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Lane, Rm. 1061Rockville, MD 20852Re: FDA-2008-D-0394: Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Notice of Availability1To whom it may concern:Thank you for the opportunity to provide comments to the Food and Drug Administration (FDA) on the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

The Biotechnology Innovation Organization (BIO) is the world's largest trade association representing biotechnology 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 innovative healthcare, agricultural, industrial and environmental biotechnology products. Our members are working every day to solve the greatest challenges facing society – whether it is finding a cure for cancer, protecting the public against bio-terror threats, feeding hungry people nutritious food, or generating renewable fuels, renewable chemicals and biobased products. We support public policies, including government funding for key agencies and programs that unleash our members’ scientific innovation potential and grow the bioeconomy. BIO also is one of the founding members of the Agriculture Energy (Ag Energy) Coalition, a coalition of trade groups, companies, and organizations representing thousands of farmers and businesses across the United States who are developing an “all-of-the-above” approach to renewable energy, energy efficiency, and farm and forest resources.

What an honor it is to speak to you today on behalf of the Biotechnology Innovation Organization (BIO) about the Biosimilars User Fee Act reauthorization. This Committee planted the seed that has grown into multiple user fee programs that provide FDA with a significant portion of the resources it needs to ensure that patients have timely access to safe and effective new drugs and biologics, generic drugs, biosimilars, and medical devices. This Committee also tilled the ground and successfully produced, with an overwhelming bipartisan House vote, the legislation that established an FDA pathway for the approval of biosimilars – the Biologics Price Competition and Innovation Act (BPCIA). BIO was an early and strong supporter of this legislation to create a facilitated and balanced pathway for greater competition in the biologics marketplace.