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 really opening the decision back up and reconsidering it, the agency’s initial action is the only final agency action to review.” (quotation omitted)).

Courts have articulated various tests for determining whether an agency has reopened a prior decision. These tests fall into two general categories.

Under the first, courts look “to the entire context of the [relevant agency action] including all relevant proposals and reactions of the agency to determine whether an issue was in fact reopened.” ''Pub. Citizen v. Nuclear Regul. Comm’n, 901 F.2d 147, 150 (D.C. Cir. 1990); see also, e.g., id. at 150–53; Growth Energy, 5 F.4th at 21–22; Nat’l Ass’n of Reversionary Prop. Owners v. Surface Transp. Bd.'', 158 F.3d 135, 141–46 (D.C. Cir. 1998). An agency can reopen an earlier decision in many ways, but the quintessential example of this type of reopening is when an agency “hold[s] out [its prior rule] as a proposed regulation, offer[s] an explanation for its language, solicit[s] comments on its substance, and respond[s] to the comments in promulgating the regulation in its final form.” ''Am. Iron & Steel Inst. v. EPA'', 886 F.2d 390, 397 (D.C. Cir. 1989). Under the second reopening category, courts consider whether an agency “constructively reopened” its prior decision. Kennecott Utah Copper Corp. v. DOI, 88 F.3d 1191, 1214–15 (D.C. Cir. 1996). They do so by evaluating whether “the revision of accompanying regulations significantly alters the stakes of judicial review as the result of a change that could have not been reasonably anticipated.” NRDC v. EPA, 571 F.3d 1245, 1266 (D.C. Cir. 2009) (quotation omitted).

Although a close call, we are unsure at this preliminary juncture and after truncated review that FDA reopened the 2000 Approval in its 2016 Major REMS Changes and its 2021 Petition Denial.

As for the first reopening test, neither the 2016 Major REMS Changes nor the 2021 Petition Denial appears to “substantive[ly] reconsider[]”