[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: 21CFR1271.25]

[Page 695-696]
 
                        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. 1271.25  What information is required for establishment registration and HCT/P listing?

    (a) Your establishment registration Form FDA 3356 must include:
    (1) The legal name(s) of the establishment;
    (2) Each location, including the street address of the establishment 
and the postal service zip code;
    (3) The name, address, and title of the reporting official; and
    (4) A dated signature by the reporting official affirming that all 
information contained in the establishment registration and HCT/P 
listing form is true and accurate, to the best of his or her knowledge.
    (b) Your HCT/P listing must include all HCT/P's (including the 
established name and the proprietary name) that you recover, process, 
store, label, package, distribute, or for which you perform donor 
screening or testing. You must also state whether each HCT/P meets the 
criteria set out in Sec. 1271.10.
    (c) Your HCT/P listing update must include:

[[Page 696]]

    (1) A list of each HCT/P that you have begun recovering, processing, 
storing, labeling, packaging, distributing, or for which you have begun 
donor screening or testing, that has not been included in any list 
previously submitted. You must provide all of the information required 
by Sec. 1271.25(b) for each new HCT/P.
    (2) A list of each HCT/P formerly listed in accordance with 
Sec. 1271.21(a) for which you have discontinued recovery, processing, 
storage, labeling, packaging, distribution, or donor screening or 
testing, including for each HCT/P so listed, the identity by established 
name and proprietary name, and the date of discontinuance. We request 
but do not require that you include the reason for discontinuance with 
this information.
    (3) A list of each HCT/P for which a notice of discontinuance was 
submitted under paragraph (c)(2) of this section and for which you have 
resumed recovery, processing, storage, labeling, packaging, 
distribution, or donor screening or testing, including the identity by 
established name and proprietary name, the date of resumption, and any 
other information required by Sec. 1271.25(b) not previously submitted.
    (4) Any material change in any information previously submitted. 
Material changes include any change in information submitted on Form FDA 
3356, such as whether the HCT/P meets the criteria set out in 
Sec. 1271.10.