Gabriella Miller Kids First Research Act 2.0 This bill modifies funding for a pediatric disease research initiative within the National Institutes of Health (NIH). Currently, this initiative receives funding through FY2023 from the 10-Year Pediatric Research Initiative Fund. This bill directs certain penalties assessed by the Securities and Exchange Commission against pharmaceutical companies for specified violations to that fund. In making allocations from the fund, the NIH must prioritize pediatric research that does not duplicate existing research activities.
Sponsored bills
USTR Inspector General Act of 2021 This bill requires the President to appoint an Inspector General of the Office of the U.S. Trade Representative (USTR). Among other responsibilities, the Inspector General shall (1) conduct and supervise audits and investigations relating to the programs and operations of the USTR, (2) recommend policies for preventing and detecting fraud and abuse in those programs, and (3) provide a means for keeping the USTR and Congress informed about problems and deficiencies in those programs and operations.
Access to Genetic Counselor Services Act of 2021 This bill provides for coverage under Medicare of genetic counseling services that are furnished by genetic counselors. Covered services include those services, as well as incidental services and supplies, that would otherwise be covered under Medicare if provided by a physician.
Simplifying the Generic Drug Application Process Act This bill removes a requirement for a generic drug maker to, in some instances, petition the Food and Drug Administration (FDA) before seeking market approval for a generic drug. Currently, if an applicant wishes to submit an abbreviated application (i.e., the type of application typically used to get market approval for a generic drug) for a drug that has a different dosage form or strength from an already-approved drug, the applicant must first petition the FDA for permission to submit the application. Under this bill, an applicant is no longer required to petition the FDA for permission in these instances.
Net Price Calculator Improvement Act This bill establishes requirements concerning the information that must be provided to prospective students about the cost of attendance at an institution of higher education (IHE). Specifically, the bill establishes the minimum requirements for the net price calculator that an IHE must include on its website. An IHE's net price is the average yearly price actually charged to first-time, full-time undergraduate students receiving student aid at the IHE after deducting such aid. The bill also authorizes the Department of Education to develop a universal net price calculator that enables users to answer one set of questions and receive net prices for several IHEs and compare those prices.
This bill establishes that certain data and determinations from a request for emergency use authorization for a drug, biological product, or medical device may apply to later regulatory procedures for that product. Specifically, data generated to support a request for emergency use authorization may constitute valid scientific evidence to be considered for various later submissions to the Food and Drug Administration (FDA), including a request for market approval. Also, when granting emergency use authorization for a medical device, if the FDA determines that the device performs certain simple low-risk examinations, that determination shall apply to certain other regulatory submissions unless additional information contradicts that determination.
Understanding the True Cost of College Act of 2021 This bill requires standardized financial aid terminology and offer forms. Specifically, the Department of Education (ED) must develop standard terminology and a format for financial aid offer forms based on recommendations from representatives of certain groups, including students, veterans, and institutions of higher education (IHEs). The consumer-friendly form must include specified details and disclosures, including the estimated cost of attendance, the net price that a student or family is estimated to pay, and the terms and conditions of financial aid. In addition, ED must (1) test the form with representatives of students, students' families, IHEs, secondary school and postsecondary counselors, and nonprofit consumer groups; and (2) use the results to develop the final form. Each IHE that participates in federal student-aid programs must (1) use the standard form when offering financial aid to students, and (2) use the standard terminology and definitions developed by ED for all communications related to financial aid offers.
Know Before You Owe Federal Student Loan Act of 2021 This bill expands lender disclosure requirements and revises loan counseling requirements. First, the bill requires a lender to provide a quarterly statement to a Federal Family Education Loan or Direct Loan borrower during a period when loan payments are not required. The statement must include specified information on the loan and interest amounts and explain the option to pay accrued interest while in deferment or forbearance. In addition, the bill requires an institution of higher education (IHE) that participates in federal student-aid programs to provide pre-loan counseling to a student borrower of a federal student loan upon or prior to the first disbursement of each new loan. Currently, an IHE must provide one-time entrance counseling to a student who is a first-time federal student loan borrower. The bill also revises and expands required elements of pre-loan counseling to include an estimate of the borrower's monthly payment amount compared to the borrower's estimated monthly income after taxes and other expenses, a statement to borrow the minimum necessary amount, a warning that a high debt-to-income ratio makes repayment more difficult, options to reduce borrowing, and an explanation of the importance of on-time graduation. Prior to certifying a Federal Direct Loan disbursement to a student, an IHE must ensure that the student manually enters the exact dollar amount of the loan.
Cover Crop Flexibility Act of 2021 This bill modifies the federal crop insurance program to address the planting of cover crops following prevented planting. Specifically, the bill allows a producer that is prevented from planting its first crop to plant a second crop and receive an indemnity equal to the full guarantee for the first crop if the second crop (1) is an approved cover crop, and (2) cannot be harvested for grain or other uses unrelated to livestock forage or conservation. Under current law, if a producer plants a second crop it can only get an indemnity worth at most 35% of the prevented planting guarantee for the first crop. For a producer planting a cover crop following prevented planting, the Federal Crop Insurance Corporation (FCIC) may provide separate prevented planting coverage factors that include preplanting costs and the cost of cover crop seed. Further, the FCIC must conduct research and development regarding a policy to insure crops on fields that regularly utilize cover crops, including research to examine the extent that cover crops reduce risks of prevented planting and other crop insurance losses.
Coronavirus Housing Counseling Improvement Act This bill authorizes additional housing counseling services provided through the Neighborhood Reinvestment Corporation. Funding priority is given to counseling organizations that target low-income and minority homeowners, renters, individuals experiencing homelessness, and individuals at risk of homelessness.