The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the U.S. Environmental Protection Agency’s (EPA) proposed Renewable Fuel Standard (RFS) Program: RFS Annual Rules (86 Fed. Reg. 72436).

On Friday, February 4th, BIO submitted comments on the Food & Drug Administration’s (FDA) recent draft guidance regarding the data standards for product submissions containing Real-World Data (RWD). In the comments submitted, BIO thanked the Agency for the opportunity to provide input on this important topic. In addition to specific line edits, BIO provided several overarching recommendations for the Agency to consider prior to finalizing the guidance. For example, BIO recommended that the Agency consider highlighting the strengths and limitations of prospective and retrospective real-world data and providing language to delineate the challenges more clearly with each type of data source. In particular, acknowledgement of the challenges sponsors face when utilizing retrospective data would be helpful. Furthermore, BIO advised that the current guidance seeks to align modern data sets to data standards that were created for a different era in healthcare research. To address this issue, BIO suggested the Agency consider providing guidance for a more far-reaching approach to data standards and create a new data standard approach tailored for RWD, given the evolving and emerging nature of RWD assets that can be at the FDA's disposal to facilitate data use for 21st Century research problems. Also included in the comment submitted, BIO agreed that data standardization is a worthwhile goal for the use of RWD in the evaluation of product benefit/risk; however, rigid requirements to transform all data into a format that was designed for clinical trials may not be practical, scientifically appropriate, or feasible. An appropriate degree of flexibility along with guidance for when it is not feasible for data to be standardized would make the incorporation of RWD in product submissions more feasible. BIO also stated appreciation for the Agency’s mention of the challenges in mapping and transforming RWD into data that meet FDA-supported data standards. Nevertheless,…