RE: Petition for Reconsideration of 40 C.F.R. §80.1405(c), EPA Docket No. EPA–HQ–OAR–2005–0161, promulgated in 75 Fed. Reg. 14,670 (Mar. 26, 2010); Petition for Reconsideration of Periodic Reviews for the Renewable Fuel Standard Program, 82 Fed. Reg. 58,364 (Dec. 12, 2017)

May 31, 2018 Re: Docket No. FDA-2018-N-1010: Food and Drug Administration Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan.Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the Prescription Drug User Fee Act VI Benefit-Risk Implementation Plan.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 Comments:BIO supports the FDA's continued efforts to evaluate and improve upon the clarity of the complex and critical process of benefit-risk assessment (B/R assessment) throughout the lifecycle of drug evaluation. While BIO commends the FDA for the great progress in implementing the benefit-risk framework (B/R framework), especially as it relates to transparency and communication of benefit-risk assessments (B/R assessment), additional work is needed to continue to advance and improve upon the current FDA B/R framework. In order to continue to advance the science of B/R assessments and the ability of the framework to inform regulatory decision making, BIO believes that there should be increased emphasis and guidance on the utilization of the B/R framework as a decision support tool, implemented earlier in development, rather than just to support communication following a regulatory decision. For example, the FDA has identified additional opportunities to advance their B/R work, through: (1) incorporation of patient experience into drug development, evaluation, and review and (2) exploration of more quantitative approaches to inform B/R assessments in targeted cases, we ask that these efforts be highlighted as…

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Compounded drugs can serve an important role for patients who have clinical needs that cannot be met by an FDA-approved product. Access to medically necessary compounded medicines is important – but access cannot and should not come at the expense of product quality and patient safety. BIO strongly encourages and supports the FDA’s allocation of resources to enable the safety of compounded drugs. BIO agrees these drugs should only be used by patients whose medical needs cannot be met by an FDA-approved drug. In addition, BIO is pleased to see the FDA discuss the importance of the drug approval process and the need to ensure compounded drugs do not weaken incentives for companies to conduct clinical testing and bring new drugs to market. In the comments, BIO also discusses issues including the process for nomination and review of the 503B list for bulk compounding, clarification of what constitutes “clinical need,” and non-biologic complex drugs and narrow therapeutic index drugs.