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FDA Memoranda of Understanding

Domestic MOUs

List of Memoranda of Understanding
MOU No. Purpose Parties FDA Lead
Center or
Office/
Contact
Effective
Date
Expiration
Date
224-75-3003 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) 443-5373
10-24-1974
Revised on
05-01-1987
Indefinite
224-76-8049 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
Dave Gallant
(240) 632-6812
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. Agriculture CFSAN
Laura Tarantino
(301) 436-1200
01-31-2000 Indefinite
225-00-6000 Facilitate interactions between NIDCR and FDA regarding improvements in the quality and relevance of pre-clinical and clinical research that is directed to the development of products for use in oral health care. DHHS CDRH
Susan Runner
(240) 276-3376
12-06-2000 12-06-2005
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
225-00-8002 Establish framework for the parties to collaborate on mutually agreed upon activities in the scientific and regulatory areas as they pertain to products under FDA and FSIS jurisdiction. Agriculture,
University of Puerto Rico
CFSAN
David Acheson
(301) 436-1910
12-07-2000 12-06-2005
225-02-1000 Provides a framework for FDA/CBER and NIH/NINDS to coordinate and collaborate efforts on protecting and improving the public health. NIH/NINDS CBER
Kimberly Benton, Ph.D.
(301) 827-5102
02-12-2002 02-12-2007
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
225-03-8001 Provides a framework for coordination and collaborative efforts between FDA and CDC re: information exchanges. DHHS OC
Ellen Morrison
(301) 827-5600
06-19-2003 06-25-2006
225-04-4000 Establishes the framework for collaborative research and development and emergency response triage efforts for Homeland Security. EPA ORA
Carl Sciacchitano
(301) 827-1232
02-19-2003 Indefinite
225-04-4001 Allows FDA to commission Custom and Border Protection Officers. DHS ORA
Domenic Veneziano
(301) 443-6553
12-03-2003 Indefinite
225-04-4007 Establishes the general policies and procedures between FDA and the FBI for administrative, logistical, and operational support. DOJ CFSAN
Cassandra Jackson
(301) 436-2394
12-22-2004 11-02-2007
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) 827-4406
10-17-2003 Indefinite
225-05-2001 Collaboration between FDA and EPA on environmental contaminants in fish and shellfish and the safety of fish and shellfish for consumption by U.S. consumers. EPA CFSAN
Jason Dietz
(301) 436-2282
06-08-2005 06-08-2010
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
225-05-6002 Authorizes South Carolina through SC Department of Health and Environmental Control (DHEC) to conduct a State as certifiers program in South Carolina under MQSA. South Carolina
DHES
CDRH
Joanne Choy
(240) 276-3259
04-29-2005 04-29-2012
225-06-8001 FDA, NCI, and CMS agree to develop strategic plans, set priorities, and leverage resources and expertise from multiple sources in order to improve the clinical utility of biomarker technologies as diagnostic and assessment tools to develop safer and more effective cancer therapies NCI
CMS
OC
Wendy Sanhai
(301) 827-7867
01-23-2006 01-23-2009
225-06-8401 Provides a framework for coordination and collaborate efforts between FDA and CDC. CDC OC
Ellen Morrison
(301) 827-5660
06-14-2006 06-14-2009
225-06-8402 Collaboration between FDA and NCI to develop and implement the Federal Investigation Registry of Biomedical Information Research Data (FIREBIRD) NCI CDER
Randy Levin
(240) 460-6283
08-10-2006 08-10-2008
225-06-8403 FDA, NCI, and NIST agree to collaborate with each other to develop nanotechnologies for safe and effective cancer therapies by establishing a framework for effective risk ID, assessment, and evaluation of emerging products based on nanotechnology NCI
NIST
OC
Wendy Sanhai
(301) 827-7867
06-22-2006 06-22-2009
225-07-3002 To coordinate the Clinical Pharmacology Training Program for active duty military and PHS Medical Corps officers and facilitate rotation of Clinical Pharmacology Fellows through CDER's Office of Clinical Pharmacology. The Walter Reed Army Institute of Research

The F. Edward Herbert School of Medicine of the Uniformed Services University of Health Sciences
OC
Mary Poos
(301) 827-2825
01-08-2008 09-30-2011
225-07-4300 FDA/VHA agree to share information related to the review and use of FDA-regulated drugs, biologics, and medical devices, as devined by the FD&C VHA OC
Poppy Kendall
(301) 827-3360
01-23-2007 01-23-2010
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
Sharon Benz
(240) 453-6864
08-30-2007 09-01-2012
225-07-8003 To share data and expertise related to review and use of FDA-regulated medical products and promote efficient utilization of tools and expertise for product risk identification, validation and analysis. DoD
OC
Jeffrey Shuren, Assistant Commissioner for Policy
(301) 827-3360
07-30-2007 07-30-2010
225-07-8007 To collaborate on the development of a “Rational Questionnaire” and a prototype to test the feasibility of a central web-based method for consumers, health professionals, investigators, sponsors, and other parties to electronically submit Adverse Event reports.  DHHS/NIH OC
Daryl Allis
301-827-7868
09-27-2007 09-27-2012
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 OPPL
Jarilyn Dupont
301-827-5906
01-24-2008 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
(301) 436-1700
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
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
(301) 436-2410
10-07-1963
Revised on
11-19-1985
Indefinite
225-72-2009 Inspections and standardization activities regarding food products. Agriculture CFSAN
Robin Woo
(301) 436-2776
05-11-1972
Revised on
06-25-1975
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
Henry Kim
(301) 436-2023
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
225-74-8013 Outlines 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. DOJ ORA
Dave Gallant
(240) 632-6812
07-01-1974 Indefinite
225-75-3001 Cooperative agreement between NIH and FDA regarding anticancer drugs. DHHS CDER
Diane Ehrlich
(301) 443-5373
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
225-75-4072 The recall and disposition of Class I and Class II recalled products for human consumption. Agriculture ORA
Fred Richman
(240) 632-6862
06-03-1975 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
225-76-2001 Agreement regarding inspection programs for fishery products. DoC CFSAN
Donald Kraemer
(301) 436-2300
10-10-1974 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
(301) 436-2359
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
225-78-1002 Coordination 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. Agriculture CVM
Tracey Forfa
(240) 276-9006
05-25-1978 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
(301) 436-1489
09-14-1978 Indefinite
225-79-2001 Control of Direct and Indirect Additives to and substances in drinking water. EPA CFSAN/ORA
Henry Kim
(301) 436-2023
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
(301) 436-1700
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) 443-5373
11-20-1980 Indefinite
225-81-6000 Identifies the respective responsibilities of each agency with regard to peacetime radiological emergencies and how emergency planning and action will be coordinated. DHHS CDRH
Michael Noska
(240) 276-3331
09-10-1992 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) 443-5373
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
(301) 436-2300
07-24-1986 Indefinite
225-86-8251 Outlines methods for determining a product's eligibility for patent term restoration DoC CDER
Diane Ehrlich
(301) 443-5373
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
(301) 436-1700
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
(301) 436-2359
04-11-1989 Indefinite
225-89-8000 Cooperative efforts to educate and inform the U.S. population in the basics of food safety, nutrition, and veterinary medicine. Agriculture ORA
Steve Toigo
(301) 827-2906
02-16-1989 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
(301) 436-1910
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) 443-5373
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) 443-5373
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
225-96-2001 Aflatoxin testing of domestic and imported peanuts. Agriculture CFSAN
Nega Beru
(301) 436-1700
10-01-1995
Revised on
10-08-1997
Indefinite
225-96-2002 Aflatoxin testing of imported in-shell Brazil nuts. Agriculture CFSAN
Nega Beru
(301) 436-1700
10-01-1995
Revised on
10-08-1997
Indefinite
225-96-2003 Aflatoxin testing of imported in-shell pistachio nuts Agriculture CFSAN
Nega Beru
(301) 436-1700
10-01-1995
Revised on
10-08-1997
Indefinite
225-96-2006 Establishment of standards for the National Laboratory Accreditation Program through the regulation process. Agriculture CFSAN
Mark Wirtz
(301) 436-2001
05-31-1996 Indefinite
225-97-4000 FDA provides the quality assurance support for DoD centrally managed contracts for drug, biologics, and medical devices. DoD ORA
Dave Gallant
(240) 632-6812
01-14-1997 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 CFSAN
David Acheson
(301) 436-1910
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 OC 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
Jeanne Roman
(301) 827-0947
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) 443-5373
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  
225-99-6001 Transfer of CLIA Complexity Categorization Functions from CDC to FDA DHHS CDRH
Steve Gutman
(240) 276-0484
02-27-1999  
distilled spirits Labeling of distilled spirits, wine, and malt beverages. ATF CFSAN
Felicia Satchell
(301) 436-2371
09-16-1974  
USDA-FDA-OBESITY Framework for cooperation between Departments to combat obesity by coordinating efforts to encourage youth to adopt healthy eating and physical activity behaviors. USDA,
Department of Education
CFSAN
Anne Crawford
(301) 436-1543
06-21-2002 06-21-2007
(may be extended)

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