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Concerns regarding unilateral actions that the USDA is poised to take in the name of coexistence

Dec 23 2010
BIO letter to Mr. Cass R. Sunstein regarding its concerns on unilateral actions that the U.S. Department of Agriculture (USDA or the Department) is poised to take in the name of coexistence.

Parallel Review of Medical Products

Dec 16 2010
BIO does not believe that the existence of separate, serial FDA and CMS review processes has resulted in significant problems in the review and coverage of drugs and biologicals, and questions whether there is any need for a new parallel process. Sponsors who wish to involve both FDA and CMS in clinical development and premarket review discussions may do so voluntarily under current practice, and we encourage both agencies to maintain this opportunity for early consultation, outside of any formal parallel review process, where it is desired by sponsors.

Climate Change and IP: Letter Urges US to Protect Intellectual Property Rights at Conference

Dec 7 2010
BIO co-signs a letter to Secretary of State Hillary Clinton and Ambassador Todd Stern that argues strong intellectual property protection is key to achieving the innovation and worldwide technology deployment necessary to reach climate change goals.

Comments to the Institute of Medicine on the Determination of Essential Health Benefits

Dec 6 2010
BIO submitted comments to the Institute of Medicine (IOM) in response to a survey on the criteria and methods for determining and updating the essential health benefits package.

BIO comments submitted to United States Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS

Dec 6 2010
BIO in response to the November 4, 2010 announcement (the Notice) by the United States Department of Agriculture's (USDA's) Animal and Plant Health Inspection Service (APHIS or the Agency) of APHIS's preparation of a draft environmental assessment (EA) as part of its decision making process to address a supplemental request for partial deregulation of sugar beets genetically engineered (GE) for tolerance to the herbicide glyphosate.

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."