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
More than 135 Emerging Biotech Leaders Urge…

We represent the community of emerging biotechnology companies whose researchers and scientists strive daily to develop innovative life-changing therapies and cures for patients. We take pride that we are providing hope to patients and their families and changing the world through medical breakthroughs

BIO Comments on CMS National Coverage Decision…

BIO provided comments on the Centers for CMS’ National Coverage Determination for Diagnostic Laboratory Tests using NGS for Medicare Beneficiaries with Germline (Inherited) Cancer.

BIO Comments on RFS Standards for 2020 and…
BIO's comments on the EPA’s administration of the of the Renewable Fuel Standard (RFS)  program and how it has put the investments made by BIO Member companies at risk and threatens to prevent growth in advanced and cellulosic biofuels as the…
All Letters, Testimony & Comments
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…
February 6, 2020
Section 182 of the Trade Act of 1974, known as the “Special 301” provisions, requires the United States Trade Representative to identify countries that deny adequate and effective intellectual property protections or fair and equitable market access…
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…
August 5, 2019
On behalf of the Biotechnology Innovation Organization (BIO), thank you for the opportunity to provide comments to the United States Department of Agriculture on its June 6, 2019 Proposed Rule regarding the movement of certain genetically engineered…
March 27, 2020
March 18, 2020 FDA Docket No: FDA-2019-D-4964: FDA Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Dear Sir/Madam: BIO thanks FDA for developing this additional guidance on…
March 27, 2020
March 15, 2020 Re: Docket No. FDA–2019-D-4752: FDA Draft Guidance, Pediatric Study Plans for Oncology Drugs: Questions and Answers BIO appreciates FDA’s efforts to develop a document that outlines questions and answers pertaining to Pediatric…
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…
May 14, 2019
The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments on LD 1698, HP 1213, An Act To Create Jobs and Slow Climate Change by Promoting the Production of Natural Resources Bioproducts. We strongly support the…
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…
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 &…