changing the applicable standards that other applicants are required to meet, including requesting testing, data, or labeling standards that are more onerous or rigorous than the standards applicable to the listed drug, reference product, or petitioner’s version of the same drug. (gg) The petitioner's record of submitting petitions to the Food and Drug Administration that have been determined by the Secretary to have been submitted with the primary purpose of delay. (hh) Other relevant and appropriate factors, which the Secretary shall describe in guidance. (III) Guidance The Secretary may issue or update guidance, as appropriate, to describe factors the Secretary considers in accordance with subclause (II).