[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: 21CFR607.22]

[Page 56]
 
                        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. 607.22  How and where to register establishments and list blood products.

    (a) The first registration of an establishment shall be on Form FD-
2830 (Blood Establishment Registration and Product Listing) obtainable 
on request from the Department of Health and Human Services, Food and 
Drug Administration, Center for Biologics Evaluation and Research (HFB-
240), 8800 Rockville Pike, Bethesda, MD 20892, or from Food and Drug 
Administration district offices. Subsequent annual registration shall 
also be accomplished on Form FD-2830 which will be furnished by the Food 
and Drug Administration before November 15 of each year to 
establishments whose product registration for that year was validated 
pursuant to Sec. 607.35. The completed form shall be mailed to the above 
address before December 31 of that year.
    (b) The first list of blood products and subsequent June and 
December updatings shall be on Form FD-2830, obtainable upon request as 
described in paragraph (a) of this section. In lieu of Form FD-2830, 
tapes for computer input may be submitted if equivalent in all elements 
of information as specified in Form FD-2830. All formats proposed for 
such use will require initial review and approval by the Office of 
Compliance, Center for Biologics Evaluation and Research, Food and Drug 
Administration.

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