eCFR Reference Browser

---

title: "21 CFR §528.1092"

source: "https://www.ecfr.gov/current/title-21/section-528.1092"

title_number: "21"

volume_number: "6"

chapter_number: "Unknown"

subchapter_code: "E"

subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"

part_code: "528"

part_subject: "NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS"

subpart_code: "B"

subpart_subject: "Specific Administrative Rulings and Decisions"

section_number: "528.1092"

section_subject: "opAFP-GHc2 recombinant deoxyribonucleic acid construct."

cfr_reference: "21 CFR 528.1092"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 500 to 599"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§528.1092 - opAFP-GHc2 recombinant deoxyribonucleic acid construct.