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An rDNA construct that is intended to affect the structure or function of a transgenic animal meets the statutory definition of a new animal drug and must be approved by FDA prior to commercialization. FDA regulates indeed animals containing rDNA constructs under the new animal drug provisions of the FD&C Act, and meets it obligations for environmental analysis under Approvals of this type constitute “major Federal actions” for which FDA must meet environmental review requirements under the National Environmental Policy Act (NEPA) and FDA’s regulations, thus triggering the requirement to perform such environmental assessment.
FDA approvals for articles regulated under the new animal drug provisions of the FD&C Act may be for a specific set of conditions that are proposed in the drug sponsor’s New Animal Drug Application (NADA), or are required by FDA to mitigate potential risks, and are explicitly set forth in the conditions of approval. Sponsors must notify FDA of any modifications to the approved conditions of use, ranging from changes in labels to alterations of the conditions of husbandry. Major and moderate changes require a supplemental application that must be approved by the agency prior to implementation.
