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BIO Comments on FDA Draft Guidance: Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only

Sep 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(BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration’s (“FDA’s”) draft guidance document entitled Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions (“the Draft Guidance”).

Comments to the CY 2012 Outpatient Prospective Payment System (OPPS) Proposed Rule

Aug 30 2011

Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for Calendar Year 2012; Proposed Rule

Aug 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Nanotechnology: BIO's Comments on Draft Guidance for Industry on Principles for Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

Aug 15 2011

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BIO Comments at August Meeting of the National Advisory Council Subcommittee Identifying Quality Measures for Medicaid Eligible Adults

Aug 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 use of appropriate, evidence-based quality measures throughout the healthcare system, and we feel that adult immunizations should be included in the Medicaid core quality measures. Creating comprehensive quality measures for adult immunizations will help ensure that healthcare providers routinely discuss and offer vaccines to their patients, resulting in higher vaccine uptake among adults, better health outcomes, and cost savings for the Medicaid program. BIO recommends that CMS, AHRQ, and the Subcommittee conduct a rigorous gap analysis to assess areas where ACIP recommendations exist but quality measures do not. New adult immunization quality measures should then be elevated to the highest priority for development, testing, and validation, as immunizations have a proven history of providing quality outcomes.

Comments of Biotechnology Industry Organization on DRAFT LCFS Sustainability Principles, Criteria, Indicators Principles 4, 5, 6, 7

Aug 5 2011
Comments on the DRAFT document by California Air Resources Board’s (CARB) Low Carbon Fuel Standard (LCFS) Sustainability Working Group on LCFS Sustainability Principles, Criteria, Indicators for Principles 4, 5, 6, and 7 (Draft Sustainability Principles).

Comments of Biotechnology Industry Organization on DRAFT LCFS Sustainability Principles, Criteria, Indicators Principles 4, 5, 6, 7

Aug 5 2011
Comments on the DRAFT document by California Air Resources Board’s (CARB) Low Carbon Fuel Standard (LCFS) Sustainability Working Group on LCFS Sustainability Principles, Criteria, Indicators for Principles 4, 5, 6, and 7 (Draft Sustainability Principles).

Animal Biotechnology: Letter in Support of a Science-Based Review Process at FDA

Aug 2 2011
In this letter to Congress, the members of the Animal Agriculture Coalition urge members not to disrupt funding for the FDA's review of genetically enhanced salmon.

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

Aug 1 2011
The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) memorandum regarding proposed changes to the Medicare Coverage Gap Discount Program Agreement relating to low volume claims (Low-Volume Memorandum).

BIO Comments on a Prospective Standard to Mitigate the Risk of Occupational Exposure to Infectious Agents in Healthcare and Healthcare-related Settings

Jul 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 standard. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) strongly recommends that HCWs receive vaccinations against the following diseases: hepatitis B, influenza, measles-mumps-rubella, varicella, and tetanus-diphtheria-pertussis. An OSHA standard that requires employers to make ACIP-recommended vaccines available to HCWs has the potential to impact worker safety significantly by increasing vaccination coverage.