Tissue Action Plan Annual Reports

2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1999 | 1998

FY 2005 Significant Accomplishments

Published a standard operating procedure for "Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based Products".
Published an interim final rule to amend certain regulations regarding the screening and testing of donors of HCT/Ps, and related labeling. These requirements became effective May 25, 2005.

FY 2004 Significant Accomplishments

Published the final rule, "Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products on May 25, 2004." This rule requires manufacturers of HCT/Ps to perform and document donor screening and testing and determine donor eligibility for a wide range of HCT/Ps. The Donor Eligibility rule will become effective May 25, 2005.
Published the final rule, "Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement" on November 24, 2004, This rule requires manufacturers of HCT/Ps to recover, process, store, label, package and distribute HCT/Ps in a way that prevents the introduction, transmission, or spread of communicable diseases. This rule also requires adverse reaction and HCT/P deviation reporting and includes the provisions for inspection and enforcement of establishments. The GTP rule, which applies to all non-reproductive cells and tissues, and completes rulemaking for 21 CFR Part 1271, will become effective on May 25, 2005.
Published the draft guidance for industry, "Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products" on May 25, 2004.
Published guidance for industry, " Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, November 2004."
Fully implemented electronic web-based registration process. Implemented a public web based query that allows instant access to database information on registrations. Over 1500 establishments registered.
Established an inter-office Tissue Safety Team (OCTGT, OBE, OCBQ, OCTMA, OD) to receive and promptly investigate reports of adverse reactions following tissue transplantation. This Team also interacts with other FDA centers and with other government agencies (CDC, HRSA, and CMS).
Licensed the first HIV-1/HCV NAT test for use with cadaveric specimens.

FY 2003 Significant Accomplishments

On August 8, 2003, FDA initiated electronic, web-based registration for HCT/Ps.
FDA completed establishment registration and listing for 1003 establishments.

FY 2002 Significant Accomplishments

On January 30, 2002, FDA sent a letter to clinicians concerning "Lymphocyte Immune Therapy" for miscarriages.
On March 8, 2002, the guidance "Validation of Procedures for Processing of Human Tissues Intended for Transplantation" published.
On March 8, 2002, FDA sent a letter to clinicians concerning "Human Cells or Tissues Intended for Transplant Into a Human Recipient That Have Ex-vivo Contact With Live Nonhuman Animal Cells, Tissues, or Organs".
On June 7, 2002, the Tissue Reference Group updated and published its SOP (8004).
On June 25, 2002, the draft guidance: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" published.
On September 18, and 19, 2002, DHHS/OWH, FDA and NIH held a public workshop, "Evidence Based Assisted Reproductive Technologies (ART)".

FY 2001 Significant Accomplishments

On January 8, 2001, the proposed rule, "Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement" published.
On January 19, 2001, the final rule, "Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing' published.
On July 6, 2001, FDA sent a letter to sponsors and researchers advising that FDA has jurisdiction over human cells used in therapy involving the transfer of genetic material by means other than the union of gamete nuclei.
On August 29, 2001, FDA held a public workshop to discuss the Tissue Reference Group process.

FY 2000 Significant Accomplishments

In October 1999, FDA published a compliance program guideline on the Inspection of Tissue Establishments.
On April 18, 2000, FDA reopened the comment period on the proposed rule for Suitability Determination for Donors of Human Cellular and Tissue-Based Products.
On June 23, 2000, FDA issued guidance for industry on the Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens.
On June 26 and 27, 2000, FDA and CDC co-sponsored a Donor Suitability Workshop.
On August 2, 2000, FDA conducted an open public meeting on Human Bone Allograft: Manipulation and Homologous Use in Spine and Other Orthopedic Reconstruction and Repair.
On August 14 and 14, 2000, FDA and NIH co-sponsored a forum on Allogeneic Unrelated Cord Blood Banking and Transplantation.

FY 1999 Significant Accomplishments

To assist FDA investigators of tissue products, a list of tissue products regulated by CBER and CDRH was made publicly available on December 1, 1998.
On March 10, 1999 CBER published TAP Internet and Intranet web pages.
Import Alert #57-08, Human Tissue Intended for Transplantation (updated on June 7, 1999) was made available on the TAO Internet web page.
On September 30, 1999 a proposed regulation, "Suitability Determination for Donors of Human Cellular and Tissue-based Products," was published.

FY 1998 Significant Accomplishments

Publication of a Federal Register notice; Request for Proposed Standards for Unrelated Allogeneic Peripheral and Placental/Umbilical Cord Blood Hematopoietic Stem/Progenitor Cell Products; Request for Comments, January 20, 1998.
Publication of Industry Guidance; For Human Somatic Cell Therapy and Gene Therapy, March 30, 1998.
Publication of a Proposed Rule and a Direct Final Rule; Revisions to the General Safety Requirements for Biological Products, April 20, 1998.
Publication of a Proposed Rule; Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-based Products, May 14, 1998.
Development completed of software database for establishment registration and product listing, June 15, 1998.
OMB approval of Form 3356; Establishment Registration and Product Listing for Manufacturers of Human Cellular and Tissue-based Products, July, 1998.
Workshop on; Hematopoietic Stem/Progenitor Cell Products, Discussion of Unrelated Allogeneic Placental/Umbilical Cord Blood and Peripheral Blood Cell Banking and Transplantation, September 10, 1998.