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DSCSA: BIO Files Comments on FDA Product Identifier Compliance Policy

Dear Sir/Madam:

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BIO comments on EPA’s proposed rule on the Renewable Fuel Standard Program: Standards for 2018 and Biomass-Based Diesel Volume for 2019

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.

BIO comments to USD-AMS on the National Bioengineered Food Disclosure Law (RE: Questions Under Consideration)

August 25, 2017

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BIO Submits Comments Re: Medicare CY 2018 Updates to the Quality Payment Program

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 Submits Comments Re: Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule

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's 2017 Special 301 Submission

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

Biosimilars: BIO Submits Comments on Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II

Re: Docket No. FDA-2017-N-3199: Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II

BIO comments to FDA Regarding the Regulation of Intentionally Altered Genomic DNA in Animals

BIO appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its request for comments on the draft guidance for industry (GFI) #187, entitled Regulation of Intentionally Altered Genomic DNA in Animals2. This draft guidance would revise GFI #187 entitled “Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs” (current GFI #187)3. 

BIO Comments to FDA on Genome Editing in New Plant Varieties Used for Foods

BIO appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its request for comments on genome editing in plants.

BIO Comments to USDA on its 340 Biotech Rules

BIO is pleased to submit these comments in response to the USDA Animal and Plant Health Inspection Service’s (APHIS’) request for public input on the proposed revisions to its biotechnology regulations in 7 CFR Part 340.