21 CFR § 528.1070 - Bc6 recombinant deoxyribonucleic acid construct.
(a)Specifications and indications for use. Five copies of a human Bc6 recombinant deoxyribonucleic acid (rDNA) construct located at the GTC 155-92 site in a specific hemizygous diploid line of dairy breeds of domestic goats (Capra aegagrus hircus) directing the expression of the human gene for antithrombin (which is intended for the treatment of humans) in the mammary gland of goats derived from lineage progenitor 155-92.
(b)Sponsor. See No. 086047 in § 510.600 of this chapter.
(c)Limitations. Food or feed from GTC-155-92 goats is not permitted in the food or feed supply.