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 Collection: Congressional Research Service Reports
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Follow-On Biologics: Intellectual Property and Innovation Issues

Follow-On Biologics: Intellectual Property and Innovation Issues

Date: October 31, 2008
Creator: Schacht, Wendy H. & Thomas, John R.
Description: This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.
Contributing Partner: UNT Libraries Government Documents Department
Intellectual Property Rights Violations: Federal Civil Remedies and Criminal Penalties Related to Copyrights, Trademarks, and Patents

Intellectual Property Rights Violations: Federal Civil Remedies and Criminal Penalties Related to Copyrights, Trademarks, and Patents

Date: October 31, 2008
Creator: Yeh, Brian T.
Description: This report provides information describing the federal civil remedies and criminal penalties that may be available as a consequence of violations of the federal intellectual property laws: the Copyright Act of 1976, the Patent Act of 1952, and the Trademark Act of 1946 (conventionally known as the Lanham Act).
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Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation

Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation

Date: November 4, 2008
Creator: Thomas, John R.
Description: This report introduces and analyzes innovation policy issues concerning pharmaceutical patent litigation settlements, including pharmaceutical patent litigation procedures under the Hatch-Waxman Act, the concept of reverse payment settlements, the status of reverse payment settlements under the antitrust laws, and congressional issues and alternatives.
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The Special Inspector General for the Troubled Asset Relief Program (SIG TARP)

The Special Inspector General for the Troubled Asset Relief Program (SIG TARP)

Date: November 5, 2008
Creator: Burrows, Vanessa K.
Description: This report discusses the Special Inspector General provisions in the Emergency Economic Stabilization Act of 2008, H.R. 1424, which was enacted as P.L. 110-343 on October 3, 2008. This Act created a Special Inspector General (SIG) for the Troubled Asset Relief Program (TARP). This report will compare the duties and authorities of the SIG TARP to those of the Special Inspector General for Iraq Reconstruction (SIGIR) and the Special Inspector General for Afghanistan Reconstruction (SIGAR), as well as statutory IGs under the Inspector General Act of 1978, as amended (IG Act).
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Climate Change Legislation in the 110th Congress

Climate Change Legislation in the 110th Congress

Date: November 7, 2008
Creator: Ramseur, Jonathan L. & Yacobucci, Brent D.
Description: This report briefly discusses the basic concepts on which climate change bills are based, and compares major provisions of the bills in each of the following categories: climate change research; emissions reduction technologies; U.S. actions pursuant to international emission reduction agreements; adaptation to the effects of climate change; GHG reporting and registration; and GHG emissions reduction programs.
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"Fast Track" Parliamentary Procedures of the Emergency Economic Stabilization Act

"Fast Track" Parliamentary Procedures of the Emergency Economic Stabilization Act

Date: November 14, 2008
Creator: Davis, Christopher M.
Description: The Emergency Economic Stabilization Act of 2008 (Division A of H.R. 1424, P.L. 110-343) empowers the Secretary of the Treasury to purchase certain "troubled assets" as a means to stabilize the economy. This report examines this procedure and explains how it differs from the regular parliamentary mechanisms of the House and Senate.
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Border Searches of Laptop Computers and Other Electronic Storage Devices

Border Searches of Laptop Computers and Other Electronic Storage Devices

Date: November 17, 2008
Creator: Kim, Yule & Henning, Anna C.
Description: This report discusses a developing issue in the law of search and seizure: whether the Fourth Amendment of the U.S. Constitution permits warrantless searches of the content of laptop computers and other electronic storage devices at U.S. borders. The federal courts that have addressed this issue have held that the border search exception to the Fourth Amendment applies to these searches, making warrantless searches permissible.
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Ocean Dumping Act: A Summary of the Law

Ocean Dumping Act: A Summary of the Law

Date: November 17, 2008
Creator: Copeland, Claudia
Description: The Marine Protection, Research, and Sanctuaries Act of 1972 (MPRSA, P.L. 92-532) has two basic aims: to regulate intentional ocean disposal of materials, and to authorize related research. This report presents a summary of the law, describing the essence of the statute.
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Water Infrastructure Projects Designated in EPA Appropriations: Trends and Policy Implications

Water Infrastructure Projects Designated in EPA Appropriations: Trends and Policy Implications

Date: November 17, 2008
Creator: Copeland, Claudia
Description: This report discusses appropriations for Environmental Protection Agency (EPA) water infrastructure programs, focusing on congressional special project designations in the account that funds these programs. While some Members of Congress, interest groups, and Administration officials are critical of these types of congressional actions, there is little indication that the practice will cease. Information on the programmatic history of EPA involvement in assisting wastewater treatment and drinking water projects also is provided in two appendixes.
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The Constitutionality of Campaign Finance Regulation: Buckley v. Valeo and Its Supreme Court Progeny

The Constitutionality of Campaign Finance Regulation: Buckley v. Valeo and Its Supreme Court Progeny

Date: November 18, 2008
Creator: Whitaker, L. Paige
Description: This report first discusses the key holdings enunciated by the Supreme Court in Buckley, including those upholding reasonable contribution limits, striking down expenditure limits, upholding disclosure reporting requirements, and upholding the system of voluntary presidential election expenditure limitations linked with public financing. It then examines the Court's extension of Buckley in several subsequent cases, evaluating them in various regulatory contexts: contribution limits, expenditure limits, disclosure requirements, and political party soft money and electioneering communication restrictions.
Contributing Partner: UNT Libraries Government Documents Department
Water Rights Related to Oil Shale Development in the Upper Colorado River Basin

Water Rights Related to Oil Shale Development in the Upper Colorado River Basin

Date: November 18, 2008
Creator: Brougher, Cynthia
Description: Concerns over fluctuating oil prices and declining petroleum production worldwide have revived interest in oil shale as a potential resource. The Energy Policy Act of 2005 (P.L. 109-58) identified oil shale as a strategically important domestic resource and directed the Department of the Interior to promote commercial development. Oil shale development would require significant amounts of water, however, and water supply in the Colorado River Basin, where several oil shale reserves are located, is limited. This report will provide a brief overview of water rights in Colorado, Utah, and Wyoming, including changes that may be made to currently held water rights and the possibility for abandonment of unused water rights.
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Emergency Communications: The Future of 911

Emergency Communications: The Future of 911

Date: November 21, 2008
Creator: Moore, Linda K.
Description: Today's 911 system is built on an infrastructure of analog technology that does not support many of the features that most Americans expect are part of an emergency response. Recognizing the importance of providing effective 911 service, Congress has passed three major bills supporting improvements in the handling of 911 emergency calls. This report includes a detailed overview of the 911 system, as well as related legislation and policies currently in consideration by Congress.
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Climate Change and the EU Emissions Trading Scheme (ETS): Kyoto and Beyond

Climate Change and the EU Emissions Trading Scheme (ETS): Kyoto and Beyond

Date: November 24, 2008
Creator: Parker, Larry
Description: This report discusses the development in global warming as a global issue. Topics include issues that have arisen regarding the ETS and considerations for cap-and-trade.
Contributing Partner: UNT Libraries Government Documents Department
The World Bank's Clean Technology Fund (CTF)

The World Bank's Clean Technology Fund (CTF)

Date: November 24, 2008
Creator: Weiss, Martin A. & Logan, Jeffrey
Description: The United States Treasury has led efforts to create a $10 billion Clean Technology Fund (CTF), located at the World Bank, to help fund deployment of clean technology to reduce greenhouse gas emissions in developing economies. The Bush administration has asked Congress to authorize and appropriate U.S. funding of $2 billion over three years (FY2009 to FY2011). While many Members of Congress have expressed support for the CTF, others have raised concerns, primarily with respect to whether the CTF should finance carbon-based energy projects. To date, Congress has not passed legislation authorizing or appropriating U.S. contributions to the Fund.
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Compulsory DNA Collection: A Fourth Amendment Analysis

Compulsory DNA Collection: A Fourth Amendment Analysis

Date: November 26, 2008
Creator: Henning, Anna C.
Description: This report examines compulsory DNA collection by law enforcement and its implications in regards to 4th amendment protections by examining legal precedents and considering the contemporary scientific understanding of DNA.
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Medicaid Regulatory Issues

Medicaid Regulatory Issues

Date: November 26, 2008
Creator: Herz, Elicia J. & Burrows, Vanessa K.
Description: This report provides a summary of seven proposed and final rules affecting the Medicaid program that were issued by the Bush Administration during 2007 and 2008. Six of the seven rules are currently under a congressional moratorium on further administrative action until April 1, 2009. A description of possible administrative and legislative actions to modify these rules, which could be taken by the next administration or the 111th Congress, is also provided.
Contributing Partner: UNT Libraries Government Documents Department
The President-Elect: Succession and Disability Issues During the Transition Period

The President-Elect: Succession and Disability Issues During the Transition Period

Date: November 26, 2008
Creator: Neale, Thomas H.
Description: Procedures governing replacement of a President or Vice President-elect during the transition period depend on when the events that might lead to a temporary or permanent replacement occur. This report describes the general election process by which American voters directly choose members of the electoral college and indirectly choose the President and Vice President. This report also describes the so-called "lame duck" period between the election and the incoming President's inauguration, specifically regarding questions of disability or resignation by a President or Vice President-elect during this time.
Contributing Partner: UNT Libraries Government Documents Department
FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

FDA’s Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective

Date: December 2, 2008
Creator: Thaul, Susan
Description: The Food and Drug Administration (FDA) has approved for adult use many drugs never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults probably reasonably transfers to younger patients. The data show that this is not always true. To encourage industry to develop drugs and medical devices for pediatric use, Congress has established three programs. The Food and Drug Administration Amendments Act of 2007 (FDAAA, P.L. 110-85) reauthorized and strengthened two laws addressing drugs—the Best Pharmaceuticals for Children Act (BPCA) of 2002 and the Pediatric Research Equity Act (PREA) of 2003—and enacted a new law addressing devices—the Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007. The historical approach of this report allows an understanding of how and why Congress took these steps.
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Ocean Piracy and Its Impact on Insurance

Ocean Piracy and Its Impact on Insurance

Date: December 3, 2008
Creator: King, Rawle O.
Description: This report examines the issue of piracy off the coast of East Africa in the Indian Ocean and the Gulf of Aden. The report looks into the impact of such piracy on the insurance industry and explains the available options for Congress to mitigate piracy's negative effects on the industry.
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Immigration Legislation and Issues in the 110th Congress

Immigration Legislation and Issues in the 110th Congress

Date: December 10, 2008
Creator: Bruno, Andorra
Description: This report discusses immigration-related issues that have seen legislative action or are of significant congressional interest.
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Brief Summaries of Federal Animal Protection Statutes

Brief Summaries of Federal Animal Protection Statutes

Date: December 18, 2008
Creator: Cohen, Henry
Description: This report contains summaries of federal animal protection statutes, listed alphabetically. It does not include treaties, although it does include statutes enacted to implement treaties. It includes statutes concerning animals that are not entirely, or not at all, animal protection statutes. For example, it includes a statute authorizing the eradication of predators, because one of the statute's purposes is to protect domestic and "game" animals; and it includes statutes to conserve fish, although their ultimate purpose may not be for the fishes' benefit. It also includes statutes that allow the disabled to use service animals, and even includes statutes aimed at acts of animal rights advocates (the Animal Enterprise Protection Act of 1992, and the Recreational Hunting Safety and Preservation Act of 1994).
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Food Safety on the Farm: Federal Programs and Selected Proposals

Food Safety on the Farm: Federal Programs and Selected Proposals

Date: December 19, 2008
Creator: Becker, Geoffrey S.
Description: This report discusses bills introduced into the 110th Congress pertaining to food safety that could affect farmers and ranchers. Several of these bills would expressly have required enforceable on-farm safety standards. Others that focused primarily on post-harvest food safety measures nonetheless might have led to changes in on-farm practices if the regulated sectors (handlers and processors of agricultural products) placed new demands on their suppliers in order to comply. Similar proposals are re-emerging in the 111th Congress, where food safety reform is expected to be on the agenda.
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A Low Carbon Fuel Standard: State and Federal Legislation and Regulations

A Low Carbon Fuel Standard: State and Federal Legislation and Regulations

Date: December 23, 2008
Creator: Yacobucci, Brent D.
Description: This report analyzes the draft California standards, and discusses how those standards might work. Next, the report analyzes federal Low Carbon Fuel Standard (LCFS) legislation proposed in the 110th Congress. Finally, the report analyzes what effects an LCFS might have on state and national fuel supplies.
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A U.S.-centric Chronology of the International Climate Change Negotiations

A U.S.-centric Chronology of the International Climate Change Negotiations

Date: December 23, 2008
Creator: Leggett, Jane A.
Description: This document provides a U.S.-centric chronology of the international policy negotiations to address climate change. It covers the United Nations Framework Convention on Climate Change in 1992, the Kyoto Protocol in 1997, the Marrakesh Accords of 2001, and the Bali Action Plan of 2007 that mandates the current negotiations toward a new agreement by the end of 2009 on commitments for the period beyond 2012. Today's negotiations under the Bali Action Plan focus on four elements: mitigation of greenhouse gas emissions; adaptation to impacts of climate change; financial assistance to low income countries; and technology development and transfer. For U.S. legislators, important issues include the compatibility of any international agreement with U.S. domestic policies and laws; the adequacy of appropriations, fiscal measures and programs to achieve any commitments under the agreement; and the desirable form of the agreement and related requirements for potential Senate ratification and federal implementing legislation.
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