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GUIDANCE DOCUMENT

CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products October 2017

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2016-D-4482
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance provides information for industry and other stakeholders regarding regulatory oversight of articles, including substances, for use in or on mosquitoes (“mosquito-related products”). We are providing this guidance to clarify circumstances under which such products are regulated by the Food and Drug Administration (FDA) as new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other circumstances under which such products are regulated by the Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-4482.

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