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Letters, Testimony & Comments

BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.

Featured Letters, Testimony, & Comments
CSBA Letter to Congressional Leadership…
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John F. Crowley, President and CEO of the…
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
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CSBA Letter to Congressional Leadership on Most…
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BIO Comments to USDA’s Office of Budget and Program Analysis on Identifying Regulatory Reform Initiatives, September 15, 2017
September 21, 2017
United States Department of Agriculture Jamie L. Whitten Building, Room 101-A 1400 Independence Ave SW Washington DC 20250 Re: Identifying Regulatory Reform Initiatives Dear Ms. Adcock: The Biotechnology Innovation Organization (BIO) is pleased…
BIO Submits Comments Re: Medicare CY 2018 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Part B
September 20, 2017
BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS) proposed rule regarding the calendar year (CY) 2018 Physician Fee Schedule (PFS), other revisions to Part B, and Medicare Shared Savings Program (MSSP). BIO…
BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule
September 20, 2017
BIO submitted comments on the Centers for Medicare and Medicaid Services’ (CMS’s) Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Proposed Rule for calendar year (CY) 2018 (the …
SB 539 complaint
September 1, 2017
DSCSA: BIO Files Comments on FDA Product Identifier Compliance Policy
September 1, 2017
Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to FDA’s Draft Guidance entitled Product Identifier Requirements Under the Drug Supply Chain Security…
BIO Submits Comments to EPA on the Renewable Fuel Standards for 2018 and Biomass-Based Diesel Volume for 2019
August 31, 2017
BIO requests that EPA revise its proposed 2018 RFS rule to build upon the successes of the 2017 RFS and send a signal that there will be market growth for advanced and cellulosic biofuels. The proposed rule in its current form puts at risk industry…
BIO comments to USD-AMS on the National Bioengineered Food Disclosure Law (RE: Questions Under Consideration)
August 25, 2017
August 25, 2017Mr. Bruce SummersActing AdministratorAgricultural Marketing ServiceUnited States Department of Agriculture1400 Independence Avenue, SWRoom 3069 South BuildingWashington, DC 20250Submitted via GMOlabeling@ams.usda.govRE: Proposed Rule…
BIO Submits Comments Re: Medicare CY 2018 Updates to the Quality Payment Program
August 23, 2017
BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS's) CY 2018 Updates to the Quality Payment Program Proposed Rule. BIO supports the development and implementation of the Quality Payment Program (QPP) tracks:…
BIO Submits Comments Re: Hospital Inpatient Prospective Payment Systems (IPPS) Proposed Rule
August 8, 2017
BIO submitted comments in response to 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 Proposed Policy Changes…
BIO's 2017 Special 301 Submission
July 31, 2017
BIO submitted a report to the United States Trade Representative regarding the agency’s 2017 Special 301 Review.