PATRICIA KNIGHT

Potential amendments to the SNAP program in the farm bill - farm bill extension continued in American Relief Act. HR 10545

Funding for the Food and Drug Administration regulation of dietary supplement products, HR 9027, Fy 2025 Agriculture Appropriations Act, HR 10545- American Relief Act.

Legislation to allow HSA/FSA coverage of dietary supplements (HR 5967, HSA Modernization Act)

Potential amendments related to dietary supplements in HELP Committee legislation being developed with respect to pharmaceutical pricing and consumer access (S 1339, pharmacy Benefit Manger Reform Act) Legislation including provisions to allow and clarify Food and Drug Administration regulation of hemp-derived/CBD products (HR 1629, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act, S 2451, the Cannabinoid Safety and Regulation Act; HR 1628, the CBD Product Safety and Standardization Act).

Legislation to allow HSA/FSA coverage of dietary supplements (HR 5967, HSA Modernization Act)

Funding for the Food and Drug Administration regulation of dietary supplement products, HR 9027, Fy 2025 Agriculture Appropriations Act

Potential amendments to the SNAP program in the farm bill

Potential amendments related to dietary supplements in HELP Committee legislation being developed with respect to pharmaceutical pricing and consumer access (S 1339, pharmacy Benefit Manger Reform Act) Legislation being developed to clarify Food and Drug Administration regulation of hemp-derived/CBD products (no bill numbers yet)

Funding for the Food and Drug Administration regulation of dietary supplement products, HR 9027, Fy 2025 Agriculture Appropriations Act

Potential amendments to the SNAP program in the farm bill

Funding for programs to support substance abuse education and treatment (Labor-HHS Appropriations bill for Fy 2025/ mo bill number yet)

Access to medication-assisted therapy for opioid overuse, and the use of telemedicine for provision of services (HR 4531, Support for Patients and Communities Reauthorization/ no Senate number yet )

Medicaid Reentry Act - Legislation to allow Medicaid reimbursement for health care services 30 days prior to release from incarceration. HR 2400/ S. 1165).

Potential amendments related to dietary supplements in HELP Committee legislation being developed with respect to pharmaceutical pricing and consumer access (S 1339, pharmacy Benefit Manger Reform Act) Legislation being developed to clarify Food and Drug Administration regulation of hemp-derived/CBD products (no bill numbers yet)

Legislation to allow HSA/FSA coverage of dietary supplements (HR 5967, HSA Modernization Act)

Funding for the Food and Drug Administration regulation of dietary supplement products, HR 4368/ S 2131 Fy 2024 Agriculture Appropriation; the Continuing Appropriations Act, 2024 (HR 5860)

Implementation of funding for programs to support substance abuse education and treatment (HR 4368, Labor-HHS Appropriations bill for Fy 2024/ S. 2624)

Potential amendments to the Inflation Reduction Act dealing with policies for treatment of opioid overuse disorder.

Access to medication-assisted therapy for opioid overuse, and the use of telemedicine for provision of services (HR 4531, Support for Patients and Communities Reauthorization/ no Senate number yet )

Issues affecting biotechnology firms engaged in developing gene therapies, including: the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDAcAAP-approved products under certain circumstances.) Potential amendments to the Food, Drug and Cosmetic Act, the Public Health Service Act, or the Social Security Act that would impact the provision of cell and gene therapies (no specific legislation):. -

Monitor discussion of proposals to affect the R&D Tax Credit (no specific legislation)

Potential amendments to the Inflation Reduction Act dealing with policies for treatment of opioid overuse disorder.

Access to medication-assisted therapy for opioid overuse, and the use of telemedicine for provision of services (HR 4531, Support for Patients and Communities Reauthorization/ no Senate number yet )

Adequacy of funding for programs to support substance abuse education and treatment (HR 4368, Labor-HHS Appropriations bill for Fy 2024/ S. 2624)

Potential amendments related to dietary supplements in HELP Committee legislation being developed with respect to pharmaceutical pricing and consumer access (S 1339, pharmacy Benefit Manger Reform Act) Legislation being developed to clarify Food and Drug Administration regulation of hemp-derived/CBD products (no bill numbers yet)

Legislation to allow HSA/FSA coverage of dietary supplements (HR 5967, HSA Modernization Act)

Funding for the Food and Drug Administration regulation of dietary supplement products, HR 4368/ S 2131 Fy 2024 Agriculture Appropriation; the Continuing Appropriations Act, 2024 (HR 5860)

Medicaid Reentry Act - Legislation to allow Medicaid reimbursement for health care services 30 days prior to release from incarceration. HR 2400/ S. 1165).

Access to medication-assisted therapy for opioid overuse, and the use of telemedicine for provision of services (HR 4531, Support for Patients and Communities Reauthorization/ no Senate number yet

Potential amendments to the Inflation Reduction Act dealing with policies for treatment of opioid overuse disorder.

Monitor discussion of proposals to affect the R&D Tax Credit (no specific legislation)

Development of legislation that would affect the research, regulation or pricing of biopharmaceuticals, including implementation of the Inflation Reduction Act (no specific legislation)

Issues affecting biotechnology firms engaged in developing gene therapies, including: the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDAcAAP-approved products under certain circumstances.) Potential amendments to the Food, Drug and Cosmetic Act, the Public Health Service Act, or the Social Security Act that would impact the provision of cell and gene therapies (no specific legislation):. -

Legislation to allow HSA/FSA coverage of dietary supplements (HR 5967, HSA Modernization Act)

Funding for the Food and Drug Administration regulation of dietary supplement products, HR 4368/ S 2131 Fy 2024 Agriculture Appropriation; the Continuing Appropriations Act, 2024 (HR 5860)

Potential amendments related to dietary supplements in HELP Committee legislation being developed with respect to pharmaceutical pricing and consumer access (S 1339, pharmacy Benefit Manger Reform Act) Legislation being developed to clarify Food and Drug Administration regulation of hemp-derived/CBD products (no bill numbers yet)

Potential amendments to the Inflation Reduction Act dealing with pharmaceutical reimbursements.

Adequacy of funding for programs to support substance abuse education and treatment (HR 4368, Labor-HHS Appropriations bill for Fy 2024)

Access to medication-assisted therapy for opioid overuse, and the use of telemedicine for provision of services (HR 4531, Sipport for Patients and Communities Reauthorization)

Monitor discussion of proposals to affect the R&D Tax Credit (no specific legislation)

Potential amendments to the Social Security Act to allow value-based pricing under Medicaid (HR 2666)

Issues affecting biotechnology firms engaged in developing gene therapies, including: the MVP Act (H.R.2666) authorizing value based payments under the Medicaid program; Proposals to amend the drug pricing provisions of the Inflation Reduction Act such as reducing the 13-year period before newly approved biologics are subject to negotiated prices; Changes to the Orphan Drug Act; and, Potential legislative or administrative changes to the FDA accelerated approval program including reimbursement of AAP-approved gene therapies (e.g., MedPAC recommendations to cap prices for FDAcAAP-approved products under certain circumstances.) Potential amendments to the Food, Drug and Cosmetic Act, the Public Health Service Act, or the Social Security Act that would impact the provision of cell and gene therapies (no specific legislation):. -

Funding for the Food and Drug Administration regulation of dietary supplement products, HR 4368/ S 2131 Fy 2024 Agriculture Appropriations

Potential amendments related to dietary supplements in HELP Committee legislation being developed with respect to pharmaceutical pricing and consumer access (S 1339, pharmacy Benefit Manger Reform Act) Legislation being developed to clarify Food and Drug Administration regulation of hemp-derived/CBD products (no bill numbers yet)

Potential amendments to the SNAP program in the farm bill (no bill number yet)

Adequacy of funding for programs to support substance abuse education and treatment (no legislation yet);

Access to medication-assisted therapy for opioid overuse, and the use of telemedicine for provision of services (no specific legislation yet)

Potential amendments to the Inflation Reduction Act dealing with pharmaceutical reimbursements.

Development of legislation that would affect the research, regulation or pricing of biopharmaceuticals (no specific legislation)

Potential amendments to the Food, Drug and Cosmetic Act, the Public Health Service Act, or the Social Security Act that would impact the provision of cell and gene therapies (no specific legislation):to any successor to the Guthrie-Schrader MVP Act (formerly HR 7389) authorizing Medicaid value-based payments; -Changes to the Orphan Drug Act; -legislation affecting reimbursement of pharmaceuticals, including potential amendments to the Inflation Reduction Act; -

Potential amendments to the Social Security Act to allow value-based pricing under Medicaid (no bill number yet)

Potential amendments to the SNAP program in the farm bill (no bill number yet)

Funding for the Food and Drug Administration regulation of dietary supplement products, no specific legislation

Potential amendments related to dietary supplements in HELP Committee legislation being developed with respect to pharmaceutical pricing and consumer access (no bill yet) Legislation being developed to clarify Food and Drug Administration regulation of hemp-derived/CBD products.

Funding for mental health and substance abuse research and grants; issues related to regulation and pricing of pharmaceuticals in any FY 2023 Labor-HHS appropriations act or in the Consolidated Appropriations Act PL 117-328).

Mainstreaming Addiction Treatment Act ( HR 1384; S 445, PL 117-328, Consolidated Appropriations Act)); Medication Access and Training Expansion Act, (HR 2067, HR 7667, PL 117-328); Reducing Barriers to Substance use Training Act (no bill number in this Congress).

The Medicaid Re-entry Act (H.R. 955/S. 445); policies related to reimbursement of substance use disorder treatment (Restoring Hope for Mental Health and Well-Being Act, HR 7666). Possible changes in reimbursement for pharmaceuticals (HR 3, HR 5376 - Build Back Better Act, and any successor legislation, budget reconciliation legislation (no bill numbers)

Potential changes in the corporate tax rate or other provisions of interest to business (Build Back Better Act, H.R. 5376 or any successor budget reconciliation legislation; Consolidated Appropriations Act, 2023, PL 117-328).

Potential legislation implementing value based purchasing for pharmaceuticals (HR 7389); Possible provisions related to Drug Pricing Legislation that affect biological products' development, approval, accelerated approval, and marketing, including deliberations associated with the Reauthorization of the Prescription Drug User Fee Act ( HR 7667) (S 4348), or the continuing resolution(Further Extendjnf Government Funding Act P.L. 117-70. Possible drug pricing legislation included in any budget reconciliation legislation ( no specific number). Reauthorization of the Newborn Screening Saves Lives Act (HR 482, S 350.) Consolidated Appropriations Act, 2033. ( PL 117-328).

Adequacy of Food and Drug Administration budget for dietary supplement policy making and enforcement for FY 2023 - (HR 2617- Consolidated Appropriations Act of 2023 (PL 117-327).

Impact on agricultural interests of FDA's lack of clarity on CBD/hemp dietary supplement products (S. 1698/ H.R. 841).

Potential dietary supplement mandatory product listing program (S. 4090), Dietary Supplement Listing Act, (S. 4348, Food and Drug Administration Safety and Landmark Advancement Act FDASLA, no House companion measure (PL 117-328, Consolidated Appropriations Act, 2023).

Monitor NIOSH proceedings with respect to worker safety and closed-system transfer devices.

Mainstreaming Addiction Treatment Act (HR 2067, HR 7667); Drug Enforcement Administration regulation of buprenorphine under the Controlled Substances Act. Food and Drug Administration Safety and Landmark Advancement act FDASLA / FDA user fee reauthorization (HR 7667, S 4348, PL 117-70, Further Extending Government Funding Act) ; Restoring Hope for Mental Health and Well-Being Act (HR 7666); Medication Access and Training Expansion Act (HR 2067, S 2235); the MOBILE Act, Maximizing Outcomes through Better Investment in Life Saving Equipment Act (PL 117-204).

Mainstreaming Addiction Treatment Act ( HR 1384; S 445); Medication Access and Training Expansion Act, (HR 2067, HR 7667); Reducing Barriers to Substance use Training Act (no bill number in this Congress).

Adequacy of Food and Drug Administration budget for dietary supplement policy making and enforcement. FY 2023 Agriculture Appropriations or the FY 2023 continuing resolution (PL 117-103).

Potential dietary supplement mandatory product listing program (S. 4090), Dietary Supplement ListingAct, (S. 4348, Food and Drug Administration Safety and Landmark Advancement Act FDASLA, no House companion measure, FZy 2023 continuing resolution (PL 117-103).

Impact on agricultural interests of FDA's lack of clarity on CBD/hemp dietary supplement products (S. 1698/ H.R. 841).

Potential legislation implementing value based purchasing for pharmaceuticals (HR 7389); Possible provisions related to Drug Pricing Legislation that affect biological products' development, approval, accelerated approval, and marketing, including deliberations associated with the Reauthorization of the Prescription Drug User Fee Act ( HR 7667) (S 4348), or the continuing resolution(Further Extendjnf Government Funding Act P.L. 117-70. Possible drug pricing legislation included in any budget reconciliation legislation ( no specific number). Reauthorization of the Newborn Screening Saves Lives Act (HR 482, S 350.)

Inclusion of provisions affecting the reimbursement of gene therapies that may be contained in any drug pricing legislation or budget legislation (H.R. 3 or its successor; the Build Back Better Act (HR 5376)/or any successor reconciliation bill. Development of Value Based Purchasing legislation ( HR 7389).

Monitor NIOSH proceedings with respect to worker safety and closed-system transfer devices.

Implementation of section 3204 of the SUPPORT Act, PL 115-271; Mainstreaming Addiction Treatment Act (HR 2067, HR 7667); Drug Enforcement Administration regulation of buprenorphine under the Controlled Substances Act. Food and Drug Administration Safety and Landmark Advancement act FDASLA / FDA user fee reauthorization (HR 7667, S 4348; Restoring Hope for Mental Health and Well-Being Act (HR 7666).

Funding for mental health and substance abuse research and grants; issues related to provisions affecting regulation and pricing of pharmaceuticals in any FY 2034 Labor-HHS appropriations act ( no bill yet)

Mainstreaming Addiction Treatment Act ( HR 1384; S 445); Medication Access and Training Expansion Act, (HR 2067, HR 7667);

Implementation of section 3204 of the SUPPORT Act, PL 115-271; Mainstreaming Addiction Treatment Act (HR 2067, HR 7667); Drug Enforcement Administration regulation of buprenorphine under the Controlled Substances Act. Food and Drug Administration Safety and Landmark Advancement act FDASLA / FDA user fee reauthorization (HR 7667, S 4348; Restoring Hope for Mental Health and Well-Being Act (HR 7666).

Funding for mental health and substance abuse research and grants; issues related to provisions affecting regulation and pricing of pharmaceuticals in any FY 2034 Labor-HHS appropriations act ( no bill yet)

Inclusion of provisions affecting the reimbursement of gene therapies that may be contained in any drug pricing legislation or budget legislation (H.R. 3 or its successor; the Build Back Better Act (HR 5376)/or any successor reconciliation bill.

Potential changes in the corporate tax rate or other provisions of interest to business (Build Back Better Act, H.R. 5376 or any successor budget reconciliation legislation).

Possible legislation which may affect Food and Drug Administration review of biologic products (no specific bill)

Monitor NIOSH proceedings with respect to worker safety and closed-system transfer devices.

Adequacy of funding for the National Institute of Occupational Safety and Health ( FY 2023 Labor-HHS appropriations)

Provisions affecting vial reuse being discussed in connection with any potential drug pricing legislation or budget reconciliation bill (no specific bills)

Adequacy of Food and Drug Administration budget for dietary supplement policy making and enforcement. FY 2023 Agriculture Appropriations

Potential dietary supplement mandatory product listing program (S. 4090), Dietary Supplement ListingAct, (S. 4348, Food and Drug Administration Safety and Landmark Advancement Act FDASLA, no House companion measure.

Impact on agricultural interests of FDA's lack of clarity on CBD/hemp dietary supplement products (S. 1698/ H.R. 841).

Funding for research and clinical trials related to long term studies of COVID-19 at the National Institutes of Health provided in the Consolidated Appropriations Act of 2021 (PL 116-260); Funding for Long-Covid studies in the FY 2023 appropriations. Potential funding for long COVID-related research (HR 4502, no Senate number yet).

Issues associated with diagnosing and treating the effects of COVID-19 appropriately (HR 2754).; NASH Care Act (no bill number yet).

Food and Drug Administration regulation of medical devices, monitor development of Medical device user fee legislation

Inclusion of provisions affecting the reimbursement of gene therapies that may be contained in any drug pricing legislation or budget legislation (H.R. 3 or its successor; the Build Back Better Act (HR 5376)/or any successor reconciliation bill.

Potential legislation implementing value based purchasing for pharmaceuticals (no specific bill); Possible provisions related to Drug Pricing Legislation that affect biological products' development and marketing, including deliberations associated with the Build Back Better Act (H.R. 5376) and the Infrastructure, Investment and Jobs Act (PL 117-58). Possible authority for a new ARPA-H ( HR 5585)

Reimbursement of new technologies in Medicare, including the Medicare Coverage of Innovative Technology Program (No specific legislation) and ARPA-H legislation (DeGette/Upton, HR 5585)

Food and Drug Administration regulation of medical devices, monitor development of Medical device user fee legislation

Funding for research and clinical trials related to long term studies of COVID-19 at the National Institutes of Health provided in the Consolidated Appropriations Act of 2021 (PL 116-260); Funding for Long-Covid studies in the FY 2023 appropriations. Potential funding for long COVID-related research (HR 4502, no Senate number yet).

Funding for mental health and substance abuse research and grants; issues related to provisions affecting regulation and pricing of pharmaceuticals in the Build Back Better Act (H.R. 5376).

The Medicaid Re-entry Act (H.R. 955/S. 445); policies related to reimbursement of substance use disorder treatment (no specific legislation). Possible changes in reimbursement for pharmaceuticals (HR 3, HR 5376 - Build Back Better Act, and any successor legislation)

Implementation of section 3204 of the SUPPORT Act, PL 115-271; Mainstreaming Addiction Treatment Act (HR 2067); Medication Access and Training Expansion Act; (S 5000). Drug Enforcement Administration regulation of buprenorphine under the Controlled Substances Act.

Adequacy of funding for the National Institute of Occupational Safety and Health

Monitor NIOSH proceedings with respect to worker safety and closed-system transfer devices.

Provisions affecting vial reuse being discussed in connection with drug pricing legislation (H.R. 5376, Build Back Better Act).

Need for FDA action to clarify regulation of dietary supplement products containing hemp/CBD, including H.R. 841, Hemp and Hemp-Derived Consumer Protection and Market Stabilization Act

Impact on agricultural interests of FDA's lack of clarity on CBD/hemp dietary supplement products (S. 1698/ H.R. 841).

Adequacy of Food and Drug Administration budget for dietary supplement policy making and enforcement. FY 2023 Agriculture Appropriations

Reimbursement of new technologies in Medicare, including the Medicare Coverage of Innovative Technology Program (No specific legislation) and ARPA-H legislation (DeGette/Upton,no bill number yet).

Food and Drug Administration regulation of medical devices, including Emergency Use Authorizations for critical products during the COVID-19 crisis.

Issues associated with diagnosing and treating the effects of COVID-19 appropriately (no specific legislation). Commission to study COVID-19 (draft Menendez proposal, no bill number yet); NASH Care Act (no bill number yet).

Possible legislation which may affect Food and Drug Administration review of biologic products (no specific bill)

Potential changes in the corporate tax rate or other provisions of interest to business (Build Back Better Act, H.R. 5376 or any successor legislation).

Potential legislation implementing value based purchasing for pharmaceuticals (no specific bill); Possible provisions related to Drug Pricing Legislation that affect biological products' development and marketing, including deliberations associated with the Build Back Better Act (H.R. 5376) and the Infrastructure, Investment and Jobs Act (PL 117-58). Possible authority for a new ARPA-H.

The Medicaid Re-entry Act (H.R. 955/S. 445); policies related to reimbursement of substance use disorder treatment (no specific legislation). Possible changes in reimbursement for pharmaceuticals (HR 3, HR 5376 - Build Back Better Act, and any successor legislation)

Implementation of section 3204 of the SUPPORT Act, PL 115-271; Mainstreaming Addiction Treatment Act (HR 2067); Medication Access and Training Expansion Act; (S 5000). Drug Enforcement Administration regulation of buprenorphine under the Controlled Substances Act.

Adequacy of funding for state-based efforts to provide treatment for substance use disorders (H.R. 4502/No Senate bill yet)

Provisions affecting vial reuse being discussed in connection with drug pricing legislation (H.R. 5376, Build Back Better Act).

Adequacy of funding for the National Institute of Occupational Safety and Health (HR 4502/no Senate number yet)

Monitor NIOSH proceedings with respect to worker safety and closed-system transfer devices.

Need for FDA action to clarify regulation of dietary supplement products containing hemp/CBD, including H.R. 841, Hemp and Hemp-Derived Consumer Protection and Market Stabilization Act

Adequacy of Food and Drug Administration budget for dietary supplement policy making and enforcement. FY 2022 Agriculture Appropriations (HR 4356)

Impact on agricultural interests of FDA's lack of clarity on CBD/hemp dietary supplement products (S. 1698/ H.R. 841).

Potential changes in the corporate tax rate or other provisions of interest to business (Build Back Better Act, H.R. 5376).

Potential legislation implementing value based purchasing for pharmaceuticals (no specific bill); Possible provisions of Drug Pricing Legislation (H.R. 3, H.R. 19, S. 2543 and successor legislation) that affect biological products' development and marketing, including deliberations associated with the Build Back Better Act (H.R. 5376) and the Infrastructure, Investment and Jobs Act (H.R. 3684). Possible authority for a new ARPA-H.

Inclusion of provisions affecting the reimbursement of gene therapies that may be contained in any drug pricing legislation or legislation (H.R. 3 or its successor, including the Build Back Better/reconciliation bill) on infrastructure (H.R. 3684)

Food and Drug Administration regulation of medical devices, including Emergency Use Authorizations for critical products during the COVID-19 crisis.

Funding for research and clinical trials related to long term studies of COVID-19 at the National Institutes of Health provided in the Consolidated Appropriations Act of 2021 (PL 116-260); Funding for Long-Covid studies in the FY 2022 appropriations bill for HHS (H.R. 4502/no Senate bill yet).

Reimbursement of new technologies in Medicare, including the Medicare Coverage of Innovative Technology Program. (No specific legislation)

Implementation of section 3204 of the SUPPORT Act, PL 115-271; Mainstreaming Addiction Treatment Act (HR 2067); Medication Access and Training Expansion Act; (S 5000)

Funding for mental health and substance abuse research and grants (H.R. 4502/no Senate bill yet); issues related to provisions affecting regulation of pharmaceuticals in the Build Back Better Act (H.R. 5376).

American Rescue Plan and funding for substance use disorder and mental health treatment (PL 117-2), the Medicaid Re-entry Act (H.R. 955/S. 445); policies related to reimbursement of substance use disorder treatment (no specific legislation). Possible changes in reimbursement for pharmaceuticals (HR 3 and any successor legislation)

Monitor NIOSH proceedings with respect to worker safety and closed-system transfer devices.

Adequacy of funding for the National Institute of Occupational Safety and Health (HR 4502/no Senate number yet)

Provisions affecting vial reuse being discussed in connection with drug pricing legislation (H.R. 5376, Build Back Better Act).

Need for FDA action to clarify regulation of dietary supplement products containing hemp/CBD, including H.R. 841, Hemp and Hemp-Derived Consumer Protection and Market Stabilization Act

Impact on agricultural interests of FDA's lack of clarity on CBD/hemp dietary supplement products (S. 1698/ H.R. 841).

Adequacy of Food and Drug Administration budget for dietary supplement policy making and enforcement. FY 2022 Agriculture Appropriations (HR 4356)

Potential includes of Life Insurance Product and Tax Stabilization Proposal; Ordinary Treatment of Bonds in Infrastructure Package (H.R. 3684) or reconciliation bill, Build Back Better Act (H.R. 5376).

Potential issues of interest to the life insurance industry, including those affecting retirement savings, in the infrastructure/reconciliation legislation now being considered (Infrastructure, Investment and Jobs Act (H.R. 3684); Build Back Better Act (H.R. 5376).

Impact on agricultural interests of FDA's lack of clarity on CBD/hemp dietary supplement products

Need for FDA action to clarify regulation of dietary supplement products containing hemp/CBD, including H.R. 841, Hemp and Hemp-Derived Consumer Protection and Market Stabilization Act

Adequacy of Food and Drug Administration budget for dietary supplement policy making and enforcement. FY 2022 Agriculture Appropriations (HR 4356)

Inclusion of provisions affecting the reimbursement of gene therapies that may be included in any drug pricing legislation or legislation on infrastructure (no specific bills)

Possible legislation which may affect Food and Drug Administration review of biologic products (no specific bill)

Potential legislation implementing value based purchasing for pharmaceuticals (no specific bill); Possible provisions of Drug Pricing Legislation (H.R. 3, H.R. 19, S. 2543 and successor legislation) that affect biological products' development and marketing. Possible authority for a new ARPA-H.

Issues associated with diagnosing and treating the effects of COVID-19 appropriately (no specific legislation).

Reimbursement of new technologies in Medicare, including the Medicare Coverage of Innovative Technology Program.

Funding for research and clinical trials related to long term studies of COVID-19 at the National Institutes of Health provided in the Consolidated Appropriations Act of 2021 (PL 116-260).

Funding for research and clinical trials related to long term studies of COVID-19 at the National Institutes of Health provided in the Consolidated Appropriations Act of 2021 (PL 116-260).

Food and Drug Administration regulation of medical devices, including Emergency Use Authorizations for critical products during the COVID-19 crisis.

Reimbursement of new technologies in Medicare, including the Medicare Coverage of Innovative Technology Program.

Implementation of section 3204 of the SUPPORT Act, PL 115-271

Adequacy of funding for state-based efforts to provide treatment for substance use disorders (bill not written yet)

American Rescue Plan and funding for substance use disorder and mental health treatment (PL 117-2), the Medicaid Re-entry Act (H.R. 955/S. 445); policies related to reimbursement of substance use disorder treatment (no specific legislation). Possible changes in reimbursement for pharmaceuticals (HR 3 and any successor legislation)

Life Insurance Product and Tax Stabilization Proposals (no bill number yet) Ordinary Treatment of Bonds (no bill number yet) Infrastructure Package (no bill introduced yet)

Potential issues of interest to the life insurance industry, including those affecting retirement savings, in the infrastructure legislation now being written (no bill introduced yet)

Monitor NIOSH proceedings with respect to worker safety and closed-system transfer devices.

Adequacy of funding for the National Institute of Occupational Safety and Health - no specific legislation yet.

Provisions affecting vial reuse being discussed in connection with drug pricing legislation (no specific bills)

Adequacy of Food and Drug Administration budget for dietary supplement policy making and enforcement. FY 2022 Agriculture Appropriations (HR 4356)

Impact on agricultural interests of FDA's lack of clarity on CBD/hemp dietary supplement products

Need for FDA action to clarify regulation of dietary supplement products containing hemp/CBD, including H.R. 841, Hemp and Hemp-Derived Consumer Protection and Market Stabilization Act

Development of innovative therapies using gene therapy; biomedical research; Prescription drug user fee implementing legislation

Implementation of section 3204 of the SUPPORT Act, PL 115-271

American Rescue Plan and funding for substance use disorder and mental health treatment (PL 117-2), the Medicaid Re-entry Act (H.R. 955/S. 445); policies related to reimbursement of substance use disorder treatment (no specific legislation).

Adequacy of funding for state-based efforts to provide treatment for substance use disorders (no specific legislation)

Provisions affecting vial reuse being discussed in connection with drug pricing legislation (no specific bills)

Adequacy of funding for the National Institute of Occupational Safety and Health - no specific legislation yet.

Monitor NIOSH proceedings with respect to worker safety and closed-system transfer devices.

Potential issues of interest to the life insurance industry, including those affecting retirement savings, in the Biden Administration's American Jobs Act (no bill introduced yet)

Life Insurance Product and Tax Stabilization Proposals (no bill number yet) Ordinary Treatment of Bonds (no bill number yet) Infrastructure Package (no bill introduced yet)

Impact on agricultural interests of FDA's lack of clarity on CBD/hemp dietary supplement products

Need for FDA action to clarify regulation of dietary supplement products containing hemp/CBD, including H.R. 841, Hemp and Hemp-Derived Consumer Protection and Market Stabilization Act

Adequacy of Food and Drug Administration budget for dietary supplement policy making and enforcement.

Funding for NIH and CDC programs dealing with COVID and long-COVID research and service delivery.

Omnibus legislation affecting prescription drug pricing (Senate HELP -Lower Healthcare Costs Act (S. 1895), Senate Finance - S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019.

DEA implementation of the SECURE Act and specifically Section 3204 addressing specialty pharmacy delivery providerS of long-acting injectable buprenorphine products. Fairness in Orphan Drug Exclusivity Act, H.R. 4712/S. 3271, included in H.R. 133, Consolidated Appropriations Act of 2021, PL 116-196).

Implementation of the Support for Patients and Communities Act (P.L. 115-271), including section 3204; funding levels and distribution of funding for treatment of opioid overuse disorder (OUD) (including any successor legislation to PL 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act; PL 116-127,Families First Coronavirus Response Act; PL 116-136, CARES Act; and HR 133, Consolidated Appropriations Act of 2021, PL 116-196.)

Potential changes to retirement security law in any tax or appropriations bills, including the Consolidated Appropriations Act, P.L. 116-260.

Potential changes to tax law with respect to life insurance, including Net Operating Loss deductions, included in any COVID legislation or H.R. 133, the Consolidated Appropriations Act (PL 116-196).

Efforts by the National Institute on Occupational Safety and Health to develop testing methods for hazardous chemical use in hospitals (The Consolidated Appropriations Act of 2021, PL 116-260).

Provisions affecting vial reuse being discussed in conjunction with any pending legislation, including the Prescription Drug Pricing Reduction Act of 2019 (S. 2543)

Efforts to ensure worker safety in the administration of hazardous chemicals (no specific legislation).

Implementation of the hemp farming provisions of the Agriculture Improvement Act of 2018 (P.L. 115-334), including H.R. 5587, regarding regulation of hemp-derived cannabidiol.

Regulation of CBD as a dietary supplement.

Potential language affecting: adequacy of appropriations for FDA regulation of dietary supplements; regulation of CBD as a dietary supplement in the Consolidated Appropriations Act 2021 (PL 116-260)

Omnibus legislation affecting prescription drug pricing (Senate HELP -Lower Healthcare Costs Act (S. 1895), Senate Finance - S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019.

DEA implementation of the SECURE Act and specifically Section 3204 addressing specialty pharmacy delivery to the provider of long-acting injectable buprenorphine products. Fairness in Orphan Drug Exclusivity Act, H.R. 4712/S. 3271.

Implementation of the Support for Patients and Communities Act (P.L. 115-271), including section 3204; funding levels and distribution of funding for treatment of opioid overuse disorder (OUD) (including any successor legislation to PL 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act; PL 116-127,Families First Coronavirus Response Act; and PL 116-136, CARES Act.)

Provisions affecting vial reuse being discussed in conjunction with any pending legislation, including the Prescription Drug Pricing Reduction Act of 2019 (S. 2543)

Efforts to ensure worker safety in the administration of hazardous chemicals (no specific legislation).

Worker safety issues in any Labor-HHS Appropriations bill (HR 7614/no Senate number yet)

Potential changes to tax law with respect to life insurance included in H.R. 6800, the HEROES Act, or any successor COVID legislation.

Potential changes to retirement security law in any tax or appropriations bills, including the HEROES Act, H.R. 6800 and any other successor legislation to PL 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act; PL 116-127,Families First Coronavirus Response Act; and PL 116-136, CARES Act.

Potential language affecting: adequacy of appropriations for FDA regulation of dietary supplements; regulation of CBD as a dietary supplement in any appropriations bills for FY 2021 (or successor bills to: PL 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act; PL 116-127,Families First Coronavirus Response Act; and PL 116-136, CARES Act.)

Implementation of the hemp farming provisions of the Agriculture Improvement Act of 2018 (P.L. 115-334), including H.R. 5587, regarding regulation of hemp-derived cannabidiol.

DEA implementation of the SECURE Act and specifically Section 3204 addressing specialty pharmacy delivery to the provider of long-acting injectable buprenorphine products. Fairness in Orphan Drug Exclusivity Act, H.R. 4712/S. 3271.

Potential additional funding for opioid overuse treatment activities for FY 2020 (including H.R. 6800, HEROES Act, and any successor COVID-related bills to PL 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act; PL 116-127,Families First Coronavirus Response Act; and PL 116-136, CARES Act.)

Implementation of the Support for Patients and Communities Act (P.L. 115-271), including section 3204; funding levels and distribution of funding for treatment of opioid overuse disorder (OUD) (including any successor legislation to PL 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act; PL 116-127,Families First Coronavirus Response Act; and PL 116-136, CARES Act.) Promote awareness of medication assisted treatment/treatment of OUD with long-acting injectable products (no specific legislation).

Worker safety issues in any Labor-HHS Appropriations bill (HR 7614/no Senate number yet)

Vial reuse provisions of the Prescription Drug Pricing Reduction Act of 2019 (S. 2543)

Efforts to ensure worker safety in the administration of hazardous chemicals (no specific legislation).

Potential changes to retirement security law in any tax or appropriations bills, including the HEROES Act, H.R. 6800 and any other successor legislation to PL 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act; PL 116-127,Families First Coronavirus Response Act; and PL 116-136, CARES Act.

Potential changes to tax law with respect to life insurance included in H.R. 6800, the HEROES Act, or any successor COVID legislation.

Implementation of the hemp farming provisions of the Agriculture Improvement Act of 2018 (P.L. 115-334), including H.R. 5587, regarding regulation of hemp-derived cannabidiol.

Potential tariffs for essential oils imported from Europe

Potential language affecting: appropriations for FDA regulation of dietary supplements; regulation of CBD as a dietary supplement in any appropriations bills for FY 2021 (or successor bills to: PL 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act; PL 116-127,Families First Coronavirus Response Act; and PL 116-136, CARES Act.)

Omnibus legislation affecting prescription drug pricing (Senate HELP -Lower Healthcare Costs Act (S. 1895), Senate Finance - S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019.

DEA implementation of the SECURE Act and specifically Section 3204 addressing specialty pharmacy delivery to the provider of long-acting injectable buprenorphine products. Fairness in Orphan Drug Exclusivity Act, H.R. 4712/S. 3271.

Potential additional funding for opioid overuse treatment activities for FY 2020 (including PL 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act; PL 116-127,Families First Coronavirus Response Act; and PL 116-136, CARES Act.)

Worker safety issues in any Labor-HHS Appropriations bill (no legislation yet)

Efforts to ensure worker safety in the administration of hazardous chemicals (no specific legislation).

Vial reuse provisions of the Prescription Drug Pricing Reduction Act of 2019 (S. 2543)

Potential changes to retirement security law in any tax or appropriations bills, including PL 116-123, Coronavirus Preparedness and Response Supplemental Appropriations Act; PL 116-127,Families First Coronavirus Response Act; and PL 116-136, CARES Act.

Potential changes to Tax Cuts and Jobs Act that affect retirement security/life insurers (no specific legislation)

Implementation of the hemp farming provisions of the Agriculture Improvement Act of 2018 (P.L. 115-334).

Regulation of CBD as a dietary supplement.

Potential tariffs for essential oils imported from Europe

Omnibus legislation affecting prescription drug pricing (Senate HELP -Lower Healthcare Costs Act (S. 1895), Senate Finance - S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019.

Implementation of the Support for Patients and Communities Act (P.L. 115-271); funding levels and distribution of funding for treatment of opioid overuse disorder (OUD) (Further Consolidated Appropriations Act, PL 116-94) promote awareness of medication assisted treatment/treatment of OUD with long-acting injectable products (no specific legislation).

Vial reuse provisions of the Prescription Drug Pricing Reduction Act of 2019 (S. 2543)

Legislation to repeal the 2.3%$ excise tax on medical devices, the Protect Medical Innovation act of 2019 (S. 692 contained in the Further Consolidated Appropriations Act, PL 116-94)

Efforts to ensure worker safety in the administration of hazardous chemicals (no specific legislation).

Passage of the Setting Every Community up for Retirement Enhancement Act of 2019 ("SECURE Act" - H.R. 1994 included in the Further Consolidated Appropriations Act PL 116-94)

Potential changes to Tax Cuts and Jobs Act that affect retirement security/life insurers (no specific legislation)

Potential tariffs for essential oils imported from Europe

Potential language affecting: appropriations for FDA regulation of dietary supplements; regulation of CBD as a dietary supplement in the Agriculture Appropriations Bill (H.R. 3164) and then the Further Consolidated Appropriations Act (PL 116-94).

Implementation of the hemp farming provisions of the Agriculture Improvement Act of 2018 (P.L. 115-334).

Funding for opioid overuse treatment activities for FY 2020 (H.R. 2740/no Senate bill number yet)

Implementation of the Support for Patients and Communities Act (P.L. 115-271); funding levels and distribution of funding for treatment of opioid overuse disorder (OUD) (H.R. 2740);no Senate number yet) promote awareness of medication assisted treatment/treatment of OUD with long-acting injectable products.

Omnibus legislation affecting prescription drug pricing (Senate HELP -Lower Healthcare Costs Act (S. 1895), Senate Finance - S. 2543, Prescription Drug Pricing Reduction Act (PDPRA) of 2019 and H.R. 3, Lower Drug Costs Now Act of 2019. Provision related to Medicaid best price calculation in Public Law No: 116-59, FY 2020 Continuing Appropriations.

Efforts to ensure worker safety in the administration of hazardous chemicals (no specific legislation).

Vial reuse provisions of the Prescription Drug Pricing Reduction Act of 2019 (S. 2543)

Legislation to repeal the 2.3%$ excise tax on medical devices, the Protect Medical Innovation act of 2019 (S. 692)

Potential changes to Tax Cuts and Jobs Act that affect retirement security/life insurers (no specific legislation)

Passage of the Setting Every Community up for Retirement Enhancement Act of 2019 ("SECURE Act" - H.R. 1994). Social Security 2100 Act - (H.R. 860)

Implementation of the hemp farming provisions of the Agriculture Improvement Act of 2018 (P.L. 115-334).

Potential tariffs for essential oils imported from Europe

Potential language affecting: appropriations for FDA regulation of dietary supplements; regulation of CBD as a dietary supplement in the Agriculture Appropriations bill (S. 2522)

Funding for opioid overuse treatment activities for FY 2020 (H.R. 2740/no Senate bill number yet)

Implementation of the Support for Patients and Communities Act (P.L. 115-271); funding levels and distribution of funding for treatment of opioid overuse disorder (OUD) (H.R. 2740); promote awareness of medication assisted treatmennt/treatment of OUD with long-acting injectable products.

Omnibus legislation affecting prescription drug pricing (Senate HELP "Lower Healthcare Costs Act (S. 1895) and Finance bill (in development); H.R. 965, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019; and S. 102/H.R. 465, Prescription Drug Pricing Relief Act

Legislation to repeal the 2.3%$ excise tax on medical devices, the Protect Medical Innovation act of 2019 (S. 692)

Efforts to ensure worker safety in the administration of hazardous chemicals (no specific legislation).

Passage of the Setting Every Community up for Retirement Enhancement Act of 2019 ("SECURE Act" - H.R. 1994). Social Security 2100 Act - (H.R. 860)

Potential changes to Tax Cuts and Jobs Act (no specific legislation)

Implementation of the hemp farming provisions of the Agriculture Improvement Act of 2018 (P.L. 115-334).

Potential language affecting: appropriations for FDA regulation of dietary supplements; regulation of CBD as a dietary supplement in the Agriculture Appropriations bill (HR 3055/no Senate number yet)

H.R. 2021, Investing for the People Act of 2019, budget legislation, potential provisions relating to prescription drug pricing, reporting and oversight. H.R. 2113, the Prescription Drug Sunshine, Transparency, Accountability and Reporting Act or Prescription Drug STAR Act, provisions relating to prescription drug pricing, reporting and oversight requirements. H.R. 938, the Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019, provisions relating to patent exclusivity. H.R. 1503, the Orange Book Transparency Act of 2019, provisions to ensure that the Orange Book is accurate and up-to-date; Omnibus legislation affecting prescription drug pricing (Senate HELP and Finance bills in development); H.R. 965, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019; and S. 102/H.R. 465, Prescription Drug Pricing Relief Act

Implementation of the Support for Patients and Communities Act (P.L. 115-271)

Legislation to repeal the 2.3%$ excise tax on medical devices, the Protect Medical Innovation act of 2019 (S. 692)

Efforts to ensure worker safety in the administration of hazardous chemicals (no specific legislation).

Development of Retirement Enhancement and Savings Act (S. 972) Setting Every Community Up for Retirement Enhancement (SECURE) Act of 2019

Potential changes to Tax Cuts and Jobs Act (no specific legislation)

Potential language affecting regulation of CBD as a dietary supplement in the Agriculture Appropriations bill (no bill yet)

Implementation of the hemp farming provisions of the Agriculture Improvement Act of 2018 (P.L. 115-334).

Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act - issues related to Medication-Assisted Therapy. (P.L. 115-271)

Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 (Section 3204 of the SUPPORT Act, P.L. 115-271)

Implementation of funding for opioid overuse disorder treatment in FY 2019 Labor-HHS Appropriations bills (PL 115-245)

Efforts to improve health care worker safety (no specific legislation)

Medical Device Excise Tax Repeal (H.R. 2018) and possible inclusion in any year-end tax legislation