This resolution calls on the Office for Civil Rights within the Department of Education and state attorneys general to assist elementary and secondary schools in complying with existing civil rights laws and investigate and enforce such laws. In addition, the resolution condemns the practice of requiring teachers to receive education in critical race theory as a condition of certification.
This resolution expresses support for the designation of National Senior Fraud Awareness Day and encourages the development of policies that help prevent scams targeting older adults.
Stop EITC and CTC Seizures Act This bill prohibits the Department of the Treasury from reducing a taxpayer's tax refund for student loan debt to the extent that such reduction would cause the refund to be less than the sum of the earned income tax credit and the child tax credit.
This bill prohibits any executive agency from contravening Executive Order 13950 (Combating Race and Sex Stereotyping), except as such order relates to contractors and grant recipients.
This resolution requires the Office of the Sergeant at Arms and Doorkeeper of the Senate to establish a McCain-Mansfield Fellowship Program through which certain veterans may participate in a two-year fellowship in the personal office of a Senator.
This resolution designates National Pregnancy Center Week.
This resolution expresses support for the goals and ideals of National Nurses Week.
Limiting CDC to Disease Control Act This bill modifies and limits the authority of the Department of Health and Human Services (HHS) to issue regulations to control communicable diseases. Current law authorizes HHS to make and enforce regulations to prevent the introduction or spread of communicable diseases. In particular, current law provides that HHS may make and enforce regulations addressing (1) isolation and quarantine of infected individuals (subject to certain restrictions); and (2) inspection, fumigation, disinfection, sanitation, pest extermination, destruction of infected animals or articles, and other measures that the department determines may be necessary. HHS has delegated this authority to the Centers for Disease Control and Prevention (CDC). This bill eliminates the authority of the CDC to make and enforce regulations that provide for other measures it determines may be necessary to prevent the spread of communicable diseases, thereby limiting the scope of its regulations to the other specific purposes set out in current law.
Accelerated Drug Approval for Prescription Therapies Act or the ADAPT Act This bill authorizes the Food and Drug Administration (FDA)to create an expedited drug approval process specifically for drugs that are currently approved for sale in certain countries (i.e., a European Economic Area member country, Australia, Canada, Israel, Japan, New Zealand, South Africa, or Switzerland) and meet certain criteria. Such criteria shall include establishing that (1) the drug is safe and effective, (2) all relevant U.S. patents or legal exclusivities have expired, and (3) the United States has a public health or unmet medical need for the drug. The FDA must process and review an application under this bill within 180 days of submission.
Save Local Business Act This bill provides that a person may be considered a joint employer in relation to an employee under federal labor law only if such person directly, actually, and immediately (and not in a limited and routine manner) exercises significant control over the essential terms and conditions of employment. Such control may by demonstrated by hiring and discharging employees, determining individual employee rates of pay and benefits, day-to-day supervision of employees, assigning individual work schedules, positions, and tasks, and administering employee discipline.
FDA Review of Efficacy of EERW Double-Blinds of Opioids Act or the FREED of Opioids Act This bill requires the Food and Drug Administration (FDA) to take certain actions to determine whether to permit the use of a certain methodology for drug clinical trials. Specifically, the FDA must seek to contract with the National Academy of Sciences (NAS) for the NAS to conduct a study on the effectiveness of using enriched enrollment randomized withdrawal methodology in demonstrating the efficacy of opioid drugs in treating chronic pain. The FDA must also convene a meeting of two specified FDA advisory committees to review the NAS study and vote on whether to permit the use of this methodology in drug clinical trials.
Promising Pathway Act This bill establishes a provisional approval pathway for medicines intended for serious or life-threatening diseases, including illnesses posing a threat of epidemic or pandemic. The period of the provisional approval is for two years and is potentially renewable. The Food and Drug Administration (FDA) must establish a priority review system to evaluate completed provisional approval applications within 90 days of receipt. A provisional approval application may be approved if the FDA determines that (1) there is substantial evidence of safety for the drug; and (2) there is relevant early evidence of efficacy, based on adequate and well-controlled investigations. During the COVID-19 (i.e., coronavirus disease 2019) pandemic, or another epidemic or pandemic, the FDA must accept and review various portions of a provisional approval application on a rolling basis. The manufacturer of a provisionally approved drug must require patients to participate in an observational registry. A manufacturer that fails to comply with registry requirements is subject to civil penalties. A provisionally approved drug must be labeled as such. If a drug that receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded. The bill also limits the liability of a manufacturer of a provisionally approved drug with respect to any claim under state law alleging that the drug is unsafe or ineffective. Private health insurers and federal health care programs shall not deny coverage of a provisionally approved drug on the basis of it being experimental.
