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Letters, Testimony & Comments

Biofuels and the Environment: EPA Report to Congress
February 28, 2011
Comments of Biotechnology Industry Organization on EPA’s Draft Report Biofuels and the Environment: First Triennial Report to Congress EPA Docket # EPA-HQ-ORD-2010-1077 BIO is pleased to submit comments on EPA’s Draft Report...
Australian Gene Patent Bill: BIO Comments to the Australian Senate Committee on Proposed Patent Amendment
February 25, 2011
Patent Amendment (Human Genes and Biological Materials) Bill 2010 Submission to the Senate Legal and Constitutional Affairs Legislation Committee by the Biotechnology Industry Organization February 25, 2011   About BIO/Introduction...
BIO Defending Existing Funding for Bioenergy Programs
February 25, 2011
Dear Majority Leader Reid and Minority Leader McConnell: On behalf of the Biotechnology Industry Organization (BIO), Advanced Biofuels Association (ABFA), Algal Biomass Organization (ABO) and our more than 100 advanced biofuels, renewable...
BIO Comments to CMS on Draft Update of Chapter 4 of the Medicare Managed Care Manual, "Benefits and Beneficiary Protections"
February 24, 2011
RE: Draft Update to Chapter 4 of the Medicare Managed Care Manual Dear Ms. Moon: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments to the Centers for Medicare & Medicaid Services (CMS) on the draft...
BIO Submits Comments on FDA’s Good Laboratory Practice for Nonclinical Laboratory Studies
February 22, 2011
Re: Docket No. FDA–2010–N–0548: Good Laboratory Practice for Nonclinical Laboratory Studies Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
2011 Special 301: BIO Comments to USTR
February 15, 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to participate in the Special 301 process and is hopeful that our contribution will assist the United States Trade Representative’s (USTR) efforts in preserving strong...
BIO Submits Comments on FDA’s Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination
February 14, 2011
Re: Docket No. FDA–2010–D–0616 Draft Guidance for Industry Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and...
Stanford University v. Roche
February 1, 2011
No. 09-1159 IN THE Supreme Court of the United States ___________ BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY, Petitioner, v. ROCHE MOLECULAR SYSTEMS, INC., et al., Respondents. ___________ On Writ of Certiorari to the...
Statement of Support for Montana SB218
February 1, 2011
"An Act establishing procedures for sampling plants protected by patent or other intellectual property laws; requiring mediation of claims involving protected plants; providing an exception; providing rulemaking authority; and providing an...
BIO Comments on FDA’s Draft Guidance for Industry on Qualification Process for Drug Development Tools
January 24, 2011
Re: Docket No. FDA–2010–D–0529 Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
Compensation Tax Fund Will Hurt Farmers and Undermine Coexistence
January 20, 2011
Compensation Tax Fund Will Hurt Farmers and Undermine Coexistence SUMMARY Coexistence in agriculture has been pushed to the forefront with policymakers, farmers and agriculture groups by the current “dialogue” in the context of an...
Microsoft v. i4i Case: BIO Joins 260 Business, Research Institutions and Organizations to Urge Caution in
January 13, 2011
Re: Microsoft Corp. v. i4i L.P. and Infrastructures for Information Inc., pending in the United States Supreme Court, No. 10-290 Washington, D.C., December 22, 2010; With 90 additional signatories, January 13, 2011 Dear Attorney General...
BIO Comments to CMS on Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012
January 11, 2011
Re: Medicare Program; Proposed Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs for Contract Year 2012 and Other Proposed Changes [CMS-4144-P] Dear Dr. Berwick: The Biotechnology Industry Organization (BIO...
BIO Submits Comments on FDA’s Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters
January 11, 2011
Re: Docket No. FDA-2010-D-0319 Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information; Availability Dear Sir/Madam: The Biotechnology...
Ag, Energy Groups Renew Call for Full Farm Bill Energy Funding
January 11, 2011
Dear President Obama: The organizations below urge your Administration to maintain robust funding levels for the Department of Agriculture’s innovative clean energy programs in its upcoming Fiscal Year 2012 budget proposal. We recognize...
President's Council of Advisors on Science and Technology (PCAST)
January 11, 2011
January 7, 2011 President's Council of Advisors on Science and Technology (PCAST) Public Oral Comments Ladies and Gentlemen: The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments today and would...
USDA Proposal to Deregulate Genetically Engineered Alfalfa
January 6, 2011
Farmers Successfully Practice Coexistence USDA must base its decision to deregulate GE alfalfa on science and within its existing statutory authority The U.S. Department of Agriculture is considering whether to deregulate genetically...
New Report Analyzes Impact of Limitations of Current Reimbursement System on Development of Novel Diagnostics
January 6, 2011
A report by Health Advances found that significant limitations in the current reimbursement system for novel diagnostics lead to inconsistent coverage decisions and impede the investment necessary for the development of the next generation of...
Adopting the technical regulation on requirements for the labelling of food and the identification of raw materials for human consumption which contain genetically modified organisms, and adopting other provisions
January 3, 2011
BIO Comments on Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies
December 28, 2010
Re: Docket No. FDA-2010-D-0482-0001: Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies Dear Sir/Madam: The Biotechnology Industry...