at parties across the country will file similar lawsuits seeking a similar result—or a different one, thereby increasing the likelihood of drawing the US Supreme Court into the fray. Already, another party in the Northern District of Ohio has filed a similar lawsuit, but this one seeks a nationwide injunction against the enforcement of the CTA. That case is in its early stages. Additionally, other parties may seek to intervene into the Alabama litigation to avail themselves of the same relief that was provided to the named plaintiffs, a strategy that was recently used in the Section 1071 litigation in Texas.Ultimately, the CTA remains in effect for all covered entities, aside from the NSBA plaintiffs. Affected parties should watch the possible appeal of this case to the Eleventh Circuit and the Northern District of Ohio case and future announcements from FinCEN about how these developments will impact a party’s duty to report.1 31 U.S.C. § 5336.2 87 Fed. Reg. 59,498 (Sept. 30, 2022).3 88 Fed. Reg. 83,499 (Nov. 30, 2023).4 Complaint, Nat’l Small Bus. United v. Yellen, No. 5:22-cv-01448-LCB (N.D. Ala. Nov. 15, 2022).5Nat’l Small Bus. United v. Yellen, No. 5:22-cv-01448-LCB, 2024 WL 899372 (N.D. Ala. Mar. 1, 2024).6 The Court addressed only the constitutionality of the statute, not the rulemaking that implemented the statute. That rulemaking may remain subject to challenge on other grounds (e.g., compliance with the Administrative Procedure Act (“APA”)).7Id. at *1.8Id. at *5.9Id.10Id. at *7.11Id. at *8.12Id. at *9.13Id. at *10.14Id. at *11.15Id. at *1316Id.17Id. at *14.18Id. at *16 (citing United States v. Lopez, 514 U.S. 549, 567 (1995) (internal quotation marks omitted)).19Id. at *18.20Id.21Id. at *20.22Id.23Id. at *21 (citing Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519, 560 (2012) (internal quotation marks omitted)).24Id.25 FinCEN, Notice Regarding National Small Business United v. Yellen, No. 5:22-cv-01448 (N.D. Ala.) (Mar 4, 2024).26 Complaint, Robert J. Gargasz Co. v. Yellen, No. 1:23-cv-

ore to the Proposed Rule than we could cover in this short analysis. Comments on the Proposed Rule are due February 28, 2024. If you have questions or would like assistance drafting and submitting a comment, please do not hesitate to contact us.188 Fed. Reg. 83,774 (Nov. 30, 2023) [hereinafter “Proposed Rule”].2Plant-derived materials that are highly purified (e.g., cellulose) or well-characterized (e.g., cotton) are not considered “other chemicals.” Id. at 83,778.3Id. at 83,778.4See id. (referencing WHO, Critically Important Antimicrobials for Human Medicine: 6th Edition, Table 1 (2018)).5See id. at 83,797-98.6Id. at 83,796-97.7Id. at 83,798.8Id. at 83,800.9See FDCA § 201(h), 21 U.S.C. § 321(h).10See 21 C.F.R. Part 3.11Id. at 83,792.12See FDA, Proposed Order, Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials, 88 Fed. Reg. 83,802 (Nov. 30, 2023) [hereinafter “Proposed Order”].13See id. at 83,805.14See Proposed Rule, 88 Fed. Reg. at 83,793.15See id.16Id. at 83793.