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  1. Non-Profit and Other MOUs

August 8, 2017

CAPT Denise Hinton, MS, BSN, RN, Acting Chief Scientist
September 8, 2017



 I. Preamble:
The Food and Drug Administration (FDA) and Reagan-Udall Foundation (RUF)(collectively referred to as a Partners) are collaborating to sponsor the RUF Fellowship Program at FDA (the RUF fellowship) under section 770(d)(2)(A)(ix) of the Food, Drug and Cosmetic Act (21 U.S.C. 379dd(d)(2)(A)(ix)).  The Partners are committed to training scientists in regulatory science and policy so that they can foster a better understanding of FDA’s work in their post-fellowship employment. It is expected that the RUF fellowship will contribute to a workforce that can advance the field of regulatory science and provide leadership in this area in policy organizations, industry, academia, or the government.
II. Purpose:
This MOU forms the basis for development and management of the RUF Fellowship Program at FDA. The RUF fellowship is intended to:
·       Train scientists in regulatory science and policy for post-fellowship employment at FDA, industry, academia or other government agencies; and
·       Contribute to research projects that address FDA’s regulatory challenges. 
III. 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, dietary supplements, and cosmetics. 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 within the RUF will contribute greatly to FDA’s mission.
RUF is an independent 501(c)(3) not-for-profit organization created by Congress to support the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety. With the ultimate goal of improving public health, the Foundation provides a unique opportunity to build multi- stakeholder collaborations in a transparent way. The RUF supports activities, such as  Fellowship programs, that promote science and technical capabilities that can advance the FDA’s mission. RUF does not advise the FDA on its mission or operations and consequently does not advise on Agency policy, regulations or product approvals.
IV. Substance of Agreement:
1.     Description of the Fellowship Program
The RUF Fellowship Program at FDA provides a unique research and training experience. Research projects conducted or contributed to by the fellows may help address FDA’s regulatory challenges. Examples of possible research topics include epidemiology, biostatistics, bioinformatics, engineering, comparative effectiveness research, and clinical trial design. Innovative topics in the use of “big data” are encouraged.
The RUF Fellowship provides up to three years of experiential training at the FDA. Some level of customization is allowed depending on a candidate’s interests and experience. The selection of candidates and their research projects is made by a joint RUF-FDA Fellowship Steering Committee.
Applicants must demonstrate expertise in a scientific area relevant to FDA’s regulatory science priorities through their academic studies, research, or prior work experiences with government agencies, non-government agencies, or industry. Successful applicants demonstrate that a RUF fellowship is a logical progression in their career path and that they will benefit from participation in the RUF fellowship.
Candidates are post-Doctoral level (PhD, MD, DrPH, DO, PharmD, ScD, VMD or DVM), or in some cases may be Master’s level, trained individuals in specialty fields such as engineering, medical informatics, or bioinformatics. Applicants must be US citizens or hold permanent residence in the US through the end of their fellowship.All applicants meeting the eligibility requirements may apply. Generally, applicants who are selected for a fellowship must resign from their current employment as a condition of acceptance.  On a case-by-case basis, and dependent on an ethics review (including a conflict of interest review), other arrangements may be possible, except that fellows may not be current employees of regulated industry. Any selected candidate who accepts a RUF Fellowship and is not required to resign his/her current employment (e.g., takes a leave of absence or a sabbatical from an academic position or work at a non-profit organization), must acknowledge that FDA requires 100% effort on their RUF Fellowship research to the exclusion of other research or responsibilities, e.g., continued academic- related research or responsibilities.
Program Overview
In general, the program entails activities including, but not limited to:

. Participation in FDA mission-related research project(s) that are funded by FDA and conducted under the guidance of an FDA mentor/scientist. Examples of such FDA research include:

o   Conducting laboratory regulatory science research such as developing laboratory methods or models;

o   Conducting non-laboratory FDA-related research, such as analyses of data across regulatory submissions to address a regulatory science question;
·       Participation in FDA meetings with sponsors, advisory committee members, and other stakeholders;
·       Attendance at FDA-sponsored training; or
·       Participation in RUF’s program evaluation, including reporting to the RUF Fellowship Steering Committee on progress and achievements.
FDA reserves the right to determine the specific day-to-day work of each fellow. As necessary, FDA and RUF will discuss issues regarding re-direction or termination of a project.
RUF Fellows may learn about the review process and support regulatory review actions. However, while at FDA, RUF fellows may not perform activities that are so intimately
related to FDA’s mission as to require performance by FDA employees.  Examples of such prohibited activities include determining agency policy, exercising agency discretion, making FDA regulatory decisions, and representing the FDA before advisory committees.
RUF Fellows may also have additional opportunities such as:
·       Supporting possible FDA regulatory actions and possible legal actions such as reviewing historical inspection data and enforcement actions for a defined subset of a regulated industry;
·       Contributing to regulatory science papers and/or publications such as research reports and/or results;
·       Attending or presenting, in their individual capacity, at relevant conferences;
·       Undertaking activities to support agency planning, policy, and priorities, researching related issues, drafting documents, and exploring options;
·       Providing assistance to support the development of regulations and legislative proposals;
·       Supporting regulatory review activities, such as evaluating historical regulatory submissions to help devise options for clinical study design or learning and conducting preliminary evaluation of data in regulatory submissions and discussing preliminary analysis with their mentor; and
·       Assisting in developing communications projects such as reviewing public and/or internal information, or analyzing communication or marketing activities.
Program Duration
The duration of the FDA component of the RUF Fellowship is expected to be 1-3 years at FDA, depending on the specific research project or external rotations.
The fellows will, most likely, be located at an FDA facility either in the Washington DC Metro area or across the country.
Compensation is determined by RUF based on the applicants’ background and relevant experience.
Other Research Support
Fellows are allocated a RUF stipend annually to cover such expenses as: a computer, lab and office supplies, training, and travel expenses. Such funds will be allocated as appropriate consistent with other applicable requirements.
Organizational Structure
The RUF Fellow will be considered an employee of RUF and not FDA.
2.     Roles and responsibilities
The RUF Office, FDA and RUF Fellowship Steering Committee are involved in the joint planning, implementation and evaluation of the fellowship program.
RUF Office responsibilities include:
·       Providing personnel to manage the fellowship program;
·       Developing an annual program timeline, budget, and workflow documentation;
·       Advertising/marketing the program;
·       Developing a funding approach and raising funds for the program;
·       Managing the joint RUF-FDA Fellowship Steering Committee;
·       Collecting and reviewing the fellowship applications for completeness and eligibility requirements to include citizenship and permanent residence status;
·       Inviting candidates for interviews and scheduling interviews;
·       Notifying candidates on the outcome of their applications;
·       Establishing stipends based on applicants background and benefits;
·       Extending offers and providing the “RUF Fellow at FDA Agreement” to applicants as a RUF Fellow at FDA;
·       Hiring and orienting new fellows as an RUF employee;
·       Liaising with the FDA Office of the Chief Scientist who places and monitors the fellows at the FDA for discussions of:
o   the progress of fellows on a regular basis; and
o   whether critical program requirements are met;
·       Providing support on an individual basis as needed;
·       Approving research projects as member of the RUF Fellowship Steering Committee;
·       Managing the evaluation of the overall program, individual fellows, their mentors, and revising procedures based on the assessment;
·       Providing FDA with an evaluation report annually;
·       Managing the RUF personnel separation process when the fellowship is completed; and
·       Maintaining follow-up on program alumni for evaluation outcomes purposes.
RUF Fellowship Steering Committee
The Committee is composed of senior scientists and educators from the FDA and RUF Board of Directors as well as invited members from academia and others as necessary and appropriate.
Responsibilities include:
·       Assisting in marketing the program and recruiting high-level candidates;
·       Working with the FDA to establish program goals and criteria for applicants;
·       Developing/refining the FDA fellowship curriculum in collaboration;
·       Reviewing applications;
·       Selecting candidates;
·       Interviewing candidates;
·       Awarding the fellowships;
·       Approving research projects;
·       Developing a process, with the FDA, for assigning mentors to the fellows, establishing expectations for the mentors and reviewing/approving Individual Development Plans;
·       Monitoring the progress of research projects;
·       Evaluating all aspects of the program including the fellows, mentors, and curriculum;
·       Revising the scientific aspects of the program and curriculum as indicated by an established assessment process;
·       Attending fellows’ mid-year in-person presentations and evaluations and providing feedback on their progress; and
·       Reviewing longitudinal outcomes data on program alumni as part of the evaluation process.
FDA Office of the Chief Scientist
The FDA Office of the Chief Scientist is responsible for the administrative aspects of the program that take place onsite at the FDA. Responsibilities include:
·       Consulting regularly with the RUF Office including appointing a single point of contact with the managerial authority to implement agreed upon procedures;
·       Participating as needed on the RUF Fellowship Steering Committee;
·       Establishing and managing the RUF Fellowship Program at FDA by coordinating the development and implementation of standard operating procedures;
·       On-boarding fellows with the required “RUF Fellow at FDA Agreement,” government background security and conflict of interest checks;
·       Assigning fellows to FDA mentors;
·       Coordinating the FDA acceptance of RUF funds to cover the fellows’ operating costs, consistent with FDA Gift Acceptance Authority and procedures;
·       Ensuring the joint implementation of an FDA fellows’ curriculum to include development of the Individual Development Plan (IDP);
·       Providing the RUF Fellowship Program at FDA orientation for fellows and mentors;
·       Coordinating fellows’ mid-year and year-end in-person presentations and evaluations for RUF Fellowship Steering Committee;
·       Providing the RUF Office and RUF Fellowship Steering Committee feedback on the fellows as requested;
·       Managing the FDA departure process when the fellowship is completed; and
·       Complying with a RUF evaluation process. The FDA Centers/Offices are responsible for:
·       Participating as needed on the RUF Fellowship Steering Committee;
·       Approving research projects as member of the RUF Steering Committee;
·       Providing mentors and ensuring that mentors attend orientation training;
·       Managing the day to day activities of the RUF Fellows;
·       Mentoring fellows’ research projects;
·       Developing fellows’ individual development plans to include attendance at FDA sponsored training and other professional events;
·       Ensuring that fellows complete required training such as orientation, computer security awareness, lab safety, and records management;
·       Ensuring that fellows have access to necessary and appropriate FDA data sets to complete research projects and requirements of the program;
·       Managing the fellows’ operating costs to include purchase of an FDA-compliant computer;
·       Attending the fellows’ mid-year and year-end in-person presentations and evaluations with the RUF Fellowship Steering Committee;
·       Providing reports and documents to the Office of the Chief Scientist as requested; and
·       Complying with an RUF evaluation process.
V. General Provisions:
·        Conflict of Interest:  As specified in section 746 of the Food, Drug and Cosmetic Act (21U.S.C. 379l), participants in the RUF Fellowship Program will be required to comply with all legal and ethical requirements otherwise applicable to officers or employees of the Department of Health and Human Services. This includes, but is not necessarily limited to, the statutory conflict of interest requirements at 18 U.S.C. 208, and the following regulations: Standards of Ethical Conduct for Employees of the Executive Branch (5 C.F.R. 2635 et seq.), and the Supplemental Standards of Ethical Conduct for Employees of the Department of Health and Human Services applicable to FDA employees (5 C.F.R. and 5 C.F.R 5501.106).  Consistent with these requirements, fellows may be required to disclose their financial holdings and those of their spouse and minor children, and will be limited in their ability to accept gifts and have employment relationships with entities that are substantially regulated by FDA.  In general, unless subject to specific exceptions (5 CFR 5501.104(b)), fellows will not be permitted to have financial interests in entities regulated by FDA.
·        Disqualification: Participants in this program will not be permitted to serve on FDA advisory panels reviewing a product for which they provided consultative or review services. Participants will agree that they will be disqualified from any FDA decisions regarding approval of products that result directly from activities conducted under this MOU.
·        Citizenship and security clearance: RUF fellows participating in this MOU will be United States citizens or permanent residents. Regarding the latter, all federal restrictions will be adhered to. Information may be obtained from participants by the agency for security clearance or access to FDA facilities and offices. Information obtained may be shared with other Federal agencies for the above purposes and in fulfillment of official responsibilities as disclosure is permitted by law.
·        Protection of nonpublic information: Residents, fellows, faculty and students appointed to a position at FDA will be required to sign a Commitment to Protect Nonpublic Information Agreement. When access to privileged information in the files of the Food and Drug Administration is required in performing official duties, the Partner(s) will agree and certify in writing that they shall not further release, publish, or disclose such information and that they shall protect such information in compliance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, the Freedom of Information Act (5 U.S.C. 552), the Privacy Act (5 U.S.C. 552a), and other pertinent laws and regulations governing the confidentiality of privileged information.
·        Intellectual Property Guidelines: “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 the MOU. “Intellectual Property” refers to patents, patent applications, know-how, trade secrets, copyrights and computer programs either use or developed under the activities of the MOU. Rights to Inventions or Intellectual Property developed under the MOU will be addressed in the RUF Fellow at FDA Agreement. Inventorship will be governed by U.S. law. In the case of sole inventorship, ownership will be governed by the policies of the employer of the Invention. In the case of joint inventorship, ownership of Inventions will be jointly owned. Inventions made under a Federal grant or contract will be subject to the Bayh-Dole Act. No Partner, by virtue of its participation in activities under the MOU, will be required to disclose or license intellectual property to the other Partner.
VI. Resource Obligations:
This MOU represents the broad outline of the Partners’ present intent to enter specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and RUF. All activities undertaken pursuant to the 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 Partner(s). This MOU does not create binding, enforceable obligations against any Party. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and the RUF operate.
VII. Liaison Officers:
A.     For The Reagan-Udall Foundation for the FDA
June S. Wasser, MA, Executive Director
1025 Connecticut Avenue, NW Suite 1000
Washington, DC 20036
Office: 202-828-1204
Direct: 202-828-1203
B.     For the Food and Drug Administration:
Leslie D. Wheelock, MS, RN
Director, Office of Scientific Professional Development,
10903 New Hampshire Avenue WO 1 RM 4345
Silver Spring, MD 20993 Office: 301- 796-8450
Each Partner may designate new liaisons at any time by notifying the other Partner’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 Partners will name a new liaison within 2 weeks and notify the other Partner through the designated administrative liaison.
VIII. Terms, Termination and Modification:  
This agreement will be effective when accepted by all participating parties. This agreement may be modified or terminated by mutual written consent by both parties or may be terminated by either party upon a 60-day advance written notice to the other.


june s. wasser, ma, executive director




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