Document ID: FDA-2008-N-0042-0001
Agency: fda
Document Type: Rule
Title: Human Cells, Tissues, and Cellular and Tissue-Based Products
Posted Date: 2008-01-18T05:00Z

[Federal Register: January 18, 2008 (Volume 73, Number 13)]
[Rules and Regulations]               
[Page 3387]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ja08-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1271

 
Human Cells, Tissues, and Cellular and Tissue-Based Products

CFR Correction

    In Title 21 of the Code of Federal Regulations, Parts 800 to 1299, 
revised as of April 1, 2007, in part 1271, on page 718, Sec.  1271.22 
is reinstated to read as follows:

Sec.  1271.22  How and where do I register and submit an HCT/P list?

    (a) You must use Form FDA 3356 for:
    (1) Establishment registration,
    (2) HCT/P listings, and
    (3) Updates of registration and HCT/P listing.
    (b) You may obtain Form FDA 3356:
    (1) By writing to the Center for Biologics Evaluation and Research 
(HFM-775), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, Attention: Tissue Establishment Registration 
Coordinator;
    (2) By contacting any Food and Drug Administration district office;
    (3) By calling the CBER Voice Information System at 1-800-835-4709 
or 301-827-1800; or
    (4) By connecting to http://www.fda.gov/opacom/morechoices/fdaforms/cber.html
 on the Internet.

    (c)(1) You may submit Form FDA 3356 to the Center for Biologics 
Evaluation and Research (HFM-775), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, Attention: Tissue 
Establishment Registration Coordinator; or
    (2) You may submit Form FDA 3356 electronically through a secure 
web server at http://www.fda.gov/cber/tissue/tisreg.htm.

[69 FR 68681, Nov. 24, 2004]
[FR Doc. 08-55500 Filed 1-17-08; 8:45 am]

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