Preserve Access to Affordable Generics and Biosimilars Act This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar. An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market and secure final approval for its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects. When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations. The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.
EDUCATORS for America Act This bill provides resources to support the recruitment, retention, and preparation of educators. These resources include, among others, expanding the Teacher Quality Partnership program to include training and professional development opportunities for principals and other school leaders, updating the Augustus F. Hawkins Centers of Excellence program to support underrepresented candidates in educator preparation programs, and revising the Teacher Education Assistance for College and Higher Education (TEACH) grant program to raise the maximum amount for TEACH grants. The bill also directs the Department of Education to carry out a program to provide loan credits to eligible educator borrowers enrolled in income-contingent or income-based repayment plans.
Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act or the Stop STALLING Act This bill makes it an unfair method of competition to submit an objectively baseless petition to the Food and Drug Administration (FDA) in an attempt to interfere with a competitor's application for market approval of a drug. The bill authorizes the Federal Trade Commission to sue an individual or entity that submits such a petition to the FDA. A party found liable in such a lawsuit shall be subject to civil penalties, such as a fine of up to $50,000 for each day that the FDA spent reviewing the baseless petition.
Critical Infrastructure Manufacturing Feasibility Act This bill requires the Department of Commerce to study and report on products that are in high demand across the critical infrastructure sectors. Critical infrastructure sectors are those whose assets, systems, and networks are vital to national security, the economy, public health or safety, or any combination of those matters. The study must (1) identify the products in high demand across those sectors that are being imported due to manufacturing, material, or supply chain constraints; and (2) analyze the costs, benefits, and feasibility of manufacturing those products in the United States.
Allied Health Workforce Diversity Act of 2021 This bill allows the Department of Health and Human Services to provide grants to accredited education programs to increase diversity in the physical therapy, occupational therapy, respiratory therapy, audiology, and speech-language pathology professions. Grants may be used to provide scholarships or to support recruitment and retention of students from underrepresented groups.
Community Bank Relief Act of 2021 This bill requires banking agencies to set the community bank leverage ratio between 8% and 8.5% for calendar years 2022, 2023, and 2024 for community banks seeking to satisfy simplified capital adequacy requirements. Currently, banking agencies are statutorily required to set the rate between 8% and 10% through rulemaking. Under current regulations, the rate will increase from 8.5% to 9% on January 1, 2022.
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.
CNL Update Act This bill makes changes to the procedures for competitive need limitations (CNL) and de minimis waivers under the Generalized System of Preferences (GSP) program. CNLs are quantitative ceilings on GSP benefits for each product and beneficiary developing country; a beneficiary developing country loses its GSP eligibility with respect to a product if the CNLs are exceeded and no waiver is granted. Currently, the President must terminate the duty-free treatment for a product from a beneficiary developing country if (1) imports of a product from a single country reach a specified threshold value, which increases by $5 million each calendar year; or (2) 50% or more of total U.S. imports of a product entering under the GSP come from a single country. This bill revises the annual adjustment amount from $5 million to an amount equal to 6.5%. Further, the bill sets the annual increase in the de minimis level to 6.5%. Currently, the de minimis level is adjusted each year in increments of $500,000.
Department of Veterans Affairs Telehealth Strategy Ac t This bill requires the Department of Veterans Affairs (VA) to submit a strategy to Congress for the telehealth services furnished by the Veterans Health Administration. Additionally, the VA must report on the utilization of end-user devices provided to veterans by the VA to facilitate telehealth during FY2020 and FY2021.
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.
Protect American Taxpayer Dollars from Illegal Immigration Act This bill prohibits expending federal funds for legal settlements to individuals who violated certain laws relating to the proper time and place to enter the United States, if the settlement pertains to claims based on the lawful detention of such an individual as part of a family unit after the individual's entry into the United States at the southern border after January 20, 2017.
Eliminating Global Market Distortions to Protect American Jobs Act of 2021 This bill addresses unfair trade practices by making various changes to U.S. antidumping and countervailing duty law. Antidumping provides relief to U.S industries and workers that are materially injured or threatened with injury due to imports of like products sold in the U.S. market at less than fair value, while countervailing duty provides such relief from imports of products subsidized by a foreign government or public entity. Specifically, the bill establishes a process for successive antidumping and countervailing duty investigations. Successive investigations may be concurrent (an ongoing investigation of the same product from different countries) or recently completed (not more than two years before the date of the initiation of the successive investigation). Further, the bill establishes a time line for the Department of Commerce to issue determinations in successive investigations. Among other provisions, the bill authorizes Commerce to apply countervailing duty law to subsidies provided by a foreign government or public entity to a company operating in a different country, use another method for calculating the cost of production in specific circumstances, and require importers to provide a certification that the imported merchandise is not subject to an antidumping or countervailing duty order. Additionally, the bill establishes procedures for Commerce to conduct circumvention inquiries, including by specifying the deadlines for preliminary and final determinations. The bill repeals the Softwood Lumber Act of 2008, which addresses the importation of softwood lumber and softwood lumber products.
