; and (3) by adding at the end the following: (l) Separate REMS When used in this section, the terms “different, comparable aspect of the elements to assure safe use” or “different, comparable approved risk evaluation and mitigation strategies” means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section 505(j) that uses different methods or operational means than the strategy required under subsection (a) for the applicable listed drug, or other application under section 505(j) with the same such listed drug, but achieves the same level of safety as such strategy. .