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2015-10-06
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Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology
Notices
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United States
Science and Technology Policy Office
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United States Government Agency or Subagency
On July 2, 2015, the Executive Office of the President (EOP) issued a memorandum (Ref. 1) directing the primary agencies that regulate the products of biotechnology--the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA)--to update the Coordinated Framework for the Regulation of Biotechnology (51 FR 23302; June 26, 1986) (Ref. 2), develop a long-term strategy to ensure that the Federal biotechnology regulatory system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support this effort. The memorandum's objectives are to ensure public confidence in the regulatory system and to 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 purpose of this Request for Information (RFI) is to solicit relevant data and information, including case studies, that can assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (CF) to clarify the current roles and responsibilities of the EPA, FDA, and USDA and the development of a long-term strategy consistent with the objectives described in the July 2, 2015 EOP memorandum. In addition to this RFI, the update to the CF will undergo public comment before it is finalized.
80 FR 60414
https://www.govinfo.gov/app/details/FR-2015-10-06/2015-25325
2015-25325
fr06oc15-89
3270-F5-P
https://www.govinfo.gov/app/details/FR-2015-10-06/2015-25325
https://www.govinfo.gov/content/pkg/FR-2015-10-06/html/2015-25325.htm
https://www.govinfo.gov/content/pkg/FR-2015-10-06/pdf/2015-25325.pdf
3 p.
60414
60416
80 FR 60414
Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology; Federal Register Vol. 80, Issue
NOTICE
2015-25325
SCIENCE AND TECHNOLOGY POLICY OFFICE
3270-F5-P
2015-25325
Notice of request for information.
On July 2, 2015, the Executive Office of the President (EOP) issued a memorandum (Ref. 1) directing the primary agencies that regulate the products of biotechnology--the U.S. Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA)--to update the Coordinated Framework for the Regulation of Biotechnology (51 FR 23302; June 26, 1986) (Ref. 2), develop a long-term strategy to ensure that the Federal biotechnology regulatory system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support this effort. The memorandum's objectives are to ensure public confidence in the regulatory system and to 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 purpose of this Request for Information (RFI) is to solicit relevant data and information, including case studies, that can assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (CF) to clarify the current roles and responsibilities of the EPA, FDA, and USDA and the development of a long-term strategy consistent with the objectives described in the July 2, 2015 EOP memorandum. In addition to this RFI, the update to the CF will undergo public comment before it is finalized.
Responses must be received by November 13, 2015 at 5:00 p.m. EST to be considered.
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., Washington DC 20504, Phone: 202-456-4444, Online: https://www.whitehouse.gov/webform/contact- emerging-technologies-interagency-policy-coordinating-committee- national-science-and
Requests for Information:
Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology
,
http://www.aphis.usda.gov/brs/fedregister/coordinated_framework.pdf
http://www.epa.gov/biotech_rule/
http://www.epa.gov/pesticides/biopesticides/regtools/biotech-reg-prod.htm
http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/GeneticEngineering/GeneticallyEngineeredAnimals/ucm113605.htm
http://www.fda.gov/Food/FoodScienceResearch/Biotechnology/
http://www.regulations.gov
https://www.aphis.usda.gov/wps/portal/aphis/ourfocus/biotechnology
https://www.whitehouse.gov/sites/default/files/microsites/ostp/57_fed_reg_6753__1992.pdf
https://www.whitehouse.gov/sites/default/files/microsites/ostp/modernizing_the_reg_system_for_biotech_products_memo_final.pdf
https://www.whitehouse.gov/webform/contact-emerging-technologies-interagency-policy-coordinating-committee-national-science-and
Federal Register
Vol. 80, no. 193
Office of the Federal Register, National Archives and Records Administration
2015-10-06
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244 p.
Table of Contents:
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AE 2.106:
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https://www.govinfo.gov/app/details/FR-2015-10-06
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https://www.govinfo.gov/app/details/FR-2015-10-06
https://www.govinfo.gov/content/pkg/FR-2015-10-06/pdf/FR-2015-10-06.pdf
https://www.govinfo.gov/content/pkg/FR-2015-10-06/xml/FR-2015-10-06.xml
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2015-10-06
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