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MEMORANDUMS OF UNDERSTANDING
DOMESTIC
Promote collaboration between FDA and DARPA, and to provide a mechanism for the sharing of certain nonpublic information. Replaces 225-12-0037.
Defense Advanced Research Projects Agency (DARPA)
OC RADM Carmen T. Maher Office of Counterterrorism and Emerging Threats (301) 796-8513
2017-06-01
Indefinite
Collaborate in clinical proteogenomics cancer research - statistical study design, sample collection, preparation, storage and processing, bioinformatics and data analysis/integration, diagnostic assay development, discovery, and validation of biomarkers and surrogate biomarkers of cancer development and drug response, including standardization among technology platforms and assay standards development. Replaces 225-12-0009.
National Cancer Institute (NCI)
CDRH Wendy Rubinstein, M.D., Ph.D. (240) 402-7070 OCE Reena Philip, Ph.D. (301) 796-6179
2017-05-23
2027-08-24
21st Century Cures Regenerative Medicine Innovation Project. Development of platforms and technologies to address critical issues in product development relevant for regulatory submissions, including areas such as tools, methods, standards, or applied science that support a better understanding and improved evaluation of product manufacturing, quality, safety, or effectiveness. Evidence for clinical development, including but not limited to the submission of a pre-Investigational New Drug (IND) or pre-Investigational New Device Exemption (IDE) package.
National Institutes of Health (NIH)
NIH Gary H. Gibbons, Director, National Heart, Blood, and Lung Institute
2017-04-24
2021-09-31
Establishes a training program
United States Army Medical Research and Materiel Command (USAMRMC)
OC Office of the Chief Scientist Office of Counterterrorism and Emerging Threats
2017-01-23
2026-09-30
The purpose of this MOU is to establish a mutually acceptable understanding between FDA and DoD that will strengthen global and national food protection in routine and emergency situations. Replaced MOU 225-09-0006.
U.S. Department of Defense (DoD)
ORA/OHAFO Kathryn Nagy, Liaison W: (404) 253-1225 C: (404) 782-9013 Email ORA/ORS Paul Norris, D.V.M. W: (870) 543-4099 C: (870) 489-7463
2016-11-22
Indefinite
Stimulating Peripheral Activity to Relieve Conditions (SPARC): Use of Existing Market-Approved Technology for New Market Indications
NIH Division of Program Coordination, Planning, and Strategic Initiatives
OC Frank Weichold Office of the Chief Scientist (301) 796-5370
2016-11-18
2021-11-17
Encouraging the identification, mitigation, and prevention of cybersecurity threats to medical devices.
National Health Information Sharing and Analysis Center, Inc (NH_ISAC), Medical Device Innovation, Safety and Security Consortium (MIDISS)
CDRH Suzanne B. Schwartz, MD, MB (301) 796-6937 CDRH Seth Carmody, PhD (301) 796-6944
2016-09-30
2021-09-30
To establish a Center of Excellence in Regulatory Science and enable the agency to leverage its existing scientific resources and community with those of the state of Arkansas’ academic and medical institutions as well as private research and development entities within the state.
State of Arkansas
NCTR William Slikker, Jr., Ph.D. Director (870) 543-7517
2016-08-31
2021-08-30
MOU on Environmental Contaminants in Fish and Shellfish between FDA and EPA.
U.S. Environmental Protection Agency's Office of Water (EPA/OW)
Steven Bloodgood Center for Food Safety and Applied Nutrition (CFSAN)Steven.Bloodgood@fda.hhs.gov
2016-08-02
2027-05-12
To further a common interest in facilitating the development of in vitro microphysiological systems that represent major organs and tissues in the human body, for prediction of efficacy, bioavailability and toxicity.
NIH National Center for Advancing Translational Sciences (NCATS)
OC Carol D. Linden, Ph.D. Director, Office of Regulatory Science and Innovation Office of the Chief ScientistEmail
2016-06-13
2022-06-13
Establish a framework for coordination and collaborative efforts to spur innovation in the development of diagnostic devices that would be of great clinical and public health utility in combating the development and spread of bacteria that are resistant to antimicrobial drugs. Development of innovative technologies to identify antimicrobial-resistant bacteria.
National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Biomedical Advanced Research and Development Authority (BARD A)
OC Office of the Chief Scientist
2016-05-19
2021-05-18
A framework for reciprocal cooperation in responsibilities in promoting proper laboratory animal care and welfare. Supercedes MOU 225-06-4000.
USDA Animal and Plant Health Inspection Service (APHIS), National Institutes of Health (NIH)
OFVM Jeffrey L. Ward, DVM, MS, PhD (240) 402-0885
2016-04-25
2021-04-24
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