Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca9-13-15197/USCOURTS-ca9-13-15197-0/pdf.json

Nature of Suit Code: 899
Nature of Suit: Other Statutes - Administrative Procedure Act/Review or Appeal of Agency Decision
Cause of Action: 

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FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

W. SCOTT HARKONEN, M.D.,

Plaintiff-Appellant,

v.

UNITED STATES DEPARTMENT OF

JUSTICE; UNITED STATES OFFICE OF

MANAGEMENT AND BUDGET,

Defendants-Appellees.

No. 13-15197

D.C. No.

4:12-cv-00629-

CW

OPINION

Appeal from the United States District Court

for the Northern District of California

Claudia Wilken, Senior District Judge, Presiding

Argued and Submitted

March 9, 2015—San Francisco, California

Filed September 8, 2015

Before: John T. Noonan, William A. Fletcher,

and Andre M. Davis,* Circuit Judges.

Opinion by Judge Noonan

* The Honorable Andre M. Davis, Senior Circuit Judge for the U.S.

Court of Appeals for the Fourth Circuit, sitting by designation.

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2 HARKONEN V. U.S.D.O.J.

SUMMARY**

Information Quality Act

The panel affirmed the district court’s Fed. R. Civ. P.

12(b)(6) dismissal of Dr. W. Scott Harkonen’s action seeking

the correction of statements the United States Department of

Justice made about Dr. Harkonen in a 2009 press release.

The Information Quality Act required the Office of

Management and Budget to draft guidelines for federal

agencies that disseminate information, and required each

agency to issue its own agency-specific guidelines to correct

disseminated information. The DOJ issued a 2009 press

release concerningDr. Harkonen’s wire fraud conviction, and

Dr. Harkonen alleged that DOJ’s refusal to issue a correction

was arbitrary and capricious.

The panel applied Chevron analysis, and held that the

Office of Management and Budget’s and DOJ’s exclusion of

press releases from the coverage of the Information Quality

Act guidelines was not arbitrary and capricious, or manifestly

contrary to the Information Quality Act. The panel also held

that DOJ’s exclusion of press releases applied to the press

release of which Dr. Harkonen sought correction.

** This summary constitutes no part of the opinion of the court. It has

been prepared by court staff for the convenience of the reader.

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HARKONEN V. U.S.D.O.J. 3

COUNSEL

Mark E. Haddad (argued), Sidley Austin LLP, San Francisco,

California; Coleen Klasmeier and Kathleen M. Mueller,

Sidley Austin LLP, Washington, D.C., for PlaintiffAppellant.

Melissa N. Patterson (argued) and Alisa B. Klein, Appellate

Staff Attorneys, Melinda Haag, United States Attorney, and

Stuart F. Delery, Assistant Attorney General, United States

Department of Justice, Civil Division, Washington, D.C., for

Defendants-Appellees.

William G. Kelly, Jr., Multinational Legal Services, PLLC,

Driggs, Idaho, for Amicus Curiae Center for Regulatory

Effectiveness.

OPINION

NOONAN, Circuit Judge:

In this case we must decide whether the Administrative

Procedure Act and the Information Quality Act confer the

right to judicial review of a federal agency’s refusal to correct

allegedly false or misleading information published by the

agency in a press release. Dr. W. Scott Harkonen argues that

he has the right to obtain, and that the Department of Justice

(“DOJ”) has an obligation to provide, the correction of

statements DOJ made about him in a 2009 press release. Not

so, the government counters: Individuals have no such right,

even if the information DOJ published was misleading, false,

or even defamatory. We conclude that in the circumstances of

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4 HARKONEN V. U.S.D.O.J.

this case the government is correct, and therefore we

AFFIRM.1

I.

A.

The Information Quality Act (“IQA”) was included as a

brief note to the Consolidated Appropriations Act of 2001,

Pub. L. No. 106-554, 114 Stat. 2763 (2000). The IQA

required the Office of Management and Budget (“OMB”) to

draft guidelines “that provide policy and procedural guidance

to Federal agencies for ensuring and maximizing the quality,

objectivity, utility, and integrity of information . . .

disseminated by Federal agencies in fulfillment of the

purposes and provisions” of the Paperwork Reduction Act. Id.

§ 515(a). The IQA further required each agency to which the

guidelines applied to issue its own agency-specific guidelines

and to “establish administrative mechanisms allowing

affected persons to seek and obtain correction of information

maintained and disseminated by the agency that does not

comply with the guidelines . . . .” Id. § 515(b)(2). OMB

published its proposed guidelines with a request for public

comment on June 28, 2001, an interim set of guidelines on

September 28, 2001, and its final guidelines on February 22,

2002.

In formulating its guidelines, OMB attempted to balance

several often-competing concerns. OMBrecognized that “the

fact that the Internet enables agencies to communicate

1 Because we find that Harkonen does not have the right to judicial

review of DOJ’s refusal to correct information DOJ published about him,

we do not reach his contention that some of the information was false.

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HARKONEN V. U.S.D.O.J. 5

information quickly and easily to a wide audience . . .

increases the potential harm that can result from the

dissemination of information that does not meet basic

information quality guidelines.” Guidelines for Ensuring and

Maximizing the Quality, Objectivity, Utility, and Integrity of

Information Disseminated by Federal Agencies;

Republication (“Final OMB Guidelines”), 67 Fed. Reg. 8452

(Feb. 22, 2002). OMB also recognized that “information

quality comes at a cost.” Id. at 8453. Based on this concern,

OMBinstructed that “agencies should weigh the costs . . . and

the benefits of higher information quality” during the

formulation of their guidelines. Id. After receiving

commentary from, among other sources, several federal

agencies, OMB revised its definition of “dissemination” to

exclude information distributed through press releases from

coverage by the guidelines. Guidelines for Ensuring and

Maximizing the Quality, Objectivity, Utility, and Integrity of

Information Disseminated by Federal Agencies (“Interim

Final OMB Guidelines”), 66 Fed. Reg. 49,718, 49,723,

49,725. (Sept. 28, 2001). OMB’s final guidelines maintained

the exclusion of press releases from the definition of

“dissemination.” Final OMB Guidelines, 67 Fed. Reg. at

8460.

DOJ subsequently issued its own agency-specific

guidelines on October 4, 2002. See Information Quality:

DOJ Information Quality Guidelines, available at

http://www.justice.gov/iqpr/information-quality (updated

Dec. 31, 2014). These closely mirrored the OMB final

guidelines. Id. Relevant here, the scope of the guidelines

“does not apply to information disseminated in . . . press

releases fact sheets, press conferences or similar

communications (in any medium) that announce, support or

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6 HARKONEN V. U.S.D.O.J.

give public notice of information in DOJ.” Id. DOJ also

expressly stated that the

guidelines are not a regulation. They are not

legally enforceable and do not create any legal

rights or impose any legally binding

requirements or obligations on the agency or

the public. Nothing in these guidelines affects

any otherwise available judicial review of

agency action.

Id.

B.

W. Scott Harkonen is a medical doctor who served as

Chief Executive Officer and member of the Board of

Directors for InterMune, Inc. InterMune developed,

marketed, and sold drugs, including a drug called

Actimmune. Actimmune was approved by the FDA for the

treatment of two rare disorders, chronic granulomatous

disease and severe, malignant osteopetrosis. In October

2000, InterMune began a Phase III clinical trial (GIPF-001)

to determine whether Actimmune would be effective in

treating patients suffering from a different, more common

disorder, idiopathic pulmonary fibrosis (“IPF”). Enrollment

of 330 patients in the clinical trial was completed in October

2001. On August 27, 2002, Harkonen and other InterMune

employees met with staff of the FDA to review the results of

an interim analysis of the GIPF-001 study data. The FDA

staff told Harkonen that because the study did not meet its

primary endpoint–Actimmune had failed to reduce death or

disease progression in the entire group of treated subjects–the

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HARKONEN V. U.S.D.O.J. 7

data were insufficient for the FDA to grant approval for the

use of Actimmune in the treatment of IPF.

Nonetheless, on August 28, 2002, Harkonen distributed

a press release titled “InterMune Announces Phase III Data

Demonstrating Survival Benefit of Actimmune in IPF.” The

first paragraph of the press release stated that the GIPF-001

study “demonstrate[d] a significant survival benefit in

patients with mild to moderate disease randomly assigned to

Actimmune versus control treatment.” The first paragraph

concluded that “[t]here was also approximately a 10%

relative reduction in the rate of progression-free survival

associated with Actimmune versus placebo, the trial’s

primary endpoint, but this was not a statistically significant

difference.” The third paragraph of the press release quoted

Harkonen as stating, “Actimmune may extend the lives of

patients suffering from [IPF].” The fourth paragraph quoted

a study investigator as stating, “Actimmune should be used

early in the course of [IPF] in order to realize the most

favorable long-term survival benefit.” Not until the sixth

paragraph did the press release again address the failure of the

study to reach its primary endpoint. Even there, the press

release described the failure as demonstrating “a strong

positive trend in increased survival in the overall patient

population.” The tenth paragraph quoted an InterMune

officer as stating “we believe [there] is compelling rationale

for consideration of Actimmune for the treatment of patients

with [IPF].”

On March 18, 2008, the government indicted Harkonen

on one count of wire fraud for making allegedly false

statements in the press release, and one count of felony

misbranding related to InterMune’s alleged off-label

marketing and sale of Actimmune for IPF. Following a jury

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8 HARKONEN V. U.S.D.O.J.

trial, Harkonen was convicted on September 29, 2009, of wire

fraud but was acquitted on the misbranding count. 

Harkonen’s appeal of his criminal conviction and sentence

was affirmed by this court on March 4, 2013. United States

v. Harkonen, 510 Fed. App’x. 633 (9th Cir. 2013), cert.

denied, 134 S. Ct. 824 (2013).

On the day the verdict was announced, DOJissued a press

release titled “W. Scott Harkonen, Former Biotech CEO,

Convicted of Wire Fraud.” The DOJ press release included

the two statements at issue in this case:

• “Mr. Harkonen lied to the public about the

results of a clinical trial and offered false

hope to people stricken with a deadly

disease.”

• “The actions of this defendant served to

divert precious financial resources from

the VA’s critical mission of providing

healthcare to this nation’s military

veterans.”

The press release was posted on the DOJ website.

On February 11, 2010, during the pendency of his appeal

of his conviction and sentence, Harkonen filed a “Request for

Correction under Information Quality Guidelines” with DOJ. 

Harkonen requested that “the government issue a retraction

of the statement in the September 29, 2009 press release that

[he had] ‘falsif[ied] test results,’” publish the retraction, and

“remove the original September 29 press release from all

official government websites.”

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HARKONEN V. U.S.D.O.J. 9

On March 15, 2010, DOJ denied Harkonen’s request,

explaining in a letter to Harkonen’s counsel that the request

“falls outside the scope of the Department’s guidelines,” and

further stating that “regardless of the guidelines’ application,

we do not believe a retraction is warranted under the

circumstances.” Letter from H. Marshall Jarrett, Director of

the Executive Office for United States Attorneys, to

Harkonen’s Counsel. DOJ explained that under DOJ

guidelines, “press releases . . . that announce, support or give

public notice of information in DOJ” were excluded from

coverage of the guidelines. Id. Further, DOJ maintained the

challenged statement was correct. Id. DOJ admitted that

while Harkonen did not change the study data, “he

nevertheless used it to support his false and misleading

conclusions.” Id.

On April 20, 2010, Harkonen filed a “Request for

Reconsideration under Information Quality Guidelines.” 

DOJ rejected this request on July 2, 2010.

On June 8, 2011, Harkonen filed another request for

correction with the DOJ, requesting the retraction of the

statement in the DOJ press release that Harkonen “divert[ed]

precious financial resources from the VA’s critical mission of

providing healthcare to this nation’s military veterans.” DOJ

denied this request on August 4, 2011, and denied

Harkonen’s request for reconsideration on October 7, 2011.

On February 8, 2012, Harkonen filed a complaint in the

U.S. District Court for the Northern District of California,

claiming DOJ’s denials of his requests for correction under

Information Quality Guidelines was arbitrary and capricious,

an abuse of discretion, and contrary to law (Count I), and that

the exclusion of press releases from DOJ’s and OMB’s

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10 HARKONEN V. U.S.D.O.J.

Information Quality Guidelines was arbitrary and capricious,

an abuse of discretion, and contrary to law (Counts II and III). 

Harkonen sought declaratoryjudgments that DOJ’s denials of

his requests for correction and DOJ’s and OMB’s exclusion

of press releases from their guidelines were arbitrary and

capricious, an abuse of discretion, and contrary to law. He

sought a permanent injunction requiring DOJ to retract the

press release statements about falsifying test results and

diverting financial resources from the VA, and to remove the

press release from all official government websites.

On December 3, 2012, the district court granted the

government’s motion to dismiss under Rule 12(b)(6). 

Harkonen timely appealed.

II.

We review de novo a district court’s dismissal for failure

to state a claim under Rule 12(b)(6). ASARCO, LLC v. Union

Pac. R.R. Co., 765 F.3d 999, 1004 (9th Cir. 2014). In order

for Harkonen to prevail, he must be able to assert a cause of

action for the violation of a legal right. Absent a statutory

provision, an individual can not assert a cause of action

against the government for the dissemination of inaccurate,

incorrect, or defamatory information. See Salt Inst. v. Leavitt,

440 F.3d 156, 158 (4th Cir. 2006) (“[T]here is no general

common law right to . . . informational correctness . . . .”). It

is against this backdrop that we must inquire as to whether

Congress intended the IQA to provide individuals a right to

judicial review of a federal agency’s rejection of a request to

obtain correction of information disseminated by the

government.

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HARKONEN V. U.S.D.O.J. 11

A.

Harkonen argues that the APA provides for judicial

review of DOJ’s denial of his correction requests under the

IQA. The IQA directs OMB to “issue guidelines . . . that

provide policy and procedural guidance to Federal agencies

for ensuring and maximizing the quality, objectivity, utility,

and integrityof information (including statistical information)

disseminated by Federal agencies in fulfillment of the

purposes and provisions of . . . the Paperwork Reduction

Act.” Consolidated Appropriations Act of 2001, Pub. L. No.

106-554, 114 Stat. 2763 (2000). The guidelines “apply to the

sharing by Federal agencies of, and access to, information

disseminated by Federal agencies.” Id. The guidelines “shall

. . . require that each Federal agency to which the guidelines

apply . . . establish administrative mechanisms allowing

affected persons to seek and obtain correction of information

maintained and disseminated by the agency that does not

comply with the guidelines.” Id. The IQA further establishes

an administrative mechanism that enables OMB to track the

“number and nature of complaints received by” each covered

agency and “how such complaints were handled by the

agency.” Id.

The focus of the IQA, as stated in Section 515(b), is on

the quality of information shared by federal agencies, and on

ensuring broad access to information. Id. Thus, the IQA

creates an administrative system designed to permit federal

agencies and OMB to monitor and improve the information

used and disseminated by federal agencies. Harkonen argues

on appeal that the IQA imposes an obligation on the DOJ to

correct information disseminated by the agency, and creates

a right under the APA to judicial review of DOJ decisions not

to correct this information. (Harkonen denied in the district

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12 HARKONEN V. U.S.D.O.J.

court that he was arguing the IQA created a private right of

action, claiming instead that his claim arose under the APA). 

The government argues the IQA does not authorize courts to

review the correctness of information disseminated by an

agency.

We have no reason in this case to reach the broad

question of whether the IQA confers upon a private

individual the right to seek judicial review of the correctness

of all information published by the government. Here, both

OMB and DOJ excluded press releases from the coverage of

the IQA guidelines. If these decisions were within the

agencies’ authority, the review and correction mechanisms

required by § 515(b)(2) do not apply to press releases, and

neither OMB nor DOJ had an obligation to review for

correctness the DOJ press release about Harkonen. Thus, our

review must begin with the threshold question of whether

OMB and DOJ had the authority to exclude press releases

from the coverage of the IQA guidelines.

B.

1.

Whether OMB’s and DOJ’s decisions to exclude press

releases from the coverage of the IQA guidelines were within

their authority is analyzed using the familiar two-step

framework established by Chevron, U.S.A., Inc. v. Natural

Res. Def. Council, Inc., 467 U.S. 837 (1984). At the first step,

if Congress “has directly spoken to the precise question at

issue . . . the court, as well as the agency, must give effect to

the unambiguously expressed intent of Congress.” Id. at 842.

The issue here is whether the IQA unambiguously expressed

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HARKONEN V. U.S.D.O.J. 13

the intent of Congress to include press releases in the

guidelines.

The analysis begins with the plain language of the statute.

Resident Councils of Wash. v. Leavitt, 500 F.3d 1025, 1034

(9th Cir. 2007). The relevant provision of the Act states:

The guidelines under subsection (a) shall

(1) apply to the sharing by Federal

agencies of, and access to, information

disseminated by Federal agencies; and

(2) require that each Federal agency to

which the guidelines apply

(A) issue guidelines ensuring and

maximizing the quality, objectivity, utility,

and integrity of information (including

statistical information) disseminated by the

agency, by not later than 1 year after the date

of issuance of the guidelines under subsection

(a);

(B) establish administrative mechanisms

allowing affected persons to seek and obtain

correction of information maintained and

disseminated by the agency that does not

comply with the guidelines issued under

subsection (a).

Consolidated Appropriations Act of 2001, Pub. L. No. 106-

554, 114 Stat. 2763 (2000).

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14 HARKONEN V. U.S.D.O.J.

The issue here is whether “disseminated” unambiguously

applies to information contained in a press release. The IQA

does not define “disseminated.” See generally id. Nor does

the Paperwork Reduction Act, which the IQA amended. See

44 U.S.C. §§ 3501–3521 (using, but not defining,

“disseminated” in multiple provisions). There is minimal

legislative history for the IQA, and the scope of

“disseminated” appears not have been discussed at all.

FEDERAL ADMINISTRATIVE PROCEDURE SOURCEBOOK

779–80 (William F. Funk et al. eds., 4th ed. 2008). The

overall structure of the IQA indicates that Congress had two

concerns. First, Congress was concerned that information

shared by Federal agencies, Sec. 515(b)(1), be of maximal

“quality, objectivity, utility, and integrity,” Sec. 515(a).

Second, Congress was concerned that access to information

possessed by Federal agencies be ensured. Sec. 515(b)(1).

Neither of these concerns reflects, or even suggests, an intent

by Congress that all information released by the government

fall under the ambit of the guidelines.

The only other appellate court to examine this issue has

found the IQA to have committed the definition of

“disseminated” to OMB’s discretion. Prime Time Int’l Co. v.

Vilsack, 599 F.3d 678, 685 (D.C.C. 2010).

Because Congress was silent on the definition of

“dissemination,” and left OMB at least some discretion to

determine how broadly “dissemination” applied, we must

proceed to the second step of the Chevron analysis.

2.

If a statute is ambiguous with respect to a specific issue,

the second step of the Chevron analysis establishes that “the

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HARKONEN V. U.S.D.O.J. 15

question for the court is whether the agency’s answer is based

on a permissible construction of the statute.” Chevron,

467 U.S. at 843. If “Congress has left a gap for the

administrative agency to fill, we . . . must uphold the

administrative regulation unless it is arbitrary, capricious, or

manifestly contrary to the statute.” Defenders of Wildlife v.

Browner, 191 F.3d 1159, 1162 (9th Cir. 1999) (internal

quotation marks omitted).

Here, Congress left a gap in the IQA for OMB and DOJ

to fill regarding the definition of “disseminated.” Thus, the

highly deferential standard of review at Step Two of the

Chevron analysis applies. This analysis leads to the

conclusion OMB’s and DOJ’s exclusion of press releases was

not arbitrary and capricious, or manifestly contrary to the

statute.

Government agencies make extensive use of press

releases. In formulating its guidelines, and specifically its

definition of the scope of “dissemination,” OMB balanced

several concerns. OMB recognized that “the fact the Internet

enables agencies to communicate information quickly and

easily to a wide audience . . . increases the potential harm that

can result from the dissemination of information that does not

meet basic information quality guidelines.” Final OMB

Guidelines, 67 Fed. Reg. at 8452. OMB also recognized that

“information quality comes at a cost.” Id. at 8453. After

considering comments received from, among others, several

federal agencies, OMB revised its definition of

“dissemination” to exclude information distributed through

press releases. Interim Final OMB Guidelines, 66 Fed. Reg.

at 49,725. Given the deference accorded to agency

interpretations of ambiguous statutes and the careful

consideration OMB, and DOJ, gave to the relevant issues, we

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16 HARKONEN V. U.S.D.O.J.

find that excluding press releases from the ambit of the IQA

guidelines was “a permissible interpretation of the statute.”

Prime Time Int’l, 599 F.3d at 685.

3.

Having determined that DOJ’s exclusion of press releases

from the ambit of the IQA guidelines was within the

discretion accorded to the agency, the only remaining

question is whether DOJ’s exclusion of press releases applies

to the press release of which Harkonen seeks correction.

An agency’s interpretation of its own regulations is

entitled to judicial deference unless that interpretation is

“plainly erroneous or inconsistent with the regulation.” Auer

v. Robbins, 519 U.S. 452, 461 (1997). The scope of DOJ’s

guidelines “does not apply to information disseminated in . . .

press releases fact sheets, press conferences or similar

communications (in any medium) that announce, support or

give public notice of information in DOJ.” Information

Quality: DOJ Information Quality Guidelines, available at

http://www.justice.gov/iqpr/information-quality (updated

Dec. 31, 2014). DOJ’s determination that the 2009 press

release fell within its exclusion of press releases is neither

erroneous nor inconsistent with the scope of dissemination as

defined in the agency-specific guidelines. Therefore, DOJ’s

determination is accorded Auer deference.

III.

Harkonen relies heavily on this court’s decision in Barber

v. Widnall, 78 F.3d 1419 (9th Cir. 1996). There, a retired Air

Force pilot sought correction of his military records under a

federal statute providing “the Secretary ‘may correct any

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HARKONEN V. U.S.D.O.J. 17

military record . . . when the Secretary considers it necessary

to correct an error or remove an injustice.’” Id. at 1423

(quoting 10 U.S.C. § 1552). However, in Barber there was no

question that the plaintiff’s military records fell within the

scope of § 1552; clearly, the plaintiff had the right to invoke

the administrative process that had been created to evaluate

requests for corrections of military records. The issue in

Barber was not that the Secretary refused to put the request

through the administrative process. In fact, that process had

been conducted extensively, resulting in the inability of the

Air Force Board for Correction of Military Records to reach

consensus and the Secretary’s subsequent denial of the

request.Id. at 1422. Here, the guidelines clearlyexclude press

releases from the coverage of the guidelines and hence from

application of the administrative review process for

correction. Thus, Harkonen’s primary challenge is not to a

decision made after a review, but rather is a challenge to

OMB’s and DOJ’s interpretation of the IQA that excluded

press releases from the definition of disseminated

information. Because this challenge fails the test established

byChevron, U.S.A., Inc., Harkonen’s references to Barber are

inapposite.

AFFIRMED.

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