Food and Drug Administration Mission Reform 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

H. Res. 98, expressing the sense of the House 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. H.R. 1364, to amend the Federal Food, Drug, and Cosmetic Act concerning the distribution of information on legitimate scientific research in connection with foods and dietary supplements, and for other purposes. H.R. 1382, to require the president to call a White House conference on food and nutrition; to Agriculture. H.R. 2044, to amend the Federal Food, Drug, and Cosmetic Act concerning claims about the effects of foods and dietary supplements on health-related conditions and disease, and for other purposes; to Energy & Commerce. H.R.2045, to amend the Federal Trade Commission Act concerning the burden of proof in false advertising cases involving dietary supplements and dietary ingredients. H.R.2045, to amend the Federal Trade Commission Act concerning the burden of proof in false advertising cases involving dietary supplements and dietary ingredients. H.R. 3214, to amend the Food and Drug Administration's mission; to Energy & Commerce. S. 216, to increase criminal penalties for certain knowing and international violations relating to food that is misbranded or adulterated. S. 1581, to improve the importer of record program and the collection of fees and duties in connection with the importation of merchandise into the United States, and for other purposes. S. 1662, to amend the Federal Food, Drug, and Cosmetic Act to establish a nanotechnology regulatory science program.

Client expense: $110,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of, 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

H. Res. 98, expressing the sense of the House 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. H.R. 1364, to amend the Federal Food, Drug, and Cosmetic Act concerning the distribution of information on legitimate scientific research in connection with foods and dietary supplements, and for other purposes. H.R. 1382, to require the president to call a White House conference on food and nutrition. H.R. 2044, to amend the Federal Food, Drug, and Cosmetic Act concerning claims about the effects of foods and dietary supplements on health-related conditions and disease, and for other purposes; to Energy & Commerce. H.R.2045, to amend the Federal Trade Commission Act concerning the burden of proof in false advertising cases involving dietary supplements and dietary ingredients. H.R. 3214, to amend the Food and Drug Administration's mission; to Energy & Commerce. S. 216, to increase criminal penalties for certain knowing and international violations relating to food that is misbranded or adulterated; to Judiciary. S. 1581, to improve the importer of record program and the collection of fees and duties in connection with the importation of merchandise into the United States, and for other purposes; to Finance. S. 1662, to amend the Federal Food, Drug, and Cosmetic Act to establish a nanotechnology regulatory science program; to Health, Education, Labor, & Pensions.

Client expense: $110,000 · Firm income: Not reported

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). 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)

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)

H. Res. 98, expressing the sense of the House 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. H.R. 1364, to amend the Federal Food, Drug, and Cosmetic Act concerning the distribution of information on legitimate scientific research in connection with foods and dietary supplements, and for other purposes. H.R. 1382, to require the president to call a White House conference on food and nutrition; to Agriculture. H.R. 2044, to amend the Federal Food, Drug, and Cosmetic Act concerning claims about the effects of foods and dietary supplements on health-related conditions and disease, and for other purposes; to Energy & Commerce. H.R.2045, to amend the Federal Trade Commission Act concerning the burden of proof in false advertising cases involving dietary supplements and dietary ingredients. H.R.2045, to amend the Federal Trade Commission Act concerning the burden of proof in false advertising cases involving dietary supplements and dietary ingredients. H.R. 3214, to amend the Food and Drug Administration's mission; to Energy & Commerce. S. 216, to increase criminal penalties for certain knowing and international violations relating to food that is misbranded or adulterated. S. 1581, to improve the importer of record program and the collection of fees and duties in connection with the importation of merchandise into the United States, and for other purposes. S. 1662, to amend the Federal Food, Drug, and Cosmetic Act to establish a nanotechnology regulatory science program.

Client expense: $110,000 · Firm income: Not reported

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

Biosimilars Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Reimbursement Issues Comparative Effectiveness Research Initiatives Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Funding for National Institutes of Health Cures Acceleration Network National Center for Advancing Translation Science (NCATS) S. 3295: Departments of Labor, HHS, and Education, and Related Agencies Appropriations Act for FY 2013 Funding for Centers for Disease Control and Prevention Vaccine Programs S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Vaccine Access/Financing Tax for Seasonal Influenza Funding Adult Immunization Policies Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act 340B Drug Pricing Program HRSA Implementation of Program Changes Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act Rare Pediatric & Tropical Disease Drug Development Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R. 2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Independent Payment Advisory Board H.R. 5: Protecting Access to Healthcare Act of 2011 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement S. 3295: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2013 Biodefense Research, Development and Procurement (Non-Funding Issues) S. 1855: Pandemic and All Hazards Preparedness Act (PAHPA) Reauthorization of 2011 Reimbursement for Innovative Products Medicare Part B Physician-Administered Products Medicare Part D Prescription Drug Program TransPacific Partnership Data and Intellectual Property Protection for Pharmaceuticals Regulatory Transparency Therapeutic Discovery Project Tax Credit Extension S.3232: A Bill to Amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to Extend, Expand, and Improve the Qualifying Therapeutic Discovery Project Program

Client expense: $2,070,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Navy, Dept of, Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

Livestock Cloning/Product Labeling Discussions with EU on Animal Cloning USDA/APHIS Agricultural Biotechnology Regulations Efficient Science-Based Review of Biotech Products National Environmental Policy Act Requirements Coexistence of Production Systems S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Federal Agriculture Reform and Risk Management Act of 2012 (House Farm Bill Discussion Draft) Genetically Engineered Animals Labeling FDA Approval S. 1717: Prevention of Escapement of Genetically Altered Salmon in the United States Act of 2012 S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Amendment to Restrict FDA Approval of GE Salmon S. 3187: Food and Drug Administration Safety and Innovation Act of 2012 Amendment to Restrict FDA Approval of GE Salmon Labeling of Genetically Engineered Crops S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 S. 3240: Agriculture Reform, Food, and Jobs Act of 2012 (Farm Bill) Amendment to Require Labeling of Biotech Food Drug Safety and Review/Prescription Drug User Fee Act (PDUFA) Reauthorization Critical Path Initiative E-Pedigree and Anti-Counterfeiting Regulatory Reforms for Innovative Products Supply Chain Integrity Conflicts of Interest FDA Mission Drug Shortages Expedited Approval Pathways Access to External Experts FDA Globalization Act (Discussion Draft) Senate HELP Committee Discussion Draft House Energy and Commerce Committee Discussion Draft H.R.4132: Faster Access to Specialized Treatments (FAST) Act S. 3187:The Food and Drug Administration Safety and Innovation Act S. 2113: Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act of 2011 H.R.2182: Generating Antibiotic Incentives Now Act of 2011 H.R.3214: Food and Drug Administration Mission Reform Act of 2011 H.R.1483: Drug Safety Enhancement Act of 2011 Funding for FDA (Human Drug Review, Biologics, Food Safety, Critical Path, Reagan-Udall Foundation, Medical Countermeasures, Center for Veterinary Medicine, Scientific Infrastructure) S.R.2375/H.R. 5973: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2013 Reporting of Physician Payments Implementation of H.R. 3590: (Senate) Patient Protection and Affordable Care Act

Client expense: $2,070,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), Navy, Dept of, Patent & Trademark Office (PTO), SENATE, Small Business Administration (SBA), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

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

H.R. 1483, Drug Safety Enhancement Act of 2011: Provisions related to supply chain issues H.R. 2227, Medical Gas Safety Act: Provisions regarding the regulation of medical gases H.R. 2245, Preserving Access to Life-Saving Medications Act of 2011: Provisions related to prescription drug shortages H.R. 2674, 340B Program Improvement Act: Provisions related to 340B H.R. 3204, Guidance Accountability and Transparency Act: Provisions to set forth interpretation policy of FDA guidance H.R. 3214, Food and Drug Administration Mission Reform Act of 2011: Provisions to revise the mission of the Food and Drug Administration H.R. 3261, Stop Online Piracy Act: Provisions related to anti-counterfeiting H.R. 3468, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti-counterfeiting H.R. 3839, Drug Shortage Prevention Act of 2012: Provisions related to prescription drug shortages H.R. 4095, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies H.R. 4132, FAST Act: Provisions related to accelerated approval and other FDA matters H.R. 4156, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases H.R. 4223, Safe Doses Act: Provisions related to supply chain security H.R. 4274, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003 H.R. 4332, Generic Drug Application Review Fairness Act of 2012: Provisions related to FDA review and exclusivity H.R. 5651, Food and Drug Administration Reform Act of 2012: Provisions related to user fee reauthorization and FDA reform S. 296, Preserving Access to Life-Saving Medications Act: Provisions related to prescription drug shortages S. 1002, Safe Doses Act: Provisions related to supply chain security S. 1584, Drug Safety and Accountability Act of 2011: Provisions related to supply chain issues S. 1699, Prescription Drug Cost Reduction Act: Provisions related to 340B S. 1886, Counterfeit Drug Penalty Enhancement Act of 2011: Provisions related to anti- counterfeiting S. 2002, Online Pharmacy Safety Act: To improve the safety of Internet pharmacies S. 2113, Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act: Provisions related to accelerated approval and other FDA matters S. 2236, Advancing Breakthrough Therapies for Patients Act of 2012: Provisions related to FDA regulation S.2281, Expanding and Promoting Expertise in Rare Treatments Act of 2012: To strengthen the FDAs ability to seek advice from external experts regarding rare diseases S. 3187, Food and Drug Administration Safety and Innovation Act: Provisions related to user fee reauthorization and FDA reform Comparative effectiveness policy issues Health care reform implementation issues General HHS and FDA related advocacy Biopharmaceutical innovation policy issues

Client expense: $4,840,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Security Council (NSC), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

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

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

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

S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.

Client expense: $1,440,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.

Client expense: $1,220,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

**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