Novel Device Regulatory Relief Act of 2011

See page 7 Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 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. 1995 Medical Device Patient Safety Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

See page five Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S.1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 6446 Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 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. 1995 Medical Device Patient Safety Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

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]

Client expense: $366,862 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Patient Protection and Affordable Care Act implementation. S. 99, American Medical Isotopes Production Act of 2011; issues related to nuclear medicine. FDA approval process/510(k). Medical device tax. H.R. 3209, Premarket Predictability Act. H.R. 3203 / S. 1943, 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. S. 1700, The Medical Device Regulatory Improvement Act. S. 1865, The Patient Access to Medical Innovation Act. S. 1972, A bill to amend the Food and Drug Administrations 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. CMS coverage for transcutaneous electrical nerve stimulation for lower back pain

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation FDA User Fee Reauthorization - S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - Patient Access to Medical Innovation Act S. 1995 Medical Device Patient Safety Act 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 ***, no specific bill(s), 510k reform, imaging policy, medical device user fee reauthorization and all related policies

Client expense: Not reported · Firm income: $60,000

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

See page five Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 HR 6446, Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 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. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

See page three Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 HR 6446, Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 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. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

See page 7 Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 HR 6446, Improving Diagnostic Innovations Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 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. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

General issues related to FDA device approval process; issues related to Patient Protection and Affordable Care Act Implementation (Accountable Care Organization, Medical Device Tax); S.17/S.262/H.R.436/H.R.488/H.R.734: Medical Device Access and Innovation Protection Act (all provisions); HEU/LEU related issues for Nuclear Medicine. S.99: American Medical Isotopes Production Act (all provisions). H.R. 3209: Premarket Predictability Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3203: Novel Device Regulatory Relief Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3230: Keeping America Competitive Through Harmonization Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3205: FDA Renewing Efficiency from Outside Review Management Act. (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3211: Humanitarian Device Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3208: Patients Come First Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3206: Cultivating Scientific Experts to Foster Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3214: Food and Drug Administration Mission Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3204: Guidance Accountability and Transparency Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1700: The Medical Device Regulatory Improvement Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1865: The Patient Access to Medical Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1943: Novel Device Regulatory Relief Act of 2011(All provisions related to the FDA and the regulation of medical devices generally); S. 1972: A bill to amend the Food and Drug Administrations mission (All provisions related to the FDA and the regulation of medical devices generally); 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 (All provisions related to the FDA and the regulation of medical devices generally); S.3187: Food and Drug Administration Safety and Innovation Act as well as Amendment 2151 on reclassification of hydrocodone sponsored by Senator Manchin; Coverage issues for Transcutaneous Electronic Stimulation for chronic lower back pain.

Client expense: $460,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

General issues related to FDA device approval process; issues related to Patient Protection and Affordable Care Act Implementation (Accountable Care Organization, Medical Device Tax); S.17/S.262/H.R.436/H.R.488/H.R.734: Medical Device Access and Innovation Protection Act (all provisions); HEU/LEU related issues for Nuclear Medicine. S.99: American Medical Isotopes Production Act (all provisions). H.R. 3209: Premarket Predictability Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3203: Novel Device Regulatory Relief Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3230: Keeping America Competitive Through Harmonization Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3205: FDA Renewing Efficiency from Outside Review Management Act. (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3211: Humanitarian Device Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3208: Patients Come First Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3206: Cultivating Scientific Experts to Foster Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3214: Food and Drug Administration Mission Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3204: Guidance Accountability and Transparency Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1700: The Medical Device Regulatory Improvement Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1865: The Patient Access to Medical Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1943: Novel Device Regulatory Relief Act of 2011(All provisions related to the FDA and the regulation of medical devices generally); S. 1972: A bill to amend the Food and Drug Administrations mission (All provisions related to the FDA and the regulation of medical devices generally); 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 (All provisions related to the FDA and the regulation of medical devices generally)

Client expense: $700,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), 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 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

Client expense: $360,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - Patient Access to Medical Innovation Act S. 1995 - Medical Device Patient Safety Act 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 ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics

Client expense: Not reported · Firm income: $70,000

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

**add addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) FDA User Fee Reauthorizations S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - Patient Access to Medical Innovation Act S. 1995 Medical Device Patient Safety Act 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 ***, no specific bills, FDA related issues, diagnostics, drug shortages

Client expense: Not reported · Firm income: $60,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Please see next page Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 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. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Please see attached page Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 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. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Please see next page Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 H.R. 5651, the Food and Drug Administration Reform Act of 2012 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 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. 1995 Medical Device Patient Safety Act S. 3187, the Food and Drug Administration Safety and Innovation Act

Client expense: $70,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE

Patient Protection and Affordable Care Act implementation. S. 99, American Medical Isotopes Production Act of 2011; issues related to nuclear medicine. FDA approval process/510(k). Medical device tax. H.R. 3209, Premarket Predictability Act. H.R. 3203 / S. 1943, 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. S. 1700, The Medical Device Regulatory Improvement Act. S. 1865, The Patient Access to Medical Innovation Act. S. 1972, A bill to amend the Food and Drug Administrations 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. CMS coverage for transcutaneous electrical nerve stimulation for lower back pain

Client expense: Not reported · Firm income: $60,000

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 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]

Client expense: $559,267 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $1,450,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

- 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.

Client expense: $1,200,000 · Firm income: Not reported

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

policy ideas/legislation on innovation/science/tech and related start-up issues including: H.R. 3606 JOBS Act; S. 3217/H.R. 5893 Startup Act 2.0; S. 17/H.R. 436 Repeal of Medical Device Tax; S. 3187/H.R. 5651 FDA User Fee Reauthorization; H.R. 3203 Novel Device Regulatory Relief Act; H.R. 5334 Breakthroughs Therapy Act; issues related to innovation and domestic production; and issues related to wireless health and spectrum.

Client expense: $90,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Economic Development Administration, HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA)

**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation FDA User Fee Reauthorization - S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - Patient Access to Medical Innovation Act S. 1995 Medical Device Patient Safety Act 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 ***, no specific bill(s), 510k reform, imaging policy, medical device user fee reauthorization and all related policies

Client expense: Not reported · Firm income: $60,000

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

**add addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) FDA User Fee Reauthorizations S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - Patient Access to Medical Innovation Act S. 1995 Medical Device Patient Safety Act 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 ***, no specific bills, FDA related issues, diagnostics, drug shortages

Client expense: Not reported · Firm income: $60,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation S. 3187 - The Food and Drug Administration Safety and Innovation Act (H.R. 3988, H.R. 4087, H.R. 5334, S. 2236, S. 2289, S. 2516) S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - Patient Access to Medical Innovation Act S. 1995 Medical Device Patient Safety Act 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 ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics

Client expense: Not reported · Firm income: $70,000

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

General issues related to FDA device approval process; issues related to Patient Protection and Affordable Care Act Implementation (Accountable Care Organization, Medical Device Tax); S.17/S.262/H.R.436/H.R.488/H.R.734: Medical Device Access and Innovation Protection Act (all provisions); HEU/LEU related issues for Nuclear Medicine. S.99: American Medical Isotopes Production Act (all provisions). H.R. 3209: Premarket Predictability Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3203: Novel Device Regulatory Relief Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3230: Keeping America Competitive Through Harmonization Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3205: FDA Renewing Efficiency from Outside Review Management Act. (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3211: Humanitarian Device Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3208: Patients Come First Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3206: Cultivating Scientific Experts to Foster Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3214: Food and Drug Administration Mission Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3204: Guidance Accountability and Transparency Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1700: The Medical Device Regulatory Improvement Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1865: The Patient Access to Medical Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1943: Novel Device Regulatory Relief Act of 2011(All provisions related to the FDA and the regulation of medical devices generally); S. 1972: A bill to amend the Food and Drug Administrations mission (All provisions related to the FDA and the regulation of medical devices generally); 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 (All provisions related to the FDA and the regulation of medical devices generally); S.3187: Food and Drug Administration Safety and Innovation Act as well as Amendment 2151 on reclassification of hydrocodone sponsored by Senator Manchin; Coverage issues for Transcutaneous Electronic Stimulation for chronic lower back pain.

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

HR 3203, Military Health Care Protection; HR 5707, Doc Fix;

Client expense: $140,000 · Firm income: Not reported

Government targets: Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, SENATE, U.S. Coast Guard (USCG), Veterans Affairs, Dept of (VA)

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

Client expense: $360,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 3203, Novel Device Regulatory Relief Act of 2011 H.R. 3204, Guidance Accountability and Transparency Act H.R. 3205, FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206, Cultivating Scientific Expertise to Foster Innovation Act H.R. 3207, Modernizing Laboratory Test Standards for Patients Act H.R. 3208, Patients Come First Act H.R. 3209, Premarket Predictability Act H.R. 3211, Humanitarian Device Reform Act of 2011 H.R. 3214, FDA Mission Reform Act H.R. 3230, Keeping America Competitive through Harmonization Act Potential FDA reform legislation (specific legislation not yet introduced)

Client expense: $20,200,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

H.R. 10 / S. 299, Regulations From the Executive in Need of Scrutiny Act of 2011 H.R. 373, Unfunded Mandates Information and Transparency Act of 2011 H.R.735 / S. 119, Government Neutrality in Contracting Act H.R. 931, To make participation in the American Community Survey voluntary, except with respect to certain basic questions H.R. 2250 / S. 1392, EPA Regulatory Relief Act of 2011 H.R. 2309 / S. 1625, Postal Reform Act of 2011 H.R. 2401, Transparency in Regulatory Analysis of Impacts on the Nation (TRAIN) Act of 2011 H.R. 2483, Whistleblower Improvement Act of 2011 H.R. 2898 / S.1438, Regulation Moratorium and Jobs Preservation Act of 2011 H.R. 3010 / S. 1606, Regulatory Accountability Act of 2011 H.R. 3203, Novel Device Regulatory Relief Act of 2011 H.R. 3204, Guidance Accountability and Transparency Act H.R. 3205, FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206, Cultivating Scientific Expertise to Foster Innovation Act H.R. 3207, Modernizing Laboratory Test Standards for Patients Act H.R. 3208, Patients Come First Act H.R. 3209, Premarket Predictability Act H.R. 3211, Humanitarian Device Reform Act of 2011 H.R. 3214, FDA Mission Reform Act H.R. 3230, Keeping America Competitive through Harmonization Act H.R. 3416 / S. 1483, Incorporation Transparency and Law Enforcement Act H.R. 3596, United States Call Center Worker and Consumer Protection Act H.R. 3634, Federal Prison Industries Competition in Contracting Act of 2011 H.R. 3813, Securing Annuities for Federal Employees Act of 2012 H.R. 3850, Government Efficiency through Small Business Contracting Act of 2012 H.R. 3851, Small Business Advocate Act of 2012 H.R. 3862, Sunshine for Regulatory Decrees and Settlements Act of 2012 H.R. 3893, Subcontracting Transparency and Reliability Act of 2012 H.R. 3980, Small Business Opportunity Act of 2012 H.R. 3985, Building Better Business Partnerships Act of 2012 H.R. 3987, Small Business Protection Act of 2012 H.R. 4078, Regulatory Freeze for Jobs Act of 2012 H.R. 4081, Contractor Opportunity Protection Act of 2012 S. 370, A bill to require contractors to notify small business concerns that have been included in offers relating to contracts let by Federal agencies, and for other purposes S. 1536, NOTICE Act of 2011 S. 1736, Acquisition Savings Reform Act of 2011 S. 1720, Jobs Through Growth Act S. 1789, 21st Century Postal Service Act of 2011 S. 2169, Federal Prisons Accountability Act of 2012 S. 3862, Sunshine for Regulatory Decrees and Settlements Act FY 2013 Appropriations Legislation Farm and agricultural legislation (specific legislation not yet introduced) Department of Agriculture Animal and Plant Health Inspection Service Proposed Rule: Importation of Wood Packaging Material From Canada, Docket No. APHIS-2010-0019 Executive Order 12688, Estimating direct and indirect employment impacts of regulations - need for surveys and experiments to establish compliance costs Executive Order 13563, Improving Regulation and Regulatory Review Various issues relating to Congressional oversight of the NLRB and DOL (no specific legislation); statistical programs (need for consistent and timely data to support economic impact analysis of regulation impacts); NIOSH Diesel Emissions study data quality; regulatory implementation of the Food Safety Modernization Act, PL 111-353

Client expense: $20,200,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

Affordable Care Act implementation issues regarding ACO's General support for the reauthorization of the medical device user fee modernization act. General support for FDA regulatory reforms in conjucntion with the medical device user fee reauthorization. H.R. 3209 The Premarket Predictability Act, H.R. 3203 Novel Device Regulatory Relief Act of 2011, H.R. 3230 Keeping America Competitive through Harmonization Act, H.R. 3211 Humanitarian Device Reform Act of 2011, H.R. 3208 Patients Come First Act, H.R. 3206 Cultivating Scientific Expertise to Foster Innovation Act, H.R. 3214 Food and Drug Administration Mission Reform Act, H.R. 3204 Guidance Accountability and Transparency Act, H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 201, S.1700 The Medical Device Regulatory Improvement Act, S 1865Patient Access to Medical Innovation Act, Discussion drafts regarding medicial device user fee reauthoiization from the House Energy and Commerce Committee and the Senate.Health, Education, Labor and Pensions Committee

Client expense: $150,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

See page 7 Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 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. 1995 Medical Device Patient Safety Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

See page three Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S. 1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 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. 1995 Medical Device Patient Safety Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

See page five Lobbying Issues: Molecular diagnostic tests, infection control and prevention programs (Multidrug resistant organisms (MDRO)), CDC-related issues (MDRO research and surveillance), hospital and other provider quality improvement programs CMS-related issues (reimbursement and coverage policies), FDA oversight, global health funding comparative effectiveness, personalized medicine/pharmacogenomics, Veterans Affairs healthcare-related issues H.R. 436/ S. 17 Protect Medical Innovation Act of 2011 H.R. 488 Save Our Medical Devices Act of 2011 H.R. 755 Investing in Our Future Act of 2011 H.R. 965/ S.1211 Preservation of Antibiotics for Medical Treatment Act of 2011 H.R. 2182 / S. 1732 Generating Antibiotic Incentives Now (GAIN) Act H.R. 3203 Novel Device Regulatory Relief Act of 2011 H.R. 3204 Guidance Accountability and Transparency Act of 2011 H.R. 3205 FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206 Cultivating Scientific Experts to Foster Innovation Act of 2011 H.R. 3207 Modernizing Laboratory Test Standards for Patients Act of 2011 H.R. 3208 Patients Come First Act of 2011 H.R. 3209 Premarket Predictability Act of 2011 H.R. 3211 Humanitarian Device Reform Act of 2011 H.R. 3214 / S. 1972 Food and Drug Administration Mission Reform Act of 2011 H.R. 3230 Keeping America Competitive through Harmonization Act of 2011 H.R. 3497 Modernizing Our Drug & Diagnostics Evaluation and Regulation Network (MODDERN) Cures Act of 2011 S. 660 Preserving Access to Targeted Individualized and Effective New Treatments and Services (PATIENTS) Act of 2011 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. 1995 Medical Device Patient Safety Act

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

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), SENATE

Patient Protection and Affordable Care Act implementation. S. 99, American Medical Isotopes Production Act of 2011; issues related to nuclear medicine. FDA approval process/510(k). Medical device tax. H.R. 3209, Premarket Predictability Act. H.R. 3203 / S. 1943, 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. S. 1700, The Medical Device Regulatory Improvement Act. S. 1865, The Patient Access to Medical Innovation Act. S. 1972, A bill to amend the Food and Drug Administrations 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.

Client expense: Not reported · Firm income: $50,000

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]

Client expense: $378,488 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

FDA approval issues. De Novo reform and support for H.R. 3203, "Novel Device Regulatory Relief Act of 2011." MDUFA reauthorization. Support for Section 721 of the House MDUFA draft and Section 611 of the Senate MDUFA draft. Support for S. 2067, "Safe, Efficient, and Transparent Medical Device Approval Act." Congressional oversight of the memorandum of understanding between the FDA and FCC.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**add addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation FDA User Fee Reauthorizations S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - Patient Access to Medical Innovation Act S. 1995 Medical Device Patient Safety Act 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 ***, no specific bills, FDA related issues, diagnostics, drug shortages

Client expense: Not reported · Firm income: $60,000

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation FDA User Fee Reauthorizations S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - Patient Access to Medical Innovation Act S. 1995 Medical Device Patient Safety Act 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 ***, no specific bill(s), 510k reform, imaging policy, medical device user fee reauthorization and all related policies

Client expense: Not reported · Firm income: $60,000

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

**see addendum page PL 111-148 - The Patient Protection and Affordable Care Act, implementation FDA User Fee Reauthorizations S. 1700 - The Medical Device Regulatory Improvement Act S. 1865 - Patient Access to Medical Innovation Act S. 1995 Medical Device Patient Safety Act 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 ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics

Client expense: Not reported · Firm income: $70,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE

H.R. 10 / S. 299, Regulations From the Executive in Need of Scrutiny Act of 2011 H.R. 373, Unfunded Mandates Information and Transparency Act of 2011 H.R.735 / S. 119, Government Neutrality in Contracting Act H.R. 931, To make participation in the American Community Survey voluntary, except with respect to certain basic questions H.R. 2250 / S. 1392, EPA Regulatory Relief Act of 2011 H.R. 2309 / S. 1625, Postal Reform Act of 2011 H.R. 2401, Transparency in Regulatory Analysis of Impacts on the Nation (TRAIN) Act of 2011 H.R. 2483, Whistleblower Improvement Act of 2011 H.R. 2898 / S.1438, Regulation Moratorium and Jobs Preservation Act of 2011 H.R. 3010 / S. 1606, Regulatory Accountability Act of 2011 H.R. 3203, Novel Device Regulatory Relief Act of 2011 H.R. 3204, Guidance Accountability and Transparency Act H.R. 3205, FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206, Cultivating Scientific Expertise to Foster Innovation Act H.R. 3207, Modernizing Laboratory Test Standards for Patients Act H.R. 3208, Patients Come First Act H.R. 3209, Premarket Predictability Act H.R. 3211, Humanitarian Device Reform Act of 2011 H.R. 3214, FDA Mission Reform Act H.R. 3230, Keeping America Competitive through Harmonization Act H.R. 3416 / S. 1483, Incorporation Transparency and Law Enforcement Act H.R. 3596, United States Call Center Worker and Consumer Protection Act H.R. 3634, Federal Prison Industries Competition in Contracting Act of 2011 H.R. 3813, Securing Annuities for Federal Employees Act of 2012 H.R. 3850, Government Efficiency through Small Business Contracting Act of 2012 H.R. 3851, Small Business Advocate Act of 2012 H.R. 3862, Sunshine for Regulatory Decrees and Settlements Act of 2012 H.R. 3893, Subcontracting Transparency and Reliability Act of 2012 H.R. 3980, Small Business Opportunity Act of 2012 H.R. 3985, Building Better Business Partnerships Act of 2012 H.R. 3987, Small Business Protection Act of 2012 H.R. 4078, Regulatory Freeze for Jobs Act of 2012 H.R. 4081, Contractor Opportunity Protection Act of 2012 S. 370, A bill to require contractors to notify small business concerns that have been included in offers relating to contracts let by Federal agencies, and for other purposes S. 1536, NOTICE Act of 2011 S. 1736, Acquisition Savings Reform Act of 2011 S. 1720, Jobs Through Growth Act S. 1789, 21st Century Postal Service Act of 2011 S. 2169, Federal Prisons Accountability Act of 2012 S. 3862, Sunshine for Regulatory Decrees and Settlements Act FY 2013 Appropriations Legislation Farm and agricultural legislation (specific legislation not yet introduced) Department of Agriculture Animal and Plant Health Inspection Service Proposed Rule: Importation of Wood Packaging Material From Canada, Docket No. APHIS-2010-0019 Executive Order 12688, Estimating direct and indirect employment impacts of regulations - need for surveys and experiments to establish compliance costs Executive Order 13563, Improving Regulation and Regulatory Review Various issues relating to Congressional oversight of the NLRB and DOL (no specific legislation); statistical programs (need for consistent and timely data to support economic impact analysis of regulation impacts); NIOSH Diesel Emissions study data quality; regulatory implementation of the Food Safety Modernization Act, PL 111-353

Client expense: $20,200,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

H.R. 3203, Novel Device Regulatory Relief Act of 2011 H.R. 3204, Guidance Accountability and Transparency Act H.R. 3205, FDA Renewing Efficiency from Outside Review Management Act of 2011 H.R. 3206, Cultivating Scientific Expertise to Foster Innovation Act H.R. 3207, Modernizing Laboratory Test Standards for Patients Act H.R. 3208, Patients Come First Act H.R. 3209, Premarket Predictability Act H.R. 3211, Humanitarian Device Reform Act of 2011 H.R. 3214, FDA Mission Reform Act H.R. 3230, Keeping America Competitive through Harmonization Act Potential FDA reform legislation (specific legislation not yet introduced)

Client expense: $20,200,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Commodity Futures Trading Commission (CFTC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Federal Highway Administration (FHA), Federal Reserve System, Federal Trade Commission (FTC), Federal Transit Administration (FTA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Labor Relations Board (NLRB), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation Security Administration (TSA), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office

- 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.

Client expense: $2,260,000 · Firm income: Not reported

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

General issues related to FDA device approval process; issues related to Patient Protection and Affordable Care Act Implementation (Accountable Care Organization, Medical Device Tax); S.17/S.262/H.R.436/H.R.488/H.R.734: Medical Device Access and Innovation Protection Act (all provisions); HEU/LEU related issues for Nuclear Medicine. S.99: American Medical Isotopes Production Act (all provisions). H.R. 3209: Premarket Predictability Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3203: Novel Device Regulatory Relief Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3230: Keeping America Competitive Through Harmonization Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3205: FDA Renewing Efficiency from Outside Review Management Act. (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3211: Humanitarian Device Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3208: Patients Come First Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3206: Cultivating Scientific Experts to Foster Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3214: Food and Drug Administration Mission Reform Act (All provisions related to the FDA and the regulation of medical devices generally); H.R. 3204: Guidance Accountability and Transparency Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1700: The Medical Device Regulatory Improvement Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1865: The Patient Access to Medical Innovation Act (All provisions related to the FDA and the regulation of medical devices generally); S. 1943: Novel Device Regulatory Relief Act of 2011(All provisions related to the FDA and the regulation of medical devices generally); S. 1972: A bill to amend the Food and Drug Administrations mission (All provisions related to the FDA and the regulation of medical devices generally); 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 (All provisions related to the FDA and the regulation of medical devices generally)

Client expense: $610,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

510(k) Reform; Medical device user fee implementation; H.R. 3209, the "Premarket Predictability Act"; H.R. 3203, the "Novel Device Regulatory Relief Act of 2011"; H.R. 3230, "Keeping America Competitive through Harmonization Act"; H.R. 3211, "Humanitarian Device Reform Act of 2011"; H.R. 3208, "Patients Comfe First Act"; H.R. 3206, "Cultivating Scientific Expertise 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. 3205, "FDA Renewing Efficiency from Outside Review Management Act of 2011"; S. 1700 "The Medical Device Regulatory Act"; S.1865 "The Patient Access to Medical Innovation Act"; S. 1943 "Novel Device Regulatory Relief Act"; 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. 2067Safe, Transparent, and Efficient Medical Device Act or SET Device Act; S. 2113A 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."; S. 219, Ensuring Safe Medical Devices for Patients

Client expense: $360,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, White House Office

Reauthorization of the FDA Medical Device User Free program and associated FDA legislation such as H.R. 3209, H.R. 3203, H.R. 3230, H.R. 3205, H.R. 3208, H.R. 3206, H.R. 3214, H.R. 3204 and S. 1700, S. 1865 and S. 1995. Discussion drafts on medical device user fee legislation from the House Energy & Commerce Committee and the Senate Health, Education, Labor and Pensions Committee

Client expense: $120,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE