Letters, Testimony & Comments

Mon, 2016-02-08 14:50
Executive Summary:  The Biotechnology Innovation Organization (BIO) appreciates the opportunity to participate in the Special 301 process and is hopeful that our contribution will assist the United States Trade Representative’s (USTR)...
Mon, 2016-02-08 00:00
Dear Sir/Madam:   The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry and Review Staff entitled “Best Practices for...
Tue, 2016-01-26 14:59
Dear Sir/Madam:   The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide input on the U.S. Food and Drug Administration’s (FDA) draft guidance for industry on voluntary labeling of food derived from...
Tue, 2015-12-22 17:22
RE: CMS Regarding Implementation of the Merit-Based Incentive Payment System, Promotion of Alternative Payment Models, and Incentive Payments for Participation in Eligible Alternative Payment Models   Dear Acting Administrator Slavitt...
Tue, 2015-12-22 16:58
Captain Krista M. Pedley, PharmD, M.S., USPHS, Director Office of Pharmacy Affairs Health Resources and Services Administration Department of Health and Human Services 5600 Fishers Lane, Parklawn Building, Mail Stop 10C-03 Rockville,...
Tue, 2015-12-22 16:46
The Biotechnology Industry Organization (BIO) is pleased to submit feedback in response to the U.S. Department of Health and Human Services’ (HHS’s) Health Care Payment and Learning Action Network’s (HCP LAN) “Alternative...
Tue, 2015-12-22 16:37
Sylvia Mathews Burwell Secretary U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201   Andrew M. Slavitt Acting Administrator Centers for Medicare and Medicaid Services 7500...
Tue, 2015-12-22 16:23
Andrew Slavitt Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC 20201   Re: Medicaid...
Tue, 2015-12-22 16:21
Andrew Slavitt Acting Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200 Independence Avenue, SW Washington, DC 20201   RE: Data...
Tue, 2015-12-22 15:59
Marilyn Tavenner  Administrator Centers for Medicare & Medicaid Services  Department of Health and Human Services  Room 445-G  Hubert H. Humphrey Building 200 Independence Avenue, S.W.  Washington, D.C....
Tue, 2015-12-22 15:56
Sean Cavanaugh Deputy Administrator Director, Center for Medicare Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244 cc: Jennifer Wuggazer Lazio, F.S.A., M.A.A.A. Director Parts C & D Actuarial Group Office...
Tue, 2015-12-22 15:48
Andy Slavitt Acting Administrator Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, M.D. 22224 BY ELECTRONIC DELIVERY RE: CMS Regarding Implementation of the Merit-Based Incentive Payment System, Promotion of Alternative...
Tue, 2015-12-22 13:59
BIO Draft Comments in Response to the 2017 Star Ratings Update Request for Comments Note to Members: CMS requires that responses to individual proposed updates be submitted through an online form individually. Given these formatting requirements,...
Tue, 2015-12-22 13:53
Re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective payment System Policy Changes and Fiscal Year 2016 Rates; Revisions of Quality Reporting Requirements for...
Thu, 2015-12-17 16:39
Sylvia Mathews Burwell  Secretary U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201   BY ELECTRONIC DELIVERY   RE: Nondiscrimination in Health Programs and Activities [...
Thu, 2015-12-17 11:24
In view of the far reaching implications of the Federal Circuit’s decision for the nation’s patent system, The Biotechnology Industry Organization (“BIO”) and the Pharmaceutical Research and Manufacturers of ...
Tue, 2015-12-15 15:24
Dear Shri Aggarwal:   At the outset, the Biotechnology Industry Organization (BIO) greatly appreciates the opportunity to provide comments/suggestions of the stakeholders on the Draft Patents (Amendment) Rules 2015 published by the...
Wed, 2015-12-09 00:32
The Biotechnology Industry Organization (BIO) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS) Proposed Rule entitled Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System. In...
Tue, 2015-12-01 17:13
November 13, 2015 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Submitted Electronically via Federal eRulemaking Portal (http://www.regulations.gov) Re: Food and Drug...