CFR Part 528

CFR Part 528
in effect

21 C.F.R. § 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.

21 C.F.R. § 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.

21 C.F.R. § 528.2001 pPL657 recombinant deoxyribonucleic acid construct.

(a) Specifications. pPL657 in the glycoprotein galactosyltransferase alpha-1,3 (GGTA1) gene in domestic pigs. (b) Sponsor. See No. 086134 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Intended use. pPL657 rDNA construct in the glycoprotein galactosyltransferase alpha-1,3 gene (GGTA1) in the lineage of domestic pigs (Sus scrofa domesticus) hemizygous and homozygous for the intentional genomic alteration resulting in undetectable endogenous galactose alpha-1,3-galactose sugar residues on biological derivatives of domestic pigs homozygous for the intentional genomic alteration lineage that are intended to be used as sources of food or human therapeutics including excipients, devices, drugs, or biological products. (2) Limitations. Pigs of this lineage (possessing the intentional genomic alteration (pPL657 rDNA construct)) should not be treated with aminoglycoside drugs and must only be housed in physically contained facilities specified in the approved application.

21 C.F.R. § 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.

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