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

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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, § 1271.22 is reinstated to read as follows:

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]
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[FR Doc. 08-55500 Filed 1-17-08; 8:45 am]

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