[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.21]

[Page 685]
 
                        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. 1271.21  When do I register, submit an HCT/P list, and submit updates?


    (a) You must register and submit a list of every HCT/P that your 
establishment manufactures within 5 days after beginning operations or 
within 30 days of the effective date of this regulation, whichever is 
later.
    (b) You must update your establishment registration annually in 
December, except as required by Sec. 1271.26. You may accomplish your 
annual registration in conjunction with updating your HCT/P list under 
paragraph (c) of this section.
    (c)(i) If no change described in Sec. 1271.25(c) has occurred since 
youpreviously submitted an HCT/P list, you are not required to update 
your listing.
    (ii) If a change described in Sec. 1271.25(c) has occurred, you must 
update your HCT/P listing with the new information:
    (a) At the time of the change, or
    (b) Each June or December, whichever month occurs first after the 
change.