Safe Tissue Act
Latest action · Apr 7, 2006 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedApr 7, 2006
- Passed SenateNot reached
- Passed HouseNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 1
Members who signed on, in the order they did. All signed on Apr 7, 2006.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-VT | Patrick J. Leahy | Original | Apr 7, 2006 |
Actions 2
Everything that happened, newest first.
- Apr 7, 2006Introduced in Senate
- Apr 7, 2006Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 5209 | Safe Tissue Act | Identical bill | Apr 26, 2006 |
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Accreditation (Medical care)
- Administrative procedure
- Auditing
- Crime and Law Enforcement
- Cytology
- Department of Health and Human Services
- Donation of organs, tissues, etc.
- Economics and Public Finance
- Federal preemption
- Fines (Penalties)
- Fraud
- Government Operations and Politics
- Government publicity
- Health
- Informed consent (Medical law)
- Law
- Medical ethics
- Medical records
- State laws
- Tissue banks
- User charges
Text 1
Each version as it was printed, newest first.
- Apr 7, 2006Introduced in Senate
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.