{ "id": "R41033", "type": "CRS Report", "typeId": "REPORTS", "number": "R41033", "active": false, "source": "EveryCRSReport.com, University of North Texas Libraries Government Documents Department", "versions": [ { "source": "EveryCRSReport.com", "id": 388310, "date": "2011-05-27", "retrieved": "2016-04-07T00:48:41.257706", "title": "Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress", "summary": "In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to encourage the private sector to develop medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents and to provide a novel mechanism for federal acquisition of those newly developed countermeasures. Although some countermeasures have been acquired through this law, Congress continues to address several Project BioShield-related policy issues. These include whether to continue diverting Project BioShield acquisition funding to other purposes; whether to change the countermeasure development and acquisition process; how to replace stockpiled countermeasures as they expire; and whether to alter federal efforts to encourage the development of broad-spectrum countermeasures.\nThis law provides three main authorities: (1) relaxing regulatory requirements for some CBRN terrorism-related spending, including hiring personnel and awarding research grants; (2) guaranteeing a federal market for new CBRN medical countermeasures; and (3) permitting emergency use of unapproved countermeasures. The Department of Health and Human Services (HHS) has used each of these authorities. The HHS used expedited review authorities to approve contracts and grants related to CBRN countermeasure research and development. The HHS used the authority to guarantee a government market to obligate approximately $2.5 billion to acquire countermeasures against anthrax, botulism, radiation, and smallpox. The HHS has also employed the emergency use authority several times, including during the 2009 H1N1 influenza pandemic. \nThe Department of Homeland Security (DHS) Appropriations Act, 2004 (P.L. 108-90) advance-appropriated $5.593 billion for FY2004 to FY2013 for CBRN countermeasures acquisition through Project BioShield. Through FY2011, subsequent Congresses have removed $1.461 billion from this account through rescissions and transfers, more than 25% of the advance appropriation. The transfers from this account supported CBRN medical countermeasure advanced development, pandemic influenza preparedness and response, and basic biomedical research. The President\u2019s FY2012 budget requests a transfer of $765 million out of this account to support CBRN countermeasure advanced development and to establish a CBRN countermeasure strategic investment corporation.\nSince passing the Project BioShield Act, subsequent Congresses have considered additional measures to further encourage countermeasure development. The 109th Congress created the Biomedical Advanced Research and Development Authority (BARDA) in HHS through the Pandemic and All-Hazard Preparedness Act (P.L. 109-417). Among other duties, BARDA oversees all of HHS\u2019s Project BioShield procurements. The Pandemic and All-Hazard Preparedness Act also modified the Project BioShield procurement process. Some stakeholders question whether these changes have sufficiently improved federal countermeasure development and procurement. The Administration plans to improve the countermeasure research, development, and acquisition process based on the findings of a 2010 HHS review.", "type": "CRS Report", "typeId": "REPORTS", "active": false, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R41033", "sha1": "336e25ec84306ba1a80d9e5733386e63043cc43f", "filename": "files/20110527_R41033_336e25ec84306ba1a80d9e5733386e63043cc43f.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R41033", "sha1": "7208c676cc521004ec7104c857c4e0538b89deb0", "filename": "files/20110527_R41033_7208c676cc521004ec7104c857c4e0538b89deb0.pdf", "images": null } ], "topics": [] }, { "source": "University of North Texas Libraries Government Documents Department", "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc40085/", "id": "R41033_2011April22", "date": "2011-04-22", "retrieved": "2011-08-27T10:13:38", "title": "Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress", "summary": "This report discusses the Project BioShield Act (P.L. 108-276), In 2004, passed by Congress to encourage the private sector to develop medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents and to provide a novel mechanism for federal acquisition of those newly developed countermeasures. 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In 2004 Congress passed the law to encourage the private sector to develop medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents and to provide a novel mechanism for federal acquisition of those newly developed countermeasures. This law provides three main authorities: (1) relaxing regulatory requirements for some CBRN terrorism-related spending, including hiring personnel and awarding research grants; (2) guaranteeing a federal market for new CBRN medical countermeasures; and (3) permitting emergency use of unapproved countermeasures.", "type": "CRS Report", "typeId": "REPORT", "active": false, "formats": [ { "format": "PDF", "filename": "files/20110303_R41033_d22c702718c00b9e43006b9540c8336a68ae9972.pdf" }, { "format": "HTML", "filename": "files/20110303_R41033_d22c702718c00b9e43006b9540c8336a68ae9972.html" } ], "topics": [ { "source": "LIV", "id": "Chemical warfare", "name": "Chemical warfare" }, { "source": "LIV", "id": "Biological warfare", "name": "Biological warfare" }, { "source": "LIV", "id": "Nuclear terrorism", "name": "Nuclear terrorism" } ] }, { "source": "University of North Texas Libraries Government Documents Department", "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc103074/", "id": "R41033_2011Feb07", "date": "2011-02-07", "retrieved": "2012-09-19T20:16:14", "title": "Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress", "summary": "This report discusses the Project BioShield Act (P.L. 108-276). In 2004 Congress passed the law to encourage the private sector to develop medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents and to provide a novel mechanism for federal acquisition of those newly developed countermeasures. This law provides three main authorities: (1) relaxing regulatory requirements for some CBRN terrorism-related spending, including hiring personnel and awarding research grants; (2) guaranteeing a federal market for new CBRN medical countermeasures; and (3) permitting emergency use of unapproved countermeasures.", "type": "CRS Report", "typeId": "REPORT", "active": false, "formats": [ { "format": "PDF", "filename": "files/20110207_R41033_2382e3c215b80dafd78b89a0af8efbd72c0cf738.pdf" }, { "format": "HTML", "filename": "files/20110207_R41033_2382e3c215b80dafd78b89a0af8efbd72c0cf738.html" } ], "topics": [ { "source": "LIV", "id": "Chemical warfare", "name": "Chemical warfare" }, { "source": "LIV", "id": "Biological warfare", "name": "Biological warfare" }, { "source": "LIV", "id": "Nuclear terrorism", "name": "Nuclear terrorism" } ] }, { "source": "University of North Texas Libraries Government Documents Department", "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc491508/", "id": "R41033_2010Jul15", "date": "2010-07-15", "retrieved": "2015-01-27T19:40:46", "title": "Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress", "summary": "This report discusses the Project BioShield Act (P.L. 108-276). In 2004 Congress passed the law to encourage the private sector to develop medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents and to provide a novel mechanism for federal acquisition of those newly developed countermeasures. This law provides three main authorities: (1) relaxing regulatory requirements for some CBRN terrorism-related spending, including hiring personnel and awarding research grants; (2) guaranteeing a federal market for new CBRN medical countermeasures; and (3) permitting emergency use of unapproved countermeasures.", "type": "CRS Report", "typeId": "REPORT", "active": false, "formats": [ { "format": "PDF", "filename": "files/20100715_R41033_0d8bdd111c9273767597ff945af3c19835d32f3c.pdf" }, { "format": "HTML", "filename": "files/20100715_R41033_0d8bdd111c9273767597ff945af3c19835d32f3c.html" } ], "topics": [ { "source": "LIV", "id": "Chemical warfare", "name": "Chemical warfare" }, { "source": "LIV", "id": "Biological warfare", "name": "Biological warfare" }, { "source": "LIV", "id": "Nuclear terrorism", "name": "Nuclear terrorism" } ] }, { "source": "University of North Texas Libraries Government Documents Department", "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc490861/", "id": "R41033_2010Jul07", "date": "2010-07-07", "retrieved": "2015-01-27T19:40:46", "title": "Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress", "summary": "This report discusses the Project BioShield Act (P.L. 108-276), In 2004, passed by Congress to encourage the private sector to develop medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents and to provide a novel mechanism for federal acquisition of those newly developed countermeasures. This law provides three main authorities: (1) relaxing regulatory requirements for some CBRN terrorism-related spending, including hiring personnel and awarding research grants; (2) guaranteeing a federal market for new CBRN medical countermeasures; and (3) permitting emergency use of unapproved countermeasures.", "type": "CRS Report", "typeId": "REPORT", "active": false, "formats": [ { "format": "PDF", "filename": "files/20100707_R41033_ef3d324ad75585871ae5ae4df19cdeea9b21c2b9.pdf" }, { "format": "HTML", "filename": "files/20100707_R41033_ef3d324ad75585871ae5ae4df19cdeea9b21c2b9.html" } ], "topics": [ { "source": "LIV", "id": "Chemical warfare", "name": "Chemical warfare" }, { "source": "LIV", "id": "Biological warfare", "name": "Biological warfare" }, { "source": "LIV", "id": "Nuclear terrorism", "name": "Nuclear terrorism" }, { "source": "KWD", "id": "BioShield", "name": "BioShield" } ] }, { "source": "University of North Texas Libraries Government Documents Department", "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc491110/", "id": "R41033_2010Jun23", "date": "2010-06-23", "retrieved": "2015-01-27T19:40:46", "title": "Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress", "summary": "This report discusses the Project BioShield Act (P.L. 108-276), In 2004, passed by Congress to encourage the private sector to develop medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents and to provide a novel mechanism for federal acquisition of those newly developed countermeasures. This law provides three main authorities: (1) relaxing regulatory requirements for some CBRN terrorism-related spending, including hiring personnel and awarding research grants; (2) guaranteeing a federal market for new CBRN medical countermeasures; and (3) permitting emergency use of unapproved countermeasures.", "type": "CRS Report", "typeId": "REPORT", "active": false, "formats": [ { "format": "PDF", "filename": "files/20100623_R41033_7963284a14a54159427586c125770f512b347cfe.pdf" }, { "format": "HTML", "filename": "files/20100623_R41033_7963284a14a54159427586c125770f512b347cfe.html" } ], "topics": [ { "source": "LIV", "id": "Chemical warfare", "name": "Chemical warfare" }, { "source": "LIV", "id": "Biological warfare", "name": "Biological warfare" }, { "source": "LIV", "id": "Nuclear terrorism", "name": "Nuclear terrorism" }, { "source": "KWD", "id": "BioShield", "name": "BioShield" } ] }, { "source": "University of North Texas Libraries Government Documents Department", "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc491377/", "id": "R41033_2010Jan22", "date": "2010-01-22", "retrieved": "2015-01-27T19:40:46", "title": "Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress", "summary": "This report discusses the Project BioShield Act (P.L. 108-276), In 2004, passed by Congress to encourage the private sector to develop medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents and to provide a novel mechanism for federal acquisition of those newly developed countermeasures. 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