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        FDA Memoranda of Understanding

Non-Profit and Other MOUs Home
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          Partnerships: Enhancing Science Through Collaborations With FDA
          FDA Memoranda of Understanding
          Non-Profit and Other MOUsFDA Memoranda of Understanding Non-Profit and Other MOUs
  	
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    PrintMOU No.
			Purpose
			Parties
			FDA Lead Center or
			Office Contact
			Effective Date
			Expiration Date
			Last Revision Date225-22-018
			Share interest in scientific progress in the disciplines that directly and indirectly affect human and animal health and medicine.
			Society of Toxicology
			Office of the Chief Scientist
			Chad P. Nelson, Ph.D., M.S.P.H
			301-796-4643
			2022-07-29
			2027-07-29225-20-015
			The Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), the American Association for Cancer Research (AACR), Oncology Nursing Society (ONS) and Hematology/Oncology Pharmacy Association (HOPA) agree to collaborate in Project Livin’ Label, a new educational initiative aimed at increasing awareness of recent FDA oncology drug approvals and understanding of the associated drug product label. The FDA, AACR, ONS and HOPA share interests in promoting scientific progress through exchange of scientific capital in oncology education, collaborative learning, and research. All institutions foresee benefits from collaborating in this new educational initiative focused on regulatory policy. This Memorandum of Understanding (MOU) establishes the terms for the collaboration for Project Livin’ Label and provides a basis for other related efforts to promote these shared, mutual interests in collaborative education and learning.
			American Association for Cancer Research (AACR), Oncology Nursing Society (ONS) and Hematology/Oncology Pharmacy Association (HOPA)
			Oncology Center of Excellence
			Laura B. Wisch
			Program Manager for Education
			10903 New Hampshire Ave, WO 22/2135
			Silver Spring, MD 20993
			Laura.wisch@fda.hhs.gov
			301-538-6580
			2022-05-03
			2027-05-03225–20–018
			FDA and the Academy will collaborate to increase the awareness of agricultural biotechnology/genetically engineered foods and develop educational materials for dietitians.
			Academy of Nutrition and Dietetics
			CFSAN
			Sharmi Das
			Phone: (240) 402-3786
			2020-09-04
			Lifespan of the CPE Learning Series (a maximum of 3 years)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
			1977-09-12
			Indefinite225-83-3000
			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
			1983-09-07
			Indefinite225-84-2003
			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
			1984-03-14
			Indefinite225-93-4006
			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
			1993-08-01
			Indefinite225-93-7000
			Evaluating test kits for detecting animal drug residues in milk.
			AOAC
			CVM
			Tracey Forfa
			(240) 276-9006
			1992-10-22
			Indefinite225-03-4000B
			FDA and NTEU agree to work together regarding mandatory foreign inspection assignments.
			National Treasury Employees Union (NTEU)
			ORA
			Diana Kolaitis
			(718) 662-5416
			2003-06-11
			expires w/contract225-04-4002
			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
			2003-10-22
			Indefinite225-10-0021
			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
			2014-06-07
			2019-06-06225-11-0017
			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
			2014-07-17
			Indefinite225-11-0021
			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
			2012-05-15
			Indefinite225-12-0001
			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
			2012-02-02
			Indefinite225-12-0038
			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
			2012-09-06
			Indefinite225-13-0027
			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
			2013-09-12
			Indefinite225-14-0006
			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
			2008-12-16
			Indefinite225-14-0019
			The FDA/CDRH and H-ISAC have a shared interest in encouraging the identification, mitigation, and prevention of cybersecurity threats to medical devices. The purpose of this collaboration is to establish a basis upon which to foster and improve the safety of medical devices from cybersecurity threats.
			The Health Information Sharing  & Analysis Center, INC (H-ISAC)
			CDRH
			Suzanne Schwartz
			Deputy Director, OST
			(301) 796-6937
			2020-01-31
			2025-01-30225-14-012
			Collaborative health professional training, outreach, and research initiatives.
			American Nurses Association
			Teresa Rubio
			(301) 796-5113
			2013-05-17
			Indefinite225-14-023
			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
			2014-10-3
			2019-10-2225-15-010
			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
			2015-03-29
			2020-3-28225-15-012
			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
			2015-05-29
			Indefinite225-15-017
			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
			2015-04-09
			Indefinite225-16-026
			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
			2015-11-01
			2021-10-31225-16-025
			Provide and promote FDA information in the form of FDA health consumer information to consumers.
			Healheo360
			Steve Morin
			301-796-0161
			2017-03-22
			2022-03-21225-16-027
			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
			2016-12-06
			2021-12-05225-17-001
			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
			Pras Pathmanathan, Ph.D.
			2017-05-30
			2027-05-31
			2023-10-13225-17-003
			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
			2016-10-21
			2021-10-20225-17-005
			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
			2016-11-08
			2019-11-07225-17-008
			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)
			Dayle Cristinzio and Beth Fritsch
			Office of External Affairs
			2016-12-02
			2028-05-22
			2023-05-23225-17-019
			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
			2017-06-27
			Indefinite225-17-020
			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 OfficerMichael.murphy@fda.hhs.gov
			2017-10-18
			Indefinite225-17-022
			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
			2017-08-10
			2022-08-10225-17-027
			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
			2018-04-11
			2023-04-10225-17-029
			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
			CVMAskCVM@fda.hhs.gov
			(240) 402-7002
			2019-02-27
			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
			2017-10-08
			Indefinite225-17-020
			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
			2017-10-18
			Indefinite225-18-007
			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
			2018-02-02
			2023-02-02225-18-008
			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
			2018-02-20
			2021-02-20225-18-009
			Collaboration to promote the inclusion of diverse women in clinical trials
			Society for Clinical Research Sites
			Pamela Scott, Ph.D., OWH
			301-796-0530
			2018-03-05
			2019-03-05225-18-011
			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
			2018-04-26
			2021-04-26225-18-012
			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
			CDER/OSE
			2021-10-05
			Indefinite225-18-20
			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
			2018-06-19
			2023-06-19225-18-024
			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
			2018-10-09
			Indefinite225-18-028
			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
			2018-09-14
			2023-09-14225-18-030
			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
			2018-09-30
			2023-09-30225-19-004
			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
			2019-06-04
			2024-06-04225-19-023
			Promote shared interests in various science-based initiatives, outreach, training, fellowships/internships, research and scientific education to advance health equity.
			The Alliance of Multicultural Physicians [a collective of five national organizations - The Association of American Indian Physicians (AAIP), Association of Black Cardiologists (ABC), National Council of Asian Pacific Islander Physicians (NCAPIP), National Hispanic Medical Association (NHMA),
			and National Medical Association (NMA)]
			Office of Minority Health and Health Equity (OMHHE)
			CDR Yvonne Santiago
			(240) 753-5808
			2019-07-24
			Indefinite
			2023-04-13225-19-024
			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 EpidemiologyClaudia.Manzo@fda.hhs.gov
			2019-06-17
			2025-01-31
			2022-01-31225-20-009
			This MOU between FDA and the Foundation will expedite collaborative research and data collection efforts related to COVID-19.  Under this MOU, FDA and the Foundation will seek opportunities to participate in collaborative research related to COVID-19 data collection.
			Reagan-Udall Foundation for the FDA
			Trudy Lilly/OC/Senior Policy Coordinatortrudy.lilly@fda.hhs.gov
			2021-04-13
			2022-04-13225-20-013
			To establish the FDA-AACR Oncology Educational Fellowship, as well as other collaborative educational efforts, as appropriate. The FDA and AACR share interests in promoting scientific progress through exchange of scientific knowledge in oncology education, collaborative learning, and research. Both institutions foresee benefits from the mutual exchange of educational expertise in translational oncology drug development and regulatory policy.
			American Association for Cancer Research
			Oncology Center of Excellence
			Jennifer Gao
			Associate Director for Education
			10903 New Hampshire Ave, WO 22/2135
			Silver Spring, MD 20993Jennifer.gao@fda.hhs.gov
			240-402-4683
			2020-05-28
			2025-05-28225-20-014
			FDA and AMA will collaborate to develop and disseminate educational and outreach information to physicians on dietary supplements.
			American Medical Association
			CFSAN
			Sharmi Das
			Director, Division of Education, Outreach, and Information
			5001 Campus Drive
			College Park, MD 20740Sharmi.Das@fda.hhs.gov
			240-402-3786
			2020-05-27
			2025-05-27225-21-004
			FDA and the Truth Initiative will share research and scientific information to increase our understanding about e-cigarettes and new tobacco products to improve youth prevention campaign messages and cessation tools.
			Truth Initiative
			CTP Office of Health Communications and Education
			Dr. Tesfa Alexander
			Director, Division of Research and EvaluationTesfa.Alexander@fda.hhs.gov
			301-796-7745
			2020-11-01
			2025-10-31
Sub-Topic Paragraphs
          Other CategoriesDomestic 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.

                                                                                  Content current as of:
      10/30/2023Non-Profit and Other MOUs
 
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