Rep. Michael F. Doyle

Diverse and Equitable Participation in Clinical Trials Act or the DEPICT Act This bill requires applications for an investigational use exemption of a new drug or medical device to include information about the demographic diversity of the clinical trial population and addresses related issues. (Generally, a developer of a new drug or device may seek an investigational use exemption to facilitate clinical investigations, as part of the process to obtain approval to sell that drug or device.) Specifically, the Food and Drug Administration (FDA) must issue regulations to require applications for such exemptions to include certain information, including (1) demographic data disaggregated by subgroup, where such data is available, about the expected or potential patient population; (2) the applicant's enrollment targets for the clinical trials involved, disaggregated by age group, sex, race, and ethnicity; (3) a diversity plan for how the applicant will meet these targets; and (4) what is known about the patient population, such as comorbidities. The regulations must also require certain applicant reports to the FDA to address issues related to demographic diversity in clinical trials and product safety and effectiveness for demographic subgroups. The bill also authorizes the FDA to, in certain instances, require additional studies or surveillance after a drug or device has been approved if the clinical trials used in the application process did not meet the demographic enrollment targets.

Black Lung Benefits Disability Trust Fund Solvency Act of 2022 This bill extends until December 31, 2031, the excise tax on coal. The revenues from such tax provide funding for the Black Lung Disability Trust Fund.

Leading Infrastructure For Tomorrow’s America Act or the LIFT America Act This bill establishes several programs and incentives to modernize the nation's communications, drinking water, energy, transportation, health care, and other related infrastructure. For example, the bill provides incentives to make broadband internet more accessible and affordable. It also establishes grants to implement next generation 9-1-1 services. In addition, it supports drinking water programs, including the drinking water state revolving fund program. Further, it provides grants to treat perfluoroalkyl or polyfluoroalkyl substances (commonly referred to as PFAS) in drinking water and to replace lead service lines. The bill establishes a variety of programs to support clean energy infrastructure and address climate change, including efforts to (1) modernize the electric grid and make it more resilient, efficient, and secure; (2) increase energy efficiency in buildings; and (3) support renewable energy infrastructure. Further, it provides incentives for vehicle infrastructure, such as incentives to develop infrastructure for electric vehicles and grants to reduce air pollution at ports by electrifying port infrastructure. Additionally, the bill establishes grants and programs for health care infrastructure, including by providing support for the Centers for Disease Control and Prevention, laboratories, and state, local, tribal, and territorial health departments. Finally, the bill reauthorizes grant programs to remediate brownfield sites (i.e., sites contaminated with hazardous substances) through FY2026.

Maddy summaryThis bill (H.J.Res. 68) is a symbolic, procedural measure that would require the President to issue an annual proclamation designating a day as "Democracy Day." It directs the President to call on state/local governments and citizens to observe the day through programs and activities, with January 6 referenced as a potential date. The bill does not create new government programs or change existing laws - it only establishes a recurring presidential proclamation. It directly affects federal, state, and local governments by encouraging them to participate in annual observances. The bill has no budgetary impact and remains focused on promoting civic engagement through a designated day.

PrEP Access and Coverage Act This bill requires private health insurance plans to cover prescription drugs that prevent HIV, including related screenings, diagnostic procedures, administrative fees, and clinical follow-ups, without any cost-sharing obligation for the plan holder. Further, insurance plans must not impose any preauthorization requirement for this coverage. These coverage requirements also apply to public health insurance programs, including Medicare, Medicaid, and the Children's Health Insurance Program. Additionally, the bill prohibits denying, limiting, or qualifying coverage or increasing premiums for disability insurance, long-term care insurance, or life insurance policies based on an individual taking medication for HIV prevention. The bill further requires the Department of Health and Human Services to award grants to states, or directly to eligible local organizations, to provide uninsured individuals and underinsured individuals access to prescription drugs and related services that prevent HIV. The Centers for Disease Control and Prevention also must develop a public awareness campaign that focuses efforts in communities with a high need for HIV prevention treatment.

Cures 2.0 Act This bill addresses pandemic preparedness and public health issues, caregiver and patient engagement, drug development, insurance coverage, and biomedical research. The Department of Health and Human Services (HHS) must undertake research and other activities concerning COVID-19 and develop a strategy for future pandemics and declared emergencies. Additionally, the bill specifies actions to combat antimicrobial resistance. HHS may award grants for caregiver training. The bill also addresses diversity in clinical trials, collecting patient experience data during clinical trials, and coverage for care related to participation in specified clinical trials. The bill modifies the timeframe and requires additional guidance relating to expedited approval of certain breakthrough drugs, devices, or products. It also establishes two intercenter institutes within the Food and Drug Administration (FDA) focused on particular diseases that meet specified criteria. The bill also addresses (1) coverage in Medicare, Medicaid, and the Children's Health Insurance Program for telehealth, genetic and genomic testing, and other services; (2) electronic prescribing standards for Medicare drug benefits; and (3) access to Medicare and Medicaid claims data by certain registries. Furthermore, the bill prohibits the use of geographic tracking or biometrics in Medicaid electronic visit verification systems. The bill establishes the Advanced Research Projects Agency for Health (ARPA-H) within the National Institutes of Health to accelerate biomedical research and innovation through grants, contracts, cash prizes, and other means. The FDA may work with ARPA-H to expedite the development of medical products through specified activities.

This concurrent resolution expresses the sense of Congress that tax-exempt fraternal benefit societies provide critical benefits to the people and communities of the United States and their work should continue to be promoted.

Protecting Our Democracy Act This bill addresses issues involving (1) abuses of presidential power; (2) checks and balances, accountability, and transparency; and (3) election integrity and security. Specifically, regarding abuses of presidential power, the bill requires the Department of Justice (DOJ) and the President to submit to Congress specified materials relating to certain pardons, prohibits presidential self-pardons, suspends the statute of limitations for federal offenses committed by a sitting President or Vice President, prohibits the acceptance of foreign or domestic emoluments, and sets forth provisions regarding Office of Government Ethics and Office of Special Counsel jurisdiction and enforcement authority. To address checks and balances, accountability, and transparency, the bill authorizes specified actions to enforce congressional subpoenas, imposes limits on presidential declarations of emergencies, requires DOJ to maintain a log of specified communications between it and the White House, requires cause for removal of inspectors general, increases whistleblower protections, and requires a candidate for President or Vice President to provide copies of tax returns for the 10 most recent taxable years to the Federal Election Commission. To address election integrity and security, the bill requires federal campaign reporting of foreign contacts, makes various changes to requirements concerning foreign donations to political campaigns and candidates and foreign contributions to online electioneering communications, prohibits distribution of materially deceptive audio or visual media prior to an election (i.e., deepfakes), and establishes a program to support states and localities transition to ranked choice voting systems.

Forbidding Airlines from Imposing Ridiculous Fees Act of 2021 or the FAIR Fees Act of 2021 This bill directs the Department of Transportation to prescribe regulations (1) prohibiting an air carrier from imposing specified fees relating to a flight in passenger air transportation that are unreasonable or disproportional to the costs it incurs, and (2) establishing standards for assessing whether such fees are reasonable and proportional to those costs.

Humane Cosmetics Act of 2021 This bill generally prohibits animal testing in the evaluation of cosmetic products, and it prohibits the sale or transport of cosmetics developed using animal testing, subject to civil penalties. These prohibitions begin one year after enactment. The bill specifies exceptions to these prohibitions, including if such animal testing (1) is conducted outside the United States to comply with a foreign regulatory authority; (2) is pursuant to a specified finding that there are no nonanimal alternatives to test the safety of a potentially dangerous cosmetic product or ingredient; (3) is of a product or ingredient for a drug or device subject to regulation by the Food and Drug Administration (FDA); or (4) is required for a noncosmetic purpose pursuant to a state, federal, or foreign regulatory authority. Further, no animal-testing evidence may be used to establish the safety of a cosmetic product or ingredient that is regulated by the FDA after the effective date of this bill, subject to limited exceptions.