Health Subcommittee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Shandra Eisenga Human Cell and Tissue Product Safety Act This bill requires federal agencies to update guidance, regulations, and educational materials about transplants involving human cell and tissue products, particularly with respect to safety and eligibility standards. Specifically, the Department of Health and Human Services must support the development of educational materials for health care providers about issues relating to organ, tissue, and eye donations; screening tests; and other aspects of donations. The Food and Drug Administration (FDA) must review current guidance on donor eligibility and, if appropriate, update it with information on how to reduce the spread of tuberculosis or sepsis in association with donations. The FDA must also publish information about its Tissue Reference Group and data about FDA inspections and registrations of human cell and tissue establishments. The bill also establishes specific civil penalties for violations of regulations governing procedures for human cell and tissue products. The FDA must consider and recommend ways to update these regulations after a public comment period.
Administrative law and regulatory proceduresCivil actions and liabilityCongressional oversightDepartment of Health and Human ServicesHealth programs administration and fundingHealth promotion and preventive careOrgan and tissue donation and transplantation
Shandra Eisenga Human Cell and Tissue Product Safety Act
USA118th CongressHR-7188| House
| Updated: 12/17/2024
Shandra Eisenga Human Cell and Tissue Product Safety Act This bill requires federal agencies to update guidance, regulations, and educational materials about transplants involving human cell and tissue products, particularly with respect to safety and eligibility standards. Specifically, the Department of Health and Human Services must support the development of educational materials for health care providers about issues relating to organ, tissue, and eye donations; screening tests; and other aspects of donations. The Food and Drug Administration (FDA) must review current guidance on donor eligibility and, if appropriate, update it with information on how to reduce the spread of tuberculosis or sepsis in association with donations. The FDA must also publish information about its Tissue Reference Group and data about FDA inspections and registrations of human cell and tissue establishments. The bill also establishes specific civil penalties for violations of regulations governing procedures for human cell and tissue products. The FDA must consider and recommend ways to update these regulations after a public comment period.
Administrative law and regulatory proceduresCivil actions and liabilityCongressional oversightDepartment of Health and Human ServicesHealth programs administration and fundingHealth promotion and preventive careOrgan and tissue donation and transplantation