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        FDA Memoranda of Understanding

Domestic MOUs

                        
                MOU 225-22-029
          MOU 225-22-024
          MOU 225-22-026
          MOU 225-23-001
          MOU 225-23-003
          MOU 225-23-008
          MOU 225-23-009
          MOU 225-23-012 Home
          About FDA
          Partnerships: Enhancing Science Through Collaborations With FDA
          FDA Memoranda of Understanding
          Domestic MOUsFDA Memoranda of Understanding Domestic MOUs
  	
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    PrintMOU No.
			Purpose
			Parties
			FDA Lead Center or
			Office Contact
			Effective Date
			Expiration Date
			Last Revision Date225-22-012
			Enhance knowledge and efficiency by sharing of information and expertise between the Food and Drug Administration (FDA) and Defense Health Agency (DHA).
			Defense Health Agency (DHA)
			CDER
			Wei Hua
			240-402-8658
			2023-07-05
			2033-07-05
			2023-07-05225-23-006
			The purpose of this Partnership Agreement is to coordinate on activities related to oversight of imported drug, medical device, biological product, tobacco product, food, and cosmetic products in support their respective public health and consumer protection missions.
			Guam Department of Public Health and Social Services (DPHSS) and Guam Customs and Quarantine Agency (CQA)
			Office of Regulatory Affairs/ Office of Partnership and Operational Policy

			Office of Regulatory Affairs/ Office of Import Operations/ Division of West Coast Imports

			Office of Regulatory Affairs/ Office of Regulatory Science

			Office of Regulatory Affairs/Office of Criminal Investigations
			2023-10-18
			2026-10-17225-23-013
			The purpose of this Partnership Agreement is to coordinate and expand food protection efforts between the FDA and the Pennsylvania Department of Agriculture, Bureau of Food Safety & Laboratory Services.
			Pennsylvania Department of Agriculture’s (PDA) Bureau of Food Safety & Laboratory Services
			Office of Regulatory Affairs/ Office of Partnership and Operational Policy

			Office of Regulatory Affairs/ Office of Human and Animal Food Operations/ Human and Animal Food East – Division 2
			2023-09-22
			2026-09-21
			2023-09-22225-23-012
			This Memorandum of Understanding delineates the partnership of the Food and Drug Administration, National Institute of Environmental Health Sciences, and National Institute for Occupational Safety and Health as participating members of the National Toxicology Program.
			National Institutes of Health (NIH) / National Institute of Environmental Health Sciences (NIEHS), Centers for Disease Control and Prevention (CDC) / National Institute for Occupational Safety and Health (NIOSH)
			Goncalo Gamboa da Costa, Ph.D.
			Senior Science Advisor
			Office of the Center Director
			National Center for Toxicological Research
			2023-07-19
			2028-07-19225-23-009
			To facilitate the exchange of information between CFSAN and DEA’s Diversion Control Division with respect to food that may contain controlled substances.
			Drug Enforcement Agency (DEA), Diversion Control Division
			CFSAN, Office of Analytics and Outreach (OAO)
			Katherine Vierk
			Director, Division of Public Health Informatics & Analytics
			Katherine.Vierk@fda.hhs.gov
			2023-06-19
			Indefinite
			2023-06-19225-23-008
			This new MOU will help facilitate the development of requirements for trusted networks needed to enable the use of distributed manufacturing and digital stockpiles, which could ultimately enable veterans and civilians to more rapidly access innovative medical products to support their care.
			Veterans Health Administration (VHA)
			OCS/OCET
			CDR James Coburn
			Senior Advisor
			James.Coburn@fda.hhs.gov
			2023-05-10
			2028-05-10225-22-026
			The MOU provides a framework for continued collaboration between FDA/CDRH, CDC/NIOSH, and DOL/OSHA, including the sharing of certain information, between and among the Parties to facilitate coordination, decision-making, law enforcement activities, and guidance or regulation development through the agencies’ respective authorities and overlapping missions.
			CDC/NIOSH and DOL/OSHA
			Director, FDA/CDRH/OST, Silver Spring, MD
			2023-04-12
			2028-04-12
			2023-04-12225-23-003
			Coordination and collaborative efforts towards widespread use of MPS in advancing novel therapies that are safe and effective, and in biomedical research.
			National Institutes of Health (NCATS)
			Khaled Bouri, Ph.D; MPH
			ORSI/OCS/OC/FDA 
			10903 New Hampshire Ave, Silver Spring, MD 20993 
			Phone: (301) 796-8476 
			Email: khaled.bouri@fda.hhs.gov
			2023-01-12
			Indefinite
			2023-01-12225-22-029
			DACO MOU for furthering mutual reliance.
			Puerto Rico Department of Consumer Affairs (DACO)
			Ramon Hernandez
			San Juan District Director 
			FDA Office of Regulatory Affairs 
			Division of Human and Animal Food East-4
			Ramon.hernandez@fda.hhs.gov
			2023-05-08
			2026-05-08
			2023-05-08225-23-001
			The purpose of this Partnership Agreement is to coordinate and expand food protection efforts between the FDA and the New York State Department of Agriculture and Markets.
			New York State Department of Agriculture and Markets
			Office of Regulatory Affairs/ Office of Partnership and Operational Policy
			Office of Regulatory Affairs/ Office of Human and Animal Food Operations/ Human and Animal Food East – Division 1
			Office of Regulatory Affairs/ Office of Import Operations/ Division of Northeast Imports
			Office of Regulatory Affairs/ Office of Regulatory Science / Office of Human and Animal Foods Laboratory Operations/ New York Human and Animal Food Laboratory
			2023-02-15
			2026-02-14
			2023-02-15225-22-024
			To foster cooperation, communication, and common practices in human health assessments and to harmonize hazard assessment methodologies.
			Center for Public Health and Environmental Assessment (CPHEA) of the U.S. Environmental Protection Agency (EPA)
			CFSAN
			Office of the Center Director (OCD)
			Suzanne Fitzpatrick
			Senior Advisor for Toxicology
			Suzanne.Fitzpatrick@fda.hhs.gov
			2023-01-09
			2028-01-09
			2023-01-09225-22-023
			The purpose of this Partnership Agreement is to coordinate, streamline processes, and enhance food protection efforts between the FDA and Virginia Department of Agriculture and Consumer Services.
			Virginia Department of Agriculture and Consumer Services
			Office of Regulatory Affairs
			Office of Partnership and Operational Policy Office of Regulatory Affairs
			Office of Human and Animal Food Operations/Human and Animal Food East - Division 2
			2022-09-30
			2025-08-31
			2022-09-30225-22-027
			CDC MOU to advance safe food practices
			Centers for Disease Control and
			Prevention’s (CDC) National Center
			for Environmental Health (NCEH)
			Abe Brown
			Office of Partnerships
			Abe.brown@fda.hhs.gov
			2022-09-21
			2023-09-21
			2022-09-21225-22-025
			Provides a framework for collaboration intended to facilitate regulatory and basic science innovation surrounding the medical device development pathway with respect to emerging technologies.
			VA Ventures (VA Ventures) of the U.S. Department of Veterans Affairs (VA)
			Ed Margerrison, PhD 
			Organizational Sponsor
			Edward.Margerrison@fda.hhs.gov
			240-402-0241

			Zane Arp, PhD
			Project Manager
			zane.arp@fda.hhs.gov 
			240-402-0241

			Dorn Carranza, PhD MBA
			Program Manager
			Dorn.Carranza@fda.hhs.gov 
			301-796-8338
			2022-09-22
			2027-09-22
			2022-09-22225-22-015
			To improve and sustain federal coordination and collaboration on issues related to pharmaceuticals in drinking water.
			Environmental Protection Agency (EPA/OW)
			Department of Agriculture (USDA/ARS)
			Department of Interior (DOI/USGS)
			CDER
			Dr. Douglas C. Throckmorton
			301-796-5400
			2022-08-30
			2027-08-30
			2022-05-27225-22-022
			Partnership Agreement Between the U.S. Food and Drug Administration and the Iowa Department of Inspections & Appeals, Food and Consumer Safety
			Iowa Department of Inspections & Appeals, Food and Consumer Safety
			LaTonya Mitchell
			Program Division Director
			FDA Office of Regulatory Affairs
			Office of Human and Animal Food Operations West 2
			2022-07-18
			2025-07-18
			2022-07-18225-21-002
			Research and education in the development and validation of cancer screening and diagnostic devices for near patient use for rural and medically underserved communities.
			National Cancer Institute (NCI)/National Institutes of Health (NIH), and Health Resources and Services Administration (HRSA)
			CDRH
			Brittany Caldwell
			Director of CDRH/OST/PAIRSBrittany.Caldwell@fda.hhs.gov
			2021-06-09
			2026-06-09
			2021-07-29225-21-003
			Establish a framework for the sharing of information between the Alcohol and Tobacco Tax and Trade Bureau (TTB) and the FDA Center for Tobacco Products (CTP) relating to tobacco products regulated by the respective agencies.
			Alcohol and Tobacco Tax and Trade Bureau (TTB)
			CTP
			Office of ManagementTobaccoUserFees@fda.hhs.gov
			2022-06-21
			IndefiniteNTP-15-1
			The National Toxicology Program (NTP) is an interagency program encompassing activities from the Food and Drug Administration (FDA), National Institute of Environmental Health Sciences (NIEHS) and National Institute for Occupational Safety and Health (NIOSH). This amendment extends a 2015 MOU establishing the terms of the partnership.
			National Toxicology Program (NTP), National Institutes of Health's National Institute of Environmental Health Sciences (NIH/NIEHS), and Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health (CDC/NIOSH)
			National Center for Toxicological Research (NCTR)
			Goncalo Gamboa da Costa, Ph.D.
			Senior Science Advisorgoncalo.gamboa@fda.hhs.gov
			2015-10-30
			2023-06-30225-22-020
			To enhance testing surge capacity outside of CDC and public health laboratories before and during public health emergencies
			Advanced Medical Technology Association (AdvaMed), the American Clinical Laboratory Association (ACLA), the Association for Molecular Pathology (AMP), the Association of Public Health Laboratories (APHL), the College of American Pathologists (CAP), the Council of State and Territorial Epidemiologists (CSTE), the National Independent Laboratory Association (NILA), and the Centers for Disease Control and Prevention/Center for Surveillance, Epidemiology and Laboratory Services/Division of Laboratory Systems (CDC/CSELS/DLS)
			Jennifer Ross
			Regulatory Counsel
			Jennifer.ross@fda.hhs.gov
			2022-05-06
			Indefinite225-22-016
			MOU with the USU regarding the 4-Dimensional Bioprinting, Biofabrication and Biomanufacturing Program, DHP, DoD (4D Bio 3) which provides a framework for research coordination and collaborative efforts.
			Uniformed Services University of the Health Sciences (USU)
			Suzanne Fitzpatrick, PhD, DABT, ERT
			Senior Advisor for Toxicology
			Center for Food Safety and Applied Nutritionsuzanne.fitzpatrick@fda.hhs.gov
			2020-11-20
			2024-08-19225-21-016
			Hawaii MOU for Consumer Protection
			Hawaii Dept of Agriculture
			Hawaii Dept of Health
			University of Hawaii
			Dan Solis
			Office of Enforcement & Import Operationsdan.solis@fda.hhs.gov
			2022-03-10
			2025-03-10225-22-014
			This MOU provides a framework for coordination, collaborative efforts, and information sharing between FDA and National Institutes of Health /Clinical Center’s participation in CDER’s Drug Safety Oversight Board (DSOB).
			National Institutes of Health (NIH)/Clinical Center (CC)
			CDER 
			Nancy Guan, PharmD
			Public Health Analyst
			(301) 348-1549
			2021-10-04
			2026-10-04225-22-011
			Provides a framework for NIH NCATS and FDA CDER discussion with scientific, medical and regulatory communities about rare disease drug and biological product development.
			NIH National Center for Advancing Translational Sciences (NCATS)
			Kerry Jo Lee, MD 
			Associate Director for Rare Diseases, 
			DRDMG, ORPURM, OND, CDER
			2022-03-07
			Indefinite225-22-006
			Provide technical support regarding radioanalytical analyses of food products and radioisotopes found in the food monitoring program.
			Rhode Island Emergency Mgmt. Agency
			Brian Baker
			Director 
			ORS Winchester Engineering and Analytical CenterBrian.Baker@fda.hhs.gov
			2021-12-03
			2024-12-03225-22-008
			Support implementation and enforcement of the FD&C Act with the regulation of human and animal food that is manufactured/processed in the State of Minnesota.
			Minnesota Department of Agriculture
			Michael Dutcher, DVM 
			District Director
			FDA ORA
			HAF W-1Michael.Dutcher@fda.hhs.gov
			2022-02-18
			2025-02-15225-21-018
			The purpose of this Partnership Agreement is to coordinate and expand food protection efforts between the FDA and the California Department of Public Health Food and Drug Branch
			California Department of Public Health, Food and Drug Branch
			Office of Regulatory Affairs / Office of Partnership and Operational Policy
			Office of Regulatory Affairs / Office of Human and Animal Food Operations/Human and Animal Food West - Division 5
			Office of Regulatory Affairs/Office of Enforcement and Import Operations/Division of West Coast Imports
			2021-09-13
			2024-09-12225-21-020
			The purpose of this Partnership Agreement is to coordinate and expand food protection efforts between the FDA and the Wisconsin Department of Agriculture, Trade and Consumer Protection Division of Food and Recreational Safety
			Wisconsin Department of Agriculture, Trade and Consumer
			Office of Regulatory Affairs / Office of Partnership and Operational Policy
			Office of Regulatory Affairs / Office of Human and Animal Food Operations/Human and Animal Food West - Division 1
			2021-09-24
			2024-09-24225-20-019
			This MOU facilitates the exchange of information about dual jurisdiction establishments and operations (DJEs) between FDA and FSIS. The DJEs under this MOU are limited to human food operations and exclude animal food operations, which are regulated by the FDA.
			USDA Food Safety Inspection Service (FSIS)
			ORA
			Martha Myrick
			Program Expert
			Divisions of Domestic Human and Animal Foods Operation Branch
			(240) 402-5840martha.myrick@fda.hhs.gov
			2021-08-03
			Indefinite225-21-007
			To put in place a formal framework to be able to accommodate FEMA’s request to FDA to be a cold storage back-up for their COVID-19 vaccines currently stored at York College, NY.
			FEMA
			ORA
			John Leazer
			Director of FDA ORA New York Food and Feed Labjohn.leazer@fda.hhs.gov

			OO/OFEMS
			Don Demers
			Director, OFEMSdonald.demers@fda.hhs.gov
			2021-05-07
			2023-05-07225-21-010
			The purpose of this Partnership Agreement is to coordinate and expand food protection efforts between the FDA and the Utah State Department of Agriculture and Food Division of Regulatory Services.
			Utah State Department of Agriculture and Food Division of Regulatory Services
			Office of Regulatory Affairs / Office of Partnership and Operational Policy

			Office of Regulatory Affairs / Office of Human and Animal Food Operations
			2021-04-21
			2024-04-21225-21-006
			Collaboration to increase U.S. supply chain resilience and adoption of advanced manufacturing
			National Institute of Standards and Technology
			Office of the Commissioner 
			Office of the Chief Scientist 
			Office of Counterterrorism and Emerging Threats
			2021-01-15
			2026-01-15225-21-001
			Collaboration between FDA, DHS CBP, ICE-HSI, to respond to illegal controlled substances, drug imports, medical devices, and combination products at International Mail Facilities (IMF).
			DHS CBP
			ICE-HSI
			ORA OEIO
			Tammy Burkey
			Special Assistant to the Assistant Commissioner
			(301) 796-3711
			2020-10-15
			Indefinite225-21-019
			The purpose of this Partnership Agreement is to coordinate and expand food protection efforts between the FDA and the Florida Department of Agriculture and Consumer Services.
			Florida Department of Agriculture and Consumer Services (FDACS)
			Office of Regulatory Affairs / Office of Partnership and Operational Policy
			Office of Regulatory Affairs / Office of Human and Animal Food Operations/Human and Animal Food East – Division 4
			2021-10-06
			2024-10-06225-20-017
			This agreement outlines the coordination between the Food and Drug Administration and the U.S. Department of Agriculture’s Agricultural Marketing Service and Foreign Agricultural Service related to the export of milk and milk products from the United States.
			USDA Agricultural Marketing Service (AMS),
			USDA Foreign Agricultural Service (FAS)
			CFSAN
			Julie Moss
			2020-10-01
			2025-10-01225-00-2000
			Joint effort by FSIS and FDA to respond to requests for sanctioning the use of food ingredients and sources of radiation intended for use in the products of meat products and poultry products.  This MOU was first signed in 2000 and amended in 2015.
			USDA Food Safety Inspection Service (FSIS)
			CFSAN
			Dennis Keefe
			(240) 402-1200
			2015-01-15
			Indefinite225-00-8001
			Designed to implement the nondiscrimination provisions applicable to programs and activities receiving Federal financial assistance from FDA and to make civil rights an essential part of every program in the Department.
			Office for Civil Rights
			OC
			2000-06-27
			Indefinite225-03-7000
			To ensure that sponsors of new antimicrobial animal drugs have access to an effective means for evaluating the effects of their drugs on current FSIS detection tests.
			USDA Agricultural Marketing Service (AMS)
			CVM
			Marleen Wekell
			(301) 210-4760
			2003-01-23
			Indefinite225-04-4001
			Allows FDA to commission Custom and Border Protection Officers.
			Customs and Border Protection (CBP)
			ORA
			Domenic Veneziano
			(301) 443-6553
			2003-12-03
			Indefinite225-04-8000A
			Transfer of records from FDA to the National Library of Medicine (NIH) to ensure the preservation of and access to these historically significant records.
			NIH National Library of Medicine
			ORA
			John Swann
			(301) 827-3756
			2003-12-30
			Indefinite225-04-8000B
			Collaboration between FDA and AoA to support education and information initiatives for older Hispanic Americans to promote health.
			Administration on Aging (AoA)
			OC
			Mary Hitch
			(301) 796-8639
			2003-10-17
			Indefinite225-05-2001
			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
			2027-05-12225-05-3001
			FDA and General Services Administration (GSA) agree to work together to accomplish the removal of mercury-contaminated laboratory waste plumbing system and to coordinate with its contractors the hazmat removal and demolition of F08.
			General Services Administration (GSA)
			OC
			Kathleen Heuer
			(301) 255-6762
			2005-11-18
			Indefinite225-05-7000
			To provide procedures and responsibilities for resolving jurisdictional issues/ questions concerning the regulation of certain animal products as biologicals under the Virus-Serum-Toxin Act, or as drugs under the Federal Food, Drug, and Cosmetic Act.
			USDA Animal and Plant Health Inspection Service (APHIS)
			Center for Veterinary MedicineAskCVM@fda.hhs.gov
			2013-02-04
			Indefinite225-07-1000
			Establish a framework for collaboration between the NIH/NHLBI and FDA to use available clinical trial data to identify and evaluate prognostic factors that may contribute to hard clinical outcomes in cardiometabolic disorders and therapeutic interventions.  This is Modification 3 of the MOU.
			NIH National Heart, Lung, and Blood Institute (NHLBI)
			CBER
			Deborah Hursh
			(240) 402-9597
			2018-09-23
			2023-09-09225-07-7001
			To provide a mechanism for developing and implementing uniform and equitable laws, regulations, standards, definitions, and enforcement policies for the manufacturing, labeling, and sale of animal feeds and ingredients.
			Association of American Feed Control Officials
			CVM
			David Edwards
			(240) 402-6205
			2019-06-25
			2024-10-01225-08-8002
			To establish a procedure to allow DSAT to confirm that FDA has accepted or approved, an IND, a request to establish an INAD file, or an IDE application for a clinical trial involving the use of an investigational product that is, bears, or contains a select agent or toxin.
			Centers for Disease Control and Prevention (CDC)
			Elizabeth Sadove Senior Regulatory Counsel Office of Chief Scientist 
			(240) 753-3705 
			Elizabeth.Sadove@fda.hhs.gov
			2008-01-24
			2028-06-28
			2023-06-28225-08-8003
			To enhance knowledge and efficiency by providing for the sharing of information and expertise between the Federal partners
			Indian Health Service (IHS),
			Office of the Assistant Secretary of Defense (Health Affairs),
			Veterans Health Administration (VHA)
			OC
			Jeffrey Shuren, Assistant Commissioner for Policy
			(301) 827-3360
			CDER
			OSE VA
			Gwen Zornberg
			(301) 796-2199
			DOD
			Rita Ouellet-Hellstrom
			(301) 796-0515
			2008-11-25
			Indefinite225-09-0008
			Agreement regarding inspection programs for fishery products.
			National Oceanic and Atmosphere Administration (NOAA)
			CFSAN
			William Jones
			(240) 402-2300
			2009-10-09
			Indefinite225-10-0010
			To promote initiatives related to the review and use of FDA-regulated drugs, biologics, medical devices, and foods, including dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act and the Public Health Service Act.
			Centers for Medicare & Medicaid Services (CMS)
			OC
			OPPB
			Peter Lurie
			CDER
			OSE
			David Graham
			(301) 796-0163
			2010-06-25
			Indefinite225-11-0001
			To share information between EPA, FDA, USDA's Animal and Plant Health Inspection Service/Biotechnology Regulatory Services, in the regulatory oversight over genetically-engineered plants and the foods derived from such plants.
			Environmental Protection Agency (EPA),
			USDA Animal and Plant Health Inspection Service/Biotechnology Regulatory Services (APHIS/BRS)
			CFSAN
			Jason Dietz
			(240) 402-2282
			CVM
			Jeanette Murphy
			(301) 453-6845
			ORA
			Andrea Chamblee
			(301) 796-3820
			2011-02-02
			2021-02-02225-11-0028
			Coordination of resources to develop a unified program, maximize efficient utilization of government facilities, and strengthen joint education and research efforts.  Supersedes MOU 225-07-3002 (9/30/11). This MOU was first signed in 2013 and amended in 2018.
			Walter Reed Army Institute of Research
			CDER
			Russell G. Katz, MD
			(301) 796-2250
			CDER
			Shiew-Mei Huang, MD
			(301) 796-5008
			2018-12-09
			Indefinite225-11-0007
			To facilitate information sharing with respect to matters affecting the occupational safety and health of workers and the safety and security of our nation's food supply in facilities where food is produced, processed or held.
			Occupational Safety and Health Administration (OSHA)
			ORA
			Howard Sklamberg
			(301) 796-8314
			2011-06-20
			Indefinite225-12-0007
			Establishes policies and procedures to enhance the exchange of information between participating agencies of the USDA and FDA of DHHS related to food safety, public health, and associated regulatory, marketing, trade, and research activities substantially affecting the public health.
			U.S. Department of Agriculture  (USDA)
			ORA
			Martha Myrick
			(240) 402-5840
			2012-01-19
			Indefinite225-12-0020
			Assign responsibilities to the Food and Drug Administration (FDA) and National Library of Medicine (NLM) for the distribution of Structured Product Labeling (SPL) documents. Replaces MOU 225-05-3000.
			NIH National Library of Medicine (NLM)
			OC
			Lonnie Smith
			(301) 796-8503
			2012-05-30
			Indefinite225-12-0023
			Offer assistance to the NIH Centers for Accelerated Innovations (NCAI) grantees intending to develop drugs for commercialization with regulatory guidance on technology development.
			NIH National Heart, Lung, and Blood Institute (NHLBI)
			CDER
			Norman Stockbridge, MD, PhD
			(301) 796-2240
			2015-02-16
			2019-12-31225-13-023
			Collaboration and information sharing.
			NIH National Institute of Neurological Disorders and Stroke (NINDS)
			CDRH
			John Doucet, PhD
			(301) 796-6474
			2015-05-08
			2020-05-08225-13-028
			Establishes a framework to promote efficiency and collaboration between FDA and PHEMCE Partners to meet common needs for considering issues related to safety, efficacy, and utilization of drugs, biologics, and medical devices for use in emergencies, including response preparedness and planning.
			HHS,
			DoD,
			DHS,
			DVA,
			USDA
			OC
			Luciana Borio MD
			(301) 796-8510
			2014-03-11
			Indefinite225-14-001
			Establishes a framework and procedures to enhance collaborations and exchange of information.
			NCI Center to Reduce Cancer Health Disparities (CRCHD)
			OWH
			Brent Howard
			(301) 796-1409
			2014-01-02
			Indefinite225-14-002
			Work to promote a health information technology (IT) framework that promotes innovation, protects patient safety, and avoids regulatory duplication
			Office of the National Coordinator for Health Information Technology (ONC), 
			Federal Communications Commission (FCC)
			CDRH
			Bakul Patel
			(301) 796-5528
			2014-04-22
			Indefinite225-14-009
			Framework for cooperation between FDA and FSIS/USDA for regulation of Siluriformes fish and fish products re 2014 Farm Bill.
			USDA Food Safety Inspection Service (FSIS)
			CFSAN
			(240) 402-1729
			2014-04-30
			Indefinite225-14-015
			The purpose of this MOU is to enhance knowledge and efficiency by providing for the sharing of information and expertise between the federal partners (e.g., BOP participation in FDA’s, Drug Safety Oversight Board (DSB) Center for Drug Evaluation and Research’s (CDER)).
			Federal Bureau of Prisons (BOP)
			CDER 
			Nancy Guan, PharmD
			Public Health Analyst
			(301) 348-1549
			2021-12-07
			2025-11-20225-14-016
			The purpose of this MOU is to allow FDA/CDRH to offer assistance to the NIH Centers for Accelerated Innovations (NCAI) grantees with the regulatory processes involved in technology development and commercialization.
			NIH National Heart, Lung, and Blood Institute (NHLBI)
			CDRH
			Murry Sheldon, MD
			(301) 797-5443
			2015-01-15
			Indefinite225-14-017
			Establishes a framework for information sharing. Replaces MOU 225-09-0002. This MOU was first signed in 2014, amended in 2019, and revised in 2023.
			Centers for Disease Control and Prevention (CDC)
			Susan Lance FDA Liaison to CDC Office of Coordinated Outbreak Response and Evaluation (CORE) Network
			Phone: (404) 639-3378
			2023-06-30
			2028-06-30
			2023-06-30225-14-022
			Information sharing on food safety pesticide data in an electronic formation including pesticide labeling, maximum residue levels (MRLs) and research activities substantiality affecting the public health.
			Environmental Protection Agency (EPA)
			CFSAN
			Randy Levin
			2014-09-10
			Indefinite225-14-025
			Promote scientific progress through the exchange of scientific capital in a Cardiovascular Disease Drug Development Fellowship Training and Research Program.
			National Capital Consortium
			CDER
			Karen Hickman, M.D.
			(301) 796-1089
			2014-10-17
			2019-10-16225-14-026
			Coordinates staffing, space and equipment requirements for the new National Targeting Center facility.
			Customs and Border Protection (CBP)
			ORA
			Anthony C. Taube
			(571) 468-1489
			2013-05-28
			Indefinite225-15-003
			Establishes the framework for collaboration on women's health initiatives between two components of the Department of Health and Human Services (DHHS): The Food and Drug Administration (FDA), Office Women's Health (OWH) and the National Institutes of Health (NIH), Office of Research on Women's Health(ORWH).FDA OWH and NIH ORWH share common priorities and interests in promoting awareness and understanding of the science of sex-based differences.
			NIH Office of Research on Women's Health (ORWH)
			OC
			OWH
			Deborah Kallgren
			(301) 796-9442
			2014-12-10
			2019-12-09225-15-004
			Establishes a formal mechanism for sharing information in areas of mutual interest to assist public health protection and the effective and efficient execution of federal responsibilities.
			EPA Office of Chemical Safety and Pollution Prevention
			CFSAN
			Sharon Koh-Fallet
			(301) 796-7732
			CVM
			Gorka Garcia Malene
			(240) 276-9120
			2015-09-01
			Indefinite
			2022-01-07225-15-007
			Collaboration to develop strategic plans, set priorities, and leverage resources and expertise toward facilitating development of nanotechnologies for safer and effective cancer diagnostics and therapies.
			National Cancer Institute (NCI),
			National Institute of Standards and Technology (NIST)
			OC
			Office of the Chief Scientist
			Frank Weichold, M.D.
			(301) 975-6759
			2015-01-20
			2020-01-19225-15-008
			Facilitate concurrent access to the United States Department of Agriculture's (USDA) Tobacco Transition Assessment Program (TTAP) application and to ensure proper data protection and safeguards of market share information about tobacco manufacturers and importers between the USDA, Commodity Credit Corporation (CCC), Farm Service Agency (collectively, "USDA" unless otherwise noted) and the U.S. Department of Health and Human Services, Food and Drug Administration ("FDA") for the purpose of implementing the Family Smoking Prevention and Tobacco Control Act
			USDA,
			Commodity Credit Corporation,
			Farm Service Agency
			CTP
			Bryan Walsh
			(301) 796-6735
			2015-03-16
			2021-03-15225-15-11
			The purpose of MOU 225-15-11 is to create a mechanism to facilitate timely sharing of information and to build upon and establish additional collaborative efforts between the FDA and DEA. This MOU supersedes in its entirety MOU #225-74-8013.
			Drug Enforcement Agency
			OC
			Mitchell Weitzman, Regulatory Counsel
			2018-03-14
			2021-03-14225-15-016
			FDA provides the quality assurance support for DoD centrally managed contracts for drug, biologics, and medical device.  Replaces MOU 225-97-4000.
			Defense Logistics Agency (DLA)
			ORA
			Director, Division of Compliance
			2015-07-21
			Indefinite225-15-018
			Modernizing regulatory science to support the development of useful medical products.
			Defense Advanced Research Projects Agency
			Carlos Pena, PhD, MS,
			CDRH
			(301) 796-6610
			2016-04-13
			2025-09-12225-15-019
			Promote initiatives related to the review and use of FDA-regulated medical devices, as defined by the Federal Food, Drug and Cosmetic Act (see 21 U.S.C. § 321(h)) that utilize radiofrequency emissions or otherwise fall under the jurisdiction of the FCC.
			Federal Communications Commission
			CDRH
			Baku Patel
			(301) 796-5528
			2015-09-11
			Indefinite225-15-020
			Establish procedures and guidelines to accommodate and facilitate the exchange of data through the Automated Commercial Environment (ACE).
			Customs and Border Protection (CBP)
			ORA
			Office of Information Systems ManagementEmail
			2015-06-08
			Indefinite225-16-004
			Stream and facilitate efficient categorization of investigational medical devices to support CMS's ability to make Medicare coverage determinations for investigational devices.
			Centers for Medicare and Medicaid Services (CMS)
			CDRH
			Owen Faris, PhD
			(301) 796-6735
			2015-12-02
			Indefinite225-16-007
			This MOU serves to confirm the mutual interest of the Parties to discuss and explore collaborative opportunities in supporting translational and regulatory science, including but not limited to joint financial support for applications submitted in response to the Clinical and Translational Science Awards (CTSA) Collaborative Innovation Awards program.
			National Center for Advancing Translational Sciences
			CDER
			Office of Translational Sciences
			Chekesha S. Clingman, Ph.D., M.B.A.
			Special Assistant to the Director
			(301) 796-8531
			2016-04-13
			Indefinite225-16-008
			Establishes a framework for the agencies’ coordination in support of CDC’s use of its delegated authority to develop and issue emergency use instructions (EUI) for eligible medical countermeasures (MCMs)
			Centers for Disease Control and Prevention (CDC)
			OCS
			Elizabeth Sadove, JD
			(301) 796-8515
			2016-02-22
			Indefinite225-16-010
			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
			2021-04-24225-16-011
			Discuss and explore collaborative opportunities in supporting translational and regulatory science, including but not limited to joint financial support for applications submitted in response to the Clinical and Translational Science Awards (CTSA) Collaborative Innovation Awards program, or other scientific research funded by DCI, and training initiatives.
			NIH NCAT Division of Clinical Innovation (DCI)
			CDER
			Chekesha S. Clingman, PHD, MBA
			(301) 796-8531
			2016-04-13
			Indefinite225-16-012
			Ensure the safety, efficacy, and quality of medical products regulated by FDA and procured for the U.S. President's Emergency Plan for AIDS Relief (PEPFAR).
			U.S. Agency for International Development
			FDA PEPFAR Liaison
			Office of International ProgramsEmail
			2016-04-12
			Indefinite225-16-013
			Modernizing regulatory science to support development of useful medical products prior to use in humans.
			Defense Advanced Research Projects Agency (DARPA)
			CDRH
			Carlos Pena, PhD, MS
			(301) 796-6610
			2016-04-13
			2025-04-12225-16-015
			Ensure the safety, efficacy, and quality of medical products regulated by FDA and procured for the U.S. President's Emergency Plan for AIDS Relief (PEPFAR).
			U.S Department of State
			OIP
			PEPFAR LiaisonEmail
			2016-04-15
			Indefinite225-16-018
			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
			2021-05-18225-16-019
			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
			2021-08-30225-16-020
			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
			Indefinite225-16-022
			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
			2022-06-13225-16-024
			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
			2021-09-30225-17-014
			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
			2022-08-24225-17-015
			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
			Indefinite225-17-016
			This MOU establishes the parameters for the assignment of representative employee(s) partner government agencies (PGAs) to the Commercial Targeting and Analysis Center (CTAC).  Furthermore, this MOU outlines the mission of the CTAC, recognizes the responsibilities of all PGAs, and memorializes the relationships among PGAs in order to maximize cooperation.
			CBP,
			ICE,
			CPSC,
			FSIS,
			APHIS,
			PHMSA,
			NHTSA,
			EPA,
			FWS,
			NMFS,
			TTB
			ORA
			Division of Import Operations
			2010-10-21
			Indefinite225-17-023
			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
			2021-09-31225-17-025
			Recognize the need for a unified approach to advancing scientific knowledge related to cancer and women's health.
			National Cancer Institute (NCI)
			CDRH
			Dr. Pamela Scott, Office of Women's Health
			(301) 796-0630
			2015-08-10
			Indefinite225-17-0007
			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
			2021-11-17225-18-003
			Labeling of distilled spirits, wine, and malt beverages.
			Bureau of Alcohol, Tobacco and Firearms
			CFSAN
			Felicia Satchell
			(240) 402-2371
			1974-09-16
			Indefinite225-18-005
			To establish the framework between FDA and USAID for testing the ability of the Counterfeit Detection Device to identify counterfeit drugs, including falsified products and substandard anti-malarial drugs in Ghana
			U.S. Agency for International Development
			OIP
			Leigh Verbois
			2014-04-21
			Indefinite225-18-006
			Provides a framework for coordination and collaboration between the Agencies relating to their regulation of Surgical N95 Respirators and N95 Filtering Facepiece Respirators (FFRs) used in healthcare settings
			CDC National Institute for Occupational Safety and Health (NIOSH)
			CDRH
			Director, Emergency Preparedness and Medical Countermeasures
			2017-11-29
			Indefinite225-18-010
			The organizations share a mutual interest in collaborating on compliance, enforcement, and information sharing activities that directly impact food safety and public health.
			Wisconsin Department of Agriculture, Trade, and Consumer Protection (WDATCP)
			ORA
			Michael Dutcher
			District Director
			Office of Human and Animal Food Operations – Division 1 West
			2018-05-10
			2021-05-10225-18-014
			Provides the principles and procedures by which information exchanges between Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), and a framework for coordination and collaborative efforts between these two organizations.
			Office for Human Research Protections (OHRP)
			ORA
			Office of Bioresearch Monitoring Operations
			David Glasgow
			(301) 796-5403
			2018-03-19
			Indefinite225-18-017
			Provides a framework for coordination and collaborative efforts between these two entities in the Department of Health and Human Services.  Replaces 225-13-009.
			National Institutes of Health (NIH),
			National Institute of Neurological Disorders and Stroke (NINDS)
			CBER
			Division of Cellular and Gene Therapies
			Office of Tissues and Advanced Therapies
			Steven Oh, Ph.D.
			(240) 402-8337
			2001-02-12
			Indefinite
			2023-04-13225-18-026
			Provide a framework under which FDA and AHRQ will provide the principles and procedures by which information exchange shall take place.
			Agency for Healthcare Research and Quality (AHRQ)
			CDER
			Richard Currey

			CDER 
			Nancy Guan (secondary contact)
			2018-09-17
			2023-09-17225-18-027
			Provide mutual support to biomedical research on drugs, biologics, and medical devices and for medical countermeasure development.
			National Aeronautics and Space Administration (NASA)
			Office of Counterterrorism and Emerging Threats
			Michael Mair, M.P.H.Email
			2018-09-27
			Indefinite225-19-001
			Establish the framework under which DOD and FDA will implement the 2017 law for enhanced engagements to facilitate the development and availability of safe and effective medical products that serve the military’s needs.
			U.S. Department of Defense (DoD)
			OC
			Elizabeth Sadove
			(301) 796-8515
			2018-11-02
			Indefinite225-19-002
			To formalize and enhance the working relationship of the Parties, including roles and responsibilities, when sharing information related to vulnerabilities and threats to the healthcare and public health that involve the cybersecurity of medical devices.
			National Protection and Programs Directorate (NPPD)
			CDRH
			Suzanne B. Schwartz, M.D., M.B.A
			(301) 796-6937

			CDRH
			Seth Carmody, Ph.D.
			(301) 796-6944
			2018-10-15
			Indefinite225-19-007
			The purpose of MOU 225-19-007 is to establish a framework for collaborative educational, research and training opportunities. The joint efforts will be undertaken to develop collaborative research and training programs as permitted under appropriate statutory authority.
			National Institute of Environmental Health Sciences National Toxicology Program,
			Health and Environmental Sciences Institute (HESI)
			CDER
			Norman Stockbridge, MD
			Director, Division of Cardiovascular and Renal Products
			2019-02-12
			2024-02-12225-19-009
			The purpose of MOU 225-19-009 is to establish the framework under which FDA and AAP will collaborate on physician continuing medical education
			American Academy of Pediatrics
			CFSAN
			Lisa Lubin
			2018-12-14
			2023-12-14225-19-010
			A public-private partnership is envisioned to accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases.
			Department of Health & Human Services (HHS),
			Centers for Medicare & Medicaid Services (CMS),
			National Institutes of Health (NIH),
			Centers for Disease Control and Prevention (CDC)
			N/A
			2019-06-12
			2021-06-12225-19-012
			CDRH and NCI collaboration on HPV screening and diagnostic tools.
			National Cancer Institute (NCI)
			CDRH
			2019-04-02
			2024-04-02225-19-013
			MOU for coordination and collaborative efforts related to the development and availability of drugs, biological products, and devices regulated by FDA for use as medical countermeasures in public health emergencies.
			Administration for Strategic Preparedness and Response
			OCS
			OCET
			2019-04-10
			Indefinite225-19-014
			To set forth the terms and conditions under which the Parties may share information concerning household substances that are subject to the Poison Prevention Packaging Act.
			Consumer Product Safety Commission
			CDER
			Executive SecretariatEmail
			2019-06-13
			Indefinite225-19-015
			MOU to establish collaborative efforts to support the U.S. food manufacturing sector and advance and improve safe food manufacturing practices in the U.S.
			US NIST Hollings Manufacturing Extension Partnership Program
			ORA
			OPOP/Office of Partnerships
			Alan Tart, Deputy Director
			2019-08-02
			2024-08-02225-19-017
			This MOU provides a framework for coordination and collaborative efforts between FDA and NIDA.
			National Institute on Drug Abuse
			CDRH
			Carlos Pena, Ph.D.
			(301) 796-6610
			2019-05-30
			2024-05-30225-19-018
			Sharing information between FDA and NCI/DCTD
			NCI Division of Cancer Treatment and Diagnosis
			CDER
			Libero Marzella M.D., Ph.D.
			Supervisory Medical Officer
			(301) 796-1414
			E-mail: libero.marzella@fda.hhs.gov
			2019-08-30
			2027-09-01225-19-021
			This MOU outlines the framework for University of Guelph’s participation as a member of Vet-LIRN, a network of veterinary diagnostic laboratories that supports the documentation, investigation, and diagnosis of animal feed or drug related illnesses.
			University of Guelph, Animal Health Laboratory
			CVM
			Dr. Gregory Tyson
			(240) 402-5426
			2021-01-11
			Indefinite225-19-027
			To provide a framework for coordination and collaborative efforts.
			National Institute of Neurological Disorders and Stroke
			CDER
			Patrizia Cavazzoni, M.D.
			Deputy Center Director for Operations
			(240) 402-3743Email
			2019-08-01
			Indefinite225-19-030
			Formalizes an understanding between the Department of Veterans Affairs and the FDA whereby FDA provides quality assurance support for the VA’s centrally managed contracts for human drugs, biologics, and combination products, as defined by the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act.
			Department of Veterans Affairs
			ORA
			Angela Davis
			(301) 796-5084
			2020-06-30
			Indefinite225-19-031
			Establishing procedures to coordinate the inspecting, sampling, and testing of raw peanuts, Brazil nuts, and pistachio nuts for aflatoxins.
			USDA Agricultural Marketing Service (AMS)
			CFSAN
			2019-09-05
			Indefinite225-19-032
			Joint effort by FDA, NIEHS, and HESI to establish the Botanical Safety Consortium (BSC), a forum for scientists from government, academia, consumer health groups, industry, and non-profit organizations to work collaboratively to generate a sound scientific basis for integrating existing safety data and the latest toxicology tools to evaluate botanical safety in dietary supplements.
			National Institute of Environmental Health Sciences (NIEHS),
			Health and Environmental Sciences Institute (HESI)
			CFSAN
			Sibyl Swift, Ph.D.
			(240) 402-1455
			2019-10-30
			2024-10-30225-19-033
			Establishes an agreement among FDA, EPA, USDA, and the founding partners of the Food Waste Reduction Alliance to increase collaboration and coordination in areas of mutual interest relating to the reduction of food loss and waste.
			EPA,
			USDA,
			Food Marketing Institute,
			National Restaurant Association,
			Grocery Manufacturers Association
			CFSAN
			Office of Analytics and Outreach
			2019-10-25
			2021-10-25225-20-003
			This MOU outlines the framework for Cornell University’s participation as a member of Vet-LIRN, a network of veterinary diagnostic laboratories that supports the documentation, investigation, and diagnosis of animal feed or drug related illnesses.
			Cornell University Animal Health Diagnostic Center
			CVM
			Dr. Gregory Tyson
			(240) 402-5426
			2020-04-22
			Indefinite225-20-004
			This MOU outlines the framework for Texas A&M AgriLife Research’s participation as a member of Vet-LIRN, a network of veterinary diagnostic laboratories that supports the documentation, investigation, and diagnosis of animal feed or drug related illnesses.
			Texas A&M AgriLife Research
			CVM
			Dr. Gregory Tyson
			(240) 402-5426
			2020-05-08
			Indefinite225-20-005
			This MOU outlines the process for sharing of pharmacovigilance data between the FDA and Banfield.
			Banfield Pet Hospital
			CVM
			Hesha J. Duggirala
			(240) 402-6218
			2020-04-02
			Indefinite225-20-007
			This Partnership Agreement is a type of MOU used to renew the loan of a Portable Gamma-ray Analysis System to the Alaskan Dept. of Conservation which provides the state radioanalytical capacity and expertise, emergency response capability and provides for continued monitoring of Alaskan Coastal water finfish for radionuclides in response to the Fukushima emergency.
			Alaska Department of Environmental Conservation (ADEC)
			ORA
			Miriam Burbach, Seattle District Director, Division of Human and Animal Food Operations West VI
			2020-04-02
			2024-05-30
			2023-05-30225-20-008
			Provides a framework for collaboration intended to facilitate regulatory and basic science innovation with 3D printing technologies to respond to COVID-19. The Parties anticipate that this collaboration will yield metrics, training, protocols, and programs for medical products that are manufactured close to the patient or at point of care.
			National Institutes of Health (NIH),
			Veterans Health Administration
			OC
			Office of Counterterrorism and Emerging Threats
			CDR James Coburn
			(301) 796-0286
			2020-03-25
			2022-03-25225-20-010
			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
			2026-09-30225-20-011
			Establishes agreement between FDA and USDA regarding the potential use of the Defense Production Act (DPA) with regard to FDA-regulated food during the COVID-19 pandemic.
			U.S. Department of Agriculture  (USDA)
			OC
			OFPRCOVID19.FoodDPA@fda.hhs.gov
			2020-05-18
			Indefinite225-20-021
			This MOU outlines the framework for The Pennsylvania State University’s participation as a member of Vet-LIRN, a network of veterinary diagnostic laboratories that supports the documentation, investigation, and diagnosis of animal feed or drug related illnesses.
			The Pennsylvania State University
			CVM
			Dr. Gregory Tyson
			(240) 402-5426
			2020-10-08
			Indefinite225-22-005
			This MOU renews and strengthens Toxicology in the 21st Century (Tox21), a federal research collaboration advancing the science of toxicology and toxicity testing, and its application to regulatory decision making.
			NIEHS/DNTP, NCATS/DPI, EPA/ORD, and FDA
			Suzanne C. Fitzpatrick, Ph.D., DABT
			Senior Advisor for Toxicology
			Office of the Center Director
			CFSAN
			2021-08-26
			08-26-2026225-22-004
			This MOU establishes procedures for the exchange of information between CVM and the DEA regarding controlled substances used in animal drug products.
			Drug Enforcement Administration
			CVM
			Cindy L. Burnsteel
			(240) 402-0817
			2021-11-19
			Indefinite225-22-001
			The purpose of the MOU is to provide a framework for coordination and collaborative efforts between the Parties and enhance knowledge and efficiency through the sharing of information and expertise with respect to the review and use of diagnostic, preventative, and therapeutic products for use in hearing, balance, taste, smell, voice, speech, and language disorders.
			NIH National Institute on Deafness and Other Communication Disorders (NIDCD)
			Center for Devices and Radiological Health (CDRH)
			2021-11-09
			2026-11-09225-71-2006
			To furnish ATF, IRS information concerning legal actions taken by FDA against alcoholic beverage firms for underfilling of containers.
			Internal Revenue Service (IRS)
			CFSAN
			Terry Troxell
			(240) 402-1700
			1971-07-13
			Indefinite225-71-4007
			Consumer protection during times of natural disasters caused by flooding.
			DoD U.S. Army Corps of Engineers
			ORA
			Michael Rodgers
			(301) 827-5653
			1971-07-27
			Indefinite225-71-8003
			Information exchange to develop Mutual Program Planning & Liaison on Consumer Deception.
			Federal Trade Commission (FTC)
			ORA
			Dave Gallant
			(240) 632-6812
			CDER
			Mark Lauda
			(301) 796-0381
			1971-05-14
			Indefinite225-72-2001
			To outline the authority or basis for cooperative efforts between USDA and FDA regarding the inspection, sampling, and examination of imported dates and date materials. This MOU was first signed in 1953 and amended in 1985.
			USDA Agricultural Marketing Service (AMS)
			CFSAN
			Doug Park
			(240) 402-2410
			1985-11-19
			Indefinite225-72-2009
			Cooperation and information sharing in the inspection of food products and establishments. This MOU was first signed in 1975 and amended in 2011.
			USDA Agricultural Marketing Service (AMS)
			ORA
			Martha Myrick
			(240) 402-5840
			2011-03-04
			Indefinite225-73-2007
			To outline the authority or basis for cooperative efforts between AMS/USDA and FDA regarding the inspection, sampling, and examination of imported raisins.
			USDA Agricultural Marketing Service (AMS)
			CFSAN
			Amy Miller
			(240) 402-1658

			Monica Pava-Ripoll
			(240) 402-1630
			1973-05-07
			Indefinite225-73-8010
			Mutual Responsibilities under FD&C Act and FIFR Act regarding pesticides. This MOU was first signed in 1971 and amended in 1973.
			Environmental Protection Agency (EPA)
			ORA
			Michael Rodgers
			(301) 827-5653
			1973-08-28
			Indefinite225-74-1010
			Importation of biological specimens under the US-USSR scientific exchange agreement for collaborative research in viral oncology.
			USDA Animal and Plant Health Inspection Service (APHIS),
			National Institutes of Health (NIH)
			NIH
			1974-07-15
			Indefinite225-74-1017
			Establishes a uniformed policy between DoD and FDA relative to the voluntary licensure of military blood banks.
			U.S. Department of Defense (DoD)
			CBER
			Elaine Cole
			(301) 827-6352
			1974-06-20
			Indefinite225-74-6004
			Identify the authority and roles for cooperative efforts between USCS and FDA regarding entry and clearance operations, the determination of compliance status, and the sampling procedures of imported electronic products.
			U.S Department of the Treasury
			CDRH
			George Kraus
			(240) 276-3298
			1974-03-20
			Indefinite225-74-6008
			To identify the authorities and roles for cooperative efforts between FDA and OSHA in establishing uniform Federal standards relative to electronic product radiation and determining compliance with these standards
			Occupational Safety and Health Administration (OSHA)
			CDRH
			Dan Kassiday
			(240) 276-3280
			1974-04-10
			Indefinite225-74-8001
			Provide means for CPSC to obtain access and use of certain FDA documents that contain privileged information and to establish a system to control and protect these documents. This MOU was first signed in 1973 and amended in 1974.
			Consumer Product Safety Commission (CPSC)
			OC
			1974-03-18
			Indefinite225-75-3001
			Cooperative agreement between NIH and FDA regarding anticancer drugs.
			National Institutes of Health (NIH)
			CDER
			Diane Ehrlich
			(301) 796-3452
			1979-02-05
			Indefinite225-75-3003
			Establishes the procedures to be followed regarding the investigational use of drugs, including antibiotics and biologics, and medical devices by DoD. This MOU was first signed in 1974 and amended in 1987.
			U.S. Department of Defense (DoD)
			CDER
			Diane Ehrlich
			(301) 796-3452
			1987-05-01
			Indefinite225-75-4002
			Establishes procedures for the exchange of information and coordination of activities between AMS/USDA and FDA to avoid duplication of effort in inspecting and sampling dry milk product plants to determine whether products manufactured at one plant may be contaminated with salmonella microorganisms. This MOU was first signed in 1975 and amended in 1987.
			USDA Agricultural Marketing Service (AMS)
			ORA
			Michael Rodgers
			(301) 827-5653
			1987-11-18
			Indefinite225-75-5011
			Agreement between FDA and VA to establish procedures for exchanging medical device experience data.
			Veterans Administration (VA)
			CDRH
			Cap Uldricks
			(240) 276-0106
			1975-03-19
			Indefinite225-75-5012
			Establishes procedures to foster information exchange and scientific coordination between CDC and FDA regarding in vitro diagnostic products.
			Department of Health and Human Services (DHHS)
			CDRH
			Steve Gutman
			(240) 276-0484
			1975-12-13
			Indefinite225-75-7001
			Inspection of Industrial Fishery Products intended for animal feed use to eliminate Salmonella.
			USDA Animal and Plant Health Inspection Service (APHIS),
			National Oceanic and Atmospheric Administration (NOAA)
			CVM
			Daniel McChesney
			(240) 453-6830
			1974-11-13
			Indefinite225-75-8004
			Interagency postattack working relationships regarding food inspections for purity and safety in the event of general War between Agriculture & DHEW. This MOU was first signed in 1974 and amended in 1983.
			U.S. Department of Agriculture (USDA)
			ORA
			Michael Rodgers
			(301) 827-5653
			1983-12-13
			Indefinite225-76-2002
			To provide a mechanism for the exchange of information concerning the shipment of food, drug, and cosmetics.
			Interstate Commerce Commission
			ORA
			Michael Rodgers
			(301) 827-5653
			1976-04-14
			Indefinite225-76-2003
			To delineate areas of jurisdiction in the administration of the Consumer Product Safety Act and the FD&C Act with respect to food, food containers, and food-related articles and equipment.
			Consumer Product Safety Commission (CPSC)
			CFSAN
			Joe Baca
			(240) 402-2359
			1976-07-26
			Indefinite225-76-3009
			Outlines the working arrangements between DEA/FDA regarding the approval or denial procedures for narcotic treatment programs.
			Drug Enforcement Administration (DEA)
			CDRH
			Alberto Gutierrez
			(240) 276-0376
			1976-07-02
			Indefinite225-76-8049
			Agreement between FDA and VA, which FDA is responsible for providing quality assurance for all drugs, biologics, chemicals, and reagents VA procures, stores, and distributes, including its Federal Supply Schedule assignment.
			Veterans Administration (VA)
			ORA
			Angela Davis
			(301) 796-5084
			1975-06-19
			Indefinite225-78-4006
			To provide a mechanism for FDA and EPA to coordinate their regulatory activities with respect to the suitability of potable water intended for drinking and culinary purposes onboard Interstate Carrier Conveyances.
			Environmental Protection Agency (EPA)
			CFSAN
			Art Banks
			(240) 402-1489
			1978-09-14
			Indefinite225-79-2001
			Control of Direct and Indirect Additives to and substances in drinking water.
			Environmental Protection Agency (EPA)
			CFSAN/ORA
			Henry Kim
			(240) 402-2023
			1979-06-22
			Indefinite225-79-4003
			Cooperative enforcement of the FD&C Act between USCS and FDA
			Department of Homeland Security
			ORA
			Joe McCallion
			(301) 594-1218
			1979-08-14
			Indefinite225-80-2000
			Agreement between FGIS and FDA regarding their responsibilities in the inspection and standardization of grain, rice, pulses, and food products.
			U.S. Department of Health and Human Services (DHHS)
			CFSAN
			Nega Beru
			(240) 402-1700
			1985-11-08
			Indefinite225-80-4000
			Coordination of activities between FDA and HCFA regarding blood-banking and transfusion programs. This MOU was first signed in 1980 and amended in 1983.
			U.S. Department of Health and Human Services (DHHS)
			ORA/CBER
			Elaine Cole
			(301) 827-6352
			1983-06-06
			Indefinite225-81-3000
			Mutual responsibilities between FDA and NIDA regarding the implementation of the jointly published narcotic addict treatment regulations.
			U.S. Department of Health and Human Services (DHHS)
			CDER
			Diane Ehrlich
			(301) 796-3452
			1980-11-20
			Indefinite225-82-4003
			FDA and the Defense Personnel Support Center providing each other with information on food and cosmetic recalls.
			U.S. Department of Defense (DoD)
			ORA
			Mel Szymanski
			(240) 632-6856
			1982-03-23
			Indefinite225-82-7000
			Agreement between FDA and APHIS regarding the regulation of animal biological products as biologicals under the Virus, Serum, and Toxin Act 1913 or as drugs under the FD&C Act.
			USDA Animal and Plant Health Inspection Service (APHIS)
			CVM
			Daniel McChesney
			(240) 453-6830
			1982-05-07
			Indefinite225-82-8000
			FDA and CDC's responsibilities regarding the exchange and coordination of information in epidemiologic investigations and related activities.
			Centers for Disease Control and Prevention (CDC)
			OC
			1982-01-12
			Indefinite225-82-8400
			Agreement between FDA and VA to identify specific responsibilities between them in the area of clinical research with investigational new drugs and medical devices, including biologicals.
			Veterans Administration (VA)
			ORA
			Dave Gallant
			(240) 632-6812
			1982-08-20
			Indefinite225-83-6000
			Establishes a mechanism for the regular exchange of information in areas of common interest and shared responsibility, and provides a procedure that fosters the development of collaborative projects.
			U.S. Department of Health and Human Services (DHHS)
			CDRH
			1983-08-09
			Indefinite225-84-8000
			To establish a continuing procedure where the U.S. Patent and Trademark Office determines whether a U.S. patent can be issued for certain orphan products.
			Patent and Trademark Office
			OC/OPD
			Marlene Haffner
			(301) 827-3666
			1984-03-22
			Indefinite225-85-8251
			Describes procedures for the cooperative and timely interaction between FDA and NIDA for the domestic scheduling of drugs of abuse.
			National Institute of Drug Abuse
			CDER
			Diane Ehrlich
			(301) 796-3452
			1985-05-01
			Indefinite225-85-8400
			Federal regulatory activities concerning residues of drugs, pesticides and environmental contaminants that may adulterate food.
			U.S. Department of Agriculture (USDA)
			CVM
			Steven Vaughn
			(301) 827-1796
			1984-11-21
			Indefinite225-86-2000
			Enforcement of laws against illegal harvest, transport, export, import, sale, and purchase of molluscan shellfish.
			National Marine Fisheries Service
			CFSAN
			Donald Kraemer
			(240) 402-2300
			1986-07-24
			Indefinite225-86-8251
			Outlines methods for determining a product's eligibility for patent term restoration
			Patent and Trademark Office
			CDER
			Diane Ehrlich
			(301) 796-3452
			1986-09-17
			Indefinite225-88-2000
			To clarify the enforcement responsibilities between FDA and ATF regarding alcoholic beverages that are considered adulterated under the FD&C Act.
			Department of Homeland Security (DHS)
			CFSAN
			Nega Beru
			(240) 402-1700
			1987-11-20
			Indefinite225-89-2000
			To promote the coordination between FDA and NSB to achieve greater effectiveness in assuring that feeding programs in Head Start Centers conform with the Federal food safety and sanitation recommendations.
			Department of Health and Human Services (DHHS)
			CFSAN
			Joe Baca
			(240) 402-2359
			1989-04-11
			Indefinite225-91-4003
			FDA and USCS meeting the needs of the trading public in expediting the collection, processing, and use of import information, while protecting the public health.
			Department of Homeland Security (DHS)
			ORA
			Joe McCallion
			(301) 594-1218
			1991-08-09
			Indefinite225-93-4005
			Regulation of liquid chemical germicides for use on medical devices. This MOU was first signed in 1993 and amended in 1994.
			Environmental Protection Agency (EPA)
			CDRH
			Elaine Mayhall
			(240) 276-3749
			1994-06-20
			Indefinite225-94-2001
			USDA/FDA establishment of a foodborne illness education information center as central source for foodborne illness education activities.
			U.S. Department of Agriculture (USDA)
			CFSAN
			David Acheson
			(240) 402-1910
			1994-03-16
			Indefinite225-94-3000
			To establish a relationship between FDA and NIH so that joint experiments can be conducted related to drug metabolism and drug to drug interactions.
			National Institutes of Health (NIH)
			CDER
			Diane Ehrlich
			(301) 796-3452
			1993-12-13
			Indefinite225-94-3001
			To maintain a relationship between FDA and the Laboratory of Neurosciences to continue and complete studies, gather and examine data in the area of detecting neurotoxicity based on the autoradiographic measurement of cellular metabolic markers.
			National Institutes of Health (NIH)
			CDER
			Diane Ehrlich
			(301) 796-3452
			1994-01-04
			Indefinite225-94-6001
			To facilitate development of Standard Reference Materials for materials used in medical implant applications.
			National Institute of Standards and Technology (NIST)
			CDRH
			1994-01-14
			Indefinite225-96-0000
			Defines the respective authorities and responsibilities of the ASM and the FDA in regards to the administration of the Egg Products Inspection Act.
			USDA Agricultural Marketing Service (AMS)
			CFSAN
			1996-06-10
			Indefinite225-97-8000
			Defines and delineate the responsibilities of the DCS and PSC for the efficient and timely handling and pick-up of all excess personal property including scientific equipment in the Washington Metro area.
			Department of Health and Human Services (DHHS)
			U.S. Department of Health and Human Services (DHHS)
			1997-02-11
			Indefinite225-97-8002
			To provide a framework of cooperation between FDA, CDC, FSIS, and CSREES as each develops science-based consumer-oriented messages to promote safe food handling practices.
			Centers for Disease Control and Prevention (CDC),
			USDA Food Safety Inspection Service (FSIS),
			USDA Cooperative State Research, Education, and Extension Service,
			U.S. Department of Education,  
			The Partnership for Food Safety Education
			CFSAN
			David Acheson
			(240) 402-1910
			1997-05-12
			Indefinite225-98-8000
			FDA and the Indian Health Service will work to develop more cohesive relationship to mutually address American Indian and Alaska Native issues within each.
			Indian Health Service (IHS)
			OC
			Mary Hitch
			(301) 796-8639
			1997-07-09
			Indefinite225-99-2001
			To facilitate an exchange of information between FDA and FSIS about establishments and operations that are subject to the jurisdiction of both agencies.
			USDA Food Safety Inspection Service (FSIS)
			ORA
			Martha Myrick
			(240) 402-5840
			1999-02-23
			Indefinite225-99-3001
			Establishes a relationship between CDER and the Pharmacology and Experimental Therapeutics Section (PETS) so that joint experiments can be conducted relating to drug metabolism and drug-drug interaction.
			NIH Pharmacology and Experimental Therapeutics Section,
			Center for Disease Control and Prevention (CDC)
			CDER
			Diane Ehrlich
			(301) 796-3452
			1999-01-11
			Indefinite225-99-6000
			Outlines the mechanism for cooperation between CDRH and FAA in matters concerning operation of lasers in airspace
			Federal Aviation Administration (FAA)
			CDRH
			Dale Smith
			(240) 276-3295
			1998-11-25
			Indefinite225-99-6001
			Transfer of CLIA Complexity Categorization Functions from CDC to FDA
			Center for Disease Control and Prevention (CDC),
			Health Care Financing Administration
			CDRH
			Steve Gutman
			(240) 276-0484
			1999-02-27
			Indefinite




Sub-Topic Paragraphs
          Other CategoriesAcademic MOUs
            Agreements between FDA and academic institutions and organizations.Non-Profit and Other MOUs
            Agreements between FDA and other organizations, including non-profits.

                                                                                  Content current as of:
      10/19/2023Domestic MOUs                
                          

                        MOU 225-22-029
          MOU 225-22-024
          MOU 225-22-026
          MOU 225-23-001
          MOU 225-23-003
          MOU 225-23-008
          MOU 225-23-009
          MOU 225-23-012
 
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