21 CFR § 528.1080 - Bc2371 recombinant deoxyribonucleic acid construct.

---
identifier: "/us/cfr/t21/s528.1080"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 528.1080 - Bc2371 recombinant deoxyribonucleic acid construct."
title_number: 21
title_name: "Food and Drugs"
section_number: "528.1080"
section_name: "Bc2371 recombinant deoxyribonucleic acid construct."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "528"
part_name: "INTENTIONAL GENOMIC ALTERATIONS IN ANIMALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "74 FR 6823, Feb. 11, 2009, unless otherwise noted."
cfr_part: "528"
---


# 528.1080 Bc2371 recombinant deoxyribonucleic acid construct.

(a) *Specifications and intended use.* A single copy of Bc2371, a human Factor VII recombinant deoxyribonucleic acid (rDNA) gene construct, located on chromosome 3p1.1-2 in a diploid line (R69) of hemizygous and homozygous New Zealand white rabbits (*Oryctolagus cuniculus*).

(b) *Sponsor.* See No. 086047 in § 510.600 of this chapter.

(c) *Conditions of use*—(1) *Intended use.* The construct directs gene expression of recombinant human Factor VII (hFVII) in the mammary gland such that recombinant hFVII zymogen is present in the rabbit milk, enabling purification and activation of recombinant hFVIIa intended for the treatment of hemophilia A or B in humans with inhibitors to Factors VIII and IX.

(2) *Limitations.* Food or feed from R69 rabbits is not permitted in the food or feed supply.

[84 FR 12494, Apr. 2, 2019]