Home » Advocacy » Letters, Testimony & Comments

Letters, Testimony & Comments

Comments of Biotechnology Industry Organization on Proposed Regulations to Implement the Low Carbon Fuel Standard
October 4, 2011
BEFORE THE CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY AIR RESOURCES BOARD   Comments of Biotechnology Industry Organization on Proposed Regulations to Implement the Low Carbon Fuel Standard     BIO is the world...
Affordable Care Act: BIO Comments on Coverage of Preventive Services by Group Health Plans and Health Insurance Issuers
September 30, 2011
  Re:  Group Health Plans and Health Insurance Issuers Relating to Coverage of Preventive Services under the Patient Protection and Affordable Care Act; Interim Final Rules [CMS-9992-IFC2]   The Biotechnology Industry...
CDER Science & Research Needs: BIO Comments on CDER Draft Report
September 26, 2011
  Re: Docket No. FDA-2011-D-0239: Identifying the Center for Drug Evaluation and Research’s Science and Research Needs Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for...
Sterility Testing: BIO's Comments on Amendments to Sterility Test Requirements for Biological Products
September 19, 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Amendments to Sterility Test Requirements for Biological Products.”  BIO supports...
Testimony in Support of Economic Development and Jobs for the Michigan Bioscience Industry
September 13, 2011
Economic Development and Jobs for the Michigan Bioscience Industry Michigan House and Senate Standings Committee on the Biosciences Peter M. Pellerito, Interim Vice President Biotechnology Industry Organization, Washington, DC Tuesday,...
BIO Comments on CARB Draft Chapter on Environmental Impacts
September 12, 2011
BEFORE THE CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY AIR RESOURCES BOARD DRAFT CHAPTER ON ENVIRONMENTAL IMPACTS COMMENTS OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION SEPTEMBER 12, 2011 The Biotechnology Industry Organization (BIO) is...
BIO Comments on CARB Draft Chapter on Environmental Impacts
September 12, 2011
BEFORE THE CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY AIR RESOURCES BOARD DRAFT CHAPTER ON ENVIRONMENTAL IMPACTS COMMENTS OF THE BIOTECHNOLOGY INDUSTRY ORGANIZATION SEPTEMBER 12, 2011 The Biotechnology Industry Organization (BIO) is...
BIO's Comments on PCOR Definition
September 2, 2011
RE:      Comments on Proposed Definition of PCORI  1.   Does the definition place appropriate emphasis on, and convey the importance of, the “patient-centeredness” of the PCORI mission? Yes...
BIO Comments on FDA Draft Guidance: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only
September 1, 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration’s (“FDA’s”) draft guidance document entitled Commercially Distributed In Vitro...
ICH Q11: BIO Comments on International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances
September 1, 2011
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “International Conference on Harmonisation (ICH); Draft Guidance on Q11 Development and Manufacture of...
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for Calendar Year 2012; Proposed Rule
August 30, 2011
Comments to the CY 2012 Outpatient Prospective Payment System (OPPS) Proposed Rule
August 30, 2011
Nanotechnology: BIO's Comments on Draft Guidance for Industry on Principles for Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
August 15, 2011
Re: Docket No. FDA-2010-D-0530:  Draft Guidance for Industry on Principles for Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks...
BIO Comments at August Meeting of the National Advisory Council Subcommittee Identifying Quality Measures for Medicaid Eligible Adults
August 9, 2011
The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the core set of health quality measures for the Medicaid Quality Measurement Program created by the Affordable Care Act (ACA). BIO supports the development and...
Comments of Biotechnology Industry Organization on DRAFT LCFS Sustainability Principles, Criteria, Indicators Principles 4, 5, 6, 7
August 5, 2011
BEFORE THE CALIFORNIAENVIRONMENTAL PROTECTION AGENCY AIR RESOURCES BOARD     Comments of Biotechnology Industry Organization on     DRAFT LCFS Sustainability Principles, Criteria, Indicators Principles 4, 5, 6...
Comments of Biotechnology Industry Organization on DRAFT LCFS Sustainability Principles, Criteria, Indicators Principles 4, 5, 6, 7
August 5, 2011
BEFORE THE CALIFORNIAENVIRONMENTAL PROTECTION AGENCY AIR RESOURCES BOARD     Comments of Biotechnology Industry Organization on     DRAFT LCFS Sustainability Principles, Criteria, Indicators Principles 4, 5, 6...
Animal Biotechnology: Letter in Support of a Science-Based Review Process at FDA
August 2, 2011
Dear Senators Reid and McConnell and Representatives Boehner and Pelosi: We are deeply concerned about recent action in the U.S. House of Representatives to amend H.R. 2112, the Fiscal Year 2012 Agriculture, Rural Development, Food and Drug...
Medicare Coverage Gap Discount Program: BIO’s Comments on CMS’s Memorandum on Proposed Changes to the Medicare Coverage Gap Discount Program – Low-Volume Claims and Clarifications
August 1, 2011
RE:     June 29, 2011 Memorandum on Proposed Changes to the Medicare Coverage Gap Discount Program – Low-Volume Claims and Clarifications The Biotechnology Industry Organization (BIO) appreciates this opportunity to...
BIO Comments on a Prospective Standard to Mitigate the Risk of Occupational Exposure to Infectious Agents in Healthcare and Healthcare-related Settings
July 29, 2011
  BIO fully supports the creation of an infectious disease standard by the Occupational Safety and Health Administration (OSHA) to protect healthcare workers (HCWs), and BIO believes that vaccinations should be an integral part of this...
Testimony in Support of USDA Research
July 28, 2011
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. BIO members are involved in the...