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RG-1 Regulatory Guidance:
Chapter 5 - Research with Livestock Feeds

Section 5: Notification of change – post-approval or -authorization

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The applicant is required to notify the AFD should they plan to make any modifications or changes to the research feeding trial(s), the livestock used in the trial, or the Research Feed, other than what has already been provided to the AFD in the application package. The applicant can notify the AFD either by email or letter, and must clearly state the planned changes. The notification is required to ensure that any changes to the research from the original information reviewed will not result in any safety concerns and/or non-compliance. The AFD will review the proposed changes and provide direction on what steps or procedures will be required. For example, it is common for the start and end dates of a trial to change, and these may be recognized by a simple response to the applicant. The changes made to the original decision will be kept on file for future reference.

Any major changes to the protocol, livestock species, containment, addition of other Research Feeds, etc., would necessitate the submission of a new application.

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