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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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Data Modernization: BIO Comments on Modernizing the Food and Drug Administration’s Data Strategy
July 30, 2020
July 30, 2020 Re: Docket No. FDA–2019-D-5799: FDA’s Public Meeting, Modernizing the Food and Drug Administration’s Data Strategy. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or…
BIO Joins Letter to FDA Commissioner on Clarifying Guidance for Plant Gene Editing
July 29, 2020
New innovations capable of advancing plant breeding, such as gene editing, have immense potential to improve agriculture and food production. Researchers are exploring genetic innovations aimed at increasing agricultural productivity; improving…
BIO Comments on Proposed Rule on Value-Based Arrangements
July 20, 2020
The following letter provides BIO’s feedback on a number of regulatory proposals by the Centers for Medicare & Medicaid Services that would ease barriers to use of value-based purchasing arrangements within Medicaid and commercial plans, broaden…
BIO Signs Letter to Congress Urging More Relief for Agriculture Amid COVID-19
July 9, 2020
As Congress develops and debates additional bipartisan legislation in response to COVID-19 and the resulting impacts to workers and the economy, the economic losses persisting across U.S. agriculture must be addressed in the legislation and in…
Orphan Drugs: BIO Comments on Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations
June 23, 2020
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the Draft Guidance for Industry “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug…
Letter to Congress to Support Animal Health Infrastructure Amid COVID-19
June 19, 2020
On behalf of the Animal Agriculture Coalition (AAC), representing veterinary medicine, animal science, state agricultural leaders, and various livestock or animal agricultural interests in the U.S., we applaud lawmakers’ ongoing attention to the…
BIO and CSBA Letter to Congress to Support One Health and Advance Animal Biotech
June 2, 2020
The Biotechnology Innovation Organization (BIO), along with the 27 members of the Council of State Bioscience Associations (CSBA), urge Congress to support the Advancing Emergency Preparedness Through One Health Act and advance legislation…
An Inclusive and Impactful Approach to Transparency
May 14, 2020
The U.S. government’s regulatory approach cannot exist in isolation. It should be supported by credible transparency measures. A proactive approach to transparency stands to build trust and foster an inclusive environment to address our most…
Governor's Biofuels Coalition Letter Urges EPA to Reject RFS Waivers
May 8, 2020
Undermining the RFS at a time when rural America is struggling economically, farmers are fighting to stay in business, and the biofuels industry has been impacted by furloughs and plant closures is unconscionable. We respectfully urge you to reject…
Senate Letter to Administration to Reject RFS Waivers
May 7, 2020
We urge you to direct the EPA to reject all calls to waive the RFS. The RFS is more important now than ever as farmers, the biofuel sector, and rural America struggle to remain operating amid the COVID-19 crisis.