William H. Frist Gift of Life Congressional Medal Act of 2007

3)FDA's proposed rule (1/8/01) Current Good Manufacturing Practice for Manufacturers of Cellular and Tissue-Based Products 4)FDA's draft guidance (6/25/02) Preventive Measures to Reduce the Possible Risk of CJD and vCJD by Human Cells, Tissues and Cellular and Tissue Based-Products. 5)FDA's final rule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Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). 6) FDA's draft guidance for industry (5/25/04) Eligibility Determination for Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). 7)FDA's final rule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 Practice for Human Cells, Tissues, and Cellular and Tissue-Based Product Establishments, Inspection and Enforcement. 8)P.L108-216, the "Organ Donation and Recovery and Improvement Act," implementation by DHHS. 9)S.1479, the "Safe Tissue Act," entire bill. 10)H.R.2731, the "Safe Tissue Act," entire bill. 11)Tissue Education Initiative; assess perception of tissue community and congressional interest. 12)S.1062, William H. Frist Gift of Life Congressional Medal Act of 2007, entire bill. 13)H.R.1764, William H. Frist Gift of Life Congressional Medal Act of 2007, entire bill. 14)Department of Health adn Human Services, Advisory Committee on Organ Transplantation, jurisdictional questions, tissue-related input. 15)Department of Health and Human Services, Blood Products Advisory Committee, Issues related to tissue and disease transmission. 16) Department of Health and Human Services, Advisory Committee on Blood Safety and Availability, Issues related to tissue and disease transmission. 17)FDA Final Guidance Document (2/27/07), Eligibility Determination for Donors of Human Cells, Tissues and Cellular Tissue-Based Products (HCT/Ps). 18)Food and Drug Administration, Human Tissue Task Force, "Report of the Human Tissue Task Force", June 17, 2007, entire report. 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-Basd Products

Client expense: Not reported · Firm income: $20,000

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, Veterans Affairs, Dept of (VA)