2022-27599: Request for Information; Identifying Ambiguities, Gaps, Inefficiencies, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology
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The National Biotech and Biomanufacturing Initiative (NBBI) identified biotechnology regulation clarity and efficiency as a priority of the Administration. Thus, the White House Office of Science and Technology Policy (OSTP)--on behalf of 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)--requests relevant data and information, including case studies, that may assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology, particularly with regard to new and emerging biotechnology products. The information provided will inform regulatory agency efforts to improve the clarity and efficiency of the regulatory processes for biotechnology products.
The agency’s own summary, as published.
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