{ "id": "R42349", "type": "CRS Report", "typeId": "REPORTS", "number": "R42349", "active": true, "source": "EveryCRSReport.com, University of North Texas Libraries Government Documents Department", "versions": [ { "source": "EveryCRSReport.com", "id": 415233, "date": "2012-12-21", "retrieved": "2016-04-06T21:32:04.487147", "title": "The Project BioShield Act: Issues for the 112th Congress", "summary": "In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to provide the federal government with new authorities related to the development, procurement, and use of medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) terrorism agents. As the expiration of some of these authorities approaches, Congress is considering whether these authorities have sufficiently contributed to national preparedness to merit extension. \nThe Project BioShield Act provides three main authorities: (1) guaranteeing a federal market for new CBRN medical countermeasures, (2) permitting emergency use of countermeasures that are either unapproved or have not been approved for the intended emergency use, and (3) relaxing regulatory requirements for some CBRN terrorism-related spending. The Department of Health and Human Services (HHS) has used each of these authorities. The HHS obligated approximately $2.625 billion to guarantee a government market for countermeasures against anthrax, botulism, radiation exposure, and smallpox. The HHS allowed the emergency use of several unapproved products, including during the 2009 H1N1 influenza pandemic. The HHS used expedited review authorities to approve contracts and grants related to CBRN countermeasure research and development.\nThe Department of Homeland Security (DHS) Appropriations Act, 2004 (P.L. 108-90) advance-appropriated $5.593 billion to acquire CBRN countermeasures through Project BioShield for FY2004-FY2013. Subsequent Congresses have removed $2.078 billion from this account through rescissions and transfers, more than one-third of the advance appropriation. The transfers from this account supported CBRN medical countermeasure advanced development, pandemic influenza preparedness and response, and basic biomedical research. \nSince passing the Project BioShield Act, Congress has considered additional measures to further encourage countermeasure development. The Pandemic and All-Hazards Preparedness Act (P.L. 109-417) created the Biomedical Advanced Research and Development Authority (BARDA) in HHS and modified the Project BioShield procurement process. Among other duties, BARDA oversees all of HHS\u2019s Project BioShield procurements. \nThe 112th Congress is considering several Project BioShield-related policy questions. One question is whether the Project BioShield acquisition mechanism merits extension based on its relative cost and contribution to national preparedness. If so, congressional policymakers may consider whether changes to the funding levels or how Congress provides Project BioShield funds would improve the program\u2019s efficiency or performance. Additionally, congressional policymakers are considering whether the federal government sufficiently plans and coordinates its CBRN countermeasure efforts from basic research to distribution. Finally, Congress is considering whether changes to the emergency use authority will improve preparedness and planning.\nFour bills in the 112th Congress address some of these Project BioShield-related issues, H.R. 2356, H.R. 2405, H.R. 6672, and S. 1855.", "type": "CRS Report", "typeId": "REPORTS", "active": true, "formats": [ { "format": "HTML", "encoding": "utf-8", "url": "http://www.crs.gov/Reports/R42349", "sha1": "d98fc654cfe8c317d4671b2af79b6c902c71822b", "filename": "files/20121221_R42349_d98fc654cfe8c317d4671b2af79b6c902c71822b.html", "images": null }, { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/R42349", "sha1": "ed588d4833ab9279feb44de6a1a4dd4811e6ae49", "filename": "files/20121221_R42349_ed588d4833ab9279feb44de6a1a4dd4811e6ae49.pdf", "images": null } ], "topics": [] }, { "source": "University of North Texas Libraries Government Documents Department", "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc227745/", "id": "R42349_2012Oct26", "date": "2012-10-26", "retrieved": "2013-11-05T18:07:05", "title": "The Project BioShield Act: Issues for the 112th Congress", "summary": "Report that provides a brief overview of the authorities established by the Project BioShield Act of 2004, discusses the availability of Project BioShield appropriations, identifies the medical countermeasures obtained through Project BioShield, reviews the relationship between Project BioShield and the Biomedical Advanced Research and Development Authority (BARDA), reviews policy issues and options faced by congressional policymakers, and reviews current Project BioShield-related legislation.", "type": "CRS Report", "typeId": "REPORT", "active": false, "formats": [ { "format": "PDF", "filename": "files/20121026_R42349_5fb5a424ef551bf511527d6066eaac10a841b9a9.pdf" }, { "format": "HTML", "filename": "files/20121026_R42349_5fb5a424ef551bf511527d6066eaac10a841b9a9.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/metadc93923/", "id": "R42349_2012Jun15", "date": "2012-06-15", "retrieved": "2012-07-24T12:39:36", "title": "The Project BioShield Act: Issues for the 112th Congress", "summary": "This report discusses the Project BioShield Act, 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/20120615_R42349_d612a16ab35632f3f3d9c7b07e58cf48a2ae630a.pdf" }, { "format": "HTML", "filename": "files/20120615_R42349_d612a16ab35632f3f3d9c7b07e58cf48a2ae630a.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/metadc86591/", "id": "R42349_2012Mar13", "date": "2012-03-13", "retrieved": "2012-06-15T10:07:48", "title": "The Project BioShield Act: Issues for the 112th 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/20120313_R42349_625388507e65e1aa8b68e17a71da5720d6ca88c3.pdf" }, { "format": "HTML", "filename": "files/20120313_R42349_625388507e65e1aa8b68e17a71da5720d6ca88c3.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/metadc87211/", "id": "R42349_2012Feb08", "date": "2012-02-08", "retrieved": "2012-07-03T07:51:21", "title": "The Project BioShield Act: Issues for the 112th 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/20120208_R42349_2c43bf8ac2b90eaf72de9e81b9e79ea133ff2192.pdf" }, { "format": "HTML", "filename": "files/20120208_R42349_2c43bf8ac2b90eaf72de9e81b9e79ea133ff2192.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" } ] } ], "topics": [ "Appropriations", "Foreign Affairs", "Intelligence and National Security" ] }