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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 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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Ag Biotech Alliance Response to Biotech RFI
February 5, 2023
ABA has submitted comments to the Office of Science & Technology Policy on how regulations underpinning the Coordinated Framework for the Regulation of Biotechnology can better facilitate the use of biotechnology to stimulate the economy…
BIO Response to Biotech RFI
February 5, 2023
BIO has submitted comments to the Office of Science & Technology Policy on how regulations underpinning the Coordinated Framework for the Regulation of Biotechnology can better facilitate the use of biotechnology to stimulate the economy…
BIO comments to USTR on the Agency’s 2023 Special 301 Review, January 30, 2023
January 31, 2023
BIO Response to RFI: National Biotechnology & Biomanufacturing Initiative
January 23, 2023
BIO's response to the Office of Science & Technology Policy's Request for Information concerning the National Biotechnology & Biomanufacturing Initiative
BIO Submits Comments on FDA Guidance: Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials
January 3, 2023
On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which…
BIO Comments on FDA Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs
December 13, 2022
On Tuesday, December 13th, BIO submitted comments in response to a recent FDA discussion paper for stakeholders on distributed manufacturing (DM) and point-of-care (POC) manufacturing. In the comments submitted, BIO commended the FDA on its…
BIO/Stakeholder letter to the Senate Judiciary Committee in opposition to the “Pride in Patent Ownership Act” (S. 2774)
December 9, 2022
Letter to the U.S. Patent and Trademark Office offering recommendations to strengthen the Patent Trial and Appeal Board (PTAB) process
December 9, 2022
BIO Letter to the EEOC on Special Carve Outs
December 5, 2022
Notice of Availability and Request for Comment: Equal Employment Opportunity Commission (EEOC) Draft Strategic Plan 2022–2026
Coalition Letter in Support of McKalip & Taylor Nominations
November 29, 2022
A coalition of groups, including BIO and several of its member companies, wrote Senate leaders urging confirmation of Doug McKalip as Chief Agricultural Negotiator for USTR and Alexis Taylor as Under Secretary for Trade and Foreign Agricultural…