Speeding Therapy Access Today Act of 2021 This bill requires and authorizes various actions to accelerate the development of therapies for rare diseases. The Food and Drug Administration (FDA) shall establish the Intercenter Institute on Rare Diseases and Conditions. The institute shall (1) coordinate engagement with relevant stakeholders, (2) build the FDA's expertise in the review of medical products to treat rare diseases, (3) coordinate regulatory science initiatives related to rare diseases, (4) establish and implement a program to make recommendations to address challenges associated with developing medical products to treat rare diseases in an individual or in very small populations, (5) convene a stakeholder meeting to consider potential amendments to labels for medical products to treat rare diseases, and (6) establish and carry out a program to facilitate voluntary communication between the sponsors of such medical products and third-party payers (e.g., insurance companies). The bill also authorizes the FDA to make grants to assist in developing practices related to the development and production of individualized therapies or therapies to treat very small populations. The bill also establishes an advisory committee to advise the FDA on issues related to the development of therapies to treat rare diseases.
Rep. Rodney Davis
Sponsored bills
Fair Access to Banking Act This bill restricts certain banks, credit unions, and payment card networks from refusing to do business with a person who is in compliance with the law. Restrictions include prohibiting the use of certain lending programs, initiating the process of terminating an institution's depository insurance, and instituting specified civil penalties.
COVID-19 Mental Health Research Act This bill requires the National Institute of Mental Health to support mental health research activities related to COVID-19 (i.e., coronavirus disease 2019). The institute must coordinate these activities with other components of the National Institutes of Health.
This resolution expresses support for the goals and ideals of National Colorectal Cancer Awareness Month.
This resolution supports the designation of a National FFA Week. It also (1) recognizes the important role of the National FFA Organization (Future Farmers of America) in developing the next generation of leaders who will change the world, and (2) celebrates 50 years of National FFA alumni and supporters.
Death Tax Repeal Act This bill repeals the estate and generation-skipping transfer taxes. It also makes conforming amendments related to the gift tax.
Prevent Interruptions in Physical Therapy Act of 2021 This bill allows a physical therapist to receive payment under Medicare for services provided to the physical therapist's patients by another physical therapist through a qualifying temporary arrangement, regardless of the geographic area or population served. Currently, physical therapists may only receive payment with respect to such arrangements for services provided in medically underserved, rural, or health professional shortage areas.
Donald Payne Sr. Colorectal Cancer Detection Act of 2021 This bill provides for Medicare coverage and payment, subject to specified frequency limits, of certain colorectal cancer screening blood-based tests.
Rural Hospital Closure Relief Act of 2021 This bill allows additional hospitals to qualify as critical access hospitals (CAHs) that receive special payment under Medicare. Currently, in order to qualify as a CAH under Medicare, a hospital must either (1) be located more than 35 miles (or 15 miles in mountainous regions or areas with only secondary roads) from another hospital, or (2) have been certified prior to January 1, 2006, by the state as a necessary provider of services in the area. The bill allows a hospital to also qualify if the hospital is a small, rural hospital that (1) serves a health professional shortage area, or a high number of low-income individuals or Medicare or Medicaid beneficiaries; (2) has experienced financial losses for two consecutive years; and (3) attests to having a strategic plan to address financial solvency. In addition, the Center for Medicare and Medicaid Innovation must test a new delivery and payment model for rural hospitals that promotes financially sustainable access to care and must establish a corresponding transition process for CAHs.
This bill expedites the approval process for renewable fuels under the renewable fuel standard (RFS) program. The existing RFS program requires transportation fuel to contain a minimum volume of renewable fuel. Producers must register renewable fuels under the program. The bill considers an application to register a renewable fuel under the RFS program to be approved by the Environmental Protection Agency (EPA) if the fuel has been approved under any state renewable fuel program. It also establishes a deadline for the EPA to make a decision on any pending application for a renewable fuel that has not yet been approved under any state program. In addition, the bill establishes deadlines for the EPA to make decisions on pending pathway petitions by producers to register biofuels. If the EPA does not make decisions on the petitions by the deadlines, then petitions are automatically approved.