On November 6, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Biotechnology Regulatory Services (BRS) announced the completion of the final version of the Guide to Submitting Data for Reports and Notices in APHIS eFile and the Response to Comments: Guide to Submitting Data for Reports and Notices in APHIS eFile. In October 2023, to clarify and streamline its biotechnology regulations further, BRS published for comment a draft guide to assist developers with submitting data to meet permitting requirements for reports and notices on Regulations.gov. According to BRS, it received comments on a range of different issues and grouped the comments into the following categories:

• Dates and data requirements for reports and notices;
• Compliance requirements;
• Technical challenges for APHIS eFile users; and
• Permits and alignment with data fields in APHIS eFile.

BRS revised the draft Guide in response to stakeholder feedback to clarify information requirements. According to BRS, the Guide provides specific examples to help developers understand the data requirements and due dates for compliance reports and/or notices submitted using APHIS eFile. BRS “continues its work on other deliverables to further clarify and streamline its biotechnology regulations.”