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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
Comments of the Biotechnology Innovation…
On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…
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BIO Comments to FWS on Use of GMOs on National…
BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands. 
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BIO Comments to the Minnesota Department of…
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.    
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State Biotech Associations Warn Part D Redesign Puts New Treatments for Patients at Risk
November 4, 2019
In a letter to Chairman Grassley (R-IA) and Ranking Member Wyden (D-OR), the leaders of the Senate Finance Committee, state biotech associations warn that the Committee’s proposed redesign of Medicare Part D puts new, innovative treatments for…
BIO Comments from Stephen Rapundalo (MichBio) on 2020 RFS SRE Public Hearing
October 31, 2019
October 30, 2019 Docket ID: No. EPA-HQ-OAR-2019-0136 Public Hearing: Renewable Fuel Standard Program: Standards for 2020 and Biomass Based Diesel Volume for 2021, and Response to the Remand of the 2016 Standards; Supplemental Notice of Proposed…
BIO Submits Comments to the House Energy and Commerce Hearing on "Protecting the RFS: The Trump Administration's Abuse of Secret Waivers"
October 31, 2019
Dear Chairman Tonko, Chairman Pallone, Ranking Member Shimkus, Ranking Member Walden, and Members of the Subcommittee: The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the to the United States House…
BIO Commends the Introduction of the Helping Startups Continue to Grow Act
October 30, 2019
In a recent letter, BIO’s Jim Greenwood commended Representative Steil (R-WI) for introducing the “Helping Startups Continue to Grow Act,” which extends the exemption afforded to Emerging Growth Companies under the JOBS Act from certain executive…
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)…