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Patient Engagement: BIO Comments FDA Docket "Enhancing Patient Engagement Efforts Across FDA"

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on Enhancing Patient Engagement Efforts Across the Food and Drug Administration.

BIO IES: Advanced Biofuel RVP EPW Letter 170612

BIO IES: Advanced Biofuel RVP EPW letter 170612

Advanced Biofuel RVP EPW letter 170612

GHG Benefits of the Consumer and Fuel Retailer Choice Act

GHG Benefits of the Consumer and Fuel Retailer Choice Act

BIO submits comments to USDA’s Animal and Plant Health Inspection Service RE: Availability of an Environmental Assessment for the Field Release of Genetically Engineered Diamondback Moths

May 19, 2017

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BIO Submits Comments Re: 340 B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (CMP) Regulation Interim Final Rule

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.  

BIO Comment on Executive Order 13777, Enforcing the Regulatory Reform Agenda

The Biotechnology Innovation Organization’s (“BIO”) Industrial and Environmental Section (“IES”) is pleased to provide the U.S. Environmental Protection Agency (“EPA”) input to inform its Task Force evaluation of existing regulations under Executive Order 13777, “Enforcing the Regulatory Reform Agenda.”

BIO Comment on EPA’s Renewables Enhancement and Growth Support (REGS) Proposed Rule

BIO supports EPA’s ongoing efforts to improve the efficiency and effectiveness of the federal Renewable Fuel Standard (“RFS”) program, which was created by Congress, with bipartisan support, in statutory provisions that President George W. Bush signed into law as part of the Energy Policy Act of 2005 and Energy Independence and Security Act of 2007.