CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER L—REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION (parts 1210 to 1272) > PART 1271—HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS > SUBPART B—Procedures for Registration and Listing (§1271.21 to §1271.37) > 1271.22—How and where do I register and submit an HCT/P list?

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]