[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR607.31]

[Page 57-58]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS--Table of Contents
 
     Subpart B--Procedures for Domestic Blood Product Establishments
 
Sec. 607.31  Additional blood product listing information.

    (a) In addition to the information routinely required by 
Secs. 607.25 and 607.30, the Commissioner may require submission of the 
following information by letter or by Federal Register notice:

[[Page 58]]

    (1) For a particular blood product so listed, upon request made by 
the Commissioner for good cause, a copy of all advertisements.
    (2) For a particular blood product so listed, upon a finding by the 
Commissioner that it is necessary to carry out the purposes of the act, 
a quantitative listing of all ingredients.
    (3) For each registrant, upon a finding by the Commissioner that it 
is necessary to carry out the purposes of the act, a list of each listed 
blood product containing a particular ingredient.
    (b) It is requested but not required that information concerning the 
quantity of blood product distributed be submitted in conjunction with 
the annual registration in the format prescribed in a section of Form 
FD-2831 (Blood Establishment Resource Summary), for each blood product 
currently listed.