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MOU 225-10-0019

 

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/NOISH). This agreement between 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 Iiterature-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, principle 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-or-interest documents in accordance with DHHS and PHS
regulations.
• Provide reports on specific projects and/or arrange for special on-site visits
as required.
 
The NTP Steering Committee, composed of the directors of the three NTP participating agencies (or their designees) will meet with the NTP Director, as
Needed, to review and evaluate the appropriateness of designated NTP-related
activities and to discuss NTP programmatic directions.
 
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 Contact
FDA/NCTR: Paul C. Howard, Ph.D.
Liaison to the NTP
National Center for Toxicological Research (NCTR)
U.S. Food & Drug Administration
3900 NCTR Rd
Jefferson, AR 72079
Tel: 870-543-7672
Fax: 870-543-7792
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
Tel: 919-541-4532
Email: bucher@niehs.nlh.gov
 
CDC/NIOSH: Mark A. Toraason, Ph.D.
Senior Science Fellow
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
4676 Columbia Parkway, MS C23
Cincinnati, OH 45226
Tel: 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.
Approved and Accepted
for the National Institutes of Health
Signed by: Linda Birnbaum, P.h.D, DABT, ATS
Director
National Toxicology Program and National Institutes of Environmental Health Sciences
Date: October 27, 2010
 
Approved and Accepted
for the Centers for Disease Control and Prevention
Signed by: John Howard, M.D., M.P.H., J.D., LLM
Director
National Institute for Occupational Safety and Health
Date: October 25, 2010
 
Approved and Accepted
for the Food and Drug Administration
Signed by: Jesse L. Goodman, M.D., M.P.H.
Chief Scientist and Deputy Commissioner
Date: October 7, 2010