Safe Tissue Act

3. FDA's proposed rule (1/08/01) Current Good Manufacturing Practice for Manufacturers of Cellular and Tissue-Based Products. 4. FDA's draft guidance (6/25/02) Preventive Measures to Reduce the Possible Risk of CJD and and vDJD by Human Cells, Tissues and Cellular and Tissue-Based Products 5. FDA's final rule (5/25/04) Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 6. FDA's draft guidance for industry (5/25/04) Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) 7. FDA's final rule (11/24/04) Current Good Tissue Practice for Human Cells, Tissues, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement 8. P.L. 108-216, the "Organ Donation and Recovery and Improvement Act;" implementation by DHHS. 9. S.2609, the "Safe Tissue Act" entire bill 10. H.R. 5209, the Safe Tissue Act", entire bill. 11. FDA Federal Register (12/4/06); Proposed Collection; Comment Request; Human Tissue Intended for Transplantation. 1. Ongoing discussions with FDA officials; response to FDA's proposed regulation of Cellular and Tissue-Based Products (12/28/97) and proposed regulation thereto. 2. FDA's proposed rule (9/30/99) Suitability Determination of Cellular and Tissue-Based Products.