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Re: FDA-2008-D-0394: Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Notice of Availability

March 13, 2017

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

Re: FDA-2008-D-0394: Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Notice of Availability1

To whom it may concern:

Thank you for the opportunity to provide comments to the Food and Drug Administration (FDA) on the 19 January 2017 draft revisions to FDA Guidance for Industry (GFI) #187. For a number of reasons, as noted below, we are requesting additional time to complete these comments. We request an extension of the comment period until at least June 19, 2017. Our request is consistent with, and furthers, the spirit and text of the Administration’s recent Executive Orders and guidance aimed at a measured approach to new regulations and guidance2.

First, FDA is seeking comments on five questions, four of which ask for empirical evidence. The scientific literature on the impacts of genomic changes on 1) the structure and function of the genome; 2) cell biology; 3) phenotypic expression of genetic information; and 4) associated risks, or lack thereof, is extensive. Members of the public and other stakeholders who want to provide empirical evidence to assist FDA in developing a science-based, risk-based regulatory system likely require more time to conduct a thorough literature review.

Second, an extension would foster greater coordination between the three regulatory agencies that participated in development of the White House Office of Science and Technology Policy (OSTP) January 4, 2017 update3 of the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework)4. The Coordinated Framework update was accompanied by development of a National Strategy for Modernizing the Regulatory System for Biotechnology Products (the Strategy)5, which provides a process for regular review of the agencies’ regulation of biotechnology products...

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