White House Seeks Input on Updating Biotech Regulatory System

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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.

Agency Role Clarification Requested

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:

  • clarify which biotechnology product areas are within the authority and responsibility of each agency
  • clarify the roles that each agency plays for different product areas, particularly for those product areas that fall within the responsibility of multiple agencies, and how those roles relate to each other in the course of a regulatory assessment;
  • clarify a standard mechanism for communication and, as appropriate, coordination among agencies that also will identify agency designees responsible for this coordination function; and
  • clarify the mechanism and time-line for regularly reviewing and updating the CF in order to minimize delays and innovation, protect health and the environment and promote public trust in the regulatory systems for biotechnology products.

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.

Submission Information

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.