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Letters, Testimony & Comments

Letter to Puerto Rico Governor Fortuño Regarding Tax on Foreign Corporations
October 24, 2010
Dear Governor Fortuño: In what is currently one of the worst economic recessions to be experienced in our lifetime, the life sciences industry, and the biotechnology sector in particular, is defying all odds – Biotechnology companies...
Advanced Biofuels: White House Meets with Industry Leaders
October 21, 2010
Dear President Obama: On behalf of the Biotechnology Industry Organization (BIO), Advanced Biofuels Association (ABFA), Algal Biomass Organization (ABO) and our over 100 advanced biofuels, renewable chemicals and biobased product member...
Sustainable Agriculture: Setting Sustainable Agriculture Standards
October 18, 2010
Dear Mr. Arny: U.S. farmers are concerned about the long-term sustainability of their farms and their place in society. For this reason, farmers will embrace an achievable roadmap for the environmental, social and economic aspects of...
Biological Diversity: Draft Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity
October 14, 2010
October 14, 2010 To: Members of the Ad Hoc Open-ended Working Group on Access and Benefit-sharing of the Convention on Biological Diversity Cc: Convention on Biological Diversity Secretariat From: The Heads of Biotechnology...
Low Level Presence
October 14, 2010
District Court Ruling Exposes Biotechnology to Unprecedented Tort Liability. BIO disputes the District Court Ruling that exposes biotechnology companies to unprecedented tort liability for the development and sale of biotechnology products that are...
Letter to Ms. Cindy Smith, USDA APHIS Regarding BRS Notification Planting Reports
October 6, 2010
Dear Ms. Smith: Thank you for taking the time to meet with BIO members on September 8. The information that you and Mike Gregoire provided was very informative. As we mentioned to you and Mike at that meeting, BIO's member companies are...
USTR’s Annual Report on Sanitary and Phytosanitary (SPS)
October 4, 2010
Dear Ms. Blue: This letter is submitted by the Biotechnology Industry Organization (BIO) in response to the request for public comments regarding USTR’s annual Report on Sanitary and Phytosanitary (SPS) Measures. BIO represents more than 1...
Stewardship: Actions to be Taken Prior to Launching Special Traits
October 4, 2010
      Product Launch Stewardship Introduction Through its advocacy efforts, BIO’s Food and Agriculture Section supports a regulatory framework that facilitates and enables the development and commercialization of...
Stewardship: Actions to be Taken Prior to Launching Special Traits
October 4, 2010
Dear Secretary Vilsack: For the past 15 years, agricultural products derived from modern biotechnology have provided significant agronomic benefits to America's farmers. From increased yields, to reducing the impact of agriculture on the...
Pandemic Influenza: Vaccine production and additional planning for future possible pandemic influenza
October 1, 2010
Comments to the International Trade Administration: Vaccine production and additional planning for future possible pandemic influenza Dear Mrs. Earley, The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment the...
Synthetic Biology: Proposals for Regulating Industry Uses of New Biotechnologies
October 1, 2010
The Biotechnology Industry Organization (BIO) is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,100 members worldwide. Our mission is to be the champion of...
IRS: Implementation of Biopharmaceuticals Manufacturers Fee
September 30, 2010
Dear Ms. Maloy, As President and CEO of the Biotechnology Industry Organization (BIO) and on behalf of our more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S....
Intellectual Property: Compulsory Licenses Published by the Department of Industrial Policy and Promotion within India's Ministry of Commerce and Industry
September 29, 2010
The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide comments on India’s Department of Industrial Policy and Promotion’s (DIPP) discussion paper on compulsory licenses published on August 24, 2010....
FDA: Chemistry, Manufacturing, and Controls (CMC) Reporting
September 23, 2010
Re: Docket No. FDA-2010-D-0283: Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes Reportable in Annual Reports; Availability Dear Sir/Madam: The Biotechnology Industry Organization (BIO)...
Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals
September 23, 2010
Re: Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals [DoD-2008-HA- 0029; 0720-AB22] Dear Captain Blanche: The Biotechnology...
Genetically Engineered Salmon: FDA, VMAC Advisory Committee Meeting
September 20, 2010
Members of the Veterinary Medical Advisory Committee, My name is Dr. David Edwards, and I am the Director of Animal Biotechnology for the Biotechnology Industry Organization (BIO). We represent 1,100 member organizations that research, develop...
DOE: Loan Guarantee Program for Advanced Biofuels, Renewable Chemicals
September 20, 2010
Dear President Obama: We are writing to ask for your support to provide additional guidance to the Department of Energy’s (DOE) Loan Guarantee Program (LGP) to unlock funding for advanced biofuels, biochemicals and bioproducts projects....
HHS: Interim Final Rules for Health Plans as They Relate to Vaccine Coverage Under the Patient Protection and Affordable Care Act
September 17, 2010
Re: Interim Final Rules for Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act Please Refer to OCIIO-9992-IFC Dear Mr. Mayhew: The Biotechnology...
Intellectual Property: BIO’s Amicus Brief in the Sun Pharmaceuticals v. Eli Lilly Case
September 8, 2010
BIO urges the Court of Appeals for the Federal Circuit to exclude the disclosure of the patent specification to support a finding of double-patenting.
FDA: Investigational New Drug Applications; Co-Development of Investigational New Drugs
September 7, 2010
BIO suggests the proposed guidance address dose finding, additive or synergistic efficacy, additive or synergistic safety, drug interactions, special populations, unique toxicities, and study design.