Pediatric Medical Device Safety and Improvement Act of 2006

S.4098, A bill to improve the process for the development of needed pediatric medical devices, all provisions. P.L.109-43, Implementation of Medical Device User Fee Stabilization Act of 2005, all provisions. Issues related to regulatory pathways for clinical laboratory tests. Issues related to FDA oversight and regulation of the reprocessed single-use medical devices. Issues related to mitigation of healthcare infections. Issues related to re-authorization of MDUFMA. S.3822, A bill to improve access to and appropriate utilization of valid, reliable and accurate molecular genetic tests by all populations thus helping to secure the promise of personalized medicine for all Americans, all provisions.

Client expense: $610,861 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE

HR 5115-U.S Healthcare Technologies Competitiveness Act of 2006 (Bill to modernize the tax treatment as related to medical devices and biomedical research corporations) HR 4388-Tax Revision Act of 2005 (Bills to amend the Internal Revenue Code of 1986 to extend certain expiring provisions) HR 4297-Tax Relief Extension Reconciliation Act of 2005 (Bill to extend credit for increasing research activities) HR 4845-Innovation and Competitiveness Act HR 1736/S 627-Investment in America Act of 2005 (Bills to make permanent the tax credit for increasing research activities) S 978-Healthcare Tax Relief for the Uninsured Act of 2005 HR 1872-Health Coverage for the Uninsured Act of 2005 (Bills to provide tax incentives for the purchase of quality health care, and for other purposes) HR 5-Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2005 (Bill to provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system) HR 6406-The Tax Relief and Health Care Act of 2006 (Bill to improve temporarily certain rates of duty and make other technical amendments to the trade laws, and to extend certain trade preference programs) S Cong Res 67/H Cong Res 311-Concurrent resolution urging Japan to honor its commitments under the 1986 Market-Oriented Sector-Selective (MOSS) Agreement on Medical Equipment and for other purposes (Bill to reduce regulatory barriers to the approval and adoption of new medical technologies) S 2467-United States Trade Enhancement Act of 2006 (Congressional resolutions on trade enforcement efforts as relates to trade with China) S 295-To authorize appropriate action if the negotiations with the People’s Republic of China’s undervalued currency are not successful) (Bill to impose an additional duty of 27.5% on Chinese imports) HR 3004-Currency Harmonization Initiative through Neutralizing Action Act of 2005 (Bill to impose additional tariffs on Chinese imports on the basis of the rate of manipulation by that country of the rate of exchange between the Chinese currency and the U.S dollar) HR 3283/S 1421-United States Trade Rights Enforcement Act (Bills to enhance resources to enforce U.S trade rights) HR 4157-Health Information Technology Promotion Act of 2005 (Bill to provide for establishment of uniform confidentiality and security standards with respect to individually identifiable patient health information) S 1355-Better Healthcare Through Information Technology Act S 1418-Wired for Health Care Quality Act (Bills to enhance the adoption of health information technology and to improve the quality and reduce the cost of healthcare in the United States) S 1952-Critical Access to Health Information Technology Act of 2005 (Bill to provide for grants to states to increase access to health care in rural areas by improving health information technology) S 1223-Information Technology for Health Care Quality and Improvement Act (Bill to improve the quality and efficiency of health care delivery through improvements in health care information technology) S 1262-Health Technology to Enhance Quality Act of 2005 (Bill to reduce healthcare costs, improve efficiency and healthcare quality through the development of a nation-wide interoperable health information technology system) S 2480-Contact Lens Consumer Protection Act (Bill to amend the Fairness to Contact Lens Consumers Act with respect to the availability of contact lenses) HR 6111-Tax Relief and Health Care Act of 2006 (President Bush signed into Public Law # 109-432 on 12/20/2006) HR 5975-Prescription Drug Comparative Effectiveness Act of 2006 (Bill to require the Agency for Healthcare Research and Quality, in consultation with NIH Director, to conduct research to develop valid scientific evidence regarding clinical effectiveness, outcomes, and appropriateness as relates to medical devices and procedures and for other purposes) S 4098-Pediatric Medical Devices and Safety Improvement Act of 2006 (Bill to improve the process for development of needed pediatric medical devices) S 3778-Small Business Reauthorization and Improvements Act of 2006 HR 5352-Small Business Reauthorization Act of 2006 (Bills to reauthorize programs to assist small business concerns) S 1263-Save America’s Biotechnology Innovative Research Act of 2005 HR 2943-Save Biotechnology Innovative Research Act of 2005 (Bills to establish eligibility requirements for business concerns to receive awards under the Small Business Innovative Research program) S 3678-Pandemic and All Hazards Preparedness Act (Bill with respect to public health security and all-hazards preparedness and response, and for other purposes) HR2863-Division E – Public Readiness and Emergency Preparedness Act (Division E provisions of the bill as relates to targeted liability for pandemic and epidemic products and security countermeasures) S 2564/HR 5533-Biodefense and Pandemic Vaccine and Drug Development Act of 2006 S 1873-Biodefense and Pandemic Vaccine and Drug Development Act of 2005 (Bills to prepare and strengthen the development of countermeasures or pandemic or epidemic products against deliberate, accidental, and natural outbreaks of illness) S-1880-National Biodefense and Pandemic Preparedness Act of 2005 (Bill to enhance biodefense and pandemic preparedness activities) S 2792-Emergency Preparedness and Response Security, Accountability, and Flexibility Enhancement Act (SAFE Act) (Bill to revise provisions relating to bioterrorism and other public health emergencies preparedness grants including development of measurable critical benchmarks and performance standards) S 3-Protecting American in the War on Terror Act of 2005 (Bill sets provisions concerning bioterrorism preparedness and defense as pertaining to medical devices and for other purposes) S 975-The Project Bioshield II Act of 2005 (Bill to provide incentives to increase research by private sector entities to develop medial countermeasures to prevent, detect, identify, contain, and treat illnesses, including those associated with biological, chemical, nuclear, or radiological weapons attack or an infectious disease outbreak) S 22/S23-Malpractice Liability Reform Bill (a.k.a. Medical Care Access Protection Act of 2006, MCAP Act) (Bills setting forth provisions regulating lawsuits for health care liability claims related to the provision of health care services) HR 2090- Food and Drug Administration Improvement Act of 2005 (Bill related to FDA Advisory panels) S. 3807-Enhancing Drug Safety and Innovation Act of 2006 (Draft bill to improve oversight as related to drugs includes medical devices in some provisions)