Project BioShield: Authorities, Appropriations, Acquisitions, and Issues for Congress

Frank Gottron
Specialist in Science and Technology Policy

Many potential chemical, biological, radiological, and nuclear (CBRN) terrorism agents lack available medical 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 regulatory requirements for some CBRN terrorism-related spending, including hiring personnel 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 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 allowing young children with H1N1 "swine" influenza to receive specific antiviral drugs. 

The Department of Homeland Security (DHS) Appropriations Act, 2004 (P.L. 108-90) advance-appropriated $5.593 billion for FY2004 to FY2013 for CBRN countermeasures acquisition through Project BioShield. Subsequent Congresses have rescinded or transferred to other accounts approximately 19% of the advance appropriation. In FY2004 and FY2005, Congress removed a total of approximately $25 million from this account through rescissions included in the Consolidated Appropriations Act, 2004 (P.L. 108-199) and the Consolidated Appropriations Act, 2005 (P.L. 108-447). In the Omnibus Appropriations Act, 2009 (P.L. 111-8), Congress transferred $412 million from this account to support countermeasure advanced research and development and pandemic influenza preparedness and response. The Consolidated Appropriations Act, 2010 (P.L. 111-117) transferred $609 million from this account to support basic research and advanced countermeasure development. P.L. 111-117 also transferred the remaining Project BioShield funds from DHS to HHS. For FY2011, President Obama has requested the transfer of at least $476 million from this account to support countermeasure advanced development. 

Since passing the Project BioShield Act, subsequent Congresses have considered additional measures to further encourage countermeasure development. The 109th Congress passed the Pandemic and All-Hazard Preparedness Act (P.L. 109-417) which created the Biomedical Advanced Research and Development Authority (BARDA) in HHS. Amongst other duties, BARDA oversees all of HHS' Project BioShield activities. The Pandemic and All-Hazard Preparedness Act also modified the Project BioShield procurement process. Some stakeholders question whether these changes have sufficiently improved countermeasure development and procurement. The Administration is considering implementing additional changes to the countermeasure research, development, and acquisition process. 

The 111th 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.


Date of Report: June 23, 2010
Number of Pages: 17
Order Number: R41033
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The Technology Innovation Program

Wendy H. Schacht
Specialist in Science and Technology Policy

The Technology Innovation Program (TIP) at the National Institute of Standards and Technology (NIST) was established in 2007 to replace the Advanced Technology Program (ATP). This effort is designed "to support, promote, and accelerate innovation in the United States through highrisk, high-reward research in areas of critical national need," according to the authorizing legislation. Grants are provided to small and medium-sized firms for individual projects or joint ventures with other research organizations.

While similar to the Advanced Technology Program in the promotion of R&D that is expected to be of broad-based economic benefit to the nation, TIP appears to have been structured to avoid what was seen as government funding of large firms that opponents argued did not necessarily need federal support for research. The committee report to accompany H.R. 1868, part of which was incorporated into the final legislation, stated that TIP replaces ATP in consideration of a changing global innovation environment focusing on small and medium-sized companies. The design of the program also "acknowledges the important role universities play in the innovation cycle by allowing universities to fully participate in the program."

The elimination of ATP and the creation of TIP have renewed the debate over the role of the federal government in promoting commercial technology development. In arguing for less direct federal involvement, advocates of this approach believe that the market is superior to government in deciding technologies worthy of investment. Mechanisms that enhance the market's opportunities and abilities to make such choices are preferred. It is suggested that agency discretion in selecting one technology over another can lead to political intrusion and industry dependency. On the other hand, supporters of direct methods argue that it is important to focus on those technologies that have the greatest promise as determined by industry and supported by matching funds from the private sector. They assert that the government can serve as a catalyst for cooperation. As the 111th Congress continues to make budget decisions, the discussion may serve to redefine thinking about governmental efforts in facilitating technological advancement in the private sector.


Date of Report: June 14, 2010
Number of Pages: 8
Order Number: RS22815
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America COMPETES Reauthorization Act of2010 and the America COMPETES Act: Selected Policy Issues

Heather B. Gonzalez, Coordinator
Specialist in Science and Technology Policy

John F. Sargent Jr.
Specialist in Science and Technology Policy

Patricia Moloney Figliola
Specialist in Internet and Telecommunications Policy

Enacted in 2007, the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Act (P.L. 110-69) is being considered for reauthorization this year. The law responded to concerns about long-term U.S. economic competitiveness and innovative capacity by authorizing increased investments in science, technology, engineering, and mathematics (STEM) education and federal research in the physical sciences and engineering.

Statutory authorities for certain America COMPETES Act provisions will expire in 2010. Committees in the House and Senate have begun the process of re-examining the policy rationale behind the law and determining whether to continue, alter, add to, or terminate its various provisions. On May 28, 2010, the House passed a reauthorization measure titled the America COMPETES Reauthorization Act of 2010 (H.R. 5116) by a vote of 262 to 150. Similar legislation has not been introduced in the Senate.

H.R. 5116 builds upon, and differs from, the original America COMPETES Act. Among its many provisions, the bill augments and amends P.L. 110-69's provisions in STEM education and federal research in the physical sciences and engineering. H.R. 5116 seeks to increase the coordination of federal STEM education programs and to improve STEM teaching and learning in higher education. It would also increase authorizations for the National Science Foundation, National Institute of Standards and Technology laboratories, and Department of Energy Office of Science for five years; and would make program changes designed to provide for high-risk, highreward research, increased collaboration, and commercialization.

H.R. 5116 would also expand provisions of P.L. 110-69 that sought to increase the participation of underrepresented populations in STEM education and employment, and would reauthorize the National Nanotechnology Initiative and Networking and Information Technology Research and Development program, two federal multi-agency R&D initiatives.

In both the debates about H.R. 5116 and the evaluation of P.L. 110-69, critics have raised concerns about appropriations. Some critics argue these measures are fiscally unsustainable in the current economic and budgetary environment. Supporters contend existing weaknesses in STEM education and federal research in the physical sciences and engineering threaten the fundamental underpinnings of the economy and therefore justify national investment even in an era of fiscal constraint.


Date of Report: June 17, 2010
Number of Pages: 17
Order Number: R41231
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CRS Issue Statement on Privacy and Data Security

Gina Stevens, Coordinator
Legislative Attorney

Issues likely to be of concern to Congress include online behavioral advertising, financial privacy, health information technology and privacy, social security number privacy, and data mining. Data security issues of possible interest to lawmakers are data breach notification requirements, customer access to and amendment of records, enhanced enforcement authority for the Federal Trade Commission and state attorneys general, and preemption of state data breach laws. 

Privacy 

Online Behavioral Advertising. The monitoring of consumers' web activity for marketing purposes will likely continue to be an important privacy issue in the 111th Congress. Technology has been developed which enables online advertisements to be targeted directly at individual users based on their web activities. This practice is widely known as online "behavioral" advertising. Gathering personally identifiable information about an individual's web activities without consent has raised privacy concerns. Some have alleged that online behavioral targeting by advertisers is a violation of certain privacy laws, such as the Electronic Communications Privacy Act and provisions within the Communications Act of 1934. There are no current federal regulations specific to online behavioral advertising. The Federal Trade Commission (FTC) has put forth guiding principles for industry self-regulation. Meanwhile, privacy advocates have called for government regulation in order to protect consumer privacy. Organizations such as the Network Advertising Initiative have created privacy policies for online advertising providers that represent industry best practices. Members have expressed interest in legislative action. Among the issues that might emerge for online behavioral advertising are: If legislation is enacted to require consent and disclosure of online behavioral advertising practices, what will the disclosure look like? How will consent be obtained? Will there be classifications of data that may be collected, and, if so, will there be different methods of obtaining consent for the collection of the different classes of data? How long may data be maintained? It is expected that the 111th Congress will address these issues through oversight and legislative proposals. 

Financial Privacy. With modern technology's ability to gather and retain data, financial services businesses have increasingly found ways to take advantage of their large reservoirs of customer information. Not only can they serve their customers better by tailoring services and communications to customer preferences, but they can profit from sharing that information with others willing to pay for customer lists or targeted marketing compilations. Although some consumers are pleased with the wider access to information about available services that information sharing among financial services providers offers, others have raised privacy concerns, particularly with respect to secondary usage. 

Title V of the Gramm-Leach-Bliley Act of 1999 (GLBA) (P.L. 106-102) covers financial institutions. Banks, thrifts, securities firms, insurance companies, credit unions and other providers of financial services are subject to the Gramm-Leach-Bliley Act's (GLBA) privacy regime covering disclosures of nonpublic personal information to third parties and standards for safeguarding such information. Subject to certain exceptions, it prohibits them from sharing nonpublic personally identifiable customer information with non-affiliated third parties without providing an opportunity to opt out and mandates various privacy policy notices. It requires financial institutions to safeguard the security and confidentiality of customer information. Among the issues that might emerge are: If general data breach bills are enacted, will entities subject to GLBA rules be given a safe harbor? Will additional enforcement tools, such as a private right of action or enforcement by states' attorneys general, be added to the GLBA regime? 

Will there be statutory requirements for financial institutions to include in outsourcing contracts? It is expected that in the 111th Congress there will be legislative proposals to enhance the protection offered personal financial information. 

Consolidation in one regulator of federal financial consumer protection authority—including rulemaking and enforcement authority over GLBA's privacy provisions—is a component of several 111th Congress bills. 

Health Information Technology. Electronic health records are controversial among many privacy advocates and citizens, who are concerned about information security and the potential for the exploitation of personal medical information by hackers, companies, or the government, and the sharing of health information without the patients' knowledge. The American Recovery and reinvestment Act of 2009 (P.L. 111-5) incorporated the Health Information Technology for Economic and Clinical Health (HITECH) Act. The HITECH Act, based on legislation introduced in the 110th Congress, is intended to promote the widespread adoption of health information technology (HIT) for the electronic sharing of clinical data among hospitals, physicians, and other health care stakeholders. First, it codifies the Office of the National Coordinator for Health Information Technology (ONCHIT) within the Department of Health and Human Services (HHS). Second, the HITECH Act provides financial incentives for HIT use among health care practitioners. Finally, the HITECH Act includes a series of privacy and security provisions that amend and expand the current HIPAA requirements. Among other things, the HITECH Act extends application of the HIPAA Privacy and Security Rules to the business associates of health care entities, establishes a new federal data breach law for health information, and includes new tools for enforcement of the HIPAA Privacy and Security Rules. 

In light of the fact the Congress has recently passed legislation to promote widespread adoption of HIT and use of electronic health records, congressional attention during the 111th Congress is likely to be focused on oversight activities. 

Social Security Number Privacy. The privacy of a person's social security number is of significant concern to individuals both for security of personal information and for preventing identity theft. A patchwork of federal laws limits compulsory divulgence of social security numbers (SSNs)by federal, state, and local governmental entities. Private sector use of the social security number is, however, widespread and continues to be largely unregulated by the federal government. Recently Congress has sought to further limit uses of the social security number, and is likely to continue to examine such measures, including proposals to remove social security numbers from Medicare cards, and to limit or prohibit the sale or purchase of SSNs. 

Data Mining. Data mining technologies and related analysis programs can be used by government agencies to sift through information held in public and private databases; to find patterns and associations connected to terrorist threats and activities, such as money transfers and communications; and to identify and track terrorists, such as through travel and immigration records. As data mining technology advances in the quantity and scope of data that can be analyzed, and as data mining efforts by federal agencies continue to expand, concerns over individual privacy will likely be raised. Congressional oversight of such data mining programs may examine whether the programs maintain the information in a manner that insures privacy and protects against its loss and against inappropriate use or disclosure. Other considerations include access to commercial databases by government agencies and the retention of such data by the government, whether data is being used for purposes other than those for which it was originally collected, and the application of the Privacy Act of 1974 to these data mining initiatives. 

Data Security 

In the absence of a comprehensive federal data breach notification law, many states enacted laws requiring notice of security breaches of personal data. The majority of states have passed bills to require entities to notify persons affected by breaches involving their personal information, and in some cases, to implement information security programs to protect the security, confidentiality, and integrity of data. A few states have reportedly introduced bills designed to strengthen merchant security and/or hold companies liable for third party companies' costs arising from data breaches. In response to these laws, numerous data breaches and computer intrusions have been disclosed by the nation's largest data brokers, retailers, educational institutions, government agencies, health care entities, financial institutions, and Internet businesses. A data breach occurs when there is a loss or theft of, or other unauthorized access to, data containing sensitive personal information that results in the potential compromise of the confidentiality or integrity of data. Sensitive personal information generally includes an individual's name, address, or telephone number, in conjunction with the individual's social security number, driver's license number, account number, credit or debit card number, or a personal identification number or password. 

Concerns about possible identity theft and financial crimes (e.g., credit card fraud, phone or utilities fraud, bank fraud, mortgage fraud, employment-related fraud, government documents or benefits fraud, loan fraud, and health-care fraud) resulting from such breaches are widespread. According to the Federal Trade Commission, identity theft is the most common complaint from consumers in all 50 states. Identity theft involves the misuse of any identifying information to commit a violation of federal or state law. 

These public disclosures have heightened interest in the security of sensitive personal information; security of computer systems; applicability of existing federal laws to the protection of sensitive personal information; adequacy of enforcement tools available to law enforcement officials and federal regulators; regulation of data brokers; liability of retailers, credit card issuers, payment processors, banks, and furnishers of credit reports for costs arising from data breaches; remedies available to individuals whose personal information was accessed without authorization; prosecution of identity theft crimes related to data breaches; and criminal liability of persons responsible for unauthorized access to computer systems. 

Congress continues to consider the creation of a legal framework to respond to improper disclosures of personally identifiable information; and whether to require covered entities to implement information security plans. Key areas of attention involve data breach notification requirements; safe harbors for entities regulated under federal privacy laws; customer access to and amendment of records; creation of a private right of action; the right to place a credit freeze or fraud alert on one's credit report; restrictions on the sale and use of social security numbers; enhanced enforcement authority for the Federal Trade Commission and state attorneys general; and preemption of state data breach laws. 

Computer Security 

Cybercrimes. With the proliferation of potential uses and abuses of the Internet, the crime of Internet harassment presents challenges for law enforcement, legislators, educators, and parents. These challenges are exacerbated by a lack of uniformity in defining the terms cyberharassment and cyberbullying. In addition, jurisdictional limits and the anonymity of the Internet sometimes make it difficult for law enforcement personnel to identify, locate, arrest, and prosecute alleged offenders. As Internet harassment may cause its victims emotional harm as opposed to physical harm, legislators must determine what level, if any, of harassment should be criminalized.


Date of Report: June 9, 2010
Number of Pages: 5
Order Number:IS40366
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Spectrum Policy in the Age of Broadband: Issues for Congress

Linda K. Moore
Specialist in Telecommunications Policy

The convergence of wireless telecommunications technology with the Internet Protocol (IP) is fostering new generations of mobile technologies. This transformation has created new demands for advanced communications infrastructure and radio frequency spectrum capacity that can support high-speed, content-rich uses. Furthermore, a number of services, in addition to consumer and business communications, rely at least in part on wireless links to broadband backbones. Wireless technologies support public safety communications, sensors, smart grids, medicine and public health, intelligent transportation systems, and many other vital communications. 

Existing policies for allocating and assigning spectrum rights may not be sufficient to meet the future needs of wireless broadband. A challenge for Congress is to provide decisive policies in an environment where there are many choices but little consensus. In formulating spectrum policy, mainstream viewpoints generally diverge on whether to give priority to market economics or social goals. Regarding access to spectrum, economic policy looks to harness market forces to allocate spectrum efficiently, with spectrum license auctions as the driver. Social policy favors ensuring wireless access to support a variety of social objectives where economic return is not easily quantified, such as improving education, health services, and public safety. Both approaches can stimulate economic growth and job creation. 

Deciding what weight to give to specific goals and setting priorities to meet those goals pose difficult tasks for federal administrators and regulators and for Congress. Meaningful oversight or legislation may require making choices about what goals will best serve the public interest. Relying on market forces to make those decisions may be the most efficient and effective way to serve the public but, to achieve this, policy makers may need to broaden the concept of what constitutes competition in wireless markets. 

The National Broadband Plan (NBP), a report on broadband policy mandated by Congress, has provided descriptions of perceived issues to be addressed by a combination of regulatory changes and the development of new policies at the Federal Communications Commission, with recommendations for legislative actions that Congress might take. 

Among the spectrum policy initiatives that have been proposed in Congress in recent years are: allocating more spectrum for unlicensed use; auctioning airwaves currently allocated for federal use; and devising new fees on spectrum use, notably those collected by the FCC's statutory authority to implement these measures is limited. The NBP reiterates these proposals and adds several more. 

Substantive modifications in spectrum policy would almost surely require congressional action. The Radio Spectrum Inventory Act introduced in the Senate (S. 649, Kerry) and the similar House-introduced Radio Spectrum Inventory Act (H.R. 3125, Waxman) would require an inventory of existing users on prime radio frequencies, a preliminary step in evaluating policy changes. The Spectrum Relocation and Improvement Act of 2009 (H.R. 3019, Inslee) would amend the Commercial Spectrum Enhancement Act of 2004 (P.L. 108-494, Title II). The Broadband for First Responders Act (H.R. 5081, King) would allocate additional radio frequencies for public safety use.


Date of Report: June 9, 2010
Number of Pages: 36
Order Number: R40674
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Critical Infrastructures: Background, Policy, and Implementation

John D. Moteff
Specialist in Science and Technology Policy

The nation's health, wealth, and security rely on the production and distribution of certain goods and services. The array of physical assets, functions, and systems across which these goods and services move are called critical infrastructures (e.g., electricity, the power plants that generate it, and the electric grid upon which it is distributed).

The national security community has been concerned for some time about the vulnerability of critical infrastructure to both physical and cyber attack. In May 1998, President Clinton released Presidential Decision Directive No. 63. The Directive set up groups within the federal government to develop and implement plans that would protect government-operated infrastructures and called for a dialogue between government and the private sector to develop a National Infrastructure Assurance Plan that would protect all of the nation's critical infrastructures by the year 2003. While the Directive called for both physical and cyber protection from both man-made and natural events, implementation focused on cyber protection against man-made cyber events (i.e., computer hackers). However, given the physical damage caused by the September 11 attacks, physical protection of critical infrastructures has received increased attention.

Following the events of September 11, the Bush Administration released Executive Order 13228, signed October 8, 2001, establishing the Office of Homeland Security and the Homeland Security Council. In November 2002, Congress passed legislation creating a Department of Homeland Security. Among its responsibilities is overall coordination of critical infrastructure protection activities. In December 2003, the Bush Administration released Homeland Security Presidential Directive 7, reiterating and expanding upon infrastructure protection policy and responsibilities. In June 2006, the Bush Administration released a National Infrastructure Protection Plan. This Plan presents the process by which the Department of Homeland Security intends to identify those specific assets most critical to the United States, across all sectors, based on the risk associated with their loss to attack or natural disaster, and then to prioritize activities aimed at maximizing the reduction of those risks for a given investment.

This report discusses in more detail the evolution of a national critical infrastructure policy and the institutional structures established to implement it. The report highlights five issues of Congressional concern: identifying critical assets; assessing vulnerabilities and risks; allocating resources; information sharing; and regulation.


Date of Report: June 7, 2010
Number of Pages: 42
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Nanotechnology: A Policy Primer

John F. Sargent Jr.
Specialist in Science and Technology Policy

Nanoscale science, engineering and technology—commonly referred to collectively as nanotechnology—is believed by many to offer extraordinary economic and societal benefits. Congress has demonstrated continuing support for nanotechnology and has directed its attention primarily to three topics that may affect the realization of this hoped for potential: federal research and development (R&D) in nanotechnology; U.S. competitiveness; and environmental, health, and safety (EHS) concerns. This report provides an overview of these topics—which are discussed in more detail in other CRS reports—and two others: nanomanufacturing and public understanding of and attitudes toward nanotechnology.

The development of this emerging field has been fostered by significant and sustained public investments in nanotechnology R&D. Nanotechnology R&D is directed toward the understanding and control of matter at dimensions of roughly 1 to 100 nanometers. At this size, the properties of matter can differ in fundamental and potentially useful ways from the properties of individual atoms and molecules and of bulk matter. Since the launch of the National Nanotechnology Initiative (NNI) in 2000 through FY2010, Congress has appropriated approximately $12.4 billion for nanotechnology R&D. In addition, the President requested an additional $1.8 billion in funding for nanotechnology R&D for FY2011. More than 60 nations have established similar programs. In 2006 alone, total global public R&D investments reached an estimated $6.4 billion, complemented by an estimated private sector investment of $6.0 billion. Data on economic outputs used to assess competitiveness in mature technologies and industries, such as revenues and market share, are not available for assessing nanotechnology. Alternatively, data on inputs (e.g., R&D expenditures) and non-financial outputs (e.g., scientific papers, patents) may provide insight into the current U.S. position and serve as bellwethers of future competitiveness. By these criteria, the United States appears to be the overall global leader in nanotechnology, though some believe the U.S. lead may not be as large as it was for previous emerging technologies.

Some research has raised concerns about the safety of nanoscale materials. There is general agreement that more information on EHS implications is needed to protect the public and the environment; to assess and manage risks; and to create a regulatory environment that fosters prudent investment in nanotechnology-related innovation. Nanomanufacturing—the bridge between nanoscience and nanotechnology products—may require the development of new technologies, tools, instruments, measurement science, and standards to enable safe, effective, and affordable commercial-scale production of nanotechnology products. Public understanding and attitudes may also affect the environment for R&D, regulation, and market acceptance of products incorporating nanotechnology.

In 2003, Congress enacted the 21st Century Nanotechnology Research and Development Act providing a legislative foundation for some of the activities of the NNI, addressing concerns, establishing programs, assigning agency responsibilities, and setting authorization levels. Legislation has been introduced in the House (H.R. 554) and Senate (S. 1482) that would amend the act. The House passed H.R. 554 on February 11, 2009; the Senate has not acted on this legislation. On May 7, 2010, the House Committee on Science and Technology reported the America COMPETES Reauthorization Act of 2010 (H.R. 5116) which includes, as Title I, Subtitle A, the National Nanotechnology Initiative Amendments Act of 2010. Provisions of this subtitle are nearly identical to the provisions of H.R. 554. On May 13, the House voted to recommit the bill to committee with instructions. Subsequently, the bill was pulled from consideration at the request of the chairman of the House Committee on Science and Technology.


Date of Report: June 2, 2010
Number of Pages: 16
Order Number: RL34511
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Spectrum Policy in the Age of Broadband: Issues for Congress

Linda K. Moore
Specialist in Telecommunications Policy

The convergence of wireless telecommunications technology with the Internet Protocol (IP) is fostering new generations of mobile technologies. This transformation has created new demands for advanced communications infrastructure and radio frequency spectrum capacity that can support high-speed, content-rich uses. Furthermore, a number of services, in addition to consumer and business communications, rely at least in part on wireless links to broadband backbones. Wireless technologies support public safety communications, sensors, smart grids, medicine and public health, intelligent transportation systems, and many other vital communications.

Existing policies for allocating and assigning spectrum rights may not be sufficient to meet the future needs of wireless broadband. A challenge for Congress is to provide decisive policies in an environment where there are many choices but little consensus. In formulating spectrum policy, mainstream viewpoints generally diverge on whether to give priority to market economics or social goals. Regarding access to spectrum, economic policy looks to harness market forces to allocate spectrum efficiently, with spectrum license auctions as the driver. Social policy favors ensuring wireless access to support a variety of social objectives where economic return is not easily quantified, such as improving education, health services, and public safety. Both approaches can stimulate economic growth and job creation.

Deciding what weight to give to specific goals and setting priorities to meet those goals pose difficult tasks for federal administrators and regulators and for Congress. Meaningful oversight or legislation may require making choices about what goals will best serve the public interest. Relying on market forces to make those decisions may be the most efficient and effective way to serve the public but, to achieve this, policy makers may need to broaden the concept of what constitutes competition in wireless markets.

The National Broadband Plan (NBP), a report on broadband policy mandated by Congress, has provided descriptions of perceived issues to be addressed by a combination of regulatory changes and the development of new policies at the Federal Communications Commission, with recommendations for legislative actions that Congress might take.

Among the spectrum policy initiatives that have been proposed in Congress in recent years are: allocating more spectrum for unlicensed use; auctioning airwaves currently allocated for federal use; and devising new fees on spectrum use, notably those collected by the FCC's statutory authority to implement these measures is limited. The NBP reiterates these proposals and adds several more.

Substantive modifications in spectrum policy would almost surely require congressional action. The Radio Spectrum Inventory Act introduced in the Senate (S. 649, Kerry) and the similar House-introduced Radio Spectrum Inventory Act (H.R. 3125, Waxman) would require an inventory of existing users on prime radio frequencies, a preliminary step in evaluating policy changes. The Spectrum Relocation and Improvement Act of 2009 (H.R. 3019, Inslee) would amend the Commercial Spectrum Enhancement Act of 2004 (P.L. 108-494, Title II). The Broadband for First Responders Act (H.R. 5081, King) would allocate additional radio frequencies for public safety use. .


Date of Report: June 3, 2010
Number of Pages: 35
Order Number: R40674
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Manufacturing Extension Partnership Program: An Overview

Wendy H. Schacht
Specialist in Science and Technology Policy

The Hollings Manufacturing Partnership (MEP) is a program of regional centers that assist smaller, U.S.-based manufacturing companies in identifying and adopting new technologies. Operating under the auspices of the National Institute of Standards and Technology (NIST), centers in all 50 states and Puerto Rico provide technical and managerial assistance to firms. Federal funding is matched by non-federal sources. Existing resources in government, business, and academia are leveraged while the program endeavors to build on current state and local activities and industrial extension efforts. 

The MEP program has, at times, been included in the discussion surrounding termination of government programs that provide direct federal support for industry. Questions have been raised in congressional debate as to the appropriateness of government funding for this program when the technologies are available in the marketplace. Instead of the government picking "winners and losers," opponents argue, the marketplace should make decisions regarding firms worthy of investment. However, proponents of the program stress that no direct funding is available to companies through MEP and that assistance is technical, scientific, and/or managerial. The centers facilitate the adoption of new technologies that foster competition and promote innovation. As the 111th Congress continues to make budget decisions, support for manufacturing extension may be discussed in the context of the role of the federal government in facilitating research and technological advancement. .


Date of Report: June 2, 2010
Number of Pages: 10
Order Number: 97-104
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The Advanced Spectroscopic Portal Program: Background and Issues for Congress

Dana A. Shea
Specialist in Science and Technology Policy

John D. Moteff
Specialist in Science and Technology Policy

Daniel Morgan
Specialist in Science and Technology Policy

The Domestic Nuclear Detection Office (DNDO) of the Department of Homeland Security (DHS) is charged with developing and procuring equipment to prevent a terrorist nuclear or radiological attack in the United States. At the forefront of DNDO's efforts are technologies currently deployed and under development whose purpose is to detect smuggled nuclear and radiological materials. These technologies include existing radiation portal monitors and next generation replacements known as advanced spectroscopic portals (ASPs).

Customs and Border Protection officers use radiation portal monitors to detect radiation emitted from conveyances, such as trucks, entering the United States. When combined with additional equipment to identify the source of the emitted radiation, they provide a detection and identification capability to locate smuggled nuclear and radiological materials. The ASPs currently under testing integrate these detection and identification steps into a single process. By doing this, DHS aims to reduce the impact of radiation screening on commerce while increasing its ability to detect illicit nuclear material.

The speed of ASP development and deployment, the readiness of ASP technology, and the potential benefits of the ASP program relative to its cost have all been topics of extensive congressional interest. Congress has held oversight hearings on the ASP program since 2006. Additionally, since FY2007, Congress has each year required that the Secretary of Homeland Security certify that ASPs will result in a "significant increase in operational effectiveness" before DHS can obligate appropriated funds for full-scale ASP procurement. The DNDO asserts that the secretarial certification and the full-scale production decision will be made separately. Secretarial certification is still pending.

Laboratory and field tests of the ASPs, cost-benefit analyses, and other activities are under way to inform the Secretary's certification decision. Among the issues Congress faces are whether to further define the expected performance of the ASP systems through additional legislation; how to assess whether the ASP systems are technologically ready to be deployed; how to weigh the potential economic and security benefits of ASP deployment against its financial cost; and whether the certification process developed by DHS to establish a "significant increase in operational effectiveness" is well founded.


Date of Report: May 21, 2010
Number of Pages: 21
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Staffing for Adequate Fire and Emergency Response: The SAFER Grant Program

Lennard G. Kruger
Specialist in Science and Technology Policy

In response to concerns over the adequacy of firefighter staffing, the Staffing for Adequate Fire and Emergency Response Act—popularly called the "SAFER Act"—was enacted by the 108th Congress as Section 1057 of the FY2004 National Defense Authorization Act (P.L. 108-136). The SAFER Act authorizes grants to career, volunteer, and combination local fire departments for the purpose of increasing the number of firefighters to help communities meet industry-minimum standards and attain 24-hour staffing to provide adequate protection from fire and fire-related hazards. Also authorized are grants to volunteer fire departments for activities related to the recruitment and retention of volunteers. The SAFER grant program is authorized through FY2010.

With the economic turndown adversely affecting budgets of local governments, concerns have arisen that modifications to the SAFER statute may be necessary to enable fire departments to more effectively participate in the program. The American Recovery and Reinvestment Act of 2009 (P.L. 111-5) included a provision (section 603) that waives the matching requirements for SAFER grants awarded in FY2009 and FY2010. The FY2009 Supplemental Appropriations Act (P.L. 111-32) included a provision authorizing the Secretary of Homeland Security to waive further limitations and restrictions in the SAFER statute for FY2009 and FY2010.

P.L. 111-83, the FY2010 Department of Homeland Security appropriations bill, provided $420 million for SAFER, double the amount appropriated in FY2009. The Administration's FY2011 budget proposed $305 million for SAFER, a 27% decrease from the FY2010 level. The FY2011 budget proposal for SAFER could receive heightened interest, given high rates of unemployment and the local budgetary cutbacks that many fire departments are now facing. Meanwhile, on May 26, 2010, the House Appropriations Committee released a summary of draft legislation for its version of the FY2010 Supplemental Appropriations bill. Title III of the draft legislation would provide $500 million in additional FY2010 funding for SAFER.

Concerns over local fire departments' budgetary problems have also framed debate over the SAFER reauthorization, which is included in H.R. 3791, the Fire Grants Reauthorization Act of 2009, passed by the House on November 18, 2009. On April 27, 2010, S. 3267, the Fire Grants Reauthorization Act of 2010, was introduced and referred to the Senate Committee on Homeland Security and Governmental Affairs. On April 28, the Committee ordered S. 3267 to be reported with an amendment favorably. Congress is considering whether some SAFER rules and restrictions governing the hiring grants should be permanently eliminated or altered in order to make it economically feasible for more fire departments to participate in the program.


Date of Report: June 4, 2010
Number of Pages: 13
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A Federal Chief Technology Officer in the Obama Administration: Options and Issues for Consideration

John F. Sargent Jr.
Specialist in Science and Technology Policy

In November 2007, Senator Barack Obama announced his intention, if elected president, to appoint a federal chief technology officer (CTO). He also identified several specific areas of responsibility of the CTO including transparency of government operations, computer and network security (sometimes referred to as cybersecurity), identification and adoption of best technologies and practices by federal agencies, and interoperability of emergency communications technologies for first responders.

On April 18, 2009, President Obama appointed Virginia Secretary of Technology Aneesh P. Chopra to serve in the newly created position of federal chief technology officer. In announcing the appointment, the president indicated that Mr. Chopra would undertake roles beyond what might be considered traditional CTO responsibilities. As the president described them, these roles include promoting technological innovation to help the United States create jobs, reduce health care costs, protect the homeland, and address other national goals. Mr. Chopra serves as assistant to the president and chief technology officer, as well as associate director for technology in the White House Office of Science and Technology Policy. Under a provision of Executive Order 13500, issued on February 5, 2009, he also serves as a member of the White House Domestic Policy Council in his capacity as assistant to the president and CTO.

The CTO may face a variety of challenges in executing the mission envisioned by the President. Among the early challenges will be negotiating domains of responsibilities within the White House and with executive branch agencies that have overlapping missions. Some commentators have expressed concerns about the impact the creation of a CTO might have on existing offices and agencies with respect to the allocation and coordination of authorities and responsibilities. Other commentators have asserted that a high-level CTO could serve as an advocate for technological innovation and foster increased knowledge sharing among federal agencies to more effectively implement information technology solutions to meet disparate mission requirements. Mr. Chopra's appointment as both CTO and associate director for technology at OSTP may address, in part, questions related to mission alignment, coordination, and integration. Since assuming his dual roles, Mr. Chopra has publicly engaged in discussions covering a wide range of technology policy-related areas, including research and development, innovation, open government, government performance, education, science and engineering workforce, health care information technology, broadband, patent reform, and net neutrality.

Congress faces President Obama's appointment of Mr. Chopra and the president's stated plans for the federal CTO. There is currently no formal position description for the CTO. Accordingly, the official duties of the CTO remain largely undefined. Congress may elect to provide a statutory foundation for the CTO, define the roles and authorities of the CTO, authorize and appropriate funds, provide for oversight, and address other aspects of the position.


Date of Report: June 4, 2010
Number of Pages: 19
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How the Satellite Television Extension and Localism Act (STELA) Updates Copyright and Carriage Rules for the Retransmission of Broadcast Television Signals

Charles B. Goldfarb
Specialist in Telecommunications Policy

The Satellite Television Extension and Localism Act of 2010 (STELA), P.L. 111-175, modifies the copyright and carriage rules for satellite and cable retransmission of broadcast television signals. The legislation was needed to reauthorize (through December 31, 2014) certain expiring provisions in the Copyright Act and the Communications Act and to update the language in those acts to reflect the transition from analog to digital transmission of broadcast signals, as well as to address certain public policy issues. Had the expiring provisions not been reauthorized, satellite operators would have lost access to a statutory compulsory copyright license and to statutory relief from retransmission consent requirements. This would have made it difficult, if not impossible, for them to retransmit certain distant broadcast signals to their subscribers, including signals providing otherwise unavailable broadcast network programming.

The Copyright Act and Communications Act distinguish between the retransmission of local signals—the broadcast signals of stations located in the same local market as the subscriber—and distant signals. Statutory provisions block or restrict the retransmission of many distant broadcast signals in order to foster local programming. These provisions typically take the form of defining which households are "served" or "unserved" by local broadcasters, with unserved households eligible to receive distant signals. But there are many grandfather clauses and other exceptions built into the rules that allow households to receive otherwise proscribed distant signals. STELA generally retains, and in some cases expands upon, these grandfathered and exceptional cases.

STELA provides broadcasters two new incentives to use their digital technology to broadcast multiple video streams (to "multicast"). It clarifies that royalty fees are payable to copyright owners of the materials on non-primary digital voice streams as well as primary streams, thus encouraging broadcasters (who often hold some of those copyrights) to expand their multicasting. STELA specifically gives broadcasters the incentive to undertake such multicasting to offer otherwise unprovided network programming in so-called "short markets"—markets that do not have network affiliates for all four major networks. It does this by defining households that can receive the programming of a particular network from the non-primary multicast video stream of a local broadcaster as being served, rather than unserved, with respect to that network, thus prohibiting satellite operators from retransmitting to those households distant signals that carry that network's programming. The local broadcaster can then seek retransmission consent payments from satellite operators. Several other provisions in STELA also are intended to reduce the number of short markets or increase the flow of distant network signals into short markets.

Today, satellite operators are allowed, but not required, to offer subscribers the signals of the broadcast stations in their local market. The satellite operators have chosen not to offer this "local-into-local" service in many small markets, preferring to use their satellite capacity to provide additional high definition and other programming to larger, more lucrative markets. The costs associated with providing local-into-local service in small markets may exceed the revenues. STELA provides DISH Network, which currently is subject to a permanent court injunction that in effect prohibits it from retransmitting to its subscribers the signals of distant broadcast stations, the opportunity to have that injunction waived if it provides local-into-local service in all 210 local markets in the United States, which it began doing on June 3, 2010.

STELA does not address the issue of "orphan counties"—counties located in one state that are assigned to a local market, as defined by the Nielsen Media Research designated market areas, for which the principal city and most or all of the local broadcast stations are in another state.


Date of Report: June 4, 2010
Number of Pages: 26
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P.L. 111-148: Intellectual Property Provisions for Follow-On Biologics

Wendy H. Schacht
Specialist in Science and Technology Policy

John R. Thomas
Visiting Scholar

Congressional interest in the biotechnology industry parallels congressional attention to the availability of lower-cost pharmaceuticals. The market for biologic drugs is expanding by a number of measures including the quantity of approved products, the size of the market, and the importance of these pharmaceuticals to the health of U.S. citizens. Concurrently, patents on many biologics are expected to expire in the next few years. Some commentators have expressed concerns that patent expirations may not be accompanied by the introduction of competing, lower-cost follow-on drugs (also known as biosimilars) in the marketplace.

Biologics differ from traditional pharmaceuticals in their complexity and mode of manufacture. Typical pharmaceutical products consist of small molecules, on the order of dozens of atoms, that may be readily characterized and reproduced through well-understood chemical processes. In contrast, biologics are often made up of millions of atoms, feature a more intricate structure than traditional pharmaceuticals, and are manufactured from living cells through biological processes.

An expedited approval process and a patent dispute resolution procedure for traditional, small molecule pharmaceuticals was created by the Drug Price Competition and Patent Term Restoration Act of 1984, a statute commonly known as the "Hatch-Waxman Act." This law, which amended the Federal Food, Drug, and Cosmetic Act, is widely believed to have encouraged the availability of generic substitutes for many brand-name pharmaceuticals upon patent expiration. However, because biologics are typically approved under the Public Health Service Act, these mechanisms were not available for most follow-on biotechnology products.

The Patient Protection and Affordable Care Act, P.L. 111-148, offers several provisions designed to encourage innovation in biotechnology while creating an accelerated approval process for a biosimilar drug. The legislation also permits limited market exclusivity for the first follow-on biologic to be designated "interchangeable" with the reference product. At the same time, the innovator biologic is afforded a 12-year data exclusivity period during which time the Food and Drug Administration will not approve a follow-on biopharmaceutical. In addition, the legislation establishes a specialized patent dispute resolution proceeding for biologic drugs.

Some experts maintain that the intellectual property provisions of P.L. 111-148 will foster both the development of new biotechnology products and the availability of lower-cost follow-on biologics. Other commentators argue that the need for additional safety and efficacy trials to test these products, and the fact that these drugs may be similar, but not identical, may add to the prices charged for the follow-on product. High manufacturing costs associated with biopharmaceuticals also may reduce significant cost savings from biosimilars.


Date of Report:: May 25, 2010
Number of Pages: 9
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Federal Research and Development Funding: FY2011

John F. Sargent Jr., Coordinator
Specialist in Science and Technology Policy

President Obama has requested $147.696 billion for research and development (R&D) in FY2011, a $343 million (0.2%) increase from the estimated FY2010 R&D funding level of $147.353 million. Congress will play a central role in defining the nation's R&D priorities, especially with respect to two overarching issues: the extent to which the federal R&D investment can grow in the context of increased pressure on discretionary spending and how available funding will be prioritized and allocated. Low or negative growth in the overall R&D investment may require movement of resources across disciplines, programs, or agencies to address priorities. This report will be updated as Congress acts on appropriations bills that include funding for research, development and related funding.

Under the President's request, six federal agencies would receive 94.8% of total federal R&D spending: the Department of Defense (52.5%), Department of Health and Human Services (largely the National Institutes of Health) (21.8%), National Aeronautics and Space Administration (7.4%), Department of Energy (7.6%), National Science Foundation (3.8%), and Department of Agriculture (1.7%). NASA would receive the largest dollar increase for R&D of any agency, $1.700 billion (18.3%) above its FY2010 funding level. The Department of Defense would receive the largest reduction in R&D funding, $3.542 billion (4.4%) below its FY2010 level.

The President's FY2011 request includes: $31.341 billion for basic research, up $1.339 billion (4.5%) from FY2010; $30.276 billion for applied research, up $1.949 billion (6.9%); $81.455 billion for development, down $2.918 billion (3.5%); and $4.624 billion for R&D facilities and equipment, down $27 million (0.6%). The FY2011 request includes funding for three multiagency R&D initiatives: the National Nanotechnology Initiative, $1.776 billion, down $5 million (0.3%); the Networking and Information Technology R&D program, $4.281 billion, down $9 million (0.2%); and the U.S. Global Change Research Program, $2.561 billion, up $439 million (20.7%).

President Obama has requested increases in the R&D budgets of the three agencies that were targeted for doubling in the America COMPETES Act (over seven years) and by President Bush under his American Competitiveness Initiative (over ten years) as measured using FY2006 R&D funding as the baseline. Under President Obama's FY2011 budget, the Department of Energy's Office of Science would receive an increase of $226 million (4.6%), the National Science Foundation's budget would rise by $551 million (8.0%), and funding for the National Institute of Standards and Technology's core research and facilities would grow by $48 million (7.3%).

For the past four years, federal R&D funding and execution has been affected by mechanisms used to complete the annual appropriations process—the year-long continuing resolution for FY2007 (P.L. 110-5) and the combining of multiple regular appropriations bills into the Consolidated Appropriations Act, 2008 for FY2008 (P.L. 110-161), the Omnibus Appropriations Act, 2009 (P.L. 111-8), and the Consolidated Appropriations Act, 2010 (P.L. 111-117). Completion of appropriations after the beginning of each fiscal year may cause agencies to delay or cancel some planned R&D and equipment acquisition. .


Date of Report: June 3, 2010
Number of Pages: 51
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Deferred Examination of Patent Applications: Implications for Innovation Policy

John R. Thomas
Visiting Scholar

Recent congressional interest in the patent system has in part focused upon the capabilities of the U.S. Patent and Trademark Office (USPTO). Many experts have expressed concern that the USPTO lacks the capacity to process the large number of patent applications that it receives. The USPTO's growing inventory of filed, but unexamined applications could potentially lead to longer delays in the USPTO patent-granting process. 

Under current law, a USPTO examiner automatically reviews each patent application that is filed. Some observers have suggested that the USPTO instead adopt a system of "deferred examination" in order to alleviate its growing backlog. Under this system, the USPTO would not automatically review each application. Applicants would instead be required to submit a specific request for examination. Failure to file such a request within a specified time period—typically ranging from three to five years—would result in the abandonment of the application. 

Deferred examination may hold potential benefits. For example, some inventors who file a patent application may subsequently decide ultimately not to expend further resources in obtaining a patent on that technology due to marketplace developments or other reasons. The USPTO then does not need to review those applications, allowing others to move through the agency more quickly. Deferred examination may be particularly suitable for enterprises that sell products, including pharmaceuticals and medical devices, that may have a long development cycle and be subject to regulatory approval. Proponents of deferred examination observe that numerous foreign patent offices have used this system for many years. They further explain that given increasingly lengthy delays, the USPTO effectively operates under a de facto deferral regime today. 

On the other hand, some experts believe that deferred examination holds negative consequences. Deferred examination may cause many years to pass between the time an application was filed and the date a patent issues. Other firms may not know for some time whether their new products will infringe a patent that resulted from deferred examination. It is also possible that applicants could use the system strategically. They may choose to defer examination, monitor the industry, and then amend their applications in order to obtain patents that cover the successful products of their competitors. Opponents of deferred examination are also skeptical that a significant number of applications will "drop out" of the USPTO if this system were adopted. They also explain that the USPTO currently allows applicants to delay prosecution for up to three years, but that this procedure is rarely used. 

Designers of a deferred examination system may potentially manipulate a number of parameters in an attempt to maximize potential benefits while minimizing perceived disadvantages. Among these parameters are the maximum length of the deferral period, the ability of third parties to request examination of a deferred application, the framing of the system as an "opt-in" or "optout" procedure for applicants, pre-grant publication of deferred applications, the fee structure, the impact of deferred examination upon patent term, and the availability of third party "intervening rights" for patents that issue from deferred applications. Options for implementing deferred examination include both legislation and USPTO rulemaking.


Date of Report: May 27, 2010
Number of Pages: 17
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Nanotechnology: A Policy Primer

John F. Sargent Jr.
Specialist in Science and Technology Policy

Nanoscale science, engineering and technology—commonly referred to collectively as nanotechnology—is believed by many to offer extraordinary economic and societal benefits. Congress has demonstrated continuing support for nanotechnology and has directed its attention primarily to three topics that may affect the realization of this hoped for potential: federal research and development (R&D) in nanotechnology; U.S. competitiveness; and environmental, health, and safety (EHS) concerns. This report provides an overview of these topics—which are discussed in more detail in other CRS reports—and two others: nanomanufacturing and public understanding of and attitudes toward nanotechnology.

The development of this emerging field has been fostered by significant and sustained public investments in nanotechnology R&D. Nanotechnology R&D is directed toward the understanding and control of matter at dimensions of roughly 1 to 100 nanometers. At this size, the properties of matter can differ in fundamental and potentially useful ways from the properties of individual atoms and molecules and of bulk matter. Since the launch of the National Nanotechnology Initiative (NNI) in 2000 through FY2010, Congress has appropriated approximately $12.4 billion for nanotechnology R&D. In addition, the President requested an additional $1.8 billion in funding for nanotechnology R&D for FY2011. More than 60 nations have established similar programs. In 2006 alone, total global public R&D investments reached an estimated $6.4 billion, complemented by an estimated private sector investment of $6.0 billion. Data on economic outputs used to assess competitiveness in mature technologies and industries, such as revenues and market share, are not available for assessing nanotechnology. Alternatively, data on inputs (e.g., R&D expenditures) and non-financial outputs (e.g. scientific papers, patents) may provide insight into the current U.S. position and serve as bellwethers of future competitiveness. By these criteria, the United States appears to be the overall global leader in nanotechnology, though some believe the U.S. lead may not be as large as it was for previous emerging technologies.

Some research has raised concerns about the safety of nanoscale materials. There is general agreement that more information on EHS implications is needed to protect the public and the environment; to assess and manage risks; and to create a regulatory environment that fosters prudent investment in nanotechnology-related innovation. Nanomanufacturing—the bridge between nanoscience and nanotechnology products—may require the development of new technologies, tools, instruments, measurement science, and standards to enable safe, effective, and affordable commercial-scale production of nanotechnology products. Public understanding and attitudes may also affect the environment for R&D, regulation, and market acceptance of products incorporating nanotechnology.

In 2003, Congress enacted the 21st Century Nanotechnology Research and Development Act providing a legislative foundation for some of the activities of the NNI, addressing concerns, establishing programs, assigning agency responsibilities, and setting authorization levels. Legislation has been introduced in the House (H.R. 554) and Senate (S. 1482) that would amend the act. The House passed H.R. 554 on February 11, 2009; the Senate has not acted on this legislation. On May 7, 2010, the House Committee on Science and Technology reported the America COMPETES Reauthorization Act of 2010 (H.R. 5116) which includes, as Title I, Subtitle A, the National Nanotechnology Initiative Amendments Act of 2010. Provisions of this subtitle are nearly identical to the provisions of H.R. 554. On May 13, the House voted to recommit the bill to committee with instructions. Subsequently, the bill was pulled from consideration at the request of the chairman of the House Committee on Science and Technology


Date of Report: May 18, 2010
Number of Pages: 16
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