US Federal 2025-2026 Regular Session

US Federal House Bill HB340

Introduced
1/13/25  

Caption

The HCT/P Modernization Act of 2025This bill requires the Food and Drug Administration (FDA) to provide information to stakeholders and report on the regulation of human cell and tissue products, also referred to as human cells, tissues, or cellular or tissue-based products (HCT/Ps), which are articles containing or consisting of human cells or tissues that are intended for use in a human recipient.The bill requires the FDA to conduct workshops to educate stakeholders and facilitate discussion with them on advancing the science and regulation of human cell and tissue products. The FDA must establish a public docket to receive written comments on this topic, and submit to Congress a report with recommendations on regulating these products. Additionally, the bill requires the FDA to publish on its website educational materials about the Tissue Reference Group and best practices for obtaining a recommendation about products from them. Also, annually for three years, the FDA must publish on its website information on the inquiries submitted and average response times for the Tissue Reference Group, as well as the number of human cell and tissue manufacturers that have registered with the FDA and the number of inspections the FDA has conducted with respect to these manufacturers since 2019. (The Tissue Reference Group is a working group within the FDA that receives product-specific questions from, and provides recommendations for, stakeholders on the regulation of human cell and tissue products under the FDA’s rules.) 

Congress_id

119-HR-340

Policy_area

Health

Introduced_date

2025-01-13

Companion Bills

US HB1082

Related bill Shandra Eisenga Human Cell and Tissue Product Safety Act

Previously Filed As

US HB798

Dignity for Aborted Children ActThis bill establishes requirements for abortion providers with respect to the disposal of human fetal tissue from an abortion.Specifically, it requires abortion providers to obtain a patient's informed consent for one of two specified methods of disposition and to retain the corresponding documentation in the patient's file.First, patients may choose to retain possession of the tissue. A patient may choose to transfer the tissue to an entity that provides interment or cremation services.Second, patients may choose to release the tissue to the provider. Providers must ensure any tissue released to them is interred or cremated within seven days of the procedure in a manner consistent with state law regarding the disposal of human remains.Abortion providers must submit reports annually to the Department of Health and Human Services about these requirements and other specified information.The bill establishes civil penalties for violations of the requirement to retain documentation of informed consent, and it establishes criminal penalties for violations of the requirement regarding the disposal of human fetal tissue.

US HB1082

Shandra Eisenga Human Cell and Tissue Product Safety Act

US SB122

Relating to required labeling of certain products containing or derived from aborted human fetal tissue.

US HB1304

Relating to required labeling of certain products containing or derived from aborted human fetal tissue.

US HB422

No Subsidies for Wealthy Universities ActThis bill limits the indirect costs that are allowable under federal research awards to institutions of higher education (IHEs) with endowments above specified thresholds. (Generally, indirect costs represent expenses that are not specific to a research project but are needed to maintain the infrastructure and administrative support for federally funded research.)Specifically, the National Center for Education Statistics (NCES) must annually collect information regarding the endowments of each IHE that has entered into a program participation agreement with the Department of Education.With this collected information, NCES must identify and make lists of (1) each IHE with an endowment of more than $5 billion, and (2) each IHE with an endowment of more than $2 billion (but not more than $5 billion). NCES must submit these lists to the Office of Management and Budget, which must then distribute the lists to federal agencies, Congress, and the public.The bill establishes the following limits on the indirect costs allowable under federal research awards:for an IHE with an endowment of more than $5 billion, the IHE is prohibited from using these awards for indirect costs;for an IHE with an endowment of more than $2 billion (but not more than $5 billion), the IHE is limited to an indirect cost rate of 8%; andfor all other IHEs, an indirect cost rate of 15%.The Government Accountability Office must annually report to Congress on indirect cost reimbursement on federal research awards for IHEs.

US HB1116

Right to Eat Authentic and Legitimate Meat Act of 2025 or the REAL Meat Act of 2025This bill prohibits the use of federal funds to support, directly or indirectly, the production, advancement, or enhancement of cell-cultured meat. Under the bill, cell-cultured meat means meat that is sourced from the cells of animals and artificially produced in a laboratory.The bill includes an exemption for federal funds of the National Aeronautics and Space Administration (NASA) that are used for activities related to cell-cultured meat that is intended for off-planet consumption.

US SB1214

stem cells; birth tissue; therapy

US HB1006

Cultivate food products; prohibit manufacture and sale of items produced from cultured animal cells.

US HB675

Domestic Security Using Production Partnerships and Lessons from Yesterday Act of 2025 or the Domestic SUPPLY Act of 2025This bill establishes a program and sets out other requirements to promote domestic manufacturing of personal protective equipment (PPE) to address infectious diseases and other public health emergencies.Specifically, the Department of Health and Human Services (HHS) must establish a program to enter into purchasing agreements with eligible domestic manufacturers for PPE to prepare for and respond to public health emergencies. To be eligible, manufacturers must be majority owned and operated by U.S. citizens and must manufacture a majority of their contracted products domestically, with 100% of products manufactured domestically by 2028. HHS must coordinate with the Department of Defense and the Department of Homeland Security on this program.In addition, the federal government must only procure, subject to limited exceptions, clothing or equipment that is produced domestically to prevent the transmission of an infectious disease. If using federal funds, states or localities must also procure such items domestically.Further, the bill requires HHS to submit to Congress a report about changes to federal requirements for PPE since the beginning of the COVID-19 pandemic and the impact of those changes on health care workers who cared for patients in 2020 and 2021.

US S1310

Adds to existing law to establish provisions regarding the use of human fetal tissue in products.

Similar Bills

No similar bills found.