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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 Comments on FDA Guidance - IVD Device Studies Frequently Asked Questions
December 17, 2019
On December 16, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Food and Drug Administration’s (FDA’s) Notice to Public of Website Location of CDRH Fiscal Year 2020 Proposed Guidance Development; In Vitro…
BIO Comments on CMS National Coverage Decision Memo for Advanced Cancer Next Generation Sequencing
December 17, 2019
On November 27, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Centers for Medicare and Medicaid Services’ (CMS’) National Coverage Determination for Diagnostic Laboratory Tests using Next Generation Sequencing (NGS)…
More than 135 Emerging Biotech Leaders Urge Congress to Reject H.R. 3
December 5, 2019
In a letter addressed to House Speaker Nancy Pelosi (D-CA) and House Republican Leader Kevin McCarthy (R-CA), 138 emerging biotech leaders warn that H.R. 3, the Lower Drug Cost Now Act, will “shatter the dreams” of patients and families who stand to…
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…