[Federal Register Volume 76, Number 223 (Friday, November 18, 2011)]
[Notices]
[Pages 71604-71607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29708]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 10-53]


Kamal Tiwari, M.D.; Pain Management and Surgery Center of 
Southern Indiana; Decision and Order

    On April 23, 2010, I, the Administrator of the Drug Enforcement 
Administration, issued an Order to Show Cause and Immediate Suspension 
of Registration to Kamal Tiwari, M.D. (Respondent Tiwari), holder of 
DEA Certificate of Registration BT2936411, and his principal place of 
business, the Pain Management and Surgery Center (Respondent PMSC), 
holder of DEA Certificate of Registration BP4917413, both of 
Bloomington, Indiana. The Show Cause Order proposed the revocation of 
each Respondent's registration, on the ground that Respondent Tiwari 
had committed acts which render the continued registration of each 
Respondent ``inconsistent with the public interest.'' Show Cause Order, 
at 1 (citing 21 U.S.C. 823(f) and 824(a)(4)).
    The Show Cause Order specifically alleged that between March 2003 
and August 2008, Respondent Tiwari issued ``numerous'' prescriptions 
for controlled substances to three patients, who were addicts, and 
``who did not exhibit any verifiable medical indications warranting the 
prescribing of controlled substances.'' Id. at 2. The Order thus 
alleged that Respondent lacked a legitimate medical purpose and acted 
outside the usual course of professional practice in issuing the 
prescriptions and violated federal and state laws. Id. (citing 21 
U.S.C. 841(a)(1); 21 CFR 1306.04(a); Ind. Code Sec.  25-1-9-4(a)(9)). 
With respect to these patients, the Show Cause Order further alleged 
that Respondent prescribed controlled substances to them ``in exchange 
for their agreements to undergo medical procedures * * * for profit,'' 
and that ``[t]his prescribing pattern indicates'' that he issued the 
``prescriptions without a legitimate medical purpose and outside the 
scope of professional practice.'' Id. at 2-3.
    The Show Cause Order also alleged that a medical expert concluded 
that Respondent's prescribing to these three patients lacked ``a 
legitimate medical purpose and [was] outside the scope of professional 
practice.'' Id. at 3. The Order further alleged that the expert 
concluded with respect to these three patients, as well as nine other 
patients, that Respondent's ``actions encouraged the abuse of 
controlled substances and allowed their misuse,'' that his prescribing 
of controlled substances contributed to the deaths of six patients, and 
that there was no justification for his ``long-term prescribing of 
controlled substances * * * or the administration of procedures using 
controlled substances'' to these patients. Id.
    Next, the Show Cause Order alleged that a second medical expert 
concluded that Respondent Tiwari had prescribed controlled substances 
to, and/or performed medical procedures using controlled substances 
without medical justification on, several other patients. Id. Finally, 
the Show Cause Order alleged that ``at least nine of'' Respondent's 
patients had died over a six-year period, the most recent being in 
February 2009, and that Respondent had ``continue[d] to prescribe 
controlled substances to patients at per-patient rates that [we]re 
similar to the prescribing rates in 2008, when two of [his] patients 
died of conditions related to drug abuse.'' Id.
    Based on the above, I concluded that Respondents' continued 
registration during the pendency of the proceeding ``constitutes an 
imminent danger to the public health and safety.'' Id. at 4. I 
therefore ordered that each Respondent's registration be immediately 
suspended. Id.
    On May 24, 2010, Respondents filed a request for a hearing and the 
matter was assigned to an Administrative Law Judge (ALJ), who proceeded 
to conduct pre-hearing procedures. However, on May 27, 2010, the 
Government moved for Summary Disposition and filed a Motion to Stay the 
Filing of Prehearing Statements. Mot. Summ. Disp., at 2-3.
    The basis of the Government's motion was that each Respondent 
currently lacks authority to handle controlled substances in the State 
of Indiana, the jurisdiction where the Respondents are licensed to 
practice medicine and hold their DEA registrations. Mot. Summ. Disp., 
at 1-2 (citing 21 U.S.C. 801(21), 823(f), 824(a)(3)). In support of its 
motion, the Government attached a letter from the Medical Licensing 
Board of Indiana (MLB) to Respondent Kamal Tiwari, dated May 26, 2010, 
stating that

[[Page 71605]]

his Indiana controlled substance registration (CSR) Number 01034945B, 
had been suspended pursuant to Indiana Code Sec.  35-48-3-5(e).\1\ Id. 
at Ex. 3. The Government also attached a printout from the Indiana 
Online Licensing Web site which shows that Indiana CSR Number 
61100223B, held by Respondent PMSC, has also been suspended. Id. at Ex. 
4.
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    \1\ This provision states: ``If the Drug Enforcement 
Administration terminates, denies, suspends or revokes a federal 
registration for the manufacture, distribution, or dispensing of 
controlled substances, a registration issued by the board under this 
chapter is automatically suspended.'' Ind. Code Sec.  35-48-3-5(e).
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    Thereafter, the ALJ issued an Order for Respondents' Response to 
Government's Motion for Summary Disposition and to Stay the Filing of 
Prehearing Statements; she also stayed the filing of the Prehearing 
statements. ALJ's Recommended Ruling (also ALJ), at 4.
    On June 16, 2010, Respondents filed their Response. Therein, 
Respondents argued that granting summary disposition based on their 
lack of state authority to handle controlled substances would be 
circular and violate their right to Due Process, because the State's 
suspension of their state CSRs was based on the DEA Order to Show Cause 
and Immediate Suspension of Registration. Resps. Response at 1, 3-6. 
Respondents also argued that in suspending their state registrations, 
the MLB cited ``no basis for the State suspension other than the 
federal suspension.'' Id. at 2. Respondents further maintain that the 
MLB ``has no authority concerning controlled substances registrations, 
which are instead under the jurisdiction of the Indiana State Board of 
Pharmacy.'' Id. at 2-3 (citations omitted).
    Respondents also argued that in none of the cases cited by the 
Government did it ``attempt to rely * * * on a derivative state action 
triggered by the Government's suspension,'' and that ``[n]ot a single 
one of the Government's cases revoke[d] a registration under 21 U.S.C. 
843(a)(3) without some independent determination'' by the respective 
state authority. Id. at 4. Respondents thus maintained that 
``[d]epriving a practitioner of the right to review of a DEA action 
based solely on a State suspension that was in turn based solely on the 
original DEA action would violate Due Process.'' Id. at 5. Finally, 
Respondents also contended that ``[p]ractitioners may not be able to 
obtain review of either suspension, if the State takes the same 
position that the [DEA] does here.'' Id.
    On June 17, the Government filed its Reply to Opposition to 
Government's Motion for Summary Disposition and to Stay the Filing of 
Pre-hearing Statements (Reply). The Government argued that ``Indiana 
law specifically provides a basis for substantive review of any state 
suspension which is triggered by a DEA suspension.'' Reply at 1 (citing 
Ind. Code Sec.  35-48-3-5(f)).\2\ The Government further argues that 
under DEA precedent, ``when a state suspends a respondent's controlled 
substance privileges, Federal revocation is warranted as long as the 
respondent has some mechanism to challenge the state action.'' Id. at 2 
(citing Odette Louise Campbell, M.D., No. 09-62, Order Remanding for 
Further Proceedings).\3\
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    \2\ ``The board may reinstate a registration that has been 
suspended under subsection (e), after a hearing, if the board is 
satisfied that the applicant is able to manufacture, distribute, or 
dispense controlled substances with reasonable skill and safety to 
the public.'' Ind. Code Sec.  35-48-3-5(f).
    \3\ The Government also argued that ``to the extent that 
Respondents argue that the Medical Licensing Board of Indiana * * * 
has no authority concerning controlled substance registrations, that 
jurisdictional argument must be made to the Board of Pharmacy,'' and 
that in ``its letter to [Respondent] Tiwari, the Medical Licensing 
Board * * * merely informed Respondent that his CSR was suspended 
pursuant to the appropriate statute.'' Reply at 3. Finally, the 
Government attached a May 27, 2010 letter from the Indiana Board of 
Pharmacy to Respondents which stated that Indiana CSR Number 
61100223B, which is held by Respondent PMSC, had been suspended 
pursuant to Ind. Code Sec.  35-48-3-5(e). Reply at 3, Ex. 3-A.
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    On June 18, 2010, Respondents filed a Surreply in Opposition to 
Government's Motion for Summary Disposition (Surreply), in which they 
assert that the Government ``fundamentally misunderstands the Indiana 
statutory scheme.'' Surreply, at 1. Therein, the Respondents again 
argued that the ``Government's Motion for Summary Disposition should be 
denied because it relies on a potential, nonbinding state hearing, a 
theoretical possibility that cannot be triggered until the Indiana 
Board that actually has authority to suspend the Respondents' 
controlled substances registrations issues an order to show cause, 
which it has not.'' Id. Respondents further maintained that ``the 
Indiana Advisory Committee could avoid the hearing provision on which 
the Government relies solely by not issuing the show cause notice.'' 
Id. at 2.
    On June 21, 2010, the ALJ issued an Order for Government's Response 
to Surreply in Opposition to Government's Motion for Summary 
Disposition. On July 2, 2010, the Government filed its Response to 
Surreply. The Government reiterated that the Respondents' Indiana CSRs 
have been suspended and that while the issuance of the DEA Immediate 
Suspension Orders ``may have been the cause of the state suspension, 
[they] do not govern whether those state suspensions remain in 
effect.'' Response to Surreply, at 1.
    The Government again argued that under Indiana law, the Board of 
Pharmacy `` `may reinstate a [CSR] that has been suspended under 
subsection (e), after a hearing, if the board is satisfied that the 
applicant is able to * * * dispense controlled substances with 
reasonable skill and safety to the public.' '' Id. (quoting Ind. Code 
Sec.  35-48-3-5(f)). The Government also noted that Respondents had 
filed a Petition for Review of the state suspensions, albeit with the 
Medical Licensing Board and not the Board of Pharmacy. Id. The 
Government argued that this nonetheless demonstrated that Respondents 
knew of, and were pursuing, their right to seek administrative review 
of the State's suspensions, pursuant to section 35-48-3-5(f).
    Next, the Government argued that Respondents' contention that 
Indiana must issue an Order to Show Cause prior to suspending their 
CSRs is without merit, and that in any case, the issue is a matter of 
state law, and not a matter for a DEA ALJ to decide. Response to 
Surreply, at 2. Finally, the Government argued that the Respondents' 
interpretation of the Indiana statutes would render them inconsistent 
and meaningless. Id. at 2-3.
    On July 7, 2010, the ALJ issued her recommended decision 
(hereinafter ALJ). Therein, the ALJ specifically found that the Indiana 
Board of Pharmacy had automatically suspended the Indiana CSRs held by 
the Respondents. ALJ at 5. Noting the settled Agency rule that 
``possessing authority under state law to handle controlled substances 
is an essential condition for holding a DEA registration,'' id. at 6 
(quoting Joseph Baumstarck, M. D., 74 FR 17525, 17527 (2009)), and 
rejecting Respondents' contention that granting summary disposition 
would deny them their right to Due Process, the ALJ granted the 
Government's Motion for Summary Disposition. ALJ at 5-7, 9. The ALJ 
thus recommended that I revoke the Respondents' DEA Certificates of 
Registration and deny any pending applications to renew their 
registrations. Id. at 9.
    Neither party filed exceptions to the ALJ's decision. Thereafter, 
the record was forwarded to me for final agency action.

[[Page 71606]]

    Having considered the record as a whole including the parties' 
pleadings, I adopt the ALJ's findings of fact and recommended sanction. 
I will therefore revoke Respondents' respective DEA Certificates of 
Registration and deny any pending applications to renew their 
registrations. I make the following findings.

Findings

    Respondent Tiwari is the holder of Certificate of Registration 
BT2936411, which authorizes him to dispense controlled substances in 
schedules II through V, as a practitioner. While this registration was 
due to expire on November 30, 2009, on October 2, 2009, Respondent 
Tiwari submitted a timely renewal application. Respondent Tiwari's 
registration thus remains active, albeit in suspended status, pending 
the issuance of the Final Order in this matter. 5 U.S.C. 558(c).
    Respondent PMSC is the holder of Certificate of Registration 
BP4917413, which authorizes it to dispense controlled substances in 
schedules II through V, as a hospital/clinic. This registration is due 
to expire on March 31, 2011. According to the registration records of 
this Agency, Respondent Tiwari has also submitted an application to 
renew Respondent PMSC's registration.
    On or about May 27, 2010, the Indiana Board of Pharmacy placed 
Respondent PMSC's Indiana CSR in suspended status. See Reply to Opp. to 
Gov. Mot. for Summ. Disp., at Ex. 3-A. Moreover, according to a letter 
from the MLB to Respondent Tiwari, on or about May 26, 2010, his 
Indiana CSR was placed in suspended status. Id. at Ex. 3. According to 
the Indiana Online Licensing Web site, of which I take official notice, 
each Respondent's CSR remains suspended as of the date of this Decision 
and Final Order.\4\
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    \4\ Under the Administrative Procedure Act (APA), an agency 
``may take official notice of facts at any stage in a proceeding-
even in the final decision.'' U.S. Dept. of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and 
DEA's regulations, Respondent is ``entitled on timely request, to an 
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21 
CFR 1316.59(e). Respondent can dispute the facts of which I take 
official notice by filing a properly supported motion for 
reconsideration within twenty days of service of this Order, which 
shall begin on the date it is mailed.
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Discussion

    Under the Controlled Substances Act (CSA), a practitioner must be 
currently authorized to handle controlled substances in ``the 
jurisdiction in which he practices'' in order to maintain a DEA 
registration. See 21 U.S.C. 802(21) (``[t]he term `practitioner' means 
a physician * * * pharmacy, hospital, or other person licensed, 
registered, or otherwise permitted, by * * * the jurisdiction in which 
he practices * * * to distribute, dispense, [or] administer * * * a 
controlled substance in the course of professional practice''). See 
also id. Sec.  823(f) (``The Attorney General shall register 
practitioners * * * if the applicant is authorized to dispense * * * 
controlled substances under the laws of the State in which he 
practices.''). As these provisions make plain, possessing authority 
under state law to handle controlled substances is an essential 
condition for obtaining and maintaining a practitioner's registration.
    Accordingly, DEA has held that revocation of a practitioner's 
registration is warranted whenever his (or its) state authority to 
dispense controlled substances has been suspended or revoked. David W. 
Wang, 72 FR 54297, 54298 (2007); Sheran Arden Yeates, 71 FR 39130, 
39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby 
Watts, 53 FR 11919, 11920 (1988). See also 21 U.S.C. 824(a)(3) 
(authorizing revocation of a registration ``upon a finding that the 
registrant * * * has had his State license or registration suspended 
[or] revoked * * * and is no longer authorized by State law to engage 
in the * * * distribution [or] dispensing of controlled substances'').
    DEA has further held that revocation is warranted even where a 
practitioner's state authority has been summarily suspended and the 
State has yet to provide the practitioner with a hearing to challenge 
the State's action and at which he (or it) may ultimately prevail. See 
Robert Wayne Mosier, 75 FR 49950 (2010) (``revocation is warranted * * 
* even in those instances where a practitioner's state license has only 
been suspended, and there is the possibility of reinstatement''); 
accord Bourne Pharmacy, 72 FR 18273, 18274 (2007); Anne Lazar Thorn, 62 
FR 12847 (1997).
    Here, it is undisputed that the State has suspended the state 
controlled substance registration of each Respondent. DEA has long held 
that the order of a state agency suspending or revoking a 
practitioner's state authority cannot be collaterally attacked in a 
proceeding under the CSA. See Hicham K. Riba, 73 FR 75773, 75774 (2008) 
(rejecting claim that state proceeding was fundamentally unfair based 
on alleged improper ex parte influence of director of state board as 
``not addressable in'' DEA proceeding); Sunil Bhasin, 72 FR at 5082, 
5083 (2007) (rejecting claim that settlement agreement in which 
Respondent surrendered state license was produced by fraud and was 
unconscionable; ``a DEA Show Cause Proceeding is not the proper forum 
to litigate the issue''); see also Shahid Musud Siddiqui, 61 FR 14818 
(1996); Robert A. Leslie, 60 FR 14004 (1995).
    The underlying premise of these cases is that the States exercise 
sovereign powers in regulating the medical profession and that 
challenges to the validity of state board orders should be raised and 
litigated in state forums. See, e.g., Riba, 73 FR at 75774 (claim that 
``state proceeding was fundamentally unfair * * * is not addressable 
in'' DEA proceeding). These cases likewise implicitly recognize that 
state boards and state courts are fully cognizant of their obligation 
under the Due Process Clause to provide a full and fair opportunity to 
litigate the issues. Cf. University of Tennessee v. Elliott, 478 U.S. 
788, 797-98 (1986) (``When an administrative agency is acting in a 
judicial capacity and resolves disputed issues of fact properly before 
it which the parties have had an adequate opportunity to litigate, the 
courts have not hesitated to apply res judicata[.]'') (int. quotations 
and citations omitted).
    It is true that in Odette Louise Campbell, M.D., No. 09-62, I 
denied the Government's request for a final order based on the 
registrant's loss of her controlled substance prescribing authority 
under Texas law where the State had suspended that authority based on 
DEA's issuance of an immediate suspension order and remanded the matter 
for further proceedings. Campbell, Order Remanding for Further 
Proceedings, at 10-11. However, I noted that specific provisions of 
Texas law and regulations suggested that the registrant was not 
entitled to a hearing to challenge the merits of the state suspension 
because it was based on the DEA immediate suspension. Id. at 9 (citing 
Texas Health & Safety Code Sec. Sec.  481.063(e)(3), 481.063(h), 
481.066(g), and Tex. Admin. Code Sec.  13.272(h)). Moreover, I ordered 
the ALJ to first determine whether the State had provided, or would 
provide, the registrant with a hearing; I further ordered that if the 
State had provided or would provide a hearing, the Government could 
renew its motion for summary disposition. Id. at 10.
    By contrast, while the Indiana Board(s) suspended Respondents' 
state registrations based on the state law provision that ``[i]f the 
Drug Enforcement Administration * * * suspends * * * a federal 
registration for the * * * dispensing of controlled substances, a 
registration issued by the board under this chapter is automatically 
suspended,'' Ind. Code

[[Page 71607]]

Sec.  35-48-3-5(e), state law further provides that ``[t]he board may 
reinstate a registration that has been suspended under subsection(e) 
after a hearing, if the board is satisfied that the applicant is able 
to manufacture, distribute or dispense controlled substances with 
reasonable skill and safety to the public.'' Id. Sec.  35-48-3-5(f). 
(emphasis added). Thus, it appears that Respondents are entitled to a 
hearing to challenge the underlying allegations before the State board.
    Respondents contend that their right to a hearing under section 35-
48-3-5(f) ``is not triggered until the Indiana Controlled Substances 
Advisory Committee serves upon the * * * registrant an order to show 
cause why registration should not be denied, revoked or suspended,'' 
and that ``absent such a step, the purported suspension issued by the 
board * * * is a nullity, and cannot form the basis for a federal 
suspension.'' Surreply at 2 (citing Ind. Code Sec.  35-48-3-6(a)).\5\ 
Respondents further argue that ``[i]f it could, then the Indiana 
Advisory Committee could avoid the hearing provision on which the 
Government relies solely by not issuing the show cause notice.'' Id.
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    \5\ This provision states:
     Before recommending a denial, suspension, or revocation of a 
registration, or before refusing a renewal of registration, the 
board shall serve upon the applicant or registrant an order to show 
cause why registration should not be denied, revoked, or suspended * 
* *. The order to show cause shall contain a statement of the basis 
therefor [sic] and shall call upon the applicant or registrant to 
appear before the board at a time and place not less than thirty 
(30) days after the date of service of the order * * *.
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    Beyond the fact that Respondents' argument appears to be based on 
the speculative premise that the Indiana authorities will attempt to 
prevent them from obtaining a hearing, the Indiana statute makes clear 
that Respondents are entitled to a hearing. Presumably, the Indiana 
courts are open and can provide an appropriate remedy in the event the 
state board refuses to provide Respondents with a hearing. See Ind. 
Code Sec.  34-27-3-1 (``An action for mandate may be prosecuted against 
any inferior tribunal * * * public * * * officer, or person to compel 
the performance of any * * * act that the law specifically 
requires[.]'').
    Moreover, the question of whether the Indiana suspensions are a 
nullity because the State did not serve Respondents with a Show Cause 
Order is an issue of state law and for the Indiana courts to decide. As 
such, it is outside the scope of this proceeding. See George S. Heath, 
M.D., 51 FR 26610 (1986) (``DEA accepts as valid and lawful the action 
of a state regulatory board unless that action is overturned by a state 
court or otherwise pursuant to state law. * * * The [DEA] will not 
consider a challenge to the lawfulness of a Georgia Board Order. Such a 
challenge must be made in another forum.''); see also Shahid Musud 
Siddiqui, M.D., 61 FR 14818, 14818-19 (DEA 1996) (A ``DEA 
administrative proceeding is not an appropriate forum for wholesale 
review of state criminal and administrative actions taken by the State 
of New York arising out of the laws of the State of New York. To allow 
it to be so would be to permit a wide collateral attack upon such 
convictions.'') (int. quotations and citation omitted).
    Finally, Respondents argue that the suspensions of their state CSRs 
are invalid because they were suspended by the MLB and only the 
Pharmacy Board has authority under state law to suspend their 
registrations. However, the Pharmacy Board's May 27, 2010 letter makes 
clear that it (and not the MLB) was suspending Respondent PMSC's 
registration, and even if Respondent Tiwari's controlled substance 
registration was suspended by the MLB, the validity of this action is 
also a question of state law and for the Indiana courts to decide. 
Riba, 73 FR at 75774; Heath, 51 FR at 26610.
    Because there is no dispute over the material fact that each 
Respondent's Indiana controlled substance registration has been 
suspended, each is without authority to hold a DEA registration.\6\ See 
21 U.S.C. 802(21). Accordingly, Respondents' registrations will be 
revoked and any pending applications will be denied.
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    \6\ Where, as here, no material fact is in dispute, there is no 
need for an evidentiary hearing and summary disposition is 
appropriate. See Michael G. Dolin, M.D., 65 FR 5661 (2000); see also 
Philip E. Kirk, M.D., 48 FR 32887 (1983), aff'd sub nom Kirk v. 
Mullen, 749 F.2d 297 (6th Cir. 1984).
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Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 28 CFR 0.100(b) and 0.104, I order that DEA 
Certificate of Registration, BT2936411, issued to Respondent Kamal 
Tiwari, M.D., and DEA Certificate of Registration, BP4917413, issued to 
Respondent Pain Management and Surgery Center of Southern Indiana, be, 
and they hereby are, revoked. I further order that any pending 
applications of Kamal Tiwari, M.D. and Pain Management and Surgery 
Center of Southern Indiana, to renew or modify such registrations, be, 
and they hereby are, denied. This Order is effective immediately.\7\
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    \7\ For the same reason that I ordered that the Respondents' 
registration be immediately suspended, I conclude that the public 
interest necessitates that this Order be effective immediately. See 
21 CFR 1316.67.

    Dated: November 8, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-29708 Filed 11-17-11; 8:45 am]
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