Extended Comment Deadline: FDA Regulation of Intentionally Altered Genomic DNA in Animals (Draft Guidance)
The Food and Drug Administration (FDA or we) is extending the comment period for the draft guidance for industry (GFI) #187 entitled “Regulation of Intentionally Altered Genomic DNA in Animals” that was announced in the Federal Register of January 19, 2017. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
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.