To require the Secretary of Health and Human Services to conduct a national, evidence-based education campaign to increase public and health care provider awareness regarding the potential risks and benefits of human cell and tissue products transplants, and for other purposes.
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.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Subcommittee Consideration and Mark-up Session Held
Forwarded by Subcommittee to Full Committee (Amended) by the Yeas and Nays: 27 - 0.
Committee Consideration and Mark-up Session Held
Ordered to be Reported (Amended) by the Yeas and Nays: 40 - 0.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-766.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 118-766.
Placed on the Union Calendar, Calendar No. 632.
Mr. Bucshon moved to suspend the rules and pass the bill, as amended.
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Considered under suspension of the rules. (consideration: CR H7167-7170)
DEBATE - The House proceeded with forty minutes of debate on H.R. 7188.
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H7167-7168)
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H7167-7168)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate.