IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

____________________________________ ) NATIONAL ASSOCIATION OF CHAIN ) DRUG STORES et al. , ) ) Plaintiffs, ) ) v. ) Civil Action No. 07-02017 (RCL) ) U.S. DEPARTMENT OF HEALTH & ) HUMAN SERVICES, et al. , ) ) Defendants. ) ____________________________________)

MEMORANDUM OPINION Before the Court is plaintiffs’ Motion [ 63] to Compel Production of Documents and a Privilege Log. Upon consideration of the mo tion, the opposition, and reply thereto, the Court will grant in part and deny in part plaintiffs’ mo tion. The Court will grant plaintiffs’ motion to compel defendants to produce comments and any other documents added to the record of the Average Manufacturer Price (“AMP”) Rule duri ng the official regulatory comment period between July 17, 2007 and January 2, 2008, and will deny plaintiffs’ motion to compel defendants to produce a privilege log of any materials withheld from the administrative record based on the deliberative process privilege.

I. BACKGROUND Plaintiffs have brought this lawsuit to chal lenge the July 2007 AMP Rule as well as the March 2008 and October 2008 revisions to the AMP Rule. ( See Second Am. Compl. [66].) On July 17, 2007, the Centers for Medicare and Medicai d Services (“CMS”) of the U.S. Department

1of Health & Human Services (“HHS”) issued a rule (“AMP Rule”) implementing the Medicaidrelated provisions of the Defi cit Reduction Act of 2005 (“DRA”) and defining the term “average manufacturer price.” See 72 Fed. Reg. 39142. When they issued the AMP Rule, defendants left open the record and invited the public to submit comments on the AMP Rule until January 2, 2008. Defendants explicitly stated that they woul d consider the comments submitted prior to the end of the comment period. See, e.g., id. (“To be assured consideration, comments must be received at one of the addresses provided be low, no later than 5 p.m. on January 2, 2008.”) Following the comment period, defendants promulga ted a revision to the AMP Rule regarding the definition of “multiple source drug” (“MSD”). See 73 Fed. Reg. 13785 (Mar. 14, 2008). Defendants once again sought comme nts and then further revised the MSD definition in October
2008. See 73 Fed. Reg. 58491 (Oct. 7, 2008). The Court has ordered defendants to produce the administrative record related to the AMP Rule. ( See Scheduling Order [49], June 24, 2008, amended Aug. 6, 2008.) Defendants filed a portion of the administrative record on May 30, 2008, then filed a supplement to the administrative record on September 30, 2008. Defendants filed a second supplement to the administrative record on October 6, 2008. Plaintiffs have asked defendants to produce the comments and other documents added to the administrative record duri ng the official comment period between July 17, 2007 and January 2, 2008. (Mot. to Compel [63] 2.) Defendants claim that the comments and other documents from July 17, 2007 and January 2, 2008 are not part of the administrative reco rd in this case and therefore need not be produced. ( Id. ) Defendants also contend that the deliberative process privilege protects certain unidentified documents wh ich are not part of the administrative record and have refused to provide a privilege log or otherwise identify those documents. ( Id. )

2Plaintiffs have thus requeste d that defendants produce a priv ilege log detailing all of the materials withheld on the basi s of this privilege. ( Id. )

II. ANALYSIS A. Defendants must produce documents added to the record from July 17, 2007 to January 2, 2008 The public comments and documents added to the administrative record between July 17, 2007 and January 2, 2008 are part of the administrative record and therefore must be produced. The Administrative Procedures Act, 5 U.S.C. § 7 06, directs a court reviewing an agency decision to “review ‘the whole record or t hose parts of it cited by a party.’” Am. Wildlands v. Kempthorne , 530 F.3d 991, 1002 (D.C. Cir. 2008) ( quoting 5 U.S.C. § 706 (1966)); Pac. Shores Subdiv., Cal. Water Dist. v. United States Army Corps of Engineers , 448 F. Supp. 2d 1, 4 (D.D.C. 2006) (Facciola, J.). Judicial review of administrative action “should normally be based on the full administrative record that was before a decision maker at the time the challenged action was taken.” Cmty. for Creative Non-Violence v. Lujan , 908 F.2d 992, 998 (D.C. Cir. 1990). The administrative record consists of all documents and materials gathered by an agency when creating or revising a rule. See Citizens to Preserve Overton Park, Inc. v. Volpe , 401 U.S. 402, 419 (1971). The “whole record” has been interpreted to include documents and materials directly and indirectly co nsidered by the agency. Pac. Shores , 448 F. Supp. 2d at 4. An informal rulemaking record consists of the following materials: (1) the notice of proposed rulemaking; (2) comments submitted by inte rested persons; (3) hearing transcripts, if any; (4) other factual information considered by the agency; (5) reports of advisory committees, if any; and (6) the agency’s statement of basis and purpose. See Home Box Office, Inc. v. Fed.

3Commc’n Comm’n , 567 F.2d 9, 57 note 130 (D.C. Cir. 1977) (citing Recommendation 74-4 of the Administrative Conference of the United States); see also Rodway v. United States Dep’t of Agric. , 514 F.2d 809, 817 (D.C. Cir. 1975) (“The whole r ecord of an informal rule-making case is comprised of comments received, hearings held , if any, and the basis and purpose statement.”). Defendants assert that, because the AMP Rule was issued on July 17, 2007, any comments and other documents genera ted after that date are not partof the administrative record in this case because the comments and documents were not before the agency at the time the challenged action was taken. (Defs.’ Opp’n [67] 12.) However, defendants’ argument ignores the fact that plaintiffs have also challenged the March 14, 2008 revision to the AMP Rule, which occurred after the close of th e comment period on January 2, 2008. Defendants’ argument also neglects to consider that the defendants themselves invited the public to submit comments for the specific purpose of helping the defendants consid er issues and develop policies related to the AMP Rule. Defendants point out th at they did not base their re visions to the AMP Rule on the public comments submitted during the commen t period between July 17, 2007 and January 2, 2008. (Defs.’ Opp’n at 12.) However, the fact that defendants ignored the comments does not mean that the comments should be excluded from the record. See Fund for Animals v. Williams , 391 F. Supp. 2d 191, 199 (D.D.C. 2005) (Urbina, J. ) (agency cannot exclude documents from administrative record “simply by claiming that th e documents were not ‘directly or indirectly considered’ by the agency”). As the public comments at issue we re generated during the official comment period established by the defendants, and those records were generated prior to defendants’ decision to revise the AMP Rule in March 2008, the documents that plaintiffs request are in fact part of the administrative record and defendants therefore must produce the documents.

4B. Defendants do not need to produce a privilege log describing documents withheld from the administrative record As they are not part of the administrativ e record to begin w ith, defendants’ predecisional, deliberative documents do not need to be logged as withheld from the administrative record. In this Court, there is a well-estab lished presumption that an agency has properly designated the administrative record abse nt clear evidence to the contrary. See Blue Ocean Inst. v. Gutierrez , 503 F. Supp. 2d 366, 369 (D.D.C. 2007) (Facciola, J.); Fund for Animals , 391 F. Supp. 2d at 197. “The Agency decision and the Administrative Record are clothed with a presumption of regularity until proven otherwise by the Plaintiff.” Oceana, Inc. v. Guitterez , 2009 WL 1491516, 4 (D.D.C.) (Kay, J.). Furthermor e, internal deliberative materials are not part of the administrative recor d. “Deliberative intra-agency me moranda and other such records are ordinarily privileged, and need not be included in the record.” Amfac Resorts, L.L.C. v. U.S. Dep’t of the Interior , 143 F. Supp. 2d 7, 13 (D.D.C. 2001) (Lamberth, J.). Deliberative documents are excluded from the record because , when a party challenges agency action as arbitrary and capricious, the reasonableness of the agency’s action “is judged in accordance with its stated reasons.” In re Subpoena Duces Tecum Served on Office of Comptroller of Currency , 156 F.3d 1279, 1279 (D.C. Cir. 1998). “[T]he act ual subjective motivation of agency decisionmakers is immaterial as a matter of la w – unless there is a showing of bad faith or improper behavior.” Id. As pre-decisional, deliberative documents are immaterial to the court’s decision, they are not designated pa rt of the administrative record that forms the basis of the court’s decision. Since deliberative documents are not part of the administrative record, an agency that withholds these privileged documents is not requi red to produce a privilege log to describe the

5documents that have been withheld. In Blue Ocean , the Court found that agencies need not file privilege logs of deliberative documents absent a “clear command from the court of appeals, particularly in light of the unequi vocal statement by that court that such materials are not a part of the administrative record when an agency de cision is challenged as ar bitrary and capricious.” 503 F. Supp. 2d at 372. This was reaffirmed in Oceana when the Court ruled in favor of the contention that “excluding deliberative documents from the administrative record does not necessitate the preparation of a privilege log.” 2009 WL 1491516 at note 5. Another judge in this District also recently denie d, in an unpublished order, a simila r request for a privilege log in a record review case. See Order, Greater Yellowstone Coal. v. Kempthorne , No. 07-211 (May 23, 2008) (Sullivan, J.). Here, the internal delib erative materials that plaintiffs seek from defendants are no more a part of the administrative record than were the materials in Blue Ocean , Oceana , or Greater Yellowstone Coalition . Defendants need not, therefore, file a privilege log pertaining to the withheld documents. Plaintiffs claim to seek a privilege log so that they can particip ate in the process of determining what documents are and are not part of the administrative record. ( See Mem. of P. & A. in Supp. of Pls.’ Mot. to Compel [63] 5) (“The Court and the Plaintiffs have no way to determine whether the deliberative process privile ge protects the documents that the Defendants claim should be withheld from the administra tive record.”) However, the argument that a plaintiff and the Court should be permitted to par ticipate in an agency’s record compilation as a matter of course contravenes “the standard pres umption that the agency properly designated the Administrative Record.” Amfac Resorts , 143 F. Supp. 2d at 12 (quotations omitted). To overcome the assumption that the agency properl y designated the record, a party must make a “significant showing” that the agency has acted in bad faith. Id. Plaintiffs here have not alleged

6any bad faith on the part of defendants, and abse nt such an allegation and showing, defendants’ determination as to which materials are and are not part of the administrative record is conclusive. The documents plaintiffs request from de fendants amount to internal deliberative material, which has been designated to be outside of the administrative record. Since the agency is entitled to a presumption that it has prope rly designated the documents, and no bad faith or improper motive has been alleged or proven, defenda nts are not required to provide plaintiffs with a privilege log deta iling the documents.

III. CONCLUSION & ORDER For the foregoing reasons, it is hereby ORDERED that the motion [63] is GRANTED IN PART and DENIED IN PART. With respect to the motion to compel defendants to produce comments and any other documents added to the record of the AMP Rule during the offi cial regulatory comment period between July 17, 2007 and January 2, 2008, the motion is GRANTED. With respect to the motion to compel defendants to produce a privilege log of any materials withheld from the administrative record based on the deliberative process privilege, the motion is DENIED.
SO ORDERED.

Signed by Royce C. Lamberth, United States District Judge, June 23, 2009.

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