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e-CFR data is current as of March 4, 2021

Title 21Chapter ISubchapter EPart 528 → §528.1092


Title 21: Food and Drugs
PART 528—NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS


§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]

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