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  1. Partnerships: Enhancing Science Through Collaborations With FDA

Non-Profit and Other MOUs

Non-Profit and Other MOUs

MOU No. Purpose Parties FDA Lead Center or Office Contact Effective Date Expiration Date
225-78-1000 States the responsibilities of the FDA and NCIMS for execution of the Interstate Milk Shippers Program, the means for resolving questions of interpretation that may arise in the execution of the Program, and the means for making modifications in the Program. National Conference on Interstate Milk Shipments CFSAN
Monica Metz
(240) 402-2041
09-12-1977 Indefinite
225-83-3000 Defines the working arrangements between FDA and USPC in regards to the review revisions to compendial requirements for drugs. U.S. Pharmacopeial Convention, Inc. (USPC) CDER
Diane Ehrlich
(301) 443-5373
09-07-1983 Indefinite
225-84-2003 To foster and improve the sanitation and quality of shellfish in the U.S. Interstate Shellfish Sanitation Conference (ISSC) CFSAN
Donald Kraemer
(240) 402-2300
03-14-1984 Indefinite
225-93-4006 CFP and FDA agree to establish a working relationship to address issues on food safety in order to implement the recommendations adopted at Conference meetings. Conference for Food Protection (CFP) ORA
Diana Kolaitis
(718) 662-5416
08-01-1993 Indefinite
225-93-7000 Evaluating test kits for detecting animal drug residues in milk. AOAC CVM
Tracey Forfa
(240) 276-9006
10-22-1992 Indefinite
225-03-4000B FDA and NTEU agree to work together regarding mandatory foreign inspection assignments. National Treasury Employees Union (NTEU) ORA
Diana Kolaitis
(718) 662-5416
06-11-2003 expires w/contract
225-04-4002 FDA and BIG will work together to address issues affecting children, families, and communities within each organizations jurisdiction through educational campaigns-food safety. Blacks in Government (BIG) OC
LaJuana Caldwell
(301) 827-4450
10-22-2003 Indefinite
225-10-0021 Defines the framework in which the FDA will provide publicly available content to be used in health professional informational, educational, and training programs that will be run by WebMD LLC ("WebMD") and Medscape, LLC ("Medscape"), an entity accredited by ACCME, ANCC, and the ACPT to provide continuing professional education to physicians, nurses and pharmacists, respectively. Amended to extend expiration date. Medscape, LLC and WebMD OC/OEA
Anna Fine
(301) 796-8471
06-07-2014 06-06-2019
225-11-0017 Defines the framework for collaboration between CDER and FDA and the Institute for Safe Medication Practices. The purpose of the collaboration is to improve the safety of the American public when using CDER-regulated products. Amendment 1 to extend timeframe. Amendment 2 to clarify point of contact for conveyance of information. Institute for Safe Medication Practices CDER
Cynthia Fitzpatrick
(301) 796-3115
07-17-2014 Indefinite
225-11-0021 Establishes a strategic framework for collaboration between FDA and the Uppsala Monitoring Centre (UMC) in Sweden and outlines the process for collaborative sharing of public information between the FDA and the UMC for carrying out their common goal to improve the global safety and effective use of medicinal products. Uppsala Monitoring Centre (Sweden) CDER
Gerald Dal Pan
(301) 796-2380
05-15-2012 Indefinite
225-12-0001 The purpose of MOU 225-12-0001 is to promote initiatives related to radiation protection from CT medical imaging. Heads of the European Radiological protection Competent Authorities (HERCA) CDRH 02-02-2012 Indefinite
225-12-0038 Establishes the terms for collaboration to promote these shared interests education and research, and mutual exchange of training and research expertise in clinical pharmacology and translational science. American Society of Nephrology CDER
Patrick Archdeacon
(301) 796-3952
09-06-2012 Indefinite
225-13-0027 Collaborate on developing new methods to evaluate the toxicity of substances regulated by the FDA; improving the pathway for the review and approval of regulated substances; facilitating the FDA’s engagement with scientists from academia, government and industry on regulatory science questions that impact drug development and safety prediction; sharing information that is in the public domain and considered non-confidential; and publicly disseminating scientific knowledge to help bring safe and effective products to market. ILSI Health and Evironmental Sciences Institute CDER 09-12-2013 Indefinite
225-14-0006 Establish framework for collaboration between FDA and Washington Adventist Hospital including collaborative research, public outreach, extension activities, training, and exchange of medical professionals and staff by the two organizations. Washington Adventist Hospital Eileen Parish, M.D.
Office of the Chief Scientist
(301) 796-8522
12-16-2008 Indefinite
225-14-012 Collaborative health professional training, outreach, and research initiatives. American Nurses Association Teresa Rubio
(301) 796-5113
05-17-2013 Indefinite
225-14-0019 Encouraging the identification, mitigation, and prevention of cybersecurity threats to medical devices. National Health Information Sharing and Analysis Center, Inc. Suzanne Schwartz, M.D., MBA
(301) 796-6937
08-26-2014 08-26-2019
225-14-023 Promoting scientific progress, furthering public policy efforts, and translating innovation and discoveries into practice in the areas of medical and biological engineering. American Institute for Medical and Biological Engineering AIMBE CDRH
Anindita Saha (301) 796-2537
10-3-2014 10-2-2019
225-14-024 Promote and Provide FDA Consumer Updates on public health and safety messages on emerging issues and product recalls to consumers. Healthline.com OEA/OC
Jason Brodsky
(301) 796-8234
09-30-2014 09-29-2019
225-15-010 Sets forth principles and guidelines by which the parties intend to engage in a cooperative public education program. It is the parties’ intent to promote and increase the use of health knowledge, skills, and practices by the general population in its patterns of daily living. The National Forum for Heart Disease and Stroke Prevention OEA/OC
Helene Clayton-Jeter
(301) 796-8452
03-29-2015 3-28-2020
225-15-012 Engage in sharing of pre-decisional nonpublic compliance and enforcement policy information is intended to improve Federal-State uniformity, cooperative regulatory activities, or implementation of Federal-State agreements. National Association of Attorneys General CTP
Ann Simoneau
(301) 796-9295
05-29-2015 Indefinite
225-15-017 Promoting scientific progress through the exchange of scientific capital to develop innovative, collaborative projects in research, education, and outreach for the purpose of fostering medical product innovation, enabling the acceleration of medical product development, manufacturing, and translational therapeutics, and enhancing medical product safety.  Replaces MOU 225-05-8000. Critical Path Institute CDER
ShaAvheree Buckman-Garner
(301) 796-2600
04-09-2015 Indefinite
225-16-002 Collaborate in educating the public about health issues National Consumers League CDER
Kimberly Rawlings
(301) 796-3818
11-10-2015 11-09-2018
225-16-026 Shared interests in promoting scientific progress through exchange of scientific capital in cardio-vascular education, training, and research. Inova Heart and Vascular Institute Anindita Saha, CDRH
301-796-2537
11-01-2015 10-31-2021
225-16-025 Provide and promote FDA information in the form of FDA health consumer information to consumers. Healheo360 Steve Morin,
301-796-0161
03-22-017 03-21-2022
225-16-027 Share interest in scientific progress in the disciplines that directly and indirectly affect human and animal health and medicine. Society for Toxicology Office of the Chief Scientist 12-6-2016 12-05-2021
225-17-001 Promoting progress in the application of computer modelling and simulation in healthcare through the exchange of knowledge, information, case studies and policy. The Avicenna Alliance for Predictive Medicine Tina M. Morrison, PhD 05-30-2017 05-31-2022
225-17-003 Shared interest in facilitating the successful adoption of Unique Device Identifiers (UDIs) across the healthcare device ecosystem especially with regard to the initial capture of UDI in supply chain and clinical health information technology (IT) systems. Association of Healthcare Resource and Materials Management (AHRMM) CDRH Terry L. Reed
301-796-6130
10-21-2016 10-20-2021
225-17-005 FDA and AMA will collaborate to develop and distribute educational and outreach information to physicians to help them diagnose, treat and report foodborne illnesses; and educate patients on preventing foodborne illness. American Medical Association CFSAN,
Sharmi Das
202-402-3786
11-08-2016 11-07-2019
225-17-008 Partnership between FDA and FDAAA on future specific undertakings that are considered beneficial for both organizations and are directly related to FDA's mission. Replaces MOU 225-03-8004. Food and Drug Administration Alumni Association (FDAAA) Heidi Marchand, OC/OER
301-796-8457
12-02-2016 12-01-2021
225-17-019 Establishes a framework for collaboration to facilitate existing and new mutually agreed upon programs and activities and to carry out their common goal to improve public health by stimulating and fostering medical product innovation and enabling medical product development. Bill and Melinda Gates Foundation RADM Carmen Maher
Assistant Surgeon General
Acting Assistant Commissioner for Counterterrorism and Emerging Threats,
Acting Director, Office of Counterterrorism & Emerging Threats (OCET)
Carmen.Maher@fda.hhs.gov
06-27-2017 Indefinite
225-17-020 This MOU establishes a cooperative relationship between the American Association of Veterinary State Boards (AAVSB) and the U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM), regarding the exchange of veterinarian licensure status and enforcement information. American Association of Veterinary State Boards CVM
Michael Murphy, DVM, JD, Ph.D.
Veterinary Medical Officer
Michael.murphy@fda.hhs.gov
10-18-2017 Indefinite
225-17-022 Promote scientific progress in food sciences through exchange of scientific capital in analytical methods development and validation, as well as in educational initiatives. Independent Laboratories Institute Palmer A. Orlandi, RADM, 301-796-6592 08-10-2017 08-10-2022
225-17-027 Establishes a framework for this collaboration to promote shared interests, which can be pursued through areas of
innovative toxicity testing, regulatory science, education and training.

The American College of Toxicity (ACT)

Office of the Chief Scientist

RADM Denise Hinton, Acting Chief Scientist
301-796-4880

04-11-2018 04-10-2023
225-17-029 Accessing information to aid in assessing whether a particular intended use of a proposed new animal drug product meets the definition of "minor use." Medical Management International, Inc. d.b.a. Banfield Pet Hospital CVM AskCVM@fda.hhs.gov (240) 402-7002  2-27-2019  Indefinite (Renewed Yearly)
225-17-030 Provide training scientists in regulatory science and policy to foster a better understanding of FDA’s work in their post-fellowship employment. Contribute to a workforce that can advance the field of regulatory science and provide leadership in this area in policy organizations, industry, academia, or the government. Reagan-Udall Foundation Office of the Chief Scientist
Leslie Wheelock, MS, RN
301-706-8450
10-08-2017 Indefinite
225-17-020 Exchange of veterinarian licensure status and enforcement information, including information from the AAVSB licensure and disciplinary database and publicly available untitled letters and warning letters and publicly available information regarding enforcement actions FDA CVM pursues against veterinarians. American Association of Veterinary State Boards Michael Murphy, DVM, JD, Ph.D.
230-402-6217
10-18-2017 Indefinite

225-18-007

Share common goals, priorities, and interests in promoting awareness and understanding of gender medicine and the science of sex-based differences and through mutually beneficial exchange of information of significance to/for women’s health.  Replaces MOU 225-14-8000. Karolinska Institutet and Stockholms Läns Landsting/Hälso-Och Sjukvårdsförvaltningen (Stockholm County Council/ Healthcare Administration) OWH
Pamela E. Scott, Ph.D.
(301) 796-9440
02-02-2018 02-02-2023
225-18-008 Collaborate to promote scientific progress in innovation, patient education, drug safety communications, training, research, including risk evaluation and mitigation strategies (REMS), and adverse event reporting. National Organization for Rare Disorders Andrea Furia-Helms, OMPT
301-796-8455
02-20-2018  02-20-2021
225-18-009 Collaboration to promote the inclusion of diverse women in clinical trials Society for Clinical Research Sites
 
Pamela Scott, Ph.D., OWH
301-796-0530
03-05-2018 03-05-2019
225-18-011 The purpose of the collaboration is to improve the safety of the American public when using FDA-regulated medical products. This MOU establishes the terms for collaboration to promote these shared interests. American Society of Health-System Pharmacists Office of External Affairs
Lubna Merchant
(301) 796-5162
04-26-2018 04-26-2021
225-18-012 Establishes the terms for collaboration to promote scientific progress through exchange of scientific capital in medication error prevention and medication safety including risk evaluation and mitigation strategies (REMS) and related implementation, MedWatch adverse event reporting, scientific education, training and research programs.  The American Pharmacist Association

OC/OHCA
Heidi C. Marchand, OHCA
301-796-8457

CDER
Lubna Merchant
301‐796‐5162
Effective Date:
 

04-11-2018 04-11-2023
225-18-20 Shared interest in promoting scientific progress in diverse disciplines that affect human and animal health and medicine.
 
Institute of Quantitative Systems Pharmacology CDER
Padmaja Mummaneni, PhD.
301-796-2027
06-19-2018 06-19-2023
225-18-024 To have a shared interest in scientific progress in the diverse disciplines and indirectly affect human and animal health and medicine. The Parties also endorse scientific training for faculty and staff to foster a well-grounded foundation in interdisciplinary fields in which academia and government share mutual interest. St. Jude Children’s Research Hospital CDER,
Padmaja Mummaneni
10-09-2018 Indefinite
225-18-028 Established to promote a shared interest to encourage the identification, mitigation, and prevention of cybersecurity threats to medical devices. Health Information Sharing & Analysis Center and MedISAO

CDRH
Suzanne B. Schwartz, M.D., M. B.A
301-796-6937

CDRH
Seth Carmody, Ph.D.
301-796-6944

09-14-2018 09-14-2023
225-18-030 Established to promote a shared interest to encourage the identification, mitigation, and prevention of cybersecurity threats to medical devices. Health Information Sharing & Analysis Center and Sensato Critical Infrastructure ISAO

CDRH
Suzanne B. Schwartz, M.D., M. B.A
301-796-6937

CDRH
Seth Carmody, Ph.D.
301-796-6944

09-30-2018 09-30-2023
225-19-004 This MOU provides a framework for coordination and collaboration to promote the best science and practices associated with food chemistry and regulatory science. American Chemical Society CFSAN
Allen Rudman, Ph.D.
Senior Advisor
Senior Science and Policy Staff
240-402-1400
06-04-2019 06-04-2024
225-19-024 The purpose of the collaboration is to improve the safety of the American public when using FDA‐regulated medical products. National Council for Prescription Drug Programs CDER
Claudia Manzo, Director 
Office of Medication Error Prevention and Risk Management 
Office of Surveillance and Epidemiology 
Claudia.Manzo@fda.hhs.gov
06-17-2019 06-17-2022

 


Sub-Topic Paragraphs

Other Categories

Domestic MOUs

Agreements between FDA and other domestic government entities, including federal, state, and local agencies.

Academic MOUs

Agreements between FDA and academic institutions and organizations.