[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: 21CFR607.37]

[Page 64]
 
                        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. 607.37  Inspection of establishment registrations and blood product 

listings.

    (a) A copy of the Form FD-2830 (Blood Establishment Registration and 
Product Listing) filed by the registrant will be available for 
inspection under section 510(f) of the act, at the Department of Health 
and Human Services, Food and Drug Administration, Office of 
Communication, Training and Manufacturers' Assistance (HFM-40), Center 
for Biologics Evaluation and Research (see mailing addresses in Sec. 
600.2 of this chapter). In addition, for domestic firms, the same 
information will be available for inspection at each of the Food and 
Drug Administration district offices for firms within the geographical 
area of such district office. Upon request and receipt of a self-
addressed stamped envelope, verification of registration number, or 
location of registered establishment will be provided. The following 
information submitted under the blood product listing requirements is 
illustrative of the type of information that will be available for 
public disclosure when it is compiled:
    (1) A list of all blood products.
    (2) A list of all blood products manufactured by each establishment.
    (3) A list of blood products discontinued.
    (4) All data or information that has already become a matter of 
public knowledge.
    (b) Requests for information regarding blood establishment 
registrations and blood product listings should be directed to the 
Department of Health and Human Services, Food and Drug Administration, 
Office of Communication, Training and Manufacturers' Assistance (HFM-
40), Center for Biologics Evaluation and Research (see mailing addresses 
in Sec. 600.2 of this chapter).

[40 FR 52788, Nov. 12, 1975, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11014, Mar. 26, 1990; 66 FR 59159, Nov. 27, 2001; 70 FR 14984, Mar. 
24, 2005]