New Animal Drugs in Genetically Engineered Animals; opAFP-GHc2 Recombinant Deoxyribonucleic Acid Construct
other · Food and Drug Administration · Rule · Published 2015-11-24 · Effective 2015-11-24 · 80 FR 73104
Document
Document number
2015-29902
Federal Register citation
80 FR 73104
CFR reference
21 CFR 510
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2015-11-24
Effective date
2015-11-24
HHS docket
Docket No. FDA-2015-N-0002
Abstract
The Food and Drug Administration (FDA, the Agency) is amending the animal drug regulations to reflect the approval of a new animal drug application (NADA) filed by AquaBounty Technologies, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) gene construct in a lineage of genetically engineered Atlantic salmon.