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MOU 225-10-0006



Memorandum of Understanding
United States Department of Health and Human Services
Food and Drug Administration
National Alliance for Hispanic Health

I.  Purpose

The Food and Drug Administration, U.S. Department of Health and Human Services, and the National Alliance for Hispanic Health (The Alliance) 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 and public health orientation for socio-economically disadvantaged 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 the diversity of the pool of candidates and to promote shared interests in increasing science and public health internships opportunities for socio-economically disadvantaged students. 

II.  Background

FDA is responsible for protecting the public health by ensuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, the United States food supply and cosmetics.  FDA is also responsible for advancing the public health by helping to speed innovations that make medical products and foods more effective, safer, and more affordable.  FDA also helps the public get accurate, scientific-based information they need to use medical products and foods to improve their health.
The Alliance, a nonprofit entity as described in section 501(c)(3) of the Internal Revenue Code of 1968, is the oldest and largest network of Hispanic health and human service providers for the target population. As an umbrella organization, the Alliance represents thousands of healthcare providers across the nation who provide services to more than 15 million health consumers each year.  The Alliance is a recognized leader within in the United States among Hispanic and socio-economically disadvantaged communities.  The Alliance works with diverse organizations such as community-based organizations, foundations, corporations, government agencies, universities, and private industry to carrying out its mission with the objective of improving public health. The Alliance also works with these organizations to support internship opportunities for socio-economically disadvantaged students to gain exposure to career in science and public health.

III.  Substance of Agreement:

FDA enters this MOU with the Alliance to:  1) Expose socio-economically disadvantaged students to scientific and allied health professions through experiential and educational internship opportunities in science, public health and biomedical sciences in mentored laboratory settings, and 2) Promote student education and matriculation into the science, public health and biomedical science professions to contribute to a diversified pool of candidates for employment opportunities in science and public health.

IV. Resource Obligations 

This MOU represents the broad outline of the parties’ present intent to enter specific agreements for collaborative efforts between FDA and the Alliance.  It does not create binding or enforceable obligations against any party to commit resources.  This MOU does not affect or supersede any existing or future agreements or arrangements among the parties.  It also 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, regulations and statutes affecting FDA, and NAHH and its members.

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:
Mary C. Hitch
Senior Policy Advisor
Office of External Relations
U.S. Food and Drug Administration
5600 Fishers Lane, Room 15A07
Rockville, Maryland 20857
301-827-4406 (Telephone)
301-827-8030 (FAX)

Adolph Falcon
Vice President
National Alliance for Hispanic Health
1501 16th Street, N.W.
Washington, D.C. 20036

V.  Terms, Termination, Modification

This agreement, when accepted by both parties, will have an effective period of performance from date of signature until five year after the date of signature and may be modified by mutual consent or may be terminated by either party on a 60- day advance written notice to the other.



Signed by: Jane Delgado, President and CEO

Date: 01/20/2010


Signed by Joshua Sharfstein, Deputy Commissioner of Food and Drugs