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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 Letter to Agriculture Secretary Mike Johanns
March 10, 2016
BIO urges support from the U.S. Department of Agriculture for FDA’s release of the final risk assessment on animal cloning.
Federal Register Notice of 2010 TIP Competition: NIST issues notice of 2010 TIP competition
March 10, 2016
NIST includes biomanufacturing as an area of "critical national need" for 2010 TIP competition.
Promoting Health and Preventing Disease: Childhood and Adult Vaccine Updates and Recommendations
March 10, 2016
Centers for Disease Control & Prevention, Clinician Outreach and Community Activity (COCA) Conference Call July 27, 2010.
Biodefense: 2010 National Security Strategy
March 10, 2016
May 2010 National Security Strategy from the White House
Amendment to Federal Register Notice: NIST issues amendments 2010 TIP competition
March 10, 2016
NIST clarifies that device development is not a focus of 2010 TIP competition.
Vaccines: 2008 Draft Strategic National Vaccine Plan
March 10, 2016
The National Vaccine Program was established in 1986 to achieve optimal prevention of infectious diseases through immunization and optimal prevention of adverse reactions to vaccines.
Agriculture and Weed Resistance
March 10, 2016
The environmental challenges of weed resistance are the same for biotech crops and conventional crops if farmers do not use herbicides as directed. Learn more about stewardship practices that help farmers better control weeds and how biotechnology…
Vaccines: 2009-H1N1 Influenza NVAC Vaccination Program Financing
March 10, 2016
This Report contains NVAC recommendations based on the Working Group’s findings and conclusions, and includes recommendations developed by the NVAC Adolescent Working Group. It takes into account public comments and extensive stakeholder input…
Biodefense: 2009 National Strategy for Countering Biological Threats
March 10, 2016
White House National Security Council - November 2009 National Strategy for Countering Biological Threats
Sarbanes Oxley 404(b) recommendations made by the 2009 Government-Business Forum on Small Business Capital Formation
March 10, 2016
The 2009 Government-Business Forum on Small Business Capital Formation recommended a permanent exemption for small companies from Section 404(b) of Sarbanes-Oxley. Additionally, they recommended that the SEC increase the public float threshold for…