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 § 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 § 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]
Title 21 published on 2012-04-01
no entries appear in the Federal Register after this date.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.