; (B) by striking the second sentence and inserting the following: (ii) Factors In determining whether a petition was submitted with the primary purpose of delaying the approval of an application, the Secretary shall consider— (I) whether it appears, based on the date that relevant information relied upon in the petition became known to the petitioner (or reasonably should have been known to the petitioner), as certified by the petitioner in accordance with subparagraph (H), that the petitioner has taken an unreasonable length of time to submit the petition; (II) whether the petitioner has submitted multiple or serial petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions; (III) whether the petition was submitted close in time to a known, first date upon which an application under subsection (b)(2) of this section or section 351(k) of the Public Health Service Act could be approved; (IV) whether the petition was submitted without any data or information in support of the scientific positions set forth in the petition; (V) whether the petition raises the same or substantially similar issues as a prior petition to which the Secretary has responded substantively already, particularly if the subsequent submission follows the earlier response closely in time; (VI) whether the petition concerns standards for approval of a drug for which the Secretary has provided an opportunity for public input, such as draft or final product-specific guidance applicable to the drug, and the petitioner has not provided comment other than through the petition; (VII) whether the petition requests that other applicants meet standards for testing, data, or labeling for a drug that are more onerous or rigorous than the standards applicable to, as applicable, the listed drug, reference product, or petitioner’s version of the same drug