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Letters, Testimony & Comments

BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.

Featured Letters, Testimony, & Comments
BIO Letter to Congressional Leadership on the…
One thing that we can all agree on is the need to give our children a fighting chance so they can lead long and productive lives. That is why it is critical to pass the bipartisan Give Kids a Chance Act and ensure the Pediatric Priority Review…
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John F. Crowley's One-Year Anniversary Letter to…
Dear Colleagues, This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
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BIO Comments on Office of Management and Budget …
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
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BIO Testimony to the House Energy and Commerce Subcommittee on Environment and Climate Change: “Building a 100 Percent Clean Economy”
October 24, 2019
Thanks to biotechnology, advances in biofuels made from renewable resources and waste feedstocks can be used to decarbonize our roadways, seaways, and airways. In order to achieve the goal of a 100 Percent Clean Economy for this segment of the…
BIO Submits Comments to the Office of Science Technology and Policy (OSTP) on the Bioeconomy
October 22, 2019
The Biotechnology Innovation Organization (BIO) has submitted comments to the Office of Science Technology and Policy (OSTP) on the bioeconomy, explaining the critical role America’s biotechnology industry plays in feeding, fueling, and healing the…
BIO Submits Comments re: CY 2020 Medicare Physician Fee Schedule Proposed Rule
October 21, 2019
Dear Administrator Verma:The Biotechnology Innovation Organization (BIO) appreciates the opportunity to commenton the Center for Medicare and Medicaid Services’ (CMS’s) CY2020 Revisions to PaymentPolicies under the Physician Fee Schedule (PFS) and…
BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule
October 21, 2019
Dear Administrator Verma,The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment onthe Centers for Medicare & Medicaid Services’ (CMS’) Medicare Hospital OutpatientProspective Payment and Ambulatory Surgical Center…
Pediatrics: BIO Comments on FDA Draft Guidance on Rare Pediatric Priority Review Vouchers
October 2, 2019
September 30, 2019Re: Docket No. FDA–2014-D-1461: FDA Draft Guidance, Rare Pediatric Priority Review Vouchers.Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity…
ICH: BIO Comments on ICH E8(R1) General Considerations for Clinical Studies
September 30, 2019
September 30, 2019Re: Docket ID FDA-2019-D-3049: E8(R1) General Considerations for Clinical Studies; International Council for HarmonisationDear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA)…
BIO Comments on FDA Draft Guidance on ICH E19 Optimization of Safety Data Collection
September 27, 2019
BIO submitted comments to the Food and Drug Administration (FDA) on E19 Optimisation of Safety Data Collection; International Council for Harmonisation. BIO welcomes this document on the optimization of safety data collection and supports the goal…
ICH: BIO Submits Comments on FDA Draft Guidance ICH M10 Bioanalytical Method Validation
September 25, 2019
September 25, 2019Re: FDA-2019-D-1469: M10 Bioanalytical Method Validation; International Council for Harmonisation; Draft Guidance for IndustryDear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration …
BIO Comments on ICER’s Value Assessment Framework for Transformative Therapies
September 6, 2019
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Institute for Clinical and Economic Review’s (ICER’s) solicitation for input on draft revisions to its Value Assessment Framework for the…
BIO Comments on RFS Standards for 2020 and Biomass-Based Diesel Volumes for 2021, Response to the Remand of the 2016 Standards
August 30, 2019
BIO's comments on the EPA’s administration of the of the Renewable Fuel Standard (RFS)  program and how it has put the investments made by BIO Member companies at risk and threatens to prevent growth in advanced and cellulosic biofuels as the…