Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Correction

The Food and Drug Administration (FDA) is correcting an interim final rule that published in the Federal Register on January 27, 2004 (69 FR 3823). The interim final rule excepted human dura mater and human heart valve allografts, currently subject to application or notification requirements under the Federal Food, Drug, and Cosmetic Act from the scope of the definition of "human cells, tissues, or cellular or tissue-based products (HCT/P's)" subject to the registration and listing requirements contained in 21 CFR Part 1271. That definition became effective on January 21, 2004. The interim final rule published with some errors. This document corrects those errors.