Letters, Testimony & Comments

Thu, 2016-04-21 12:04
We share the Department’s goals of improving population health, improving individual health outcomes, and rewarding high value care delivery. While the goals of the DSRIP program focus more specifically on decreasing unnecessary...
Sun, 2016-04-17 23:00
Dear Dr. Taichman:   The Biotechnology Innovation Organization (BIO) is pleased to offer the following comments on Sharing Clinical Trial Data: A proposal from the International Committee of Medical Journal Editors (“ICMJE...
Tue, 2016-04-05 11:34
Dear Chairman Upton and Ranking Member Pitts:   We are writing to you on behalf of the Biotechnology Innovation Organization (BIO) in response to your letter dated February 5, 2015, requesting feedback related to the enactment of...
Tue, 2016-04-05 11:31
Dear Ms. Kemp:   The Biotechnology Innovation Organization (BIO) appreciates the opportunity to submit comments to the Health Services Cost Review Commission (HSCRC) in response to its proposal to amend Regulation .07-1 under COMAR 10...
Tue, 2016-04-05 11:28
Dear Ms. Drew:   The Biotechnology Innovation Organization (BIO) appreciates the opportunity to respond to the solicitation for proposals and recommendations for developing new, and modifying existing, safe harbor provisions under the...
Tue, 2016-04-05 11:23
Dear Captain Pedley:   The Biotechnology Innovation Organization (BIO) appreciates the opportunity to submit the following comments in response to the proposed Information Collection Request (ICR), issued by the Health Resources and...
Tue, 2016-04-05 11:18
Dear Acting Administrator Slavitt:   The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments regarding the Centers for Medicare and Medicaid Services (CMS) Episode Groups Request for Comment (the...
Tue, 2016-04-05 11:10
Dear Mr. Cavanaugh:   The Biotechnology Innovation Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) draft 2017 Call Letter.1 BIO is the world's largest...
Tue, 2016-04-05 11:03
Dear Acting Administrator Slavitt:   The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments in response to the CMS Quality Strategy 2016 (the “2016 Strategy”).1 BIO is the world's...
Tue, 2016-04-05 10:57
Dear Dr. Goodrich:   The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments in response to the CMS Quality Measure Development Plan: Supporting the Transition to the Merit-based Incentive Payment...
Tue, 2016-04-05 10:52
Ranking Member Wyden and Senator Grassley:   The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments regarding Ranking Member Wyden’s and Senator Grassley’s January 21 Letter to the Health...
Tue, 2016-04-05 10:23
Dear Majority Leader McConnell, Minority Leader Reid, Speaker Ryan, Minority Leader Pelosi, Chairman Hatch, Ranking Member Wyden, Chairman Brady, Ranking Member Levin: Thank you for your leadership in extending a suite of critical advanced biofuels...
Mon, 2016-04-04 15:43
The Biotechnology Innovation Organization (BIO) is pleased to submit comments in response to the Centers for Medicare & Medicaid Services’ (CMS’s) Final Rule with Comment entitled Medicaid Program; Covered Outpatient Drugs Final Rule...
Sun, 2016-03-13 23:00
Dear Sir/Madam:   The Biotechnology Innovation Organization (BIO) applauds the Food and Drug Administration’s (FDA’s) efforts to compile and provide information to the public regarding Clinical Outcome Assessments (COAs) that...
Thu, 2016-03-03 16:50
Modern pharmaceutical and biotechnology products typically require lengthy, costly, and resource-intensive development periods before they reach the marketplace. BIO members devote many years and millions of dollars in direct ...
Wed, 2016-03-02 13:42
The questions presented in this case implicate two of the foundational legal conclusions that have allowed the PTAB, even in a relatively short time, to cut a remarkable swath through the ranks of issued patents with barely a...
Thu, 2016-02-18 17:11
February 18, 2016 Regulatory Analysis and Development PPD, APHIS, Station 3A-03.8 4700 River Road Unit 118 Riverdale, MD 20737-1238 Submitted Electronically via Federal eRulemaking Portal (http://www.regulations.gov) Re: Docket No. APHIS-2014-...
Tue, 2016-02-16 16:56
BIO as Amicus Curiae supporting en banc reconsideration in Prolitec, Inc. v. ScentAir Technologies, Inc. (US Court of Appeals for the Federal Circuit)   STATEMENT OF INTEREST OF AMICUS CURIAE The Biotechnology Innovation Organization (...
Tue, 2016-02-16 16:45
Brief of Amicus Curiae Biotechnology Innovation Organization in Support of Plaintiffs-Appellees in Amgen Inc. v. Apotex Inc. (U.S. Court of Appeals for the Federal Circuit) INTEREST OF AMICUS CURIAE   The Biotechnology Innovation...