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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 Signs on to Multi-Industry Letter Supporting Critical Infrastructure in Wake of COVID-19 Outbreak
March 25, 2020
In the wake of the COVID-19 outbreak, the Biotechnology Innovation Organization (BIO) joins 111 industry groups across sectors in a letter to federal, state and local lawmakers supporting uniform definitions of "critical infrastructure" as outlined…
Sustainable Aviation Fuels (SAF) Tax Incentive Letter to Congress
March 19, 2020
BIO greatly appreciates efforts from Congress to mitigate the current economic crisis for employers, employees, and all our families. In recent days, we have been asked by several of your colleagues for policy ideas that could assist with…
BIO Comments on FDA’s Proposal on Importation of Prescription Drugs from Canada
March 11, 2020
The Biotechnology Innovation Organization (“BIO”) would like to submit the following comments regarding FDA’s recent proposal to implement aspects of the Canadian importation provisions of Section 804 of the Food Drug & Cosmetics Act (“FD&C…
Council of State Bioscience Associations Comments on FDA’s Proposal on Importation of Prescription Drugs from Canada
March 11, 2020
The Council of State Bioscience Associations (“CSBA”) appreciates the opportunity to submit the following comments regarding FDA’s recent proposal to implement aspects of the Canadian importation provisions of Section 804 of the Food Drug &…
BIO Submits Letter to Office of Management and Budget on Part 340
March 6, 2020
Each of the below signatories submitted comments to the United States Department of Agriculture on the June 6, 2019, proposed rule regarding the movement of certain genetically engineered (GE) organisms [Docket No. APHIS-2018-0034] (OMB RIN 0579…
BIO Testifies on Biobased Products to Address Plastic Waste
March 5, 2020
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, “Reduce,…
Governors Letter to President Trump on Animal Biotechnology
February 25, 2020
We the undersigned Governors would like to draw your attention to an important issue facing U.S. agriculture. Farmer access to new biotechnologies, such as gene editing, is critical to maintaining the security and stability of the rural economy and…
21st Century Cures: BIO Comments on FDA Draft Guidance Qualification Process for Drug Development Tools
February 14, 2020
Dear Sir/Madam:  The Biotechnology Innovation Organization (BIO) thanks to the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the Draft Guidance, Qualification Process for Drug Development Tools. …
Pediatrics: BIO Comments on FDA Draft Guidance on Pediatric Studies of Molecularly Targeted Oncology Drugs
February 13, 2020
February 11, 2020 Re: Docket No. FDA–2019-D-4751: Food and Drug Administration Reauthorization Act Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs Dear Sir/Madam: The Biotechnology Innovation Organization (BIO…
Request to EPA for Analysis of Lifecycle Ethanol GHG Emissons
February 12, 2020
Dear Administrator McCarthy, We write to request that the Environmental Protection Agency (EPA) update its greenhouse gas life-cycle emissions analysis for corn ethanol to include consideration of the current state of the industry and the published…