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FDA COVID-19 Response 'At-a-Glance Summary as of July 19, 2021'
From the Document: "The U.S. Food and Drug Administration, along with other federal, state, and local agencies and public health officials across the country, continues critical work to protect public health during the pandemic of COVID-19 [coronavirus disease 2019]. Major focus areas of the FDA's response include increasing the availability of tests, therapeutics, vaccines and devices such as ventilators and personal protective equipment, and many other important items necessary for the response. The FDA is also monitoring the human and animal food supply and taking swift action on fraudulent COVID-19 products."
United States. Food and Drug Administration
2021-07-19
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Vaccines and Related Biological Products Advisory Committee Meeting: EUA Amendment Request for Pfizer-BioNTech COVID-19 Vaccine for Use in Children 5 Through 11 Years of Age
From the Executive Summary: "On October 6, 2021, Pfizer submitted a request to FDA to amend its Emergency Use Authorization (EUA) to expand use of Pfizer-BioNTech COVID-19 [coronavirus disease 2019] Vaccine (BNT162b2) for prevention of COVID-19 caused by SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] in individuals 5 through 11 years of age (hereafter 5-11 years of age). The proposed dosing regimen is a 2-dose primary series, 10 µg mRNA/per dose, administered 3 weeks apart. This EUA request initially included safety data from 1,518 BNT162b2 recipients and 750 placebo (saline) recipients 5-11 years of age who are enrolled in the Phase 2/3 portion (Cohort 1) of an ongoing randomized, double-blinded, placebo-controlled clinical trial, C4591007. [...] This October 26, 2021 VRPBAC [sic] [Vaccines and Related Biological Products Advisory Committee] meeting is being held to discuss whether, based on the totality of scientific evidence available, the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 2-dose series (10 µg each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age."
United States. Food and Drug Administration
2021-10-26
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Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff: Draft Guidance
From the Introduction: "With the increasing integration of wireless, Internet- and network- connected capabilities, portable media (e.g., USB [universal serial bus] or CD [compact disc]), and the frequent electronic exchange of medical device related health information, the need for robust cybersecurity controls to ensure medical device safety and effectiveness has become more important. In addition, cybersecurity threats to the healthcare sector have become more frequent and more severe, carrying increased potential for clinical impact. Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the U.S. and globally. Such cyber attacks and exploits may lead to patient harm as a result of clinical hazards, such as delay in diagnoses and/or treatment."
United States. Food and Drug Administration
2022-04-08
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Overview of the CARVER Plus Shock Method for Food Sector Vulnerability Assessments
"The CARVER plus Shock method is an offensive targeting prioritization tool that has been adapted for use in the food sector. This tool can be used to assess the vulnerabilities within a system or infrastructure to an attack. It allows you to think like an attacker by identifying the most attractive targets for attack. By conducting such a vulnerability assessment and determining the most vulnerable points in your infrastructure, you can then focus your resources on protecting your most vulnerable points. CARVER is an acronym for the following six attributes (discussed in further detail later) used to evaluate the attractiveness of a target for attack: Criticality -- measure of public health and economic impacts of an attack. Accessibility -- ability to physically access and egress from target. Recuperability -- ability of system to recover from an attack. Vulnerability -- ease of accomplishing attack. Effect -- amount of direct loss from an attack as measured by loss in production. Recognizability -- ease of identifying target. In addition, the modified CARVER tool evaluates a seventh attribute, the combined health, economic, and psychological impacts of an attack, or the SHOCK attributes of a target."
United States. Department of Agriculture; United States. Food and Drug Administration
2007-07-18
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CBER Intrim Strategic Plan: FY 2017-2019
"This document provides a broad overview of how CBER [Center for Biologics Evaluation and Research] seeks to fulfill its mission of protecting the public's health over the next three years. CBER has experienced a number of changes -- both internal and external -- since publication of the CBER Strategic Plan FY 2012-2016 four years ago. Some changes, such as new legislative mandates from the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), have expanded our responsibilities for ensuring access to safe and effective biological products. Other changes, such as the physical relocation and consolidation of all eight offices and associated laboratories to FDA [Food and Drug Administration] headquarters for the first time in the Center's history, have expanded opportunities for cross-Office and cross-Center collaboration to accomplish our mission. In 2015, CBER conducted a comprehensive review of the oversight and management of its regulatory science program and in 2016 gained a new Center Director and Deputy-- both of which entailed taking stock of current progress and identifying future needs and direction. For all these reasons, it was important for the Center to engage in a gap analysis that identifies where we currently are in fulfilling our mission, where we are headed in the next few years, and how we propose to get there."
United States. Food and Drug Administration; United States. Department of Health and Human Services
2016?
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Environmental Assessment for Investigational Use of 'Aedes Aegypti' OX513A: In Support of a Proposed Field Trial of Genetically Engineered (GE) Male 'Ae. aegypti' Mosquitoes of the Line OX513A in Key Haven, Monroe County, Florida under an Investigational New Animal Drug Exemption
"Oxitec Ltd. ('Oxitec') has developed a mosquito control program which is an adaptation of the Sterile Insect Technique (SIT), a methodology that has successfully controlled several insect species in different countries over the last 50 years using radiation based sterilization. The Oxitec mosquito control program involves the repeated controlled release of genetically engineered (GE) male 'Aedes aegypti' mosquitoes (line OX513A), expressing a conditional lethality trait and a fluorescent marker. The line was first constructed in 2002, and a publication about it was published in a peer-reviewed scientific journal in 2007 (Phuc et al. 2007). This line has been characterized for over 10 years. Male OX513A mosquitoes mate with the wild females of their own species only, leading to a reduction in the population of the local population of 'Ae. aegypti'. Male mosquitoes do not bite humans or animals and therefore are unable to transmit or vector viruses or other saliva constituents. Oxitec mosquitoes can be used in two ways: to reduce the 'Ae. aegypti' population in an area, and/or to prevent its recurrence once control in the area has been achieved. The purpose of this proposed investigational field trial is to evaluate the mating ability of released OX513A mosquitoes with local wild-type 'Ae. aegypti' females, to assess the survival of the resultant progeny in order to estimate mortality related to inheritance of the #OX513 recombinant DNA (rDNA) construct, and to determine the efficacy of sustained releases of OX513A mosquitoes for the suppression of a local population of 'Ae. aegypti' in the defined release area in the Florida Keys, specifically an area known as Key Haven, in Monroe County, which is within the jurisdiction of the Florida Keys Mosquito Control District for mosquito control."
United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Veterinary Medicine (U.S.)
2016-08-05
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Finding of No Significant Impact: In Support of a Proposed Field Trial of Genetically Engineered (GE) Male Aedes Aegypti Mosquitoes of the Line OX513a in Key Haven, Monroe County, Florida under an Investigational New Animal Drug Exemption
"Oxitec, Ltd. (Oxitec, the sponsor) has provided data and information to the U.S. Food and Drug Administration (FDA)'s Center for Veterinary Medicine (CVM, we) for its proposed field trial of genetically engineered (GE) male 'Aedes aegypti' mosquitoes of the line OX513A, under an investigational new animal drug (INAD) exemption (21 CFR 511.1(b)). 'Ae. aegypti' is a vector for human diseases including those associated with Zika, dengue, and chikungunya viruses. OX513A have been genetically engineered to express a gene that encodes a conditional or repressible lethality trait (also known as selflimiting) and a red fluorescent marker protein to aid in their identification. The proposed investigational field trial would be carried out in Key Haven, Monroe County, Florida under Oxitec's supervision in conjunction with the Florida Keys Mosquito Control District (FKMCD)."
United States. Department of Health and Human Services; United States. Food and Drug Administration; Center for Veterinary Medicine (U.S.)
2016-08-05
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Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus: Guidance for Industry
From the introduction: "We, FDA, are notifying you, blood establishments that collect blood and blood components for transfusion or further manufacture, including Source Plasma, that we have determined Ebola virus to be a transfusion-transmitted infection (TTI) under Title 21 of the Code of Federal Regulations (CFR) 630.3(l). We are also providing you with recommendations for assessing blood donor eligibility, donor deferral and blood product management in the event that an outbreak of Ebola virus disease (EVD) with widespread transmission occurs in at least one country. This guidance document applies to Ebola virus (species Zaire ebolavirus). The recommendations in section III. of this guidance document apply to the routine collection of blood and blood components for transfusion or further manufacture, including Source Plasma. The collection of convalescent plasma from EVD survivors is addressed in section V. of this guidance document. This guidance finalizes the draft guidance entitled, 'Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus,' dated December 2015."
United States. Food and Drug Administration; United States. Department of Health and Human Services
2017-01
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Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
"The Food and Drug Administration (FDA) is issuing this guidance to inform industry and FDA staff of the Agency's recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices. In addition to the specific recommendations contained in this guidance, manufacturers are encouraged to address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device. A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats. The exploitation of vulnerabilities may represent a risk to health and typically requires continual maintenance throughout the product life cycle to assure an adequate degree of protection against such exploits. Proactively addressing cybersecurity risks in medical devices reduces the overall risk to health."
United States. Food and Drug Administration; United States. Department of Health and Human Services
2016-12-28
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Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies
Recommendations on accidental radioactive contamination of human food and animal feeds were issued in 1982 by the Food and Drug Administration (FDA) (FDA 1982, Shleien et al 1982). Since then, there have been enough significant advancements related to emergency planning to warrant updating the recommendations. New scientific information and radiation protection philosophy are incorporated, experience gained since 1982 is included, and guidance developed by international organizations is taken into account (Schmidt 1988a, l988b, 1990, Burnett and Rosenstein 1989). These recommendations provide guidance applicable to accidents at nuclear power plants and many other types of accidents where a significant radiation dose2 could be received as a result of consumption of contaminated food. These recommendations rescind and replace the 1982 FDA recommendations."
United States. Food and Drug Administration; Center for Devices and Radiological Health (U.S.). Office of Health and Industry Programs
1998-08-13
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What You Need to Know About Administrative Detention of Food
"The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take additional steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies. The Bioterrorism Act authorizes an officer or qualified employee of FDA to order the detention of any article of food that is found during an inspection, examination, or investigation under the Federal Food, Drug, and Cosmetic Act, if the officer or qualified employee has credible evidence or information indicating that the article of food presents a threat of serious adverse health consequences or death to humans or animals. FDA has now issued its Administrative Detention final rule with procedures for instituting on an expedited basis certain enforcement actions against perishable foods subject to a detention order. This final rule also describes the process for appealing a detention order. The authority in section 303 of the Bioterrorism Act to detain administratively an article of food took effect on June 12, 2002, and immediately upon enactment of the Bioterrorism Act. The procedures specified in the final rule that FDA would use to detain food administratively took effect on July 6, 2004. This booklet was created to inform food manufacturers, processors, packers, transporters, importers, and exporters about a new FDA bioterrorism regulation that is in effect. It contains important information that may affect your firm."
United States. Department of Health and Human Services; United States. Food and Drug Administration
2004-11
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Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables
"Fresh fruits and vegetables are important to the health and well being of the American consumer. Consumers enjoy one of the safest supplies of fresh produce in the world. However, over the last several years, the detection of outbreaks of foodborne illness associated with both domestic and imported fresh fruits and vegetables has increased. In a January 1997 radio address, President Clinton announced a Food Safety Initiative to improve the safety of the nation's food supply (Ref. 1). In May of 1997, as part of the President's Food Safety Initiative, the Department of Health and Human Services, the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) sent to the President a report that identified produce as an area of concern (Ref. 2). On October 2, 1997, President Clinton announced a plan entitled 'Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegetables' (produce safety initiative) to provide further assurance that fruits and vegetables consumed by Americans, whether grown domestically or imported from other countries, meet the highest health and safety standards (Ref. 3). This guidance document ('the guide') addresses microbial food safety hazards and good agricultural and management practices common to the growing, harvesting, washing, sorting, packing, and transporting of most fruits and vegetables sold to consumers in an unprocessed or minimally processed (raw) form. This voluntary, science-based guidance can be used by both domestic and foreign fresh fruit and vegetable producers to help ensure the safety of their produce. The voluntary guidance is consistent with U.S. trade rights and obligations and will not impose unnecessary or unequal restrictions or barriers on either domestic or foreign producers."
United States. Food and Drug Administration; Centers for Disease Control and Prevention (U.S.)
1998-10-26
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What you Need to Know about Establishment and Maintenance of Records (December 2004)
"The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Secretary of Health and Human Services to issue final regulations that establish requirements regarding the establishment and maintenance of records " for not longer than two years " by persons (excluding farms, restaurants, and certain others) who manufacture, process, pack, transport, distribute, receive, hold, or import food. The records that must be kept by these regulations are those that are needed by the Secretary for inspection, to allow the Secretary to identify the immediate previous sources and immediate subsequent recipients of food, including its packaging. This, in turn, will help address credible threats of serious adverse health consequences or death to humans or animals. This regulation implements the recordkeeping authority in the Bioterrorism Act."
United States. Department of Health and Human Services; United States. Food and Drug Administration
2004-12
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What You Need to Know About Registration of Food Facilities
"This guidance document is a restatement of the Food and Drug Administration's (FDA's) current requirements for registration of food facilities presented in simplified format and language. As guidance, it is not binding on either FDA or the public. FDA notes, however, that the regulation that is the basis for this pamphlet establishes requirements for all covered activities. For this reason, FDA strongly recommends that affected parties consult the regulation at 21 CFR Part 1, Subpart H, in addition to reading this pamphlet. The Food and Drug Administration has prepared this guidance to restate the legal requirements set forth in 21 CFR 1.225 through 1.243 concerning registration of food facilities under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This guide is intended to help any entity, regardless of size, to comply with the regulations that require domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA."
United States. Department of Health and Human Services; United States. Food and Drug Administration
2003-11
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Criminal Investigation Handbook for Agroterrorism
"Recent events have shown that the United States is not impervious to acts of terrorism intended to inflict death, injury, and destruction of assets within our borders. Current information indicates that, regardless of location, American infrastructures and citizens will continue to be targets of terrorist activities. Terrorists have demonstrated their willingness to employ asymmetrical warfare to achieve their goals. Agroterrorism represents one such class of nontraditional warfare. Chemical, biological, and radiological agents pose new challenges to law enforcement, food and agriculture regulatory agencies, and public health officials in their efforts to minimize the effects of a terrorist attack and apprehend those responsible for the attack. In the past, law enforcement and food/agriculture regulatory agencies commonly conducted separate and independent investigations. An attack against the food or agriculture sector, however, requires a high level of cooperation between these disciplines to achieve their objectives of identifying the threat, preventing the spread of the disease or further contamination of a food product, preventing public panic, and apprehending those responsible. Lack of mutual awareness and understanding, as well as the absence of established communication procedures, could hinder the effectiveness of joint law enforcement investigations. Due to the continued likelihood of attacks against the U.S. food and agriculture sector, the effective use of all resources during an incident will be critical to ensure an efficient and appropriate response."
United States. Department of Agriculture; United States. Food and Drug Administration; United States. Department of Justice
2008-07
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Guidance for Industry: Target Animal Safety for Veterinary Pharmaceutical Products
"The purpose of this harmonized guidance is to provide recommendations regarding TAS [target animal safety] evaluation for regulatory submission of an Investigational Veterinary Pharmaceutical Product
(IVPP), which is appropriate for determining the safety of an IVPP in the target animal, including identification of target organs, where possible, and confirmation of margin of safety, using the minimum number of animals appropriate for the studies."
United States. Department of Health and Human Services; United States. Food and Drug Administration
2009-04-24
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Generating Antibiotic Incentives Now, Required by Section 805 of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144
"Generating Antibiotic Incentives Now (GAIN) was passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). It addresses the public health threat of antibacterial drug resistance by stimulating the development and approval of new antibacterial and antifungal drugs. [...] This report describes the progress made in facilitating the development and approval of new antibacterial drugs and implementing stewardship programs to ensure their judicious use, and it assesses the incentives available under GAIN five years following enactment."
United States. Food and Drug Administration; United States. Department of Health and Human Services
2017?
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Guidance for Industry: Internal Radioactive Contamination--Development of Decorporation Agents
"This document provides guidance to industry on the development of decorporation agents for which evidence is needed to demonstrate effectiveness but for which human efficacy studies are unethical or infeasible. In such instances, the Animal Efficacy Rule, 21 CFR part 314 subpart I, may be invoked to approve new decorporation agents not previously marketed or new indications for previously marketed drug products. Specifically, this document provides guidance on (1) chemistry, manufacturing, and controls (CMC) information; (2) animal efficacy, safety pharmacology, and toxicology studies; (3) clinical pharmacology, biopharmaceutics, and human safety studies; and (4) postapproval commitments, for such drug products."
United States. Food and Drug Administration; Center for Drug Evaluation and Research (U.S.)
2006-03
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Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products
This guidance document represents the agency's current thinking on the topic of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products. CJD is a rare but invariably fatal degenerative disease of the central nervous system, associated with a poorly understood transmissible agent. This document offers continued recommendations for halting the proliferation of CJD and nvCJD in America. The authors write, "This guidance document contains comprehensive revised recommendations based upon advisory committee discussions, public comments to the docket and at advisory committee meetings, and internal Public Health Service and FDA deliberations. We have developed recommendations for donor deferral, product retrieval, and quarantine and disposition based upon consideration of risk in the donor and product, and the effect that withdrawals and deferrals might have on the supply of life-and health-sustaining blood, blood components and plasma derivatives. In particular, donors with vCJD are distinguished from those with CJD or CJD risk factors, because of very limited historical and epidemiological experience with vCJD, known pathological differences between CJD and vCJD, and uncertainty about the potential for vCJD transmission by blood transfusion. The new recommendations reflect an attempt to minimize the possible risk of vCJD transmission from blood and blood products consistent with maintaining their availability." The authors further submit that, "in anticipation of the new geographic deferral recommendation, we strongly encourage proactive planning to ensure blood supply adequacy before, during, and after implementation."
United States. Food and Drug Administration; Center for Biologics Evaluation and Research (U.S.)
2002-01
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Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders
"This guidance explains FDA's [Food and Drug Administration] general recommendations and procedures applicable to the authorization of the emergency use of certain medical products under sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). The provisions in PAHPRA, described in section II of this guidance, include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats such as pandemic influenza. PAHPRA clarifies and enhances FDA's authority to support emergency preparedness and response and foster the development and availability of medical products for use in these emergencies. These medical products, also referred to as 'medical countermeasures' or 'MCMs,' include drugs (e.g., antivirals and antidotes), biological products (e.g., vaccines, blood products, and biological therapeutics), and devices (e.g., 'in vitro' diagnostics and personal protective equipment)."
United States. Department of Health and Human Services; United States. Food and Drug Administration
2017-01
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Guidance for Clinical Investigators, Sponsors, and IRBs: Adverse Event Reporting to IRBs - Improving Human Subject Protection
"This guidance is intended to assist the research community in interpreting requirements for submitting reports of unanticipated problems, including certain adverse events reports, to the institutional review board (IRB) under Title 21 of the Code of Federal Regulations (21 CFR) part 56 (Institutional Review Boards), part 312 (Investigational New Drug Application), and part 812 (Investigational Device Exemptions). Specifically, the guidance provides recommendations for sponsors and investigators conducting investigational new drug (IND) trials to help them differentiate between those adverse events that are unanticipated problems that must be reported to an IRB and those that are not. The guidance also makes suggestions about how to make communicating adverse events information to IRBs more efficient. FDA developed this guidance in response to concerns raised by the IRB."
United States. Department of Health and Human Services; United States. Food and Drug Administration
2009-01
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Medical Countermeasures Initiative Strategic Plan 2012 ‐ 2016
"This document sets forth the strategic goals and key objectives that FDA [Food and Drug Administration] will pursue through 2016 to build and sustain the programs needed to achieve the MCMi [Medical Countermeasures Initiative] mission. FDA's MCMi strategic goals include: 1) Goal 1: Develop and maintain the highly qualified workforce with appropriate technical training, scientific skill, and subject‐matter expertise, and improve infrastructure at FDA (e.g., information technology, laboratory equipment) so that the MCMi workforce has the tools required to succeed 2) Goal 2: Build and sustain the integrated, coordinated programs necessary to ensure that the MCMi reflects medical countermeasure priorities and objectives and that MCMi programs are sufficiently resourced and aligned to fulfill MCMi program initiatives 3) Goal 3: Engage MCMi stakeholders to foster effective collaboration, solicit input and feedback, improve program implementation, and maximize the transparency of programs and priorities 4) Goal 4: Integrate MCMi programs to foster effective preparedness, planning, and response capabilities 5) Goal 5: Establish and support Public Health and Security Action Teams to support development of high‐priority candidate medical countermeasure products, product classes, and critical medical countermeasure technologies 6) Goal 6: Establish and sustain a medical countermeasures regulatory science program to develop solutions to complex regulatory challenges and facilitate the incorporation of new, cutting edge science into the regulatory review process to speed product development 7) Goal 7: Modernize the legal, regulatory, and policy environment to adequately support preparedness for and response to CBRN [Chemical, Biological, Radiological, Nuclear] and EID [Emerging Infectious Diseases] threats with medical countermeasures."
United States. Department of Health and Human Services; United States. Food and Drug Administration
2011-12
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Food Related Emergency Exercise Boxed-set (FREE-B) How Sweet It Is(n't) Facilitator's Guide
"This facilitator guide provides you with all you need to conduct a tabletop exercise based on the How Sweet it Is(n't) scenario. This scenario will focus attention on the regulatory traceback investigation that occurs after standard product testing shows that a food product contains excessive levels of a contaminant, as well as a recall of contaminated food from commerce. Like typical foodborne outbreaks, the response will initially be at the local and State levels; however, this scenario will also introduce participants, to a minor extent, to the unique aspects of an international investigation."
United States. Food Safety and Inspection Service; United States. Food and Drug Administration
2011-07-20
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Food Related Emergency Exercise Boxed-set (FREE-B) Insider Addition Facilitator's Guide
"This facilitator guide provides you with all you need to conduct a tabletop exercise based on the Insider Addition scenario. This scenario focuses attention on the intentional aspect of contamination of a raw meat product at the processor with a chemical agent, including the various untraditional organizations and expertise needed to investigate intentional contaminations, the establishment of collaborative processes, and roles and responsibilities with the traditional public health and regulatory partners. Also included will be development of the complex internal and external communication mechanisms that need to be established with this larger group of stakeholders. It is designed to be a four hour tabletop exercise."
United States. Food and Drug Administration; United States. Food Safety and Inspection Service
2011-07-20
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Food Related Emergency Exercise Boxed-set (FREE-B) Stealthy Situation Situation Manual
"This exercise is a comprehensive scenario, scheduled to take two days, and includes the epidemiological investigation, traceback and recall identification and implementation, role of regulatory agencies, and other issues associated with a cluster of illness linked to a foodservice establishment. The food product causing illness is a multi-ingredient product, containing both USDA [United States Department of Agriculture]- and FDA [Food and Drug Administration]-regulated components, and illness is associated with institutional and foodservice settings in different jurisdictions."
United States. Food Safety and Inspection Service; United States. Food and Drug Administration
2011-07-20
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Food Related Emergency Exercise Boxed-set (FREE-B) Insider Addition Situation Manual
"To protect the health of the American public, it is crucial that we ensure that food products are safe for consumption. Everyone involved in the food chain, from farmer through consumer, has a responsibility to keep the food supply safe. [...] This scenario focuses attention on the intentional aspect of contamination of a raw meat product at the processor with a chemical agent, including the various untraditional organizations and expertise needed to investigate intentional contaminations, the establishment of collaborative processes and roles and responsibilities with the traditional public health and regulatory partners. Also included will be development of the complex internal and external communication mechanisms that need to be established with this larger group of stakeholders."
United States. Food Safety and Inspection Service; United States. Food and Drug Administration
2011-07-20
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Food Related Emergency Exercise Boxed-set (FREE-B) Highplains Harbinger Situation Manual
"To protect the health of the American public, it is crucial that we ensure that food products are safe for consumption. Everyone involved in the food chain, from farmer through consumer, has a responsibility to keep the food supply safe. [...] This scenario focuses on the investigation of animal disease caused by intentional infection of cattle with Foot and Mouth Disease (FMD) virus, highlighting the various animal agriculture agencies (Federal, State, local, Tribal and territorial) and their roles and responsibilities. It will also introduce the roles and responsibilities of law enforcement agencies during an intentional disease introduction incident. Communication to the public and issues of mental health and consumer confidence will also be addressed through this scenario."
United States. Food and Drug Administration; United States. Food Safety and Inspection Service
2011-07-20
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Food Related Emergency Exercise Boxed-set (FREE-B) Stealthy Situation Facilitator's Guide
"This facilitator's guide provides you with all you need to conduct a tabletop exercise based on the Stealthy Situation scenario. This is a comprehensive scenario that includes the epidemiological investigation, traceback and recall identification and implementation, role of regulatory agencies and other issues associated with a cluster of illness linked to a foodservice establishment. The food product causing illness is a multi-ingredient product, containing both USDA [United States Department of Agriculture] and FDA [Food and Drug Administration] regulated components, and illness is associated with institutional and foodservice settings in different jurisdictions. It is designed to be two days long."
United States. Food Safety and Inspection Service; United States. Food and Drug Administration
2011-07-20
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Food Related Emergency Exercise Boxed-set (FREE-B) Highplains Harbinger Facilitator's Guide
"This facilitator guide provides you with all you need to conduct a tabletop exercise based on the High Plains Harbinger scenario. This scenario focuses on the investigation of animal disease caused by intentional infection of cattle with Foot and Mouth Disease (FMD) virus, highlighting the various animal agriculture agencies (Federal, State, local, Tribal and territorial) and their roles and responsibilities. It will also introduce the roles and responsibilities of law enforcement agencies during an intentional disease introduction incident. Communication to the public and issues of mental health and consumer confidence will also be addressed through this scenario."
United States. Food and Drug Administration; United States. Food Safety and Inspection Service
2011-07-20
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Food Related Emergency Exercise Boxed-set (FREE-B) Insider Addition Tabletop Exercise
"It is crucial that we ensure that food products are safe for consumption. Everyone involved in the food chain, from farmer through consumer, has a responsibility to keep the food supply safe. At any point during production or distribution, food can be contaminated either accidentally (food safety), or on purpose from sabotage, fraud or terrorist activities (food defense). [...] This tabletop exercise provides participants with an overview of what happens at the local, State and Federal levels during a food related incident."
United States. Food Safety and Inspection Service; United States. Food and Drug Administration
2011-07-20
