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COVID-19 and Domestic PPE Production and Distribution: Issues and Policy Options [December 7, 2020]
From the Summary: "The novel Coronavirus Disease 2019 (COVID-19) and its rapid emergence as a pandemic have highlighted issues relating to the production and distribution of personal protective equipment (PPE). PPE refers to worn articles or equipment that help minimize exposure to various hazards, including infectious pathogens. Given the role that PPE plays in mitigating the spread and reducing the impacts of COVID-19, PPE demand has spiked both globally and domestically while supply has been undercut by both rapid consumption as well as supply chain disruptions. According to multiple federal agencies, including the Government Accountability Office, the Food and Drug Administration, and various independent organizations, PPE continues to be in short supply, which has led to broad congressional and public interest in PPE production and distribution issues. The availability of effective PPE is critical to the ongoing pandemic response, but also has broader public health, emergency preparedness, and national security implications. This report considers aspects of domestic production and distribution of PPE in the context of the COVID-19 pandemic. Specifically, the report considers (1) the availability of PPE supplies, including an assessment of PPE demand related to the COVID-19 pandemic; (2) federal actions and activities undertaken to increase PPE supplies in response to the pandemic, organized by executive agency and program; and (3) other policy options under consideration concerning PPE production and distribution, also organized by executive agency and program."
Library of Congress. Congressional Research Service
Cecire, Michael H.; Bodie, Agata; Gottron, Frank . . .
2020-12-07
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Development and Regulation of Medical Countermeasures for COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked Questions [June 25, 2020]
From the Summary: "In recent months, the Coronavirus Disease 2019 (COVID-19) pandemic has spread globally, with the United States now reporting the highest number of cases of any country in the world. Currently, there are few treatment options available to lessen the health impact of the disease and no vaccines or other prophylactic treatments to curb the spread of the virus. [...] This report answers frequently asked questions about current efforts related to research and development of medical countermeasures, their regulation, and related policy issues. Although several efforts are underway, medical product research, development, and approval is a difficult and high-risk endeavor that takes years in typical circumstances. In response to COVID-19, this process has been expedited, including through several federal programs and mechanisms covered in this report. However, expedited medical product development can carry certain risks, such as a more limited safety profile for new products upon approval."
Library of Congress. Congressional Research Service
Dabrowska, Agata; Gottron, Frank; Sarata, Amanda K. . . .
2020-06-25
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National Stockpiles: Background and Issues for Congress [June 15, 2020]
From the Document: "The United States maintains several distinct stockpiles of supplies, equipment, and raw materials that may be used for a national emergency, military operation, or other natural disaster or manmade event where commercial supply and distribution are unavailable.Some of these stockpiles were established by Congress in law, while others began as policy-driven initiatives of federal departments and agencies.In general, there are two types of stockpiles that the U.S. government owns and manages: (1) those intended to support a subset of the general public in an emergency (i.e., public stockpiles) and (2) those intended to support the national defense during a war or other type of military operation (i.e., defense stockpiles). Typically, a single federal department (including military departments)is responsible for managing each stockpile. Within departments, stockpiles are often supported by one or more logistics organizations that provide procurement, storage, transportation, disposal, and/or other technical services to stockpile managers. The degree to which stockpile managers store certain goods,instead of relying on pre-negotiated or rapidly executed contracts to deliver goods in an emergency, varies. Stockpile managers often consider several factors when making a decision to stockpile, including:statutory requirements, forecasted commercial availability of a product/material, anticipated loss of suppliers in a certain geographic area during an emergency, forecasted demand during peacetime and emergencies, the rareness or criticality of a material, and a department's overall stockpiling strategy."
Library of Congress. Congressional Research Service
Herrera, G. James; Gottron, Frank
2020-06-15
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COVID-19: Global Implications and Responses [Updated June 12, 2020]
From the Overview: "Severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) is believed to have emerged in Wuhan, China, in late 2019, and it has since spread around the globe. Confirmed cases of Coronavirus Disease 2019 (COVID-19) are most numerous in the United States, Russia, and Brazil (Figure 1). As of June 11, 2020, the World Health Organization (WHO) estimated that over 7.4 million people had contracted COVID-19 worldwide, and that over 400,000 people had died from it. WHO declared the outbreak a Public Health Emergency of International Concern (PHEIC) on January 30 and labeled it a 'pandemic' on March 11."
Library of Congress. Congressional Research Service
Tharakan, Sara M.; Salaam-Blyther, Tiaji; Gottron, Frank . . .
2020-06-12
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COVID-19: Global Implications and Responses [Updated May 8, 2020]
From the Overview: "Congressional interest in the global implications of pandemics and the novel coronavirus pandemic is high, with over 50 pieces of related legislation introduced in the 116th Congress to date (see CRS Report R46319, 'Novel Coronavirus 2019 (COVID-19): Q&A on Global Implications and Responses').The virus, which is believed to have started in Wuhan, China, in late 2019, is now named 'severe acute respiratory syndrome coronavirus 2' (SARSCoV-2) and is known by the disease it causes, 'coronavirus disease 2019' (COVID-19). The virus has spread across the globe and is now concentrated in the United States and Europe. As of May 7, 2020, the World Health Organization (WHO) estimated that 3.6 million people had contracted the disease, with over 250,000 deaths. WHO declared the outbreak a Public Health Emergency of International Concern (PHEIC) on January 30 and labeled it a 'pandemic' on March 11."
Library of Congress. Congressional Research Service
Tharakan, Sara M.; Salaam-Blyther, Tiaji; Gottron, Frank . . .
2020-05-08
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COVID-19: Global Implications and Responses [Updated March 19, 2020]
From the Document: "As of March 18, 2020, the novel coronavirus that began sickening patients in Wuhan, China, in early December 2019 had spread across the globe. According to the World Health Organization (WHO), 15 countries, including the United States, have reported more than 1,000 infections. Europe is the current epicenter for cases and deaths related to the virus. WHO has named the new virus 'severe acute respiratory syndrome coronavirus 2' (SARS-CoV-2) and the disease that it causes 'coronavirus disease 2019' (COVID-19). WHO declared the outbreak a Public Health Emergency of International Concern on January 30, raised its global risk assessment to 'Very High' on February 28, and labeled the outbreak a 'pandemic' on March 11. In using the term pandemic, WHO Director-General Tedros Adhanom Ghebreyesus cited COVID-19's 'alarming levels of spread and severity' and governments' 'alarming levels of inaction.' President Donald J. Trump declared a national emergency in the United States on March 13."
Library of Congress. Congressional Research Service
Tharakan, Sara M.; Gottron, Frank; Lawrence, Susan V. . . .
2020-03-19
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COVID-19: Global Implications and Responses [Updated March 5, 2020]
From the Overview: "As of March 4, 2020, the novel coronavirus that began sickening patients in Wuhan, China, in early December 2019 had spread to over 75 countries, including the United States. Daily new cases and deaths related to the virus outside China now exceed those reported in China, where the epidemic appears to be coming under control. The World Health Organization (WHO) has named the new virus 'severe acute respiratory syndrome coronavirus 2' (SARS-CoV-2) and the disease that it causes 'coronavirus disease 2019' (COVID-19). WHO has declared the outbreak a Public Health Emergency of International Concern and raised its global risk assessment to 'Very High.' It has refrained from labeling the outbreak a 'pandemic,' however. Doing so, WHO Director-General Tedros Adhanom Ghebreyesus has said, could 'signal that we can no longer contain the virus, which is not true.' On March 5, Tedros told countries, 'This is not the time to give up.' Rather, 'This is a time for pulling out all the stops.'"
Library of Congress. Congressional Research Service
Tharakan, Sara M.; Gottron, Frank; Lawrence, Susan V. . . .
2020-03-05
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Overview of U.S. Domestic Response to Coronavirus Disease 2019 (COVID-19) [Updated March 2, 2020]
From the Background: "This report discusses selected actions taken by the U.S. federal government to quell the introduction and spread of COVID-19 [coronavirus disease 2019] in the United States. The President, the HHS [Health and Human Services] Secretary, and other federal officials have taken several specific actions to address this threat. While some of these actions are based in generally applicable authorities, others may be contingent upon the Secretary or another federal official making a determination or declaration, specific to that action, regarding the existence of a public health emergency or threat. Key actions and their legal basis are discussed in this report."
Library of Congress. Congressional Research Service
Lister, Sarah A.; Sekar, Kavya; Dabrowska, Agata . . .
2020-03-02
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Overview of U.S. Domestic Response to the 2019 Novel Coronavirus (2019-nCoV) [February 10, 2020]
From the Background: "This report discusses selected actions taken by the federal government to quell the introduction and spread of 2019-nCoV [2019 Novel Coronavirus] in the United States. The HHS [U.S. Department of Health and Human Services] Secretary has taken several specific actions to address the 2019-nCoV threat. While some of these actions are based in generally applicable authorities of the Secretary, other authorities may be contingent upon the Secretary or another federal official making a determination or declaration, specific to that authority, regarding the existence of a public health emergency or threat. Each of the actions taken by the Secretary, its statutory basis, and any distinct declarations and determinations supporting the action is presented in this report."
Library of Congress. Congressional Research Service
Lister, Sarah A.; Sekar, Kavya; Dabrowska, Agata . . .
2020-02-10
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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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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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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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DHS Appropriations FY2017: Research and Development, Training, and Services [October 20, 2016]
"This report is part of a suite of reports that discuss appropriations for the Department of Homeland Security (DHS) for FY2017. It specifically discusses appropriations for the components of DHS included in the fourth title of the homeland security appropriations bill--in past years, this has comprised U.S. Citizenship and Naturalization Services, the Federal Law Enforcement Training Center, the Science and Technology Directorate, and the Domestic Nuclear Detection Office (DNDO). In FY2017, the Administration proposed moving the Domestic Nuclear Detection office into a new Chemical, Biological, Radiological, Nuclear, and Explosives Office, along with several other parts of DHS. Congress has labeled this title of the bill in recent years as 'Research and Development, Training, and Services.' The report provides an overview of the Administration's FY2017 request for these components, and the appropriations proposed by the Senate and House appropriations committees in response. Rather than limiting the scope of its review to the fourth title of the bills, the report includes information on provisions throughout the bills and report that directly affect these components. [...] On September 29, 2016, the President signed into law P.L. 114-223, which contained a continuing resolution that funds the government at the same rate of operations as FY2016, minus 0.496% through December 9, 2017. For details on the continuing resolution and its impact on DHS, see CRS [Congressional Research Service] Report R44621, Department of Homeland Security Appropriations: FY2017, which also includes additional information on the broader subject of FY2017 funding for DHS as well as links to analytical overviews and details regarding components in other titles."
Library of Congress. Congressional Research Service
Painter, William L.; Kandel, William; Morgan, Daniel (Daniel L.) . . .
2016-10-20
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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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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 April 19, 2013]
From the Summary: "In April 2013, envelopes sent to President Obama and a U.S. Senator tested 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
2013-04-19
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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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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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Project BioShield Act: Issues for the 112th Congress [October 26, 2012]
"Following the terrorist attacks of 2001, both the Administration and Congress determined that the federal government needed new medical countermeasures (such as diagnostic tests, drugs, vaccines, and other treatments) to respond to an attack using chemical, biological, radiological, or nuclear (CBRN) agents. Representatives of the pharmaceutical industry attributed the paucity of CBRN agent countermeasures to the lack of a significant commercial market. They argued that, because these diseases and conditions occur infrequently, the private sector perceived little economic incentive to invest the millions of dollars required to bring treatments to market. [...] This report will provide a brief overview of the authorities established by the Project BioShield Act of 2004, discuss the availability of Project BioShield appropriations, identify the medical countermeasures obtained through Project BioShield, review the relationship between Project BioShield and the Biomedical Advanced Research and Development Authority (BARDA), review policy issues and options faced by congressional policymakers, and review current legislation."
Library of Congress. Congressional Research Service
Gottron, Frank
2012-10-26
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Publishing Scientific Papers with Potential Security Risks: Issues for Congress [July 12, 2012]
"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
Gottron, Frank; Shea, Dana A.
2012-07-12
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Project BioShield Act: Issues for the 112th Congress [June 15, 2012]
"Following the terrorist attacks of 2001, both the Administration and Congress determined that the federal government needed new medical countermeasures (such as diagnostic tests, drugs, vaccines, and other treatments) to respond to an attack using chemical, biological, radiological, or nuclear (CBRN) agents. Representatives of the pharmaceutical industry attributed the paucity of CBRN agent countermeasures to the lack of a significant commercial market. They argued that, because these diseases and conditions occur infrequently, the private sector perceived little economic incentive to invest the millions of dollars required to bring treatments to market. [...] This report will provide a brief overview of the authorities established by the Project BioShield Act of 2004, discuss the availability of Project BioShield appropriations, identify the medical countermeasures obtained through Project BioShield, review the relationship between Project BioShield and the Biomedical Advanced Research and Development Authority (BARDA), review policy issues and options faced by congressional policymakers, and review current legislation."
Library of Congress. Congressional Research Service
Gottron, Frank
2012-06-15
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Project BioShield Act: Issues for the 112th Congress [March 13, 2012]
"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. The 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 112th Congress is considering several Project BioShield-related policy questions. One question is whether the Project BioShield acquisition mechanism has sufficiently improved national preparedness relative to its costs to merit extension. If so, congressional policymakers may consider whether changes to the funding levels or how Congress provides Project BioShield funds would improve the program's 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."
Library of Congress. Congressional Research Service
Gottron, Frank
2012-03-13
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Project BioShield Act: Issues for the 112th Congress [February 8, 2012]
"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. The 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 $2.5 billion to guarantee a government market for countermeasures against anthrax, botulism, radiation, 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. The Department of Homeland Security (DHS) Appropriations Act, 2004 (P.L. 108-90) advanceappropriated $5.593 billion to acquire CBRN countermeasures through Project BioShield for FY2004-FY2013. Through FY2012, subsequent Congresses have removed $1.876 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. Since passing the Project BioShield Act, subsequent Congresses have 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's Project BioShield procurements."
Library of Congress. Congressional Research Service
Gottron, Frank
2012-02-08
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Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress [May 27, 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 $2.5 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."
Library of Congress. Congressional Research Service
Gottron, Frank
2011-05-27
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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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Federal Efforts to Address the Threat of Bioterrorism: Selected Issues and Options for Congress [February 8, 2011]
From the Document: "Reports by congressional commissions, the mention of bioterrorism in President Obama's 2010 State of the Union address, and issuance of executive orders have increased congressional attention to the threat of bioterrorism. Federal efforts to combat the threat of bioterrorism predate the anthrax attacks of 2001 but have significantly increased since then. The U.S. government has developed these efforts as part of and in parallel with other defenses against conventional terrorism. Continued attempts by terrorist groups to launch attacks targeted at U.S. citizens have increased concerns that federal counterterrorism activities insufficiently address the threat. […] Congressional oversight of bioterrorism crosses the jurisdiction of many congressional committees. As a result, congressional oversight is often issue-based. Because of the diversity of federal biodefense efforts, this report does not provide a complete view of the federal bioterrorism effort. Instead, this report focuses on four areas under congressional consideration deemed critical to the success of the biodefense enterprise: strategic planning; risk assessment; surveillance; and the development, procurement, and distribution of medical countermeasures. Congress, through authorizing and appropriations legislation and oversight activities, continues to influence the federal response to the bioterrorism threat. Congressional policymakers may face many difficult choices about the priority of maintaining, shrinking, or expanding existing programs or creating new programs to address identified deficiencies. Augmenting or creating programs may result in additional costs in a time of fiscal challenges. Maintaining or shrinking programs may pose unacceptable risks, given the potential for significant casualties and economic effects from a large-scale bioterror attack."
Library of Congress. Congressional Research Service
Shea, Dana A.; Gottron, Frank
2011-02-08
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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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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
