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Federal Research and Development Funding: FY2017 [June 24, 2016]
"President Obama's budget request for FY2017 includes $152.333 billion for research and development (R&D), an increase of $6.195 billion (4.2%) over the estimated FY2016 enacted R&D funding level of $146.138 billion. The request represents the President's R&D priorities; Congress may opt to agree with part or all of the request, or it may express different priorities through the appropriations process. In particular, Congress will play a central role in determining the growth rate and allocation of the federal R&D investment in a period of intense pressure on discretionary spending. Budget caps may limit overall R&D funding and may require movement of resources across disciplines, programs, or agencies to address priorities. Funding for R&D is concentrated in a few departments and agencies. Under President Obama's FY2017 budget request, seven federal agencies would receive 95.6% of total federal R&D funding, with the Department of Defense (47.8%) and the Department of Health and Human Services (21.5%) accounting for nearly 70% of all federal R&D funding. In dollars, the largest increases in agency R&D funding in the President's request would go to the Department of Energy (up $2.755 billion, 19.1%), the Department of Defense (up $1.953 billion, 2.8%), and the Department of Health and Human Services (up $772 million, 2.4%). The President's FY2017 request continues support for a number of multiagency R&D initiatives: the National Nanotechnology Initiative, Networking and Information Technology Research and Development program, U.S. Global Change Research Program, Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative, Precision Medicine Initiative, Cancer Moonshot, Materials Genome Initiative, National Robotics Initiative, and National Network for Manufacturing Innovation."
Library of Congress. Congressional Research Service
Sargent, John F.; Esworthy, Robert; Gottron, Frank . . .
2016-06-24
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Project BioShield Act: Issues for the 113th Congress [June 18, 2014]
"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. However, the government still lacks countermeasures against many of the CBRN terrorism agents determined by the government to pose the greatest threat. Congress is likely to consider whether modifications of these authorities or new authorities would help address remaining gaps. The authority generally referred to as Project BioShield allows the government to guarantee a market for CBRN medical countermeasures. Under this provision, the Secretary of Health and Human Services (HHS) may obligate funds to purchase countermeasures that still need up to 10 more years of development. Since 2004, HHS has obligated approximately $3.309 billion to guarantee a government market for countermeasures against anthrax, smallpox, botulism, radiation, and nerve agents."
Library of Congress. Congressional Research Service
Gottron, Frank
2014-06-18
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Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress [February 7, 2011]
"In 2004, Congress passed the Project BioShield Act (P.L. 108-276) to encourage the private sector to develop medical countermeasures to 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. This law has three main provisions: (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. [...] Since 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's 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 findings of an HHS review."
Library of Congress. Congressional Research Service
Gottron, Frank
2011-02-07
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Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress [April 22, 2011]
"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. 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. 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 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."
Library of Congress. Congressional Research Service
Gottron, Frank
2011-04-22
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Ricin: Technical Background and Potential Role in Terrorism [December 21, 2010]
"On December 20, 2010, CBS News reported that the Department of Homeland Security had uncovered a credible threat of attacks using poisons, such as ricin, in salad bars and buffets. Ricin, a deadly toxin derived from castor beans, has been identified as a potential bioweapon. Ricin is extremely toxic by ingestion, inhalation, and injection. No treatment or prophylaxis currently exists, though research into new therapies and vaccines against ricin exposure continues. Additionally, research to improve ricin detection is ongoing. Although ricin's potential use as a military weapon was investigated, its predominant use has been in small quantities against specific individuals. Most experts believe that ricin would be difficult to use as a weapon of mass destruction, but do not discount its potential as a weapon of terror. Ricin is on the Select Agent list, and its possession, transfer, or use is regulated under domestic and international law. This report will not be updated."
Library of Congress. Congressional Research Service
Shea, Dana A.; Gottron, Frank
2010-12-21
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National Bio- and Agro-Defense Facility: Issues for Congress [Updated November 25, 2008]
"The agricultural and food infrastructure of the United States is potentially susceptible to terrorist attack using biological pathogens. In addition to the effects of such an attack on the economy, some animal diseases could potentially be transmitted to humans. These diseases are known as zoonotic diseases. Scientific and medical research on plant and animal diseases may lead to the discovery and development of new diagnostics and countermeasures, reducing the risk and effects of a successful terrorist attack. [...]. Homeland Security Presidential Directive 9 tasks the Secretaries of Agriculture and Homeland Security to develop a plan to provide safe, secure, and state-of-the-art agriculture biocontainment laboratories for research and development of diagnostic capabilities and medical countermeasures for foreign animal and zoonotic diseases. To partially meet these obligations, DHS has requested Congress to appropriate funds to construct a new facility, the National Bio- and Agro-Defense Facility (NBAF). This facility would house high-containment laboratories able to handle the pathogens currently under investigation at PIADC, as well as other pathogens of interest. Six candidate sites have been identified, one of which is Plum Island. The DHS plans to select the site in 2009 and open NBAF in 2015. The final construction cost will depend on the site location and has been estimated to range between $648 million and $939 million, significantly exceeding 2005 baseline projections. Additional expenses, such as equipping the new facility, relocating existing personnel and programs, and preparing the PIADC facility for disposition, may exceed an additional $100 million."
Library of Congress. Congressional Research Service
Gottron, Frank; Shea, Dana A.; Monke, James
2008-11-25
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Publishing Scientific Papers with Potential Security Risks: Issues for Congress [March 18, 2013]
"The federal government generally supports the publication of federally funded research results because wide dissemination may drive innovation, job creation, technology development, and the advance of science. However, some research results could also be used for malicious purposes. Congress, the Administration, and other stakeholders, are considering whether current policies concerning publishing such research results sufficiently balances the potential benefits with the potential harms. The current issues under debate cut across traditional policy areas, involving simultaneous consideration of security, scientific, health, export, and international policy. Because of the complexity of these issues, analysis according to one set of policy priorities may adversely affect other policy priorities. For example, maximizing security may lead to detriments in public health and scientific advancement, while maximizing scientific advancement may lead to security risks. Accounting for such trade-offs may allow policymakers to establish regulatory frameworks that more effectively maximize the benefits from dual-use research while mitigating its potential risks. […] This report describes the underlying controversy, the potential benefits and harms of publishing these manuscripts, the actions taken by domestic and international stakeholders, and options to improve the way research is handled to minimize security concerns."
Library of Congress. Congressional Research Service
Shea, Dana A.; Gottron, Frank
2013-03-18
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Ricin: Technical Background and Potential Role in Terrorism [April 18, 2013]
"In April 2013 envelopes sent to President Obama and a U.S. Senator tested preliminarily positive for ricin, a deadly toxin derived from castor beans. Ricin has been identified as a potential bioweapon. Ricin is extremely toxic by ingestion, inhalation, and injection. No treatment or prophylaxis currently exists, though research into new therapies and vaccines against ricin exposure continues. Additionally, research to improve ricin detection is ongoing. Although governments have investigated ricin's potential use as a military weapon, individuals have used ricin in small quantities. Most experts believe that ricin would be difficult to use as a weapon of mass destruction, but do not discount its potential as a weapon of terror. Ricin is a select agent, and its possession, transfer, or use is regulated under domestic and international law. This report will not be updated."
Library of Congress. Congressional Research Service
Shea, Dana A.; Gottron, Frank
2013-04-18
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Project BioShield: Purposes and Authorities [May 4, 2009]
"Following the terrorist attacks of 2001, the federal government determined that it would need additional medical countermeasures (e.g., diagnostic tests, drugs, vaccines, and other treatments) to respond to an attack using chemical, biological, radiological, or nuclear (CBRN) agents. The paucity of CBRN agent countermeasures is attributed to the lack of a significant commercial market. Because these diseases and conditions occur infrequently, little economic incentive exists to invest the millions of dollars required to bring treatments to market.[…] To encourage the development of new CBRN countermeasures, President Bush proposed Project BioShield in his 2003 State of the Union address. The 108th Congress considered this proposal and passed the Project BioShield Act of 2004 (P.L. [Public Law] 108-276, signed into law July 21, 2004). This act has three main provisions. It provides the Department of Health and Human Services (HHS) expedited procedures for CBRN terrorism-related spending including procuring products, hiring experts, and awarding research grants. The act creates a government-market guarantee by allowing the HHS Secretary to obligate funds to purchase countermeasures while they still have several more years of development. However, companies only receive payment when development is complete and the product is delivered. The act also authorizes the HHS Secretary to temporarily allow the emergency use of countermeasures that lack Food and Drug Administration (FDA) approval."
Library of Congress. Congressional Research Service
Gottron, Frank
2009-05-04
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Science and Technology Issues in the 115th Congress [March 14, 2017]
"Science and technology (S&T) have a pervasive influence over a wide range of issues confronting the nation. Public and private research and development spur scientific and technological advancement. Such advances can drive economic growth, help address national priorities, and improve health and quality of life. The constantly changing nature and ubiquity of science and technology frequently create public policy issues of congressional interest. The federal government supports scientific and technological advancement directly by funding and performing research and development and indirectly by creating and maintaining policies that encourage private sector efforts. Additionally, the federal government establishes and enforces regulatory frameworks governing many aspects of S&T activities. This report briefly outlines an array of science and technology policy issues that may come before the 115th Congress. Given the rapid pace of S&T advancement and its importance in many diverse public policy issues, S&T-related issues not discussed in this report may come before the 115th Congress."
Library of Congress. Congressional Research Service
Gottron, Frank
2017-03-14
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Science and Technology Issues in the 113th Congress [December 27, 2013]
"Science and technology (S&T) have a pervasive influence over a wide range of issues confronting the nation. Public and private research and development spurs scientific and technological advancement. Such advances can drive economic growth, help address national priorities, and improve health and quality of life. The constantly changing nature and ubiquity of science and technology frequently create public policy issues of congressional interest. The federal government supports scientific and technological advancement by directly funding research and development and indirectly by creating and maintaining policies that encourage private sector efforts. Additionally, the federal government establishes and enforces regulatory frameworks governing many aspects of S&T activities. This report briefly outlines an array of science and technology policy issues that may come before the 113th Congress. Given the ubiquity of science and technology and its constantly evolving nature, some science and technology related-issues not discussed in this report may come before the 113th Congress."
Library of Congress. Congressional Research Service
Gottron, Frank
2013-12-27
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Science and Technology Issues in the 113th Congress [June 20, 2013]
"Science and technology [S&T] have a pervasive influence over a wide range of issues confronting the nation. Public and private research and development spurs scientific and technological advancement. Such advances can drive economic growth, help address national priorities, and improve health and quality of life. The constantly changing nature and ubiquity of science and technology frequently creates public policy issues of congressional interest. The federal government supports scientific and technological advancement by directly funding research and development and indirectly by creating and maintaining policies that encourage private sector efforts. Additionally, the federal government establishes and enforces regulatory frameworks governing many aspects of S&T activities. This report briefly outlines an array of science and technology policy issues that may come before the 113th Congress. Given the ubiquity of science and technology and its constantly evolving nature, some science and technology related-issues not discussed in this report may come before the 113th Congress."
Library of Congress. Congressional Research Service
Gottron, Frank
2013-06-20
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Ricin: Technical Background and Potential Role in Terrorism [Updated February 4, 2004]
"On February 2, 2004, the deadly toxin ricin was detected in the Dirksen Senate Office Building. Ricin, derived from castor beans, has been identified as a potential bioweapon. Ricin is extremely toxic by ingestion, inhalation and injection, causing organ damage that can lead to death. While research continues on new therapies and vaccines against ricin exposure, no approved treatments or prophylaxis for human use currently exist. Research to develop sensitive, portable detectors capable of detecting the release of ricin is ongoing. Although ricin was investigated as a potential military weapon, it has predominantly been used in small quantities against specific individuals. Most experts believe that ricin would be difficult to use as a weapon of mass destruction, but do not discount its potential as a weapon of terror. Ricin is on the Centers for Disease Control and Prevention Select Agent list, and its possession, transfer, or use, is regulated under domestic and international law. This report will be updated as events warrant."
Library of Congress. Congressional Research Service
Shea, Dana A.; Gottron, Frank
2004-02-04
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Science and Technology Issues in the 116th Congress [Updated February 6, 2019]
From the Document, "Science and technology (S&T) play an important role in our society. Advances in science and technology can help drive economic growth and meet national priorities in public health, environmental protection, agricultural productivity, defense, and many other areas.' [...] This report serves as a brief introduction to many of the science and technology policy issues that may come before the 116th Congress. Each issue section provides background information and outlines selected policy issues that may be considered. Each issue includes a heading entitled 'For Further Information' that provides the author's name and the titles of relevant CRS [Congressional Research Service] reports containing more detailed policy analysis and information. Cited reports are current as of their individual publication dates, but may not reflect developments that have occurred since their publication."
Library of Congress. Congressional Research Service
Gottron, Frank
2019-02-06
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Project BioShield: Purposes and Authorities [July 6, 2009]
"Many potential chemical, biological, radiological, and nuclear (CBRN) terrorism agents lack available countermeasures. In 2003, President Bush proposed Project BioShield to address this need. The Project BioShield Act became law in July 2004 (P.L. 108-276). This law has three main provisions: (1) relaxing procedures for some CBRN terrorism-related spending, including hiring and awarding research grants; (2) guaranteeing a federal government 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 grants relating to developing treatments for radiation exposure and used the authority to guarantee a government market to obligate approximately $2.3 billion to acquire countermeasures against anthrax, botulism, radiation, and smallpox. The HHS has also employed the emergency use authority several times including allowing young children with H1N1 'swine flu' to receive specific antiviral drugs. The Department of Homeland Security Appropriations Act, 2004 (P.L. 108-90) advanceappropriated $5.593 billion for FY2004 to FY2013 for Project BioShield. In addition to the approximately $2.3 billion used for countermeasure procurement, Congress has decreased the available amount in the BioShield account. In FY2004 and FY2005, Congress removed approximately a total of $25 million through rescissions. In the Omnibus Appropriations Act, 2009 (P.L. 111-8), Congress transferred $412 million to other programs to support countermeasure advanced research and development and pandemic influenza preparedness and response. President Obama has proposed transferring an additional $305 million in FY2010 to support countermeasure advanced research and development."
Library of Congress. Congressional Research Service
Gottron, Frank
2009-07-06
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Science and Technology Policy: Issues for the 109th Congress [Updated September 1, 2006]
"This report indicates the sweep of science and technology in many public policy issues, although it cannot provide a comprehensive examination of every science or technology issue which may be of interest to Congress. This report also addresses key issues that directly affect, or are affected by, science and technology. Other mechanisms which may indirectly impact science and technology such as tax, antitrust, and trade policies - are outside the scope of this report. This report also includes relevant Homeland Security issues such as counter-terrorism, chemical, biological, radiological, and nuclear terrorism countermeasures R&D."
Library of Congress. Congressional Research Service
Gottron, Frank
2006-09-01
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Selected Homeland Security Issues in the 116th Congress [Updated November 26, 2019]
From the Document: "In 2001, in the wake of the terrorist attacks of September 11, 'homeland security' went from being a concept discussed among a relatively small cadre of policymakers and strategic thinkers to one broadly discussed among policymakers, including a broad swath of those in Congress. Debates over how to implement coordinated homeland security policy led to the passage of the Homeland Security Act of 2002 (P.L. 107-296), the establishment of the Department of Homeland Security (DHS), and extensive legislative activity in the ensuing years. Initially, homeland security was largely seen as counterterrorism activities. Today, homeland security is a broad and complex network of interrelated issues, in policymaking terms. For example, in its executive summary, the Quadrennial Homeland Security Review issued in 2014 delineated the missions of the homeland security enterprise as follows: prevent terrorism and enhance security; secure and manage the borders; enforce and administer immigration laws; safeguard and secure cyberspace; and strengthen national preparedness and resilience. This report compiles a series of Insights by CRS [Congressional Research Services] experts across an array of homeland security issues that may come before the 116th Congress."
Library of Congress. Congressional Research Service
Painter, William L.; DeVine, Michael E.; Finklea, Kristin . . .
2019-11-26
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Project BioShield: Appropriations, Acquisitions, and Policy Implementation Issues for Congress [March 8, 2007]
"The Project BioShield Act of 2004 (P.L. 108-276) established a 10-year program to acquire civilian medical countermeasures to chemical, biological, radiological and nuclear (CBRN) agents for the Strategic National Stockpile. Provisions of this act were designed to encourage private companies to develop these countermeasures by guaranteeing a government market for successfully developed countermeasures. Both the Department of Homeland Security (DHS) and the Department of Health and Human Services (HHS) have responsibilities in this program. Funds for this program are appropriated to DHS, while contracts are executed through HHS. The interagency process responsible for deciding which countermeasures to procure has changed multiple times since this program's inception."
Library of Congress. Congressional Research Service
Gottron, Frank
2007-03-08
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Science and Technology Policy: Issues for the 109th Congress [Updated February 3, 2006]
"Science and technology have a pervasive influence over a wide range of issues confronting the nation. Decisions on how much federal funding to invest in research and development (R&D), and determining what programs have the highest priority, for example, may have implications for homeland security, new high technology industries, government/private sector cooperation in R&D, and myriad other areas. This report indicates the sweep of science and technology in many public policy issues, although it cannot provide a comprehensive examination of every science or technology issue which may be of interest to Congress. In some areas, such as global climate change and stem cell research, the importance of science and technology is explicit and in the forefront of the policy debate. In others, such as patent protection and telecommunications reform, science and technology may not be as explicit, but are important drivers affecting how policy makers may make decisions. This report also addresses key issues that directly affect, or are affected by, science and technology. Other mechanisms which may indirectly impact science and technology - such as tax, antitrust, and trade policies - are outside the scope of this report."
Library of Congress. Congressional Research Service
Gottron, Frank
2006-02-03
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National Bio- and Agro-Defense Facility: Issues for Congress [September 4, 2007]
"The agricultural and food infrastructure of the United States is potentially susceptible to terrorist attack using biological pathogens. In addition to the impacts of such an attack on the economy, some animal diseases could potentially be transmitted to humans. (These diseases are known as zoonotic diseases.) Scientific and medical research on plant and animal diseases may lead to the discovery and development of new diagnostics and countermeasures, reducing the risk and impact of a successful terrorist attack."
Library of Congress. Congressional Research Service
Shea, Dana A.; Gottron, Frank; Monke, James
2007-09-04
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Ricin: Technical Background and Potential Role in Terrorism [December 20, 2005]
"On February 2, 2004, the deadly toxin ricin was detected in the Dirksen Senate Office Building. Ricin, derived from castor beans, has been identified as a potential bioweapon. Ricin is extremely toxic by ingestion, inhalation, and injection. No treatment or prophylaxis currently exist, though research into new therapies and vaccines against ricin exposure continues. Additionally, research to improve ricin detectors is ongoing. Although the potential of ricin as a military weapon was investigated, it has predominantly been used in small quantities against specific individuals. Most experts believe that ricin would be difficult to use as a weapon of mass destruction, but do not discount its potential as a weapon of terror. Ricin is on the Select Agent list, and its possession, transfer, or use is regulated under domestic and international law. This report will not be updated."
Library of Congress. Congressional Research Service
Gottron, Frank; Shea, Dana A.
2005-12-20
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Small-scale Terrorist Attacks Using Chemical and Biological Agents: An Assessment Framework and Preliminary Comparisons [Updated June 23, 2004]
This report, which will be updated as necessary, presents a means of assessing the relative threat from terrorist-use of individual chemical, biological, and toxin agents. It focuses on small-scale, targeted chemical and biological attacks, rather than mass-casualty attacks. The framework considers the elements of access, public health impact, medical treatment, prophylaxis, and dissemination. Other factors that may affect potential use by terrorists include the range of lethality, covert employment of an agent, and the availability of dual-use technologies. The results of this framework may be useful in addressing the threat these agents pose, for example by indicating priorities for countermeasure funding. Other uses include weighing the potential effectiveness of policy options, assessing threat reduction approaches to specific agents, and serving as a resource for developing other specialized frameworks.
Library of Congress. Congressional Research Service
Shea, Dana A.; Gottron, Frank
2004-06-23
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Smallpox: Technical Background on the Disease and Its Potential Role in Terrorism [Updated January 10, 2003]
"Smallpox, which kills approximately 30% of its victims, is estimated to have killed between 300 and 500 million people in the twentieth century before the World Health Organization's successful eradication program. The smallpox vaccine is effective at preventing smallpox but has a higher complication rate than any other currently used vaccine. The terrorist attacks of 2001 have increased fears that smallpox might be used as a weapon of terror. Smallpox has several properties that might make it desirable by terrorists, such as contagiousness and high lethality. These factors and its limited availability also make it difficult for a terrorist to use. Most experts agree that it is very unlikely that smallpox will be used as a weapon, but the high consequences of a successful attack have prompted exploration of methods to counter this threat. Also see CRS Report RL31694 Smallpox Vaccine Stockpile and Vaccination Policy and CRS Report RL31368, Preventing Proliferation of Biological Weapons: U.S. Assistance to the Former Soviet States. This report will be updated as warranted."
Library of Congress. Congressional Research Service
Gottron, Frank
2003-01-10
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National Bio- and Agro-Defense Facility: Issues for Congress [Updated September 10, 2007]
"The agricultural and food infrastructure of the United States is potentially susceptible to terrorist attack using biological pathogens. In addition to the impacts of such an attack on the economy, some animal diseases could potentially be transmitted to humans. (These diseases are known as zoonotic diseases.) Scientific and medical research on plant and animal diseases may lead to the discovery and development of new diagnostics and countermeasures, reducing the risk and impact of a successful terrorist attack. To safeguard the United States against animal disease, the U.S. Department of Agriculture (USDA) engages in foreign animal disease research at the Plum Island Animal Disease Center (PIADC). With the formation of the Department of Homeland Security (DHS) in 2003, the PIADC facility was transferred from USDA to DHS, though USDA continues its research program at the facility. The DHS has identified the PIADC facility as too old and limited to continue to be the primary facility performing this research. Homeland Security Presidential Directive 9 tasks the Secretaries of Agriculture and Homeland Security to develop a plan to provide safe, secure, and state-of-the-art agriculture biocontainment laboratories for research and development of diagnostic capabilities and medical countermeasures for foreign animal and zoonotic diseases. To meet these obligations, DHS has announced plans to construct a new facility, the National Bio- and Agro-Defense Facility (NBAF). […] The final construction costs would depend on the site location and actual construction time lines, but are projected to exceed $460 million."
Library of Congress. Congressional Research Service
Shea, Dana A.; Gottron, Frank; Monke, James
2007-09-10
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Pandemic and All-Hazards Preparedness Act (P.L. 109-417): Provisions and Changes (P.L. 109-417): Provisions and Changes [Updated March 12, 2007]
"The 109th Congress passed P.L. 109-417, the Pandemic and All-Hazards
Preparedness Act. The act reauthorized a number of expiring preparedness and
response programs in the PHS Act, and established some new authorities, including the creation of a Biomedical Advanced Research and Development Authority (BARDA), a new office in HHS to support, coordinate, and provide oversight of advanced development of vaccines and biodefense countermeasures. The act's provisions reflected the concerns of Members of the 109th Congress and others regarding the flawed response to Hurricane Katrina in 2005, and the threat of a possible influenza pandemic. A comparison of provisions in P.L. 109-417 with preexisting law is provided in Table 1 later in this report.
The 110th Congress will likely be interested in the implementation of provisions
in P.L. 109-417, and in the continued evolution of relationships between HHS, DHS, the states, and others among whom coordination is essential in a time of heightened concern about national security. Members of the 110th Congress may wish to consider legislation to address additional expiring public health authorities, such as the Select Agent program to control access to pathogens that could be used for bioterrorism, which expires at the end of FY2007. Congress may also wish to examine the adequacy of certain permanent emergency response and funding authorities of the Secretary of HHS."
Library of Congress. Congressional Research Service
Gottron, Frank; Lister, Sarah A.
2007-03-12
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Project BioShield: Appropriations, Acquisitions, and Policy Implementation Issues for Congress [Updated June 11, 2007]
"The Project BioShield Act of 2004 (P.L. 108-276) established a 10-year program to acquire civilian medical countermeasures to chemical, biological, radiological, and nuclear (CBRN) agents for the Strategic National Stockpile. Provisions of this act were designed to encourage private companies to develop these countermeasures by guaranteeing a government market for successfully developed countermeasures. […] Both the Department of Homeland Security (DHS) and HHS have responsibilities in this program. Funds for this program are appropriated to DHS, while contracts are executed through HHS. The interagency process responsible for deciding which countermeasures to procure has changed multiple times since this program's inception. The Homeland Security Appropriations Act, 2004 (P.L. 108-90) provided an advance appropriation of $5.6 billion to acquire CBRN countermeasures over a 10- year period (FY2004-FY2013). […] HHS has awarded Project BioShield contracts for countermeasures against anthrax, smallpox, botulinum toxin, and radiological or nuclear agents. These awards total approximately $2.331 billion. However, the largest contract, $878 million for an anthrax vaccine, was cancelled in December 2006 for failure to meet a contract milestone. Taking this into account, approximately $1.889 billion remains available for obligation through FY2008 and $4.064 billion available for obligation through the end of the program in FY2013. […] This report discusses actions taken by Congress and the Administration that have affected this program, describes the decision-making process for choosing countermeasures, describes the countermeasures for which the Department of Health and Human Services (HHS) has contracted, and discusses accounting discrepancies in Project BioShield budget documents."
Library of Congress. Congressional Research Service
Gottron, Frank
2007-06-11
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National Bio-and Agro-Defense Facility: Issues for Congress [Updated May 19, 2008]
This CRS report talks about "The National Bio-and Agro-Defense Facility [NABF]," this is a facility being built by the Department of Homeland Security [DHS] and it would be a place where "scientific and medical research on plant and animal diseases" could be done. Also, this research "may lead to the discovery and development of new diagnostic and countermeasures, reducing the risk of a successful terrorist attack." More specifically, "this report outlines current progress towards establishment of the NBAF, presents current and projected funding levels and timelines, and describes policy issues of potential interest to Congress, such as agency coordination, possession of viruses, construction timelines, disposition of PIADC [Plum Island Animal Disease Center], and community safety concerns." The report also provides the following background information in regards to the program: "the agricultural and food infrastructure of the United States is potentially susceptible to terrorist attack using biological pathogens. In addition to the impacts of such an attack on the economy, some animal diseases could potentially be transmitted to humans. These diseases are known as zoonotic diseases […] To safeguard the United States against animal disease, Congress has appropriated funds to the U.S. Department of Agriculture [USDA] to engage in research at the Plum Island Animal Disease Center [PIADC], off the coast of New York, on animal diseases not native to the United States. When creating the Department of Homeland Security [DHS] in 2003, Congress transferred the PIADC facility from USDA to DHS. Both USDA and DHS, in cooperation with USDA, conduct foreign animal disease research at PIADC, but PIADC has been identified as outdated and too limited to continue as the primary facility for this research."
Library of Congress. Congressional Research Service
Shea, Dana A.; Gottron, Frank; Monke, James
2008-05-19
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National Bio- and Agro-Defense Facility: Issues for Congress [Updated April 3, 2008]
"The agricultural and food infrastructure of the United States is potentially susceptible to terrorist attack using biological pathogens. In addition to the impacts of such an attack on the economy, some animal diseases could potentially be transmitted to humans. (These diseases are known as zoonotic diseases.) Scientific and medical research on plant and animal diseases may lead to the discovery and development of new diagnostics and countermeasures, reducing the risk and impact of a successful terrorist attack. The plans announced by DHS to establish the NBAF have raised several issues. Community concerns about safety and security, previously raised about PIADC and other laboratories being built to study dangerous pathogens, are also being raised about the NBAF. Coordination between DHS and USDA, as well as prioritization and investment in agricultural biodefense may be reassessed once more high containment laboratory space becomes available. By law, research on live foot and mouth disease (FMD) virus is not permitted on the U.S. mainland. This policy would need to be changed before DHS could conduct FMD research at NBAF if it were sited on the U.S. mainland. Bills (H.R. 1717, H.R. 2419, and the Senate amendment to H.R. 2419) modifying this policy are being considered by in the 110th Congress."
Library of Congress. Congressional Research Service
Shea, Dana A.; Gottron, Frank; Monke, James
2008-04-03
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National Bio- and Agro-Defense Facility: Issues for Congress [Updated June 30, 2008]
This Congressional Research Service (CRS) report discusses the directive for the development of agricultural "biocontainment laboratories for research and development of diagnostic capabilities and medical countermeasures for foreign animal and zoonotic diseases. [Further,] To safeguard the United States against the impacts of naturally occurring and intentional animal disease outbreaks, the U.S. Department of Agriculture (USDA) engages in animal disease research, including research into highly contagious animal pathogens and animal diseases not native to the United States. Such research activities have historically been performed at the Plum Island Animal Disease Center (PIADC), located on an island near Long Island, NY. When creating the Department of Homeland Security (DHS) in 2003, Congress transferred the operation of the PIADC facility from USDA to DHS, though USDA still maintains an active research program at PIADC. The DHS, in cooperation with USDA, has established its own research and development program at PIADC. As the federal government undertakes new efforts in human biodefense and defense against agroterrorism, DHS has identified the PIADC facility as "reaching the end of its life cycle" and lacking critical capabilities to continue as the primary facility performing this research. The Department of Homeland Security has announced that, to meet the obligations of HSPD-9, it will establish a new facility, the National Bio- and Agro-Defense Facility (NBAF). This facility would have high-containment laboratories able to hold the pathogens currently under investigation at PIADC as well as other pathogens of interest. The plans announced by DHS to establish the NBAF have raised congressional and public concerns regarding its safety and security and policy questions about coordination between DHS and USDA regarding the research to be conducted at NBAF. This report outlines current progress towards establishment of the NBAF, presents current and projected funding levels and timelines, and describes policy issues of potential interest to Congress, such as agency coordination, possession of viruses, construction timelines, disposition of PIADC, and community safety concerns."
Library of Congress. Congressional Research Service
Shea, Dana A.; Gottron, Frank; Monke, James
2008-06-30
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Project BioShield [June 05, 2006]
"Many potential biological terrorism agents lack available countermeasures. President Bush proposed Project BioShield to address this need. The 108th Congress considered this proposal in S. 15, S. 1504, and H.R. 2122. President Bush signed S. 15 into law on July 21, 2004 (The Project BioShield Act of 2004, P.L. 108-276). The main provisions of this law include (1) relaxing procedures for bioterrorism-related procurement, hiring, and awarding of research grants; (2) guaranteeing a federal government market for new biomedical countermeasures; and (3) permitting emergency use of unapproved countermeasures. Project BioShield countermeasure procurement is funded by the Department of Homeland Security Appropriations Act, 2004 (P.L. 108- 90) which advance-appropriated $5.593 billion for FY2004-FY2013. Additional measures to encourage the development of countermeasures are being considered by the 109th Congress in S. 3 (Gregg), S. 975 (Lieberman), S. 1873 (Burr), S. 1880 (Kennedy), and S. 2564 (Burr). This report will be updated in response to legislative developments."
Library of Congress. Congressional Research Service
Gottron, Frank
2006-06-05
