March 9, 2017Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852.Re: FDA-2016-N-4389: Genome Editing in New Plant Varieties Used for Foods; Request for CommentTo whom it may concern:Thank you for the opportunity to provide information to the Food and Drug Administration (FDA) on the use of genome editing techniques to produce new plant varieties that are used for human or animal food. It is our intent to provide answers and supporting information that address the complexities of the questions and topics posed by FDA in the Request for Comment. For this reason, we are requesting the deadline for comment on FDA-2016-N-4389: Genome Editing in New Plant Varieties Used for Foods be extended to at least June 19, 2017.We are also seeking this extension to foster greater coordination between regulatory agencies that participated in development of the White House Office of Science and Technology Policy (OSTP) September 2016 report titled “National Strategy for Modernizing the Regulatory System for Biotechnology Products” (the Strategy) that provides a roadmap for updating the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework). In the Strategy, FDA, the Environmental Protection Agency (EPA) and the Department of Agriculture (USDA) committed to clarifying their policies for the regulation of products derived from genome editing techniques. A foundational principal of the Coordinated Framework is that similar products should be treated the same by regulatory agencies. As part of the Strategy, the three agencies also committed to increased coordination of their activities related to regulation.On January 19, 2017 USDA published a proposed rule titled “Importation, Interstate Movement, and Release Into the Environment of Certain Genetically Engineered Organisms” to update its regulation of genetically engineered organisms under 7 CFR Part 340 (APHIS-2015-0057-0016). Comments for this…

March 13, 2017Division of Dockets Management (HFA-305)Food and Drug Administration5630 Fishers Lane, Rm. 1061Rockville, MD 20852Re: FDA-2008-D-0394: Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Notice of Availability1To whom it may concern:Thank you for the opportunity to provide comments to the Food and Drug Administration (FDA) on the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...

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s revised draft Guidance for Industry “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.”

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance “Multiple Endpoints in Clinical Trials” (Draft Guidance).