CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 528—NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS > 528.1070—Bc6 recombinant deoxyribonucleic acid construct.

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. 042976 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.