Creating Efficiency in Foreign Facility Inspections Act

HR 8616: VA Loan Informed Disclosure Act of 2022 Housing Finance Reform Affordable Housing issues Expanding the supply of housing HR 3962/S.1625: Securing and Enabling Commerce Using Remote and Electronic Notarization Act of 2022 HR 7735/S.4208: Improving access to the VA Home Loan Benefit Act of 2022 HR 6109/S.3509: Middle Class Mortgage Insurance Premium Act of 2021

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

HR 8616: VA Loan Informed Disclosure Act of 2022 Housing Finance Reform Affordable Housing issues Expanding the supply of housing HR 3962/S.1625: Securing and Enabling Commerce Using Remote and Electronic Notarization Act of 2022 HR 7735/S.4208: Improving access to the VA Home Loan Benefit Act of 2022 HR 6109/S.3509: Middle Class Mortgage Insurance Premium Act of 2021

Client expense: $140,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

S.3401 - Safe Drug Act H.R. 7121, Protecting our Pharmaceutical Supply Chain from China Act of 2022 S.3509 - Creating Efficiency in Foreign Facility Inspections Act -Issues related to pharmaceutical supply chains -Issues related to reporting on location of origin of pharmaceutical products -Issues related to drug shortages -Issues related to pharmaceutical manufacturing

Client expense: $2,430,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035/S.4302: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.3548: CARES Act Reporting. H.R.5376: Inflation Reduction Act of 2022. H.R.6485/S.3495: Inflation Prevention Act. S.3799: PREVENT Pandemics Act.

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032/S.4338: Increasing Transparency in Generic Drug Applications Act of 2022. H.R.7472/S.4026: Discounted Drugs for Clinical Trials Act. H.R.5030/S.2706: DIVERSE Trials Act. H.R.3085/S.1548: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. S.3576: ADPT 2.0 Act. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. Pharmaceutical Exclusivity. 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973/S.4351: Enhanced Access to Affordable Medicines Act of 2022. Section 505(j)(10) Labeling [Legislation not yet introduced]. S.2628: Better ODDS To Reduce Diversion Act of 2021. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. Generic Formulations. H.R.7473: Generic Substitution Noninterference Act. Incentivize domestic manufacturing. H.R.6381/S.3521: CREATE Act of 2022. Drug Shortages. Stockpile of Generic Drugs. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. H.R.7377/S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. Inspections Legislative Proposals. Energy and Commerce Factory Inspection Legislation. H.R.7006: INSPECTIONS Act. H.R.6980: HHS Inspections Pilot Program. S.3509: Creating Efficiency in Foreign Facility Inspections Act. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.7667: Food and Drug Amendments of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.4348: FDASLA Act of 2022. H.R.7035: Biologics Market Transparency Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.748/S.S.3548: CARES Act Reporting. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act.

S.3401 - Safe Drug Act H.R. 7121, Protecting our Pharmaceutical Supply Chain from China Act of 2022 S.3509 - Creating Efficiency in Foreign Facility Inspections Act -Issues related to pharmaceutical supply chains -Issues related to reporting on location of origin of pharmaceutical products -Issues related to drug shortages -Issues related to pharmaceutical manufacturing

Client expense: $1,650,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1730/S. 670- Speeding Therapy Access Today Act; H.R. 483/S. 350 - Newborn Screening Saves Lives Act; H.R. 6000 Cures 2.0 Act; H.R. 6584 Diverse and Equitable Participation in Clinical Trials Act; S. 2706/H.R. 5030 Diversifying Investigations Via Equitable Research Studies for Everyone Trials Act; H.R. 6963 - Accelerated Approval Integrity Act; H.R. 6996 - Accelerating Access for Patients Act - General issues related to rare disease and orphan drugs; Reauthorization of the FDA User Fee Act; FDA modernization policy issues; Reauthorization of newborn screening programs; Buy America and other associated issues related to procurement and sourcing of finished product and active pharmaceutical ingredients; General issues related to health equity in rare disease and clinical trials; General issues related to diagnostics for patients with rare diseases Cancer screening, diagnosis & treatment Prescription drug electronic labeling H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act; H.R. 19 - Lower Costs, More Cures Act; H.R. 5260 - Reduced Costs and Continued Cures Act; H.R. 5376 - Build Back Better Act H.R. 3085/S. 1548 -ENACT Act of 2021 H.R. 5585 - Advanced Research Project Agency-Health Act H.R. 2883, Stop Stalling Access to Affordable Medications Issues related to COVID-19 vaccines and therapies; Items related to the Administrations Cancer Moonshot S. 3799, the PREVENT Pandemics Act S. 3509 Creating Efficiency in Foreign Facility Inspections Act Prescription Drug User Fee Act (PDUFA)

Client expense: $1,480,000 · Firm income: Not reported

Prescription Drug Costs. Drug Pricing. H.R.2868: Protecting Access to Affordable Medicines Act of 2021. S.2910: Expanding Access to Low-Cost Generics Act of 2021. Expanding Access to Low-Cost Generics. H.R.5237: Reduced Costs and Continued Cures Act of 2021. H.R.6000: Cures 2.0 Act. H.R.7032: Increasing Transparency in Generic Drug Applications Act of 2022. Discounted Drugs for Clinical Trials Act. H.R.5030: DIVERSE Trials Act. H.R.3085: ENACT Act of 2021. H.R.6584: DEPICT Act. Pre-Hatch-Waxman ANDAs (PANDAs). H.R.6963: Accelerated Approval Integrity Act of 2022. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.7008: Pre-approval Information Exchange Act of 2022. H.R.2831: Prompt Approval of Safe Generic Drugs Act. H.R.6431: Data Transparency and Drug Safety Act of 2022. Civil Monetary Penalties. 180-Day Exclusivity. Forfeiture of 180-Day Exclusivity. H.R.2853: BLOCKING Act of 2021. Labeling of Generic Drugs and Biosimilars. H.R.6973: Enhanced Access to Affordable Medicines Act of 2022. S.1462: Simplifying the Generic Drug Application Process Act. Generic carveouts patent protected information in drug labels, including issues related to GSK v. Teva. H.R.6519: Patients Right to Know Their Medication Act of 2022. Generic Formulations. Incentivize domestic manufacturing. Drug Shortages. Stockpile of Generic Drugs. H.R.2870: Essential Medicines Strategic Stockpile Act of 2021. Generic Drug User Fee Amendments (GDUFA). GDUFA III Negotiations. Biosimilar User Fee Act (BsUFA). BsUFA III Negotiations. Biosimilars Insulin. Cost Sharing for Biosimilars. H.R.7047: Lowering Costs by Improving Biosimilar Uptake Act. Hybrid Biosimilar Applications [Legislation not yet introduced]. Biosims Testing [Legislation not yet introduced]. Biosimilar Animal Data [Legislation not yet introduced]. 505(b)(2) Biosimilar Proposal. Eliminating Phase III Studies for Biosimilars. Same Strength Requirement for Biosimilars. H.R.2565/S.2952: FDA Modernization Act of 2021. S.1463: Modernizing Therapeutic Equivalence Rating Determination Act. FDA Inspections. H.R.7006: INSPECTIONS Act. S.3509: Creating Efficiency in Foreign Facility Inspections Act. Inspections Legislative Proposals. FDA-PTO Collaboration. FDA Genus Decision. FDA Catalyst Decision. 506I Marketing Status Updates. H.R.6483: Improved Transparency of Foreign Drug Manufacturing Act of 2022. H.R.6988: Drug Manufacturing Innovation Act of 2022. S.3576: Accelerated Drug Approval for Prescription Therapies (ADAPT) 2.0 Act. H.R.4472: BENEFIT Act of 2021. H.R.7035: Biologics Market Transparency Act of 2022. H.R.4511: FACTS Act. H.R.6888: Helping Experts Accelerate Rare Treatments Act of 2022. H.R.1730: Speeding Therapy Access Today Act of 2021. H.R.6996: Accelerating Access for Patients Act of 2022. H.R.6972: Give Kids a Chance Act of 2022. Buy American Proposals. Issues Related to COVID-19. H.R.5376: Build Back Better Act. S.3799: PREVENT Pandemics Act. H.R.5566: FORWARD Act of 2021. H.R.2910: Veterans Health Care Freedom Act. H.R.5585: Advanced Research Project Agency-Health Act. H.R.2883/S.1425: Stop Stalling Access to Affordable Medications. H.R.4369: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act of 2021.

S.3401 - Safe Drug Act H.R. 7121, Protecting our Pharmaceutical Supply Chain from China Act of 2022 S.3509 - Creating Efficiency in Foreign Facility Inspections Act -Issues related to pharmaceutical supply chains -Issues related to reporting on location of origin of pharmaceutical products -Issues related to drug shortages -Issues related to pharmaceutical manufacturing

Client expense: $3,060,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 3009 Improving Language Access in Mortgage Servicing Act of 2021 American Rescue Plan - homeowner assistance fund Financial Technology ("Fintech") (Previously HR 1500 ) -- Consumers First Act Small Business Lending Discrimination HR 4277 Overdraft Protection Act of 2021 HR 2572 Stop Debt Collection Abuse Act (Previously S.3509) - A bill to provide borrowers the right to request forbearance on mortgage loan payments... HR 963 / S. 505 Forced Arbitration Injustice Repeal (FAIR) Act True Lender CRA CFPB Big Tech Inquiry HR 5376 Build Back Better Act Blumenthal arbitration amendment to the National Defense Authorization Act for fiscal year 2022 Accountability in Student Loan Data Act (Previously HR 4662) CFPB Student Loan Integrity and Transparency Act (previously S 720) HR 6466, Student Loan Rehabilitation and Credit Score Improvement Act Stop Unfair Home Lending Act S 3844 Economic Continuity and Stability Act H.R. 7231, the Electronic Currency and Secure Hardware (ECASH) Act Crypto Regulatory Legislation (CFTC) Crypto Regulatory Legislation (Stablecoins) Crypto Regulatory Legislation (President's EO) Big Tech Crypto/Blockchain investments Green Postal Service Fleet Act CARES Act - Paycheck Protection Program H.R.4445 - Ending Forced Arbitration of Sexual Assault and Sexual Harassment Act of 2021 S.3755 - Arbitration Fairness for Consumers Act

Client expense: $150,000 · Firm income: Not reported

(previously H.R. 4403) Stop Debt Collection Abuse Act Financial Technology ("Fintech") (Previously HR 758) - the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Previously HR 1500 ) -- Consumers First Act Reg BI SEC fiduciary rule Small Business Lending Discrimination (Previously HR 4254) Overdraft Protection Act of 2019 (Previously S3565) - Small Business and Consumer Debt Collection Emergency Relief Act of 2020 (Previously S3560) - Small Business and Consumer Emergency Credit Act (Previously S.3509) - A bill to provide borrowers the right to request forbearance on mortgage loan payments... Heroes Act (COVID PACKAGE) Protecting Innocent Consumers Affected by Shutdown Act HR 1 - For the People Act Facebook' Libra cryptocurrency True Lender CRA American Rescue Plan Postal Service Reform Act

Client expense: $100,000 · Firm income: Not reported

Government targets: Commodity Futures Trading Commission (CFTC), Federal Deposit Insurance Corporation (FDIC), Federal Housing Finance Agency (FHFA), Federal Reserve System, HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of

(previously H.R. 4403) Stop Debt Collection Abuse Act Financial Technology ("Fintech") (Previously HR 758) - the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Previously HR 1500 ) -- Consumers First Act Reg BI SEC fiduciary rule Small Business Lending Discrimination (Previously HR 4254) Overdraft Protection Act of 2019 (Previously S3565) - Small Business and Consumer Debt Collection Emergency Relief Act of 2020 (Previously S3560) - Small Business and Consumer Emergency Credit Act (Previously S.3509) - A bill to provide borrowers the right to request forbearance on mortgage loan payments... Heroes Act (COVID PACKAGE) (Previously H.R. 3948) Debt Collection Practices Harmonization Act (Previously H.R. 5021) Ending Debt Collection Harassment Act of 2019 HR 1491 Fair Debt Collection Practices for Servicemembers Act (Previously H.R. 5001) Non-Judicial Foreclosure Debt Collection Clarification Act Protecting Innocent Consumers Affected by Shutdown Act HR 1 - For the People Act (Previously HR 3614) Restricting Use of Credit Checks for Employment Decisions Act (Previously HR 3618) Free Credit Scores for Consumers Act (Previously HR 3621) Student Borrower Credit Improvement Act (Previously HR 3622) Restoring Unfairly Impaired Credit and Protecting Consumers Act (Previously HR 3642 ) Improving Credit Reporting for All Consumers Act (Previously HR 3629 ) Clarity in Credit Score Formation Act HR 963 / S. 505 Forced Arbitration Injustice Repeal (FAIR) Act Facebook' Libra cryptocurrency True Lender CRA American Rescue Plan - homeowner assistance fund HR 3605 Sustainable Investment Policies Act HR 3604 Retiree Sustainable Investment Opportunities Act Improving Language Access in Mortgage Servicing Act of 2021

Client expense: $90,000 · Firm income: Not reported

(previously H.R. 4403) Stop Debt Collection Abuse Act Authority of CFPB Financial Technology ("Fintech") Funding of CFPB (Previously HR 758) - the Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. XXXX -- the "Home Mortgage Disclosure Adjustment Act" (Previously HR 1500 ) -- Consumers First Act Reg BI SEC fiduciary rule Small Business Lending Discrimination (Previously HR 4254) Overdraft Protection Act of 2019 (Previously S3565) - Small Business and Consumer Debt Collection Emergency Relief Act of 2020 (Previously S3560) - Small Business and Consumer Emergency Credit Act (Previously S.3509) - A bill to provide borrowers the right to request forbearance on mortgage loan payments... Heroes Act (COVID PACKAGE) LEP Data Acquisition in Mortgage Lending Act (Previously H.R. 3948) Debt Collection Practices Harmonization Act (Previously H.R. 5021) Ending Debt Collection Harassment Act of 2019 HR 1491 Fair Debt Collection Practices for Servicemembers Act (Previously H.R. 5001) Non-Judicial Foreclosure Debt Collection Clarification Act Protecting Innocent Consumers Affected by Shutdown Act HR 1 - For the People Act (Previously HR 3614) Restricting Use of Credit Checks for Employment Decisions Act (Previously HR 3618) Free Credit Scores for Consumers Act (Previously HR 3621) Student Borrower Credit Improvement Act (Previously HR 3622) Restoring Unfairly Impaired Credit and Protecting Consumers Act (Previously HR 3642 ) Improving Credit Reporting for All Consumers Act (Previously HR 3629 ) Clarity in Credit Score Formation Act HR 963 / S. 505 Forced Arbitration Injustice Repeal (FAIR) Act Facebook' Libra cryptocurrency (Previously S.2685 ) Consumer Credit Control Act True Lender CRA American Rescue Plan - homeowner assistance fund

Client expense: $70,000 · Firm income: Not reported