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Electronic Code of Federal Regulations

e-CFR data is current as of December 4, 2019

Title 21Chapter ISubchapter E → Part 528


Title 21: Food and Drugs


PART 528—NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS


Contents
§528.1070   Bc6 recombinant deoxyribonucleic acid construct.
§528.1080   Bc2371 recombinant deoxyribonucleic acid construct.
§528.1092   opAFP-GHc2 recombinant deoxyribonucleic acid construct.
§528.2010   Human lysosomal acid lipase recombinant deoxyribonucleic acid construct.

Authority: 21 U.S.C. 360b.

Source: 74 FR 6823, Feb. 11, 2009, unless otherwise noted.

§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.

[74 FR 6823, Feb. 11, 2009, as amended at 80 FR 34279, June 16, 2015]

§528.1080   Bc2371 recombinant deoxyribonucleic acid construct.

(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).

(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]

§528.1092   opAFP-GHc2 recombinant deoxyribonucleic acid construct.

(a) Specifications. A single copy of the α-form of the opAFP-GHc2 recombinant deoxyribonucleic acid (rDNA) construct at the α-locus in the EO-1 α lineage of triploid, hemizygous, all-female Atlantic salmon (Salmo salar).

(b) Sponsor. See No. 086053 in §510.600 of this chapter.

(c) Indications for use. Significantly more of these Atlantic salmon grow to at least 100 grams within 2,700 Celsius degree-days than their comparators.

(d) Limitations. These Atlantic salmon are produced as eyed-eggs and grown-out only in physically-contained, freshwater culture facilities specified in an FDA-approved application.

[80 FR 73104, Nov. 24, 2015]

§528.2010   Human lysosomal acid lipase recombinant deoxyribonucleic acid construct.

(a) Specifications. A single copy of a human lysosomal acid lipase (hLAL) recombinant deoxyribonucleic acid (rDNA) gene construct located at the SYN LAL-C site in chromosome 6 in a specific, diploid line (SBC LAL-C) of hemizygous and homozygous domestic chickens (Gallus gallus), derived from the lineage progenitor XLL 109.

(b) Sponsor. See No. 069334 in §510.600 of this chapter.

(c) Conditions of use—(1) Intended use. The gene construct directs the expression of that encoding gene such that recombinant, human lysosomal acid lipase (rhLAL) protein intended for the treatment of human disease is present in SBC LAL-C chicken egg whites.

(2) Limitations. Food or feed from XLL 109 chickens is not permitted in the food or feed supply.

[81 FR 17608, Mar. 30, 2016]

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