Congressional Tribute to Constance Baker Motley Act of 2022 This bill provides for the award of a Congressional Gold Medal posthumously to Constance Baker Motley in recognition of her contributions and service to the United States in advancing civil rights as an attorney, elected official, and judge.
Drug Shortages Shelf Life Extension Act This bill requires the Food and Drug Administration (FDA) to issue or revise guidance to address issues relating to extending drug expiration dates. Specifically, the guidance must address recommendations to drug companies relating to (1) submitting stability testing data in applications for market approval for drugs or biological products; and (2) establishing on drug labels the longest feasible expiration date supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages. The FDA must also periodically report to Congress certain information about requests to change the expiration date on a drug label, including the number of such requests from the FDA to the manufacturer and the rationale for each request.
Planning, Reporting, and Enabling Voluntary Expansion of Notifications Targeting Medical Device Shortages Act of 2022 or the PREVENT Medical Device Shortages Act of 2022 This bill expands existing requirements for manufacturers of certain medical devices to alert the Food and Drug Administration (FDA) of supply disruptions and addresses related issues. Under this bill, a manufacturer of a medical device that is critical to public health during a declared public health emergency must notify the FDA as soon as practicable of any circumstance that is likely to lead to a meaningful disruption to the supply of the device in the United States. Currently, the manufacturer is only required to notify the FDA of supply disruptions stemming from manufacturing issues. The bill also authorizes the FDA to receive notifications from manufacturers of medical devices that are critical to public health about manufacturing issues that are likely to lead to a meaningful disruption to the U.S. supply of the device. Each manufacturer of a medical device that is critical to the public health must develop and implement a redundancy risk management plan in each manufacturing facility for the device. Such a plan shall be subject to FDA inspection.
Securing Uninterrupted Pandemic Preparation Of Resources and Therapies Act or the SUPPORT Act This bill expressly incorporates the provision of mental health and substance use disorder services during public health emergencies into the authorities and other activities of the Substance Abuse and Mental Health Services Administration (SAMHSA). Additionally, SAMHSA must report to Congress about recommendations to improve the provision of such services during public health emergencies. The Government Accountability Office must also report on SAMHSA's programs and activities for supporting the provision of such services during the COVID-19 pandemic.
Registration of Certain Foreign Establishments Act This bill expands statutory provisions that require foreign manufacturers of drugs or medical devices for the U.S. market to register with the Food and Drug Administration. Specifically, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug or medical device to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug or medical device in question undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States.
Maddy summarySRES 485 is a Senate resolution honoring the late Senator Harry Mason Reid, Jr., of Nevada, who died in 2021. The resolution expresses the Senate's sorrow at his passing, extends condolences to his family, and directs the Secretary of the Senate to communicate the resolution to the House of Representatives and provide a copy to Reid's family. The Senate also adjourned in his memory as a mark of respect. This is a ceremonial tribute with no policy changes or legal effect.
Maddy summarySRES 484 is a ceremonial Senate resolution honoring the late Senator John "Johnny" Isakson of Georgia. It formally recognizes his 40+ years of public service, including his roles in the Georgia legislature, U.S. House, and U.S. Senate, and his reputation for bipartisan cooperation. The resolution requests the Senate Secretary communicate it to the House and send a copy to Isakson's family. As a commemorative resolution, it has no policy impact or direct effect on any individuals or programs.
Anti-Spoofing Penalties Modernization Act of 2021 This bill doubles the penalties for providing misleading or inaccurate caller identification information with intent to defraud, cause harm, or wrongfully obtain anything of value.
Supporting Early-childhood Educators' Deductions Act or the SEED Act This bill expands the tax deduction for the expenses of elementary and secondary school teachers to include early childhood educators.
Neuroscience Center of Excellence Act of 2021 This bill requires the Food and Drug Administration (FDA) to establish the Neuroscience Center of Excellence to address neuroscience diseases and disorders (e.g., addiction, Alzheimer's disease, and psychotic disorders). The center must carry out various activities, including (1) coordinating with FDA programs that focus on certain areas, such as drug evaluation; (2) convening periodic public meetings to engage with stakeholders to address challenges associated with developing medical products for neuroscience diseases and disorders; (3) establishing a program to facilitate the collection and systemic use of patient experience data to develop such medical products; and (4) convening a public meeting to discuss how to promote equity and the inclusion of traditionally underrepresented populations in the development of such medical products. The FDA must take actions related to these issues, such as issuing final guidance with recommendations on the collection and use of patient experience data for developing such medical products. The Government Accountability Office must report to Congress a study that (1) reviews the participation of traditionally underrepresented populations in clinical trials for such medical products, and (2) provides recommendations for improving the participation of these populations.
