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21 CFR Part 528 — Intentional Genomic Alterations in Animals

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united states, us regulation, us federal regulation, code of federal regulations, cfr, federal regulation, 21, 528, part 528, 21 cfr 528, 21 cfr part 528, food, and, drugs, food and drug administration, department of health and human services, animal drugs, feeds, and related products

PART 528—INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS Authority: 21 U.S.C. 360b. Source: 74 FR 6823, Feb. 11, 2009, unless otherwise noted. § 528.1080 Bc2371 recombinant deoxyribonucleic acid construct. (a) Specifications and intended use. Oryctolagus cuniculus (b) Sponsor. (c) Conditions of use Intended use. (2) Limitations. [84 FR 12494, Apr. 2, 2019] § 528.1092 opAFP-GHc2 recombinant deoxyribonucleic acid construct. (a) Specifications. opAFP-GHc2 Salmo salar (b) Sponsor. (c) Indications for use. (d) Limitations. [80 FR 73104, Nov. 24, 2015] § 528.2000 Deletion of exon 7 of CD163 gene in domestic pigs. (a) Specifications. CD163 Sus scrofa domesticus (b) Sponsor. (c) Conditions of use Intended use. CD163 Sus scrofa domesticus) D E7 [90 FR 40970, Aug. 22, 2025] § 528.2001 pPL657 (a) Specifications. pPL657 glycoprotein galactosyltransferase alpha-1,3 GGTA1 (b) Sponsor. (c) Conditions of use Intended use. pPL657 glycoprotein galactosyltransferase alpha-1,3 GGTA1 Sus scrofa domesticus (2) Limitations. pPL657 [86 FR 17064, Apr. 1, 2021] § 528.2010 Human lysosomal acid lipase recombinant deoxyribonucleic acid construct. (a) Specifications. Gallus gallus (b) Sponsor. (c) Conditions of use Intended use. (2) Limitations. [81 FR 17608, Mar. 30, 2016]

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