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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
ohn’s One-Year Anniversary Letter to BIO…
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 forComments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
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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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BIO Comments on Proposed NIST Rule
April 9, 2021
The Biotechnology Innovation Organization (BIO) submitted the below comments to the National Institute of Standards and Technology on proposed revisions to regulations that would further the Return on Investment (ROI) Initiative for Unleashing…
BIO Comments on FDA’s Draft Guidance on Human Gene Therapy for Neurodegenerative Diseases
April 6, 2021
On Tuesday, April 6th, BIO submitted comments on the U.S. Food and Drug Administration (FDA)’s January 2021 draft industry guidance on “Human Gene Therapy for Neurodegenerative Diseases.” In its comments, BIO stated that while the guidance covers…
BIO Joins Coalition Letter to Biden Administration Supporting SAF Tax Credit
April 2, 2021
Dear Secretary Buttigieg, National Climate Advisor McCarthy, and Director Deese: The undersigned organizations, representing aviation industry stakeholders including passenger and cargo carriers, business and general aviation, aircraft and engine…
BIO Comments on FDA’s Public Meeting Announcement: Best Practices for Development and Application of Disease Progression Models
March 26, 2021
On Friday, March 26th, BIO submitted comments on the U.S. Food and Drug Administration (FDA)’s public meeting announcement titled, “Best Practices for Development and Application of Disease Progression Models.” BIO appreciates that FDA is seeking…
BIO letter to the Senate Judiciary Committee in support of the Inventor Diversity for Economic Advancement Act of 2021 (IDEA Act)
March 26, 2021
The Biotechnology Innovation Organization is delighted to support the Inventor Diversity for Economic Advancement Act of 2021 and urge swift enactment of this important measure.
BIO Submits Testimony to House Science Subcommittee Hearing on Sustainable Aviation Fuels
March 24, 2021
The Biotechnology Innovation Organization is pleased to submit a statement for the record to the United States House of Representatives Committee on Science and Technology and Space and Aeronautics Subcommittee hearing entitled, "Examining R&D…
BIO Letter to New Mexico Governor on Clean Fuel Standard in Special Session
March 22, 2021
I write today on behalf of the Biotechnology Industry Organization (BIO) – the world’s largest biotechnology trade group – to urge you to put Senate Bill 11 – the New Mexico Clean Fuel Standard Act – on the agenda for the March 31 special session of…
BIO Testimony to House Energy and Commerce Subcommittee Hearing on the CLEAN Future Act
March 18, 2021
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Energy and Commerce Subcommittee on Environment and Climate Change hearing entitled, "The…
BIO Letter to DEFRA Consultation on the Regulation of Genetic Technologies
March 17, 2021
The Biotechnology Innovation Organization (BIO) welcomes the United Kingdom’s (UK) consultation on the application of genome editing in the breeding of plants and animals.  The UK has the unique opportunity to be the first country within Europe…
BIO Statement to House Ag Hearing on Food Insecurity
March 11, 2021
The Biotechnology Innovation Organization is pleased to submit a statement for the record to the United States House of Representatives Committee on Agriculture hearing entitled, "A Look at Food Insecurity in America." The Committee's hearing…