Letters, Testimony & Comments

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...
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...
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...
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Re: Docket No. FDA-2010-D-0482-0001: Draft Guidance for Industry and Investigators on Safety Reporting Requirements for Investigational New Drug Applications and Bioavailability/Bioequivalence Studies Dear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...
December 23, 2010
Dear Mr. Sunstein: The Biotechnology Industry Organization (BIO) wishes to express in the strongest possible terms its concerns regarding unilateral actions that the U.S. Department of Agriculture (USDA or the Department) is poised to take in...
December 23, 2010
Re: Docket No. FDA-2010-N-0477, Request for Comments on the Food and Drug Administration Approval Pathway for Biosimilar and Interchangeable Biological Products Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and...
December 16, 2010
Re: Parallel Review of Medical Products [FDA-2010-N-0308] Dear Dr. Berwick and Dr. Hamburg: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the notice and request for comments from the Centers for...
December 7, 2010
Re: IPR and Technology discussions at Cancún Climate Change Talks Dear Secretary Clinton and Ambassador Stern: At this very moment, language is circulating at the UNFCCC climate change meeting in Cancún that proposes to continue...
December 6, 2010
Re: APHIS-2010-0047: Availability of an Environmental Assessment for Supplemental Request for Partial Deregulation of Sugar Beets Genetically Engineered to Be Tolerant to the Herbicide Glyphosate To whom it may concern: These comments are...
December 6, 2010
Institute of Medicine Essential Health Benefits BIO Comments 1. What is your interpretation of the word “essential” in the context of an essential benefit package? “Essential” in the context of an essential benefit...
December 3, 2010
Re: Medicare Program; Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program [CMS-1345-NC] Dear Administrator Berwick: The Biotechnology Industry Organization (BIO) is pleased to submit the...
December 1, 2010
Dear Honorable Sander Levin and Honorable Dave Camp, We applaud your ongoing leadership on strengthening U.S. manufacturing and reducing our reliance on imported products. The recently released draft bill, Domestic Manufacturing and Energy Jobs...
November 22, 2010
RE: Participation of Malaysia in the Trans-Pacific Partnership Trade Negotiations Dear Ms. Blue: The Biotechnology Industry Organization (BIO) is pleased to have the opportunity to comment on the proposed accession of Malaysia to the Trans...
November 19, 2010
Re: Comments on Dispute Resolution Dear Ms. Taylor: The Biotechnology Industry Organization (“BIO”) appreciates this opportunity to respond to HRSA’s September 20, 2010 advance notice of proposed rulemaking and request for...
November 19, 2010
Re: Comments on the Civil Monetary Penalties Dear Mr. Lang: The Biotechnology Industry Organization (BIO) appreciates this opportunity to respond to HRSA’s September 20, 2010 advance notice of proposed rulemaking and request for comments...
November 19, 2010
Re: Request for Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System, 75 Fed. Reg. 181, 57261 Washington, D.C., November 19, 2010 Dear Under Secretary Kappos: The Biotechnology Industry...
November 19, 2010
Re: (Docket No. FDA-2010-N-0385) Food Labeling; Labeling of Food Made From AquAdvantage Salmon Dear Sir/Madam: The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide input on the application of the food labeling...
November 8, 2010
Re: Docket No. FDA-2010-D-0451: Draft Guidance for Industry on Suicidality: ProspectiveAssessment of Occurrence in Clinical Trials Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for...