MEMORANDUM OF UNDERSTANDING
THE STATE OF ARKANSAS AND THE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
This Memorandum of Understanding ("MOU") is made and entered into as of the 31st of August, 2016, by and between the United States Food and Drug Administration ("FDA"), and the State of Arkansas ("State"). Each FDA and the State of Arkansas is referred to individually as a "Party" and collectively as the "Parties."
A. 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 directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, 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, support activities to speed access to needed, safe, therapeutics to improve public health, provide training in areas of regulatory science and communicate with stakeholders about complex scientific and public health issues. FDA's centers and offices are more fully described in Appendix A.
B. Under the preceding MOU in effect between August 2011 and August 2016, the State of Arkansas established a virtual Arkansas Center of Excellence in Regulatory Science (ACERS) coordinated through the Governor's Office. The contributions from the State will continue and will be organized and administered by the Arkansas Research Alliance (ARA) in association with the Arkansas Economic Development Commission (AEDC), a State agency under the Governor's direction. The support and work of the ACERS are derived primarily from the University of Arkansas for Medical Sciences (UAMS), working in collaboration with the State's other universities and institutions. UAMS is an internationally recognized academic medical center with a three-part mission of research, teaching and patient care coordinated across the entire state. UAMS has enjoyed a 45-year history with
FDA's National Center for Toxicological Research (NCTR), including collaborative research and cooperative training of doctoral students and post-doctoral fellows. Additionally, the State brings the resources of the University of Arkansas at Little Rock (UALR), University of Arkansas at Pine Bluff (UAPB), University of Arkansas, Fayetteville (UAF), Arkansas State University (ASU), and the Arkansas Department of Health (ADH). There are also numerous research-related programs within the State whose programs will be shared and coordinated with work under this
Agreement to assure that areas of potential collaboration are coordinated. These programs include the Arkansas Biosciences Institute, programs managed by the Arkansas Economic Development Commission such as the Arkansas EPSCoR (Experimental Program to Stimulate Competitive Research) and IMBRE (IDeA Networks of Biomedical Research Excellence), and other programs related to the State's research programs. NCTR has historically enjoyed productive collaborations, to differing extents, with each of these State institutions.
C. FDA and Arkansas share interests in scientific progress in general, in the diverse disciplines that directly and indirectly affect human and animal health and medicine, and in particular to those related to bioinformatics and other computational disciplines. As Arkansas has focused its efforts on building on the excellence within the State in the areas of computational science, the Parties agree to optimize that excellence to the mutual benefit of the Parties. The Parties 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.
D. FDA and the State of Arkansas desire to enter into an amended MOU to set forth a framework for a continued formal working relationship between FDA and the State. Both entities understand the importance of partnerships that leverage resources and are more effective than each entity operating in isolation. The MOU is intended to leverage the Parties' combined strengths, resources, and proximity for stimulating research and innovation in regulatory science, education, and training within the scope of FDA mission and the broad academic and larger health and welfare charge of Arkansas's institutions. The activities described are focused to align with the mutual interests of the two Parties to modernize regulatory sciences with the intent to speed safer products to market and thus reduce post-marketing failure, continue to develop and refine bioinformatics tools, increase the understanding of toxicity of nanotechnology-based products, and promote education at the graduate level and to the public and increase the knowledge base available for excellence and greater productivity in these areas.
E. This MOU will, as described more fully below, be implemented when appropriate, by formal procurement instruments. In addition, collaborative Supplemental Agreements will be developed to cover specific additional collaborations as qualified by Article IV.C. FDA has statutory authority to enter into such agreements, including, inter alia, authority provided by sections 746 and1003 of the Federal Food, Drug, and Cosmetic Act (21 USC 3791 and 393). The specific authority for each such collaboration will be recited in any Supplemental Agreement covering that collaboration. (See also Article IV General Provisions, section D.)
III. SUBSTANCE OF AGREEMENT
A. Areas of Collaboration. This MOU forms the basis for development of scientific and intellectual collaborations, outreach and educational initiatives between FDA and the State of Arkansas. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. The types of activities expected to develop from this MOU include, but are not limited to the following:
1. Provide direction and coordination of the ACERS through a Steering Committee co-chaired by the NCTR Director and the President & CEO of ARA to optimize the capabilities ofthe NCTR researchers and those at the institutions of higher education, with particular focus on:
a) FDA regulatory concerns that provide for collaboration on mutually identified areas of scientific research and processes, including:
2. Clinical trials
3. Precision medicine
iii. Cancer, particularly as it relates to bioinformatics and nanomaterials
iv. Other areas identified by an Academy of ARA Scholars and Fellows in conjunction with NCTR that provide opportunities for collaboration and progress
b) Identifying and developing mutually agreed upon means of sharing scientific capabilities and resources available within ACERS that would improve and/or speed the attainment of results.
c) Conducting an annual review between the State and FDA in which FDA provides feedback to ARA in terms of activities that would be more beneficial and how ACERS can be optimally effective in accomplishing FDA goals.
d) Working to strengthen the Arkansas Bioinformatics Consortium (ARBIC), thereby, building its value to NCTR and FDA research priorities.
e) Encouraging FDA personnel to serve as adjunct faculty, advisory board members and dissertation advisors on the higher education campuses.
f) Encouraging exchanges between faculty and staff from Arkansas universities and State employees and FDA scientists and staff, as permitted by the Intergovernmental Personnel Act.
g) Sharing unique or otherwise needed equipment and facilities for improved results and cost efficiencies in research endeavors.
h) Hosting regular workshops among ACERS participants where FDA and university researchers share the results of their work.
i) Hosting joint meetings for education and research as needed in individual areas, and with no less than one formal meeting per year between the Parties to assess progress, establish priorities, and agree on future activities and resource sharing.
j) Providing educational opportunities for qualified students (graduate and undergraduate), staff, and faculty members in the Parties' laboratories, classrooms, clinical settings, campuses, and offices.
k) Participating in cooperative international activities, e.g., consensus meetings on regulatory science and innovation.
l) Continuing to develop programs with local, state and regional support, to identify non-commercialized technologies with potential public health benefits followed by development, testing, validation, approval and introduction of those technologies for public benefit through approved FDA guidelines.
m) Coordinating programs to facilitate dialogue between the Parties and the private sector for feedback and cooperation in technology and research directions. Specifically, Arkansas will, through the ARA Academy of
Scholars and Fellows:
a. Increase collaboration with NCTR researchers through the ARA's interaction with FDA stakeholders, hosting programs, such as an annual symposium, in order to highlight FDA research programs in order to identify additional areas of collaboration.
b. Interact with FDA stakeholders, to gain access to and understanding of stakeholder priorities as specifically, but not limited to, those areas identified in III.A.l.a. above.
n) Continue support for graduate-level Regulatory Science Certificate program at UAMS, expand availability of training, including online, in regulatory science, nanotoxicology, bioinformatics, and other disciplines to develop stronger capabilities and students, and work with FDA to curate curriculum to maximize the training benefits to FDA.
B. Contributions of FDA.
FDA's contributions to each of the Parties' collaborations will be detailed in the Supplemental Agreements. Such contributions, as permitted by applicable statutes and regulations and subject to the availability of funds, and as FDA deems appropriate, may include 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, insofar as such use does not interfere with the primary mission of either party;
3. Active participation in establishing collaborative research, education and training in regulatory science, and extension and outreach efforts with faculty, students, and staff within Arkansas institutions and named entities within Supplemental Agreements;
4. Active participation in courses and seminars with Arkansas institutions 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's laboratories along with sharing progress on on-going projects and associated technologies;
7. Promulgation and communication of identified collaborative efforts through appropriate means; and
8. Commitment of at least one high level official to work on a steering committee to accomplish the goals defined under III.A.l.a.
C. Contributions of Arkansas. The State of Arkansas will develop scientific proposals to FDA using instruments such as the Broad Agency Agreement and other contractual and grant mechanisms when such competitive approaches are appropriate. In cases where those instruments are not appropriate, and as qualified by Section IV.C., the State of Arkansas will make contributions to each of the Parties' collaborations to be detailed in Supplemental Agreements. Such contributions, subject to the availability of funds and as the State of Arkansas deems appropriate, may include the following:
1. Laboratory and/or office space in support of activities under this agreement at identified institutions, subject to any limitations imposed by State law or associated university or State regulations;
2. Access to facilities and equipment, including necessary training and guidance, insofar as such use does not interfere with the primary mission of either party.
3. Active participation in establishing collaborative research, education, and extension and outreach efforts with FDA's scientists and staff;
4. Continuing and frequent communication with FDA's scientists and staff;
5. Openness and welcome to FDA's scientists and staff wishing to visit relevant State of Arkansas and Arkansas's university associated programs and laboratories;
6. Promulgation and communication of identified collaborative efforts through appropriate means;
7. Appropriate faculty or affiliate 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 or affiliates;
8. Participation by agencies of State government and their employees and contractors in providing help and support in the function of transferring technology from the public to the private sector as required and directed by applicable federal legislation; and
9. Commitment of the ARA President & CEO of to participate on a steering committee and to provide administrative guidance to the ACERS whose purpose is to attain the goals defined in III.A1.a.
IV. GENERAL PROVISIONS
A. Confidentiality. Access to any confidential, non-public information shall be governed by separate Confidential Disclosure Agreements in which the Parties will agree and certify in writing that they shall not further release, publish or disclose such information, except as required by law, and that they shall protect such information in accordance with the provisions of21 U.S.C. 33l(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information. No proprietary data, trade secrets or patient confidential information shall be disclosed among the Parties unless the Parties have executed a Confidential Disclosure Agreement covering such data and such disclosure is permitted by applicable law. Such Confidential Disclosure Agreements may be part of, or be executed pursuant to, Supplemental Agreements covering specific collaborations.
B. Intellectual Property. "Invention" refers to any subject matter or discovery patentable under Title 35 of the United States Code and conceived or first reduced to practice under the activities of Supplemental Agreements to the MOU. "Intellectual Property" refers to patents, patent applications, know-how, trade secrets, copyrights and computer programs either used or developed under the activities of Supplemental Agreements to the MOU. Ownership of and rights to Inventions or Intellectual Property developed under a Supplemental Agreement will be addressed in the Supplemental Agreement. Inventions made under a Federal research and development grant or contract will be subject to the Bayh-Dole Act. Accordingly, all Arkansas employees who work on any project under this MOU shall be required to sign an agreement that effects a present assignment of their future inventions to the institution or office by which they are employed. No Party, by virtue of their participation in activities under the MOU, will be required to disclose or license intellectual property to the other Party. Neither Party shall use the name, logos, trademarks, service marks, trade names, seals, insignia, symbols or decorative designs of the other Party or any derivatives thereof without the prior written permission of the other Party.
C. Conflict of Interest. Individual participants in activities under this MOU who are not U.S. Government employees will abide by conflict of interest rules and policies as specified by FDA, and as set out in any Supplemental Agreement covering those activities. This may require individual participants to disclose their financial holdings and those of their spouse and minor children, and may limit their ability to accept gifts and have employment with entities that are substantially regulated by FDA. The Parties will be advised of any potential conflict so that conflicting assignments can be avoided consistent with the HHS/FDA requirements. If, at any time prior to or during the performance of the activities under the MOU, the Parties believe that a potential or actual conflict exists, the Parties must notify the appropriate authorities within their respective institutions and contact the designated FDA officials listed on the MOU so that the necessary action/scan be undertaken. A determination will be made by FDA as to whether a conflict of interest exists and, if so, as to how to resolve or mitigate it. The Parties to the MOU will make every effort to avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
D. Supplemental Agreements. Before any specific collaboration that is not covered by a formal procurement instrument and that exceeds what FDA considers to be common, daily research, practice is initiated or implemented, the parties shall identify priorities and topics of mutual interest and develop separate, written agreements ("Supplemental Agreements") for each collaboration that will outline each Party's financial commitments (if any), to the collaboration and terms to govern the collaboration. Where applicable, these agreements shall incorporate by reference the terms of this MOU. 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 State of Arkansas and FDA.
E. Securitv. Each Party will inform the other Party of its security policies and procedures regarding access to and use of facilities and the other Party will comply with those policies. Either Party may restrict or limit access to its property and facilities, at any time, for any reason. Arkansas individuals participating in activities under this MOU on FDA's property will comply with all applicable federal statutes and regulations.
State of Arkansas
Jerry Adams, President & CEO Arkansas Research Alliance
1125 Oak Street, Suite 301
Conway, Arkansas 72032
Food and Drug Administration
William Slikker Jr., Ph.D., Director NCTR/FDA
3900 NCTR Road, HFT-1
Jefferson Arkansas 72079
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 two weeks and notify the other Party through the designated administrative liaison.
VI. PERIOD OF AGREEMENT; MODIFICATION: TERMINATION
A. This MOU becomes effective upon acceptance by both parties and will continue in effect for five (5) years. It may be modified upon mutual agreement of the Parties.
B. Either Party may terminate the MOU upon sixty (60) days written notice to the other Party.
C. In the event of termination, any collaboration that commenced before the date of termination may be completed upon the written agreement of both Parties, provided that the terms of this MOU and any relevant Supplemental Agreement shall continue to govern such collaboration.
This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and the State of Arkansas operate.
IN WITNESS WHEREOF, the parties hereto have executed this MOU as of the day and year first above written.
The U.S. Food and Drug Administration (FDA) is comprised of an Office of the Commissioner, six product-oriented centers, a center for toxicological research, 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)- 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 oft he Chief of Staff, Office of Policy and Planning, Office of Legislation, Office of International Programs, Office of the Chief Counsel, Office of the Counselor to the Commissioner, Office of Special Medical Programs, Office of External Affairs, Office of Foods, Office of Operations, Office of Medical Products and Tobacco, Office of Global Regulatory Operations and Policy, 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 of 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. Opportunities exist for faculty and students in pharmaceutical science, biochemistry, chemistry, biotechnology, bioengineering, and chemical engineering, as well as many other scientific and engineering disciplines to engage with research and regulatory scientists in flexibly structured programs within the Center.
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, with 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 implement the Family Smoking Prevention and Tobacco Control Act. This law gives FDA authority over tobacco products by adding a new chapter to the Federal Food, Drug, and Cosmetic Act for tobacco products. 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 Toxicological Research (NCTR) - NCTR conducts peer-reviewed scientific research that supports and anticipates 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 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 OM -The FDA's Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy. ORA supports the six FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA develops FDA-wide policy on compliance and enforcement and executes FDA's Import Strategy and Food Protection Plans. ORA staffs are dispersed throughout the United States. Over 85 percent of ORA's staff works in five Regional Offices, 20 District Offices, 13 Laboratories, and more than 150 Resident Posts and Border Stations. ORA Headquarters is comprised oft he Office of Resource Management; Office of Regional Operations, the Office of Enforcement located in Maryland, and the Office of Criminal Investigations located throughout the United States. FDA maintains offices and staff in Washington, D.C., the U.S. Virgin Islands, Puerto Rico, and in all States except Wyoming. In addition to executing its mission through its Federal workforce, ORA works with its State, Local, Tribal, and Territories counterparts to further FDA's mission. ORA funds grants and cooperative agreements to perform State inspections and provide technical assistance to the States in such areas as milk, food, and shellfish safety.
APPROVED AND ACCEPTED FOR THE STATE OF ARKANSAS
Governor, State of Arkansas
August 31, 2016
APPROVED AND ACCEPTED FOR THE U.S. FOOD AND DRUG ADMINISTRATION
Robert M. Califf, M.D.
U.S. Food and Drug Administration
Department of Health and Human Services
August 31, 2016