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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 Leads Letter to Congressional Appropriations Committees for FDA Funding on Plant Biotech
April 19, 2022
The farmers, cooperatives, researchers, retailers, seed producers, scientists, and technology developers represented by the organizations below write to express our strong support for the inclusion of language in the Fiscal Year 2023 (FY 2023)…
BIO Submits Comments on CDC Clinical Practice Guideline for Prescribing Opioids
April 11, 2022
On Monday, April 11th, BIO also submitted comments in response to the CDC’s recently published Clinical Practice Guideline for Prescribing Opioids. In the comments submitted, BIO primarily requested that the CDC revise its language referencing…
BIO Submits Comments on FDA Draft Guidance for the Development of Non-Opioid Analgesics for Acute Pain
April 11, 2022
On Monday, April 11th, BIO submitted comments in response to the FDA’s recent draft guidance on the Development of Non-Opioid Analgesics for Acute Pain. In the comments submitted, BIO reaffirmed its commitment to working with the Agency to achieve…
BIO Submits Statement to House Ag Hearing on 2022 Farm Bill and Renewable Energy
April 4, 2022
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Agriculture hearing entitled, “A 2022 Review of the Farm Bill: Energy- Renewable Energy…
BIO Comments to EPA on GHG Modeling
April 1, 2022
The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Environmental Protection Agency’s (EPA’s) February 28-March 1, 2022, workshop on biofuel greenhouse gas modeling.
BIO Comments to CMS on Oregon Proposed 1115 Waiver Application
April 1, 2022
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Oregon Health Authority’s (OHA) proposed Oregon Health Plan §1115 Demonstration Waiver Application (Waiver Application), which among other things, would be…
BIO Submits Comments in Response to FDA Guidance on Digital Health Technologies
March 21, 2022
On Monday, March 21st, BIO submitted comments in response to the recent FDA draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. In the comments submitted, BIO expressed appreciation for the issuance of…
BIO Statement to House Agriculture Committee on the 2022 Farm Bill and Climate Change
March 16, 2022
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Agriculture hearing entitled, “A 2022 Review of the Farm Bill: The Role of USDA Programs…
BIO Statement on House Science Committee Hearing on Bioenergy for Tomorrow
March 16, 2022
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Science, Space, and Technology Subcommittee on Energy hearing entitled, Bioenergy…
BIO Letter to USTR Ambassador Tai and Commerce Secretary Gino Raimondo on Indo-Pacific Economic Framework
March 11, 2022
The Biotechnology Innovation Organization (BIO) welcomes the White House announcement of the Indo-Pacific Strategy and supports efforts to reaffirm U.S. economic engagement with trading partner countries in the Indo-Pacific region and build an Indo…