[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR607.30]

[Page 63]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 607_ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF 
 
     Subpart B_Procedures for Domestic Blood Product Establishments
 
Sec. 607.30  Updating blood product listing information.

    (a) After submission of the initial blood product listing 
information, every person who is required to list blood products 
pursuant to Sec. 607.20 shall submit on Form FD-2830 (Blood 
Establishment Registration and Product Listing) during each subsequent 
June and December, or at the discretion of the registrant at the time 
the change occurs, the following information:
    (1) A list of each blood product introduced by the registrant for 
commercial distribution which has not been included in any list 
previously submitted. All of the information required by Sec. 607.25(b) 
shall be provided for each such blood product.
    (2) A list of each blood product formerly listed pursuant to Sec. 
607.25(b) for which commercial distribution has been discontinued, 
including for each blood product so listed the identity by established 
name and proprietary name, and date of discontinuance. It is requested 
but not required that the reason for discontinuance of distribution be 
included with this information.
    (3) A list of each blood product for which a notice of 
discontinuance was submitted pursuant to paragraph (a)(2) of this 
section and for which commercial distribution has been resumed, 
including for each blood product so listed the identity by established 
name as defined in section 502(e) of the act and by any proprietary 
name, the date of resumption, and any other information required by 
Sec. 607.25(b) not previously submitted.
    (4) Any material change in any information previously submitted.
    (b) When no changes have occurred since the previously submitted 
list, no listing information is required.