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  1. Partnerships: Enhancing Science Through Collaborations With FDA

Domestic MOUs

Domestic MOUs

MOU No. Purpose Parties FDA Lead Center or Office Contact Effective Date Expiration Date
225-75-3003 Establishes the procedures to be followed regarding the investigational use of drugs, including antibiotics and biologics, and medical devices by DoD. DoD

CDER
Diane Ehrlich
(301) 796-3452

10-24-1974
Revised on
05-01-1987
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. VA

ORA
Angela Davis
(301) 796-5084

06-19-1975 Indefinite
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. Agriculture CFSAN
Dennis Keefe
(240) 402-1200
01-31-2000
Revised on
01-15-2015
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. DHHS OC 06-27-2000 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. Agriculture CVM
Marleen Wekell
(301) 210-4760
01-23-2003 Indefinite
225-04-4001 Allows FDA to commission Custom and Border Protection Officers. DHS Customs and Border Protection ORA
Domenic Veneziano
(301) 443-6553
12-03-2003 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. DHHS ORA
John Swann
(301) 827-3756
12-30-2003 Indefinite
225-04-8000B Collaboration between FDA and AoA to support education and information initiatives for older Hispanic Americans to promote health. DHHS OC
Mary Hitch
(301) 796-8639
10-17-2003 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. GSA OC
Kathleen Heuer
(301) 255-6762
11-18-2005 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 CVM
Vitolis Vengris
(240) 276-9063
 
02-04-2013 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. National Heart, Lung and Blood Institute, National Institutes of Health

CBER
Deborah Hursh
240-402-9597

09-23-2018 09-09-2023
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. The Association of American Feed Control Officials CVM
David Edwards
(240) 402-6205
06-25-2019 10-01-2024
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. CDC OPPLA
Jarilyn Dupont
(301) 796-4716
01-24-2008 Indefinite
225-08-8003 To enhance knowledge and efficiency by providing for the sharing of information and expertise between the Federal partners DoD
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
 
11-25-2008 Indefinite
225-09-0008 Agreement regarding inspection programs for fishery products. DoC CFSAN
William Jones
(240) 402-2300
10-09-2009 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. CMS OC/OPPB
Peter Lurie

CDER/OSE
David Graham
(301) 796-0163
 
06-25-2010 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. EPA
USDA
Jason Dietz
CFSAN
(240) 402-2282

Jeanette Murphy
CVM
(301) 453-6845

Andrea Chamblee
ORA
(301) 796-3820
 
02-02-2011 02-02-2021
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). Walter Reed Army Institute of Research CDER
Russell G. Katz, MD
(301) 796-2250

Shiew-Mei Huang, MD
(301) 796-5008
01-11-2013
Revised on
12-09-2018
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. DOL ORA
Howard Sklamberg
(301) 796-8314
06-20-2011 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. Agriculture ORA
Martha Myrick
(240) 402-5840
01-19-2012 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. National Library of Medicine OC
Lonnie Smith
(301) 796-8503
05-30-2012 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. National Heart, Blood, Lung Institute CDER
Norman Stockbridge, MD, PhD
(301) 796-2240
02-16-2015 12-31-2019
225-13-023 Collaboration and information sharing. NIH/NINDS CDRH
John Doucet, PhD
(301) 796-6474
05-08-2015 05-08-2020
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
03-11-2014 Indefinite
225-14-001 Establishes a framework and procedures to enhance collaborations and exchange of information. NCI/ Center to Reduce Cancer Health Disparities OWH
Brent Howard
(301) 796-1409
01-2-2014 Indefinite
225-14-002 Work to promote a health information technology (IT) framework that promotes innovation, protects patient safety, and avoids regulatory duplication DHHH/ Office of the National Coordinator for Health Information Technology and Federal Communications Commission Bakul Patel
(301) 796-5528
4-22-2014 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 FSIS CFSAN
(240) 402-1729
4-30-2014 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 CDER 11-19-2012
Revised on
05-11-2015
11-19-2020
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/ NHBLI CDRH
Murry Sheldon, MD
(301) 797-5443
01-15-2015 Indefinite
225-14-017 Establishes a framework for information sharing.  Replaces MOU 225-09-0002. CDC OPLIA
Nick Alexander, J.D.
Director, Intergovernmental Affairs
Phone: (301) 796-8893
06-19-14
Revised
06-12-19
06-19-2021
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. EPA CFSAN
Randy Levin
09-10-2014 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
10-17-2014 10-16-2019
225-14-026 Coordinates staffing, space and equipment requirements for the new National Targeting Center facility. Department of Homeland Security U.S. Customs and Border Protection Anthony C. Taube
(571) 468-1489
05-28-2013 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/ OWHR OC/OWH
Deborah Kallgren
(301) 796-9442
12-10-14 12-09-2019
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 OFVM
Susan Berndt
(240) 402-2143

CFSAN
Thomas Zebovitz
(240) 402-1244

CVM
Gorka Garcia Malene
(240) 276-9120
09-01-2015 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. NIH/ NCI/ NIST/ Nanotechnology Characterization Laboratory OC
Office of the Chief Scientist
Frank Weichold, M.D.
(301) 975-6759
01-20-2015 01-19-2020
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, The Commodity Credit Corporation and Farm Service Agency CTP
Bryan Walsh
(301) 796-6735
03-16-2015 03-15-2021
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 Mitchell Weitzman, Regulatory Counsel 03-14-2018 03-14-2021

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. DoD ORA, Director, Division of Compliance 07-21-2015 Indefinite
225-15-018 Modernizing regulatory science to support the development of useful medical products. DoD/Defense Advanced Research Projects Agency Carlos Pena, PhD, MS,
CDRH
301-796-6610
04-13-2016 09-12-2025

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 Baku Patel
CDRH
(301) 796-5528
09-11-2015 Indefinite
225-15-020 Establish procedures and guidelines to accommodate and facilitate the exchange of data through the Automated Commercial Environment (ACE).
 
U.S. Customs and Border Protection ORA
Office of Information Systems Management
oraoismdssaceteam@fda.hhs.gov
6-8-2015 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) Owen Faris, PhD
CDRH
(301) 796-6735
12-02-2015 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
4-13-2016 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 Elizabeth Sadove, JD
(301)  796-8515
02-22-2-16 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 and the National Institutes of Health Jeffrey L. Ward, DVM, MS, PhD
Office of Foods and Veterinary Medicine
(240) 402-0885
04-25-2016 04-24-2021
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. NCAT Chekesha S. Clingman, PHD, MBA 301-796-8531 04-13-2016 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
04-12-2016 Indefinite
225-16-013

 

Modernizing regulatory science to support development of useful medical products prior to use in humans.
DARPA Carlos Pena, PhD, MS CDRH 301-796-6610 4-13-2016 04-12-2025
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). Department of State, Office of the U.S. Global AIDS Coordinator FDA PEPFAR Liaison, Office of International Programs
Email
04-15-2016 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. NIH,CDC, BARDA Office of the Chief Scientist 05-19-2016 05-18-2021
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

William Slikker, Jr., Ph.D.
Director, NCTR
870-543-7517

08-31-2016 08-30-2021
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. DoD Kathleen Gensheimer, M.D.
OFVM/CORE
240-402-1608

Ellen F. Morrison
ORA
301-796-8257

Carl Pavetto
ORA
301-796-8406
24-hour Emergency Number: 1-866-300-4374

Paul Norris, D.V.M.
ORA
870-543-4099
11-22-2016 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. National Center for Advancing Translational Sciences, National Institutes of Health Carol D. Linden, Ph.D.
Director, Office of Regulatory Science and Innovation
Office of the Chief Scientist
Email: Carol.linden@fda.hhs.gov
6-13-2016 6-13-2022
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)

Suzanne B. Schwartz, MD, MB, CDRH 301-796-6937

Seth Carmody, PhD, CDRH 301-796-6944

09-30-2016 09-30-2021
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/NIH Douglas Jeffery, Ph.D.
CDRH
240-402-6648

Gideon Blumenthal, M.D
OCE
301-796-5369
05-23-2017 05-22-2022
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 RADM Carmen T. Maher, Office of Counterterrorism and Emerging Threats/OC  301-796-8513 06-01-2017 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 Gary H. Gibbons, Director,
National Heart, Blood, and Lung Institute
04-24-2017 9-31-2021
225-17-025 Recognize the need for a unified approach to advancing scientific knowledge related to cancer and women's health. National Cancer Institute Dr. Pamela Scott, Office of Women's Health, 301-796-0630 08-10-2015 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 Frank Weichold
Office of the Chief Scientist
301-796-5370
11-18-2016 11-17-2021
225-18-003 Labeling of distilled spirits, wine, and malt beverages. ATF CFSAN
Felicia Satchell
(240) 402-2371    
09-16-1974 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
04-21-2014 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/NIOSH CDRH/Director, Emergency Preparedness and Medical Countermeasures 11-29-2017 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
 
05-10-2018 05-10-2021
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. DHHS Office for Human Research Protections (OHRP) ORA
Office of Bioresearch Monitoring Operations
David Glasgow
(301) 796-5403
03-19-2018 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, 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
02-12-2001 02-12-2023
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)

Richard Currey
CDER
Nancy Guan (secondary contact)
CDER 

9-17-2018 9-17-2023
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
09-27-2018
 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. DoD OC
Elizabeth Sadove
301-796-8515
11-02-2018 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.  DHS National Protection and Programs Directorate (NPPD)

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

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

10-15-2018 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 and Health and Environmental Sciences Institute (HESI) Norman Stockbridge, MD
Director. Division of Cardiovascular and Renal Products, CDER
2-12-2019 2-12-2024
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 Lisa Lubin 12-14-2018 12-14-2023
225-19-010 A public-private partnership is envisioned to accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases. HHS, CMS, NIH, CDC N/A 6-12-19 6-12-2024
225-19-012 CDRH and NCI collaboration on HPV screening and diagnostic tools. NCI CDRH 4-2-2019 4-2-2024
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. ASPR OCS/OCET 4-10-19 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
CDEREXSEC@cder.fda.gov
6-13-19 Indefinite
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
05-30-2019 05-30-2024
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
Telephone: 240-402 3743
E-Mail: Patrizia.Cavazzoni@fda.hhs.gov
 
8-1-2019 Indefinite
225-71-2006 To furnish ATF, IRS information concerning legal actions taken by FDA against alcoholic beverage firms for underfilling of containers. DHS CFSAN
Terry Troxell
(240) 402-1700
07-13-1971 Indefinite
225-71-4007 Consumer protection during times of natural disasters caused by flooding. DoD ORA
Michael Rodgers
(301) 827-5653
07-27-1971 Indefinite
225-71-8003 Information exchange to develop Mutual Program Planning & Liaison on Consumer Deception. FTC ORA
Dave Gallant
(240) 632-6812

CDER/OMP
Mark Lauda
(301) 796-0381
05-14-1971 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. Agriculture CFSAN
Doug Park
(240) 402-2410
05-29-1953
Last revised on
11-19-1985
Indefinite
225-72-2009 Cooperation and information sharing in the inspection of food products and establishments.  Agriculture ORA
Martha Myrick
(240) 402-5840
06-25-1975
Revised on
03-04-2011
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. Agriculture CFSAN
Gordon Davidson
240) 402-1328
05-07-1973 Indefinite
225-73-8010 Mutual Responsibilities under FD&C Act and FIFR Act regarding pesticides. EPA ORA
Michael Rodgers
(301) 827-5653
09-04-1971
Revised on
08-28-1973
Indefinite
225-74-1010 Importation of biological specimens under the US-USSR scientific exchange agreement for collaborative research in viral oncology. Agriculture NIH 07-15-1974 Indefinite
225-74-1017 Establishes a uniformed policy between DoD and FDA relative to the voluntary licensure of military blood banks. DoD CBER
Elaine Cole
(301) 827-6352
06-20-1974 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. DHS CDRH
George Kraus
(240) 276-3298
03-20-1974 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 DOL CDRH
Dan Kassiday
(240) 276-3280
04-10-1974 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. CPSC OC 07-06-1973
Revised on
03-18-1974
Indefinite
225-75-3001 Cooperative agreement between NIH and FDA regarding anticancer drugs. DHHS CDER
Diane Ehrlich
(301) 796-3452
02-05-1979 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. Agriculture ORA
Michael Rodgers
(301) 827-5653
02-19-1975
Revised on
11-18-1987
Indefinite
225-75-5011 Agreement between FDA and VA to establish procedures for exchanging medical device experience data. VA CDRH
Cap Uldricks
(240) 276-0106
03-19-1975 Indefinite
225-75-5012 Establishes procedures to foster information exchange and scientific coordination between CDC and FDA regarding in vitro diagnostic products. DHHS CDRH
Steve Gutman
(240) 276-0484
12-13-1975 Indefinite
225-75-7001 Inspection of Industrial Fishery Products intended for animal feed use to eliminate Salmonella. Agriculture CVM
Daniel McChesney
(240) 453-6830
11-13-1974 Indefinite
225-75-8004 Interagency postattack working relationships regarding food inspections for purity and safety in the event of general War between Agriculture & DHEW. Agriculture ORA
Michael Rodgers
(301) 827-5653
10-10-1974
Revised on
12-13-1983
Indefinite
225-76-2002 To provide a mechanism for the exchange of information concerning the shipment of food, drug, and cosmetics. ICC ORA
Michael Rodgers
(301) 827-5653
04-14-1976 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. CPSC CFSAN
Joe Baca
(240) 402-2359
07-26-1976 Indefinite
225-76-3009 Outlines the working arrangements between DEA/FDA regarding the approval or denial procedures for narcotic treatment programs. DOJ CDRH
Alberto Gutierrez
(240) 276-0376
07-02-1976 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. EPA CFSAN
Art Banks
(240) 402-1489
09-14-1978 Indefinite
225-79-2001 Control of Direct and Indirect Additives to and substances in drinking water. EPA CFSAN/ORA
Henry Kim
(240) 402-2023
06-22-1979 Indefinite
225-79-4003 Cooperative enforcement of the FD&C Act between USCS and FDA DHS ORA
Joe McCallion
(301) 594-1218
08-14-1979 Indefinite
225-80-2000 Agreement between FGIS and FDA regarding their responsibilities in the inspection and standardization of grain, rice, pulses, and food products. Agriculture CFSAN
Nega Beru
(240) 402-1700
11-08-1985 Indefinite
225-80-4000 Coordination of activities between FDA and HCFA regarding blood-banking and transfusion programs. DHHS ORA/CBER
Elaine Cole
(301) 827-6352
01-21-1980
Revised on
06-06-1983
Indefinite
225-81-3000 Mutual responsibilities between FDA and NIDA regarding the implementation of the jointly published narcotic addict treatment regulations. DHHS CDER
Diane Ehrlich
(301) 796-3452
11-20-1980 Indefinite
225-82-4003 FDA and the Defense Personnel Support Center providing each other with information on food and cosmetic recalls. DoD ORA
Mel Szymanski
(240) 632-6856
03-23-1982 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. Agriculture CVM
Daniel McChesney
(240) 453-6830
05-07-1982 Indefinite
225-82-8000 FDA and CDC's responsibilities regarding the exchange and coordination of information in epidemiologic investigations and related activities. DHHS OC 01-12-1982 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. VA ORA
Dave Gallant
(240) 632-6812
08-20-1982 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. DHHS CDRH 08-09-1983 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. DoC OC/OPD
Marlene Haffner
(301) 827-3666
03-22-1984 Indefinite
225-85-8251 Describes procedures for the cooperative and timely interaction between FDA and NIDA for the domestic scheduling of drugs of abuse. DHHS CDER
Diane Ehrlich
(301) 796-3452
05-01-1985 Indefinite
225-85-8400 Federal regulatory activities concerning residues of drugs, pesticides and environmental contaminants that may adulterate food. Agriculture CVM
Steven Vaughn
(301) 827-1796
11-21-1984 Indefinite
225-86-2000 Enforcement of laws against illegal harvest, transport, export, import, sale, and purchase of molluscan shellfish. DoC CFSAN
Donald Kraemer
(240) 402-2300
07-24-1986 Indefinite
225-86-8251 Outlines methods for determining a product's eligibility for patent term restoration DoC CDER
Diane Ehrlich
(301) 796-3452
09-17-1986 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. DHS CFSAN
Nega Beru
(240) 402-1700
11-20-1987 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. DHHS CFSAN
Joe Baca
(240) 402-2359
04-11-1989 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. DHS ORA
Joe McCallion
(301) 594-1218
08-09-1991 Indefinite
225-93-4005 Regulation of liquid chemical germicides for use on medical devices. EPA CDRH
Elaine Mayhall
(240) 276-3749
06-04-1993
Revised on
06-20-1994
Indefinite
225-94-2001 USDA/FDA establishment of a foodborne illness education information center as central source for foodborne illness education activities. Agriculture CFSAN
David Acheson
(240) 402-1910
03-16-1994 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. DHHS CDER
Diane Ehrlich
(301) 796-3452
12-13-1993 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. DHHS CDER
Diane Ehrlich
(301) 796-3452
01-04-1994 Indefinite
225-94-6001 To facilitate development of Standard Reference Materials for materials used in medical implant applications. DoC CDRH 01-14-1994 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/AMS CFSAN 06-10-1996 Indefinite
225-96-2006 Establishment of standards for the National Laboratory Accreditation Program through the regulation process. Agriculture CFSAN
Mark Wirtz
(240) 402-2001
05-31-1996 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. DHHS OC 02-11-1997 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. DHHS/CDC, USDA/FSIS, and CSREES CFSAN
David Acheson
(240) 402-1910
05-12-1997 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. DHHS/ Indian Health Service OC
Mary Hitch
(301) 796-8639
07-09-1997 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. Agriculture ORA
Martha Myrick
(240) 402-5840
02-23-1999 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. NCI CDER
Diane Ehrlich
(301) 796-3452
01-11-1999 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
11-25-1998 Indefinite
225-99-6001 Transfer of CLIA Complexity Categorization Functions from CDC to FDA DHHS CDRH
Steve Gutman
(240) 276-0484
02-27-1999 Indefinite

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Academic MOUs

Agreements between FDA and academic institutions and organizations.