Rep. Val Butler Demings

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.

Accelerating Access to Critical Therapies for ALS Act This bill establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions. The Department of Health and Human Services (HHS) shall award grants to eligible entities for scientific research utilizing data from expanded access to investigational ALS treatments for individuals who are not otherwise eligible for clinical trials.  The Food and Drug Administration (FDA) shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other rare neurodegenerative diseases. HHS shall also establish the Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the FDA, and at least one eligible entity (generally, an institution of higher education or a nonprofit organization). The partnership shall support the development and regulatory review of drugs that address ALS and other rare neurodegenerative diseases. The FDA shall publish on its website a five-year action plan for fostering the development of drugs that improve or extend the lives of people living with rare neurodegenerative diseases. The Government Accountability Office must report to Congress about the grants provided under this bill, including an analysis of the impact of such grants on research and development of treatments for ALS.

National Critical Capabilities Defense Act of 2021 This bill establishes the Committee on National Critical Capabilities to review certain transactions by U.S. businesses, including those transactions that could result in an unacceptable risk to national critical capabilities. Further, the bill authorizes the President to suspend or prohibit transactions that pose an unacceptable risk to national critical capabilities.

This resolution recognizes the 73rd anniversary of the Universal Declaration of Human Rights, supports the designation of Human Rights Day, and encourages the observation of Human Rights Day and a continued commitment to upholding human rights around the globe.

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.

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.

Employee Retention Tax Credit Reinstatement Act This bill provides for a reinstatement of the employee retention tax credit through 2021. The credit was established to compensate employers whose businesses were negatively impacted by the COVID-19 pandemic for wages paid to their employees.

9/11 Memorial and Museum Act This bill directs the Department of Homeland Security (DHS) to award to the official organization that operates the National September 11 Memorial & Museum a one-time grant to be used solely for the purposes of the operation, security, and maintenance of the memorial and museum. As a condition on receipt of the grant, the organization must provide for free admission to all facilities and museums associated with the memorial and museum for active and retired members of the Armed Forces, individuals who were registered first responders to the terrorist attacks of September 11, 2001, and family members of victims of such attacks; provide for dedicated free admission hours for the general public at least once a week; and allow for annual federal audits of its financial statements.

Maddy summaryHRES 834 is a ceremonial resolution honoring the late Congresswoman Carrie Pittman Meek (1926-2021) for her congressional service and legacy. It commends her dedication to public service, her role as a trailblazer for Black women in politics, and her advocacy for communities in Florida. The resolution specifically recognizes her work securing hurricane relief funding after Hurricane Andrew and her service in the Florida State Senate and U.S. Congress. As a commemorative resolution, it contains no policy changes or funding provisions.

Immunization Infrastructure Modernization Act of 2021 This bill directs the Department of Health and Human Services (HHS) to take actions to improve data sharing and other aspects of immunization information systems. These are confidential, population-based databases that maintain a record of vaccine administrations. Specifically, HHS must develop a strategy and plan to improve these systems, including systems supported by the Centers for Disease Control and Prevention; designate data and technology standards for use in these systems; and award grants to health departments and other government agencies to improve their systems. As a condition of receiving the grants, recipients must use the designated standards. However, HHS may waive this condition in some circumstances. HHS must also report to Congress on these activities.