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About FDA
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Domestic MOUs
|
MOU No. |
Purpose |
Parties |
FDALead |
Effective |
Expiration |
| 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 |
Indefinite |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Allows FDA to commission Custom and Border Protection Officers. | DHS | ORA Domenic Veneziano (301) 443-6553 |
12-03-2003 |
Indefinite |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Consumer protection during times of natural disasters caused by flooding. | DoD | ORA Michael Rodgers (301) 827-5653 |
07-27-1971 |
Indefinite |
|
| Information exchange to develop Mutual Program Planning & Liaison on Consumer Deception. | FTC | ORA Dave Gallant (240) 632-6812 |
05-14-1971 |
Indefinite |
|
| 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 |
Indefinite |
|
| Inspections and standardization activities regarding food products. | Agriculture | CFSAN Robin Woo (301) 436-2776 |
05-11-1972 |
Indefinite |
|
| 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 |
|
| Mutual Responsibilities under FD&C Act and FIFR Act regarding pesticides. | EPA | ORA Michael Rodgers (301) 827-5653 |
09-04-1971 |
Indefinite |
|
| Importation of biological specimens under the US-USSR scientific exchange agreement for collaborative research in viral oncology. | Agriculture | NIH |
07-15-1974 |
Indefinite |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
Indefinite |
|
| 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 |
|
| Cooperative agreement between NIH and FDA regarding anticancer drugs. | DHHS | CDER Diane Ehrlich (301) 443-5373 |
02-05-1979 |
Indefinite |
|
| 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 |
Indefinite |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Inspection of Industrial Fishery Products intended for animal feed use to eliminate Salmonella. | Agriculture | CVM Daniel McChesney (240) 453-6830 |
11-13-1974 |
Indefinite |
|
| 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 |
Indefinite |
|
| Agreement regarding inspection programs for fishery products. | DoC | CFSAN Donald Kraemer (301) 436-2300 |
10-10-1974 |
Indefinite |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Control of Direct and Indirect Additives to and substances in drinking water. | EPA | CFSAN/ORA Henry Kim (301) 436-2023 |
06-22-1979 |
Indefinite |
|
| Cooperative enforcement of the FD&C Act between USCS and FDA | DHS | ORA Joe McCallion (301) 594-1218 |
08-14-1979 |
Indefinite |
|
| 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 |
|
| Coordination of activities between FDA and HCFA regarding blood-banking and transfusion programs. | DHHS | ORA/CBER Elaine Cole (301) 827-6352 |
01-21-1980 |
Indefinite |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| FDA and CDC's responsibilities regarding the exchange and coordination of information in epidemiologic investigations and related activities. | DHHS | OC |
01-12-1982 |
Indefinite |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Outlines methods for determining a product's eligibility for patent term restoration | DoC | CDER Diane Ehrlich (301) 443-5373 |
09-17-1986 |
Indefinite |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Regulation of liquid chemical germicides for use on medical devices. | EPA | CDRH Elaine Mayhall (240) 276-3749 |
06-04-1993 |
Indefinite |
|
| 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 |
|
| 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 |
|
| 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 |
|
| To facilitate development of Standard Reference Materials for materials used in medical implant applications. | DoC | CDRH |
01-14-1994 |
Indefinite |
|
| Aflatoxin testing of domestic and imported peanuts. | Agriculture | CFSAN Nega Beru (301) 436-1700 |
10-01-1995 |
Indefinite |
|
| Aflatoxin testing of imported in-shell Brazil nuts. | Agriculture | CFSAN Nega Beru (301) 436-1700 |
10-01-1995 |
Indefinite |
|
| Aflatoxin testing of imported in-shell pistachio nuts | Agriculture | CFSAN Nega Beru (301) 436-1700 |
10-01-1995 |
Indefinite |
|
| Establishment of standards for the National Laboratory Accreditation Program through the regulation process. | Agriculture | CFSAN Mark Wirtz (301) 436-2001 |
05-31-1996 |
Indefinite |
|
| 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 |
|
| 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 |
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| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
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| Transfer of CLIA Complexity Categorization Functions from CDC to FDA | DHHS | CDRH Steve Gutman (240) 276-0484 |
02-27-1999 |
|
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| Labeling of distilled spirits, wine, and malt beverages. | ATF | CFSAN Felicia Satchell (301) 436-2371 |
09-16-1974 |
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| 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 |
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