Letters, Testimony & Comments

March 4, 2011
RE: Request for comments on Appendix 3 of the Chairperson’s Report on the November 15-16, 2010 Facilitated Work Session of the Codex Committee on Food Labeling on the topic of the Labeling of Foods and Food Ingredients Obtained through...
March 4, 2011
Re: Draft Environmental Assessment: Use of Genetically Modified, Glyphosate-Tolerant Soybeans and Corn on National Wildlife Refuge Lands in the Mountain-Prairie Region (Region 6) Dear Colleague: These comments are submitted by the...
March 4, 2011
Re: Draft 2012 Part D Call Letter Dear Administrator Berwick: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) Draft 2012 Call Letter. BIO is...
March 2, 2011
Re: Docket No. FDA–2011–N–0002: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting Dear Sir/Madam: On behalf of the Biotechnology Industry Organization (BIO), thank you for the...
March 1, 2011
HHS-OS-2010-002: Request for Information Regarding Value-based Insurance Design in Connection with Preventive Care Benefits The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the design aspects of preventive...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...