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October 9, 2015

NST Council Requests Clarification Of Coordinated Framework Responsibilities


On October 6, 2015, the National Science and Technology Council, Science and Technology Policy Office published a notice of request for information (RFI) on "Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (CF) and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology" in the Federal Register. The purpose of the RFI is to obtain relevant data that will be used to update the CF to reflect the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) and to develop a long term strategy for the CF that is consistent with the objectives laid out in the July 2, 2015, Executive Office of the President memorandum on the CF update. Responses to this RFI are due by November 13, 2015, at 5:00 p.m. (EST), and may be submitted via mail or electronically (strongly preferred) though the Federal eRulemaking Portal using Docket No. FDA-2015-N-3403. More information is available in Bergeson & Campbell, P.C.'s (B&C®) memorandum Biotechnology: White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology.