; and (II) during such time was subject to sufficient monitoring by a regulatory body considered acceptable by the Secretary for such monitoring purposes, including for adverse events associated with nonprescription use of the drug; or (iii) if the Secretary determines that information described in clauses (i) or (ii) is not needed to provide a prima facie demonstration that the drug can be safely marketed and used as a nonprescription drug, such other information the Secretary determines is sufficient for such purposes. (D) Marketing pursuant to new drug application In the case of a request described in subparagraph (A)(ii), the drug subject to such request may be re-submitted for filing only if— (i) the drug is marketed as a nonprescription drug, under conditions of use comparable to the conditions specified in the request, for such period of time as the Secretary determines appropriate (not to exceed five consecutive years) pursuant to an application approved under section 505