Letters, Testimony & Comments

April 29, 2011
Re: Proposed Guidance Regarding Branded Prescription Drug Fee [Notice 2011-9] Dear Mr. Commissioner: The Biotechnology Industry Organization (BIO) is pleased to submit the following comments to the Internal Revenue Service (IRS) on the...
April 28, 2011
BIO Statement for the Institute of Medicine Committee on Pediatric Studies Conducted under BPCA and PREA April 28, 2011 The Biotechnology Industry Organization (BIO) thanks the Institute of Medicine (IOM) for the opportunity to comment on the...
April 28, 2011
The Biotechnology Industry Organization (BIO) thanks the Institute of Medicine (IOM) for the opportunity to comment on the successes and ongoing challenges related to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research...
April 28, 2011
Committee on Transportation New Hampshire State Senate Hearing on HB 374, banning corn-based ethanol as an additive to gasoline sold in New Hampshire. Written Testimony Submitted by Biotechnology Industry Organization April 28, 2011 The...
April 25, 2011
BIO Comments – Adult Immunization: Complex challenges and recommendations for improvement – A report of the Adult Immunization Working Group of the National Vaccine Advisory Committee The Biotechnology Industry Organization (BIO)...
April 22, 2011
RE: Medicare Coverage Gap Discount Program Appeals Guidance The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) draft guidance on the bases for...
April 19, 2011
RE: Docket No. FDA-2011-D-0082: Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies Submitted via email to http://www.regulations.gov Dear Sir/Madam: The Biotechnology Industry...
April 19, 2011
BIO recognizes the importance of appropriate consideration and use of clinical pharmacogenomic data by the FDA to ensure that this information is used appropriately to improve healthcare outcomes. BIO represents companies that are involved...
April 18, 2011
Re: Docket No. FDA-2011-D-0057: Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
April 13, 2011
Hearing Testimony Phyllis Arthur Senior Director for Vaccines, Immunotherapeutics and Diagnostics Policy at the Biotechnology Industry Organization (BIO) On behalf of BIO before the House of Representatives Homeland Security Emergency...
April 13, 2011
Committee on Environment and Public Works United States Senate Oversight Hearing on Domestic Renewable Fuels: From Ethanol to Advanced Biofuels Written Testimony Submitted by  Brent Erickson Executive Vice President, Biotechnology...
April 13, 2011
Testimony of the Biotechnology Industry Organization (BIO) Hearing of the House Committee on Health, Education and Welfare April 13, 2011 Regarding Rhode Island House Bill 5629: "AN ACT AMENDING THE RHODE ISLAND FOOD, DRUGS, AND...
April 11, 2011
The Biotechnology Industry Organization ("BIO") is pleased to submit responses to question numbers 1,2, 4, 5, and 6 of the Senate Energy and Natural Resources Committee's March 21, 2011 Clean Energy Standard ("CES") White...
April 7, 2011
Re: Comments on Section 6002 of the Affordable Care Act Dear Sir or Madam: BIO appreciates the opportunity to comment on the implementation of the Physician Transparency and Reporting provisions enacted in 2010 as part of the Affordable Care...
April 7, 2011
Re: Docket No. FDA–2010–D–0643: Electronic Source Documentation in Clinical Investigations Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to...
April 7, 2011
Hearing Testimony Scott Koenig, M.D., PH.D. Before the House of Representatives Committee on Small Business Good morning Chairman Graves, Ranking Member Velázquez, Members of the Committee, ladies and gentleman. I am President and...
April 4, 2011
E mail - ImprovingRegulations.SuggestionBox@epa.gov RE: Docket ID No. EPA-HQ-OA-2011-0157 (Improving Regulations: Pesticides) and EPA-HQ-OA-2011-0156 (Improving Regulations: General), 76 Fed.Reg. 9988 (February 23, 2011); To whom it may...
April 1, 2011
Re: Request for Comments on the Strategy for American Innovation Subject: Innovation Strategy RFI Email: competitiveness@doc.gov Dear Mr. Connor: The Biotechnology Industry Organization (BIO) appreciates the opportunity to respond to this...
March 24, 2011
On behalf of the Biotechnology Industry Organization (BIO) and its more than 1,100 member companies, academic institutions, state biotechnology centers and related organizations in all 50 states, I am writing to express our strong support for H.R...