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  1. FDA Memoranda of Understanding

MOU 225-14-0007(OC)

MOU 225-14-0007(OC)

Memorandum of Understanding
United States Department of Health and Human Services
Food and Drug Administration
and York College of the City College of New York

 
I.          Purpose
 
The Food and Drug Administration, U.S. Department of Health and Human Services, and York College of the City University of New York (York) share interests in promoting scientific progress through exchange of scientific capital in diverse field of science that affect human and animal health and medicine. Both institutions foresee benefits from scientific training for academicians and students to foster a well-grounded foundation in interdisciplinary science on which scientific learning can grow. This Memorandum of Understanding (MOU) establishes the terms for collaboration to enhance diversity and to promote shared interests in various science-based academic sabbaticals, fellowships, and internships. 
 
II.        Background
 
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, 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.
 
York College of the City University of New York is one of eleven senior colleges in the City University of New York (CUNY) system. It is located in Jamaica, Queens in New York City. Founded in 1966, York was the first senior college founded under the CUNY system, which united several previously independent public colleges into a single public university system in 1961. The City University of New York (CUNY) is the public university system of New York City. It is the largest urban university in the United States, consisting of 23 institutions: 11 senior colleges, six community colleges, the William E. Macaulay Honors College at CUNY, the doctorate-granting Graduate School and University Center, the City University of New York University School of Law, CUNY Graduate School of Journalism, and the Sophie Davis School of Biomedical Education.  
 
III.       Substance of Agreement:
 
FDA enters this MOU with York to:
 
Promote student education and matriculation into the health and biomedical science professions.
 
Increase outreach to encourage socio-economic disadvantaged student populations and to provide opportunities to expose motivated students to participate in medical, scientific, engineering and allied health professional fellowships, sabbaticals and internships and to gain relevant knowledge, skills and experience in the science and public health at FDA;
 
Promote community-based organizations involvement in sharing public health information from FDA with populations that surround member institutions and those who are affected by health disparities and
 
Share Web-linked public information such as public health alerts, newsletters, and notices.
 
IV. Resource Obligations 
 
This MOU represents the broad outline of the FDA and York’s intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of resources. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU. This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and York operate.
 
V. Further Information:
 
Citizenship and security clearance: Individuals 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 re-disclosed to other Federal agencies for the above purposes and in fulfillment of official responsibilities to the extent that such disclosure is permitted by law.
 
Conflict of Interest: Participants in activities under this MOU who are not U.S. Government employees will be expected to abide by conflict of interest rules and policies as specified by FDA. This may require 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 or the program participant believe that a potential or actual conflict exists, the Parties or participant must notify the appropriate authorities within their respective institutions and contact the designated FDA official 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. 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.
 
Nonpublic Information: All participants in this program must recognize that information to which they have access that contains any of the following types of information must be protected from unauthorized disclosure: (1) confidential commercial information, such as the information that would be protected from public disclosure pursuant to Exemption 4 of the Freedom of Information Act (FOIA); (2) personal privacy information, such as the information that would be protected from public disclosure pursuant to Exemption 6 or 7(c) of the FOIA; or (3) information that is otherwise protected from public disclosure by Federal statutes and their implementing regulations (e.g., Trade Secrets Act (18 U.S.C. § 1905), the Privacy Act (5 U.S.C. § 552a), the Freedom of Information Act (5 U.S.C. § 552), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), and the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191).
 
Liaison Officers:
 
Food and Drug Administration
 
Kent Hermann, Deputy Director
Office of Regulatory Affairs, Northeast Regional Laboratory
U.S. Food and Drug Administration
NE570
158-15 Liberty Avenue
Jamaica, NY 11433
 
Jonca Bull, M.D., Director
Office of Minority Health
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
 
 York College, The City Universityof New York
 
 
Panayiotis Meleties, Ph.D.
Interim Provost and Senior Vice President of Academic Affairs
Professor of Chemistry
York College, The City University of New York
94-20 Guy R. Brewer Blvd. Jamaica, NY 11451
 
Deb N. Chakravarti, Ph.D., D. Phil (Oxon) Professor of Chemistry
Director, Pharmaceutical Sciences Program
Director, York College FDA Partnership
Department of Chemistry, 3FO1
York College, The City University of New York
94-20 Guy R. Brewer Blvd. Jamaica, NY 11451
 
VI.       Terms, Termination, Modification
 
This agreement will be effective when accepted by all participating partners. This agreement may be modified or terminated by mutual written consent by the partners or may be terminated by either Partner(s) upon a 60-day advance written notice to the other.
 
Approved and Accepted by the U.S. Food and Drug Administration:
 
 
            Ken Hermann
            Deputy Director, Office of Regulatory Affairs
            Northeast Regional Laboratory
 
            February 20, 2014
 
            Jonca C. Bull
            Director, Office of Minority Health
 
            February 20, 1014
 
 
            Marcia Keizs
            President, York College, The City University of New York
           
            February 20, 2014