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. Our mission is to advance biotechnology innovation by promoting sound public policy and fostering collaboration, both locally and globally. Our members range from entrepreneurial companies developing a first product to Fortune 500 multinationals. BIO and our members appreciate the opportunity to provide comments to the 21st Century Cures 2.0 proposal discussion draft.

BIO appreciates FDA’s commitment to harmonization of regulatory concepts across regional Health Authorities through the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Harmonization of critical regulatory concepts is an important part of ensuring a consistent and predictable regulatory environment and gives sponsors confidence that their drug development program will be generally accepted within different regions. BIO believes that the concepts in Q12 are important and warrant broad recognition across the globe. Even though implementation of Q12 is voluntary, this Draft Guidance explains FDA’s expectations on implementation of Q12 (e.g., format, eCTD locations for information) if an applicant so chooses to implement Q12 and thus is a helpful document. In BIO's comments, we requested additional clarity on how the Q12 draft guidance should be utilized by industry in conjunction with previously issued FDA guidances. We also noted the importance of globally aligned requirements for Established Conditions (ECs) and urged the Agency to carefully consider the terminology used throughout the draft guidance. Furthermore, we expressed concern about the potential introduction of new terms which are not internationally aligned. In line with this overarching feedback, a number of specific redline edits were provided.

We write to express our support for the nomination of Robert Bonnie to serve as the U.S. Department of Agriculture’s Under Secretary for Farm Production and Conservation. The Under Secretary position is critical in overseeing the administration of a wide variety of USDA farm and conservation programs that directly serve farmers, ranchers, foresters, and landowners. Bonnie’s prior experiences show he is dedicated to serving U.S. agricultural producers, and improving the lands Americans depend on for food, fiber, water, recreation, and environmental enhancement. These experiences and his deep background knowledge make Bonnie uniquely qualified to serve as the USDA’s next Under Secretary for Farm Production and Conservation.

On Wednesday, July 14th, BIO submitted comments on FDA’s Guidances: 1) Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance; 2) Updated Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency: Questions and Answers; and the 3) Resiliency Roadmap for FDA Inspectional Oversight Report. In the updated Manufacturing, Supply Chain, and Inspections Questions & Answers document, BIO stated its appreciation for the clear statement in the Q&A Guidance that if a needed inspection cannot be completed due to travel restrictions but there are no other deficiencies (site/facility or otherwise in the application), FDA will defer action, rather than issuing a CRL. In terms of remote evaluations of bioresearch monitoring facilities, BIO proposed that many of the concepts introduced should be retained after the public health emergency ends and become another set of tools in FDA’s toolbox for inspectional activities, utilizing a risk-based approach. Furthermore, we emphasized that this approach could be used in the future to better distribute FDA resources for inspections, ensuring that the majority of staff time is focused on places where in-person assessment is truly needed, and information cannot be obtained via another method. Lastly, BIO requested additional detail regarding how FDA is utilizing the tools and robust dataset in its Resiliency Roadmap to address the inspectional backlog created by the COVID-19 public health emergency; how these tools fit into the larger inspectional paradigm; how remaining inspections will be prioritized; and estimates regarding the resolution of the current and additional backlog would be helpful.

We, the undersigned organizations, representing a broad and diverse group of the agriculture industry are pleased to support the consideration for Jenny Lester Moffitt, who currently serves as Undersecretary of the California Department of Food and Agriculture, to serve as Undersecretary for Marketing and Regulatory Programs at the U. S. Department of Agriculture. We greatly appreciate your efforts to directly engage our organizations, and our members as you work to develop policies that will have direct impact on our food and agriculture supply chain, and our consumers. This engagement has been vital to ensuring that the policies the administration pursues reflects the needs of our collective industries.