See supra § II. And it fails to satisfy the Act’s clear command that regulations to “govern the conduct of proceedings in the Office…shall be made in accordance with section 553 of title 5,” 35 U.S.C. § 2(b)(2). See supra § III.

Plaintiffs concede that the USPTO has inherent authority to issue interpretive rules. Pls. Mem. 21 n.12. “Interpretative rules . . . clarify or explain existing law or regulation and are exempt from notice and comment under section 553(b)(A).” Nat’l Org. of Veterans’ Advocates, Inc. v. Sec’y of Veterans Affairs, 260 F.3d 1365, 1375 (Fed. Cir. 2001) (quotation marks omitted).

Therefore, the Secretary violated section 553 of the APA, which is also a violation of APA section 706, since it was “without observance of procedure required by law.” 5 U.S.C. §§ 553, 706(2)(D). CMS neglected to disclose the adverse consequences that hospitals moved to CBSAs with few providers would face in both its FY 2015 Proposed Rule and its FY 2016 Proposed Rule, thereby depriving affected parties of the opportunity to submit meaningful comments.

REQUEST FOR RELIEF WHEREFORE, Plaintiffs respectfully request as follows: 1. That this Court rule that the Secretary’s regulations implementing the Outlier Statute and her application of same were, for the FYs here at issue, (A) in excess of statutory authority or limitations, or short of statutory right, (B) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law, (C) without observance of procedure required by law, and/or (D) unsupported by substantial evidence under the APA, 5 U.S.C. §§ 553 (c) & 706; and 2. That this Court enter an order (a) vacating the Outlier Regulations; and (b) remanding these appeals to the Secretary to: (i) recalibrate and reset the FLTs for Hospital Plaintiffs’ respective FYEs 2008 through 2011, (ii) permit the Hospital Plaintiffs to submit amended claims for Outlier Case Payments for their respective FYEs at issue in accordance with the recalibrated FLTs, and (iii) re-determine and pay the amount of Outlier Case Payments, together with interest, due the Hospital Plaintiffs under the Outlier Statute.

2. NMFS Provided a Reasonable Analysis of the Supply-Side Costs. During the comment period on the Proposed Rule, NMFS received numerous comments, including from Plaintiff National Fisheries Institute (NFI), AR 6609, about the possibility of 18 Plaintiffs cite this case for their argument under Section 706(2) yet their parenthetical quotes a part of the District Court’s opinion that analyzed the agency’s compliance with Section 553. Case 1:17-cv-00031-APM Document 56-1 Filed 05/09/17 Page 35 of 57 26 increased compliance costs, including concerns raised by importers about “the cost of paying harvesters and farmers for traceability data.”

Case 1:13-cv-01974-BAH Document 13 Filed 02/07/14 Page 36 of 38 30 Specifically, when an agency promulgates a rule, it “shall give interested persons an opportunity to participate in the rule making through submission of written data, views, or arguments with or without opportunity for oral presentation.” 5 U.S.C. § 553(c). This requirement compels an agency to set forth in a Notice of Proposed Rulemaking the most critical factual material and reasoning on which it relied to formulate the regulation.

USCIS’s implementation of the 2002 Rule requiring completion of the FBI name check prior to adjudication of naturalization applications is without any adequate legislative basis. It is thus a “legislative rule” that must comply with 5 U.S.C. § 553(a). (iii) The 2002 Rule effectively amended the prior legislative rule The AMC test utilized by the Second Circuit also requires the provision of notice and an opportunity to comment if “the rule effectively amends a prior legislative rule.”

Ecosystem Alliance v. FWS, 475 F.3d 1136, 1142 (9th Cir. 2007) (“In substance, the formality § 1533(h) requires for policy statements is Case 1:15-cv-00477-EGS Document 53 Filed 07/07/17 Page 69 of 72 60 indistinguishable from notice-and-comment rulemaking under the APA. Compare 16 U.S.C. § 1533(h) with 5 U.S.C. § 553.”).

at 49,797, RR 488. The Secretary thoroughly explained the “substance of the proposed rule,” 5 U.S.C. § 553(b)(3), which was simply the retention of an existing policy. And given this continuity, any LTCH participating in the Medicare program had sufficient information to “comment meaningfully” on the question whether the Secretary should continue to use the existing lines to calculate the wage index going forward.

Case 5:16-cv-06441-JFL Document 2 Filed 02/27/17 Page 14 of 18 9 Plaintiff’s argument fails for the simple reason that even though HUD was not legally obligated to issue the 2007 Guidance pursuant to notice and comment (because it was issuing an interpretive rule), it did so anyway. Specifically, on December 19, 2003, HUD published in the Federal Register proposed guidance summarizing the guidance it intended to issue and stating the legal basis for its guidance, just as 5 U.S.C. § 553 directs. See 68 Fed. Reg.