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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 Letter to Congressional Leadership on the Give Kids a Chance Act & Reauthorization of the Pediatric Priority Review Voucher Program (PPRV)
March 7, 2025
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…
John F. Crowley's One-Year Anniversary Letter to BIO Membership.
March 4, 2025
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…
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)
February 28, 2025
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…
BIO Letter to HRSA on 340B Rebate Model
October 10, 2024
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…
CSBA Letter to Congressional Leadership on Reauthorization of the Rare Pediatric Disease Priority Review Voucher Program
September 9, 2024
Comments of the Biotechnology Innovation Organization (BIO) to The USPTO February 13, 2024 Inventorship Guidance for AI-Assisted Inventions, 89 FR 10043
May 15, 2024
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…
BIO Comments to the USPTO’s MAY 10, 2024 Proposed Rulemaking on Terminal Disclaimer Practice, 89 Fed. Reg. 40439, Docket No. PTO-P-2024-0003
May 10, 2024
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.
BIO Comments to FWS on Use of GMOs on National Wildlife Refuge Lands
May 9, 2024
BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands. 
BIO Comments to the Minnesota Department of Health on Drugs of Substantial Public Interest: Draft Methodology for Public Comment
May 9, 2024
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.    
BIO Comments to HHS's Centers for Medicare & Medicaid Services in response to their Information Collection Request (ICR) on the Part C and Part D Medicare Prescription Payment Plan
April 19, 2024
The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.