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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
Orphan Drugs: BIO Comments on Interpreting…
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(BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the Draft Guidance for Industry “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug…
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Congressional Black Caucus and Congressional…
We are writing regarding the proposed 2018 Renewable Volume Obligation under the RFS. Rather than support continued growth in the lowest carbon types of biofuels under the statue, your proposal reduces the blending target for cellulosic biofuels and…
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Congressional Black Caucus Letter to EPA on RFS…
As you finalize the proposed rules under the Renewable Fuel Standard, we respectfully urge you to not reduce the biofuels volume requirements. The RFS program has helped the environment, our economy, and has increased our confidence in renewable…
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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(BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the Draft Guidance for Industry “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug…
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.
BIO Comments on Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics
April 20, 2020
Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of…
Combination Products: BIO Comments on FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products
April 17, 2020
April 12, 2020   Re: Docket No. FDA–2019-D-5585: FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products.   Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug…
BIO Signs on to Letter Urging Federal Government to Protect Essential Workers
April 14, 2020
We support prioritizing the healthcare sector for COVID-19 testing supplies, and as testing becomes more available and abundant, the undersigned organizations urge the federal government to provide COVID-19 testing resources to U.S. employers that…
Letter Urging USDA to Include Biofuels in COVID-19 Economic Relief
April 9, 2020
Given the impact the economic downturn has had on all biofuel technologies, we request that USDA ensures all advanced and cellulosic biofuels are eligible to receive assistance from the additional funds provided to the Commodity Credit Corporation …
BIO Letter to White House on Need for Animal Biotech Reform in Wake of COVID-19
April 7, 2020
As part of the Administration’s comprehensive response to the unprecedented health and economic impacts from the COVID-19 pandemic, the Biotechnology Innovation Organization (BIO) respectfully requests that the U.S. government immediately reform its…