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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 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.
BIO Submits Comments on Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II
July 27, 2017
BIO submitted comments to the Food and Drug Administration (FDA) on the statement of work for assessment of the Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee…
BIO comments to FDA Regarding the Regulation of Intentionally Altered Genomic DNA in Animals
June 20, 2017
BIO appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its request for comments on the draft guidance for industry (GFI) #187, entitled Regulation of Intentionally Altered Genomic DNA in Animals2…
BIO Comments to FDA on Genome Editing in New Plant Varieties Used for Foods
June 19, 2017
BIO appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its request for comments on genome editing in plants.
BIO Comments to USDA on its 340 Biotech Rules
June 19, 2017
BIO is pleased to submit these comments in response to the USDA Animal and Plant Health Inspection Service’s (APHIS’) request for public input on the proposed revisions to its biotechnology regulations in 7 CFR Part 340.
BIO IES: Advanced Biofuel RVP EPW Letter 170612
June 12, 2017
On behalf of the advanced and cellulosic biofuel industry and our respective companies and organizations, we are writing to ask for your support for the Consumer and Fuel Retailer Choice Act (S. 517), which is scheduled to be marked up in the…
BIO IES: Advanced Biofuel RVP EPW letter 170612
June 12, 2017
On behalf of the advanced and cellulosic biofuel industry and our respective companies and organizations, we are writing to ask for your support for the Consumer and Fuel Retailer Choice Act (S. 517), which is scheduled to be marked up in the…
Advanced Biofuel RVP EPW letter 170612
June 12, 2017
On behalf of the advanced and cellulosic biofuel industry and our respective companies and organizations, we are writing to ask for your support for the Consumer and Fuel Retailer Choice Act (S. 517), which is scheduled to be marked up in the…
US Biotech Alliance Sends Letter to USTR on Modernizing NAFTA
June 12, 2017
The U.S. Biotech Crops Alliance appreciates the opportunity to provide comments in response to USTR’s Request for Comments on negotiating objectives regarding modernization of the North American Free Trade Agreement with Canada and Mexico (82 FR…