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MOU NTP-15-1

MOU NTP-15-1 has been amended, effective May 25, 2022.

MEMORANDUM OF UNDERSTANDING BETWEEN THE NATIONAL TOXICOLOGY PROGRAM AND 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 responsibilities 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 [DHHS]) established the NTP. The chief goals of the NTP 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. As established, 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). This agreement between the FDA, NIH/NIEHS, CDC/NIOSH and the NTP affirms a commitment to provide resources dedicated toward carrying out the mission of the NTP and outlines various administrative and managerial actions the agencies will take to support NTP's activities.

III. Program Elements

Each participating member will identify projects complementary to or in-support of NTP's testing/research and literature-analysis activities (hereafter referred to as NTP-related activities) and determine the committed program elements for those projects including, but not limited to, research and development support contracts and cooperative agreements, inter- and intra-agency agreements, extramural grants, program management, and administrative support.

At the end of each fiscal year, each participating member will provide information on NTP-related activities for inclusion in the NTP Annual Report including, but not be limited to, for each project: name, principal investigator(s), objective(s) and aim(s), relationship to ongoing NTP testing/research or literature-analysis activity, award or cost, and related publications. Information regarding any formal reviews or institutional approvals should also be included.

IV. Resources

Each participating member agrees to provide the resources including staffing, space, and funding needed to conduct NTP-related activities. No funds will be exchanged under this agreement.

At the end of each fiscal year, each participating member agrees to provide information on the resources dedicated to NTP-related activities for inclusion in the NTP Annual Report. The information will include, but not be limited to personnel and budget.

V. Administrative Policies

Each participating member will voluntarily provide the resources required to support NTP-related activities. As such, each participating member will

  • Retain responsibility for determining which agency projects are NTP-related activities and for review of those activities.
  • Retain responsibility and accountability for the resources required to support NTP-related activities assuming the resources are used for the purpose for which appropriated.
  • Review, award, and administer relevant research programs and supporting contracts in accordance with existing practices and procedures.
  • Remain the custodian for all equipment procured by a signator institution.
  • Retain responsibility for administrative support and for the supervision of employees working on NTP-related activities.
  • Ensure that all professional-level staffs participating in NTP-related activities have filed conflict -of-interest documents in accordance with DHHS and PHS regulations.
  • Provide reports on specific projects and/or arrange for special on-site visits as required.

Each participating member will invite other NTP-member agencies, as appropriate, to designate a liaison to their external scientific advisory group(s).

VI. Points of Contacts

FDA/NCTR:

Paul C. Howard, Ph.D.
Associate Director
Director, Office of Scientific Coordination
National Center for Toxicological Research
U.S. Food and Drug Administration
3900 NCTR Road
Jefferson, AR 72079
T: 870-543 -7672
Email: paul.howard@fda.hhs.gov

NIH/ NIEHS:    

John R. Bucher, Ph.D.
Associate Director, NTP
National Institute of Environmental Health Sciences
National Institutes of Health
P.O. Box 12233, MD K2-02
Research Triangle Park, NC 27709
T: 919-541-4532
Email: bucher@niehs.nih.gov

CDC/NIOSH:

 Elizabeth Whelan, Ph.D.
Chief, Industrywide Studies Branch
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
4676 Columbia Parkway, MS C23
Cincinnati, OH 45226
T: 513-533-8207
Email: mht1@cdc.gov

VII. Duration/Modification/Termination

This MOU is to take effect upon signature of all participants and remain in effect for a period of five 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 terminations date.

VIII. Approvals

FDA

/s/
Luciana Borio, M.D.
Acting Chief Scientist
U.S. Food and Drug Administration
Date Signed: 10/19/2015

NIH/NIEHS

/s/
Linda S. Birnbaum, Ph.D., DABT, ATS
Director
National Institute of Environmental Health Sciences
National Institutes of Health
Date Signed: 9/25/2015

CDC/NIOSH

/s/
John Howard, M.D., MPH, J.D., LLM
Director
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Date Signed: 10/30/2015

National Toxicology Program

/s/
Linda S. Birnbaum, Ph.D., DABT, ATS
Director
National Toxicology Program and
National Institute of Environmental Health Sciences
National Institutes of Health
Date Signed: 9/25/2015

EXTENSION AGREEMENT

This Extension Agreement amends the Memorandum of Understanding between the National Toxicology Program (NTP) and the National Institute of Environmental Health Sciences of the National Institutes of Health (NIH/NIEHS), the Food and Drug Administration (FDA), and the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention (CDC/NIOSH) ("MOU NTP-15-1"), effective October 30, 2015.

The purpose of this amendment is to extend the termination date to June 30, 2022. This is permissible under Section VII of MOU NTP-15-1, Duration/Modification/Termination. All other content, terms, and conditions stated in the MOU NTP-15-1 between NTP, NIH/NIE HS, FDA, and CDC/NIOSH effective October 30, 2015 will remain unchanged.

This agreement, when accepted by the undersigned, will have an effective period of performance from the date of the latest signature until June 30, 2022 and may be modified by unanimous written consent or terminated by any party upon a thirty-day advance written notice to the others.

Approved and Accepted By:

/s/
Food and Drug Administration
RADM Denise, M.S., Chief Scientist
Date Signed: 7/15/2021
Approved and Accepted By:

/s/
National Institutes of Health/National Institute of Environmental Health Science
Brian R. Berridge, D.V.M., Ph.D., DACVP, Scientific Director
Division of the National Toxicology Program and NTP Associate Director
Date Signed: 7/16/2021

Approved and Accepted By:

/s/
Center for Disease Control and Prevention
National Institute for Occupational Safety and Health
John Howard, M.D., Director
Date Signed: 7/16/2021

Approved and Accepted By:

/s/
National Toxicology Program
Name: Richard Woychik, Ph.D., Director
Date Signed: 7/17/2021

EXTENSION AGREEMENT

This Extension Agreement amends the Memorandum of Understanding between the National Toxicology Program (NTP) and the National Institute of Environmental Health Sciences of the National Institutes of Health (NIH/NIEHS), the Food and Drug Administration (FDA), and the National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention (CDC/NIOSH) ("MOU NTP-15-1"), effective October 30, 2015.

The purpose of this amendment is to extend the termination date to June 30, 2023. This is permissible under Section VII of MOU NTP-15-1, Duration/Modification/Termination. Except for the Points of Contact under Section VI, all other content, terms, and conditions stated in the MOU NTP-15-1 between NTP, NIH/NIEHS, FDA, and CDC/NIOSH effective October 30, 2015, will remain unchanged. The new Points of Contact are:

FDA/NCTR:    

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
3900 NCTR Road
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
111 Alexander Drive, PO Box 12233, MD K2-02
Research Triangle Park, NC 22709
T: 919-236-3891
Email: walker3@nichs.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
1090 Tusculum Avenue, MS-R-15
Cincinnati, Ohio, 45226
T: 513-84L-4L71
Email: cj19@cdc.gov

This agreement, when accepted by the undersigned, will have an effective period of performance from the date of the latest signature until June 30, 2023, and may be modified by unanimous written consent or terminated by any party upon a thirty-date advance written notice to the others.

Approved and Accepted By:

/s/
Food and Drug Administration
Jacqueline O'shaughnessy, Ph.D., Acting Chief Scientist
Date Signed: 5/25/2022

Approved and Accepted By:

/s/
National Institutes of Health
National Institute of Environmental Health Science
Brian R. Berridge, D.V.M., Ph.D., DACVP, Scientific Director
Division of the National Toxicology Program and NTP Associate Director
Date Signed: 5/25/2022

Approved and Accepted By:

/s/
Center for Disease Control and Prevention
National Institute for Occupational Safety and Health
John Howard, M.D., Director
Date Signed: 5/25/2022

Approved and Accepted By:

/s/
National Toxicology Program
Richard Woychik, Ph.D., Director
Date Signed: 5/25/2022

 
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