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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 528 - New Animal Drugs in Genetically Engineered Animals |
§ 528.1092 - opAFP-GHc2 recombinant deoxyribonucleic acid construct.
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§ 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.
[80 FR 73104, Nov. 24, 2015]