[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: 21CFR607.31]

[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. 607.31  Additional blood product listing information.

    (a) In addition to the information routinely required by Sec. Sec. 
607.25 and 607.30, the Director of the Center for Biologics Evaluation 
and Research may require submission of the following information by 
letter or by Federal Register notice:
    (1) For a particular blood product so listed, upon request made by 
the Director of the Center for Biologics Evaluation and Research for 
good cause, a copy of all advertisements.
    (2) For a particular blood product so listed, upon a finding by the 
Director of the Center for Biologics Evaluation and Research 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 Director of the 
Center for Biologics Evaluation and Research that it is necessary to 
carry out the purposes of the act, a list of each listed blood product 
containing a particular ingredient.
    (b) [Reserved]

[66 FR 59158, Nov. 27, 2001]