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GUIDANCE DOCUMENT

CVM GFI #187 Regulation of Intentionally Altered Genomic DNA in Animals January 2017

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2008-D-0394
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

FDA is issuing this draft revised Guidance for Industry to clarify its approach to the regulation of intentionally altered genomic DNA in animals. This guidance addresses animals whose genomes have been intentionally altered using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions, or other technologies that introduce specific changes to the genome of the animal. This guidance applies to the intentionally altered genomic DNA in both the founder animal in which the initial alteration event occurred and the entire subsequent lineage of animals that contains the genomic alteration.


Submit Comments

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

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0394.

Questions?

Contact Point
Laura R. Epstein
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-1
Rockville, MD 20855