beyond. The nation's 12th largest university system, USM's network of 12 institutions (Appendix B) enrolls nearly 130,000 students worldwide in 600 degree programs delivered in classrooms, laboratories, education centers, and online. The USM's nationally ranked programs, leading-edge research collaborations, and innovative business partnerships provide an environment to support diverse multidisciplinary exchanges with FDA. The scientific, public health and policy expertise within FDA provide opportunities for collaborations that support the USM mission and strategic themes to provide access to high-quality education, research discovery, and knowledge-based services responsive to both the promises and demands of the state and the nation in the new century.

III. Substance of Agreement

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

  1. Identification and convening of a steering committee to guide a process for scientific and intellectual collaborations, outreach, and education initiatives.
  2. Personnel exchanges between university faculty and staff and FDA’s scientists and staff as permitted by the Intergovernmental Personnel Act;
  3. Opportunities to apply for a joint fellowship program at the FDA to advance student and faculty education. One mechanism to enroll students/post-doctoral trainees/residents from USM into a joint fellowship program at FDA may be through the Oak Ridge Institute for Science and Education (ORISE) fellowship program. If prospective fellows or faculty enter the program through the ORISE fellowship mechanism, FDA and the USM will adhere to the respective Agency Centers’ ORISE fellowship rules and regulations. Fellows or faculty members entering the program must agree to the ORISE terms of the appointment which will be outlined in an offer of appointment letter;
  4. Educational opportunities for qualified students (graduate and undergraduate), staff members, and faculty members in the Parties’ laboratories, classrooms, clinical settings and offices;
  5. Opportunities for FDA personnel to serve as adjunct faculty, advisory board members, and dissertation advisors at USM;
  6. Joint meetings for education and research;
  7. Research collaborations;
  8. Cooperative international activities including outreach;
  9. Sharing of unique facilities and equipment for increased results and cost efficiencies for scientific endeavors; and
  10.  Development of regular workshops where faculty from USM and FDA’s scientists and staff share information about ongoing research, education, extension, and outreach efforts of mutual interest.

A. FDA agrees to:

For programs agreed to in writing, and in advance by both parties, FDA may, as permitted by applicable statutes and regulations and subject to the availability of funds, and as it deems appropriate, offer USM the following:

  1. Laboratory and/or office space in support of activities under this agreement.
  2. Access to facilities and equipment, including necessary training and guidance, in so far as such use does not interfere with the primary mission of either party
  3. Active participation in establishing collaborative research, education, extension and outreach efforts with faculty, students, and staff within USM institutions.
  4. Willingness to participate in courses and seminars within USM, based on availability of resources.
  5. Continuing and frequent communication with faculty and staff.
  6. Openness and welcome to faculty, staff, and students wishing to visit FDA laboratories.
  7. Promulgation and communication of identified collaborative efforts through appropriate means.

B. University System of Maryland agrees to:

For programs agreed to in advance by both parties, USM may offer FDA the following: 

  1. Laboratory and/or office space in support of activities under this agreement at identified institutions.
  2. Access to facilities and equipment, including necessary training and guidance, in so far as such use does not interfere with the primary mission of either party.
  3. Active participation in establishing collaborative research, education, extension and outreach efforts with FDA scientists and staff.
  4. Continuing and frequent communication with FDA scientists and staff.
  5. Openness and welcome to FDA scientists and staff wishing to visit relevant USM programs and laboratories.
  6. Promulgation and communication of identified collaborative efforts through appropriate means.
  7. Adjunct, affiliate and research faculty appointments for appropriate FDA professional staff, provided that appointment of such candidates will advance specific programmatic objectives of the parties as appropriate, and provided that such appointments comply with university policies on appointment of faculty/affiliates.

C. It is mutually agreed that:

In an effort to enhance collaborative interactions and communication between both institutions, FDA and USM will collaborate in the development of regular workshop where faculty from all the institutions within the USM and FDA scientists and staff share information about on going research, education, extension, and outreach efforts of mutual interest.

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 USM and FDA may decide to enter into supplemental agreements that may include contracts, grants or cooperative research and development agreements (“CRADA”) between FDA and USM to the extent authorized by law and available appropriations. The terms of such supplemental agreements will address Intellectual Property rights. The terms and conditions of any Supplemental Agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within the USM and FDA.
  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. UMS 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 USM 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 federal requirements.

V. Resource Obligations

This MOU represents the broad outline of the FDA and USM 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. Contacts

A. For the University System of Maryland:

Brian Darmody
Associate Vice President for Research and Economic Development
University System of Maryland
2133 Lee Building
College Park, Maryland 20742
301-405-1990 301-405-8386 (fax)
bdarmody@umd.edu 

B. For the Food and Drug Administration:

Eileen Parish, MD
Senior Advisor for Scientific Professional Development
Office of Scientific Professional Development/Office of the Chief Scientist
Office of the Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
301-796-8522
Eileen.parish@fda.hhs.gov

Each Party may designate new contacts at any time by notifying the other Party's contact in writing. If, at any time, an individual designated as a contact under this agreement becomes unavailable to fulfill those functions, the Parties will name a new contact within 2 weeks and notify the other Party through the designated contact. 

VII. Term, Termination, and Modification

This agreement, when accepted by all partners, will have an effective period of performance from the date of the latest signature until five years (5) and may be modified or terminated by mutual written consent the partners 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, USM, and the institutions within USM operate.

Appendix A

FDA Centers/Offices

The U.S. Food and Drug Administration (FDA) is comprised of six product-oriented centers and a nationwide field force. FDA is a scientific regulatory agency responsible for the safety of the nation's domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products. It is one of the oldest federal agencies whose primary function is consumer protection. The agency touches and directly influences the lives of everyone in the United States. FDA is recognized internationally as the leading food and drug regulatory agency in the world. Many foreign nations seek and receive FDA's help in improving and monitoring the safety of their products. FDA is part of the Executive Branch of the United States Government within the Department of Health and Human Services (DHHS) and the Public Health Service (PHS).

FDA Centers/Offices include:

Office of the Commissioner (OC)
OC is committed to providing the overall scientific and regulatory policies for the entire agency, including special FDA initiatives. OC includes the Immediate Office, the Office of Women’s Health, Office of Minority Health, Office of the Chief of Staff, Office of Policy, Planning and Budget, Office of Legislation, Office of Administration, Office of International Programs, Office of Equal Opportunity and Diversity Management, Office of the Chief Counsel, Office of the Counselor to the Commissioner, Office of Special Medical Programs, Office of External Affairs, Office of Regulatory Affairs, Office of Foods, and the Office of the Chief Scientist.

Center for Biologics Evaluation and Research (CBER)
CBER is committed to advancing the public health through innovative regulations that ensure the safety, effectiveness and timely delivery to patients of biological products. CBER protects and enhances public health through regulating biological and related products including blood, vaccines, tissue, allergenic and biological therapeutics. 

Center for Drug Evaluation and Research (CDER)
CDER is committed to promoting and protecting public health by assuring that safe and effective drugs are available to Americans. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. 

Center for Devices and Radiological Health (CDRH)
CDRH assures that new medical devices are safe and effective before they are marketed. The Center also monitors devices throughout the product life cycle, including a nationwide post market surveillance system, and assures that radiation-emitting devices meet radiation safety standards. 

Center for Food Safety and Applied Nutrition (CFSAN)
CFSAN and the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. 

Center for Veterinary Medicine (CVM)
CVM is a consumer protection organization that fosters public and animal health by approving safe and effective products for animals and by enforcing other applicable provisions of the Federal Food, Drug, and Cosmetic Act and other authorities. 

Center for Tobacco (CTP)
CTP is responsible for planning, managing, directing and coordinating major tobacco program objectives to support the Family Smoking Prevention and Tobacco Control Act. This law gives FDA authority over tobacco products by adding a new chapter to the Food, Drug and Cosmetic Act for tobacco products and reinstating the 1996 final rule. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions. The law gives FDA the authority to regulate tobacco products and manufacturers - not growers.

National Center for Toxicology Research (NCTR)
NCTR conducts peer-reviewed scientific research that supports and anticipates the FDA's current and future regulatory needs. This involves fundamental and applied research specifically designed to define biological mechanisms of action underlying the toxicity of products regulated by the FDA. This research is aimed at understanding critical biological events in expressing toxicity and at developing methods to improve assessment of human exposure, susceptibility and risk. 

Office of Regulatory Affairs (ORA)
ORA is the lead office for all Field activities of the Food and Drug Administration including inspection of food, feed, and medical product manufacturing, transport and storage facilities for compliance with exiting law; as well as enforcement activities, It includes the Office of Criminal Investigations.

Appendix B

Institutions within the University System of Maryland (USM)

The University System of Maryland (USM), a public corporation, is one of the State's most valuable assets. The nation's 12th largest university system, the USM's network of 12 institutions enrolls nearly 130,000 students worldwide in 600 degree programs delivered in classrooms, laboratories, education centers, and online. The USM's nationally ranked programs, leading-edge research collaborations, and innovative business partnerships provide opportunities that support the USM mission and the goals of the USM Strategic Plan as they prepare students for both the promises and demands of the new century.

University System of Maryland institutions include:

  1. Bowie State University
  2. Coppin State University
  3. Frostburg State University
  4. Salisbury University
  5. Towson University
  6. University of Baltimore
  7. University of Maryland, Baltimore
  8. University of Maryland, Baltimore County
  9. University of Maryland, College Park
  10. University of Maryland Eastern Shore
  11. University of Maryland University College
  12. University of Maryland Center for Environmental Science

Approved and Accepted
for the University System of Maryland

Signed by: William E. Kirwan, Ph.D.
Chancellor, University System of Maryland

Date: July 2, 2012

Approved and Accepted
for the Food and Drug Administration

Signed by: Jesse L. Goodman, M.D., MPH
Chief Scientist

Date: July 3, 2012