February 5, 2017 The Food and Agriculture Section of the Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in the Federal Register entitled “Review of Existing General Regulatory and Information Collection Requirements of the Food and Drug Administration,” as well as several related Center-specific notices.

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin. BIO supports enhanced regulatory guidance on considerations for approval of generic and follow-on medicine products, as well as the FDA’s recognition of the appropriateness of the 505(b)(2) application for regulatory assessment of generic medicines and follow-on peptide products. However, BIO requests FDA provide greater scientific reasoning and specificity on its analysis for the sweeping determination that an ANDA submission may be appropriate for the five specific peptides referenced the guidance. BIO’s comments address this concern in more detail.

RE: Docket No. FDA-2010-N-0548: The Biotechnology Innovation Organization (BIO) appreciates the opportunity to offer comments to Food and Drug Administration (FDA)’s “Good Laboratory Practice for Nonclinical Laboratory Studies.” 

The Biotechnology Innovation Organization appreciates the opportunity to offer comments to the final rule Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models.

BIO appreciates the opportunity to comment on the National Quality Forum (NQF) Health and Wellbeing 2015-2017 report.