August 25, 2019 Re: Docket No. FDA–2019-N-2012: New Drug Regulatory Program Modernization: Improving Approval Package Documentation and Communication. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the New Drug Regulatory Modernization: Improving Approval Package Documentation and Communication. 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. BIO appreciates the FDA’s goal of providing greater clarity on FDA's application review and decision-making process. We commend FDA’s efforts to modernize the New Drug Regulatory Program through the use of: (1) The Clinical Data Summary Pilot Program (Pilot), through which parts of a Sponsor’s clinical study reports (CSRs) are posted and (2) a new integrated template that will be used to document FDA's review of new drug applications and efficacy supplements. BIO commends the Agency’s efforts to improve transparency in the drug approval process and believes increased transparency will ultimately benefit patients, BIO member companies themselves make strong efforts to support clinical trial transparency by posting protocols and results and sharing data consistent with the Final Rule on Clinical Trial Registration and Results Information Submission. BIO strongly supports the new integrated review process and template and agrees that this format will also clarify and improve communication between FDA and the Sponsor, as well as provide new insights regarding FDA’s regulatory decision making. The FDA has stated it is considering where to focus its efforts to increase transparency around the drug…

BIO submitted comments on the Food and Drug Administration (FDA) Draft Guidance, Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs. BIO welcomes FDA’s recommendations to broaden eligibility criteria and increase enrollment of underrepresented populations in clinical trials. BIO believes improving diversity of clinical trial populations is an important issue and agrees with the Agency’s view that adopting more inclusive enrollment practices will open clinical trials to a diverse participant population reflective of the population that will use the drug. While we understand the FDA’s goal of improving representativeness of clinical trial populations, we believe policy development on the topic requires a more comprehensive approach. BIO provides suggestions on how to increase patient representativeness as well as how to edit and clarify certain sections of the guidance, specifically around the meaning of “population diversity.”

On behalf of the Biotechnology Innovation Organization (BIO), thank you for the opportunity to provide comments to the United States Department of Agriculture on its June 6, 2019 Proposed Rule regarding the movement of certain genetically engineered (GE) organisms.

In recent years advances in animal genetics have provided significant breakthroughs that can help to address some of society's most difficult challenges. These technologies can treat and protect animals from illness; limit the transmission of dangerous diseases, like African swine fever or avian influenza; curb the use of antibiotics in agriculture; address hunger and insect-borne disease in developing nations; improve animal welfare; among many other benefits.  ... While we think a robust conversation should be had on the best way to provide transparency to consumers and users on the nature of these animals, that discussion will be moot if our nation's regulatory system prevents these animals from coming to market. We again urge you to work with other relevant agencies and stakeholder communities to develop a more appropriate, workable approach that will provide sufficient safeguards, while allowing U.S. farmers, consumers, and the public health officials access to animal innovations.