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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
BIO Letter to HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
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CSBA Letter to Congressional Leadership on…
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BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
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BIO's Letter to the Senate Committee on Judiciary Regarding Deficiencies at the USPTO
October 12, 2017
BIO President and CEO James C. Greenwood details deficiencies at the USPTO that are undermining longstanding and carefully-balanced procedures governing market entry and patent dispute resolution under the highly successful Hatch…
BIO Comments on FDA Draft Guidance on CMC Postapproval Manufacturing Changes for Specified Biological Products
October 10, 2017
BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports. BIO appreciates the…
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 [email protected]: 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:…