§ 528.2001 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. pPL657glycoprotein galactosyltransferase alpha-1,3GGTA1(a) in the () gene in domestic pigs.
Sponsor.(b) See No. 086134 in § 510.600(c) of this chapter.
Conditions of useIntended use. pPL657glycoprotein galactosyltransferase alpha-1,3GGTA1Sus scrofa domesticus(c) —(1) rDNA construct in the gene () in the lineage of domestic pigs () 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.
Limitations.pPL657(2) Pigs of this lineage (possessing the intentional genomic alteration ( rDNA construct)) should not be treated with aminoglycoside drugs and must only be housed in physically contained facilities specified in the approved application.
[86 FR 17064, Apr. 1, 2021]
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