Human Tissue Intended for Transplantation

The Food and Drug Administration (FDA) is issuing a final rule to require certain infectious disease testing, donor screening, and recordkeeping to help prevent the transmission of the human immunodeficiency virus (HIV), and hepatitis viruses through human tissue used in transplantation. In response to comments received, FDA has clarified and modified many of the provisions of the interim rule on human tissue intended for transplantation which was published in the Federal Register of December 14, 1993. The final rule requires facilities engaged in the recovery, screening, testing, processing, storing, or distributing of human tissues to ensure that specified minimum required medical screening and infectious disease testing has been performed and that records documenting such screening and testing for each human tissue are available for inspection by FDA. The regulations also contain provisions for the inspection of such facilities and for retaining, recalling, or destroying human tissue for which appropriate documentation is not available. DATES: The regulation is effective January 26, 1998. This effective date is applicable to all human tissue intended for transplantation procured on or after this date. Written comments on the information collection requirements should be submitted by September 29, 1997. ADDRESSES: Submit written comments on the information collection requirements to the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should be identified with the docket number found in brackets in the heading of this document.