[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: 21CFR607.37]

[Page 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. 607.37  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 pursuant to section 510(f) of the act, at the Department of 
Health and Human Services, Food and Drug Administration, Office of 
Compliance, Center for Biologics Evaluation and Research (HFB-100), 8800 
Rockville Pike, Bethesda, MD 20892. In addition, there will be available 
for inspection at each of the Food and Drug Administration district 
offices the same information 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 a 
registered establishment will be provided. The following information 
submitted pursuant to 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 Compliance, Center for Biologics Evaluation and Research (HFB-
100), 8800 Rockville Pike, Bethesda, MD 20892.

[40 FR 52788, Nov. 12, 1975, as amended at 49 FR 23833, June 8, 1984; 55 
FR 11014, Mar. 26, 1990]