Amicus Briefs

By Electronic Submission Ip.policy@uspto.gov Office of Policy and External Affairs United States Patent and Trademark Office Alexandria, VA 22313-1450               Re: Request for Comments on Intellectual Property Enforcement in China             Attn: Elizabeth Shaw
BEFORE THE CLEAN AIR ASSOCIATION OF THE NORTHEAST STATES   Comments of Biotechnology Industry Organization on Economic Analysis to Implement the Clean Fuel Standard    
  Dear Dr. Menikoff:     The Biotechnology Industry Organization (BIO) thanks the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) for the opportunity to submit comments on the Advanced Notice of Proposed Rulemaking (ANPRM) on "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators," published in The Federal Register on July 26, 2011. 
October 25, 2011 Secretary Kathleen Sebelius U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 Dear Secretary Sebelius:  We are writing to urge you to fully implement Section 1128G of the Social Security Act, the Physician Payments Sunshine Provision, which was added as Section 6002 of the Patient Protection and Affordable Care Act (PPACA). 
Thank you for the opportunity to present comments on behalf of the innovative biotechnology industry which is working to prevent, treat, and cure diseases through the most advanced science. My comments today focus on the affordability and access of prescription drugs as part of the Essential Health Benefits (EHB) package.
October 25, 2011 Secretary Kathleen Sebelius U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 Dear Secretary Sebelius:  We are writing to urge you to fully implement Section 1128G of the Social Security Act, the Physician Payments Sunshine Provision, which was added as Section 6002 of the Patient Protection and Affordable Care Act (PPACA). 
  On behalf of the Biotechnology Industry Organization, I thank you for the opportunity to comment on the reauthorization of the Prescription Drug User Fee Act (PDUFA).  BIO supports the PDUFA V recommendations as they will enhance the drug development and review process through increased transparency and scientific dialogue, advance regulatory science, and strengthen post-market surveillance.  Most importantly, PDUFA V will provide patients and doctors with earlier access to breakthrough therapies.
  Biotechnology Industry Organization   Comments to the California Air Resources Board   On the Harmonization Chapter   October 21, 2011