(a) Specifications and intended use. A single copy of Bc2371, a human Factor VII recombinant deoxyribonucleic acid (rDNA) gene construct, located on chromosome 3p1.1-2 in a diploid line (R69) of hemizygous and homozygous New Zealand white rabbits (Oryctolagus cuniculus).

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(b) Sponsor. See No. 086047 in § 510.600 of this chapter.

(c) Conditions of use—(1) Intended use. The construct directs gene expression of recombinant human Factor VII (hFVII) in the mammary gland such that recombinant hFVII zymogen is present in the rabbit milk, enabling purification and activation of recombinant hFVIIa intended for the treatment of hemophilia A or B in humans with inhibitors to Factors VIII and IX.

(2) Limitations. Food or feed from R69 rabbits is not permitted in the food or feed supply.

[84 FR 12494, Apr. 2, 2019]