Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 607  /  Sec. 607.30 Updating blood product listing information.

(a) After submission of the initial blood product listing information, every person who is required to list blood products pursuant to Sec. 607.20 shall submit on Form FD-2830 (Blood Establishment Registration and Product Listing) during each subsequent June and December, or at the discretion of the registrant at the time the change occurs, the following information:

(1) A list of each blood product introduced by the registrant for commercial distribution which has not been included in any list previously submitted. All of the information required by Sec. 607.25(b) shall be provided for each such blood product.

(2) A list of each blood product formerly listed pursuant to Sec. 607.25(b) for which commercial distribution has been discontinued, including for each blood product so listed the identity by established name and proprietary name, and date of discontinuance. It is requested but not required that the reason for discontinuance of distribution be included with this information.

(3) A list of each blood product for which a notice of discontinuance was submitted pursuant to paragraph (a)(2) of this section and for which commercial distribution has been resumed, including for each blood product so listed the identity by established name as defined in section 502(e) of the act and by any proprietary name, the date of resumption, and any other information required by Sec. 607.25(b) not previously submitted.

(4) Any material change in any information previously submitted.

(b) When no changes have occurred since the previously submitted list, no listing information is required.