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receives provisional approval status is not brought to market within 180 days of the approval, the approval must be rescinded.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.
Israel Sovereignty Reassurance Act of 2021 or ISRA This bill prohibits using funds made available to the Department of State for FY2022 to implement, administer, or enforce any policy that rescinds the U.S. recognition of the Golan Heights as part of Israel.
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.
Metastatic Breast Cancer Access to Care Act This bill expedites payment of Social Security Disability Insurance (SSDI) benefits and eligibility for Medicare coverage for those with metastatic breast cancer (i.e., breast cancer that has spread to other sites in the body). Specifically, the bill eliminates the 5-month waiting period for SSDI benefits and the subsequent 24-month waiting period for Medicare coverage for individuals with metastatic breast cancer. Under current law, individuals generally must wait five months after the onset of disability to begin receiving SSDI benefits and an additional 24 months to become eligible for Medicare.
I am Vanessa Guillén Act of 2021 This bill addresses the policies and procedures of the Department of Defense (DOD) for cases or allegations of sex-related offenses.
Homes for Every Local Protector, Educator, and Responder Act of 2021 or the HELPER Act of 2021 This bill establishes a program administered by the Department of Housing and Urban Development to provide mortgage assistance to law enforcement officers, elementary and secondary school teachers, firefighters, or other first responders. Specifically, these individuals may be eligible for a one-time mortgage on a primary family residence with no down payment and no monthly mortgage insurance premium.
Yes In My Backyard Act This bill requires certain Community Development Block Grant program recipients to submit to the Department of Housing and Urban Development information regarding their implementation of certain land-use policies, such as policies for expanding high-density single-family and multifamily zoning.
Stop CRT Act This bill grants Executive Order 13950 the force and effect of law. That order prohibits federal agencies and contractors from advancing specified policies or training related to race or sex.
Hot Cars Act of 2021 This bill requires safety measures in passenger cars to reduce injuries or deaths from heatstroke and other harms to occupants of unattended vehicles. Specifically, the National Highway Traffic Safety Administration (NHTSA) must issue a motor vehicle safety standard that requires certain new passenger motor vehicles to include a system that detects and warns of the presence of an unattended occupant in the passenger compartment. The NHTSA must issue the final rule prescribing the safety standard within two years after the enactment of this bill, with full compliance with the standard required not later than two years after the rule is issued. After the standard is issued, the Department of Transportation must periodically contract with an independent third party to study retrofitting passenger motor vehicles with technologies and products that detect and warn when there is an unattended occupant in the passenger compartment. The study must identify relevant technologies and products to retrofit vehicles and provide recommendations about testing such technologies and products. Information about the performance of the technologies and products must be published on the NHTSA's website.
Health Equity and Access under the Law for Immigrant Women and Families Act of 2021 or the HEAL Immigrant Women and Families Act of 20 21 This bill extends Medicaid and Children's Health Insurance Program coverage to individuals lawfully present in the United States who otherwise meet eligibility requirements. Individuals granted federally authorized presence also are required to maintain minimum essential health insurance coverage and are eligible for health insurance exchanges, reduced cost sharing, premium subsidies, and premium tax credits.
Nurse Staffing Standards for Patient Safety and Quality Care Act of 2021 This bill requires hospitals to implement and submit to the Department of Health and Human Services (HHS) a staffing plan that complies with specified minimum nurse-to-patient ratios by unit. Hospitals must post a notice regarding nurse-to-patient ratios in each unit and maintain records of actual ratios for each shift in each unit. The bill also requires hospitals to follow certain procedures regarding how ratios are determined and other staff are prohibited from performing nurse functions unless specifically authorized within a state's scope of practice rules, among other requirements. HHS must adjust Medicare payments to hospitals to cover additional costs attributable to compliance with these ratios. Nurses may object to, or refuse to participate in, an assignment if it would violate minimum ratios or if they are not prepared by education or experience to fulfill the assignment without compromising the safety of a patient or jeopardizing their nurse's license. Hospitals may not (1) take adverse actions against a nurse based on the nurse's reasonable refusal to accept an assignment; or (2) discriminate against individuals for good faith complaints relating to the care, services, or conditions of the hospital or related facilities. HHS may impose civil monetary penalties on hospitals violating the ratio requirements and must publish the names of such hospitals. The bill provides stipends to the nurse workforce loan repayment and scholarship program and expands the nurse retention grant program to include nurse preceptorship and mentorship projects.
