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Government Accountability Project v. U.S. Dep't of Health and Human Services

August 4, 2008


The opinion of the court was delivered by: Colleen Kollar-kotelly United States District Judge


The above-captioned case arises out of a request filed by Plaintiff, Government Accountability Project ("GAP") pursuant to the Freedom of Information Act ("FOIA"), 5 U.S.C. § 552 et seq., seeking the disclosure and release of agency records consisting of clinical study data regarding the drug Ciprofloxacin ("Cipro"). After Plaintiff's FOIA request had been pending for eight months with no response, Plaintiff filed a Motion for Judgment on the Pleadings. Defendants, the United States Department of Health and Human Services ("HHS") and the United States Food and Drug Administration ("FDA"), oppose Plaintiff's motion and have filed their own motion for a stay pursuant to Open America v. Watergate Special Prosecution, 547 F.2d 605 (D.C. Cir. 1976). Defendants seek to stay the proceedings in this action until August 15, 2009 in order to allow Defendants to complete their review and release the documents responsive to Plaintiff's request. Plaintiff opposes Defendants' motion for a stay. The Court has thoroughly reviewed Plaintiff's [5] Motion for Judgment on the Pleadings, Defendants' [7] Motion for an Open America Stay, supporting declarations and attached exhibits, Plaintiff's Opposition to Defendants' motion and Reply in support of its own motion, and Defendants' Reply in support of their motion, as well as the relevant statutes and case law. Based upon the foregoing, the Court concludes that Defendants have failed to demonstrate exceptional circumstances and due diligence sufficient to justify the stay they seek. Accordingly, the Court shall DENY Defendants' [7] Motion for Open America Stay and shall GRANT-IN-PART Plaintiff's [5] Motion for Judgment on the Pleadings insofar as it seeks a judgment that Defendants are required to process Plaintiff's FOIA request and release the documents on a rolling basis.

Although the Court concludes that Defendants have not established exceptional circumstances sufficient to warrant the eighteen-month stay they seek, the Court recognizes that Defendants are faced with a substantial backlog of pending FOIA requests and that Plaintiff's request is currently pending in the processing queue. Therefore, as set forth in the Order accompanying this Memorandum Opinion, the Court shall require Defendants to file a status report with the Court on or before September 5, 2008, advising the Court as to the volume of the requested records, where Plaintiff's FOIA request currently stands in the processing queue, i.e., the date by which Defendants expect to begin processing Plaintiff's FOIA request, and how long they expect it will take to process Plaintiff's request, so that the Court can set an appropriate processing schedule.


Plaintiff Government Accountability Project is a non-profit advocacy organization that frequently requests access to agency records. Compl. ¶ 3. On June 27, 2007, GAP submitted a FOIA request to the FDA, seeking records of clinical studies regarding Ciprofloxacin. Id. ¶ 5. Specifically, GAP requested "[a]ll goniometry (joint angle motion measurement) data . . . pertaining to domestic and foreign clinical trial studies 1001169 and 100201" and "all FDA Division of Scientific Investigations ("DSI") reports and records, domestic and outside of US, concerning all DSI inspections pertaining to clinical trial studies 1001169 and 100201." Compl. ¶ 6.

By letter dated June 28, 2007, the FDA acknowledged receipt of GAP's FOIA request. Compl. ¶ 7. The FDA forwarded GAP's request to the Division of Information Policy Disclosure ("DIDP"), of the Center for Drug Evaluation and Research ("CDER"). 2/4/08 Decl. of Frederick

J. Sadler (hereinafter "Sadler Decl.") ¶ 12. CDER regulates Cipro, and was therefore determined to be most likely to have responsive documents. Id. DIDP comprises 28 full-time employees and two full-time contractors. 2/4/08 Decl. of Nancy B. Sager (hereinafter "Sager Decl.") ¶ 6. In processing FOIA requests, the CDER utilizes two processing tracks. Id. ¶ 8. CDER assigns requests to the "Simple Track" when the records "do not require DIDP personnel to redact documents, . . . the documents requested are publicly available, or it is apparent from the face of the request that the documents do not exist in CDER's records." Id. ¶ 9. When records are not readily available, CDER assigns FOIA requests to the slower "Complex Track." Id. ¶ 8. DIDP personnel generally process requests within each track on a first-in, first-out basis.*fn1 Id. Because the records GAP requested were not readily available and will likely require redaction and review once located, DIDP assigned GAP's request to the Complex Track. Id. ¶¶ 29-33.

Defendants have not provided a detailed estimate of when they anticipate GAP's FOIA request will be processed, nor have they provided an estimate as to the number of records likely to be responsive to GAP's request. Instead, Ms. Sager, the Director of DIDP, asserts that, "based on DIDP's current backlog and current processing time for requests seeking this type of information," "DIDP estimates that [GAP's] request will move to the head of the Complex Track approximately 16 months from the date of [Ms. Sager's] Declaration," i.e., in June 2009. Id. ¶ 29. Ms. Sager further avers that "[i]t is impossible for DIDP to estimate precisely at this time the volume of responsive documents likely to be identified during the searches for this request . . . . However, in light of DIDP's experience with requests seeking similar types of information, DIDP estimates that it will require two months to process plaintiff's FOIA request once it rises to the head of the Complex Track." Sager Decl.¶ 30.

GAP did not receive any documents responsive to its FOIA request within the 20-working-day time frame mandated by the FOIA, and filed an appeal of the constructive denial of its FOIA request with the FDA's Freedom of Information Office on August 3, 2007. Compl. ¶¶ 8-10. By letter dated August 6, 2007, HHS Public Health Service acknowledged receipt of GAP's appeal, but GAP has not received any information regarding the status of its appeal since then. Id. ¶ 11. On September 25, 2007, GAP filed its Complaint in this action. Id. ¶ 13. On January 29, 2008, GAP filed its Motion for Judgment on the Pleadings.

In response, on February 19, 2008, Defendants filed their Motion for an Open America Stay and Opposition to Plaintiff's Motion for Judgment on the Pleadings. According to Defendants, as of the date of that Motion, GAP's request remained pending in DIDP's Complex Track processing queue. Defs.' Mot. for an Open America Stay (hereinafter "Defs.' Mot.") at 4. Both Plaintiff's Motion for Judgment on the Pleadings and Defendants' Motion for an Open America Stay are now ripe for review.


A. Legal Standard

Under Section 552(a)(6)(C)(I) of the FOIA, the Government may obtain a stay of proceedings if it "can show exceptional circumstances exist and that the agency is exercising due diligence in responding to the [FOIA] request." 5 U.S.C. § 552(a)(6)(C)(I). In Open America, the D.C. Circuit addressed Section 552(a)(6)(C)(I) and found that an agency is entitled to additional time under FOIA's "exceptional circumstances" provision when the agency: is deluged with a volume of requests for information vastly in excess of that anticipated by Congress, when the existing resources are inadequate to deal with the volume of such requests within the time limits of subsection (6)(A), and when the agency can show that it "is exercising due diligence" in processing the requests. 547 F.2d at 616 (quoting 5 U.S.C. § 552(a)(6)(C)). Effective October 2, 1997, as part of the EFOIA, Congress added the following two subsections to Section 552(a)(6)(C):

(ii) For purposes of this subparagraph, the term "exceptional circumstances" does not include a delay that results from a predictable agency workload of requests under this section, unless the agency demonstrates ...

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