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  5. Domestic MOUs
  1. FDA Memoranda of Understanding

Domestic MOUs

MOU No. Purpose Parties FDA Lead Center or Office Contact Effective Date Expiration Date
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
225-20-017 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
225-05-3001 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) CVM
Ellen J. Hart, DVM
301-348-1585
2013-02-04 Indefinite

225-07-1000

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 2023-09-09
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) OPPLA
Jarilyn Dupont
(301) 796-4716
2008-01-24 Indefinite
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),
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 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)). This MOU was first signed in 2012 and amended in 2015. Federal Bureau of Prisons CDER 2015-11-05 2020-11-19
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 and amended in 2019.

Centers for Disease Control and Prevention (CDC) OPLIA
Nick Alexander, J.D.
Director, Intergovernmental Affairs
Phone: (301) 796-8893
2019-06-12 2021-06-19
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
Thomas Zebovitz
(240) 402-1244

CVM
Gorka Garcia Malene
(240) 276-9120
2015-09-01 Indefinite
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

225-15-016

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 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

225-15-019

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 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
Email
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

225-16-010

 

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 2021-04-24
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
Email
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
01-796-6610
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
Email
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
William Slikker, Jr., Ph.D.
Director
870-543-7517

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
Kathryn Nagy, Liaison
W: 404-253-1225
C: 404-782-9013
Email

ORA/ORS
Paul Norris, D.V.M.
W: 870-543-4099
C: 870-489-7463

2016-11-22 Indefinite
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
Email
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
Suzanne B. Schwartz, MD, MB 
301-796-6937

CDRH
Seth Carmody, PhD
301-796-6944

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
Douglas Jeffery, Ph.D.
240-402-6648

OCE
Gideon Blumenthal, M.D
301-796-5369
2017-05-23 2022-05-22
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
Division of Import Operations

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
Frank Weichold
Office of the Chief Scientist
301-796-5370

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 2023-02-12
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)

CDER
Richard Currey

CDER 
Nancy Guan (secondary contact)

2018-09-17 2023-09-17
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.
Email
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
Suzanne B. Schwartz, M.D., M.B.A
301-796-6937

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

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 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. Office of the Assistant Secretary for Preparedness and Response (ASPR) 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
Email
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
225-19-027 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 3743
Email

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
Angela Davis
301-796-5084

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
Sibyl Swift, Ph.D.
240-402-1455
 

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
Renate Reimschuessel
240-402-5404
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
Renate Reimschuessel
240-402-5404
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 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 2023-04-02
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
Office of Counterterrorism and Emerging Threats
CDR James Coburn
301-796-0286

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
225-71-2006 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
Gordon Davidson
240) 402-1328
1973-05-7 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),
National Institutes of Health (NIH)
 

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
Diane Ehrlich
(301) 796-3452

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
Angela Davis
(301) 796-5084

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 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 Indefinite
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
225-96-2006 Establishment of standards for the National Laboratory Accreditation Program through the regulation process. USDA Agricultural Marketing Service (AMS) CFSAN
Mark Wirtz
(240) 402-2001
1996-05-31 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),
Health Care Financing Administration

CDRH
Steve Gutman
(240) 276-0484
1999-02-27 Indefinite

 


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Academic MOUs

Agreements between FDA and academic institutions and organizations.


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