SOUND Devices Act of 2012

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues generating antibiotic incentives. - HR 1282, "Generating Antibiotics Incentives Now Act of 2011", regarding all provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Access to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards. - HR 5937, "Breast Cancer Patient Education Act of 2012", regarding all provisions. - HR 5998, "USPSTF Transparency and Accountability Act of 2012", regarding all provisions. - S 3187, "Food and Drug Administration Safety and Innovation Act", regarding all provisions. - S 2516, "Food and Drug Administration Safety and Innovation Act", regarding all provisions.

Client expense: $1,420,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the FDA medical device regulatory system particularly to promote greater efficiency, transparency, and predictability, particularly through the 510(k) system. The following bills accomplish those goals: H.R. 3209 - Premarket Predicability Act H.R. 3203 - Novel Device Regulatory Relief Act H.R. 3230 - Keeping America Competitive through Harmonization Act H.R. 3205 - FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 - Humanitarian Device Reform Act H.R. 3208 - Patients Come First Act H.R. 3206 - Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 - Food and Drug Administration Mission Reform Act H.R. 3207 - Modernizing Laboratory Test Standards for Patients Act H.R. 3204 - Guidance Accountability and Transparency Act H.R. 3847 - Safety of Untested and New Devices Act of 2012 H.R. 3975 - A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056 - Science and Technology Regulatory Relief Act H.R. 5651 - Food and Drug Administration Reform Act 2012 S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - The Patient Access to Medical Innovation Act S. 1943 - Novel Device Regulatory Relief Act of 2011 S. 1972 - A bill to amend the Food and Drug Administration's mission S. 1995 - A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067 - Safe, Transparent, and Efficient Medical Device Act S. 2113 - A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193 - Ensuring Safe Medical Devices for Patients S. 3187 - A bill to amend the Federal Food, Drug, and Cosetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

H.R. 611, to foster transparency about the commercial use of personal information, provide consumers with meaningful choice about the collection, use, and disclosure of such information. H.R. 654, to direct the Federal Trade Commission to prescribe regulations regarding the collection and use of information obtained by tracking the Internet activity of an individual. H.R. 1528, to protect and enhance consumer privacy, and for other purposes; to Energy & Commerce. H.R. 1841, to protect consumers by requiring reasonable security policies and procedures to protect computerized data containing personal information, and to provide for nationwide notice in the event of a security breach; to Energy & Commerce. H.R. 1939, to provide the Consumer Product Safety Commission with greater authority and discretion in enforcing the consumer product safety laws, and for other purposes; to Energy & Commerce. H.R. 2132, to require the Food and Drug Administration to finalize a standard for broad-spectrum protection in sunscreen products, and for other purposes; to Energy & Commerce. H.R. 2359, to amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the safe use of cosmetics, and for other purposes; jointly to Energy & Commerce and Education & the Workforce. H.R. 2577, to protect consumers by requiring reasonable security policies and procedures to protect data containing personal information, and to provide for nationwide notice in the event of a security breach. H.R. 2715, to provide the Consumer Product Safety Commission with greater authority and discretion in enforcing the consumer product safety laws, and for other purposes. H.R. 3847, to amend the Federal Food, Drug, and Cosmetic Act to ensure that a medical device is not marketed based on a determination that the device is substantially equivalent to a predicate device that has been recalled, corrected, or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety. H.R. 4262, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of cosmetics; to Energy & Commerce. H.R. 4395, to amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient statements, and the reporting of serious and unexpected cosmetic product adverse events, and for other purposes; to Energy & Commerce. H.R. 6131, to extend the Undertaking Spam, Spyware, and Fraud Enforcement With Enforcers beyond Borders Act of 2006. S. 799, to establish a regulatory framework for the comprehensive protection of personal data for individuals under the aegis of the Federal Trade Commission, and for other purposes; to Commerce. S. 913, to require the Federal Trade Commission to prescribe regulations regarding the collection and use of personal information obtained by tracking the online activity of an individual, and for other purposes; to Commerce. S. 1064, to make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products, and for other purposes. S. 1151, to prevent and mitigate identity theft, to ensure privacy, to provide notice of security breaches, and to enhance criminal penalties, law enforcement assistance, and other protections against security breaches, fraudulent access, and misuse of personally identifiable information; to Judiciary. S. 1207, to protect consumers by requiring reasonable security policies and procedures to protect data containing personal information, and to provide for nationwide notice in the event of a security breach; to Commerce. S. 1408, to require federal agencies, and persons engaged in interstate commerce, in possession of data containing sensitive personally identifiable information, to disclose any breach of such information. S. 1434, to protect information relating to consumers, to require notice of security breaches, and for other purposes. S. 1535, to protect consumers by mitigating the vulnerability of personally identifiable information to theft through a security breach, providing notice and remedies to consumers in the wake of such a breach, holding companies accountable for preventable breaches, facilitating the sharing of post-breach technical information between companies, and enhancing criminal and civil penalties and other protections against the unauthorized collection or use of personally identifiable information, with an amendment in the nature of a substitute. S. 1652, to amend title 9 of the U.S. Code to prohibit mandatory arbitration clauses in contracts for mobile service. S. 3187, to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices. S. 3333, to require certain entities that collect and maintain personal information of individuals to secure such information and to provide notice to such individuals in the case of a breach of security involving such information, and for other purposes; to Commerce.

Issues related to the 510(k) process for medical devices. [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to diagnostics in the critical care setting. [Leah Kegler, Duane Wright] Issues related to the medical device user fee program [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S. 3187 Food and Drug Administration Safety and Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] S. 2516 Food and Drug Administration Safety and Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] H.R. 5651 Food and Drug Administration Reform Act of 2012 [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to diagnostics regulation [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] Issues related to the definition of durable for durable medical equipment [Duane Wright] HR 3209 Premarket Predictability Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3203 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3230 Keeping America Competitive Through Harmonization Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3205 FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3211 Humanitarian Device Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3208 Patients Come First Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3206 Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3214 Food and Drug Administration Mission Reform Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3207 Modernizing Laboratory Test Standards for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] HR 3204 Guidance Accountability and Transparency Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3847 Safety of Untested and New Devices Act of 2012 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3975 a bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 [Elizabeth Sharp, Elizabeth Kegler] HR 4056 Science and Technology Regulatory Relief Act [Elizabeth Sharp, Elizabeth Kegler] S 1700 Medical Device Regulatory Improvement Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1865 Patient Access to Medical Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1943 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1972 Food and Drug Administration Mission Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1995 Medical Device Patient Safety Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 2067 Safe, Transparent, and Efficient Medical Device Act [Elizabeth Sharp, Elizabeth Kegler] S 2113 A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that encourage innovative products to benefit patients and improve public health [Elizabeth Sharp] S 2193 Ensuring Safe Medical Devices for Patients [Elizabeth Sharp, Elizabeth Kegler] S 2292 PATIENTS' FDA Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S. 2289 Better Pharmaceuticals and Devices for Children Act of 2012 [Elizabeth Sharp]

Patient Protection and Affordable Health Care Act (P.L. 111-148) - provisions relating to the implementation of this Act including Accountable Care Organizations, Physician Payment Disclosure, Patient Centered Outcomes Research Institute (PCORI), and other issues H.R. 3211 - Humanitarian Device Reform Act of 2011 - provisions relating to improving of humanitarian device regulation and foster device development for rare diseases S. 1865 - Patient Access to Medical Innovation Act - provisions relating to improving humanitarian device regulation and foster device development for rare diseases H.R. 3209 - Premarket Predictability Act of 2011 - provisions relating to a new streamlined review of new devices, require reviewers to provide scientific or regulatory rationale for major decisions and establish an expedited approval appellate process, and the establishment of the two Investigational Device Exemption pathways H.R. 3203 - Novel Device Regulatory Relief Act of 2011 - provisions relating to the streamlining the de novo classification process by striking the requirement that an applicant submit a 510(k) application before entering the de novo process H.R. 3206 - Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 - provisions relating to the fixing of the FDA's conflict of interest policies to ensure the most knowledgeable experts are able to serve on FDA advisory committees H.R. 3847 - Safety of Untested and New Devices Act of 2012 - provisions relating to predicate nullification S. 2193 - Ensuring Safe Medical Devices for Patients - provisions relating to requiring the Food and Drug Administration to include devices in the postmarket risk identification and analysis system, to expedite the implementation of the unique device identification system for medical devices, and for other purposes S. 1995 - Medical Device Patient Safety Act - provisions relating to enhancing the Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes H.R. 3975 - Pediatric Medical Device Safety and Improvement Act - provisions relating to the continued availability of pediatric devices under the FDA humanitarian use device program. S. 2289 - The Better Pharmaceuticals and Devices Act for Children - provisions relating to the reauthorization of the Pediatric Device Consortia Initiative and to the continued availability of pediatric devices under the FDA humanitarian use device program. S. 3187 - Food and Drug Administration Reform Act of 2012, Public Law 112-144 - provisions relating to medical device user fees S. 2516 - Food and Drug Administration Safety and Innovation Act - provisions relating to medical device user fees H.R. 5651 - Food and Drug Administration Reform Act of 2012 - provisions relating to medical device user fees

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues generating antibiotic incentives. - HR 1282, "Generating Antibiotics Incentives Now Act of 2011", regarding all provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3209, "Premarket Predictability Act of 2011", regarding all provisions. - HR 3203/ S 1943, "Novel Device Regulatory Relief Act of 2011", regarding all provisions. - HR 3230, "Keeping America Competitive Through Harmonization Act of 2011", regarding all provisions. - HR 3211, "Humanitarian Device Reform Act of 2011", regarding all provisions. - HR 3208, "Patients Come First Act of 2011", regarding all provisions. - HR 3206, "Cultivating Scientific Expertise to Foster Inovation for Patients Act of 2011", regarding all provisions. - HR 3214/ S 1972, "Food and Drug Administration Mission Reform Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - HR 3204, "Guidance Accountability and Transparency Act of 2011", regarding all provisions. - HR 3205, "FDA Renewing Efficiency From Outside Reviewer Management Act of 2011", regarding all provisons. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Acess to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards.

Public Law No. 112-144, the "Food and Drug Administration Safety and Innovation Act," specifically those sections relating to the Medical Device User Fee program. Policy and implementation issues related to Public Law No. 111-148, the "Patiet Protection and Affordable Care Act," including Accountable Care Organizations, the Independent Payment Advisory Board, and comparative effectiveness research. H.R. 3209, Premarket Predictability Act. H.R. 3208, Patients Come First Act. H.R. 3214/S. 1972, Food and Drug Administration Mission Reform Act. H.R. 3230, Keeping America Competitive through Harmonization Act. H.R. 3847, Safety of Untested and New Devices Act. S. 1700, Medical Device Regulatory Improvement Act. S. 1865, Patient Access to Medical Innovation Act. S. 1995, Medical Device Patient Safety Act.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act H.R. 5651- Food and Drug Administration Reform Act of 2012 S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients S.3187- A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes

H.R. 611, to foster transparency about the commercial use of personal information, provide consumers with meaningful choice about the collection, use, and disclosure of such information. H.R. 654, to direct the Federal Trade Commission to prescribe regulations regarding the collection and use of information obtained by tracking the Internet activity of an individual. H.R. 1528, to protect and enhance consumer privacy, and for other purposes; to Energy & Commerce. H.R. 1841, to protect consumers by requiring reasonable security policies and procedures to protect computerized data containing personal information, and to provide for nationwide notice in the event of a security breach; to Energy & Commerce. H.R. 1939, to provide the Consumer Product Safety Commission with greater authority and discretion in enforcing the consumer product safety laws, and for other purposes; to Energy & Commerce. H.R. 2132, to require the Food and Drug Administration to finalize a standard for broad-spectrum protection in sunscreen products, and for other purposes; to Energy & Commerce. H.R. 2359, to amend title VI of the Federal Food, Drug, and Cosmetic Act to ensure the safe use of cosmetics, and for other purposes; jointly to Energy & Commerce and Education & the Workforce. H.R. 2577, to protect consumers by requiring reasonable security policies and procedures to protect data containing personal information, and to provide for nationwide notice in the event of a security breach. H.R. 2715, to provide the Consumer Product Safety Commission with greater authority and discretion in enforcing the consumer product safety laws, and for other purposes. H.R. 3847, to amend the Federal Food, Drug, and Cosmetic Act to ensure that a medical device is not marketed based on a determination that the device is substantially equivalent to a predicate device that has been recalled, corrected, or removed from the market because of an intrinsic flaw in technology or design that adversely affects safety. H.R. 4262, to amend the Federal Food, Drug, and Cosmetic Act to improve the safety of cosmetics; to Energy & Commerce. H.R. 4395, to amend the Federal Food, Drug, and Cosmetic Act to establish new procedures and requirements for the registration of cosmetic product manufacturing establishments, the submission of cosmetic product and ingredient statements, and the reporting of serious and unexpected cosmetic product adverse events, and for other purposes; to Energy & Commerce. S. 799, to establish a regulatory framework for the comprehensive protection of personal data for individuals under the aegis of the Federal Trade Commission, and for other purposes; to Commerce. S. 913, to require the Federal Trade Commission to prescribe regulations regarding the collection and use of personal information obtained by tracking the online activity of an individual, and for other purposes; to Commerce. S. 1064, to make effective the proposed rule of the Food and Drug Administration relating to sunscreen drug products, and for other purposes. S. 1151, to prevent and mitigate identity theft, to ensure privacy, to provide notice of security breaches, and to enhance criminal penalties, law enforcement assistance, and other protections against security breaches, fraudulent access, and misuse of personally identifiable information; to Judiciary. S. 1207, to protect consumers by requiring reasonable security policies and procedures to protect data containing personal information, and to provide for nationwide notice in the event of a security breach; to Commerce. S. 1408, to require federal agencies, and persons engaged in interstate commerce, in possession of data containing sensitive personally identifiable information, to disclose any breach of such information. S. 1434, to protect information relating to consumers, to require notice of security breaches, and for other purposes. S. 1535, to protect consumers by mitigating the vulnerability of personally identifiable information to theft through a security breach, providing notice and remedies to consumers in the wake of such a breach, holding companies accountable for preventable breaches, facilitating the sharing of post-breach technical information between companies, and enhancing criminal and civil penalties and other protections against the unauthorized collection or use of personally identifiable information, with an amendment in the nature of a substitute. S. 1652, to amend title 9 of the U.S. Code to prohibit mandatory arbitration clauses in contracts for mobile service.

Legislation to reauthorize the Medical Device User Fee Act. H.R. 3847, "Safety of Untested and New Devices Act of 2012". H.R. 3209, "Premarket Predictability Act of 2011".

Client expense: $245,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the 510(k) process for medical devices. [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to the medical device user fee program [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Sen. Orrin Hatch draft BETTER Patient Care Act. To restructure how the FDA regulates certain advanced diagnostics [JC Scott, Duane Wright] H.R 2182/S. 1734 Generating Antibiotic Incentives Now [Duane Wright, Leah Kegler, Elizabeth Sharp, JC Scott] Issues related to the competitiveness of the medical technology industry and the impact of Federal policies. [Elizabeth Sharp, Elizabeth Kegler, JC Scott] Issues related to diagnostics regulation [Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] Issues related to the definition of durable for durable medical equipment [Duane Wright] HR 3209 Premarket Predictability Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3203 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3230 Keeping America Competitive Through Harmonization Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3205 FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3211 Humanitarian Device Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3208 Patients Come First Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3206 Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3214 Food and Drug Administration Mission Reform Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3207 Modernizing Laboratory Test Standards for Patients Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott, Duane Wright] HR 3204 Guidance Accountability and Transparency Act of 2011[Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3847 Safety of Untested and New Devices Act of 2012 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] HR 3975 a bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 [Elizabeth Sharp, Elizabeth Kegler] HR 4056 Science and Technology Regulatory Relief Act [Elizabeth Sharp, Elizabeth Kegler] S 1700 Medical Device Regulatory Improvement Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1865 Patient Access to Medical Innovation Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1943 Novel Device Regulatory Relief Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1972 Food and Drug Administration Mission Reform Act of 2011 [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 1995 Medical Device Patient Safety Act[Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 2067 Safe, Transparent, and Efficient Medical Device Act [Elizabeth Sharp, Elizabeth Kegler, JC Scott] S 2113 A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that encourage innovative products to benefit patients and improve public health [Elizabeth Sharp] S 2193 Ensuring Safe Medical Devices for Patients [Elizabeth Sharp, Elizabeth Kegler]

- Issues related to ensuring quality of supply chain for FDA regulated products. - Issues related to Accountable Care Organizations. - Issues related to Physician Payment Sunshine provisions. - Issues generating antibiotic incentives. - HR 1282, "Generating Antibiotics Incentives Now Act of 2011", regarding all provisions. - Issues related to the "Regulation & Reimbursement of Diagnostics", regarding all provisions. - Implementation of the Health Care Reform Bill, regarding Medicare wellness benefit. - Issues related to maintaining the biosimilars statute without changes. - HR 2960, "National Diabetes Clinical Care Commission Act", regarding all provisions. - HR 3026, "Safeguarding America's Pharmaceutical Act of 2011", regarding all provisions. - Prescription Drug User Fee Act, regarding all provisions - Personalized Medicine Incentives and Regulation. - Issues related to Alzheimer's research. - HR 2939, "Pharmaceutical Stewardship Act of 2011", regarding all provisions. - HR 3497, "MODERN Cures Act of 2011", regarding all provisions. - HR 3209, "Premarket Predictability Act of 2011", regarding all provisions. - HR 3203/ S 1943, "Novel Device Regulatory Relief Act of 2011", regarding all provisions. - HR 3230, "Keeping America Competitive Through Harmonization Act of 2011", regarding all provisions. - HR 3211, "Humanitarian Device Reform Act of 2011", regarding all provisions. - HR 3208, "Patients Come First Act of 2011", regarding all provisions. - HR 3206, "Cultivating Scientific Expertise to Foster Inovation for Patients Act of 2011", regarding all provisions. - HR 3214/ S 1972, "Food and Drug Administration Mission Reform Act of 2011", regarding all provisions. - HR 3207, "Modernizing Laboratory Test Standards for Patients Act of 2011", regarding all provisions. - HR 3204, "Guidance Accountability and Transparency Act of 2011", regarding all provisions. - HR 3205, "FDA Renewing Efficiency From Outside Reviewer Management Act of 2011", regarding all provisons. - S 1700, "Medical Device Regulatory Improvement Act", regarding all provisions. - S 1865, "Patient Access to Medical Innovation Act", regarding all provisions. - S 1995, "Medical Device Patient Safety Act", regarding all provisions. - Issues related to vision care coverage under PPACA. - Medical Device User Fee Act Reauthorization. - HR 1483, "The Drug Safety Enhancement Act of 2011", regarding all provisions. - HR 3847, "Safety of Untested and New Devices Act of 2012", regarding all provisions. - HR 3975, "A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007", regarding all provisions. - S 2113, "A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve public health." regarding all provisions. - S 2193, "Ensuring Safe Medical Devices for Patients", regarding all provisions. - HR 5, "Protecting Acess to Healthcare (PATH) Act", regarding all provisions. - HR 452, "Medicare Decisions Accountability Act of 2011", regarding all provisions. - Issues related to the repeal and/or reform of Independent Payment Advisory Boards.

H.R.4056, Science and Technology Regulatory Relief Act of 2012 (provisions related to medical device company inspections) H.R.2086, Medical Debt Responsibility Act of 2011 S.2149, Medical Debt Responsibility Act of 2012 H.R.3847, Safety of Untested and New Devices (SOUND) Act of 2012 Issues related to the the reauthorization of the Medical Device User Fee and Modernization Act and the Prescription Drug User Fee Act Issues related to medical debt relief and medical loss ratios Issues related to the implementation of health exchanges under the Affordable Care Act Issues related to summary benefits coverage Issues related to healthcare-acquired infections Issues related to the FDA Sentinel Initiative

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Federal Communications Commission (FCC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Highway Traffic Safety Administration (NHTSA), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), SENATE, Transportation, Dept of (DOT), Treasury, Dept of, White House Office

Patient Protection and Affordable Health Care Act (P.L. 111-148) - provisions relating to the implementation of this Act including Accountable Care Organizations, Physician Payment Disclosure, Patient Centered Outcomes Research Institute (PCORI), and other issues H.R. 3211 - Humanitarian Device Reform Act of 2011 - provisions relating to the improving of humanitarian device regulation and foster device development for rare diseases S. 1865 - Patient Access to Medical Innovation Act - provisions relating to the improving humanitarian device regulation and foster device development for rare diseases H.R. 3209 - Premarket Predictability Act of 2011 - provisions relating to a new streamlined review of new devices, require reviewers to provide scientific or regulatory rationale for major decisions and establish an expedited approval appellate process, and the establishment of the two Investigational Device Exemption pathways H.R. 3203 - Novel Device Regulatory Relief Act of 2011 - provisions relating to the streamlining the de novo classification process by striking the requirement that an applicant submit a 510(k) application before entering the de novo process H.R. 3206 - Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 - provisions relating to the fixing of the FDA's conflict of interest policies to ensure the most knowledgeable experts are able to serve on FDA advisory committees H.R. 3847 - Safety of Untested and New Devices Act of 2012 - provisions relating to predicate nullification S. 2193 - Ensuring Safe Medical Devices for Patients - provisions relating to requiring the Food and Drug Administration to include devices in the postmarket risk identification and analysis system, to expedite the implementation of the unique device identification system for medical devices, and for other purposes S. 1995 - Medical Device Patient Safety Act - provisions relating to enhancing the Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes H.R. 3975 - Pediatric Medical Device Safety and Improvement Act - provisions relating to the continued availability of pediatric devices under the FDA humanitarian use device program.

Medical Device User Fee Program Health care reform implementation and rulemaking proceedings including Accountable Care Organizations; Independent Payment Advisory Board; and comparative effectiveness research, National Coverage Decisions, Coverage with Evidence Determination Reform of the medical device regulatory system particularly for Class II devices through the 510(k) system including the following FDA related legislation: H.R. 3209 -Premarket Predictability Act H.R. 3203 -Novel Device Regulatory Relief Act H.R. 3230 -Keeping America Competitive through Harmonization Act H.R. 3205 -FDA Renewing Efficiency from Outside Review Management Act H.R. 3211 -Humanitarian Device Reform Act H.R. 3208 -Patients Come First Act H.R. 3206 -Cultivating Scientific Experts to Foster Innovation Act H.R. 3214 -Food and Drug Administration Mission Reform Act H.R. 3207 -Modernizing Laboratory Test Standards for Patients Act H.R. 3204 -Guidance Accountability and Transparency Act H.R. 3847- Safety of Untested and New Devices Act of 2012 H.R. 3975- A bill to extend provisions of the Pediatric Medical Device Safety and Improvement Act of 2007 H.R. 4056- Science and Technology Regulatory Relief Act S. 1700 -The Medical Device Regulatory Improvement Act S. 1865 -The Patient Access to Medical Innovation Act S. 1943 -Novel Device Regulatory Relief Act of 2011 S. 1972 -A bill to amend the Food and Drug Administration's mission S. 1995 -A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes. S. 2067- Safe, Transparent, and Efficient Medical Device Act S.2113- A bill to empower the Food and Drug Administration to ensure a clear and effective pathway that will encourage innovative products to benefit patients and improve health S. 2193- Ensuring Safe Medical Devices for Patients Discussion drafts on user fee legislation from the Energy and Commerce Committee and the Health, Education, Labor and Pensions Committee

Policy issues relating to Patient Protection and Affordable Care Act (Public Law 111-148) implementation, including the medical device tax (S. 17 and H.R. 436); Accountable Care Organizations; the Independent Payment Advisory Board (H.R. 452); and comparative effectiveness research. Also, policy issues related to the FDA's 510(k) regulatory proposals and reauthorization of the Medical Device User Fee and Modernization Act. H.R. 3209, Premarket Predictability Act. H.R. 3208, Patients Come First Act. H.R. 3214/S. 1972, Food and Drug Administration Mission Reform Act. H.R. 3230, Keeping America Competitive through Harmonization Act. H.R. 3847, Safety of Untested and New Devices Act. S. 1700, Medical Device Regulatory Improvement Act. S. 1865, Patient Access to Medical Innovation Act. S. 1995, Medical Device Patient Safety Act.

Client expense: Not reported · Firm income: $30,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE