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FDA and Federal Partners Issue Request for Information on the Regulation of Biotechnology

Constituent Update

December 19, 2022

Today, the White House Office of Science and Technology Policy (OSTP) — in coordination with the U.S. Food and Drug Administration (FDA), U.S. Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) — announced a request for information related to the Coordinated Framework for the Regulation of Biotechnology. This action requests relevant data and information to help identify regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology. The request for information seeks case studies and other data that relate to new and emerging biotechnology products.

The information provided will help regulatory agencies improve the clarity and efficiency of the regulatory processes for biotechnology products, as described in Executive Order 14081, “Advancing Biomanufacturing and Biotechnology Innovation for a Sustainable, Safe, and Secure Bioeconomy.” Executive Order 14081 promotes accelerating biotechnology innovation and growing America’s bioeconomy across multiple sectors, including health, agriculture, and energy. This Executive Order will help clarify and streamline regulations to strengthen a science- and risk-based, predictable, efficient, and transparent regulatory system that supports the safe use of biotechnology products.

All information received in the docket within 45 days after the date of publication in the Federal Register will be considered by the FDA, EPA, and USDA as part of our efforts to identify regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology.

Listening Session

OSTP, the FDA, EPA, and USDA will hold a virtual listening session on Thursday, January 12, 2023 at 1:00 pm (ET).

Register

If you are interested in additional listening sessions, please contact Dominique Carter at biotech-regulation@ostp.eop.gov.
 
To learn how the FDA, EPA, and USDA will work together to implement the Executive Order 14081, visit the Unified Website for Biotechnology Regulation.

For More Information

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