A bill to provide for the regulation of human tissue for transplantation to ensure that such tissue is handled in a manner to preserve its safety and purity, and for other purposes.

referredUnited States· United States Congress· EN

Introduced

3 October 1996

Last action

3 October 1996 · Introduced

Status

Read twice and referred to the Committee on Labor and Human Resources.

Summary

Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a specific definition for "human tissue" which expressly excludes vascularized human organs, gene therapy, blood, soluble blood components, milk, or products made by combining human tissue with biomaterials. Declares that human tissue is not a drug, biological product, or device unless reclassified under this Act. Amends the Public Health Service Act (PHSA) to subject human tissue to regulation under such Act only if voluntary regulation is inadequate, or if it is reclassified as a drug, biological product, or device pursuant to specified guidelines established by this Act. Requires any person subject to such regulation who recovers, processes, stores, or distributes human tissue for transplantation or implantation in the United States to register in accordance with FFDCA drug registration procedures. Deems registrants to be authorized to conduct human tissue recovery, processing, storage, and distribution activities identified as applicable on the registration, unless, among other things, the Secretary of Health and Human Services suspends or revokes such authority after determining that the registrant fails to meet operating standards established by the Secretary. Prescribes certain human tissue labeling and advertising requirements. Authorizes the Secretary to reclassify human tissue as a drug, biological product, or device in specified circumstances. Outlines the mechanism for enforcement of this Act in the event that any violations of it constitute a significant risk to the public health. Subjects registrants to inspections under the Act. Applies the PHSA to umbilical cord blood to the same extent as it applies to human tissue. Prohibits the Secretary from regulating eyes until voluntary regulation is inadequate to protect the public health.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

3 October 1996
Introduced
Read twice and referred to the Committee on Labor and Human Resources.
Source: IntroReferral
3 October 1996
Introduced
Sponsor introductory remarks on measure. (CR S12309-12310)
Source: IntroReferral
3 October 1996
Introduced
Introduced in Senate
Source: IntroReferral

Votes

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Versions

Introduced in Senate · 3 October 1996 · Download file

Documents

3 official files

Introduced in Senate (text)

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Introduced in Senate (text)
Introduced in Senate · EN · 3 October 1996
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Introduced in Senate (PDF)
Introduced in Senate · EN · 3 October 1996
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Introduced in Senate
summary · EN · 3 October 1996
Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
Vertaal naar
Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Related records

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Sources

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Official source: https://www.congress.gov/bill/104th-congress/senate-bill/2195
Open data entity: https://api.congress.gov/v3/bill/104/s/2195
us · 104-s-2195 · source updated 21 April 2025