A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.

- HR 1978/S 912, "Protecting Seniors Through Immunization Act", regarding all provisions - HR 6007, "To amend title XVIII of the Social Security Act to provide for the expansion of coverage of vaccines under part B of the Medicare program, and for other purposes", regarding all provisions - H.Res. 446, Expressing support for the goals and ideals of National Stroke Awareness Month, regarding all provisions - S 610/HR 1667, "The Dr. Lorna Breen Health Care Provider Protection Act", regarding all provisions - HR 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - S 1784/HR 3353, Contact Lens Prescription Verification Modernization Act, regarding all provisions - HR 5030/S 2706, "The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, regarding all provisions - S 3394, "Emergency Use Transparency Act", regarding all provisions - HR 5376, "Build Back Better Act", regarding provisions on drug pricing and provisions related to revenue - HR 3990/S 2047, "No PFAS in Cosmetics Act", regarding all provisions - HR 8299/S 4386, FDA review of certain changes to software in medical devices or predetermined change control plans - HR 7667/S 4348, "Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act", regarding provisions on accelerated approval and diversity in clinical studies - HR 5801, "HELP Copays Act", regarding all provisions - HR 3173/S 3018 - "Improving Seniors Timely Access to Care Act of 2021" - S 3799 - "PREVENT Pandemics Preparedness Act" - HR 3932/S 2079 - "PASTEUR Act of 2021" - HR 5376 - "Inflation Reduction Act", regarding provisions on prescription drugs - Issues related to Dengue - Issues related to prescription drug pricing - Issues related to health care pricing transparency - Issues related to maternal health - Issues related to frontline health workers - Issues related to over the counter products - Issues related to the regulation of cosmetic products - Issues related to the regulation of dietary supplements - Issues related to stroke care - Issues related to counterfeit health care goods - Issues related to 340B drug pricing program - Issues related to antimicrobial resistance - Issues related to the COVID-19 vaccine development, including diversity in clinical trials - Issues related to Medicare Part D's 6 protected classes - Issues related to global public health and ending tuberculosis - Issues pertaining to health equity and social determinants of health - Issues related to FDA medical device shortage reporting requirements, including implementation of CARES Act requirements - Issues related to lung cancer screening - Issues related to clinical research diversity - Issues related to international harmonization of medical device regulation

Client expense: $2,170,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to H.R. 6000, Cures 2.0 Act Issues related to global medical supply chains Issues related to opioid-induced respiratory compromise continuous patient monitoring, including H.R. 5932 - Inpatient Opioid Safety Act of 2021 Issues related to disparities of care Issues pertaining to FDA, including S.4348 - FDASLA Act of 2022, H.R.7667 - Food and Drug Amendments of 2022, S. 3799 - PREVENT Pandemics Act, S. 4391 - CLEAR Documentation Act - regarding certificates to foreign government, H.R. 8299/S. 4386 - regarding device change control plans, and H.R. 7084/A. 3983 -Patch Act of 2022, pertaining to cyber security of medical devices Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices Support for the Cardiovascular Advances in Research and Opportunity Legacy (CAROL) Act (H.R. 1193 and S. 1133) Issues related to Cancer Moonshot proposals

Client expense: $1,463,550 · Firm income: Not reported

Issues related to privacy, data security, cybersecurity, net neutrality, broadband mapping, infrastructure, spectrum, contraband cell phones in correctional facilities, robocalls, taxation, and the deployment of broadband including 5G; H.R.5376, Inflation Reduction Act of 2022 (P.L.117-169); S.4386, A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan; H.R.7624, Spectrum Innovation Act of 2022; H.R.8152, American Data Privacy and Protection Act; H.R.7900/S.4543, National Defense Authorization Act for Fiscal Year 2023; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180).

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

- HR 1978/S 912, "Protecting Seniors Through Immunization Act", regarding all provisions - HR 6007, "To amend title XVIII of the Social Security Act to provide for the expansion of coverage of vaccines under part B of the Medicare program, and for other purposes", regarding all provisions - H.Res. 446, Expressing support for the goals and ideals of National Stroke Awareness Month, regarding all provisions - S 610/HR 1667, "The Dr. Lorna Breen Health Care Provider Protection Act", regarding all provisions - HR 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - S 1784/HR 3353, Contact Lens Prescription Verification Modernization Act, regarding all provisions - HR 5030/S 2706, "The Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act, regarding all provisions - S 3394, "Emergency Use Transparency Act", regarding all provisions - HR 5376, "Build Back Better Act", regarding provisions on drug pricing and provisions related to revenue - HR 3990/S 2047, "No PFAS in Cosmetics Act", regarding all provisions - HR 8299/S 4386, FDA review of certain changes to software in medical devices or predetermined change control plans - HR 7667/S 4348, "Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act", regarding provisions on accelerated approval and diversity in clinical studies - HR 5801, "HELP Copays Act", regarding all provisions - Issues related to prescription drug pricing - Issues related to health care pricing transparency - Issues related to maternal health - Issues related to frontline health workers - Issues related to over the counter products - Issues related to the regulation of cosmetic products - Issues related to the regulation of dietary supplements - Issues related to stroke care - Issues related to counterfeit health care goods - Issues related to 340B drug pricing program - Issues related to antimicrobial resistance - Issues related to the COVID-19 vaccine development, including diversity in clinical trials - Issues related to Medicare Part D's 6 protected classes - Issues related to global public health and ending tuberculosis - Issues pertaining to health equity and social determinants of health - Issues related to FDA medical device shortage reporting requirements, including implementation of CARES Act requirements - Issues related to lung cancer screening - Issues related to clinical research diversity - Issues related to international harmonization of medical device regulation

Issues related to the implementation of PL 115-52, The Food and Drug Administration Reauthorization Act Issues related to the medical supply chain Issues related to implementation of the 21st Century Cures Act Issues related to the competitiveness of the medical technology industry and the impact of Federal Policies Issues related to third party servicing of medical devices Issues related to medical device sterilization and the use of ethylene oxide to sterilize medical devices Issues related to coverage and reimbursement of COVID-19 diagnostic tests Issues related to the Valid Act of 2021 - HR 4128/S. 2209 Improving Medical Device Servicing to Protect Patient Safety Act Issues related to the Critical Medical Infrastructure Right-to-Repair Act Issues related to Health Equity Issues related to the PASTEUR Act of 2021 - S. 2076/HR 3932 Issues related to HR 1319/S 2401 Rescue America Plan Issues related to COVID-19 Clinical Testing & Testing Supplies Issues related to Public Health Emergency Preparedness Issues related to PFAS Chemical regulation, H.R. 2457 PFAS Action Act COVID-19 Clinical Testing and Testing Supplies Issues related to consumer and health data privacy Issues related to MDUFA Reauthorization Issues related to PFAS Chemical regulation, H.R. 2457 PFAS Action Act Issues related to HR 7667, Food and Drug Amendments of 2022 Issues related to S. 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act Issues related to S. 4386, A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan. Issues related to S. 3799, PREVENT Pandemics Act

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

Issues related to H.R. 6000, Cures 2.0 Act Issues related to global medical supply chains Issues related to opioid-induced respiratory compromise continuous patient monitoring, including H.R. 5932 - Inpatient Opioid Safety Act of 2021 Issues related to disparities of care Issues pertaining to FDA, including S.4348 - FDASLA Act of 2022, H.R.7667 - Food and Drug Amendments of 2022, S. 3799 - PREVENT Pandemics Act, S. 4391 - CLEAR Documentation Act, and S. 4386 - regarding device change control plans and H.R. 7084/A. 3983 -Patch Act of 2022, pertaining to cyber security of medical devices Issues related to the sterilization of medical devices Issues related to servicing and repair of medical devices Support for the Cardiovascular Advances in Research and Opportunity Legacy (CAROL) Act (H.R. 1193 and S. 1133) Issues related to Cancer Moonshot proposals

Client expense: $666,100 · Firm income: Not reported

Issues related to privacy, data security, cybersecurity, net neutrality, broadband mapping, infrastructure, spectrum, contraband cell phones in correctional facilities, robocalls, taxation, and the deployment of broadband including 5G; H.R.1848, LIFT America Act; H.R.1783, Accessible, Affordable Internet for All Act; Implementation of H.R.3684, Infrastructure Investment and Jobs Act (P.L.117-58); FY2022 Budget Reconciliation (H.R.5376); H.R.4521, America COMPETES Act of 2022; S.4386, A bill to allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan; H.R.7624, Spectrum Innovation Act of 2022; H.R.8152, American Data Privacy and Protection Act.

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