On Wednesday, April 27th, BIO submitted comments regarding an upcoming meeting of ODAC’s Pediatric Oncology Subcommittee on PREA Waivers for Same-in-Class Drugs. In particular, the subcommittee will meet to discuss the development of a conceptual framework that will inform the decision making of FDA on sponsor plans and requests for waivers of early pediatric investigations of molecularly targeted cancer drugs and biologics when multiple same-in-class products are approved and/or in development, recognizing that the rarity of pediatric cancers may preclude the feasibility of investigations of multiple products. In the comments submitted, BIO stated support for the development of a conceptual framework as the absence of an effective mechanism for making decisions about the feasibility of preliminary efficacy studies may increase the likelihood that studies cannot be fully enrolled, an outcome undesirable to all stakeholders. However, BIO emphasized that the construction of a conceptual framework to assist FDA’s regulatory decision making should avoid unduly burdening one sponsor more than its competitors, utilize scientific data (e.g., mechanistic, nonclinical, clinical, etc.), and have a patient-centric approach. 

As a diverse set of stakeholders dedicated to building a cleaner, more resilient aviation industry, we write today to urge your committees to prioritize funding for federal programs that will help develop and scale up the sustainable aviation fuel (SAF) market in the United States. In particular, we urge you to support robust funding for the Department of Energy’s Bioenergy Technologies Office (BETO) at levels that meet or exceed the President’s budget request.

As a broad coalition of aviation industry stakeholders—including passenger and cargo carriers, clean fuel producers, engine and aircraft manufacturers, labor unions, airports, business and general aviation, airline passengers, trade associations, and think tanks—committed to decarbonizing aviation, we write to express our strong support for a new, long-term, technology- and feedstock-neutral tax incentive for sustainable aviation fuel (SAF). We believe the most important action Congress can take to support the decarbonization of the aviation sector is to enact a blender’s tax credit specifically aimed at incentivizing the production and use of SAF.

The Biotechnology Innovation Organization (BIO) welcomes the opportunity to provide comments on the proposed Rules for the Implementation of Regulations on Management of Human Genetic Resources (HGR). BIO acknowledges the efforts of the Division of Science and Technology for Social Development of the Ministry of Science and Technology (MOST) to further develop rules on the management of HGR to further harmonize existing rules with the recently enacted Biosecurity Law.