21 CFR Part 607 · Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices

§ 607.31 Additional blood product listing information

Subpart B - Procedures for Domestic Blood Product Establishments Official text on eCFR Amendment history

(a) In addition to the information routinely required by §§ 607.25 and 607.30 , the Director of the Center for Biologics Evaluation and Research may require submission of the following information by letter or by Federal Register notice:

(1) For a particular blood product so listed, upon request made by the Director of the Center for Biologics Evaluation and Research for good cause, a copy of all advertisements.

(2) For a particular blood product so listed, upon a finding by the Director of the Center for Biologics Evaluation and Research that it is necessary to carry out the purposes of the act, a quantitative listing of all ingredients.

(3) For each registrant, upon a finding by the Director of the Center for Biologics Evaluation and Research that it is necessary to carry out the purposes of the act, a list of each listed blood product containing a particular ingredient.

(b) [Reserved]

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Amendment history

Federal Register documents that created or amended this section.