; (bb) safety-related changes described in section 744L–1(a)(2)(C), required under paragraph (5), or any other change the Secretary determines necessary to ensure safe use; or (cc) changes related to methods of testing safety or efficacy. (v) Listing of licensees, assignees, or successors in interest The requestors of an order described in clause (i) shall, as applicable, submit to the Secretary, at a time when a finished dosage form subject to such order is introduced or delivered for introduction into interstate commerce, a list of licensees, assignees, or successors in interest that have the exclusive right described in such clause. (vi) Human data defined For purposes of this subparagraph, the term human data means data from clinical trials of safety or effectiveness, or pharmacokinetics or bioavailability studies. (D) Information regarding safe nonprescription marketing and use as a condition for filing a GRASE request (i) In general In response to a request under this paragraph that a drug described in clause (ii) be generally recognized as safe and effective, the Secretary— (I) may file such request, if the request includes information specified under clause (iii) with respect to safe nonprescription marketing and use of such drug; or (II) if the request fails to include information specified under clause (iii), shall refuse to file such request and may require that nonprescription marketing of the drug be pursuant to a new drug application as described in clause (iv). (ii) Drug described A drug described in this clause is a monograph drug that contains an active ingredient not previously incorporated in a drug— (I) marketed in accordance with a final monograph issued under part 330 of title 21, Code of Federal Regulations (including conditions of use under such part), as in effect on the day before the date of enactment of this section