Shannon L. Gallentine, D.P.M.; Denial of Application, 45864-45867 [2011-19381]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45864-45867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19381]



[[Page 45864]]

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 DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Shannon L. Gallentine, D.P.M.; Denial of Application

    On June 25, 2010, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Shannon Gallentine, D.P.M. (Respondent), of Maypearl, 
Texas. The Show Cause Order proposed the denial of Respondent's pending 
application for a DEA Certificate of Registration as a practitioner, on 
the grounds that he had materially falsified his application and that 
his ``registration would be inconsistent with the public interest.'' 
Show Cause Order at 1 (citing 21 U.S.C. 824(a)(1) & 823 (f)).
    With respect to the material falsification ground, the Show Cause 
Order alleged that on October 1, 2007, Respondent had surrendered his 
DEA registration. Show Cause Order at 1. The Order further alleged that 
on July 16, 2009, Respondent had applied for a new DEA registration, 
but had failed to disclose that he had surrendered his prior 
registration. Id. The Order thus alleged that Respondent had materially 
falsified his application by failing to disclose the surrender and that 
this was ground to deny his application. Id. (citing 21 U.S.C. 
824(a)(1)).
    As for the public interest ground, the Show Cause Order alleged 
that between various dates beginning in May 2004 through September 
2007, Respondent prescribed controlled substances to six patients 
(M.P., H.G., D.C., P.P., K.B., N.B.), ``without a legitimate medical 
purpose and/or outside the course of professional practice.'' Id. at 1-
2. The Order further alleged that on October 1, 2007, a federal search 
warrant was executed at Respondent's registered location and that ``no 
records were found to adequately support the prescribing of control 
substances to'' these patients. Id. at 2.
    As evidenced by the signed return receipt card, on July 2, 2010, 
the Show Cause Order, which also notified Respondent of his right to 
request a hearing or to submit a written statement in lieu of a 
hearing, the procedures for doing either, and the consequences for 
failing to do either, was served on him. GX 4. Respondent did not, 
however, file his request for a hearing \1\ with the Office of 
Administrative Law Judges until August 5, 2010, which was three days 
\2\ after it was due. See GX 5, at 1; 21 CFR 1301.43(a); id. 1316.45.
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    \1\ Respondent's request was dated August 2, 2010.
    \2\ The thirty-day period for filing a request for a hearing 
ended on August 1, 2010. However, because that day fell on a Sunday, 
Respondent's request was not due until August 2, 2010, when the 
Office of Administrative Law Judges was open for business.
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    On August 12, 2010, the ALJ issued an order, a copy of which was 
not included in the record submitted to this Office. However, based on 
a subsequent order of the ALJ, it appears that the Government had 
previously filed a motion to terminate, and that in the initial order, 
the ALJ had provided Respondent with until August 23rd to file a 
response to the Government's motion. See GX 7, at 1 (Order Adjusting 
Deadlines for the Filing of Prehearing Statements).
    On August 16, 2010, the Government moved to deny Respondent's 
request for a hearing on the ground that it was untimely. GX 6. 
Therein, the Government argued that the ALJ does not have jurisdiction 
to grant a hearing when a hearing request is not timely filed, and that 
in any event, Respondent had not established ``good cause'' for his 
untimely filing. Id. at 2.
    On August 18, 2010, the ALJ issued a new order extending the 
deadlines for each party to file its prehearing statement. GX 7, at 1 
(Order Adjusting Deadlines for the Filing of Prehearing Statements).
    On August 23, 2010, Respondent filed a ``Motion To Establish 
Proceedings.'' GX 8, at 2. Therein, Respondent stated that he did not 
receive the Government's Motion to Terminate. Respondent further stated 
that he had received the Order to Show Cause on July 2, 2010, and 
asserted that he had ``provided a timely request for hearing, dated 
August 2, 2010.'' Id. Respondent further argued that because he did not 
receive the Government's Motion to Terminate, he ``was not given [an] 
opportunity to respond to'' the Motion. Id.
    On August 24, 2010, the ALJ issued an Amended Order Granting the 
Government's Motion to Terminate Proceedings. See GX 10, at 1 (Order 
Granting Respondent's Request To Stay Termination Of Proceedings And 
Consenting To Allowance Of Interlocutory Appeal). However, two days 
later, Respondent filed a Request To Stay Termination Of Proceedings. 
Id. Therein, Respondent stated that he was ``currently in bankruptcy 
proceedings'' and was ``unable to afford legal counsel.'' GX 9, at 1 
(Request To Stay Termination Of Proceedings). Respondent further argued 
that because he is not an attorney, he ``understood the due date of the 
request for hearing as needing to be dated within 30 days'' and 
``pray[ed that] the court not terminate the proceedings.'' Id.
    On August 30, 2010, the ALJ granted Respondent's request. Noting 
that his ruling terminating the proceeding constituted a departure from 
a prior Agency decision, the ALJ authorized Respondent to file an 
interlocutory appeal of his Amended Termination Order. GX 10, at 1-2 
(Order Granting Respondent's Request To State Termination Of 
Proceedings And Consenting To Allowance Of Interlocutory Appeal) 
(citing Garth A.A. Clark, M.D., 63 FR 54733 (1998)). The ALJ further 
ordered that Respondent file his interlocutory appeal with my Office no 
later than September 20, 2010; the ALJ also ordered that Respondent 
serve a copy of his filing on him and Government counsel. Id. at 2 & 
n.2.
    Respondent did not, however, file an interlocutory appeal. Instead, 
on September 20, 2010, Respondent filed a Request for Extension of Time 
to File an Interlocutory Appeal [and] Request for Appointment of Legal 
Counsel Due to Financial Hardship. GX 12. Therein, Respondent noted 
that because he is not an attorney, he ``does not know how to file an 
interlocutory appeal,'' and sought the appointment of counsel ``because 
of the financial inability'' to retain counsel. Id. Respondent also 
sought ``an extension of time after appointment of legal counsel in 
which to file an interlocutory appeal.'' Id.
    Thereafter, the ALJ denied Respondent's motion for appointed 
counsel, noting that he lacked authority to do so. GX 11, at 1-2 (Order 
Denying Respondent's Request for An Extension Of Time To File An 
Interlocutory Appeal And His Motion For Appointment Of Legal Counsel). 
The ALJ also denied Respondent's request for an extension, noting that 
the sole basis for it was to obtain appointed counsel. Id. The ALJ 
further held that because Respondent had failed to file an 
interlocutory appeal, the stay of the Amended Termination Order ``ha[d] 
expired by its own terms'' and the Order had ``become[] immediately 
effective.'' Id. at 2.
    The Government then filed a Request for Final Agency Action with my 
Office and submitted various documents as evidence in support of its 
request. Having considered the record, I conclude that Respondent did 
not submit a timely request for a hearing as required by 21 CFR 
1301.43(a), and that he has not established good cause for his failure 
to do so. Id. 1301.43(d). I therefore find that Respondent has waived 
his right to a hearing. Id.

[[Page 45865]]

    As to the merits, I find that Respondent materially falsified his 
application for registration; I also find that Respondent's 
registration ``would be inconsistent with the public interest'' because 
he issued numerous prescriptions for controlled substances which lacked 
a legitimate medical purpose and thus violated 21 CFR 1306.04(a). 21 
U.S.C. 823(f). Accordingly, Respondent's application will be denied. I 
make the following findings of fact.

Findings

    Respondent is a podiatrist licensed by the Texas State Board of 
Podiatric Medical Examiners (TSBPME). Respondent previously held DEA 
Certificate of Registration BG6902919, which authorized him to dispense 
controlled substances in schedules II through V, as a practitioner, at 
the registered location of 2700 Pleasant Run Road, Suite 360, 
Lancaster, Texas.
    According to the Affidavit of a DEA Diversion Investigator (DI), on 
November 6, 2006, DEA received information from the TSBPME which 
prompted it to investigate Respondent's prescribing practices. During 
the course of the investigation, Respondent was found to have 
authorized numerous prescriptions to six patients for narcotics such as 
codeine with acetaminophen (apap) and hydrocodone/apap, both of which 
are schedule III controlled substances. 21 CFR 1308.13(e)(1). More 
specifically, the Investigators obtained records from various 
pharmacies and found that Respondent had prescribed to: (1) M.P., a 
total of 4,230 dosage units [hereinafter, d.u.] of codeine/apap from 
January 3, 2005 through September 14, 2007; (2) H.G., a total of 3,180 
d.u. of codeine 4/apap from May 29, 2004 through November 27, 
2006; (3) D.C., a total of 2,260 d.u. of hydrocodone/apap from April 4, 
2005 through September 18, 2007; (4) P.P., a total of 3,330 d.u. of 
hydrocodone/apap from January 24, 2005 through January 9, 2007; (5) 
K.B., a total of 1,500 d.u. of hydrocodone/apap from February 21, 2005 
through December 4, 2006; (6) N.B., a total of 1,515 d.u. of 
hydrocodone/apap from October 4, 2004 through May 3, 2006. GXs 13-18.
    On October 1, 2007, federal and state Investigators executed a 
search warrant at Respondent's registered location of 2700 Pleasant Run 
Road, Suite 360, Lancaster, Texas. During the course of the search, 
Respondent stated that no other person had access to his prescription 
pad and that he personally signed all of his prescriptions. Respondent 
also stated that he only prescribed hydrocodone to patients who had a 
traumatic injury.
    Moreover, of the six patients identified above, Respondent did not 
have medical records for H.G., M.P., K.B., and N.B. While Respondent 
had records for D.C. and P.P., the records for D.C. consisted largely 
of billing records which listed various conditions and their 
reimbursement codes, as well as progress notes which were blank except 
for such information as the date, D.C.'s name, his date of birth, and 
age. P.P.'s record also consisted largely of billing records and 
progress notes. Moreover, only one of the progress notes (dated 
February 19, 2007) documented that P.P. had a medical condition and had 
pain.\3\
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    \3\ The records for D.C. and P.P. also contained medication flow 
sheets listing each patient's prescriptions and refills, some 
prescriptions, as well as various refill authorization forms sent to 
Respondent by the patient's pharmacy. For both D.C. and P.P., there 
were no such records prior to 2007.
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    Upon reviewing Respondent's records during the search, DEA 
Investigators asked Respondent if he would voluntarily surrender his 
DEA registration. Respondent agreed to do so and executed a form DEA-
104, Voluntary Surrender of Controlled Substances Privileges. GX 2, at 
5. Therein, Respondent acknowledged that he was voluntarily 
surrendering his Certificate of Registration, ``[i]n view of [his] 
alleged failure to comply with the Federal requirements pertaining to 
controlled substances.'' Id. According to an Agency Investigator, 
``Respondent was fully aware that the surrender of [his registration] 
was based upon alleged violations of the Controlled Substances Act.'' 
Declaration of DI, at 4.
    On July 14, 2009, Respondent applied for a new DEA registration. On 
the application form, Respondent was required to answer four questions. 
The second of these questions asked: ``Has the applicant ever 
surrendered (for cause) or had a federal controlled substance 
registration revoked, suspended, restricted or denied, or is any such 
action pending?'' Respondent entered ``N'' for no.

Discussion

    Section 303(f) of the Controlled Substances Act provides that an 
application for a practitioner's registration may be denied upon a 
determination ``that the issuance of such registration would be 
inconsistent with the public interest.'' 21 U.S.C. 823(f). In making 
the public interest determination, the CSA requires the consideration 
of the following factors:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing * * * controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

Id.

    ``These factors are * * * considered in the disjunctive.'' Robert 
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or 
a combination of factors, and may give each factor the weight [I] 
deem[] appropriate in determining whether * * * an application for 
registration [should be] denied.'' Id. Moreover, case law establishes 
that I am ``not required to make findings as to all of the factors.'' 
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. 
DEA, 412 F.3d 165, 173-74 (2005).
    Furthermore, under Section 304(a)(1), a registration may be revoked 
or suspended ``upon a finding that the registrant * * * has materially 
falsified any application filed pursuant to or required by this 
subchapter.'' 21 U.S.C. 824(a)(1). Under agency precedent, the various 
grounds for revocation or suspension of an existing registration that 
Congress enumerated in section 304(a), 21 U.S.C. 824(a), are also 
properly considered in deciding whether to grant or deny an application 
under section 303. See Anthony D. Funches, 64 FR 14267, 14268 (1999); 
Alan R. Schankman, 63 FR 45260 (1998); Kuen H. Chen, 58 FR 65401, 65402 
(1993).
    Thus, the allegation that Respondent materially falsified his 
application is properly considered in this proceeding. See Samuel S. 
Jackson, 72 FR 23848, 23852 (2007). Just as materially falsifying an 
application provides a basis for revoking an existing registration 
without proof of any other misconduct, see 21 U.S.C. 824(a)(1), it also 
provides an independent and adequate ground for denying an application. 
Cf. Bobby Watts, M.D., 58 FR 46995 (1993).

The Material Falsification Allegation

    As found above, on October 1, 2007, Respondent voluntarily 
surrendered his registration upon being questioned by Investigators, 
who were executing a search warrant, regarding whether he had adequate 
documentation to support the controlled substance prescriptions he 
issued to six patients. However, on

[[Page 45866]]

his July 14, 2009 application for a new DEA registration, in answering 
the application's question which asked whether he had previously 
surrendered for cause his DEA registration, Respondent answered ``no.''
    Respondent's answer was a material falsification of his 
application. As the Supreme Court has explained, ``[t]he most common 
formulation'' of the concept of materiality ``is that a concealment or 
misrepresentation is material if it `has a natural tendency to 
influence, or was capable of influencing, the decision of' the 
decisionmaking body to which it was addressed.'' Kungys v. United 
States, 485 U.S. 759, 770 (1988) (quoting Weinstock v. United States, 
231 F.2d 699, 701 (D.C. Cir. 1956)) (other citation omitted); see also 
United States v. Wells, 519 U.S. 482, 489 (1997) (quoting Kungys, 485 
U.S. at 770). The evidence must be ``clear, unequivocal, and 
convincing.'' Kungys, 485 U.S. at 772. However, ``the ultimate finding 
of materiality turns on an interpretation of substantive law.'' Id. at 
772 (int. quotations and other citation omitted).
    DEA has previously held that ``[t]he provision of truthful 
information on applications is absolutely essential to effectuating 
[the] statutory purpose'' of determining whether the granting of an 
application is consistent with the public interest. See Peter H. Ahles, 
71 FR 50097, 50098 (2006). More specifically, the public interest 
inquiry under section 303(f) requires, inter alia, that the Agency 
examine ``[t]he applicant's experience in dispensing * * * controlled 
substances,'' his ``[c]ompliance with applicable State, Federal, or 
local laws relating to controlled substances,'' and whether he has 
committed other ``conduct which may threaten public health and 
safety.'' 21 U.S.C. 823(f). Because Respondent's voluntary surrender 
was for cause and arose out of an investigation into whether he had 
violated the Controlled Substance Act by issuing prescriptions outside 
of the usual course of professional practice and which lacked a 
legitimate medical purpose, 21 CFR 1306.04(a), his failure to disclose 
the surrender was capable of influencing the Agency's evaluation of his 
experience in dispensing controlled substances, his compliance with 
Federal and State laws relating to controlled substances, and whether 
he had engaged in other conduct which may threaten public health and 
safety.
    That the Agency did not rely on Respondent's false statement and 
grant his application does not make the statement immaterial. As the 
First Circuit has noted with respect to the material falsification 
requirement under 18 U.S.C. 1001, ``[i]t makes no difference that a 
specific falsification did not exert influence so long as it had the 
capacity to do so.'' United States v. Alemany Rivera, 781 F.2d 229, 234 
(1st Cir. 1985). See also United States v. Norris, 749 F.2d 1116, 1121 
(4th Cir. 1984) (``There is no requirement that the false statement 
influence or effect the decisionmaking process of a department of the 
United States Government.'').
    I further conclude that Respondent's false statement cannot be 
attributed to a good faith misunderstanding as to whether he had 
surrendered his registration for cause (as he maintained in his letter 
requesting a hearing). On the date he completed the application, less 
than two years had passed since the search warrant was executed and 
Respondent surrendered his registration. Given the circumstances of the 
surrender, during which he was confronted with questions by the 
Investigators about his prescribing practices and lack of documentation 
to justify his prescriptions, Respondent cannot claim that he did not 
surrender his registration for cause. Moreover, on the voluntary 
surrender form, Respondent acknowledged that he was doing so ``[i]n 
view of [his] alleged failure to comply with the Federal requirements 
pertaining to controlled substances.'' Accordingly, I conclude that 
Respondent knew that he had surrendered his registration for cause and 
that he knowingly materially falsified his July 14, 2009 application 
for a new Certificate of Registration. This conclusion provides reason 
alone to deny his application.

The Public Interest Grounds

    Having considered all of the public interest factors, I conclude 
that the evidence with respect to Respondent's experience in dispensing 
controlled substances (factor two), his compliance with laws related to 
controlled substances (factor four), and whether he has committed other 
conduct which may threaten public health and safety (factor five) 
establishes that Respondent's registration ``would be inconsistent with 
the public interest.'' \4\ 21 U.S.C. 823(f). This conclusion provides 
an additional ground for denying Respondent's application.
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    \4\ I acknowledge that the investigative record contains no 
evidence that Respondent's state podiatrist's license or state 
controlled substances registration (factor one) have been suspended 
or revoked. However, DEA has long held that while possessing state 
authority is a necessary condition for obtaining and maintaining a 
DEA registration, the possession of state authority is not 
dispositive of the public interest. See Mortimer B. Levin, D.O., 55 
FR 8209, 8210 (1990). DEA has also held that the absence of a 
criminal conviction of a Federal or State offense related to the 
manufacture, distribution, or dispensing of a controlled substance 
(factor three) is not dispositive. See Edmund Chein, M.D., 72 FR 
6580, 6593 n.22 (2007).
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    Under a longstanding DEA regulation, a prescription for a 
controlled substance is not ``effective'' unless it is ``issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.'' 21 CFR 1306.04(a). This 
regulation further provides that ``an order purporting to be a 
prescription issued not in the usual course of professional treatment * 
* * is not a prescription within the meaning and intent of [21 U.S.C. 
829] and * * * the person issuing it, shall be subject to the penalties 
provided for violations of the provisions of law related to controlled 
substances.'' Id. See also 21 U.S.C. 802(10) (defining the term 
``dispense'' as meaning ``to deliver a controlled substance to an 
ultimate user by, or pursuant to the lawful order of, a practitioner, 
including the prescribing and administering of a controlled 
substance'') (emphasis added).
    As the Supreme Court has explained, ``the prescription requirement 
* * * ensures patients use controlled substances under the supervision 
of a doctor so as to prevent addiction and recreational abuse. As a 
corollary, [it] also bars doctors from peddling to patients who crave 
the drugs for those prohibited uses.'' Gonzales v. Oregon, 546 U.S. 
243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 
(1975)). Under the CSA, it is fundamental that a practitioner must 
establish and maintain a bonafide doctor-patient relationship in order 
to act ``in the usual course of * * * professional practice'' and to 
issue a prescription for a ``legitimate medical purpose.'' Laurence T. 
McKinney, 73 FR 43260, 43265 n.22 (2008); see also Moore, 423 U.S. at 
142-43 (noting that evidence established that physician ``exceeded the 
bounds of `professional practice,' '' when ``he gave inadequate 
physical examinations or none at all,'' ``ignored the results of the 
tests he did make,'' and ``took no precautions against * * * misuse and 
diversion''). The CSA, however, generally looks to state law to 
determine whether a doctor and patient have established a bonafide 
doctor-patient relationship. See Kamir Garces-Mejias, 72 FR 54931, 
54935 (2007); United Prescription Services, Inc., 72 FR 50397, 50407-08 
(2007).
    Under the rules of the Texas State Board of Podiatric Medical 
Examiners, ``[a]ll podiatric physicians shall make, maintain, and keep 
accurate records of

[[Page 45867]]

the diagnosis made and the treatment performed for and upon each of his 
or her patients for reference and for protection of the patient for at 
least five years following the completion of treatment.'' Tex. Admin 
Code tit. 22, Sec.  375.21(a). When, however, Investigators executed 
the search warrant at Respondent's registered location, Respondent did 
not have any medical records for M.P., H.G., K.B., and N.B., even 
though he had prescribed large quantities of codeine/apap to M.P. 
(4,230 d.u.) and H.G. (3,180 d.u.) and large quantities of hydrocodone/
apap to K.B. (1,500 d.u.) and N.B. (1,515 d.u.). Moreover, Respondent 
had prescribed to these persons for between a year and a half (in 
N.B.'s case) and two and a half years (in M.P.'s case). Based on 
Respondent's failure to maintain any medical records, let alone 
document a diagnosis to support his prescribing of controlled 
substances to M.P., H.G., K.B., and N.B., I conclude that Respondent 
acted outside of the usual course of professional practice and lacked a 
legitimate medical purpose when he prescribed controlled substances to 
these patients and thus violated the CSA. 21 U.S.C. 841(a)(1); 21 CFR 
1306.04(a). I also conclude that Respondent violated the Texas Board's 
regulation requiring that he ``make, maintain, and keep accurate 
records of the diagnosis made and the treatment performed for'' each of 
these patients. Tex. Admin Code tit. 22, Sec.  375.21(a).
    As for D.C., while the Investigators found a medical record, the 
progress notes did not document a diagnosis and contained no 
information other than D.C.'s name, date of birth, his age, and the 
date of the visit. Notwithstanding his failure to document a diagnosis, 
Respondent issued D.C. prescriptions for 2,260 d.u. of hydrocodone/apap 
over a nearly two and one half year period. Here again, I conclude that 
Respondent acted outside of the usual course of professional practice 
and lacked a legitimate medical purpose in prescribing hydrocodone/apap 
to D.C. and violated the CSA in doing so. 21 U.S.C. 841(a)(1); 21 CFR 
1306.04(a). Here too, Respondent also violated the Texas Board's rule.
    While P.P.'s medical record contained a progress note documenting a 
diagnosis, this note was dated February 19, 2007. However, Respondent 
had prescribed hydrocodone/apap to her since February 2005, and had 
authorized the dispensing of more than 3,300 dosage units to her before 
he even documented a diagnosis. Here again, I conclude that these 
prescriptions were issued outside of the usual course of professional 
practice and lacked a legitimate medical purpose and thus violated the 
CSA. 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a). And here too, Respondent 
violated the Board's rule by failing to document a diagnosis between 
February 2005 and February 2007.
    I therefore conclude that Respondent's experience in dispensing 
controlled substances (factor two), his failure to comply with the 
CSA's prescription requirement, 21 CFR 1306.04(a) (factor four) and his 
failure to comply with the Texas Board's rule (factor five \5\), 
establish that Respondent's registration ``would be inconsistent with 
the public interest.'' 21 U.S.C. 823(f). This conclusion provides an 
additional and independent ground for denying Respondent's application. 
Accordingly, Respondent's application for a new DEA Certificate of 
Registration will be denied.
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    \5\ As the Texas rule states, ``All podiatric physicians shall 
make, maintain, and keep accurate records of the diagnosis made and 
the treatment performed for and upon each of his or her patients for 
reference and for protection of the patient for at least five years 
following the completion of treatment.'' Tex. Admin Code tit. 22, 
Sec.  375.21(a). DEA has also held that a practitioner's failure to 
maintain medical records required by state law constitutes such 
other conduct which may threaten public health and safety. See 
Robert L. Dougherty, 60 FR 55047, 55050-51 (1995).
    The Government also asserts that Respondent materially falsified 
his application for a state controlled substances registration 
because he failed to disclose the surrender of his DEA registration. 
Req. for Final Agency Action, at 14. This allegation was not, 
however, made in the Order to Show Cause, and the ALJ's various 
orders make clear that the Government did not file a Pre-Hearing 
Statement, in which it might have provided the requisite notice. See 
CBS Wholesale Distributors, 74 FR 36746, 36749-50 (2009); see also 5 
U.S.C. Sec.  554(b) (``Persons entitled to notice of an agency 
hearing shall be timely informed of * * * the matters of fact and 
law asserted.''). I therefore do not consider it.
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Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well 
as 28 CFR 0.100(b), I order that the application of Shannon L. 
Gallentine, D.P.M., for a DEA Certificate of Registration as a 
practitioner, be, and it hereby is, denied. This Order is effective 
immediately.

    Dated: July 22, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-19381 Filed 7-29-11; 8:45 am]
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