FDA Renewing Efficiency From Outside Reviewer Management Act of 2011

Monitor federal legislation and activity related to the tobacco industry. Monitor the implementation of PACT Act, (P.L. 111-154). Monitor the implementation of Family Smoking Prevention and Tobacco Control Act, (P.L. 111-31). H.R. 65, Candy Tobacco Tax Parity Act of 2011. H.R. 1639, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. S. 1461, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. S. 299, Regulations from the Executive in Need of Scrutiny Act of 2011. H.R. 10, Regulations from the Executive in Need of Scrutiny Act of 2011. S. 1403, IDEA Full Funding Act. H.R. 3010, Regulatory Accountability Act of 2011. S. 1606, Regulatory Accountability Act of 2011. H.R. 3186, Smuggled Tobacco Prevention Act of 2011. S. 1706, Smuggled Tobacco Prevention Act of 2011. H.R. 3205, FDA Renewing Efficiency From Outside Reviewer Management Act of 2011. H.R. 3214, Food and Drug Administration Mission Reform Act of 2011. S. 1972, Food and Drug Administration Mission Reform Act of 2011. H.R. 4134, To amend the Internal Revenue Code of 1986 to clarify that any person who, for a commercial purpose, makes available for consumer use a machine capable of producing tobacco products, is a manufacturer of tobacco products. (Black) H.R. 4351, Let's Grow Act of 2012. H.R. 5952, To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of scientific information relied upon by the agency. HRes 98, Expressing the Sense of the House of Representatives that the Commissioner of the Food and Drug Administration should give the greatest weight in making critical policy decisions to readily available hard science data, including evidence from the natural sciences, physical sciences, and computing sciences. S. 968, Protect IP Act. H.R. 3261, Protect IP Act. S. 174, Healthy Lifestyles & Prevention America Act S. 216, Food Safety Accountability Act. S.2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. S. 3240, Farm Bill. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. H.R. 4116, Regulatory Accountability and Economic Freedom Act of 2012. H.R. 3804, American Opportunity and Freedom Act of 2012. H.R. 4064, Keeping Promises to Taxpayers Act of 2012. H.R. 4078, Red Tape Reduction and Small Business Job Creation Act. Draft, Foreign Counterfeit Merchandise Prevention Act. S. 3641, Family Asthma Act. H.R. 6608, Family Asthma Act. H.R. 1, Hurricane Sandy Supplemental Appropriations Bill. H.R. 8, American Taxpayer Relief Act of 2012. S. 1832, Marketplace Fairness Act. Monitor the implementation of Food and Drug Administration Safety and Innovation Act, (P.L. 112-144). Monitor the implementation of the Continuing Appropriations Resolution, 2013, (P.L. 112-175). Monitor the implementation of the Temporary Surface Transportation Extension, (P.L. 112-140). Monitor legislative and administrative action related to sequestration and The Budget Control Act, (P.L. 112-25).

Client expense: Not reported · Firm income: $490,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Monitor federal legislation and activity related to the tobacco industry. Monitor the implementation of PACT Act, (P.L. 111-154). Monitor the implementation of Family Smoking Prevention and Tobacco Control Act, (P.L. 111-31). H.R. 65, Candy Tobacco Tax Parity Act of 2011. H.R. 1639, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. S. 1461, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. S. 299, Regulations from the Executive in Need of Scrutiny Act of 2011. H.R. 10, Regulations from the Executive in Need of Scrutiny Act of 2011. S. 1403, IDEA Full Funding Act. H.R. 3010, Regulatory Accountability Act of 2011. S. 1606, Regulatory Accountability Act of 2011. H.R. 3186, Smuggled Tobacco Prevention Act of 2011. S. 1706, Smuggled Tobacco Prevention Act of 2011. H.R. 3205, FDA Renewing Efficiency From Outside Reviewer Management Act of 2011. H.R. 3214, Food and Drug Administration Mission Reform Act of 2011. S. 1972, Food and Drug Administration Mission Reform Act of 2011. H.R. 4134, To amend the Internal Revenue Code of 1986 to clarify that any person who, for a commercial purpose, makes available for consumer use a machine capable of producing tobacco products, is a manufacturer of tobacco products. (Black) H.R. 4351, Let's Grow Act of 2012. H.R. 5952, To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of scientific information relied upon by the agency. HRes 98, Expressing the Sense of the House of Representatives that the Commissioner of the Food and Drug Administration should give the greatest weight in making critical policy decisions to readily available hard science data, including evidence from the natural sciences, physical sciences, and computing sciences. S. 968, Protect IP Act. H.R. 3261, Protect IP Act. S. 174, Healthy Lifestyles & Prevention America Act S. 216, Food Safety Accountability Act. S.2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. S. 3240, Farm Bill. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. H.R. 4116, Regulatory Accountability and Economic Freedom Act of 2012. H.R. 3804, American Opportunity and Freedom Act of 2012. H.R. 4064, Keeping Promises to Taxpayers Act of 2012. H.R. 4078, Red Tape Reduction and Small Business Job Creation Act. Draft, Foreign Counterfeit Merchandise Prevention Act. S. 3641, Family Asthma Act. H.R. 6608, Family Asthma Act. H.R. 1, Hurricane Sandy Supplemental Appropriations Bill. H.R. 8, American Taxpayer Relief Act of 2012. S. 1832, Marketplace Fairness Act. Monitor the implementation of Food and Drug Administration Safety and Innovation Act, (P.L. 112-144). Monitor the implementation of the Continuing Appropriations Resolution, 2013, (P.L. 112-175). Monitor the implementation of the Temporary Surface Transportation Extension, (P.L. 112-140). Monitor legislative and administrative action related to sequestration and The Budget Control Act, (P.L. 112-25).

Client expense: Not reported · Firm income: $490,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of the Patient Protection and Affordable Care Act (PL 111-148) and the Health Care and Education Reconciliation Act (PL 111-152) Medicare and Medicaid reimbursement policies related to healthcare associated conditions, healthcare associated infections, readmission, and payment bundling Comparative effectiveness research and policies Accountable care organizations Competitive bidding Medical Device Tax - H.R. 436, the Healthcare Cost Reduction Act, and S. 17, the Medical Device Access and Innovation Protection Act Regulations related to the adoption of International Classification of Diseases, version 10 (ICD-10) Implementation of the Physician Payments Sunshine Act (PL 111-152, Section 6002) Reauthorization of the Food and Drug Administration's medical device user fee program - S. 3187, the Food and Drug Administration Safety and Innovation Act (PL 112-144); H.R. 5651, a bill to extend FDA User Fee Programs; H.R. 3205, FDA Renewing Efficiency from Outside Reviewer Management Act; S. 1700, the Medical Device Regulatory Improvement Act; and S. 1865, the Patient Access to Medical Innovation Act

Client expense: $1,710,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), 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); 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. Issue relating to MDUFA fees and sequestration.

Client expense: $470,000 · Firm income: Not reported

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

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. 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 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

Monitor federal legislation and activity related to the tobacco industry. Monitor the implementation of PACT Act, (P.L. 111-154). Monitor the implementation of Family Smoking Prevention and Tobacco Control Act, (P.L. 111-31). H.R. 65, Candy Tobacco Tax Parity Act of 2011. H.R. 10, Regulations from the Executive in Need of Scrutiny Act of 2011. S. 299, Regulations from the Executive in Need of Scrutiny Act of 2011. H.R. 1639, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. S. 1461, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. H.R. 3186, Smuggled Tobacco Prevention Act of 2011. S. 1706, Smuggled Tobacco Prevention Act of 2011. H.R. 3010, Regulatory Accountability Act of 2011. S. 1606, Regulatory Accountability Act of 2011. H.R. 3205, FDA Renewing Efficiency From Outside Reviewer Management Act of 2011. H.R. 3214, Food and Drug Administration Mission Reform Act of 2011. S. 1972, Food and Drug Administration Mission Reform Act of 2011. H.R. 3804, American Opportunity and Freedom Act of 2012. H.R. 4064, Keeping Promises to Taxpayers Act of 2012. H.R. 4116, Regulatory Accountability and Economic Freedom Act of 2012. H.R. 4134, To amend the Internal Revenue Code of 1986 to clarify that any person who, for a commercial purpose, makes available for consumer use a machine capable of producing tobacco products, is a manufacturer of tobacco products. H.R. 4351, Let's Grow Act of 2012. H.R. 4078, Red Tape Reduction and Small Business Job Creation Act. H.R. 5952, To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of scientific information relied upon by the agency. HRes 98, Expressing the Sense of the House of Representatives that the Commissioner of the Food and Drug Administration should give the greatest weight in making critical policy decisions to readily available hard science data, including evidence from the natural sciences, physical sciences, and computing sciences. S. 174, Healthy Lifestyles & Prevention America Act. S. 216, Food Safety Accountability Act. S. 968, Protect IP Act. H.R. 3261, Protect IP Act. S. 1403, IDEA Full Funding Act. S.2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. S. 3187, Food and Drug Administration Safety and Innovation Act. (P.L. 112-144). H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 3240, Farm Bill. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Monitor the implementation of the Temporary Surface Transportation Extension Act of 2012. (P.L. 112-140). H.J.Res 117, Continuing Appropriations Resolution, 2013. (P.L. 112-175) Monitor legislative and administrative action related to sequestration and S. 365, The Budget Control Act. (P.L. 112-25)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Postal Service (USPS)

Monitor federal legislation and activity related to the tobacco industry. Monitor the implementation of PACT Act, (P.L. 111-154). Monitor the implementation of Family Smoking Prevention and Tobacco Control Act, (P.L. 111-31). H.R. 65, Candy Tobacco Tax Parity Act of 2011. H.R. 10, Regulations from the Executive in Need of Scrutiny Act of 2011. S. 299, Regulations from the Executive in Need of Scrutiny Act of 2011. H.R. 1639, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. S. 1461, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. H.R. 3186, Smuggled Tobacco Prevention Act of 2011. S. 1706, Smuggled Tobacco Prevention Act of 2011. H.R. 3010, Regulatory Accountability Act of 2011. S. 1606, Regulatory Accountability Act of 2011. H.R. 3205, FDA Renewing Efficiency From Outside Reviewer Management Act of 2011. H.R. 3214, Food and Drug Administration Mission Reform Act of 2011. S. 1972, Food and Drug Administration Mission Reform Act of 2011. H.R. 3804, American Opportunity and Freedom Act of 2012. H.R. 4064, Keeping Promises to Taxpayers Act of 2012. H.R. 4116, Regulatory Accountability and Economic Freedom Act of 2012. H.R. 4134, To amend the Internal Revenue Code of 1986 to clarify that any person who, for a commercial purpose, makes available for consumer use a machine capable of producing tobacco products, is a manufacturer of tobacco products. H.R. 4351, Let's Grow Act of 2012. H.R. 4078, Red Tape Reduction and Small Business Job Creation Act. H.R. 5952, To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of scientific information relied upon by the agency. HRes 98, Expressing the Sense of the House of Representatives that the Commissioner of the Food and Drug Administration should give the greatest weight in making critical policy decisions to readily available hard science data, including evidence from the natural sciences, physical sciences, and computing sciences. S. 174, Healthy Lifestyles & Prevention America Act. S. 216, Food Safety Accountability Act. S. 968, Protect IP Act. H.R. 3261, Protect IP Act. S. 1403, IDEA Full Funding Act. S.2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. S. 3187, Food and Drug Administration Safety and Innovation Act. (P.L. 112-144). H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 3240, Farm Bill. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Monitor the implementation of the Temporary Surface Transportation Extension Act of 2012. (P.L. 112-140). H.J.Res 117, Continuing Appropriations Resolution, 2013. (P.L. 112-175) Monitor legislative and administrative action related to sequestration and S. 365, The Budget Control Act. (P.L. 112-25)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Postal Service (USPS)

Monitor federal legislation and activity related to the tobacco industry. Monitor the implementation of PACT Act, (P.L. 111-154). Monitor the implementation of Family Smoking Prevention and Tobacco Control Act, (P.L. 111-31). H.R. 65, Candy Tobacco Tax Parity Act of 2011. H.R. 10, Regulations from the Executive in Need of Scrutiny Act of 2011. S. 299, Regulations from the Executive in Need of Scrutiny Act of 2011. H.R. 1639, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. S. 1461, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. H.R. 3186, Smuggled Tobacco Prevention Act of 2011. S. 1706, Smuggled Tobacco Prevention Act of 2011. H.R. 3010, Regulatory Accountability Act of 2011. S. 1606, Regulatory Accountability Act of 2011. H.R. 3205, FDA Renewing Efficiency From Outside Reviewer Management Act of 2011. H.R. 3214, Food and Drug Administration Mission Reform Act of 2011. S. 1972, Food and Drug Administration Mission Reform Act of 2011. H.R. 3804, American Opportunity and Freedom Act of 2012. H.R. 4064, Keeping Promises to Taxpayers Act of 2012. H.R. 4116, Regulatory Accountability and Economic Freedom Act of 2012. H.R. 4134, To amend the Internal Revenue Code of 1986 to clarify that any person who, for a commercial purpose, makes available for consumer use a machine capable of producing tobacco products, is a manufacturer of tobacco products. H.R. 4351, Let's Grow Act of 2012. H.R. 4078, Red Tape Reduction and Small Business Job Creation Act. H.R. 5952, To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of scientific information relied upon by the agency. HRes 98, Expressing the Sense of the House of Representatives that the Commissioner of the Food and Drug Administration should give the greatest weight in making critical policy decisions to readily available hard science data, including evidence from the natural sciences, physical sciences, and computing sciences. S. 174, Healthy Lifestyles & Prevention America Act. S. 216, Food Safety Accountability Act. S. 968, Protect IP Act. H.R. 3261, Protect IP Act. S. 1403, IDEA Full Funding Act. S.2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. S. 3187, Food and Drug Administration Safety and Innovation Act. (P.L. 112-144). H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 3240, Farm Bill. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Monitor the implementation of the Temporary Surface Transportation Extension Act of 2012. (P.L. 112-140). H.J.Res 117, Continuing Appropriations Resolution, 2013. (P.L. 112-175) Monitor legislative and administrative action related to sequestration and S. 365, The Budget Control Act. (P.L. 112-25)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Postal Service (USPS)

Monitor federal legislation and activity related to the tobacco industry. Monitor the implementation of PACT Act, (P.L. 111-154). Monitor the implementation of Family Smoking Prevention and Tobacco Control Act, (P.L. 111-31). H.R. 65, Candy Tobacco Tax Parity Act of 2011. H.R. 10, Regulations from the Executive in Need of Scrutiny Act of 2011. S. 299, Regulations from the Executive in Need of Scrutiny Act of 2011. H.R. 1639, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. S. 1461, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. H.R. 3186, Smuggled Tobacco Prevention Act of 2011. S. 1706, Smuggled Tobacco Prevention Act of 2011. H.R. 3010, Regulatory Accountability Act of 2011. S. 1606, Regulatory Accountability Act of 2011. H.R. 3205, FDA Renewing Efficiency From Outside Reviewer Management Act of 2011. H.R. 3214, Food and Drug Administration Mission Reform Act of 2011. S. 1972, Food and Drug Administration Mission Reform Act of 2011. H.R. 3804, American Opportunity and Freedom Act of 2012. H.R. 4064, Keeping Promises to Taxpayers Act of 2012. H.R. 4116, Regulatory Accountability and Economic Freedom Act of 2012. H.R. 4134, To amend the Internal Revenue Code of 1986 to clarify that any person who, for a commercial purpose, makes available for consumer use a machine capable of producing tobacco products, is a manufacturer of tobacco products. H.R. 4351, Let's Grow Act of 2012. H.R. 4078, Red Tape Reduction and Small Business Job Creation Act. H.R. 5952, To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of scientific information relied upon by the agency. HRes 98, Expressing the Sense of the House of Representatives that the Commissioner of the Food and Drug Administration should give the greatest weight in making critical policy decisions to readily available hard science data, including evidence from the natural sciences, physical sciences, and computing sciences. S. 174, Healthy Lifestyles & Prevention America Act. S. 216, Food Safety Accountability Act. S. 968, Protect IP Act. H.R. 3261, Protect IP Act. S. 1403, IDEA Full Funding Act. S.2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. S. 3187, Food and Drug Administration Safety and Innovation Act. (P.L. 112-144). H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 3240, Farm Bill. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Monitor the implementation of the Temporary Surface Transportation Extension Act of 2012. (P.L. 112-140). H.J.Res 117, Continuing Appropriations Resolution, 2013. (P.L. 112-175) Monitor legislative and administrative action related to sequestration and S. 365, The Budget Control Act. (P.L. 112-25)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Postal Service (USPS)

Implementation of the Patient Protection and Affordable Care Act (PL - 111-148) and the Health Care and Education Reconciliation Act (PL 111-152) Medicare and Medicaid reimbursement policies related to healthcare associated conditions, healthcare associated infections, readmissions, and payment bundling Comparative effectiveness research and policies Accountable care organizations Competitive bidding Medical Device Tax - H.R. 436, the Healthcare Cost Reduction Act, and S. 17, the Medical Device Access and Innovation Protection Act Regulations related to the adoption of International Classification of Diseases, version 10 (ICD-10) Implementation of the Physician Payments Sunshine Act (PL 111-152, Section 6002) Reauthorization of the Food and Drug Administrations medical device user fee program S. 3187, the Food and Drug Administration Safety and Innovation Act (PL 112-144); H.R. 5651, a bill to extend FDA User Fee Programs; H.R. 3205, FDA Renewing Efficiency from Outside Reviewer Management Act; S. 1700, the Medical Device Regulatory Improvement Act; and S. 1865, the Patient Access to Medical Innovation Act

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

Government targets: Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)

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

Monitor federal legislation and activity related to the tobacco industry. Monitor the implementation of PACT Act, (P.L. 111-154). Mnitor the implementation of Family Smoking Prevention and Tobacco Control Act, (P.L. 111-31). H.R. 65, Candy Tobacco Tax Parity Act of 2011. H.R. 10, Regulations from the Executive in Need of Scrutiny Act of 2011. S. 299, Regulations from the Executive in Need of Scrutiny Act of 2011. H.R. 1639, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. S. 1461, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. H.R. 3186, Smuggled Tobacco Prevention Act of 2011. S. 1706, Smuggled Tobacco Prevention Act of 2011. H.R. 3010, Regulatory Accountability Act of 2011. S. 1606, Regulatory Accountability Act of 2011. H.R. 3205, FDA Renewing Efficiency From Outside Reviewer Management Act of 2011. H.R. 3214, Food and Drug Administration Mission Reform Act of 2011. S. 1972, Food and Drug Administration Mission Reform Act of 2011. H.R. 3804, American Opportunity and Freedom Act of 2012. H.R. 4064, Keeping Promises to Taxpayers Act of 2012. H.R. 4116, Regulatory Accountability and Economic Freedom Act of 2012. H.R. 4134, To amend the Internal Revenue Code of 1986 to clarify that any person who, for a commercial purpose, makes available for consumer use a machine capable of producing tobacco products, is a manufacturer of tobacco products. H.R. 4351, Let's Grow Act of 2012. H.R. 5952, To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of scientific information relied upon by the agency. H.R. 6040, Temporary Surface Transportation Extension Act of 2012. (P.L. 112-140). H.J. Res 98, Expressing the Sense of the House of Representatives that the Commissioner of the Food and Drug Administration should give the greatest weight in making critical policy decisions to readily available hard science data, including evidence from the natural sciences, physical sciences, and computing sciences. S. 174, Healthy Lifestyles & Prevention America Act. S. 216, Food Safety Accountability Act. S. 968, Protect IP Act. H.R. 3261, Protect IP Act. S. 1403, IDEA Full Funding Act. S. AMDT 1825 to S.1813, To reauthorize for 1 year the Secure Rural Schools and Community Self-Determination Act of 2000 and to provide full funding for the Payments in Lieu of Taxes program for 1 year, and for other purposes. S.2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. S. 3187, Food and Drug Administration Safety and Innovation Act. H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 3240, Farm Bill. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Congressional outreach regarding actions at the World Trade Organization specific to tobacco.

Client expense: Not reported · Firm income: $680,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Postal Service (USPS)

Monitor federal legislation and activity related to the tobacco industry. Monitor the implementation of PACT Act, (P.L. 111-154). Mnitor the implementation of Family Smoking Prevention and Tobacco Control Act, (P.L. 111-31). H.R. 65, Candy Tobacco Tax Parity Act of 2011. H.R. 10, Regulations from the Executive in Need of Scrutiny Act of 2011. S. 299, Regulations from the Executive in Need of Scrutiny Act of 2011. H.R. 1639, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. S. 1461, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. H.R. 3186, Smuggled Tobacco Prevention Act of 2011. S. 1706, Smuggled Tobacco Prevention Act of 2011. H.R. 3010, Regulatory Accountability Act of 2011. S. 1606, Regulatory Accountability Act of 2011. H.R. 3205, FDA Renewing Efficiency From Outside Reviewer Management Act of 2011. H.R. 3214, Food and Drug Administration Mission Reform Act of 2011. S. 1972, Food and Drug Administration Mission Reform Act of 2011. H.R. 3804, American Opportunity and Freedom Act of 2012. H.R. 4064, Keeping Promises to Taxpayers Act of 2012. H.R. 4116, Regulatory Accountability and Economic Freedom Act of 2012. H.R. 4134, To amend the Internal Revenue Code of 1986 to clarify that any person who, for a commercial purpose, makes available for consumer use a machine capable of producing tobacco products, is a manufacturer of tobacco products. H.R. 4351, Let's Grow Act of 2012. H.R. 5952, To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of scientific information relied upon by the agency. H.R. 6040, Temporary Surface Transportation Extension Act of 2012. (P.L. 112-140). H.J. Res 98, Expressing the Sense of the House of Representatives that the Commissioner of the Food and Drug Administration should give the greatest weight in making critical policy decisions to readily available hard science data, including evidence from the natural sciences, physical sciences, and computing sciences. S. 174, Healthy Lifestyles & Prevention America Act. S. 216, Food Safety Accountability Act. S. 968, Protect IP Act. H.R. 3261, Protect IP Act. S. 1403, IDEA Full Funding Act. S. AMDT 1825 to S.1813, To reauthorize for 1 year the Secure Rural Schools and Community Self-Determination Act of 2000 and to provide full funding for the Payments in Lieu of Taxes program for 1 year, and for other purposes. S.2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. S. 3187, Food and Drug Administration Safety and Innovation Act. H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 3240, Farm Bill. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Congressional outreach regarding actions at the World Trade Organization specific to tobacco.

Client expense: Not reported · Firm income: $680,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Postal Service (USPS)

Monitor federal legislation and activity related to the tobacco industry. Monitor the implementation of PACT Act, (P.L. 111-154). Mnitor the implementation of Family Smoking Prevention and Tobacco Control Act, (P.L. 111-31). H.R. 65, Candy Tobacco Tax Parity Act of 2011. H.R. 10, Regulations from the Executive in Need of Scrutiny Act of 2011. S. 299, Regulations from the Executive in Need of Scrutiny Act of 2011. H.R. 1639, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. S. 1461, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. H.R. 3186, Smuggled Tobacco Prevention Act of 2011. S. 1706, Smuggled Tobacco Prevention Act of 2011. H.R. 3010, Regulatory Accountability Act of 2011. S. 1606, Regulatory Accountability Act of 2011. H.R. 3205, FDA Renewing Efficiency From Outside Reviewer Management Act of 2011. H.R. 3214, Food and Drug Administration Mission Reform Act of 2011. S. 1972, Food and Drug Administration Mission Reform Act of 2011. H.R. 3804, American Opportunity and Freedom Act of 2012. H.R. 4064, Keeping Promises to Taxpayers Act of 2012. H.R. 4116, Regulatory Accountability and Economic Freedom Act of 2012. H.R. 4134, To amend the Internal Revenue Code of 1986 to clarify that any person who, for a commercial purpose, makes available for consumer use a machine capable of producing tobacco products, is a manufacturer of tobacco products. H.R. 4351, Let's Grow Act of 2012. H.R. 5952, To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of scientific information relied upon by the agency. H.R. 6040, Temporary Surface Transportation Extension Act of 2012. (P.L. 112-140). H.J. Res 98, Expressing the Sense of the House of Representatives that the Commissioner of the Food and Drug Administration should give the greatest weight in making critical policy decisions to readily available hard science data, including evidence from the natural sciences, physical sciences, and computing sciences. S. 174, Healthy Lifestyles & Prevention America Act. S. 216, Food Safety Accountability Act. S. 968, Protect IP Act. H.R. 3261, Protect IP Act. S. 1403, IDEA Full Funding Act. S. AMDT 1825 to S.1813, To reauthorize for 1 year the Secure Rural Schools and Community Self-Determination Act of 2000 and to provide full funding for the Payments in Lieu of Taxes program for 1 year, and for other purposes. S.2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. S. 3187, Food and Drug Administration Safety and Innovation Act. H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 3240, Farm Bill. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Congressional outreach regarding actions at the World Trade Organization specific to tobacco.

Client expense: Not reported · Firm income: $680,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Postal Service (USPS)

Monitor federal legislation and activity related to the tobacco industry. Monitor the implementation of PACT Act, (P.L. 111-154). Mnitor the implementation of Family Smoking Prevention and Tobacco Control Act, (P.L. 111-31). H.R. 65, Candy Tobacco Tax Parity Act of 2011. H.R. 10, Regulations from the Executive in Need of Scrutiny Act of 2011. S. 299, Regulations from the Executive in Need of Scrutiny Act of 2011. H.R. 1639, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. S. 1461, Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011. H.R. 3186, Smuggled Tobacco Prevention Act of 2011. S. 1706, Smuggled Tobacco Prevention Act of 2011. H.R. 3010, Regulatory Accountability Act of 2011. S. 1606, Regulatory Accountability Act of 2011. H.R. 3205, FDA Renewing Efficiency From Outside Reviewer Management Act of 2011. H.R. 3214, Food and Drug Administration Mission Reform Act of 2011. S. 1972, Food and Drug Administration Mission Reform Act of 2011. H.R. 3804, American Opportunity and Freedom Act of 2012. H.R. 4064, Keeping Promises to Taxpayers Act of 2012. H.R. 4116, Regulatory Accountability and Economic Freedom Act of 2012. H.R. 4134, To amend the Internal Revenue Code of 1986 to clarify that any person who, for a commercial purpose, makes available for consumer use a machine capable of producing tobacco products, is a manufacturer of tobacco products. H.R. 4351, Let's Grow Act of 2012. H.R. 5952, To require each Federal agency to submit and obtain approval from the Director of the Office of Science and Technology Policy of guidelines for ensuring and maximizing the quality, objectivity, utility, and integrity of scientific information relied upon by the agency. H.R. 6040, Temporary Surface Transportation Extension Act of 2012. (P.L. 112-140). H.J. Res 98, Expressing the Sense of the House of Representatives that the Commissioner of the Food and Drug Administration should give the greatest weight in making critical policy decisions to readily available hard science data, including evidence from the natural sciences, physical sciences, and computing sciences. S. 174, Healthy Lifestyles & Prevention America Act. S. 216, Food Safety Accountability Act. S. 968, Protect IP Act. H.R. 3261, Protect IP Act. S. 1403, IDEA Full Funding Act. S. AMDT 1825 to S.1813, To reauthorize for 1 year the Secure Rural Schools and Community Self-Determination Act of 2000 and to provide full funding for the Payments in Lieu of Taxes program for 1 year, and for other purposes. S.2375, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. H.R. 5973, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2013. S. 3187, Food and Drug Administration Safety and Innovation Act. H.R. 5651, Food and Drug Administration Reform Act of 2012. S. 3240, Farm Bill. S. 3295, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Draft, House Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2013. Congressional outreach regarding actions at the World Trade Organization specific to tobacco.

Client expense: Not reported · Firm income: $680,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Postal Service (USPS)

The Drug and Medical Device Company Gift Disclosure Act Patient Safety Legislation Healthcare Associated Conditions (HAC's) and Infections (HAI's), Readmissions and Bundling Comparative Effectiveness Research Accountable Care Organizations Competitive Bidding ICD-10 Adoption Medical Device Tax Repeal (H.R.436, S.17) Medicare and Medicaid Reimbursement Policy Implementation of the Patient Protection and Affordable Care Act (PPACA), PL111-148 S.3187 - Food and Drug Administration Safety and Innovation Act H.R.5651 - A bill to extend FDA User Fee Programs for prescription drugs, medical devices, and more H.R. 3205 - FDA Renewing Efficiency From Outside Reviewer Management Act S.1700 - The Medical Device Regulatory Improvement Act S.1865 - The Patient Access to Medical Innovation Act

Client expense: $1,760,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Defense, Dept of (DOD), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Federal Highway Administration (FHA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA)

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

- 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)

**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

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