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 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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Comments of the Biotechnology Innovation…

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…

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BIO Comments to FWS on Use of GMOs on National…

BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands.

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CSBA Comments to Centers for Medicare & Medicaid Services (CMS) on Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026

April 14, 2023

The CSBA Board of Directors endorses BIO’s formal comments on the Medicare Drug Price Negotiation Program, which are appended to this letter.

BIO Comments to Centers for Medicare & Medicaid Services (CMS) on Medicare Drug Price Negotiation Program: Initial Memorandum, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2026

April 14, 2023

BIO comments on the initial guidance regarding the Drug Price Negotiation Program (Negotiation Program) under the Inflation Reduction Act of 2022 issued by CMS on March 15, 2023 (Initial Guidance)

BIO COMMENT LETTER OMB Race and Ethnicity OMB 2023

April 12, 2023

BIO provided detailed comments to the Office of Management and Budget (OMB) regarding the Initial Proposals For Updating OMB’s Race and Ethnicity Statistical Standards.

BIO Comments to FTC

March 31, 2023

BIO response to Federal Trade Commission request for comment on the agency's Guides for the Use of Environmental Marketing Claims (Green Guides)

CSBA Letter to Congressional Leaders urging for passage of S. 866, the American Innovation & Jobs Act of 2023 (March 28, 2023)

March 30, 2023

BIO Statement to the U.S. International Trade Commission on COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities

March 29, 2023

CSBA letter to USITC Expressing Concerns with Proposed WTO TRIPS Waiver Expansion

March 17, 2023

BIO Statement to the U.S. International Trade Commission (USITC) for its Investigation into the TRIPS

March 17, 2023

Ag Value Chain Letter to President Biden on Technical Consultations with Mexico on Corn

March 9, 2023

As organizations representing America’s highly innovative and competitive food and agricultural value chain, we write to express our thanks for USTR’s announcement that it will begin technical consultations with Mexico concerning its action to ban…

BIO Comments to CMS on the Proposed Rule Dealing with Medicare Drug Pricing

February 13, 2023

BIO’s comments on specific aspects of CMS’s Proposed Rule on Medicaid drug pricing are presented below.