Urging Japan to honor its commitments under the 1986 Market-Oriented Sector-Selective (MOSS) Agreement on Medical Equipment and Pharmaceuticals, and for other purposes.

S. Con Res. 80, H Con Res. 324: Legislation urging Japan to honor its commitments under the 1986 Market-Oriented Sector-Selective (MOSS) Agreement on Medical Equipment and Pharmaceuticals, and for other purposes. Removal of trade barriers impacting U.S. medical technology companies in Japan. PL 108-175: “Syria Accountability and Lebanese Sovereignty Restoration Act of 2003” Legislation to halt Syrian support for terrorism, end its occupation of Lebanon, stop its development of weapons of mass destruction, cease its illegal importation of Iraqi oil and illegal shipments of weapons and other military items to Iraq, and by so doing hold Syria accountable for the serious international security problems it has caused in the Middle East, and for other purposes. Provisions on access to medical technology. S. 2312: “SAFE-ID Act” Legislation to regulate the transmission of personally identifiable information to foreign affiliates and subcontractors. S. 2471: “Safeguarding Americans From Exporting Identification Data Act” Legislation to regulate the transmission of personally identifiable information to foreign affiliates and subcontractors. S. 2472: “Increasing Notice of Foreign Outsourcing Act” Legislation to require that notices to consumers of health and financial services include information on the outsourcing of sensitive personal information abroad, to require relevant Federal agencies to prescribe regulations to ensure the privacy and security of sensitive personal information outsourced abroad, to establish requirements for foreign call centers, and for other purposes. S. AMDT 2918: Amendment on outsourcing of health and financial information and building privacy protections for such data. H.R. 4366: “Personal Data Off-Shoring Protection Act of 2004” Legislation to prohibit the transfer of personal information to any person outside the United States, without notice and consent, and for other purposes.

Client expense: Not reported · Firm income: $80,000

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

S. Con Res. 80, H Con Res. 324: Legislation urging Japan to honor its commitments under the 1986 Market-Oriented Sector-Selective (MOSS) Agreement on Medical Equipment and Pharmaceuticals, and for other purposes. Removal of trade barriers impacting U.S. medical technology companies in Japan. PL 108-175: “Syria Accountability and Lebanese Sovereignty Restoration Act of 2003” Legislation to halt Syrian support for terrorism, end its occupation of Lebanon, stop its development of weapons of mass destruction, cease its illegal importation of Iraqi oil and illegal shipments of weapons and other military items to Iraq, and by so doing hold Syria accountable for the serious international security problems it has caused in the Middle East, and for other purposes. Provisions on access to medical technology. S. 2312: “SAFE-ID Act” Legislation to regulate the transmission of personally identifiable information to foreign affiliates and subcontractors. S. 2471: “Safeguarding Americans From Exporting Identification Data Act” Legislation to regulate the transmission of personally identifiable information to foreign affiliates and subcontractors. S. 2472: “Increasing Notice of Foreign Outsourcing Act” Legislation to require that notices to consumers of health and financial services include information on the outsourcing of sensitive personal information abroad, to require relevant Federal agencies to prescribe regulations to ensure the privacy and security of sensitive personal information outsourced abroad, to establish requirements for foreign call centers, and for other purposes. S. AMDT 2918: Amendment on outsourcing of health and financial information and building privacy protections for such data. H.R. 4366: “Personal Data Off-Shoring Protection Act of 2004” Legislation to prohibit the transfer of personal information to any person outside the United States, without notice and consent, and for other purposes.

Client expense: Not reported · Firm income: $80,000

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)

Pl-107-250-Medical Device User Fee and Modernization Act of 2002. (Bill that became the law to finance faster FDA reviews of new medical devices and to make improvements in the regulation of medical devices.) H.R.3493/S.1881-Medical Devices Technical Corrections Act. (Bills to make technical corrections relating to the amendments made by the Medical Device User Fee and Modernizatoin Act of 2002.) S.15/H.R.2122-Project BioShield Act of 2003. S.754-Improved Vaccine Affordability and Availability Act. (Bills to enhance, research, development, procurement, and use of biomedical countermeasures to respond to public health threats affecting national security.) S.877-Patient Safety Improvement Act of 2003. H.R. 663/S.720-Patient Safety and Quality Improvement Act. S. 1775/H.R. 3038-Healthcare Safety Net Amendments Technical Corrections Act of 2003. (Bills intended to provide for the improvement of patient safety and to reduce the incidence of medical errors that adversely affect patient safety.) H.R.5-Help Efficient, Accessible, Low-Cost, Timely Healthcare (HEALTH) Act of 2003. S.11-Patients First Act of 2003. (Bills to improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system.) H.R.3140 (PL 108-164)/H.R.2221-Fairness to Contact Lens Consumers Act. H.R.2218/S.1747-To Amend Food and Drug, and Cosmetic Act to Provide for the regulation of all contact lenses as medical devices, and for other purposes. (Bills to regulate all contact lenses as medical devices.) S. Con. Res.80/H. Con. Res. 324-Concurrent resolution urging Japan to honor its commitments under the 1986 Market-Oriented Sector-Selective (MOSS) Agreeement on Medical Equipment and Pharmaceuticals, and for other purposes. (Bills providing that the revolution in medical technology has improved our ability to respond to emerging threats and prevent, identify, treat, and cure a broad range of diseases and disabilities, and has the proven potential to bring even more valuable advances in the future.) H.R.1828-Syria Accountability and Lebanese Sovereignty Restoration Act of 2003. (Section of the bill related to lifting sanctions against export of medical devices as related to Syria and Lebanon.) H.R.1561-United States Patent and Trademark Fee Modernizaton Act of 2003. (The bill to lower patent filing and basic national fees as related to medical devices.)

Client expense: $2,440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office