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Medicare Program; Request for Information Regarding Accountable Care Organizations and the Medicare Shared Savings Program

Dec 3 2010
The Biotechnology Industry Organization (BIO) is pleased to submit the following comments on the Centers for Medicare and Medicaid Services' (CMS) Request for Information (RFI) regarding Accountable Care Organizations and the Medicare Shared Savings Program.

Job Creation: Biobased Products Seek Equal Tax Credits

Dec 1 2010
Biobased products and renewable chemicals should be incentivized along with other renewable technologies in Congressional bills aimed at creating jobs, according to letters sent by BIO and biotechnology companies to House and Senate leaders.

BIO comments on the proposed accession of Malaysia to the Trans Pacific Partnership (TPP) negotiations

Nov 22 2010
Parties to the TPP negotiation are a mixture of countries that actively cultivate and import GE crops, as well as those that have yet to develop functioning regulatory systems. Therefore, the TPP offers the potential to achieve a common regulatory approach and disciplines for agricultural biotechnology.

BIO's comments to Health Resources and Services Administration (HRSA) on dispute resolution authorized in Section 7102 of the Patient Protection and Affordable Care Act

Nov 19 2010
The Biotechnology Industry Organization (“BIO”) appreciates this opportunity to respond to HRSA’s September 20, 2010 advance notice of proposed rulemaking and request for comments (“ANPRM”) seeking to obtain information and public comment on how to efficiently and effectively implement the administrative process for dispute resolution authorized in Section 7102 of the Patient Protection and Affordable Care Act (“Affordable Care Act”), Pub. L. 111-148. See 75 Fed. Reg. 57,233 (Sept. 20, 2010).

Food Labeling; Labeling of Food Made From AquAdvantage Salmon

Nov 19 2010
BIO submitted comments to the U.S. Food and Drug Administration (FDA) regarding the application of the food labeling laws and principles to food from the genetically engineered AquAdvantage salmon currently under consideration for approval by the FDA. BIO reiterates its strong support for FDA’s science-based labeling requirements that apply to all foods, which state "no special label is required if a new food is substantially equivalent to its traditional counterpart."

BIO's comments to Health Resources and Services Administration (HRSA) on the Civil Monetary Penalties authority provided by Section 7102(a) of the Patient Protection and Affordable Care Act

Nov 19 2010
The Biotechnology Industry Organization (BIO) appreciates this opportunity to respond to HRSA’s September 20, 2010 advance notice of proposed rulemaking and request for comments (“ANPRM”) seeking to obtain information and public comment on how to efficiently and effectively implement the civil monetary penalty (“CMP”) authority provided by Section 7102(a) of the Patient Protection and Affordable Care Act (“Affordable Care Act”), Pub. L. 111-148. See 75 Fed. Reg. 57,230 (Sept. 20, 2010).

BIO Comments to USPTO on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System

Nov 19 2010
BIO commends the PTO for exploring creative and market-oriented ways to incentivize the development and distribution of humanitarian technologies, a goal that BIO and its members have long shared and are working hard to achieve.

Draft Guidance for Industry on Suicidality: Prospective Assessment of Occurrence in Clinical Trials

Nov 8 2010
BIO's comments to the FDA supporting the goals of the Draft Guidance to reduce the potential for suicidal behavior, ideation and attempts during drug treatment.

FDA Guidance Document: Transdermal Drug Delivery Systems

Nov 1 2010
BIO appreciates FDA’s efforts to provide industry with additional clarity around the Agency’s current thinking and expectations regarding product manufacturing, yet we believe that this guidance document is unnecessary as the key principles contained within are covered by other means, including regulation and guidance.

FDA: Strategic Priorities for Fiscal Year 2011-2015

Nov 1 2010
BIO supports FDA’s initiative to establish a long-term vision for the Agency based upon guiding principles and expresses the biotechnology industry’s willingness to work with the Agency to promote biomedical innovation, modernize regulatory science, further secure the global supply chain, and meet the needs of special populations.