patent or exclusivity). (IV) Submission of a petition without any data or information in support of the scientific positions set forth in the petition. (V) Submission of a petition raising the same or substantially similar issues as a prior petition to which the Food and Drug Administration has already substantively responded, particularly where the subsequent submission closely follows in time the earlier response. (VI) Submission of a petition concerning standards for approval of a drug product for which— (aa) the Food and Drug Administration has provided an opportunity for public input (such as when the Food and Drug Administration has issued draft or final product-specific guidance applicable to the drug product)