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.

Code of Federal Regulations

[69 FR 68681, Nov. 24, 2004]

CFR

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

Code of Federal Regulations