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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to FDA’s Draft Guidance entitled Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy (Draft Guidance).BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related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…

BIO requests that EPA revise its proposed 2018 RFS rule to build upon the successes of the 2017 RFS and send a signal that there will be market growth for advanced and cellulosic biofuels. The proposed rule in its current form puts at risk industry progress and development with a new methodology that will in effect limit the volumes for cellulosic biofuels.

August 25, 2017Mr. Bruce SummersActing AdministratorAgricultural Marketing ServiceUnited States Department of Agriculture1400 Independence Avenue, SWRoom 3069 South BuildingWashington, DC 20250Submitted via GMOlabeling@ams.usda.govRE: Proposed Rule Questions Under Consideration (Posted June 26, 2017)Dear Mr. Summers:The Biotechnology Innovation Organization (BIO) thanks the United States Department of Agriculture (USDA) Agricultural Marketing Service (USDA-AMS or the Agency) for seeking input into the implementation of the National Bioengineered Food Disclosure Standard. BIO is pleased to submit responses to questions 1-5 and 7-12, for which BIO members have unique expertise. In addition, BIO is a member of the Coalition for Safe Affordable Food (CFSAF), a broad-based coalition spanning the food supply chain – from seed producers, to growers, to food manufacturers and retailers – dedicated to increasing the public’s understanding about the science and safety of genetically engineered organisms. In addition to these responses, BIO directs USDA- AMS to the CFSAF’s responses submitted August 25, 2017, to which BIO is a signatory.BIO is the world's largest bioscience innovation trade association representing nearly 1,000 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 represents the majority of agricultural biotechnology product developers in North America.In the past few years, a number of states passed laws requiring or conditionally requiring on-package labeling of certain bioengineered food, setting up the potential for a patchwork of differing and conflicting national, state, and local requirements. Because this patchwork legislation could threaten the free movement of food throughout the United…