This bill waives certain eligibility requirements for hospitals participating in the 340B drug discount program (i.e., a program that allows entities to receive covered outpatient drugs at reduced prices from manufacturers) during the COVID-19 (i.e., coronavirus disease 2019) public health emergency. Specifically, the bill waives the required minimum proportion of low-income patients served for hospitals that began participating in the program during or prior to the COVID-19 emergency.
COVID-19 Origin Act of 2021 This bill requires the Office of the Director of National Intelligence (ODNI) to declassify all information relating to potential links between the Wuhan Institute of Virology and the origin of COVID-19. The ODNI shall submit to Congress an unclassified report containing such information, with redactions only as necessary to protect sources and methods.
This resolution welcomes President Moon Jae-in of South Korea to the United States. It also reaffirms the importance of the U.S.-South Korea relationship to peace, security, and prosperity on the Korean Peninsula and in the Indo-Pacific region.
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.
Operation Warp Speed Act of 2021 This bill modifies procedures for Emergency Use Authorization (EUA) and provides additional authority to the Department of Health and Human Services (HHS) for vaccine production in response to a public health emergency. It also makes changes to the administration of the Strategic National Stockpile. (An EUA temporarily authorizes use of an otherwise unapproved medical product or device in certain emergency situations.) Among other modifications, the bill places additional requirements on EUA approvals. Specifically, HHS may only approve an EUA if, after consulting four specified agencies, at least three of them vote to grant approval. Currently, HHS's authority to approve an EUA, which it has delegated to the Food and Drug Administration, is not limited by the votes of consulting agencies. Additionally, the bill authorizes the use of HHS funds to produce a vaccine before it is licensed or authorized in response to a public health emergency. The bill also establishes the Office of Operation Warp Speed within the HHS Office of the Assistant Secretary for Preparedness and Response to expedite the production of vaccines and medical countermeasures to respond to public health emergencies. With respect to the Strategic National Stockpile, HHS must assess, as part of its annual threat-based review, the levels of and supply chains for materials in the stockpile. HHS must also give priority to domestic manufacturers when procuring materials for the stockpile. If materials cannot be sourced domestically, HHS must give priority to manufacturers that are not located in China.
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.
Estate Tax Rate Reduction Act This bill reduces the rate for the tax on estates, gifts, and generation-skipping transfers to 20%. (Under current law, the highest rate is 40%.) The bill also exempts the budgetary effects of the tax reduction from the Pay-As-You-Go (PAYGO) rules established by the Statutory Pay-As-You-Go Act of 2010 and the FY2018 congressional budget resolution.
Securing and Enabling Commerce Using Remote and Electronic Notarization Act of 2021 This bill allows a notary public commissioned under state law to remotely notarize electronic records and perform notarizations for remotely located individuals. The bill provides technical requirements for such notarizations, including the creation and retention of video and audio recordings and the use of communication technologies (i.e., video chat). Additionally, the bill requires U.S. courts and states to recognize notarizations—including remote notarizations of electronic records and notarizations of remotely-located individuals—that occur in or affect interstate commerce and are performed by a notary public commissioned under the laws of other states. The bill also allows a notary public to remotely notarize electronic records involving an individual located outside of the United States, subject to certain requirements.
Probation Officer Protection Act of 2021 This bill authorizes a probation officer to arrest a person other than the probationer without a warrant if there is probable cause to believe the person forcibly assaulted or obstructed a probation officer engaged in the performance of official duties.
Hizballah Money Laundering Prevention Act of 2021 This bill establishes measures to deter money laundering by Hizballah in Lebanon. Specifically, the Department of the Treasury must prohibit or place conditions on the opening or maintaining of certain correspondent or payable-through accounts by the Central Bank of Syria if Treasury determines that certain jurisdictions in Lebanon are jurisdictions of primary money laundering concern. Further, the President must sanction certain senior foreign political figures or foreign persons that the President determines have knowingly provided material support to or engaged in a significant transaction with Hizballah.
