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  6. MOU 225-23-012
  1. Domestic MOUs

MOU 225-23-012

MEMORANDUM OF UNDERSTANDING
between
THE NATIONAL INSTITUTES OF HEALTH
National Institute of Environmental Health Sciences 
and 
THE FOOD AND DRUG ADMINISTRATION
and
THE CENTERS FOR DISEASE CONTROL AND PREVENTION
National Institute for Occupational Safety and Health

 

I. Purpose

This Memorandum of Understanding (MOU) delineates the partnership of the three agencies as participating members of the National Toxicology Program (NTP).

II. Background

On November 15, 1978, the Secretary of the Department of Health, Education and Welfare (currently the Department of Health and Human Services [HHS]) established the NTP. Since then, the NTP has become a global toxicological resource, addressing emerging toxicological needs while adhering to the fundamental principles of independence, transparency, and quality. The mission of the NTP is to partner to build knowledge and advance toxicological sciences to protect and promote human health. The NTP's chief goals are to (1) characterize the toxicity of chemicals and other substances of public health concern, (2) strengthen the Department's activities related to the development and validation of new and improved toxicology test methods, (3) strengthen the knowledge base in toxicology, and (4) communicate information to all interested parties including health research and regulatory agencies, medical and scientific communities, and the public. The program is comprised of the relevant activities of the Food and Drug Administration (FDA), the National Institutes of Health's National Institute of Environmental Health Sciences (NIH/NIEHS), and the Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health (CDC/NIOSH). Working together, the NTP partners develop and apply new approaches, technologies, and research methods, necessary to achieve the vision of innovative and trusted toxicological science that protects human health. This agreement between the three member agencies and the NTP affirms a commitment to provide resources dedicated toward carrying out and supporting the NTP's mission and its activities.

III. Program Elements and Resources

Each participating member will identify projects that support NTP's research, testing, and literature-analysis activities. The NTP Director and representatives from the three NTP-partner agencies who serve on the NTP Steering Committee will discuss and agree to NTP programmatic directions and the designation of NTP activities.

Each participating member will, to the extent consistent with member policy and priorities and consistent with federal law, provide the resources required to support and conduct NTP activities. Resources for those activities might include, but not limited to, intramural research funds, research and development support contracts and cooperative agreements, inter- and intra­ agency agreements, extramural grants, program management, and administrative support. No funds are required to be specifically exchanged between NTP partner agencies under this agreement.

NTP operations will be managed by the Office of NTP Scientific Operations and Coordination, a virtual interagency administrative unit based at the National Institute of Environmental Health Sciences, with participation by all NTP partners.

IV. Points of Contact

FDA:
Goncalo Gamboa da Costa, Ph.D.
Senior Science Advisor
Office of the Center Director
National Center for Toxicological Research
U.S. Food and Drug Administration
Jefferson, AR 72079
T: 870-543-7400
Email: goncalo.gamboa@fda.hhs.gov

NIH/NIEHS:
Nigel J. Walker, Ph.D.
Acting Branch Chief
Systems Toxicology Branch
Division of the National Toxicology Program
National Institute of Environmental Health Sciences
National Institutes of Health
Research Triangle Park, NC 22709
T: 919-236-3891
Email: walker3@niehs.nih.gov

CDC/NIOSH:
Christina C. Lawson, Ph.D.
Chief, Field Research Branch
Division of Field Studies and Engineering
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Cincinnati, Ohio, 45226
T: 513-841-4171
Email: cjl9@cdc.gov

V. Duration/Modification/Termination

This MOU is to take effect upon signature of all participants and remain in effect for a period of five (5) years, unless the participants decide otherwise in writing. This MOU may be amended at any time by mutual written consent of the participants. Additionally, the participants agree to review this MOU annually to determine whether it should be revised, renewed, or cancelled. A participant may terminate its participation in this MOU by providing written notice to the other participants at least thirty (30) days in advance of the desired termination date.

VI. Approvals

FDA

/s/
Namandje Bumpus, Ph.D.
Chief Scientist
Food and Drug Administration
Date: 7/11/2023

NIH/NIEHS

/s/
Robert C. Sills, D.V.M., Ph.D.
Acting Scientific Director, Division of Translational Toxicology and Deputy Director
National Institute of Environmental Health Sciences
National Institutes of Health
Date: 7/18/2023

CDC/NIOSH

/s/
John Howard, M.D., M.P.H., J.D., L.L.M., M.B.A.
Director
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Date: 7/19/2023

National Toxicology Program

/s/
Richard Woychik, Ph.D.
Director
National Toxicology Program and
National Institute of Environmental Health Sciences
National Institutes of Health
Date: 7/19/2023

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