Domestic MOUs
| MOU No. | Purpose | Parties | FDA Lead Center or Office Contact |
Effective Date | Expiration Date | Last Revision Date |
|---|---|---|---|---|---|---|
| 225-24-023 | MOU to facilitate sharing of information to inform EPA regulation of pesticides that could potentially compromise the effectiveness of human or animal drugs. | EPA/Office of Pesticide Programs, CDC, and USDA | James Flahive, JD Senior Advisor, Office of the Commissioner 301-796-9293 James.flahive@fda.hhs.gov |
2024-09-24 | Indefinite | |
| 225-24-019 | The purpose of this MOU is create a joint research consortium to perform analysis at the DEA Special Testing and Research Laboratory. | Drug Enforcement Administration (DEA), U.S. Customs and Border Protection (CBP) | Food and Drug Administration (FDA) Forensic Chemistry Center (FDA-FCC) | 2024-07-26 | 2029-07-26 | |
| 225-24-016 | The purpose of this Partnership Agreement is to coordinate and expand food protection efforts between the FDA and the Michigan Department of Agriculture and Rural Development. | Michigan Department of Agriculture and Rural Development |
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 6 |
2024-08-02 | 2029-08-02 | |
| 225-24-015 | The MOA provides a framework to enhance awareness, information sharing, activities, and support for evaluating cybersecurity and healthcare vulnerabilities. | Cybersecurity and Infrastructure Security Agency (CISA) |
CDRH Jessica Wilkerson, J.D. |
2024-08-05 | 2029-08-05 | |
| 225-24-005 | Establishes an agreement among the founding partners of the Food Waste Reduction Alliance (FWRA) to continue collaboration and coordination in areas of mutual interest relating to the reduction of food loss and waste. | U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), Consumer Brands Association, National Restaurant Association, Food Industry Association (FMI) | CFSAN Priya Kadam, Ph.D. Senior Advisor Priyamvada.kadam@fda.hhs.gov |
2024-06-01 | 2027-06-01 | |
| 225-23-011 | This MOU establishes collaboration between the FDA/CDRH and NIH/NINDS, both HHS components. It outlines coordinated efforts in public health activities, joint meetings, and information sharing. The MOU emphasizes reciprocal presentations, consultation on policy issues, and collaboration in areas related to medical devices for neurological conditions. | National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/ NINDS) | David McMullen, M.D. Director Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality (OPEQ) Center for Devices and Radiological Health (CDRH) David.McMullen@fda.hhs.gov |
2023-08-22 | 2028-08-22 | |
| 225-24-018 | Foster collaboration between FDA medical product centers and National Institute on Aging /NIH | National Institutes of Health (NIH) / National Institute on Aging (NIA) | Teresa Buracchio Director, Office of Neuroscience, Office of New Drugs, CDER Teresa.Buracchio@fda.hhs.gov |
2024-06-27 | 2029-06-27 | |
| 225-24-013 | This MOU documents research collaboration with U.S. Army Combat Capabilities Development Command (DEVCOM). | U.S. Army Combat Capabilities Development Command (DEVCOM) | Thomas Biel, PhD. Office of Pharmaceutical Quality |
2024-07-15 | 2029-07-15 | |
| 225-24-014 | This MOU provides a framework for coordination and collaborative efforts between FDA and NIDA. | National Institute on Drug Abuse (NIDA) | CDRH John Marler, M.D. Acting Clinical Deputy Director Division of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Telephone: 301-796-4221 Email: john.marler@fda.hhs.gov |
2024-06-07 | 2029-06-07 | |
| 225-24-001 | Encourage and foster scientific exchanges in areas of mutual interest in Mathematical and Physical Sciences, Engineering, and Biomedical Research to enable an increased exchange of programmatic information, and support expanded collaboration in common research areas. | National Science Foundation (NSF) |
Ed Margerrison, PhD Dorn Carranza, PhD MBA |
2024-04-11 | 2029-04-11 | |
| 225-24-010 | This MOU outlines information sharing and regulatory cooperation related to intentional genomic alterations in animals subject to USDA jurisdiction. | U.S. Department of Agriculture | CVM Adam Moyer Adam.Moyer@fda.hhs.gov |
2024-04-18 | 2029-04-18 | |
| 225-24-004 | Facilitate information sharing between the agencies with respect to matters affecting the occupational safety and health of workers and the safety and security of our nation's medical products, cosmetics, and food supply in facilities where FDA regulated products are produced, processed, or held. |
OSHA | US Department of Labor, Occupational Safety and Health Administration (OSHA) | 2024-01-26 | 2029-01-26 | |
| 225-22-017 | Establishes framework for collaboration between FDA and NRC for information-sharing related to products that utilize or may be impacted by release of byproduct, source, or special nuclear material. | Nuclear Regulatory Commission (NRC) | Center for Devices and Radiological Health (CDRH) 10903 New Hampshire Avenue Silver Spring, MD 20993 301-796-5500 |
2023-12-20 | 2028-12-20 | |
| 225-22-012 | 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 | 2023-07-05 |
| 225-23-006 | 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 | 2026-10-17 | |
| 225-23-013 | 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 | 2023-09-22 |
| 225-23-012 | 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 | 2028-07-19 | |
| 225-23-009 | 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 | 2023-06-19 |
| 225-23-008 | 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 | 2028-05-10 | |
| 225-22-026 | 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 | 2023-04-12 |
| 225-23-003 | 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 | 2023-01-12 |
| 225-22-029 | 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 | 2023-05-08 |
| 225-23-001 | 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 |
2023-02-15 | 2026-02-14 | 2023-02-15 |
| 225-22-024 | 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 |
2023-01-09 | 2028-01-09 | 2023-01-09 |
| 225-22-023 |
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 |
2022-09-30 | 2025-08-31 | 2022-09-30 |
| 225-22-027 |
CDC MOU to advance safe food practices |
Centers for Disease Control and
|
Abe Brown |
2022-09-21 | 2023-09-21 | 2022-09-21 |
| 225-22-025 |
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 Zane Arp, PhD Dorn Carranza, PhD MBA |
2022-09-22 | 2027-09-22 | 2022-09-22 |
|
|
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 | 2022-05-27 |
| 225-22-022 | 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 | 2022-07-18 |
| 225-21-002 | 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/PAIRS Brittany.Caldwell@fda.hhs.gov |
2021-06-09 | 2026-06-09 | 2021-07-29 |
| 225-21-003 | 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 Management TobaccoUserFees@fda.hhs.gov |
2022-06-21 | Indefinite | |
| NTP-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 Advisor goncalo.gamboa@fda.hhs.gov |
2015-10-30 | 2023-06-30 | |
| 225-22-020 | To enhance testing surge capacity outside of CDC and public health laboratories before and during public health emergencies | AdvaMed, ACLA, AMP, APHL, CAP, CSTE, NILA, COLA Inc., ASPR, and the CDC/OLSS/DLS | Jennifer Ross Regulatory Counsel Jennifer.ross@fda.hhs.gov |
2022-05-06 | Indefinite | 2023-11-16 |
| 225-22-016 | 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 Nutrition suzanne.fitzpatrick@fda.hhs.gov |
2020-11-20 | 2024-08-19 | |
| 225-21-016 | Hawaii MOU for Consumer Protection | Hawaii Dept of Agriculture Hawaii Dept of Health University of Hawaii |
Dan Solis Office of Enforcement & Import Operations dan.solis@fda.hhs.gov |
2022-03-10 | 2025-03-10 | |
| 225-22-014 | 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 | 2026-10-04 | |
| 225-22-011 | 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 | Indefinite | |
| 225-22-006 | 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 Center Brian.Baker@fda.hhs.gov |
2021-12-03 | 2024-12-03 | |
| 225-22-008 | 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-1 Michael.Dutcher@fda.hhs.gov |
2022-02-18 | 2025-02-15 | |
| 225-21-018 | 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
|
2021-09-13 | 2024-09-12 | |
| 225-21-020 | 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 |
2021-09-24 | 2024-09-24 | |
| 225-20-019 | 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 |
2021-08-03 | Indefinite | |
| 225-21-007 | 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 OO/OFEMS |
2021-05-07 | 2023-05-07 | |
| 225-21-010 | 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 | 2024-04-21 | |
| 225-21-006 | 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 | 2026-01-15 | |
| 225-21-001 | 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 | Indefinite | |
| 225-21-019 | 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 | 2024-10-06 | |
| 225-20-017 | 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 | 2025-10-01 | |
| 225-00-2000 | 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 | Indefinite | |
| 225-00-8001 | 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 | Indefinite | |
| 225-03-7000 | 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 | Indefinite | |
| 225-04-4001 | Allows FDA to commission Custom and Border Protection Officers. | Customs and Border Protection (CBP) | ORA Domenic Veneziano (301) 443-6553 |
2003-12-03 | Indefinite | |
| 225-04-8000A | 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 | Indefinite | |
| 225-04-8000B | 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 | Indefinite | |
| 225-05-2001 | 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 | 2027-05-12 | |
| 225-05-3001 | 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 | Indefinite | |
| 225-05-7000 | 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 Medicine (CVM) AskCVM@fda.hhs.gov |
2013-02-04 | Indefinite | 2024-08-09 |
| This MOU establishes a framework for collaboration between the NIH/NHLBI and FDA/CBER 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 4 of the MOU.. | National Institutes of Health (NIH)/National Heart, Lung, and Blood Institute (NHLBI) |
CBER/OTP |
2008-09-11 | Indefinite | 2024-08-30 | |
| 225-07-7001 | 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 | 2024-10-01 | |
| 225-08-8002 | 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 | 2023-06-28 |
| 225-08-8003 | To enhance knowledge and efficiency by providing for the sharing of information and expertise between the Federal partners |
Indian Health Service (IHS), |
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 | Indefinite | |
| 225-09-0008 | Agreement regarding inspection programs for fishery products. | National Oceanic and Atmosphere Administration (NOAA) | CFSAN William Jones (240) 402-2300 |
2009-10-09 | Indefinite | |
| 225-10-0010 | 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 | Indefinite | |
| 225-11-0001 | 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 | 2021-02-02 | |
| 225-11-0028 |
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 | Indefinite | |
| 225-11-0007 | 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 | Indefinite | |
| 225-12-0007 | 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 | Indefinite | |
| 225-12-0020 | 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 | Indefinite | |
| 225-12-0023 | 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 | 2019-12-31 | |
| 225-13-023 | Collaboration and information sharing. | NIH National Institute of Neurological Disorders and Stroke (NINDS) | CDRH John Doucet, PhD (301) 796-6474 |
2015-05-08 | 2020-05-08 | |
| 225-13-028 | 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 | Indefinite | |
| 225-14-001 | 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 | Indefinite | |
| 225-14-002 | 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 | Indefinite |
|
| 225-14-009 | 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 | Indefinite | |
| 225-14-015 | 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 | 2025-11-20 | |
| 225-14-016 | 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 | Indefinite | |
| 225-14-017 |
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 | 2023-06-30 |
| 225-14-022 | 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 | Indefinite | |
| 225-14-025 | 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 | 2019-10-16 | |
| 225-14-026 | 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 | Indefinite | |
| 225-15-003 | 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 | 2019-12-09 | |
| 225-15-004 | 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 | 2022-01-07 |
| 225-15-007 | 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 | 2020-01-19 | |
| 225-15-008 | 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 | 2021-03-15 | |
| 225-15-11 | 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 | 2021-03-14 | |
| 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 | Indefinite | ||
| 225-15-018 | 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 | 2025-09-12 | |
| 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 | Indefinite | ||
| 225-15-020 | 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 Management |
2015-06-08 | Indefinite | |
| 225-16-004 | 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 | Indefinite | |
| 225-16-007 | 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 | Indefinite | |
| 225-16-008 | 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 | Indefinite | |
|
|
A framework for reciprocal cooperation in responsibilities in promoting proper laboratory animal care and welfare. Supercedes MOU 225-06-4000. | USDA Animal and Plant Health Inspection Service (APHIS), National Institutes of Health (NIH) |
OFVM Jeffrey L. Ward, DVM, MS, PhD (240) 402-0885 |
2016-04-25 | 2021-04-24 | |
| 225-16-011 | 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 | Indefinite | |
| 225-16-012 | 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 Programs |
2016-04-12 | Indefinite | |
| 225-16-013 |
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 | 2025-04-12 | |
| 225-16-015 | 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 Liaison |
2016-04-15 | Indefinite | |
| 225-16-018 | 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 | 2021-05-18 | |
| 225-16-019 | 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 |
2016-08-31 | 2021-08-30 | |
| 225-16-020 | 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 ORA/ORS |
2016-11-22 | Indefinite | |
| 225-16-022 | 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 Scientist |
2016-06-13 | 2022-06-13 | |
| 225-16-024 | 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 CDRH |
2016-09-30 | 2021-09-30 | |
| 225-17-014 | 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 OCE |
2017-05-23 | 2027-08-24 | 2022-08-24 |
| 225-17-015 | 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 | Indefinite | |
| 225-17-016 | 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 |
2010-10-21 | Indefinite | |
| 225-17-023 | 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 | 2021-09-31 | |
| 225-17-025 | 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 | Indefinite | |
| 225-17-0007 | 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 |
2016-11-18 | 2021-11-17 | |
| 225-18-003 | Labeling of distilled spirits, wine, and malt beverages. | Bureau of Alcohol, Tobacco and Firearms | CFSAN Felicia Satchell (240) 402-2371 |
1974-09-16 | Indefinite | |
| 225-18-005 | 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 | Indefinite | |
| 225-18-006 | 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 | Indefinite | |
| 225-18-010 | 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 | 2021-05-10 | |
| 225-18-014 | 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 | Indefinite | |
| 225-18-017 | 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 | 2023-04-13 |
| 225-18-026 | 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) |
Nancy Guan, |
2018-09-17 | 2028-09-17 | 2024-08-22 |
| 225-18-027 | 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. |
2018-09-27 | Indefinite | |
| 225-19-001 | 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 | Indefinite | |
| 225-19-002 | 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 CDRH |
2018-10-15 | Indefinite | |
| 225-19-007 | 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 | 2024-02-12 | |
| 225-19-009 | 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 | 2023-12-14 | |
| 225-19-010 | 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 | 2021-06-12 | |
| 225-19-012 | CDRH and NCI collaboration on HPV screening and diagnostic tools. | National Cancer Institute (NCI) | CDRH | 2019-04-02 | 2029-04-02 | 2024-04-02 |
| 225-19-013 | 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 | Indefinite | |
| 225-19-014 | 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 Secretariat |
2019-06-13 | Indefinite | |
| 225-19-015 | 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 | 2024-08-02 | |
| 225-19-017 | 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 | 2024-05-30 | |
| 225-19-018 | 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 | 2027-09-01 | |
| 225-19-021 | 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 | Indefinite | |
| 225-19-027 | To provide a framework for coordination and collaborative efforts. | National Institute of Neurological Disorders and Stroke |
CDER |
2019-08-01 | Indefinite | |
| 225-19-030 | 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 |
2020-06-30 | Indefinite | |
| 225-19-031 | 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 | Indefinite | |
| 225-19-032 | 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 |
2019-10-30 | 2024-10-30 | |
| 225-19-033 | 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 | 2021-10-25 | |
| 225-20-003 | 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 | Indefinite | |
| 225-20-004 | 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 | Indefinite | |
| 225-20-005 | 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 | Indefinite | |
| 225-20-007 | The purpose of this Partnership Agreement is to coordinate and expand food protection efforts between the FDA and the Alaska Department of Environmental Conservation. | Alaska Department of Environmental Conservation (ADEC) |
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 6 Office of Regulatory Affairs/ Office of Regulatory Science/ Winchester Engineering and Analytical Center |
2020-04-02 | 2027-03-19 | 2024-03-20 |
| 225-20-008 | 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 |
2020-03-25 | 2022-03-25 | |
| 225-20-010 | 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 | 2026-09-30 | |
| 225-20-011 |
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 OFPR COVID19.FoodDPA@fda.hhs.gov |
2020-05-18 | Indefinite | |
| 225-20-021 | 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 | Indefinite | |
| 225-22-005 | 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 | 08-26-2026 | |
| 225-22-004 | 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 | Indefinite | |
| 225-22-001 | 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 | 2026-11-09 | |
| 225-71-2006 | 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 | Indefinite | |
| 225-71-4007 | 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 | Indefinite | |
| 225-71-8003 | 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 | Indefinite | |
| 225-72-2001 |
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 | Indefinite | |
| 225-72-2009 |
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 | Indefinite | |
| 225-73-2007 | 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 Monica Pava-Ripoll |
1973-05-07 | Indefinite | |
| 225-73-8010 |
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 | Indefinite | |
| 225-74-1010 | 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), |
NIH | 1974-07-15 | Indefinite | |
| 225-74-1017 | 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 | Indefinite | |
| 225-74-6004 | 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 | Indefinite | |
| 225-74-6008 | 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 | Indefinite | |
| 225-74-8001 |
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 | Indefinite | |
| 225-75-3001 | Cooperative agreement between NIH and FDA regarding anticancer drugs. | National Institutes of Health (NIH) | CDER Diane Ehrlich (301) 796-3452 |
1979-02-05 | Indefinite | |
| 225-75-3003 |
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 |
1987-05-01 | Indefinite | |
| 225-75-4002 |
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 | Indefinite | |
| 225-75-5011 | 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 | Indefinite | |
| 225-75-5012 | 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 | Indefinite | |
| 225-75-7001 | 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 | Indefinite | |
| 225-75-8004 |
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 | Indefinite | |
| 225-76-2002 | 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 | Indefinite | |
| 225-76-2003 | 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 | Indefinite | |
| 225-76-3009 | 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 | Indefinite | |
| 225-76-8049 | 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 |
1975-06-19 | Indefinite | |
| 225-78-4006 | 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 | Indefinite | |
| 225-79-2001 | 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 | Indefinite | |
| 225-79-4003 | Cooperative enforcement of the FD&C Act between USCS and FDA | Department of Homeland Security | ORA Joe McCallion (301) 594-1218 |
1979-08-14 | Indefinite | |
| 225-80-2000 | 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 | Indefinite | |
| 225-80-4000 |
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 | Indefinite | |
| 225-81-3000 | 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 | Indefinite | |
| 225-82-4003 | 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 | Indefinite | |
| 225-82-7000 | 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 | Indefinite | |
| 225-82-8000 | 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 | Indefinite | |
| 225-82-8400 | The purpose of this Memorandum of Understanding (MOU) is to identify specific responsibilities of the U.S. Department of Veterans Affairs (VA), Veterans Health Administration (VHA) and the U.S. Department of Health and Human Services (HHS), Food and Drug Administration to facilitate communication and encourage effective cooperation between the agencies pertaining to VA clinical research of FDA regulated products. | U.S. Department of Veterans Affairs/ Veterans Health Administration (VHA) | Office of Regulatory Affairs (ORA) Office of Medical Products and Tobacco Operations Director, Bioresearch Monitoring Staff |
1982-08-20 | 2030-09-25 | 2024-09-25 |
| 225-83-6000 | 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 | Indefinite | |
| 225-84-8000 | 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 | Indefinite | |
| 225-85-8251 | 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 | Indefinite | |
| 225-85-8400 | 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 | Indefinite | |
| 225-86-2000 | 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 | Indefinite | |
| 225-86-8251 | 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 | Indefinite | |
| 225-88-2000 | 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 | Indefinite | |
| 225-89-2000 | 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 | Indefinite | |
| 225-91-4003 | 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 | Indefinite | |
| 225-93-4005 |
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 | Indefinite | |
| 225-94-2001 | 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 | Indefinite | |
| 225-94-3000 | 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 | Indefinite | |
| 225-94-3001 | 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 | Indefinite | |
| 225-94-6001 | 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 | Indefinite | |
| 225-96-0000 | 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 | Indefinite | |
| 225-97-8000 | 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 | Indefinite | |
| 225-97-8002 | 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 | Indefinite | |
| 225-98-8000 | 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 | Indefinite | |
| 225-99-2001 | 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 | Indefinite | |
| 225-99-3001 | 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 | Indefinite | |
| 225-99-6000 | 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 | Indefinite | |
| 225-99-6001 | Transfer of CLIA Complexity Categorization Functions from CDC to FDA |
Center for Disease Control and Prevention (CDC), |
CDRH Steve Gutman (240) 276-0484 |
1999-02-27 | Indefinite | |
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