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 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 included in P.L. 117-328, the Consolidated Appropriations Act, 2023, 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: $730,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.4373 - Further Additional Continuing Appropriations and Extensions Act, 2023 as it relates to FDA policy riders. H.R.8299 - 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.

Client expense: Not reported · Firm income: $40,000

Government targets: HOUSE OF REPRESENTATIVES

- 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