Department of Health and Human Services January 24, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests'' dated January 2007. The guidance document provides establishments that make HCT/P donor eligibility determinations with recommendations concerning the donor eligibility requirements contained in 21 CFR part 1271, subpart C, which became effective on May 25, 2005. The guidance applies only to certain HCT/Ps that were not regulated as HCT/Ps before May 25, 2005, and that were recovered from donors beginning on or after the May 25, 2005, and within 30 days of the date of publication of this document in the Federal Register. This guidance has an immediate implementation date because FDA has determined that prior public participation is not feasible or appropriate. In certain cases, donor retesting needs to be initiated quickly, and the availability of certain HCT/Ps may be critical to their intended recipients.

This Final Rule sets forth the Secretary's proposal to require HTPC grant recipients to contribute non-Federal matching funds in years 2 through 5 of the project period equal to two times the amount of the Federal Grant Award or such lesser amount determined by the Secretary for good cause shown.