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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 25 2017

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

May 16 2017
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

May 15 2017
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

Apr 26 2017
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.

BIO Comment on EPA's Proposed Denial of Petitions for Rulemaking to Change the RFS Point of Obligation

Apr 26 2017
BIO is supportive of EPA’s proposal. In BIO’s view, granting the petitions in question would add unnecessary regulatory complexity and uncertainty to the Renewable Fuel Standard ("RFS") program, jeopardize U.S. economic and job growth, and would fail to further the statutory requirements and goals that Congress directed EPA to enforce and pursue when Congress created the program.

Combo Products: BIO Comments on FDA Draft Guidance, How to Prepare a Pre-Request for Designation (Pre-RFD)

Apr 14 2017
Re: Docket No. FDA–2017-D-0040: FDA Draft Guidance, How to Prepare a Pre-Request for Designation (Pre-RFD) ...

Combo Products: BIO Comments on Topics That May be Considered by the Food and Drug Administration Combination Product Policy Council

Apr 14 2017
Re: Docket No. FDA–2017-N-0086: Suggestions, Recommendations and Comments for Topics That May be Considered by the Food and Drug Administration Combination Product Policy Council ...

BIO Submits Comments Re: ICER Proposed Value Assessment Framework Revisions

Apr 11 2017
BIO submitted comments on the Institute for Clinical and Economic Review (ICER)'s call for proposed improvements to its Value Assessment Framework. While some of the proposed revisions have the potential to make progress toward aligning the Framework with the principles of individualized patient care and holistic value assessment, ICER must provide additional details with regard to how these proposed revisions will be operationalized before stakeholders can assess whether the revisions will meaningfully address critical gaps in the Framework.

Quality Metrics: BIO Comments on FDA Revised Draft Guidance "Submission of Quality Metrics Data"

Mar 30 2017
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s Revised Draft Guidance for Industry Submission of Quality Metrics Data (Revised Draft Guidance).

Re: FDA-2016-N-4389: Genome Editing in New Plant Varieties Used for Foods; Request for Comment

Mar 16 2017

March 9, 2017

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