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Clean Energy: Biomass Should Qualify for Standard

Apr 11 2011
In comments to the Senate Energy and Natural Resources Committee's "Clean Energy Standard White Paper", BIO argues that biomass should qualify for renewable energy credits.

BIO Comments on FDA's Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations; Availability

Apr 7 2011
BIO supports the ongoing integration of electronic health records (EHR) into the healthcare delivery system and industry adoption of electronic data capture (EDC) systems, and we are hopeful that these systems will introduce new capabilities and efficiencies into the clinical trial enterprise. BIO members welcome technological advances that will assist them in conducting clinical investigations in a more efficient manner. In fact, smaller emerging companies not burdened by legacy systems and practices may have greater flexibility and willingness to adopt new EDC systems. However, while BIO appreciates the principles outlined in the Draft Guidance, many of the responsibilities placed on the investigator remain ambiguous, and may create more potential burdens and uncertainty than clarification for biotech companies involved in clinical investigations.

Biotech Leader Provides Testimony at Congressional Hearing on SBIR/STTR Renewal

Apr 7 2011
The House Subcommittee on Healthcare and Technology held a hearing on The Creating Jobs Through Small Business Innovation Act of 2011, a bill that would reauthorize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which help fund small innovative companies on the brink of new technologies and discoveries.

BIO Comments on Implementation of Physician Transparency and Reporting Provisions of PPACA

Apr 7 2011
BIO supports the goal of providing greater transparency regarding financial relationships with health care providers and believes that notice and comment rulemaking is necessary to fully and fairly address the issues raised by the statutory provisions. These issues are complex and largely of first impression in the federal arena.

Improving the Regulation of Plant Incorporated Protectants: BIO comments on Docket ID No. EPA-HQ-OA-2011-0157

Apr 4 2011
In 2007, the Environmental Protection Agency (EPA) implied that it may subject plant-incorporated protectants, or PIPs, to the establishment registration and facility-based production reporting requirements developed to address concerns with pesticide production. The substances used in PIPs are typically naturally occurring proteins that are only harmful to a narrow range of pests. BIO submitted comments to the EPA stating that the additional regulation would discourage innovation and could cause disruption in U.S. agriculture.

Strategy for American Innovation: BIO Comments to the U.S. Department of Commerce

Apr 1 2011
BIO submitted comments in response to the Request for Comments on the Strategy for American Innovation issued by the U.S. Department of Commerce. BIO addressed policies relating to government research and development, entrepreneurship, intellectual property, and incentives to innovate. BIO encouraged the Department of Commerce to help create an environment conducive to risk-taking and one that will unleash the tremendous potential of biotechnology.

The American Research and Competitiveness Act: BIO supports the Research and Development Tax Credit

Mar 24 2011
BIO submitted letters of support for the American Research and Competitiveness Act of 2011 (HR 942) to the lead House of Representatives sponsors.

Coalition Urges Enactment of Patent Reform Legislation to Drive Job Growth and Innovation

Mar 24 2011
BIO joined with 97 other manufacturers, scientists, researchers, academic institutions, and businesses to urge the U.S. House of Representatives to enact patent reform into law in order to strengthen our country's patent system which will help get breakthrough products to market faster, maximizing our opportunities for job growth.

Comments in Opposition to a North Dakota Proposed Vaccine Purchase Program

Mar 23 2011
BIO testified before the North Dakota House of Representatives committee on March 23 in opposition to SB 2276, a bill that would create a state-run vaccine purchasing program with unnecessary marketplace restrictions harmful to start-up companies. The bill was subsequently favorably amended.

BIO Comments on FDA Transparency Initiative: Improving Transparency to Regulated Industry

Mar 8 2011
Overall, BIO applauds FDA's commitment to improving transparency to manufacturers, and believes that the report Improving Transparency to Regulated Industry includes many common sense approaches for enhancing FDA transparency and represents a good starting point on which to base future enhancements. We also request that the Agency re-consider its position on several significant matters that represent missed opportunities.