Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing
other · Food and Drug Administration · Rule · Published 2003-01-21 · Effective 2001-01-19 · 68 FR 2689
Document
Document number
03-1207
Federal Register citation
68 FR 2689
CFR reference
21 CFR 1271
Type
Rule
Action
Final rule; delay of effective date.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-01-21
Effective date
2001-01-19
HHS docket
Docket No. 97N-484R
Abstract
The Food and Drug Administration (FDA) is further delaying, until January 21, 2004, the effective date for requiring establishments that engage in the recovery, screening, testing, processing, storage, or distribution of all human cells, tissues, and cellular and tissue- based products (HCT[sol]Ps) not currently regulated under section 361 of the Public Health Service Act (PHS Act) and part 1270 (21 CFR part 1270) to register with FDA and list their HCT[sol]Ps. FDA is taking this action to help ensure that the effective date for this rule is closer to the effective date of the anticipated finalization of the remaining proposed rules involving HCT[sol]Ps.