3.0.0 1479 2023-01-11T16:47:39Z 2023-01-11T16:47:39Z Senate S S 2007-05-24 110 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2007-05-24T18:06:34Z Safe Tissue Act 110 2731 HR 2007-06-14 Referred to the Subcommittee on Health. Identical bill CRS 2007-05-24 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2007-05-24 Introduced in Senate IntroReferral 10000 9 Library of Congress S000148 Sen. Schumer, Charles E. [D-NY] Charles Schumer D NY E. N L000174 Sen. Leahy, Patrick J. [D-VT] Patrick Leahy D VT 2007-05-24 True 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 User charges Health 00 2007-05-24 Introduced in Senate 2007-06-15T17:17:22Z 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.

]]> Safe Tissue Act Display Title Safe Tissue Act Official Title as Introduced A bill to improve the oversight and regulation of tissue banks and the tissue donation process, and for other purposes. Introduced in Senate IS Short Titles as Introduced Safe Tissue Act Introduced in Senate 2007-05-24T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s1479is/xml/BILLS-110s1479is.xml 2007-05-24 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.