[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: 21CFR607.22]

[Page 62]
 
                        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. 607.22  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 (HFM-
375), (see mailing addresses in Sec. 600.2 of this chapter), 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 under Sec. 607.35. The completed form shall be mailed to the 
preceding 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.

[66 FR 59158, Nov. 27, 2001, as amended at 70 FR 14984, Mar. 24, 2005]