MEMORANDUM OF UNDERSTANDING
BETWEEN THE STATE OF ARKANSAS
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 twelfth of August, 2011, 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. The State of Arkansas is represented through several entities, all coordinated through the Governor’s Office. The contributions from the State will derive primarily from its academic institutions, with major contributions coming 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 40-year history with FDA’s National Center for Toxicological Research (NCTR), including collaborative research and cooperative training of doctoral students and post-doctoral fellows. In addition, 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), Arkansas Department of Health (ADH), and other organizations such as Accelerate Arkansas that coordinate with Arkansas Science and Technology Authority (ASTA) and Arkansas Research Alliance (ARA) in bringing innovative medical and food-related products to commercial viability. NCTR has also enjoyed productive collaborations, to differing extents, with each of these other State institutions.
C. FDA and Arkansas share interests in scientific progress in the diverse disciplines that directly and indirectly affect human and animal health and medicine. 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 this MOU to set forth a framework for a 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’ 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, 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 by collaborative Supplemental Agreements covering specific collaborations. FDA has statutory authority to enter into such agreements, including, inter alia, authority provided by sections 746 and 1003 of the Federal Food, Drug, and Cosmetic Act (21 USC 379l and 393). The specific authority for each such collaboration will be recited in the Supplemental Agreement covering that collaboration.
NOW, THEREFORE, in consideration of the mutual promises herein set forth, and of other good and valuable consideration, the Parties agree as follows, intending to be bound hereby:
I. COLLABORATIONS; SUPPLEMENTAL AGREEMENTS.
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 necessarily limited to the following:
1. Identification, and convening by the Governor’s Office State of Arkansas, of a Working Group for NCTR/Arkansas Interactions comprised of individuals who are highly trained scientists and/or have experience in managing the participating entities;
(The Working Group will be co-chaired by a coordinator appointed by the Governor’s office and NCTR will:
a. establish a virtual Center of Excellence in Regulatory Science that optimizes the combined FDA/Arkansas capabilities in research, (with an initial focus on the toxicology of nanotechnology products and processes), education and training in regulatory science, and public outreach; and
b. develop other scientific and intellectual collaborations; programs to collect; consolidate and validate data from all available sources; and additional efforts to provide prudently rapid access to developing technologies that benefit the public health.)
2. Collaboration and mutual participation in developing degree-granting and non-degree granting training programs for those associated with the Parties and the general public;
3. Personnel exchanges between faculty and staff from Arkansas universities and State employees and FDA’s scientists and staff, as permitted by the Intergovernmental Personnel Act;
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 Arkansas universities;
6. Joint meetings for education and research as needed in individual areas, and with no less than one formal meeting per year between the State of Arkansas and FDA to assess progress, establish priorities, and agree on future activities and resource sharing;
7. Research collaborations;
8. Cooperative international activities, e.g.,consensus meetings on regulatory science and innovation;
9. Sharing of unique facilities and equipment for increased results and cost efficiencies for scientific endeavors;
10. Development of regular, virtual and in-person workshops where faculty from the State of Arkansas and FDA’s scientists and staff share information about on-going research, education, extension, and outreach efforts of mutual interest;
11. A program of local, regional and State support in identifying non-commercialized technologies with potential public health benefits developed in or utilized by FDA laboratories, followed by development, testing, validation, approval, and introduction of those technologies for public benefit; and
12. Coordinate programs to facilitate dialogue between the Parties and the private sector for feedback and cooperation in technology and research directions.
B. Supplemental Agreements. Before any specific collaboration 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 Supplemental Agreements may include contracts, grants or cooperative research and development agreements among FDA, the private sector, and the State of Arkansas to the extent authorized by law and available appropriations. 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.
C. Contributions of FDA. FDA’s contributions to the Parties’ collaborations will be detailed in the Supplemental Agreements for each collaboration. 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 (initially in nanotechnology), 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 whose purpose is to accomplish the goals defined under I.A.1.
D. Contributions of Arkansas. The State of Arkansas will make contributions to the Parties’ collaborations to be detailed in the Supplemental Agreements for each collaboration. 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’ 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 members of a Steering Committee whose purpose is to attain the goals defined in I.A.1.
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 of 21 U.S.C. 331(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/s can 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. Security. 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.
To be determined
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.
IV. PERIOD OF AGREEMENT; 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 Separate 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.
VI. MISCELLANEOUS TERMS
A. Neither this MOU nor any rights or obligations under this MOU may be assigned or otherwise transferred.
B. No failure by either Party at any time to insist on performance by the other Party or compliance by the other Party with any condition or provision of this MOU, or to pursue remedies relating to any breach of any provision of this MOU by the other Party shall be deemed a waiver nor shall any such failure to act affect the right at a later time to enforce the same or to pursue related remedies.
C. This MOU does not supersede any other existing agreements or grants between the Parties.
D. If any provision of this MOU is held invalid or unenforceable, the other provisions of this MOU shall remain in full force and effect.
E. This MOU may be executed in counterparts, each of which shall be deemed an original, but taken together shall constitute one instrument.
IN WITNESS WHEREOF, the parties hereto have executed this MOU as of the day and year first above written.
Approved and Accepted
for the State of Arkansas
Signed by: Mike Beebe
State of Arkansas
Date: August 12, 2011
Approved and Accepted
for the Food and Drug Administration
Signed by: Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Department of Health and Human Services
Date: August 12, 2011
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 of the 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 5 Regional Offices, 20 District Offices, 13 Laboratories, and more than 150 Resident Posts and Border Stations. ORA Headquarters is comprised of the Office of Resource Management; Office of Regional Operations; and 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.
Arkansas Participating Entities
State of Arkansas activities will be coordinated by the Governor’s Office.
· UAMS/UALR/UAF/ASU/UAPB: For efforts such as this, and others, Arkansas has an advantage in having a well funded medical school. As Arkansas’ only medical school and biomedical research center, UAMS has developed national leadership (and international leadership in some areas), most notably multiple myeloma, and continues to develop a strong reputation in oncology, spinal research, nutrition (especially childhood obesity), and other areas. In the area of nano-medicine, UAMS has established an internationally recognized program for the applications of nano-materials for use in animals and humans. In the area of nano-medicine, researchers are working collaboratively, including ties to biochemists and engineers, to design new products for new approaches. Those collaborations often involve researchers at NCTR, UALR, UAF, ASU and elsewhere.
The research and academic excellence demonstrated by UAMS was recently rewarded by inclusion into the Clinical and Translational Research Consortium, a network of 55 select medical research institutions across the U.S. which together are focused on the translation of medical research discovery from the basic research into clinical applications in man. This program is the background for the unique discoveries in nanomedicine and nanomaterials applications that are currently being validated in animal studies as a prelude to entering a regulatory development pathway for clinical development. This program is unique and has recently enjoyed strong support from the National Cancer Institute and recognition in high end publications focused on this area or nanoscience. The UAMS executive administration and key investigators have established a Center for Nanomedicine Research which will consolidate and coordinate the interests of UAMS researchers using nanomaterials as part of their research programs that address disciplines from targeting and ablating cancer cells to growth of bone in osteolytic diseases. The collaborative overlap with NCTR interests in this area offers a unique opportunity to create a training and research partnership and provide a model for other organizations to follow.
UAMS is also fortunate to partner with Arkansas Children’s Hospital (ACH) as a locus for its Department of Pediatrics. ACH is nationally recognized for its development and application of high quality care. Through its national networks and its existing relationship with FDA, the area of pediatric medicine, and particularly the ability to assess differences in pediatric and adult safety and efficacy, it offers a resource that extends the value of the resources that are available. In addition, the ACH Research Institute has a strong relationship with USDA in its nutritional research program. Considering the importance of nutritional health and the leadership of Arkansas institutions in working to stem childhood obesity, we have another strong component in our collection of assets.
In addition to these resources, the importance of data collection and validation to any effort improving regulatory science has made the area of bioinformatics even more critical. NCTR has been an FDA leader in this area, having developed systems to collect massive amounts of data from microarrays associated with genomic and other research. In order to successfully assess risk, one must have advanced capability to determine the validity of data and to include those data into risk models. Complementing these capabilities are very strong programs at UALR and UAMS in these areas, including PhD programs in bioinformatics which have been established.
Another asset relative to data collection is the medical outreach program housed at UAMS that encounters one million patients per year. This data and the participation of electronic data quality information resources from the private sector form the basis and will become a huge resource for any number of important epidemiological and disease-oriented programs.
FDA Commissioner Hamburg has also spoken about how improved public health requires the movement of new technology rapidly into consumer and medical health products. In this regard, UAMS has established a strong BioVentures organization that seeks technology that may have broader application, defines and protects the intellectual property, and works to quickly commercialize that technology for wide availability. The unique contribution of licensing and technology incubation provided by BioVentures will ensure that the value of new discovery and properties of these nanomaterials is properly realized.
UAPB is an historically black, land-grant university located in the agricultural region in southeast Arkansas with a number of connections to USDA and agri-business. UAPB has a nationally recognized fisheries program with practical experience in applying regulatory constraints in areas they believe need an approach that differs from the national model. It also has a regulatory science program that could be a feeder program to other graduate programs.
· ARA is a public–private partnership created by the Arkansas Legislature in 2007 (Act 563) and is funded through the Arkansas Science and Technology Authority (ASTA). ASTA has responsibility for promoting research, technology development, and scientific education across the State. ARA’s mission is to advance the talent and other resources necessary for Arkansas institutions to develop research that is translated into commercial products.
· Governor/State government: Governor Beebe has personally given his assurance of support for this endeavor and has promised his commitment. Beyond that, several components of state government have an interest and commitment to it. The Arkansas Economic Development Commission offers support to business development and can provide important research and incentive data for business enterprise. The Arkansas Science and Technology Authority supports new scientific endeavors and works to broker scientific arrangements and support scientific and technical development. The Arkansas Development Finance Authority works with groups and businesses to foster connections with available capital. Moreover, individuals from these agencies present a coordinated front to join their combined capabilities with individual and business needs.
Business support mechanisms: Although difficult to quantify and define, it is nonetheless important to mention the unique asset of a close working relationship among people in a small state who know and trust one another and who are able to work together effectively and consistently. This relationship extends across professional scientists, the business community, academicians, administrators, government officials, politicians and others. This type of relationship is simply not found in larger states with multiple institutions and segmented interests. UAMS BioVentures is one of three focal points for the commercialization efforts underway in Arkansas to support and assist young nanomedicine- and nanotechnology-based businesses to launch and succeed. The others include the technology transfer offices associated with UAF and UALR. These programs are closely networked and continue to capture the best nanomaterials and nanotechnology discovery as intellectual property for commercialization. These organizations work in combination with an established seed and venture fund network to deliver resources to young technology based enterprises. Also, the state support is available to help manage and advise in various commercialization efforts. The organization “Innovate Arkansas” has committed to support this partnership and currently has a portfolio of companies that include all of the nanotechnology-based businesses formed in the past 3 years. Furthermore, the partnership will also include “Accelerate Arkansas,” a volunteer organization of business and academic leadership that has agreed to be a coordinating focus for the collection of individual resources across the State. Accelerate Arkansas has worked with the State to develop more access to, and availability of, capital, and to the development of highly successful organizations such as “Innovate Arkansas.”