Tissue Action Plan
The Tissue Action Plan (TAP) was implemented in March 1998. The purpose of the TAP was to develop, on a timely basis, the policies, regulations and guidance documents needed to implement the "Proposed Approach to the Regulation of Cellular and Tissue-based Products" (Proposed Approach) announced by FDA in February 1997, and the steps that FDA agreed to take in response to the recommendations made by the Government Accounting Office in their 1997 report, "Human Tissue Banks: FDA Taking Steps to Improve Safety, but Some Concerns Remain."
The TAP Core Team met on a monthly basis and oversaw the progress of the commitments of the TAP, communicated progress to the Agency and other organizations as appropriate, and addressed resource allocation issues. It also made decisions on significant policy issues and provided final review and sign-off on TAP deliverables. It was composed of representatives from CBER's Offices of the Director, Blood, Therapeutics, and Compliance and Biologics Quality, as well as from CDRH, the Office of Regulatory Affairs and the Office of the Commissioner.
FDA has completed the goals of the TAP. It has implemented the proposed approach with finalization and publication of three rules. On January 19, 2001, FDA published the first final rule "Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing". The rule became fully effective on January 21, 2004, and requires tissue establishments to register with the FDA and list their products. On May 25, 2004, FDA published the second final rule "Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products". This rule focuses on donor screening and testing measures to prevent the unwitting use of contaminated tissues with potential to transmit infectious diseases.
On November 24, 2004, FDA published the third final rule "Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement". This rule requires establishments that recover, process, store, label, package, or distribute tissue, or that screen or test donors, to follow current good tissue practice requirements. This final rule also contains provisions for FDA inspection of establishments and enforcement of the regulations. Both the donor eligibility and current good tissue practice final rules became effective on May 25, 2005, and apply to all HCT/Ps recovered on or after that date. The three rules comprise 21 CFR Part 1271.
FDA also published and made effective on May 25, 2005 an Interim Final Rule that revised the 21 CFR Part 1271 donor eligibility requirements to facilitate embryo donation by sexually intimate couples. This regulatory change allows couples to donate their cryopreserved embryos even if they had not been screened and tested at the time the embryo was cryopreserved. . When possible, appropriate measures should be taken to screen and test the semen and oocyte donors before transfer of these donated embryos to the recipient. This rule also modified the timing of specimen collection from donors of oocytes and bone marrow to permit testing up to 30 days before recovery and it clarifies certain labeling requirements.