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Oct. 5 — The White House's National Science and Technology Council Oct. 5 asked for input to update the federal framework for biotechnology regulation in order to clarify the federal agencies' roles.
In its request for information, set to be published in a Federal Register notice on Oct. 6, the NSTC indicated that responses must be received by Nov. 13.
The RFI responds to a July 2 memorandum from the Executive Office of the President (EOP) directing the primary agencies that regulate the products of biotechnology—the Food and Drug Administration, Environmental Protection Agency and Department of Agriculture—to update the Coordinated Framework for the Regulation of Biotechnology (CF) (51 Fed. Reg. 23,302, 6/26/86) and develop a long-term strategy to ensure that the federal biotechnology regulatory system is prepared for the future landscape of biotechnology. A commissioned expert regulatory analysis will help to develop the strategy.
The memorandum’s objectives are to ensure public confidence in the regulatory system and prevent unnecessary barriers to future innovation and competitiveness by improving the transparency, coordination, predictability and efficiency of the regulation of biotechnology products while continuing to protect health and the environment, the notice said.
The EOP memorandum said the CF update should clarify the current roles and responsibilities of the agencies that regulate the products of biotechnology through four objectives:
The term “biotechnology products” refers to products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals and microbes.
Submit responses by Nov. 13, electronically to http://www.regulations.gov or by mail to the National Science and Technology Council, Emerging Technologies Interagency Policy Coordination Committee, Office of Science and Technology Policy, 1650 Pennsylvania Ave. N.W., Washington, D.C. 20504. All comments should reference Docket No. FDA-2015-N-3403.
Responses must be unclassified and shouldn't contain any proprietary, confidential or personally identifying information, such as home address or Social Security number. All information received will be publicly viewable at http://www.regulations.gov.
For further information, contact the National Science and Technology Council: Emerging Technologies Interagency Policy Coordination Committee, Office of Science and Technology Policy, Executive Office of the President, Eisenhower Executive Office Building, 1650 Pennsylvania Ave. N.W., Washington, D.C. 20504, (202) 456-4444.
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