May 19, 2017Docket No. APHIS-2014-0056Regulatory Analysis and DevelopmentPlant Protection Division - APHISStation 3A–03.84700 River Road Unit 118Riverdale, MD 20737–1238.http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0056Re: Animal and Plant Health Inspection Service Docket No. APHIS–2014–0056; Availability of an Environmental Assessment for the Field Release of Genetically Engineered Diamondback MothsTo Whom It May Concern:The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the United States Department of Agriculture (USDA) Animal Plant Health Inspection Service (APHIS). BIO is the world's largest biotechnology trade association, representing small and large 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 healthcare, agricultural, industrial and environmental biotechnology products. BIO represents its members in a number of matters related to agricultural biotechnology, and in particular, has a strong interest in the sound regulation of animal biotechnology. These comments by BIO address the environmental assessment for the field release of genetically engineered diamondback moths and further support BIO’s advocacy for the sound regulation of animal biotechnology.APHIS prepared this environmental assessment (EA) in response to Cornell University’s application for a permit1 to conduct an experimental release of the genetically engineered (GE) diamondback moth (Plutella xylostella) strain OX4319L-Pxy. Pursuant to the National Environmental Policy Act of 1969 (NEPA), APHIS thoroughly assessed the potential impacts of its decision to grant or deny a permit on key resource areas: human health, the physical and biotic environments, including threatened and endangered species. BIO concurs with the factual accuracy, scientific validity and thoroughness of…

BIO submitted comments in response to the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation Interim Final Rule (the "Interim Final Rule") published in the Federeal Register on March 20, 2017.In the balance of this letter, we discuss each of our concerns in detail, focusing on the need to delay the effective date of the Final Rule until HRSA can complete revisions to the Final Rule through notice-and-comment rulemaking that address: The significant burden of the “penny pricing” policy finalized in the Final Rule; The need to revise the regulatory definition of the “knowing and intentional” standard to comply with its statutory intent; and The need to revise the treatment of ceiling price calculations for newlylaunched drugs and the definition of “instances of overcharging” to mitigate the significant and undue burden these Final Rule provisions place on manufacturers.