; and (bb) during such period of time, was subject to sufficient monitoring by a regulatory body of any country listed in section 802(b)(1)(A) or any country designated by the Secretary in accordance with section 802(b)(1)(B); or (III) if the Secretary determines that information described in subclause (I) or (II) is not needed to provide a threshold demonstration that the drug can be safely marketed and used as a nonprescription drug, other information the Secretary determines sufficient for such purposes. (iv) Marketing pursuant to new drug application In the case of a request described in clause (i)(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 requirements specified in the request, for such period of the time as the Secretary determines appropriate (not to exceed 5 consecutive years) pursuant to an application approved under section 505