BIO is pleased to submit these comments in response to the Notice of Request for Public Comment published by the National Science and Technology Council, Science and Technology Policy Office. The Coordinated Framework for Regulation of Biotechnology (Coordinated Framework) has made it possible for BIO members to develop products that have improved the productivity of plant and animal agriculture while decreasing their environmental impacts, enhanced food safety and quality, increased the use of renewable resources and decreased manufacturing costs and energy use.

BIO issued a letter to Congressional Leadership, the Senate Finance Committee Chairs, and the House Ways and Means Committee Chairs calling for the extension of renewable energy tax credits slated to expire at the end of 2016. In its letter, BIO urges Congress to advance a multi-year extension of the Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, and the Alternative Fuel Vehicle Refueling Property.

Re: Docket No. FDA-2016-D-1703Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product; Draft Guidance for Industry and Food and Drug Administration Staff” (Draft Guidance).”BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related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.General CommentsBIO is supportive of FDA’s efforts to provide a practical regulatory guide for sponsors engaged in developing a therapeutic product and an accompanying IVD companion diagnostic (i.e. codevelopment).In general, the Draft Guidance is helpful in describing general principles to guide codevelopment for contemporaneous therapeutic product and device marketing authorizations, regulatory requirements, administrative and clinical trial planning/execution considerations. BIO notes, however, that this draft guidance seems to also refer to the concept of a “complementary” diagnostic in the text.  In light of FDA’s recent approval of a device that belongs to this this new category, we request that the Agency reference “complementary” devices in the current draft, clarify regulatory requirements for approval of “complementary” diagnostics by issuing guidance devoted to the topic as well as discuss appropriate regulatory principles to compare and contrast to companion diagnostics.  Furthermore, the guidance should discuss the principles and criteria for making an assessment to distinguish between companion and complementary diagnostics.  This will allow industry to weigh the evidentiary requirements and provide input to…

Re: Docket No. FDA-2016-D-1309: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; andFDA-2016-D-1267: Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidances entitled “Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act” (503A Draft Guidance) and “Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act” (503B Draft Guidance). 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. As articulated in previous comments and meetings, BIO strongly believes that the drug compounding provisions of the Drug Quality and Security Act (DQSA) did not alter current law with regard to biologics; therefore, there are still no applicable exemptions under the Food, Drug, and Cosmetic Act (FD&C Act) compounding provisions for entities that compound or repackage biological products. Additionally, due to special manufacturing challenges and heightened patient safety concerns, all drug products with a narrow therapeutic index should not be compounded. GENERAL COMMENTS: BIO thanks FDA for the release of the two Draft Guidances regarding…