Back in July the Office of Science and Technology Policy (OSTP) announced that it would be leading an interagency effort to review and update the Coordinated Framework for the Regulation of Biotechnology (Framework). Part of the effort would include soliciting public input on both updates to the Framework and the development of a long-term strategy for dealing with emerging biotechnologies.
Last week the OSTP published a Request for Information (RFI) in the Federal Register seeking that public input. The submission deadline is 5 pm Eastern time, November 13.
Here are the questions listed in the RFI (the product areas and agency roles are summarized in the RFI and available in the Background section of the memorandum sent to agencies on this effort):
- What additional clarification could be provided regarding which biotechnology product areas are within the statutory authority and responsibility of each agency?
- What additional clarification could be provided regarding the roles that each agency plays for different biotechnology 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?
- How can Federal agencies improve their communication to consumers, industry, and other stakeholders regarding the authorities, practices, and bases for decision-making used to ensure the safety of the products of biotechnology?
- Are there relevant data and information, including case studies, that can inform the update to the CF [Coordinated Framework] or the development of the long-term strategy regarding how to improve the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology?
- Are there specific issues that should be addressed in the update of the CF or in the long-term strategy in order to increase the transparency, coordination, predictability, and efficiency of the regulatory system for the products of biotechnology?
While submissions can be submitted by regular mail, electronic submission is preferred. Please see the Federal Register notice for additional information.