United States Department of Agriculture Jamie L. Whitten Building, Room 101-A 1400 Independence Ave SW Washington DC 20250 Re: Identifying Regulatory Reform Initiatives Dear Ms. Adcock: The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the USDA’s request for information on “Identifying Regulatory Reform Initiatives,” published in the Federal Register on July 17, 2017.1 Thank you for the opportunity to provide input as the U.S. Department of Agriculture (USDA or the Agency) considers opportunities to improve customer service and remove unintended barriers to participation in its programs in ways that least interfere with its customers and allow USDA to accomplish its mission.

BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS) proposed rule regarding the calendar year (CY) 2018 Physician Fee Schedule (PFS), other revisions to Part B, and Medicare Shared Savings Program (MSSP). BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and patient access to drugs and biological. In this letter, BIO responds to CMS’s proposals in the order in which the Agency addresses each issue in the Proposed Rule, for ease of reference. However, there are several issues of particular importance to our members given the goal of ensuring patient access to necessary vaccines, treatments, and therapies.

BIO submitted comments on the Centers for Medicare and Medicaid Services’ (CMS’s) Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Proposed Rule for calendar year (CY) 2018 (the "Proposed Rule").  BIO members are eager to improve health care through the discovery and advancement of new therapies and thus are supportive of appropriate reimbursement in our health care system both to ensure that beneficiaries have proper access to care and to encourage investment in innovation. With these goals in mind, we have evaluated each of CMS’s proposals to ensure that they support continued access to crucial treatments and therapies in the hospital outpatient setting for Medicare beneficiaries. We briefly describe our feedback on these proposals in more detail in the balance of the letter.

Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to FDA’s Draft Guidance entitled Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy (Draft Guidance).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 member companies are working hard to meet the Drug Supply Chain Security Act (DSCSA) requirements to improve security of the US drug supply chain and help ensure patients are receiving authentic products. However, as was heard at the April 25, 2017 DSCSA Listening Session, readiness across the full supply chain may vary and a number of stakeholders supported an enforcement discretion period of one year. We appreciate that after hearing this feedback, FDA released this Compliance Policy on enforcement discretion for the product identifier requirements in advance of the November 2017 implementation date. In doing so, FDA provided sufficient notice to stakeholders to plan for and prepare to be compliant with the new requirements.As we relayed at the April FDA Listening Session, without grandfathering guidance from FDA companies have had to make business decisions in order to ensure movement of product through the supply chain. Key industry stakeholders, including the manufacturers within BIO, have been operating with the understanding that the serialization obligations under DSCSA Sec 582(b)(2)(A) were tied to the date the product was packaged. That is, any product packaged on or after November 27, 2017 must be serialized while any un-serialized product packaged prior to November 27, 2017[1] could continue to be sold…