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HR 5209 109th Congress House

Safe Tissue Act

Official title: To improve the oversight and regulation of tissue banks and the tissue donation process, and for other purposes.

Introduced: April 26, 2006 Introduced by: Pallone, Frank Democratic · New Jersey See on congress.gov
Health Accreditation (Medical care)Administrative procedureAuditingCrime and Law Enforcement
More subjectsShow fewer subjects
CytologyDepartment of Health and Human ServicesDonation of organs, tissues, etc.Economics and Public FinanceFederal preemptionFines (Penalties)FraudGovernment Operations and PoliticsGovernment publicityInformed consent (Medical law)LawMedical ethicsMedical recordsState lawsTissue banksUser charges
This bill died when the 109th Congress ended
It never became law before the 109th Congress (2005–2006) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 26, 2006
Referred to the House Committee on Energy and Commerce.
Apr 26, 2006
Introduced in House
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 Latest action April 26, 2006

Referred to the House Committee on Energy and Commerce.

 Plain-English summary Congressional Research Service

Safe Tissue Act - Requires the Food and Drug Administration (FDA) to inspect, at least once every two years, each establishment that engages in the manufacture of human cells, tissues, and cellular and tissue-based products. Allows the Secretary of Health and Human Services to establish a user fee to fund such inspections.

Requires the FDA to conduct periodic audits of all documentation submitted by each such establishment to determine compliance with all applicable requirements, including requirements related to ensuring: (1) that human cells, tissues, or cellular or tissue-based products are obtained legally; (2) that donor eligibility and donor medical history interviews are based on accurate information that was not provided or obtained in a fraudulent manner; and (3) current good tissue practice.

Requires the Secretary to publish a model form containing minimum requirements for establishments to use in obtaining consent from a potential donor of human cells, tissues, or cellular or tissue-based products. Sets forth penalties for failing to comply with model form requirements or for knowingly using fraudulent information.

Directs the Secretary to: (1) accredit establishments and the personnel of such establishments who participate in the recovery, processing, storage, labeling, packaging, or distribution of human cells, tissues, or cellular or tissue-based products; and (2) define "reasonable payments" that are associated with donation of human tissue and tissue-based products for purposes of the National Organ Transplant Act.

 Related & companion bills 1
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 5209: Safe Tissue Act. 109th Congress. Open America. https://openamerica.io/bill/109-HR-5209/
MLA
"H.R. 5209: Safe Tissue Act." 109th Congress, 2026, Open America, https://openamerica.io/bill/109-HR-5209/.
Bluebook (legal)
H.R. 5209, 109th Cong. (2026), https://openamerica.io/bill/109-HR-5209/.
Markdown link
[H.R. 5209: Safe Tissue Act](https://openamerica.io/bill/109-HR-5209/)
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