ABSTRACT

Finding of No Significant Impact: In Support of a Proposed Field Trial of Genetically Engineered (GE) Male Aedes Aegypti Mosquitoes of the Line OX513a in Key Haven, Monroe County, Florida under an Investigational New Animal Drug Exemption   [open pdf - 198KB]

"Oxitec, Ltd. (Oxitec, the sponsor) has provided data and information to the U.S. Food and Drug Administration (FDA)'s Center for Veterinary Medicine (CVM, we) for its proposed field trial of genetically engineered (GE) male 'Aedes aegypti' mosquitoes of the line OX513A, under an investigational new animal drug (INAD) exemption (21 CFR 511.1(b)). 'Ae. aegypti' is a vector for human diseases including those associated with Zika, dengue, and chikungunya viruses. OX513A have been genetically engineered to express a gene that encodes a conditional or repressible lethality trait (also known as selflimiting) and a red fluorescent marker protein to aid in their identification. The proposed investigational field trial would be carried out in Key Haven, Monroe County, Florida under Oxitec's supervision in conjunction with the Florida Keys Mosquito Control District (FKMCD)."

Publisher:
Date:
2016-08-05
Copyright:
Public Domain
Retrieved From:
U.S. Food & Drug Administration: http://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
Help with citations