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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 HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
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CSBA Letter to Congressional Leadership on…
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BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
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BIO Comments on FDA docket Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction
November 18, 2019
Biotechnology Innovation Organization (BIO) comments on the FDA docket, Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction. BIO also believes that risks associated with opioid…
BIO Comments on Proposed Section 382(h) Regulations
November 13, 2019
The Biotechnology Innovation Organization provided comments to the Treasury Department and Internal Revenue Service on proposed regulations under Section 382 with respect to the built-in gain and built-in loss rules of Section 382(h).
BIO Comments on SEC Proposal to Amend the Accelerated Filer and Large Accelerated Filer Definitions
November 11, 2019
In a recent letter, BIO applauded the Securities and Exchange Commission (SEC) for taking a proactive approach in amending its accelerated and large accelerated filer definitions. “If adopted as proposed, these amendments will benefit startups and…
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…