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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
ohn’s One-Year Anniversary Letter to BIO…
Dear Colleagues,This month marks my one-year anniversary as BIO’s CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
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BIO Comments on Office of Management and Budget …
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request forComments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
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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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BIO Statement: BIO Urges FDA Release of Risk Assessment on Animal Cloning
March 10, 2016
Letter to the dairy industry urging support for the U.S. Food and Drug Administration's release of the final risk assessment on animal cloning.
Cloning Recommendation before the National Organic Standards Board
March 10, 2016
Livestock clones and their progeny can be raised in accordance with the Organic Foods Production Act (OFPA), specifically 7 USC §6502 Definitions, §6504 National standards for organic production, and §6509 Animal production practices and materials.
China's Compliance with WTO Commitments
March 10, 2016
Comments concerning China's compliance with WTO commitments.
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.
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: 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…
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.
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.
Biodefense: 2009 National Strategy for Countering Biological Threats
March 10, 2016
White House National Security Council - November 2009 National Strategy for Countering Biological Threats
Biodefense: 2010 National Security Strategy
March 10, 2016
May 2010 National Security Strategy from the White House