About FDA

Domestic MOUs

MOU No.PurposePartiesFDA Lead Center or Office ContactEffective DateExpiration Date
224-09-0006Establishes a mutually acceptable understanding between DoD and FDA that will strengthen global and national food protection, including food safety and food defense in routine and emergency situations.DoDORA
Steven Solomon
(301) 827-3108
224-75-3003Establishes the procedures to be followed regarding the investigational use of drugs, including antibiotics and biologics, and medical devices by DoD.DoDCDER
Diane Ehrlich
(301) 796-3452
Revised on
224-76-8049Agreement 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

Angela Davis
(301) 796-5084

Amendment 1
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.AgricultureCFSAN
Dennis Keefe
(240) 402-1200
225-00-8001Designed 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.DHHSOC06-27-2000Indefinite
225-03-7000To 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.AgricultureCVM
Marleen Wekell
(301) 210-4760
225-04-4000Establishes the framework for collaborative research and development and emergency response triage efforts for Homeland Security.EPAORA
Carl Sciacchitano
(301) 827-1232
225-04-4001Allows FDA to commission Custom and Border Protection Officers.DHSORA
Domenic Veneziano
(301) 443-6553
225-04-8000ATransfer of records from FDA to the National Library of Medicine (NIH) to ensure the preservation of and access to these historically significant records.DHHSORA
John Swann
(301) 827-3756
225-04-8000BCollaboration between FDA and AoA to support education and information initiatives for older Hispanic Americans to promote health.DHHSOC
Mary Hitch
(301) 796-8639
225-05-3001FDA 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.GSAOC
Kathleen Heuer
(301) 255-6762
225-05-7000To 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 ServiceCVM
Vitolis Vengris
(240) 276-9063
225-06-4000This agreement sets forth framework for reciprocal cooperation which will assist each agency in meeting its responsibilities in promoting proper laboratory animal care and welfare.Agriculture
Pamela L. Chamberlain
(301) 796-2968


Provides the principles and procedures by which information sharing between FDA/CBER and NIH/NHLBI units will occur. Modification 1.NHBLIKeith Wonnacott, Ph.D.
(240) 402-8190;

Kimberly Benton, Ph.D.
(240) 402-8190; and

Deborah Hursh, Ph.D.
(240) 402-8190
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 OfficialsCVM
Sharon Benz
(240) 453-6864
225-08-8002To 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.CDCOPPLA
Jarilyn Dupont
(301) 796-4716
225-08-8003To enhance knowledge and efficiency by providing for the sharing of information and expertise between the Federal partnersDoD
Jeffrey Shuren, Assistant Commissioner for Policy
(301) 827-3360

Gwen Zornberg
(301) 796-2199

Rita Ouellet-Hellstrom
(301) 796-0515

Amendment 2

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 PrisonsCDER05-11-201511-19-2020
225-09-0008Agreement regarding inspection programs for fishery products.DoCCFSAN
William Jones
(240) 402-2300
225-09-0009Facilitate sharing of market share information about tobacco manufacturers and importers between the USDA, Commodity Credit Corporation, Farm Service Agency, and HHS, Food and Drug Administration for the purpose of implementing the Family Smoking Prevention and Tobacco Control Act.USDA/ Commodity Credit Corporation, Farm Service AgencyOC
David Miller
(301) 796-7103
225-10-0010To 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.CMSOC/OPPB
Peter Lurie

David Graham
(301) 796-0163
225-10-0019To provide resources dedicated toward carrying out the mission of the NTP and outlines various administrative and managerial actions the agencies will take to support NTP's activities.NIH
Paul C. Howard
(870) 543-7672
225-11-0001To 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
Jason Dietz
(240) 402-2282

Jeanette Murphy
(301) 453-6845

Andrea Chamblee
(301) 796-3820
225-11-0008Aflatoxin testing of domestic and imported peanuts, imported in-shell Brazil nuts, and imported in-shell pistachio nuts. This MOU supersedes Agreement No. 225-96-2001; 225-96-2002); and 225-96-2003).AgricultureCFSAN
John Sheehan
(240) 402-1488
225-11-0019To establish a framework for FDA, FSA, FNS, and AMS to fully exchange timely information essential to minimize risk potential for foods that may be unsafe and distributed or used by USDA programs such as the National School Lunch Program, the Commodity Supplemental Food Program, the Emergency Food Assistance Program, and the Food Distribution Program on Indian Reservations.AgricultureCelia Wolyniak
(301) 796-8209
225-11-0024To 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 ArkansasTBD08-12-201108-12-16
Supersedes MOU 225-07-3002 (9/30/11)
Coordination of resources to develop a unified program, maximize efficient utilization of government facilities, and strengthen joint education and research efforts.Walter Reed Army Institute of ResearchCDER
Russell G. Katz, MD
(301) 796-2250

Shiew-Mei Huang, MD
(301) 796-5008
225-11-2007To 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.DOLORA
Howard Sklamberg
(301) 796-8314
225-12-0007 (cross reference 225-99-2001, 225-72-2009, 225-11-0002, and 225-11-0019)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.AgricultureOFVM
Jeff Farrar
(301) 796-4500

Howard Sklamberg
(301) 796-8314
225-12-0005Details the joint objectives of the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). These agencies share a common interest and goal in developing in vitro microphysiological systems that represent major organs and tissues in the human body, for prediction of efficacy, bioavailability and toxicity.NIHOC
Suzanne C. Fitzpatrick, Ph.D., DABT
(301) 796-8527
225-12-0015Promote collaboration and enhance knowledge and efficiency by providing for the sharing of information and expertise between the Federal Partners.Office of the Assistant Secretary Secretary for Preparedness and ResponseCBER
Cynthia Kelley
(301) 796-0636

Murray Malin
(301) 796-9233

Rosemary Roberts
(301) 796-1740

Alan Liss
(301) 796-5250
225-12-0020 replaces 225-05-3000Assign responsibilities to the Food and Drug Administration (FDA) and National Library of Medicine (NLM) for the distribution of Structured Product Labeling (SPL) documents.National Library of MedicineOC
Lonnie Smith
(301) 796-8503
225-12-0021Establishes the term for collaboration between the Food and Drug Administration (FDA) and the Natick Soldier Research, Development and Engineering Center (NSRDEC) to promote scientific progress in food safety through exchange of scientific capital in training and research.
U.S. Army Natick Soldier Research (NSDREC)ORA05-09-201205-08-2017
225-12-0023Offer 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 InstituteCDER
Norman Stockbridge, MD, PhD
(301) 796-2240
Establishes the collaboration between The Food and Drug Administration (FDA) and The Defense Advanced Research Projects Agency (DARPA) to facilitate innovation of medical products, including medical countermeasures and new enabling technologies that advance the regulatory sciences.DARPAOC
Luciana Borio
(301) 796-8510
225-13-0006Establishes an agreement between the EPA, the USDA, HHS, and DOI ,to improve and sustain federal coordination and collaboration on issues related to pharmaceuticals in drinking water.EPA, USDA, DOICDER
Dr. Douglas C. Throckmorton
(301) 796-5400
225-71-2006To furnish ATF, IRS information concerning legal actions taken by FDA against alcoholic beverage firms for underfilling of containers.DHSCFSAN
Terry Troxell
(240) 402-1700
225-71-4007Consumer protection during times of natural disasters caused by flooding.DoDORA
Michael Rodgers
(301) 827-5653
225-71-8003Information exchange to develop Mutual Program Planning & Liaison on Consumer Deception.FTCORA
Dave Gallant
(240) 632-6812

Mark Lauda
(301) 796-0381
225-72-2001To outline the authority or basis for cooperative efforts between USDA and FDA regarding the inspection, sampling, and examination of imported dates and date materials.AgricultureCFSAN
Doug Park
(240) 402-2410
Revised on
225-72-2009Cooperation and information sharing in the inspection of food products and establishments. This MOU supersedes Agreement No. 225-72-2009 dated June 25, 1975.AgricultureORA
David Glasgow
(301) 796-5403
225-73-2007To outline the authority or basis for cooperative efforts between AMS/USDA and FDA regarding the inspection, sampling, and examination of imported raisins.AgricultureCFSAN
Henry Kim
(240) 402-2023
225-73-8010Mutual Responsibilities under FD&C Act and FIFR Act regarding pesticides.EPAORA
Michael Rodgers
(301) 827-5653
Revised on
225-74-1010Importation of biological specimens under the US-USSR scientific exchange agreement for collaborative research in viral oncology.AgricultureNIH07-15-1974Indefinite
225-74-1017Establishes a uniformed policy between DoD and FDA relative to the voluntary licensure of military blood banks.DoDCBER
Elaine Cole
(301) 827-6352
225-74-6004Identify 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.DHSCDRH
George Kraus
(240) 276-3298
225-74-6008To 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 standardsDOLCDRH
Dan Kassiday
(240) 276-3280
225-74-8001Provide 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.CPSCOC07-06-1973
Revised on
225-74-8013Outlines the working arrangements for the operation and activities of the DEA/FDA Liaison Staff established for dealing with related objectives in carrying out their responsibilities.DOJORA
Dave Gallant
(240) 632-6812
225-75-3001Cooperative agreement between NIH and FDA regarding anticancer drugs.DHHSCDER
Diane Ehrlich
(301) 796-3452
225-75-4002Establishes 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.AgricultureORA
Michael Rodgers
(301) 827-5653
Revised on
225-75-4072The recall and disposition of Class I and Class II recalled products for human consumption.AgricultureORA
Fred Richman
(240) 632-6862
225-75-5011Agreement between FDA and VA to establish procedures for exchanging medical device experience data.VACDRH
Cap Uldricks
(240) 276-0106
225-75-5012Establishes procedures to foster information exchange and scientific coordination between CDC and FDA regarding in vitro diagnostic products.DHHSCDRH
Steve Gutman
(240) 276-0484
225-75-7001Inspection of Industrial Fishery Products intended for animal feed use to eliminate Salmonella.AgricultureCVM
Daniel McChesney
(240) 453-6830
225-75-8004Interagency postattack working relationships regarding food inspections for purity and safety in the event of general War between Agriculture & DHEW.AgricultureORA
Michael Rodgers
(301) 827-5653
Revised on
225-76-2002To provide a mechanism for the exchange of information concerning the shipment of food, drug, and cosmetics.ICCORA
Michael Rodgers
(301) 827-5653
225-76-2003To 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.CPSCCFSAN
Joe Baca
(240) 402-2359
225-76-3009Outlines the working arrangements between DEA/FDA regarding the approval or denial procedures for narcotic treatment programs.DOJCDRH
Alberto Gutierrez
(240) 276-0376
225-78-1002Coordination of industry education efforts that will assist livestock and poultry producers to apply technical information to the proper use of animal drugs in their management practices.AgricultureCVM
Tracey Forfa
(240) 276-9006
225-78-4006To 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.EPACFSAN
Art Banks
(240) 402-1489
225-79-2001Control of Direct and Indirect Additives to and substances in drinking water.EPACFSAN/ORA
Henry Kim
(240) 402-2023
225-79-4003Cooperative enforcement of the FD&C Act between USCS and FDADHSORA
Joe McCallion
(301) 594-1218
225-80-2000Agreement between FGIS and FDA regarding their responsibilities in the inspection and standardization of grain, rice, pulses, and food products.AgricultureCFSAN
Nega Beru
(240) 402-1700
225-80-4000Coordination of activities between FDA and HCFA regarding blood-banking and transfusion programs.DHHSORA/CBER
Elaine Cole
(301) 827-6352
Revised on
225-81-3000Mutual responsibilities between FDA and NIDA regarding the implementation of the jointly published narcotic addict treatment regulations.DHHSCDER
Diane Ehrlich
(301) 796-3452
225-81-6000Identifies the respective responsibilities of each agency with regard to peacetime radiological emergencies and how emergency planning and action will be coordinated.DHHSCDRH
Michael Noska
(240) 276-3331
225-82-4003FDA and the Defense Personnel Support Center providing each other with information on food and cosmetic recalls.DoDORA
Mel Szymanski
(240) 632-6856
225-82-7000Agreement 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.AgricultureCVM
Daniel McChesney
(240) 453-6830
225-82-8000FDA and CDC's responsibilities regarding the exchange and coordination of information in epidemiologic investigations and related activities.DHHSOC01-12-1982Indefinite
225-82-8400Agreement 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.VAORA
Dave Gallant
(240) 632-6812
225-83-6000Establishes 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.DHHSCDRH08-09-1983Indefinite
225-84-8000To 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.DoCOC/OPD
Marlene Haffner
(301) 827-3666
225-85-8251Describes procedures for the cooperative and timely interaction between FDA and NIDA for the domestic scheduling of drugs of abuse.DHHSCDER
Diane Ehrlich
(301) 796-3452
225-85-8400Federal regulatory activities concerning residues of drugs, pesticides and environmental contaminants that may adulterate food.AgricultureCVM
Steven Vaughn
(301) 827-1796
225-86-2000Enforcement of laws against illegal harvest, transport, export, import, sale, and purchase of molluscan shellfish.DoCCFSAN
Donald Kraemer
(240) 402-2300
225-86-8251Outlines methods for determining a product's eligibility for patent term restorationDoCCDER
Diane Ehrlich
(301) 796-3452
225-88-2000To clarify the enforcement responsibilities between FDA and ATF regarding alcoholic beverages that are considered adulterated under the FD&C Act.DHSCFSAN
Nega Beru
(240) 402-1700
225-89-2000To 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.DHHSCFSAN
Joe Baca
(240) 402-2359
225-89-8000Cooperative efforts to educate and inform the U.S. population in the basics of food safety, nutrition, and veterinary medicine.AgricultureORA
Steve Toigo
(301) 827-2906
225-91-4003FDA and USCS meeting the needs of the trading public in expediting the collection, processing, and use of import information, while protecting the public health.DHSORA
Joe McCallion
(301) 594-1218
225-93-4005Regulation of liquid chemical germicides for use on medical devices.EPACDRH
Elaine Mayhall
(240) 276-3749
Revised on
225-94-2001USDA/FDA establishment of a foodborne illness education information center as central source for foodborne illness education activities.AgricultureCFSAN
David Acheson
(240) 402-1910
225-94-3000To establish a relationship between FDA and NIH so that joint experiments can be conducted related to drug metabolism and drug to drug interactions.DHHSCDER
Diane Ehrlich
(301) 796-3452
225-94-3001To 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.DHHSCDER
Diane Ehrlich
(301) 796-3452
225-94-6001To facilitate development of Standard Reference Materials for materials used in medical implant applications.DoCCDRH01-14-1994Indefinite
225-96-0000Defines the respective authorities and responsibilities of the ASM and the FDA in regards to the administration of the Egg Products Inspection Act.USDA/AMSCFSAN06-10-1996Indefinite
225-96-2006Establishment of standards for the National Laboratory Accreditation Program through the regulation process.AgricultureCFSAN
Mark Wirtz
(240) 402-2001
225-97-8000Defines 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.DHHSOC02-11-1997Indefinite
225-97-8002To 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.DHHSCFSAN
David Acheson
(240) 402-1910
225-98-8000FDA 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 ServiceOC
Mary Hitch
(301) 796-8639
225-99-2001To facilitate an exchange of information between FDA and FSIS about establishments and operations that are subject to the jurisdiction of both agencies.AgricultureORA
Jeanne Roman
(301) 827-0947
225-99-3001Establishes 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.NCICDER
Diane Ehrlich
(301) 796-3452
225-99-6000Outlines the mechanism for cooperation between CDRH and FAA in matters concerning operation of lasers in airspaceFederal Aviation Administration (FAA)CDRH
Dale Smith
(240) 276-3295
225-99-6001Transfer of CLIA Complexity Categorization Functions from CDC to FDADHHSCDRH
Steve Gutman
(240) 276-0484
distilled spiritsLabeling of distilled spirits, wine, and malt beverages.ATFCFSAN
Felicia Satchell
(240) 402-2371
225-13-0003Information sharinga to promote initiatives related to the review and use of diagnostic, preventive and therapeutic products for use in oral health care. NIH/NIDCRCDRH
Susan Runner, DDS, MA
(301) 796-6282
225-13-013Establishes 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, USDAOC
Luciana Borio MD
(301) 796-8510
225-13-0016Collaboration and coordination of efforts towards the preclinical use of exRNA to address human health and disease.NIH/ National Center for Advancing Translational SciencesOC/OCS
Frank F. Weichold, MD, PhD
(301) 796-5370
Replaces 225-02-1000
Establishes a framework for coordination, collaborative efforts, principles and procedures for information sharing.NIH/NINDSCBER
Kimberly Benton, PhD
(301) 827-5102
225-13-023Collaboration and informtion sharingNIH/NINDSCDRH
John Doucet, PhD
(301) 796-6474
225-14-0001Establishes a framework and procedures to enhance collaborations and exchange of information.NCI/ Center to Reduce Cancer Health DisparitiesOWH
Brent Howard
(301) 796-1409
MOUTo 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 GhanaU.S. Agency for International DevelopmentOIP
Leigh Verbois
225-14-0002Work to promote a health information technology (IT) framework that promotes innovation, protects patient safety, and avoids regulatory duplicationDHHH/ Office of the National Coordinator for Health Information Technology and Federal Communications CommissionBakul Patel
(301) 796-5528
225-14-0009Framework for cooperation between FDA and FSIS/USDA for regulation of Siluriformes fish and fish products re 2014 Farm Bill.USDA FSISCFSAN
(240) 402-1729
225-14-0016The 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/ NHBLICDRH
Murry Sheldon, MD
(301) 797-5443
Replaces 225-09-0002
Establishes a framework for information sharing.CDCORA
Ellen Morrison
(301) 796-8257
225-14-022Information 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.EPACFSAN
Randy Levin
225-14-0025Promote scientific progress through the exchange of scientific capital in a Cardiovascular Disease Drug Development Fellowship Training and Research Program.National Capital ConsortiumCDER
Karen Hickman, M.D.
(301) 796-1089
225-15-003Establishes 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/ OWHROC/OWH
Deborah Kallgren
(301) 796-9442
225-15-004Establishes 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 PreventionOFVM
Susan Berndt
(240) 402-2143

Thomas Zebovitz
(240) 402-1244

Gorka Garcia Malene
(240) 276-9120
225-15-007Collaboration 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 LaboratoryOC
Office of the Chief Scientist
Frank Weichold, M.D.
(301) 975-6759
225-15-008Facilitate 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 ActUSDA, The Commodity Credit Corporation and Farm Service AgencyCTP
Bryan Walsh
(301) 796-6735
225-15-011Create a mechanism to facilitate timely sharing of information, and to build upon and establish additional collaborative efforts.Drug Enforcement Administration, DOJCDER
Christine Bechtel
(301) 796-3449

225-15-016 Replaces 225-97-4000

FDA provides the quality assurance support for DoD centrally managed contracts for drug, biologics, and medical devices.DoDORA, Director, Division of ComplianceJuly 21, 2015Indefinite


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 CommissionBaku Patel
(301) 796-5528
225-16-004Stream 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
(301) 796-6735
225-16-008Establishes 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 PreventionElizabeth Sadove, JD
(301)  796-8515
225-14-026Coordinates staffing, space and equipment requirements for the new National Targeting Center facility.Department of Homeland Security U.S. Customs and Border ProtectionAnthony C. Taube
(571) 468-1489
225-16-010A framework for reciprocal cooperation in responsibilities in promoting proper laboratory animal care and welfare.USDA/ Animal and Plant Health Inspection Service and the National Institutes of HealthJeffrey L. Ward, DVM, MS, PhD
Office of Foods and Veterinary Medicine
(240) 402-0885
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.
NCATChekesha S. Clingman, PHD, MBA 301-796-853104-13-2016Indefinite
225-16-012Ensure 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 DevelopmentFDA PEPFAR Liaison, Office of International Programs


Modernizing regulatory science to support development of useful medical products prior to use in humans.
DARPACarlos Pena, PhD, MS CDRH 301-796-66104/13/20164/12/2025
225-16-015Ensure 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 CoordinatorFDA PEPFAR Liaison, Office of International Programs
225-16-018Establish 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, BARDALuciana Borio, MDMay 19, 2016May 18, 2021
225-16-020Modernizing regulatory science to support the development of useful medical products.Defense Advanced Research Projects Agency (DARPA)Carlos Pena, PhD, MS, CDRH        301-796-6610April 13, 2016September 12, 2025
225-16-024Encouraging 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 301-796-6944September 2016September 2021


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