§ 528.2010 Human lysosomal acid lipase recombinant deoxyribonucleic acid construct.
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Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.
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Specifications.Gallus gallus(a) 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 (), derived from the lineage progenitor XLL 109.
Sponsor.(b) See No. 069334 in § 510.600 of this chapter.
Conditions of useIntended use.(c) —(1) 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.
Limitations.(2) 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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