APA provisions governing agency refusals to initiate rulemakings give a similar focal point. The APA requires agencies to allow interested persons to “petition for the issuance, amendment, or repeal of a rule,” 5 U.S.C. § 555(e) (1982), and when such petitions are denied, to give “a brief statement of the grounds for denial,” Id. § 555(e). These two provisions suggest that Congress expected that agencies denying rulemaking petitions must explain their actions. Id (emphasis added).

BIOVAIL IS SUBSTANTIALLY LIKELY TO SUCCEED ON THE MERITS For the above-stated reasons, FDA has a clear duty to act within a reasonable time on the Biovail Citizen Petition and to give Biovail prompt notice of any denial in whole or in part. 5 U.S.C. § 555(b), (e). There has been no such action of which Biovail has received notice.

Drivers Ass’n of Am., Inc. v. Skinner, 931 F.2d 582, 589 (9th Cir. 1991). Finally, neither the Administrative Procedure Act (APA), 5 U.S.C. § 555, et seq., nor the Mandamus Act, 29 U.S.C. § 1361, provide independent sources of subject matter jurisdiction to review or enjoin NLRB proceedings. Califano v. Sanders, 430 U.S. 99, 106 (1977); Starbuck v. City and County of San Francisco, 556 F.2d 450, 459 n.18 (9th Cir. 1977).

USCIS has “unlawfully withheld” adjudication of the proposed sub- class members’ naturalization applications in violation of 8 U.S.C. § 1447(b) and 8 C.F.R. § 335.3 and 5 U.S.C. § 555(b) USCIS has unlawfully withheld the adjudication of the applications of Plaintiff Sanchez and members of the proposed sub-class because USCIS has not adjudicated their applications within 120 days of their interviews. An action is “unlawfully withheld” when an agency fails to meet a clear deadline prescribed by Congress.

APA § 555(b) provides no statutory deadline, directing only that agencies conclude matters presented to them “within a reasonable time[.]” 5 U.S.C. § 555(b). And, as noted above, there is no duty under the Water Supply Act for the Corps to respond on take final action on a request to reallocate water storage—and thus no possibility that Congress indicated a deadline for a requirement that is itself absent from the statute.

2555, at *3; Wu, 2007 WL 1223858, at *2-3; Song, 2007 WL 1101283, at *4; Duan, 2007 WL 626116, at *4; Singh, 470 F. Supp. 2d at 1072; Fu, 2000 WL 1644490, at *6; American Academy of Religion, 463 F. Supp. 2d at 421; Yu, 36 F. Supp. 2d at 932; Raduga USA Corp., 440 F. Supp. 2d at 1149; Agbemaple, 1998 WL 292441, at *2 (N.D. Ill. May 18, 1998); Gelfer, 2007 WL 90382, at *3. B. The Court May Determine What is “Reasonable” Under the APA in the Absence of a Statutory Timeframe for Adjudication The Defendants also contend that the APA affords this Court no jurisdiction to review the Plaintiff’s mandamus complaint, because “no statutory or regulatory provisions provide a ‘meaningful standard’ against which to measure the Attorney General’s process of adjudicating such an application” and thus “no standard against which the Court can measure whether the Case 1:07-cv-00422-RMC Document 14 Filed 06/19/2007 Page 27 of 38 28 Agency has acted ‘within a reasonable time,’ 5 U.S.C. §555(b), or ‘unreasonably delayed’ adjudication.” MD at 12 (citing 5 U.S.C. §706(1)).

As alleged in the Count VII of the Complaint, to the extent that the OFAC’s actions, findings, and/or conclusions were based on the classified and/or privileged information in the administrative record, OFAC’s failure to provide sufficient notice of such information entitles Plaintiff to mandamus relief. This is because OFAC is in clear violation of the APA’s notice requirements, 5 U.S.C. § 555(e), and OFAC’s failure to provide such information is in contravention of its clear duty to do so under the APA. Without access to such information, Plaintiff’s ability to apprise the agency of any errors it may have made in evaluating its reconsideration request, and in availing itself of its rights in the judicial review of its denial action, are prevented.

Section 555(b) Section 555(b) provides in relevant part that "[s]o far as the orderly conduct of public business permits, an interested person may appear before an agency or its responsible employees for the presentation, adjustment, or determination of an issue, request, or controversy in a proceeding, whether interlocutory, summary, or otherwise, or in connection with an agency function." See 5 U.S.C. § 555(b). Without deciding whether Animal Legal was an "interested person" under this provision, the Judicial Officer held that, "even if I were to find that Animal Legal Defense Fund is an 'interested person,' ... I would deny the Animal Legal Defense Fund's Appeal Petition because the appearance of the Animal Legal Defense Fund in this proceeding would disrupt the orderly conduct of public business."

But if the rationale of complexity were sufficient to excuse delay, this Case 1:10-cv-05690-AKH Document 20 Filed 01/07/11 Page 16 of 31 11 would undercut the command of the Administrative Procedure Act that each agency “conclude a matter presented to it” within “a reasonable time.” 5 U.S.C. § 555(b). Examples of prior regulation supplied by the FDA’s declarant, Dr. Ganley, demonstrate that scientific uncertainty and the need to consider conflicting public comments do not prevent the agency from reaching final decisions on OTC drug regulation.

Id. (citing 5 U.S.C. §§ 555(b), 706(1)). B. The Agency’s Duty Is Not Discharged by Announcements of Plans to Regulate.