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BIO comments to FDA Regarding the Regulation of Intentionally Altered Genomic DNA in Animals

June 20, 2017

June 19, 2017

Division of Dockets Management (HFA-305) Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Submitted Electronically via Federal eRulemaking Portal (

Re: Docket Number: FDA-2008-D-0394: Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Notice of Availability

Dear Dr. Lux:

The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its request for comments on the draft guidance for industry (GFI) #187, entitled Regulation of Intentionally Altered Genomic DNA in Animals2. This draft guidance would revise GFI #187 entitled “Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs” (current GFI #187)3. As described in the Federal Register, “this draft revision of current GFI #187 expands the scope of guidance to include animals intentionally altered through the use of genome editing techniques.” The draft revised GFI#187 would apply to ‘those animals whose genomes have been intentionally altered using modern molecular techniques4’”

BIO is the world's largest biotechnology trade association, representing small and large companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of healthcare, agricultural, industrial and environmental biotechnology products. BIO represents its members in a number of matters related to the...

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2017 BIO Comments FDA CVM GFI #187
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