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BIO submits comments on FDA’s Draft Guidance for Industry: Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biologicals Products

Aug 26 2014
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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices (Draft Guidance).

BIO Submits Comments to the EPA on the Agency's Extension of Compliance and Attest Engagement Reporting Deadlines for 2013 RFS

Aug 15 2014
The Biotechnology Industry Organization (BIO) is pleased to have the opportunity today to provide non-adverse comment on the U.S. Environmental Protection Agency’s (EPA) proposed rule: Regulation of Fuels and Fuel Additives: Extension of Compliance and Attest Engagement Reporting Deadlines for 2013 Renewable Fuel Standards1 (hereinafter “proposed rule”).

BIO Submits Comments on Clinical Pharmacology Data to Support Biosimilarity

Aug 11 2014
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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”

BIO Submits Comments to CMS Regarding its Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed FY 2015 Rates Proposed Rule

Aug 8 2014
June 30, 2014   BY ELECTRONIC DELIVERY   The Honorable Marilyn B. Tavenner Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC 20201   Re:  Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2015 Rates; Quality Reporting Requirements for Specific Providers; Reasonable Compensation Equivalents for Physician Services in Excluded Teaching Hospitals; Provider Administrative Appeals and Judicial Review; Enforcement Provisions for Organ Transplant Centers; and Electronic Health Record (EHR) Incentive Program; Proposed Rule [CMS-1607-P]   Dear Administrator Tavenner:   The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2015 Rates Proposed Rule (“the Proposed Rule”), specifically with respect to the Hospital Inpatient Quality Reporting (IQR) Program and the Hospital Value-Based Purchasing (VBP) Program.[1]  BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations.  BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.  [1] 79 Fed. Reg. 27,978 (May 15, 2014).  

BIO Submits Comments on Identification of Suspect Product and Notification

Aug 7 2014
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 the Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.”

Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products

Aug 6 2014
The undersigned national and regional biotechnology industry associations appreciate this opportunity to comment on the USPTO’s March 4 guidance for the determination of subject matter eligibility of claims relating to products and processes derived from natural sources or materials (the “Guidance”). We write to express our concern over the recent judicial and administrative expansion of nonstatutory patent law governing the patent-eligibility of certain classes of biotechnology inventions in the United States, as manifested in the PTO’s March 4 Guidance.

BIO Submits Comments to the Center for Consumer Information and Insurance Oversight Regarding the Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market

Jul 31 2014
    July 17, 2014   BY ELECTRONIC DELIVERY   Mandy Cohen, M.D., MPH Acting Director, Center for Consumer Information and Insurance Oversight Centers for Medicare and Medicaid Services Department of Health and Human Services 200 Independence Avenue SW Washington, DC 20201   Re: Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market   Dear Dr. Cohen:   The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the notices issued by the Center for Consumer Information and Insurance Oversight (CCIIO) on June 26, 2014, entitled “Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market (the ‘Draft Standard Notices’).”[1]   BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO's members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, including productivity and quality of life, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.[2] [1] Center for Consumer Information and Insurance Oversight (CCIIO), Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services (HHS), Insurance Standards Bulletin Series: Draft Standard Notices When Discontinuing or Renewing a Product in the Small Group or Individual Market (2014). [2] See, e.g., Congressional Budget Office, Offsetting Effects of Prescription Drug Use on Medicare’s Spending for Medical Services (Nov. 2012).  

BIO Submits Comments on FDA's Strategic Plan, 2014-2018

Jul 30 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “The Food and Drug Administration Fiscal Year 2014-2018 Strategic Priorities.”

BIO Submits Comments on Proprietary Naming

Jul 27 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA, the Agency) for the opportunity to submit comments on the Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs.

BIO Submits Comments on Expedited Access for PMAs Intended for Unmet Medical Needs

Jul 21 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions; Draft Guidance for Industry and Food and Drug Administration Staff.”