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…

BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS's) CY 2018 Updates to the Quality Payment Program Proposed Rule. BIO supports the development and implementation of the Quality Payment Program (QPP) tracks: Advanced Alternative Payment Models (APMs) and the Merit Based Incentive Payment System (MIPS), in a manner that improves overall healthcare quality, while not compromising access to the most appropriate care and treatment.

BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS's) Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System Proposed Policy Changes and Fiscal  Year 2018 Rates Proposed Rule on June 13, 2017. BIO supports the development and use of appropriate, evidence-based quality measures throughout the healthcare system as a component of improving efficiency and clinical outcomes; additionally, we support policy proposals driven at increasing access to innovative care. BIO's comments in the letter are divided into two sections - the first focusing on the proposals contained in the FY 2018 Proposed Rule, and the second for providing feedback on the Request for Information.

BIO submitted a report to the United States Trade Representative regarding the agency’s 2017 Special 301 Review.

BIO submitted comments to the Food and Drug Administration (FDA) on the statement of work for assessment of the Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II. BIO supports the approach described in the BsUFA II Performance Goals of establishing a review approach for biosimilars applications patterned generally after the program established under PDUFA V for New Molecular Entity (NME) and new Biological License Applications (BLAs). BIO agrees the evaluation must be public, include input from FDA staff and sponsors, and provide recommendations at the mid-point and at the end of the program for any changes necessary for the program to succeed.