Source: http://science-technology-telecommunications.blogspot.com/2012_02_01_archive.html
Timestamp: 2014-10-02 00:17:51
Document Index: 525228877

Matched Legal Cases: ['§603', '§271', '§271', '§271', '§271', '§271']

Science - Technology - Telecommunications: February 2012
The fire grant program is now in its 12th year. The Fire Act statute was reauthorized in 2004 (Title XXXVI of P.L. 108-375) and provides overall guidelines on how fire grant money should be distributed. There is no set geographical formula for the distribution of fire grants—fire departments throughout the nation apply, and award decisions are made by a peer panel based on the merits of the application and the needs of the community. However, the law does require that fire grants be distributed to a diverse mix of fire departments, with respect to type of department (paid, volunteer, or combination), geographic location, and type of community served (e.g., urban, suburban, or rural).
For FY2012, P.L. 112-74, the Consolidated Appropriations Act provided $675 million for firefighter assistance, including $337.5 million for AFG and $337.5 million for SAFER. The Administration’s FY2013 budget proposed $670 million for firefighter assistance, including $335 million for AFG and $335 million for SAFER.
On June 22, 2011, H.R. 2269, the Fire Grants Reauthorization Act of 2011, was introduced into the 112th Congress. H.R. 2269 is virtually identical to House legislation that was passed in the 111th Congress.
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 recruitment and retention of volunteers.
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 (§603) that waived 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.
The Department of Defense and Continuing Appropriations Act, 2011 (P.L. 112-10) funded SAFER at $405 million. The law also contained language that removes cost-share requirements and allows SAFER grants to be used to rehire laid-off firefighters and fill positions eliminated through attrition. However, P.L. 112-10 did not remove the requirement that SAFER grants fund a firefighter position for four years, with the fifth year funded wholly by the grant recipient. The law also did not waive the cap of $100,000 per firefighter hired by a SAFER grant.
The Administration’s FY2012 budget proposed $670 million for firefighter assistance, including $420 million for SAFER, which according to the FY2012 budget proposal, would fund 2,200 firefighter positions. P.L. 112-74, the Consolidated Appropriations Act, FY2012 provided $337.5 million for SAFER, and included language permitting FY2012 grants to be used to rehire laid-off firefighters and fill positions eliminated through attrition, as well as removing other SAFER restrictions and limitations. P.L. 112-74 also reinstated waiver authority for the restrictions that were not lifted in the FY2011 appropriations act (P.L. 112-10).
The Administration’s FY2013 budget proposed $670 million for firefighter assistance, including $335 million for SAFER and $335 million for AFG.. The Administration requested that all previous SAFER waivers again be enacted for FY2013.
Concern over local fire departments’ budgetary problems has framed debate over the SAFER reauthorization, which is included in S. 550/H.R. 2269, the Fire Grants Authorization Act of 2011. Previously in the 111th Congress, reauthorization legislation for SAFER was passed by the House, but was not passed by the Senate. As part of the reauthorization debate, Congress may consider whether some SAFER rules and restrictions governing the hiring grants should be eliminated or altered in order to make it economically feasible for more fire departments to participate in the program.
Lennard G. Kruger Specialist in Science and Technology Policy The U.S. Fire Administration (USFA)—which includes the National Fire Academy (NFA)—is currently housed within the Federal Emergency Management Agency (FEMA) of the Department of Homeland Security (DHS). The objective of the USFA is to significantly reduce the nation’s loss of life from fire, while also achieving a reduction in property loss and non-fatal injury due to fire. The United States Fire Administration Reauthorization Act of 2008 was signed into law on October 8, 2008 (P.L. 110-376).
The current authorization of the USFA expires on September 30, 2012. Thus, an issue during the second session of the 112th Congress could be the possible reauthorization of the USFA. Meanwhile, as is the case with many federal programs, concerns in the 112th Congress over the federal budget deficit could impact budget levels for the USFA. Debate over the USFA budget has focused on whether the USFA is receiving an appropriate level of funding to accomplish its mission, given that appropriations for USFA have consistently been well below the agency’s authorized level. An ongoing issue is the viability and status of the USFA and National Fire Academy within the Department of Homeland Security.
John R. Thomas Visiting Scholar Concerns over the availability of affordable health care has focused national attention upon patents and other intellectual property rights awarded to pharmaceutical firms. Bills before the 112th Congress propose amendments to the Hatch-Waxman Act, legislation dating from 1984 that governs intellectual property rights in pharmaceuticals and other regulated products. Recent rulings from the federal judiciary regarding the Hatch-Waxman Act may be pertinent to congressional consideration of that statute. Both the judicial holdings, as well as possible legislative changes to the Hatch-Waxman Act, potentially affect the availability of both brandname and generic drugs in the United States.
The Hatch-Waxman Act includes two core provisions that impact the enforcement of patent rights by brand-name firms against generic pharmaceutical companies. 35 U.S.C. §271(e)(1) creates a statutory “safe harbor” that exempts firms from claims of patent infringement based on clinical trials and other acts reasonably related to seeking marketing approval from the Food and Drug Administration (FDA). Although the explicit wording of that statute does not preclude activities that occur after the receipt of FDA marketing approval from the “safe harbor,” the courts have recently held that this infringement exemption applies only to pre-approval activities.
A second provision, 35 U.S.C. §271(e)(2), allows a brand-name drug company to enforce its patents against a potential generic competitor at such time that the generic firm files an application—a so-called Abbreviated New Drug Application (ANDA)—with the FDA seeking marketing approval. Although courts have stated that this litigation may only be based upon patents identified to the FDA and listed in the so-called “Orange Book,” the express wording of the statute does not appear to impose this requirement. This issue has yet to be conclusively resolved in the courts.
Should Congress conclude that the current situation with respect to 35 U.S.C. §271(e) is satisfactory, no action need be taken. If Congress wishes to intervene, however, then some options present themselves. Congress could stipulate whether 35 U.S.C. §271(e)(1) applies to acts that occur following the award of FDA marketing approval or not. Congress could also explicitly state whether 35 U.S.C. §271(e)(2) establishes a cause of action for infringement of patents that have not been listed in the Orange Book.
Date of Report: February 9, 2012
Order Number: R42354
Lennard G. Kruger Specialist in Science and Technology Policy The Internet is often described as a “network of networks” because it is not a single physical entity, but hundreds of thousands of interconnected networks linking hundreds of millions of computers around the world. As such, the Internet is international, decentralized, and comprised of networks and infrastructure largely owned and operated by private sector entities. As the Internet grows and becomes more pervasive in all aspects of modern society, the question of how it should be governed becomes more pressing.
Currently, an important aspect of the Internet is governed by a private sector, international organization called the Internet Corporation for Assigned Names and Numbers (ICANN), which manages and oversees some of the critical technical underpinnings of the Internet such as the domain name system and Internet Protocol (IP) addressing. ICANN makes its policy decisions using a multistakeholder model of governance, whereby a “bottom-up” collaborative process is open to all constituencies of Internet stakeholders.
National governments have recognized an increasing stake in ICANN policy decisions, especially in cases where Internet policy intersects with national laws addressing such issues as intellectual property, privacy, law enforcement, and cybersecurity. Some governments around the world are advocating increased intergovernmental influence over the way the Internet is governed. For example, specific proposals have been advanced that would create an Internet governance entity within the United Nations (U.N.). Other governments (including the United States), as well as many other Internet stakeholders, oppose these proposals and argue that ICANN’s multistakeholder model, while not perfect and needing improvement, is the most appropriate way to govern the Internet.
Currently, the U.S. government, through the National Telecommunications and Information Administration (NTIA) at the Department of Commerce, enjoys a unique influence over ICANN, largely by virtue of its legacy relationship with the Internet and the domain name system. A key issue for Congress is whether and how the U.S. government should continue to maximize U.S. influence over ICANN’s multistakeholder Internet governance process, while at the same time effectively resisting proposals for an increased role by international governmental institutions such as the U.N.
The outcome of this debate will likely have a significant impact on how other aspects of the Internet may be governed in the future, especially in such areas as intellectual property, privacy, law enforcement, Internet free speech, and cybersecurity. Looking forward, the institutional nature of Internet governance could have far reaching implications on important policy decisions that will likely shape the future evolution of the Internet.
Order Number: R42351