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HR 2731 110th Congress House 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 Informed consent (Medical law) Law Medical ethics Medical records State laws Tissue banks

Safe Tissue Act

Introduced: June 14, 2007 Introduced by: Pallone, Frank Democratic · New Jersey See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jun 14, 2007
Referred to the Subcommittee on Health.
Jun 14, 2007
Referred to the House Committee on Energy and Commerce.
Jun 14, 2007
Introduced in House
 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.

What's happening now June 14, 2007

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2