Department of Health and Human Services June 19, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Pharmacogenetic Tests and Genetic Tests for Heritable Markers.'' This document is intended to provide guidance on preparing and reviewing premarket approval applications (PMAs) and 510(k) submissions for pharmacogenetic and other genetic tests, whether testing is for single markers or for multiple markers simultaneously (multiplex tests).

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue-based products (HCT[sol]Ps), and related labeling. FDA is taking this action to complete the rulemaking initiated with the interim final rule.

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of June 7, 2007 (72 FR 31587). The document announced an amendment to the notice of meeting of the Science Board to the Food and Drug Administration. The meeting was originally announced in the Federal Register of May 21, 2007 (72 FR 28499). The document was published with an incorrect docket number. This document corrects that error.