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Project Bioshield Act

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protect public health; (3) HHS must assess the availability and appropriateness of the countermeasure to address the threat; (4) DHS and HHS must jointly submit a proposal to the president to issue a call for the development of countermeasures that are not available or cleared only for alternative purposes; (5) DHS and HHS must make a commitment to recommend that the special reserve fund be available for the procurement of a countermeasure; (6) the President must approve the proposal; (7) DHS and HHS must make specified information known to those who may respond to a call for the countermeasure including the specifications of the needed countermeasure; (8) HHS must determine which countermeasures can be procured using the special reserve fund; (9) the HHS and DHS and the Director of the Office of Management Budget must submit a recommendation to the President that the special reserve fund be used to procure the countermeasure; and (10) the President must approve the recommendation. HHS and DHS must notify designated congressional committees promptly that a material threat has been identified and countermeasures are necessary to protect the public health and that the President has approved a recommendation for countermeasure procurement using the special reserve fund. Authorizes appropriations for the special reserve fund to procure security countermeasures approved by the President, for the hiring of personnel to carry out terror threat assessments, and for the development of secure intelligence-sharing facilities. Transfers the functions, personnel, assets, unexpended balances, and liabilities of the Stockpile from the Secretary of Homeland Security to the Secretary of Health and Human Services.
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determine to what extent authorized activities under this Act have enhanced the development of biomedical countermeasures; (5) assess the availability of countermeasures to address threats; (6) assess the extent to which programs and activities will reduce a gap between the threat and the availability of countermeasures to an acceptable level of risk; and (7) assess the threats to national security posed by technology that will enable the development of antibiotic-resistant, mutated, or bioengineered strains of biological agents and recommend strategies for addressing such threats, and make recommendations on possible improvements.
63: 276:, the United States government has allocated nearly $ 50 billion to address the threat of biological weapons. U.S. funding for bioweapons-related activities focuses primarily on research for and acquisition of medicines for defense. Funding also goes toward stockpiling protective equipment, increased surveillance and detection of biological agents, and improving state and hospital preparedness. The increase in this type of funding is mainly for Project BioShield. Significant funding also goes to 25: 656:
rejected for grants, cooperative agreements, or contracts under this Act. The approval and licensing processes are designed to preclude the marketing of ineffective and dangerous treatments. Only about 20% of drugs that begin the approval process actually become approved treatments. Because it is not possible to predict the outcome of the approval process, critics of this provision suggest that the government will end up purchasing countermeasures that will eventually fail to be approved.
636:, such a declaration was made on April 26, 2009. An EUA for a medical product has a term of one year, but it can be renewed, depending on the circumstances of the emergency. It is important that product development continue to focus on the goal of approval (there are ongoing clinical trials evaluating the efficacy of intravenous peramivir in treating influenza), because the EUA is only a temporary means for making a product available during an emergency." 664:, which supports basic research through funding scientists. Although the development of a new medication usually takes several years between the time that research begins to the time that the medication is marketed, developing medical interventions against potential biological weapons is especially intense in terms of time, labor, and finances. There is also no guarantee that the drug companies will purchase the vaccinations. 677:
development of medicines for serious illnesses like heart disease can be financially risky, especially when a countermeasure may never be purchased or used." Friedman argues there needs to be more sponsored research and collaborative programs that engage government, academia, and industry, as well as additional incentives for private companies.
643:. The HHS will determine that "...sufficient and satisfactory clinical experience or research data...support(s) a reasonable conclusion that the product will qualify for approval or licensing...within eight years." The HHS will write contracts on these unapproved products, help lowering the purchasing cost of the drugs. 411:
requirements and streamlines the interagency governance process. Under the reorganized structure, on behalf of the secretary of HHS, the ASPR leads the federal public health and medical response to acts of terrorism or nature and other public health and medical emergencies. In 2006, HHS announced, in
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Allows security countermeasures to be procured using the special reserve fund (an appropriations account set up by to this Act). A "security countermeasure" is a countermeasure that is either authorized for emergency use or that the Secretary determines is a priority, is necessary, and is an approved
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An Act To amend the Public Health Service Act to provide protections and countermeasures against chemical, radiological, or nuclear agents that may be used in a terrorist attack against the United States by giving the National Institutes of Health contracting flexibility, infrastructure improvements,
301:(HHS) to: (1) conduct and support research and development activities for countermeasures in biological emergencies and provide that biocontaminant laboratories and specialized research facilities will be available to the Secretary to respond to public health emergencies affecting national security. 612:
A 2007 review stated that the project is needed because when the only market is the government, there is a high risk of failure and a low expectation of profit. This discourages other manufacturers from investing research, development and funds in the bioterrorism products to be sold, because the
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The project's funding would be subject to annual review through the appropriations process. Furthermore, the law would require the HHS Secretary to prepare annual reports detailing actions taken under this Act including identification of each person or entity that received, or was considered and
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to allow the Secretary to authorize the use of a drug, device, or biological product intended for emergency use, specifically allowing the use of unapproved products, or the unapproved use of approved products, upon a determination by DHS that there is or is a significant potential for a domestic
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Provides that in order for a countermeasure to be procured using the special reserve fund: (1) HHS must identify a chemical, biological, radiological or nuclear agent as a threat to the U.S. population that may affect national security; (2) HHS must determine that a countermeasure is necessary to
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to continue provisions governing the emergency use of products with respect to members of the Armed Forces. The Secretary can authorize the use of unapproved products in an emergency only upon a determination by the Secretary of Defense of a military emergency involving a heightened risk to U.S.
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Directs the Secretary, the Secretary of Homeland Security, and the Secretary of Defense to ensure that the activities of their respective Departments coordinate, complement, and do not unnecessarily duplicate programs designed to protect the homeland from biological, chemical, radiological, and
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to: (1) review the Secretary's use of the authorities granted under this Act; (2) assess the adequacy of the internal controls instituted by the Secretary; (3) identify any procurements that would have been significantly delayed or not made without the authorities provided to the Secretary; (4)
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in Washington DC voiced additional financial concerns of the pharmaceutical industry. Michael Friedman MD explains that manufacturers of biological defense products could still be "exposed to devastating product-liability suits," adding, "The decision to divert resources from the research and
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and radiological threats have been procured. Eighty other candidate MCMs are undergoing advanced development. The authorities and funds contained in the Project BioShield Act were slated to expire at the end of year 2013. The legislative experiment of BioShield was subject to evaluation and
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Project BioShield will transform our ability to defend the nation in three essential ways. First, Project BioShield authorizes $ 5.6 billion over 10 years for the government to purchase and stockpile vaccines and drugs to fight anthrax, smallpox and other potential agents of bioterror. The
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Obstacles to pharmaceutical and vaccine development include inadequate funding for research, insufficient protections against corporate liability, and constraints related to safety considerations. Typically, the drug-development process in the United States is largely initiated by the
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notes that this kind of testing for biological weapons is ethically unacceptable to conduct on humans. "The need for expedited development of critical countermeasures must be balanced against the need to ensure that these essential interventions are safe as well as effective."
617:. Pharmaceutical and vaccine manufacturers can perceive the federal government as an uncertain and low-profit market. The project was developed in an attempt to provide a financial incentive to manufacturers to develop the products needed for defense against CBRN threats. 703: 507: 392:
Progress has been made in the establishment of both national requirements and acquisition strategies, as well as the procurement of pre- and postexposure countermeasures to meet the threat from anthrax, botulinum toxins, smallpox, and radiological and nuclear threats.
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offered budgeting strategies that they believe could lend stability to the MCM arena, some of which would call for changes to statutory processes and congressional procedures that have been implemented since the Project BioShield Act's 2004 enactment."
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emergency, or upon a determination by DHS of a public health emergency that affects or may affect national security and that involves a specified agent or a specified disease that may be attributable to such agent. Amends the
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Some provisions of Project BioShield are controversial. Some critics suggest that biotechnology and pharmaceutical companies will require even more incentives than contained in these proposals from the Government.
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in 2011. This included 20,000 doses under a 2005 contact and 37,102 doses of the 45,000 ordered in a 2009 contract option. At the end of 2010, there was a total supply of 36,102 doses of
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Allows the Secretary to respond to pressing research and development needs, including expediting peer review, contracting with experts, and appointing employees to positions at the
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and other WMD. Provisions have been made as well to ensure safer and more effective vaccinations for such threats such as smallpox. Another issue lies within the US
2190: 2146: 1349: 1157: 399:(HHS) has taken a number of additional steps to accomplish the goal of effectively and efficiently implementing the Project BioShield Act. HHS has reorganized the 879: 404: 2102: 1515: 1272: 1782: 2107: 1857: 1606: 807: 510:
reauthorized the BioShield Project. More specifically, it reauthorizes the Project BioShield Special Reserve Fund (SRF), originally established in 2004.
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released a report called "Budgeting for Medical Countermeasures: An Ongoing Need for Preparedness." Based on the report, former U.S. Senator
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the Federal Register Notice of 6 July 2006, the establishment of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).
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and expediting the scientific peer review process, and streamlining the Food and Drug Administration approval process of countermeasures
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reported that the BARDA annual report shows that the number of supplies of countermeasures for combating terrorist attacks is growing.
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nuclear agents. Directs such Secretaries to each appoint an official to coordinate such programs for their respective Departments.
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A book published in 2010 stated that the project allows the Secretary of Health and Human Services to purchase unapproved and
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Allows the Secretary to expedite purchasing related to research and development needs by simplifying limits on procurement.
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A 2005 review reported that the project had an advanced appropriation for countermeasures—ranging from vaccines to
563:(D-SD) said that the change in the way that the Project BioShield Act of 2004 is funded (it changed from a ten-year 258:
for civilian use. A key element of the Act was to allow stockpiling and distribution of vaccines which had not been
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Amends the Public Health Service Act to allow the Director of the NIH to act through the Director of the
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reconsideration in the House and the Senate, which both passed versions of reauthorization legislation.
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cycle to year-by-year funding) creates a climate of uncertainty for private firms looking to invest in
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Middle-Atlantic Regional Center of Excellence for Biodefense and Emerging Infectious Diseases Research
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to change the responsibilities of the Secretary of Homeland Security as they relate to the Stockpile.
273: 251: 375: 421: 2325: 2237: 540: 1189:"R41033: Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress" 978:"Former Sen. Daschle praises Trump's support of Project BioShield - Homeland Preparedness News" 2320: 2041: 1912: 1806: 1739: 1200:"Project BioShield: Accelerating Medical Countermeasure Development and Ensuring Availability" 1129: 1104: 1063: 1022: 900: 855: 790: 782: 614: 597: 243: 164: 2315: 2270: 2007: 1683: 1094: 1053: 845: 774: 745:
has already taken steps to purchase 75 million doses of an improved anthrax vaccine for the
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Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307; 113th Congress)
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Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307; 113th Congress)
480: 247: 149: 1209: 604:(FDA). The FDA requires clinical studies of human safety and efficacy. The Journal of the 472:, which also treats anthrax. By 2010, the supply was down to 7,327 doses, with spending on 407:) and established a dedicated strategic planning function that more efficiently integrates 2330: 2073: 2036: 1816: 1796: 1188: 1011:"Preparedness for Biological Terrorism in the United States: Project BioShield and Beyond" 531: 255: 770: 38:
Please help update this article to reflect recent events or newly available information.
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treatments, as well, including 107,560 doses of Botulinum Antitoxin Therapeutic from
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of 2002 to direct the Secretary to coordinate with Homeland Security to maintain the
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calling for $ 5 billion for purchasing vaccines that would be used in the event of a
176: 2360: 2340: 2335: 1427: 1083:"The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza" 593: 572: 239: 2186:
Global Partnership Against the Spread of Weapons and Materials of Mass Destruction
1042:"Project BioShield: What It Is, Why It Is Needed, and Its Accomplishments So Far" 1010: 834:"Project BioShield: What It Is, Why It Is Needed, and Its Accomplishments So Far" 2118: 2002: 1986: 1868: 1749: 727: 560: 473: 458: 446: 266: 1150: 497:. It ordered 200,000 doses. At the end of 2010, the supply was at 97,000 doses. 2305: 1198: 580: 408: 205: 168: 808:"Federal Funding for Bioweapons Prevention and Defense, by Agency, 2001-2009" 786: 432: 1108: 1067: 1026: 859: 794: 1665:
Johns Hopkins Center for Health Security (formerly Center for Biosecurity)
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attack. This was a ten-year program to acquire medical countermeasures to
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In 2005 the chief medical officer for biomedical preparedness at the
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In March 2013 funding was extended through 2018 via the Pandemic Act.
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Public Health Security and Bioterrorism Preparedness and Response Act
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drug or a drug reasonably likely to be approved within eight years.
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Statement on Chemical and Biological Defense Policies and Programs
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Pandemic and All-Hazards Preparedness Reauthorization Act of 2013
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Public Health Security and Bioterrorism Preparedness Response Act
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Joint Program Executive Office of Chemical and Biological Defense
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Biodefense and Pandemic Vaccine and Drug Development Act of 2005
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Integrated National Biodefense Medical Countermeasures Portfolio
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Biodefense and Pandemic Vaccine and Drug Development Act of 2005
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United States federal defense and national security legislation
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Office of the Assistant Secretary for Preparedness and Response
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National Medical Response Team/National Pharmacy Response Team
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Biomedical Advanced Research and Development Authority (BARDA)
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Joint Biological Agent Identification and Diagnostic System
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Bioterror Rapid Response and Advanced Technology Laboratory
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U.S. Army Medical Research Institute of Infectious Diseases
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Global Emerging Infections Surveillance and Response System
541:"Pandemic and All-Hazards Preparedness Reauthorization Act" 1420:
National Interagency Confederation for Biological Research
439:(a decrease from the full 200,000 doses ordered in 2006). 1903:
National Intelligence Assessments on Infectious Diseases
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Johns Hopkins Center for Civilian Biodefense Strategies
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National Biodefense Analysis and Countermeasures Center
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Gibbs, W. Wayt (October 2004), "An Uncertain Defense",
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National Center for Biodefense and Infectious Diseases
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Biomedical Advanced Research and Development Authority
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Biomedical Advanced Research and Development Authority
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United States Department of Health and Human Services
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National Institute of Allergy and Infectious Diseases
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Pharmaceutical Research and Manufacturers of America
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and deploy the Stockpile to respond to an emergency.
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The Journal of the American Osteopathic Association
147: 139: 129: 124: 104: 94: 89: 78: 69: 1128:. United States: DIANE Publishing. pp. 1–13. 871: 869: 401:Assistant Secretary for Preparedness and Response 2131:Agricultural Bioterrorism Protection Act of 2002 1021:(9). American Osteopathic Association: 417–424. 2191:United Nations Security Council Resolution 1540 2147:Public Readiness and Emergency Preparedness Act 1783:Nunn–Lugar Cooperative Threat Reduction Program 1350:National Science Advisory Board for Biosecurity 1675:Center for Advancing Microbial Risk Assessment 1280:(National Biosurvelliance Integration Center, 405:Office of Public Health Emergency Preparedness 2103:Biological Weapons Anti-Terrorism Act of 1989 1842:Global Bio-Surveillance Technology Initiative 1225: 1151:"CRS Report for Congress - Project BioShield" 573:chemical, biological, radiological or nuclear 427:According to the report, BARDA has acquired: 8: 1680:Center for Biodefense and Emerging Pathogens 1273:DHS Chemical and Biological Defense Division 55: 2108:Soviet Nuclear Threat Reduction Act of 1991 1607:Chemical Biological Incident Response Force 1125:Project BioShield: Purposes and Authorities 479:28.75 million doses of the anthrax vaccine 2412:Disaster preparedness in the United States 2204: 2063: 1964: 1772: 1652: 1549: 1532:Foreign Disease Weed Science Research Unit 1407: 1260: 1251: 1232: 1218: 1210: 2153:Pandemic and All-Hazards Preparedness Act 1627:Aeromedical Biological Containment System 1581:Nebraska Biocontainment Patient Care Unit 1456:Defense Advanced Research Projects Agency 1368:Assistant SECDEF for NCB Defense Programs 1098: 1057: 849: 2407:United States federal health legislation 2392:Acts of the 108th United States Congress 2266:United States biological weapons program 1389:National Center for Medical Intelligence 1241:United States biological defense program 1156:. Defense Technical Information Center. 844:(Supplement 1). Oxford Journals: 68–72. 1925:National Strategy for Homeland Security 1052:(Supplement 1). Oxford Journal: 68–72. 1004: 1002: 1000: 998: 743:Department of Health and Human Services 714: 260:tested for safety or efficacy in humans 1424:National Interagency Biodefense Campus 1293:National Bio and Agro-Defense Facility 1182:Full text of the Project Bioshield Act 1081:Birnkrant, Debra; Cox, Edward (2009). 299:Secretary of Health and Human Services 54: 1695:Center for Biodefense Immune Modeling 877:"U.S. grows its biodefense stockpile" 7: 2013:Autonomous Pathogen Detection System 1340:Division of Select Agents and Toxins 1318:(Advisory Committee on Bioterrorism) 1316:National Counterproliferation Center 1298:National Bioforensic Analysis Center 613:expected profits do not justify the 363:Federal Food, Drug, and Cosmetic Act 134:42: Public Health and Social Welfare 1461:Edgewood Chemical Biological Center 1009:Dudley, Gail; McFee, Robin (2005). 925:. House Republicans. Archived from 699:Vaccines for the New Millennium Act 622:The New England Journal of Medicine 1846:Bio-Surveillance Management Office 1512:Homeland Security Research Program 1160:from the original on June 24, 2013 957:Center for a New American Security 624:in 2009 noted that the FDA issued 368:National Defense Authorization Act 14: 2181:Global Health Security Initiative 1825:National Biosurveillance Strategy 1522:Plum Island Animal Disease Center 1194:. Congressional Research Service. 779:10.1038/scientificamerican1004-20 620:A perspective piece published in 2422:Vaccination in the United States 2311:Biosecurity in the United States 2217:1984 Rajneeshee bioterror attack 2047:Positive pressure personnel suit 1939:National Disaster Medical System 1149:Gottron, Frank (July 23, 2003). 606:American Osteopathic Association 476:and AIG coming to $ 478 million. 61: 23: 2366:Smallpox virus retention debate 2261:United States Army Medical Unit 1787:Defense Threat Reduction Agency 1373:Defense Threat Reduction Agency 1187:Gottron, Frank (July 7, 2010). 1087:New England Journal of Medicine 948:Kadlec, Robert (January 2013). 923:"H.R. 307 - Legislative Digest" 330:Secretary of Homeland Security 1: 2222:1989 California medfly attack 2086:Biological Weapons Convention 1884:Personnel Reliability Program 1617:Epidemic Intelligence Service 1482:Galveston National Laboratory 662:National Institutes of Health 309:National Institutes of Health 269:for pivotal animal efficacy. 56:Project BioShield Act of 2004 1945:Strategic National Stockpile 1496:Integrated Research Facility 1278:DHS Office of Health Affairs 1046:Clinical Infectious Diseases 838:Clinical Infectious Diseases 747:Strategic National Stockpile 634:2009 H1N1 influenza pandemic 602:Food and Drug Administration 341:Strategic National Stockpile 84:108th United States Congress 2008:Biological Materials MASINT 1921:National Response Framework 1830:Laboratory Response Network 1791:Biological Threat Reduction 1735:Battelle Memorial Institute 689:, nicknamed "Bioshield Two" 626:Emergency Use Authorization 596:to surveillance—related to 2438: 2276:Aeromedical Isolation Team 982:Homeland Preparedness News 577:Homeland Preparedness News 321:Provides funding for the 295:Public Health Service Act 230:was an act passed by the 228:The Project Bioshield Act 156: 60: 32:This article needs to be 1848:(BMO) (part of JPEO-CBD) 1576:State Health Departments 1560:Local Health Departments 1040:Russell, Philip (2007). 903:. United States Congress 832:Russell, Philip (2007). 647:Challenges and criticism 557:Bipartisan Policy Center 323:National Vaccine Program 2356:Isolation (health care) 2326:Biological warfare (BW) 1699:University of Rochester 1670:Henry L. Stimson Center 1122:Gottron, Frank (2010). 641:unlicensed vaccinations 630:public health emergency 569:medical countermeasures 520:medical countermeasures 466:anthrax immune globulin 204:on July 14, 2004 ( 183:Committee consideration 140:U.S.C. sections amended 632:. "In the case of the 274:2001 terrorist attacks 232:United States Congress 194:on May 19, 2004 ( 2351:Entomological warfare 2252:Defunct organizations 2232:Wood Green ricin plot 2136:Project Bioshield Act 2113:Executive Order 13139 1466:Dugway Proving Ground 555:In February 2018 the 485:Emergent BioSolutions 455:Human Genome Sciences 437:Clostridium botulinum 403:(ASPR) (formerly the 356:Homeland Security Act 325:for FY 2004 and 2005. 2397:2004 in American law 2227:2001 anthrax attacks 1895:Medical intelligence 1878:Select Agent Program 1802:Project Clear Vision 1100:10.1056/NEJMp0910479 588:Published literature 518:To June 2013, eight 442:57,102 doses of the 431:107,000 doses of an 371:forces of an attack. 771:2004SciAm.291d..20G 763:Scientific American 506:Section 401 of the 502:Related legislation 444:monoclonal antibody 388:Act accomplishments 376:Comptroller General 179:) on March 11, 2003 150:Legislative history 57: 2243:2013 ricin letters 2238:2003 ricin letters 1785:, implemented the 1714:George Mason Univ. 598:biological weapons 420:In September 2012 2374: 2373: 2321:Biological hazard 2289: 2288: 2167: 2166: 2055: 2054: 2042:Biosafety cabinet 1954: 1953: 1913:Disaster response 1807:Project Jefferson 1762: 1761: 1758: 1757: 1740:SRI International 1642: 1641: 1541: 1540: 1397: 1396: 1093:(23): 2204–2207. 875:Kellen Alexander 615:opportunity costs 416:Acquired vaccines 297:to authorize the 225: 224: 192:Passed the Senate 163:in the Senate as 107:Statutes at Large 53: 52: 2429: 2316:Biological agent 2271:Sunshine Project 2205: 2064: 1965: 1927:(DHS; including 1776:Threat reduction 1773: 1745:Idaho Technology 1684:Brown University 1656:Academic centers 1653: 1550: 1408: 1261: 1252: 1234: 1227: 1220: 1211: 1201: 1195: 1193: 1170: 1169: 1167: 1165: 1155: 1146: 1140: 1139: 1119: 1113: 1112: 1102: 1078: 1072: 1071: 1061: 1037: 1031: 1030: 1006: 993: 992: 990: 989: 974: 968: 967: 965: 963: 954: 945: 939: 938: 936: 934: 929:on 16 March 2013 919: 913: 912: 910: 908: 897: 891: 873: 864: 863: 853: 829: 823: 822: 820: 819: 810:. Archived from 804: 798: 797: 758: 752: 751: 737: 736: 719: 579:, "Daschle and 552: 550: 548: 464:10,000 doses of 218:on July 21, 2004 202:Passed the House 152: 143:Chapter 6A § 201 108: 65: 58: 48: 45: 39: 27: 26: 19: 2437: 2436: 2432: 2431: 2430: 2428: 2427: 2426: 2402:Vaccination law 2377: 2376: 2375: 2370: 2346:Decontamination 2331:Biosurveillance 2285: 2253: 2247: 2209: 2208:Past biological 2196: 2173: 2163: 2091: 2074:Geneva Protocol 2051: 2037:Biosafety level 2023: 1991: 1960: 1950: 1907: 1889: 1863: 1817:Biosurveillance 1811: 1797:Project Bacchus 1768: 1754: 1726: 1719: 1658:and think tanks 1657: 1648: 1638: 1585: 1564: 1537: 1470: 1439: 1412: 1403: 1393: 1354: 1321: 1302: 1256: 1243: 1238: 1199: 1191: 1186: 1178: 1173: 1163: 1161: 1153: 1148: 1147: 1143: 1136: 1121: 1120: 1116: 1080: 1079: 1075: 1039: 1038: 1034: 1008: 1007: 996: 987: 985: 976: 975: 971: 961: 959: 952: 947: 946: 942: 932: 930: 921: 920: 916: 906: 904: 899: 898: 894: 874: 867: 831: 830: 826: 817: 815: 806: 805: 801: 760: 759: 755: 734: 732: 731:. July 21, 2004 721: 720: 716: 712: 683: 670: 649: 590: 546: 544: 539: 532:botulinum toxin 516: 504: 449:, which treats 418: 390: 290: 221: 212:Signed into law 148: 106: 79:Enacted by 49: 43: 40: 37: 28: 24: 17: 12: 11: 5: 2435: 2433: 2425: 2424: 2419: 2414: 2409: 2404: 2399: 2394: 2389: 2379: 2378: 2372: 2371: 2369: 2368: 2363: 2358: 2353: 2348: 2343: 2338: 2333: 2328: 2323: 2318: 2313: 2308: 2303: 2301:Agro-terrorism 2297: 2295: 2294:Related topics 2291: 2290: 2287: 2286: 2284: 2283: 2273: 2268: 2263: 2257: 2255: 2249: 2248: 2246: 2245: 2240: 2235: 2229: 2224: 2219: 2213: 2211: 2202: 2198: 2197: 2195: 2194: 2188: 2183: 2177: 2175: 2174:representation 2169: 2168: 2165: 2164: 2162: 2161: 2156: 2150: 2144: 2139: 2133: 2128: 2122: 2116: 2110: 2105: 2099: 2097: 2093: 2092: 2090: 2089: 2083: 2077: 2070: 2068: 2061: 2057: 2056: 2053: 2052: 2050: 2049: 2044: 2039: 2033: 2031: 2029:Biocontainment 2025: 2024: 2022: 2021: 2015: 2010: 2005: 1999: 1997: 1993: 1992: 1990: 1989: 1984: 1979: 1973: 1971: 1962: 1956: 1955: 1952: 1951: 1949: 1948: 1942: 1936: 1917: 1915: 1909: 1908: 1906: 1905: 1899: 1897: 1891: 1890: 1888: 1887: 1881: 1874: 1872: 1865: 1864: 1862: 1861: 1855: 1849: 1839: 1833: 1827: 1821: 1819: 1813: 1812: 1810: 1809: 1804: 1799: 1794: 1779: 1777: 1770: 1764: 1763: 1760: 1759: 1756: 1755: 1753: 1752: 1747: 1742: 1737: 1731: 1729: 1721: 1720: 1718: 1717: 1707: 1702: 1692: 1687: 1677: 1672: 1667: 1661: 1659: 1650: 1644: 1643: 1640: 1639: 1637: 1636: 1630: 1624: 1614: 1604: 1593: 1591: 1587: 1586: 1584: 1583: 1578: 1572: 1570: 1566: 1565: 1563: 1562: 1556: 1554: 1547: 1543: 1542: 1539: 1538: 1536: 1535: 1529: 1519: 1509: 1503: 1493: 1478: 1476: 1472: 1471: 1469: 1468: 1463: 1458: 1453: 1447: 1445: 1441: 1440: 1438: 1437: 1431: 1416: 1414: 1405: 1399: 1398: 1395: 1394: 1392: 1391: 1386: 1380: 1375: 1370: 1364: 1362: 1356: 1355: 1353: 1352: 1347: 1337: 1331: 1329: 1323: 1322: 1320: 1319: 1312: 1310: 1304: 1303: 1301: 1300: 1295: 1290: 1285: 1275: 1269: 1267: 1258: 1257:administrative 1249: 1245: 1244: 1239: 1237: 1236: 1229: 1222: 1214: 1208: 1207: 1196: 1184: 1177: 1176:External links 1174: 1172: 1171: 1141: 1135:978-1437922844 1134: 1114: 1073: 1059:10.1086/518151 1032: 994: 969: 940: 914: 892: 882:2013-01-18 at 865: 851:10.1086/518151 824: 799: 753: 713: 711: 708: 707: 706: 701: 696: 690: 682: 679: 669: 666: 648: 645: 589: 586: 571:(MCM) against 565:appropriations 522:(MCM) against 515: 512: 503: 500: 499: 498: 488: 477: 462: 440: 417: 414: 389: 386: 385: 384: 380: 372: 359: 352: 348: 344: 333: 326: 319: 312: 305: 302: 289: 286: 256:nuclear agents 223: 222: 220: 219: 216:George W. Bush 209: 199: 189: 180: 157: 154: 153: 145: 144: 141: 137: 136: 131: 130:Titles amended 127: 126: 122: 121: 110: 102: 101: 96: 92: 91: 87: 86: 80: 76: 75: 71: 67: 66: 51: 50: 31: 29: 22: 15: 13: 10: 9: 6: 4: 3: 2: 2434: 2423: 2420: 2418: 2415: 2413: 2410: 2408: 2405: 2403: 2400: 2398: 2395: 2393: 2390: 2388: 2385: 2384: 2382: 2367: 2364: 2362: 2359: 2357: 2354: 2352: 2349: 2347: 2344: 2342: 2339: 2337: 2334: 2332: 2329: 2327: 2324: 2322: 2319: 2317: 2314: 2312: 2309: 2307: 2304: 2302: 2299: 2298: 2296: 2292: 2281: 2277: 2274: 2272: 2269: 2267: 2264: 2262: 2259: 2258: 2256: 2250: 2244: 2241: 2239: 2236: 2233: 2230: 2228: 2225: 2223: 2220: 2218: 2215: 2214: 2212: 2206: 2203: 2199: 2192: 2189: 2187: 2184: 2182: 2179: 2178: 2176: 2172:International 2170: 2160: 2157: 2154: 2151: 2148: 2145: 2143: 2140: 2137: 2134: 2132: 2129: 2126: 2123: 2120: 2117: 2114: 2111: 2109: 2106: 2104: 2101: 2100: 2098: 2094: 2087: 2084: 2081: 2078: 2075: 2072: 2071: 2069: 2065: 2062: 2058: 2048: 2045: 2043: 2040: 2038: 2035: 2034: 2032: 2030: 2026: 2019: 2016: 2014: 2011: 2009: 2006: 2004: 2001: 2000: 1998: 1994: 1988: 1985: 1983: 1980: 1978: 1975: 1974: 1972: 1970: 1966: 1963: 1961:and equipment 1957: 1946: 1943: 1940: 1937: 1934: 1930: 1926: 1922: 1919: 1918: 1916: 1914: 1910: 1904: 1901: 1900: 1898: 1896: 1892: 1885: 1882: 1879: 1876: 1875: 1873: 1870: 1866: 1859: 1856: 1853: 1850: 1847: 1843: 1840: 1837: 1834: 1831: 1828: 1826: 1823: 1822: 1820: 1818: 1814: 1808: 1805: 1803: 1800: 1798: 1795: 1792: 1788: 1784: 1781: 1780: 1778: 1774: 1771: 1765: 1751: 1748: 1746: 1743: 1741: 1738: 1736: 1733: 1732: 1730: 1728: 1722: 1715: 1711: 1708: 1706: 1703: 1700: 1696: 1693: 1691: 1688: 1685: 1681: 1678: 1676: 1673: 1671: 1668: 1666: 1663: 1662: 1660: 1654: 1651: 1645: 1634: 1631: 1628: 1625: 1622: 1618: 1615: 1612: 1608: 1605: 1602: 1598: 1595: 1594: 1592: 1588: 1582: 1579: 1577: 1574: 1573: 1571: 1567: 1561: 1558: 1557: 1555: 1551: 1548: 1544: 1533: 1530: 1527: 1523: 1520: 1517: 1513: 1510: 1507: 1504: 1501: 1497: 1494: 1491: 1487: 1483: 1480: 1479: 1477: 1473: 1467: 1464: 1462: 1459: 1457: 1454: 1452: 1449: 1448: 1446: 1442: 1435: 1432: 1429: 1425: 1421: 1418: 1417: 1415: 1409: 1406: 1400: 1390: 1387: 1384: 1381: 1379: 1376: 1374: 1371: 1369: 1366: 1365: 1363: 1361: 1357: 1351: 1348: 1345: 1341: 1338: 1336: 1333: 1332: 1330: 1328: 1324: 1317: 1314: 1313: 1311: 1309: 1305: 1299: 1296: 1294: 1291: 1289: 1286: 1283: 1279: 1276: 1274: 1271: 1270: 1268: 1266: 1262: 1259: 1253: 1250: 1248:Organizations 1246: 1242: 1235: 1230: 1228: 1223: 1221: 1216: 1215: 1212: 1206: 1202: 1197: 1190: 1185: 1183: 1180: 1179: 1175: 1159: 1152: 1145: 1142: 1137: 1131: 1127: 1126: 1118: 1115: 1110: 1106: 1101: 1096: 1092: 1088: 1084: 1077: 1074: 1069: 1065: 1060: 1055: 1051: 1047: 1043: 1036: 1033: 1028: 1024: 1020: 1016: 1012: 1005: 1003: 1001: 999: 995: 983: 979: 973: 970: 958: 951: 944: 941: 928: 924: 918: 915: 902: 896: 893: 890:, 18 Sep 2012 889: 885: 884:archive.today 881: 878: 872: 870: 866: 861: 857: 852: 847: 843: 839: 835: 828: 825: 814:on 2012-07-29 813: 809: 803: 800: 796: 792: 788: 784: 780: 776: 772: 768: 764: 757: 754: 750: 748: 744: 730: 729: 724: 718: 715: 709: 705: 702: 700: 697: 694: 691: 688: 685: 684: 680: 678: 675: 667: 665: 663: 657: 653: 646: 644: 642: 637: 635: 631: 627: 623: 618: 616: 610: 607: 603: 599: 595: 587: 585: 582: 578: 574: 570: 566: 562: 558: 553: 542: 536: 533: 529: 525: 521: 513: 511: 509: 501: 496: 492: 489: 486: 482: 478: 475: 471: 467: 463: 460: 456: 452: 448: 445: 441: 438: 434: 430: 429: 428: 425: 423: 415: 413: 410: 406: 402: 398: 394: 387: 381: 377: 374:Requires the 373: 369: 364: 360: 357: 353: 349: 345: 342: 338: 334: 331: 327: 324: 320: 317: 313: 310: 306: 303: 300: 296: 292: 291: 287: 285: 283: 279: 275: 270: 268: 265: 261: 257: 253: 249: 245: 241: 237: 233: 229: 217: 214:by President 213: 210: 207: 203: 200: 197: 193: 190: 188: 184: 181: 178: 174: 170: 166: 162: 159: 158: 155: 151: 146: 142: 138: 135: 132: 128: 123: 119: 115: 111: 109: 103: 100: 97: 93: 88: 85: 81: 77: 72: 68: 64: 59: 47: 35: 30: 21: 20: 2417:Bioterrorism 2361:Select agent 2341:CBRN defense 2336:Bioterrorism 2254:and programs 2135: 2076:(1925, 1975) 1769:and projects 1649:governmental 1428:Fort Detrick 1413:departmental 1162:. Retrieved 1144: 1124: 1117: 1090: 1086: 1076: 1049: 1045: 1035: 1018: 1014: 986:. Retrieved 984:. 2018-02-14 981: 972: 960:. Retrieved 943: 931:. Retrieved 927:the original 917: 905:. Retrieved 895: 888:BioPrepWatch 887: 841: 837: 827: 816:. Retrieved 812:the original 802: 762: 756: 739: 733:. Retrieved 726: 717: 671: 658: 654: 650: 638: 619: 611: 594:biodosimetry 591: 576: 554: 545:. Retrieved 537: 517: 505: 426: 422:BioPrepWatch 419: 395: 391: 271: 252:radiological 240:bioterrorist 227: 226: 211: 201: 191: 182: 160: 125:Codification 41: 33: 2119:Patriot Act 2096:Legislation 2003:Cell CANARY 1987:Respirators 1869:Biosecurity 1750:Phoenix Air 1727:contractors 728:White House 561:Tom Daschle 514:Recent news 474:Raxibacumab 459:Raxibacumab 447:Raxibacumab 361:Amends the 354:Amends the 335:Amends the 293:Amends the 267:Animal Rule 187:Senate HELP 44:August 2016 2381:Categories 2306:Biodefense 1969:Protection 1959:Technology 1947:(CDC, DHS) 1871:/Biosurety 1860:(Civilian) 1838:(EPA, CDC) 1793:(DoD) plus 1725:Government 1436:(DHHS/DoD) 1385:(JPEO-CBD) 988:2018-02-16 901:"H.R. 307" 818:2009-03-30 735:2008-08-01 710:References 409:biodefense 288:Provisions 280:, part of 272:Since the 244:biological 169:Judd Gregg 165:S. 15 161:Introduced 95:Public law 70:Long title 2210:incidents 1996:Detection 787:0036-8733 433:antitoxin 328:Adds the 112:118  90:Citations 2067:Treaties 2020:(JBAIDS) 1982:NBC suit 1844:(GBTI), 1836:BioWatch 1767:Programs 1712:(NCBID; 1546:Response 1475:Civilian 1444:Military 1404:research 1282:BioWatch 1158:Archived 1109:19884645 1068:17582574 1027:16239492 933:10 April 907:10 April 880:Archived 860:17582574 681:See also 528:smallpox 491:Botulism 481:BioThrax 248:chemical 2201:History 1923:of the 1852:ESSENCE 1590:Federal 1402:Federal 1255:Federal 1205:YouTube 1164:15 June 962:12 June 795:1775222 767:Bibcode 695:(BARDA) 524:anthrax 495:Cangene 470:Cangene 453:, from 451:anthrax 99:108-276 34:updated 2234:(2002) 2193:(2004) 2155:(2006) 2149:(2005) 2138:(2004) 2127:(2002) 2121:(2001) 2115:(1999) 2088:(1972) 2082:(1969) 1941:(DHHS) 1603:, HHS) 1534:(USDA) 1411:Trans- 1132:  1107:  1066:  1025:  858:  793:  785:  547:23 Feb 254:, and 116:  16:US law 1886:(DoD) 1880:(CDC) 1854:(DoD) 1832:(CDC) 1635:(CDC) 1629:(CDC) 1569:State 1553:Local 1518:/DHS) 1508:(HHS) 1500:NIAID 1498:(HHS/ 1490:NIAID 1192:(PDF) 1154:(PDF) 953:(PDF) 668:PhRMA 581:Gregg 483:from 468:from 206:414–2 114:Stat. 1977:MOPP 1931:and 1929:NIMS 1858:RODS 1789:and 1647:Non- 1611:USMC 1601:NDMS 1526:USDA 1486:UTMB 1327:DHHS 1166:2013 1130:ISBN 1105:PMID 1064:PMID 1023:PMID 964:2013 935:2013 909:2013 856:PMID 791:OCLC 783:ISSN 549:2017 435:for 236:2004 196:99-0 120:–864 82:the 2280:DoD 2060:Law 1933:ICS 1621:CDC 1516:EPA 1360:DoD 1344:CDC 1308:DNI 1265:DHS 1203:on 1095:doi 1091:361 1054:doi 1019:105 846:doi 775:doi 282:HHS 264:FDA 234:in 185:by 167:by 118:835 2383:: 1426:, 1103:. 1089:. 1085:. 1062:. 1050:45 1048:. 1044:. 1017:. 1013:. 997:^ 980:. 955:. 886:, 868:^ 854:. 842:45 840:. 836:. 789:, 781:, 773:, 738:. 725:. 530:, 526:, 250:, 246:, 177:NH 2282:) 2278:( 1935:) 1716:) 1701:) 1697:( 1686:) 1682:( 1623:) 1619:( 1613:) 1609:( 1599:( 1528:) 1524:( 1514:( 1502:) 1492:) 1488:/ 1484:( 1430:) 1422:( 1346:) 1342:( 1284:) 1233:e 1226:t 1219:v 1168:. 1138:. 1111:. 1097:: 1070:. 1056:: 1029:. 991:. 966:. 937:. 911:. 862:. 848:: 821:. 777:: 769:: 551:. 487:. 461:. 311:. 208:) 198:) 175:- 173:R 171:( 46:) 42:( 36:.

Index

Great Seal of the United States
108th United States Congress
108-276
Statutes at Large
Stat.
835
42: Public Health and Social Welfare
Legislative history
S. 15
Judd Gregg
R
NH
Senate HELP
99-0
414–2
George W. Bush
United States Congress
2004
bioterrorist
biological
chemical
radiological
nuclear agents
tested for safety or efficacy in humans
FDA
Animal Rule
2001 terrorist attacks
Biomedical Advanced Research and Development Authority (BARDA)
HHS
Public Health Service Act

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