Letters, Testimony & Comments

Mon, 2013-09-16 12:05
September 6, 2013   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence...
Sun, 2013-09-15 23:00
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments in response to its 2-day public meeting “Standardizing and Evaluating Risk Evaluation and...
Thu, 2013-09-12 23:00
GENERAL COMMENTS:   A. Comprehensive Approach to Pediatric Drug Development   BIO strongly supports a comprehensive approach to pediatric drug development crafted in the best interests of children and greatly appreciates recent...
Thu, 2013-09-12 23:00
Dear Sir/Madam: 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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying,...
Thu, 2013-09-12 23:00
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the proposed rule “Administrative Detention of Drugs Intended for Human or Animal Use....
Sun, 2013-08-25 23:00
Dear Sir/Madam:   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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Expedited Programs for Serious Conditions—...
Sun, 2013-08-18 23:00
  BIO is concerned that the panel decision could have a number of unintended consequences, such as incentivizing defendants (or declaratory judgment plaintiffs) to employ dilatory tactics in the federal courts while re-arguing already-...
Fri, 2013-08-16 12:33
  March 15, 2013 Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201 Re:...
Sun, 2013-08-04 23:00
Re: Docket No. FDA–2013–N–0271: Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request for Comments   Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the...
Fri, 2013-08-02 15:19
Joe V. Selby, M.D., M.P.H. Executive Director Patient-Centered Outcomes Research Institute 1701 Pennsylvania Ave. NW Suite 300 Washington, DC 20006   RE: Patient-Centered Outcomes Research Institute’s (PCORI’s)...
Fri, 2013-08-02 14:59
Louis Jacques, M.D. Director, Coverage and Analysis Group Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, MD 21244   RE: Proposed Decision Memorandum on National Coverage Analysis (NCA) for Beta-...
Tue, 2013-07-30 11:50
July 25, 2013 The Honorable Max Baucus, Chairman U.S. Senate Committee on Finance 219 Dirksen Senate Office Building Washington, D.C. 20510   The Honorable Orrin G. Hatch, Ranking Member U.S. Senate Committee on Finance...
Sun, 2013-07-28 23:00
Dear Sir/Madam: 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 Contract Manufacturing Agreements: Quality Agreements...
Thu, 2013-07-25 11:50
Re: Docket No. FDA–2013–N–050: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Request for Comments   Dear Sir/Madam:   The Biotechnology Industry Organization (...
Tue, 2013-07-23 15:56
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the "Notification of Comment Period- 2013 Gapfill Payment Amounts Clinical Laboratory Fee Schedule (CLFS)" published by the Centers for...
Thu, 2013-07-18 14:28
July 18, 2013 The Honorable Max Baucus                                  ...
Thu, 2013-07-18 12:48
July 15, 2013 Air and Radiation Docket and Information Center Docket ID No. EPA-HQ-OAR-2012-0401 U.S. Environmental Protection Agency Mailcode: 6406J 1200 Pennsylvania Avenue, NW Washington, DC 20460 Via email at A-and-R-Docket@...
Thu, 2013-07-18 12:33
July 1, 2013 Air and Radiation Docket and Information Center U.S. Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460 Via email at A-and-R-Docket@epamail.epa.gov Docket ID No. EPA-HQ-OAR-...
Thu, 2013-07-18 12:05
July 17, 2013 Docket No. APHIS-2013-0042 Docket No. APHIS-2013-0043 Regulatory Analysis and Development PPD, APHIS, Station 3A-03.8 4700 River Road Unit 118 Riverdale, MD 20737-1238 Re: Notice of Intent to Prepare an Environmental Impact...