Home » Advocacy » Letters, Testimony & Comments

Letters, Testimony & Comments

Sunshine: BIO submits comments to CMS on Physician Payment proposed rule
February 17, 2012
Centers for Medicare & Medicaid Services  Re:  Docket No. CMS-5060-P:  Proposed rule implementing Section 6002 of the Affordable Care Act (Pub. L. 111-148, as amended by Pub. L. 111-152)  Dear Sir or Madam:...
EPA Should Deny Petition to Waive Renewable Fuel Standard Obligations
February 16, 2012
The Honorable Lisa P. Jackson Administrator Environmental Protection Agency Ariel Rios Building 1200 Pennsylvania Avenue, N.W. Washington, DC 20460 Dear Administrator Jackson, On behalf of our advanced and cellulosic biofuel member...
2012 Special 301 Report: Biotech's International IP Issues
February 14, 2012
BIO has identified the following countries of interest and recommends the following for our 2011 Special 301 submission. Priority Foreign Country: BIO requests USTR to elevate Turkey to a Priority Foreign Country due to new alarming issues...
Marine Polymer Technologies v. Hemcon: BIO Amicus Brief
February 14, 2012
The Federal Circuit's majority panel decision in this case upsets the delicately balanced, congressionally created incentive system for reexamination.  It is inconsistent with the relevant statutes and imposes a rule that would create...
Alzheimer’s Disease: BIO's Comments on the Draft Framework for the National Plan to Address Alzheimer’s Disease
February 8, 2012
Re:    Draft Framework for the National Plan to Address Alzheimer's Disease Dear Ms. Glied:           The Biotechnology Industry Organization (BIO) is pleased to submit the following...
PDUFA V: Testimony to House Committee on Energy and Commerce, Subcommittee on Health
February 1, 2012
  Chairmen Upton and Pitts, and Ranking Members Waxman and Pallone, it is my privilege to provide testimony before this Subcommittee today. My name is Richard Pops and I am Chairman and CEO of Alkermes. I am here testifying on behalf of the...
Essential Health Benefit: BIO's Comments on the HHS Pre-rule Bulletin
January 31, 2012
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Department of Health and Human Services' (HHS) pre-rule bulletin on the essential health benefit (EHB) provisions of the Patient Protection and...
USPTO Satellite Offices: Biotechnology Hubs Ideal Place
January 30, 2012
  January 30, 2012 Azam Khan Deputy Chief of Staff, Office of the Under Secretary and Director United States Patent and Trademark Office, Alexandria, VA 22313   Re: Request for Comments on Additional USPTO Satellite...
BIO Comments on CMS Proposed Methodology for 2013 Star Ratings for Medicare Advantage and Prescription Drug Plans
January 20, 2012
Re: Request for Comments Regarding Enhancements to the Part C and Part D Plan Ratings The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) proposed...
Coverage with Evidence Development: BIO's Comments on the Centers for Medicare and Medicaid Services’ (CMS) public solicitation for comments on Coverage with Evidence Development (CED)
January 20, 2012
Re:      CED Public Solicitation Dear Dr. Jacques:             The Biotechnology Industry Organization (BIO) is pleased to submit the following response to the Centers...
Orphan Drugs: BIO Submits Comments on Orphan Drug Regulations
January 17, 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Proposed Rule: Orphan Drug Regulations.”  As an...
Bar Code Technologies: BIO Comments on FDA's Bar Code Technologies for Drugs and Biological Products; Retrospective Review under Executive Order 13563
January 9, 2012
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Retrospective Review under Executive Order...
Biologics: EMA Concept Paper on the Revision of the Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Active Substance: Non-clinical and Clinical Issues
December 31, 2011
The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on “Concept paper on the revision of the guideline on similar biological medicinal products containing...
Drug Shortages: BIO Comments on Center for Drug Evaluation and Research (CDER), Approach to Addressing Drug Shortage; Public Workshop; Request for Comments
December 23, 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Center for Drug Evaluation and Research (CDER), Approach to Addressing Drug Shortage; Public...
Biosimilar User Fees: BIO Testifies at Biosimilar User Fee Public Hearing
December 16, 2011
Dear Sir/Madam: On behalf of the Biotechnology Industry Organization, thank you for the opportunity to comment on the proposed user fee program for biosimilar and interchangeable biological product applications (BsUFA).  BIO supports FDA...
Glyphosate Tolerant H7-1 Sugar Beets Request: Environmental Impact
December 13, 2011
These comments are submitted by the Biotechnology Industry Organization (BIO) in response to the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS or the Agency) Draft Environmental Impact...
China Compulsory License Proposed Provisions Draw Reaction from BIO
December 9, 2011
By Electronic Submission To the State Intellectual Property Office, The Biotechnology Industry Organization (BIO) appreciates this opportunity to provide comments to the State Intellectual Property Office (SIPO) of the People’s Republic...
Transparency Initiative:Draft Proposals for Public Comment to Increase Transparency By Promoting Greater Access to the Agency’s Compliance and Enforcement Data
December 2, 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Proposal for Public Comment to Increase Transparency By Promoting Greater...
BIO Written Testimony: Spurring Job Growth Through Capital Formation While Protecting Investors
December 1, 2011
On December 1, BIO submitted written testimony to the Senate Committee on Banking, Housing, and Urban Affairs on the importance of implementing policies that will spur job growth through capital formation while protecting investors.  
Risk-Based Monitoring: BIO Comments on Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring
November 28, 2011
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach to...