; or (II) provides for a change in the conditions of use of a drug, for which new human data studies conducted or sponsored by the requestor (or for which the requestor has an exclusive right of reference) were essential to the issuance of such order. (iii) Drugs described The drugs described in this clause are drugs— (I) specified in subsection (a)(1), (a)(2), or (a)(3); (II) subject to a final order issued under this section; (III) subject to a final sunscreen order (as defined in section 586(2)(A)); or (IV) described in subsection (m)(1), other than drugs subject to an active enforcement action under chapter III of this Act. (iv) Limitations on exclusivity (I) In general Only one period of exclusivity shall be granted, under each order described in clause (i), with respect to changes (to the drug subject to such order) which are either— (aa) changes described in clause (ii)(I), relating to active ingredients; or (bb) changes described in clause (ii)(II), relating to conditions of use. (II) No exclusivity allowed No exclusivity shall apply to changes to a drug which are— (aa) the subject of a Tier 2 OTC monograph order request (as defined in section 744N); (bb) safety-related changes, as defined by the Secretary, or any other changes the Secretary considers necessary to assure safe use; or (cc) changes related to methods of testing safety or efficacy. (v) New human data studies defined In this subparagraph, the term new human data studies means clinical trials of safety or effectiveness (including actual use studies), pharmacokinetics studies, or bioavailability studies, the results of which— (I) have not been relied on by the Secretary to support— (aa) a proposed or final determination that a drug described in subclauses (I), (II), or (III) of clause (iii) is generally recognized as safe and effective within the meaning of section 201(p)(1); or (bb) approval of a drug that was approved under section 505 (except for an approval changing a drug from prescription to nonprescription status)