Fairness in Orphan Drug Exclusivity Act This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.) Under this bill, if a drug is designated as an orphan drug on the basis that there is no reasonable expectation that the sponsor will recover the costs of developing and distributing the drug from U.S. sales, the drug shall be granted the seven-year exclusivity period only if the sponsor demonstrates that there is no reasonable expectation that it will recover such costs specifically within its first 12 years of U.S. sales of the drug. This requirement shall also apply retroactively to an orphan drug that was granted such an exclusivity period before this bill's enactment. When deciding whether an orphan drug meets this requirement, the FDA shall consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
Sponsored bills
Senior Corps Distance Volunteering Act This bill directs the Corporation for National and Community Service to establish an online service platform to connect volunteers in the National Senior Service Corps with service projects, and enable the volunteers to carry out distance volunteering on an online network. The corporation shall provide outreach services to promote the platform, including outreach to institutions of higher education, the Department of Veterans Affairs for mentorship projects, and state and local governments for community engagement projects.
Real Economic Support That Acknowledges Unique Restaurant Assistance Needed To Survive Act of 2021 or the RESTAURANTS Act of 2021 This bill temporarily establishes and provides funding for the Restaurant Revitalization Fund, from which the Department of the Treasury shall make grants to eligible food and beverage purveyors to cover specified costs such as payroll, operational expenses, and paid sick leave. For the grant program's initial period, Treasury must (1) prioritize awarding grants to marginalized and underrepresented communities, and (2) only award grants to eligible food and beverage purveyors with annual revenues of less than $1.5 million in 2019. For tax purposes, grant amounts are excluded from the recipient's gross income. An entity that received a loan under the Paycheck Protection Program established to support small businesses in response to COVID-19 (i.e., coronavirus disease 2019) may not apply for or use a restaurant revitalization grant for the same expenses for which the entity received the paycheck protection loan. Further, a grant applicant may request an additional amount to cover the cost of providing 10 days of paid sick leave to its employees. Treasury must report a list of grant recipients with the amount each recipient received, as well as demographics and other specified information.
Patient Matching Improvement Act of 2021 This bill requires the Office of the National Coordinator for Health Information Technology (ONC) to standardize the format of postal addresses in health information technology to improve patient matching. Patient matching is the identification and linking of one patient's data within and across health care organizations using multiple demographic fields, such as name and address. The ONC must collaborate with the U.S. Postal Service (USPS) to make existing tools that automatically format addresses into a specific standard available to health care organizations. In particular, the ONC must focus on making the tools available to laboratories that test for COVID-19 (i.e., coronavirus disease 2019) to improve data collection related to that disease. If the USPS determines the tools cannot be made available to health care organizations, the Department of Health and Human Services must report to Congress on the barriers that prevent such use. In addition, the ONC must update regulations to require the use of a standard address format as a condition of certification for health information technology.
This resolution designates January 24-January 30, 2021, as National School Choice Week.
This resolution honors the life and legacy of Henry Louis Aaron for his accomplishments on and off the baseball field and for defying racism and breaking down racial barriers in the fight for equality.
This bill allows for Medicare payment of ground ambulance services that did not result in the actual transport of an individual to a permitted facility, if the lack of transport was due to community-wide COVID-19 (i.e., coronavirus disease 2019) protocols for emergency medical services during the public health emergency.
Keystone XL Pipeline Construction and Jobs Preservation Act This bill authorizes the TransCanada Keystone Pipeline to construct, connect, operate, and maintain the pipeline facilities in Phillips County, Montana, for the import of oil from Canada to the United States.
Protecting Our Wealth of Energy Resources Act of 2021 or the POWER Act of 2021 This bill requires the President and federal agencies to obtain the approval of Congress before prohibiting or substantially delaying certain new energy or mineral leases or permits on federal lands, including oil and gas leases, coal leases, hard rock leases, or critical minerals leases. In addition, the President and agencies must obtain the approval of Congress before withdrawing certain federal lands from mineral and geothermal leasing activities.
Title X Abortion Provider Prohibition Act This bill prohibits the Department of Health and Human Services (HHS) from awarding family planning grants to entities that perform abortions or provide funding to other entities that perform abortions. To receive a grant, an entity must certify it will refrain from those activities during the grant period. The bill provides exceptions for abortions (1) in cases of rape or incest; or (2) when the life of the woman is in danger due to a physical disorder, injury, or illness. It also exempts hospitals unless they provide funds to non-hospital entities that provide abortions. HHS must report annually on this prohibition.