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  6. MOU 225-14-0025
  1. Domestic MOUs

MOU 225-14-0025

1.                   This Memorandum of Understanding (MOU) documents the affiliation among the United States Food and Drug Administration (“FDA”) and the National Capital Consortium (“NCC”) to promote scientific progress through the exchange of scientific capital in a Cardiovascular Disease Drug Development Fellowship Training and Research Program. This affiliation permits the coordination of resources to develop a unified program, maximize efficient utilization of government facilities, and strengthen the joint education and research efforts among the parties. Both FDA and the NCC (“parties”) are entities of the United States government.
2.                   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, effectiveness, 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 the NCC will contribute to FDA’s mission. 
3.                   The NCC was established in 1997 as mandated by the Assistant Secretary of the Defense for Health Affairs to provide joint, centralized institutional and administrative oversight of all graduate medical education (GME) internship, residency and fellowship programs located within the National Capital Region, including those programs currently based at Walter Reed National Military Medical Center, Fort Belvoir Community Hospital and Malcolm Grow Medical Clinic of the 79th Air Wing. The NCC is responsible for ensuring the quality and overseeing the accreditation status of its
GME training programs. The NCC also ensures its program directors have sufficient financial support to effectively carry out their educational, administrative, and leadership responsibilities. In collaboration with each parent institution and accredited program, the NCC is also responsible for ensuring GME programs receive adequate support and resources to provide trainees an optimum educational learning and working environment.
4.                   The NCC has established a fellowship training program in internal medicine cardiovascular disease that has been accredited by the Accreditation Council for Graduate Medical Education. The program curriculum requires special clinical training in preparation for internal medicine cardiovascular disease fellows (“Trainees”) board certification in internal medicine cardiovascular disease. Trainees who will be trained under this agreement must be either physicians on active duty in the United States military (i.e., Army, Navy, and Air Force) or civilian physicians who are full-time employees of the United States government.
5.                   It is in the best interest of NCC Trainees to receive part of their training experience utilizing the facilities of FDA.  This experience is invaluable to the educational preparation of physicians specializing in internal medicine cardiovascular disease. It is to the benefit of FDA to receive and use Trainees’ experience and performance.
6.             This MOU represents the broad outline of FDA and NCC’s intent to collaborate in areas of mutual interest to FDA and NCC. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and NCC operate.        
7.             Rights to any inventions or intellectual property developed under the MOU will be addressed in separate project-specific development and implementation agreements among the parties. “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 used or developed under the activities of the MOU. 
8.             While training at FDA, NCC Trainees will be under the supervision of FDA officials for training purposes and will be subject to, and be required to abide by, all rules and applicable FDA regulations.
9.    FDA and NCC will not compensate or reimburse the other on account of any activities, services, or facilities provided by the other in accordance with this agreement.
10.          The number and assignment of Trainees will be agreed upon mutually between the NCC and the FDA prior to the beginning of each rotation period. FDA may refuse acceptance of any NCC Trainee and terminate any Trainee’s participation if FDA determines that the Trainee’s further participation would not be in FDA’s best interest.
11.          A Program Letter of Agreement (PLA) outlining specific goals and requirements for each rotation will be executed between the director of the NCC’s Internal Medicine Cardiovascular Disease Fellowship and the supervising official of FDA. The PLA will include a basic outline of the anticipated training, training and supervision standards to be employed, and any other issues required by the Internal Medicine Cardiovascular Disease Fellowship Program Review Committee.
12.   The parties agree that NCC Trainees will be considered providers or members of FDA’s workforce while performing duties pursuant to this agreement, and so they are not “business associates” (45 CFR 160.103) under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  No business associate agreement between the parties, therefore, is necessary. Further, no protected healthcare information is anticipated to be exchanged between the parties.
13.          For liability purposes, it is recognized that FDA and the NCC both are entities of the United States government whose employees are covered by the provisions of the Federal Tort Claims Act. In the event a potentially compensable event occurs, the institution that first learns of the event will notify as soon as practicable the point of contact of the other entity. Reasonable assistance will be provided mutually to and by the parties.
14.          While assigned to FDA and while performing services pursuant to this agreement, NCC Trainees remain employees of the United States performing duties within the course and scope of their federal employment. Consequently, the provisions of the Federal Tort Claims Act (Title 28, U.S.C. § 2671—2680), including its defense and immunities, will apply to allegations of negligence or wrongful acts or omissions by trainees while they are acting within the scope of their duties pursuant to this agreement.
15.          FDA will facilitate assessment of FDA facilities by government agencies or other agencies charged with responsibility for accreditation of school education programs. 
16.          This written statement embodies the entire agreement of the parties regarding this affiliation, and no other agreements exist between the parties except as herein expressly set forth. Any changes or modifications to this agreement must be in writing and must be signed by both parties.
17.          The terms of this agreement will commence as of the date signed by both parties and will remain in effect for a period of 5 years. In the event of an administrative delay in renewing the agreement, there shall be an automatic one year renewal, unless either party notifies the other party, in writing, not less than 6 months prior to this agreement’s termination date, that either party does not wish to renew the agreement. The Chairperson of the NCC Board of Directors and the Director, Center for Drug Evaluation and Research, FDA, will have the right to terminate the agreement at any time, if such termination is determined to be necessary in the interests of mission requirements.
18.          To the extent practicable, FDA will arrange schedules that will not conflict with other educational programs.
19.          FDA will designate an official to assist in coordinating the research-related learning experience of NCC Trainees. Such coordination will involve planning with NCC faculty or staff members for NCC Trainees’ assignment to specific projects and experiences, including attendance at selected conferences, clinics, courses, and programs conducted under FDA’s direction.
20.          FDA will facilitate assessment of FDA facilities by the government agencies or other agencies charged with the responsibility for accreditation of NCC education programs.
21.          FDA will provide necessary education facilities and access to appropriate resources for NCC Trainees.
22.          FDA will grant NCC Trainees similar access to FDA resources as FDA employees, e.g., dining facilities, library, computers, networks, telephones. 
23.          The NCC will have its faculty or staff members coordinate with the designated FDA official the assignments that will be assumed by NCC Trainees and their attendance at selected conferences, clinics, courses, and programs conducted under the direction of the FDA.
24.          The NCC will ensure Trainees comply with the following FDA rules and applicable instructions:
a.        Trainees will only be provided access to non-public information as necessary to perform their official duties in accordance with this MOU, and any such non-public information will be shared by FDA pursuant to 21 CFR 20.85. Pursuant to section 301(j) of the Federal Food, Drug, and Cosmetic Act, 21 USC 331(j), FDA will not provide to the Trainees, and the Trainees are not authorized to have access to, any method or process that is entitled to protection as a trade secret. Trainees 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 Trainees will agree and certify in writing that they shall not further release, publish, or disclose such information and that they shall protect such information by 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 privileged information.   
b.       Trainees will not be permitted to serve on FDA advisory panels or committees reviewing a product for which they provided consultative or review services. Trainees will be disqualified from any FDA decisions regarding approval of products that result directly from activities conducted under this MOU. The statutory provisions about former and post federal employment restrictions will apply to the Trainees participating in this program.
c.        Trainees will be required to abide by conflict of interest rules and policies as specified by FDA. This may require Trainees 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 NCC will be advised of any potential conflict so conflicting assignments can be avoided consistent with the HHS/FDA requirements. If before or during the performance of the activities under the MOU, a Trainee believes that a potential or actual conflict exists, the Trainee must notify the appropriate NCC authorities and contact the designated FDA officials listed on the MOU so necessary action can be undertaken. A determination will be made by FDA on whether a conflict of interest exists and, if so, as to how to resolve or mitigate it. Trainees shall avoid activities or relationships that would cause a reasonable person to question the impartiality of their actions.
d. Trainees participating in the 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.
25.          The NCC will train NCC Trainees on the protection and privacy of protected health information and will provide evidence of such training to the Hospital. Such training will meet requirements of HIPAA and its privacy rules and of DoD 6025.l8R, DoD Health Information Privacy Regulation, dated 24 January 2003.
26.          The NCC will be responsible for health examinations and such other medical examinations and protective measures necessary for trainees.
27.          Publication of any materials where NCC Trainees and/or FDA staff members participated under this MOU must be authorized in accordance with FDA and NCC applicable statutes, regulations, and policies, and must be approved in writing. 
Karen A. Hicks, M.D.
Food and Drug Administration
Division of Cardiovascular and Renal Products
10903 New Hampshire Avenue
Building 22, Room 4182
Silver Spring, MD 20993-0002
Todd C. Villines, M.D.
Director, NCC Internal Medicine
Cardiovascular Fellowship Program
Director, Cardiovascular Research
Walter Reed National Military Medical Center (Cardiology Service)
8901 Wisconsin Avenue
Bethesda, MD 20889
(301) 295-7839
Stephenye C. Tyler, M.S., FACHE
Compliance Officer, NCC
Department of Graduate Medical Education, Room E2012
4301 Jones Bridge Road
Bethesda, Maryland 20814
Janet Woodcock, M.D.
Director, Center for Drug Evaluation and Research
September 24, 2014
Arthur L. Kellermann, M.D., M.P.H.
Chairman, NCC Board Of Directors
Professor and Dean, F. Edward Hébert School of Medicine
Uniformed Services University of the Health Sciences
OCTOBER 17, 2014
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