21 CFR § 528.2010 - Human lysosomal acid lipase recombinant deoxyribonucleic acid construct.

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§ 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 (Gallusgallus), 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]