[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.22]

[Page 695]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271--HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS--Table of Contents
 
           Subpart B--Procedures for Registration and Listing
 
Sec. 1271.22  How and where do I register and submit an HCT/P list?

    (a) You must use Form FDA 3356 for:
    (i) Establishment registration,
    (ii) HCT/P listings, and
    (iii) Updates of registration and HCT/P listing.
    (b) You may obtain Form FDA 3356:
    (i) By writing to the Center for Biologics Evaluation and Research 
(HFM-305), Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448, Attention: Tissue Establishment Registration Coordinator;
    (ii) By contacting any Food and Drug Administration district office;
    (iii) By calling the CBER Voice Information System at 1-800-835-4709 
or 301-827--1800;
    (iv) By calling the Fax Information System at 1-888-CBER-FAX or 301-
827-3844; or
    (v) By connecting to http://forms.psc.gov/forms/FDA/fda.html on the 
Internet.
    (c)(i) You may submit Form FDA 3356 to the Center for 
BiologicsEvaluation and Research (HFM-305), Food and Drug 
Administration, 1401 Rockville, Pike, Rockville, MD 20852-1448, 
Attention: Tissue Establishment Registration Coordinator; or
    (ii) You may submit Form FDA 3356 electronically in accordance with 
the instructions provided with the form.