[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Notices]
[Pages 20911-20913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08244]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Vincent G. Colosimo, D.M.D.; Decision and Order

    On February 27, 2013, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Vincent G. Colosimo, D.M.D. (hereinafter, Applicant). GX 
1. The Show Cause Order proposed the denial of Applicant's application 
for a DEA Certificate of Registration as a practitioner, on the ground 
that his ``registration would be inconsistent with the public 
interest.'' Id. at 1 (citing 21 U.S.C. 823(f)).
    More specifically, the Show Cause Order alleged that on November 5, 
2009, Applicant had surrendered his previous DEA registration, and that 
on June 20, 2012, Applicant had applied for a new registration at the 
proposed registered location of Dental Village, 7117 East Broadway 
Blvd., Tucson, Arizona.\1\ Id. The Show Cause Order then alleged that 
on September 8, 2000, DEA Investigators (DIs) had conducted an 
inspection of Applicant's then-registered location, during which the 
DIs found approximately 108 dosage units of 7.5/500mg Lortab and 400 
dosage units of diazepam 10mg, and that Applicant ``told investigators 
that [he] transported the controlled substances to [his] place of 
practice in order to dispense [them] to [his] patients before and after 
procedures,'' as well as that he had ``consumed several dosage units of 
[the] diazepam . . . upon the

[[Page 20912]]

recommendation of his physician.'' Id. at 1-2.
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    \1\ Applicant initially applied for registration at a different 
address. However, several weeks before the Show Cause Order was 
issued, he changed the address of his proposed registered location 
to Dental Village. GX 15.
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    Next, the Show Cause Order alleged that on January 28, 2010, the 
United States Attorney for the Western District of Pennsylvania charged 
Applicant with ``knowingly, intentionally, and unlawfully conspiring to 
distribute and possess with intent to distribute 500 grams or more of a 
mixture and substance containing a detectable amount of cocaine, a 
Schedule II'' controlled substance. Id. at 2 (citing 21 U.S.C. 846). 
The Order then alleged that Applicant pled guilty to the charge, and 
that on July 6, 2010, the U.S. District Court for the Western District 
of Pennsylvania convicted him of the charge. Id.
    Finally, the Show Cause Order alleged that various state dental 
boards had taken action against his dental licenses based on his 
conviction. Id. The Show Cause Order alleged that these included the 
Pennsylvania State Board of Dentistry, which suspended his license for 
five years; the Nevada Board of Dental Examiners, with which he had 
entered a stipulation, pursuant to which he voluntarily surrendered his 
Nevada license; and the Arizona State Board of Dental Examiners, which 
on August 12, 2010, suspended his dental license for five years. Id. 
The Order then alleged that on June 11, 2012, Applicant entered into an 
agreement with the Arizona Board, pursuant to which he ``agreed to 
enroll in a treatment and rehabilitation program and complete 36 hours 
of continuing education in . . . substance abuse,'' and was granted a 
conditional license. Id.
    On March 4, 2013, the Show Cause Order was served on Applicant by 
Certified Mail. GX 2. On April 4, 2013, Applicant's letter requesting a 
hearing (which had been mailed) was received by the Office of 
Administrative Law Judges. GX 4, at 2. Deeming the request to be one 
day late, the ALJ ordered the Parties to file a statement addressing 
whether there was good cause to excuse the late filing. GX 3. Both 
Parties filed such statements; the Government also filed a motion to 
terminate the proceedings. GX 5. Thereafter, the ALJ granted the 
Government's motion, finding that Applicant had not demonstrated good 
cause and terminated the hearing.
    Thereafter, the Government filed a Request for Final Agency Action. 
On review, the Administrator vacated the ALJ's order terminating the 
proceeding and rejected the Government's request for final agency 
action. While noting that Applicant had not supported with affidavits 
the various factual assertions made by him in response to the ALJ's 
order, which directed the parties to address whether there was good 
cause to excuse the untimely filing, the Administrator held that if 
those assertions were supported, Applicant had demonstrated good cause. 
The Administrator further noted that while the Applicant's hearing 
``request was not received by the Hearing Clerk until the afternoon of 
April 4, 2013, the Show Cause Order instructed [him] to mail his 
hearing request to an address which is a different physical location 
than the Office of the Administrative Law Judges'' and that the record 
did not ``establish whether [the] hearing request was received by the 
former on the same day that it was received by the hearing clerk.'' 
Administrator's Order (GX 16), at 5 n.3. The Administrator further 
explained that ``any delay that is attributable to a delay in the 
delivery of mail within the Agency is not properly chargeable to'' 
Applicant. Id. The Administrator thus remanded the case to the Office 
of Administrative Law Judges for further proceedings consistent with 
her order. Id.
    On remand, the ALJ ordered the parties to file their prehearing 
statements and to serve a copy of their proposed exhibits by certain 
dates. ALJ Ex. 10. While the Government timely complied with the ALJ's 
order, ALJ Ex. 11, Applicant did not. Tr. 9-10; 14-15 (Nov. 19, 2013). 
The Government then moved to terminate the proceeding, on the ground 
that Applicant had waived his right to a hearing. ALJ Ex. 12, at 2 
(citing cases).
    Thereafter, the ALJ held the initial day of the hearing, during 
which he found that Applicant had not established good cause for 
failing to file his prehearing statement and barred him from 
subsequently introducing witness testimony as well as documentary 
evidence. GX 18, at 2. The following day, the ALJ issued an order 
setting the date for the evidentiary phase of the hearing. Id. However, 
six days before the hearing was to reconvene, Applicant's counsel 
contacted the ALJ's office and suggested that Applicant would seek to 
withdraw his application. Id. The ALJ then scheduled a Prehearing 
Conference for the purpose of determining whether there was any need to 
conduct the evidentiary phase of the hearing. Id.
    The next day, Respondent filed a motion to withdraw his application 
stating that he ``does not wish to proceed with a hearing where the DEA 
participates.'' GX 17, at 3. At the Prehearing Conference, the 
Government's counsel explained that the ALJ did not have authority to 
rule on Respondent's motion to withdraw but could grant a request to 
waive his right to a hearing. GX 18, at 1; see 21 CFR 1301.16. The ALJ 
then asked Respondent's counsel ``whether Respondent wished to withdraw 
his application or whether he wished to waive his right to a hearing.'' 
GX 18, at 2. Respondent's counsel answered that Respondent wanted to do 
both, but even if the ALJ lacked authority to grant Respondent's motion 
to withdraw his application, he ``still wished to waive his right to a 
hearing.'' Id. The Government did not object to Respondent's request to 
waive his right to a hearing. Id.
    Later that day, the ALJ issued an order in which he found that 
Respondent had ``expressly waived his opportunity for a hearing.'' 
Id.\2\ Regarding the motion to withdraw, the ALJ noted that under 21 
CFR 1301.16, an applicant, who has been issued an order to show cause, 
may withdraw his application ``with permission of the Administrator at 
any time where good cause is shown by the applicant or where the 
amendment or withdrawal is in the public interest.'' The ALJ thus 
concluded that he was without authority to act on Respondent's 
withdrawal request. While the ALJ provided that the parties could file 
an objection to his order, neither party did so, and on January 16, 
2014, the ALJ forwarded the record of the proceeding to my Office.
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    \2\ The order was entitled: ``Order Vacating Part of Order Dated 
November 20, 2013 And Remanding Case To The Administrator For Final 
Disposition.'' ALJs do not, however, remand cases to the 
Administrator or Deputy Administrator. They either terminate a 
proceeding; or conduct a proceeding, prepare a recommended decision, 
and forward the record to the Administrator's Office for review.
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    On February 28, 2014, the Government filed a Request for Final 
Agency Action seeking the denial of Respondent's application ``on the 
basis that [his] registration would be inconsistent with the public 
interest.'' Gov. Request for Final Agency Action, at 1. Therein, the 
Government states that the ALJ ``forwarded the case to the 
Administrator for either approval of Respondent's request to withdraw 
his application or for Final Agency Action.'' Id. at 3. While the 
Government observes that Respondent has waived his right to a hearing, 
it does not address whether there is either ``good cause'' to grant 
Respondent's withdrawal request (which remains pending before me) or 
whether granting his request ``is in the public interest.'' See id. at 
1-9. I conclude, however, that granting Respondent's withdrawal request 
is in the public interest.

[[Page 20913]]

Discussion

    No decision of the Agency has squarely confronted the question of 
whether the granting of a request to withdraw an application, which is 
submitted by a person after he has been issued a show cause order, is 
in the public interest. However, in Liddy's Pharmacy, L.L.C., 76 FR 
48887 (2011), the Administrator, in rejecting a motion by the 
Government to dismiss a case as moot, provided some guidance (albeit in 
dictum) as to when the granting of a withdrawal request, which is filed 
after the issuance of a show cause order, is in the public interest.
    In Liddy's Pharmacy, the Government issued a show cause order, 
which sought the revocation of the respondent's registration on the 
ground that it had committed acts which render its registration 
inconsistent with the public interest, and proceeded to a hearing 
before an ALJ, at which it prevailed. 76 FR at 48888. While the matter 
was pending the Administrator's review, the respondent agreed to 
voluntarily surrender its registration and the Government moved to 
terminate the proceeding on the ground that it had become moot. Id. The 
respondent, however, had previously filed a timely renewal application. 
Id. at 48888-89.
    After noting that the voluntary surrender form ``contain[ed] no 
language manifesting that [r]espondent ha[d] withdrawn its pending 
application,'' the Administrator explained that even if the respondent 
had requested to withdraw its application, she would have ``concluded 
that allowing [r]espondent to withdraw its application would be 
contrary to the public interest.'' Id. at 48888. In reaching this 
conclusion, the Administrator noted several factors, including the 
``extensive resources that have been expended in both the litigation 
and review of this case, the egregious misconduct established by th[e] 
record,'' and that the respondent could immediately reapply for a new 
registration. Id. While the hearing in Liddy was not particularly 
lengthy (in part, because only the Government presented evidence), the 
record was nonetheless extensive.\3\
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    \3\ A review of the Agency's decision in Liddy shows that the 
respondent had dispensed over 42,000 controlled substance 
prescriptions for millions of dosage units, which were written by 
physicians to patients who resided in States where the former were 
not licensed to practice medicine and with whom they had not 
established a valid doctor-patient relationship, and thus, were 
issued outside of the usual course of professional practice, in 
violation of 21 CFR 1306.04(a). Id. at 48893-96.
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    Of note, in Liddy, the Government was the party which moved to 
terminate the proceeding. Thus, the Administrator did not discuss the 
potential prejudice to the Government had she allowed the respondent to 
withdraw its application. However, it is manifest that where the 
Government has issued a show cause order to an applicant, the potential 
prejudice to the Government is an important factor which should be 
considered in determining whether to grant a motion to withdraw an 
application.
    It is indisputable that Applicant's conduct in engaging in a 
criminal conspiracy to distribute, and possess with intent distribute, 
500 grams or more of cocaine, is egregious misconduct. Moreover, no 
regulation bars Applicant from immediately reapplying for a 
registration. I nonetheless hold, however, that the other factors 
support the conclusion that granting his withdrawal request in in the 
public interest.
    Here, there has been no proceeding on the merits of the allegations 
and thus extensive resources have not been expended in the litigation 
and review of this case. Moreover, reviewing the allegations and the 
record submitted by the Government, I conclude that granting the 
withdrawal request will not prejudice the Government in the event 
Applicant reapplies in the future.
    In this matter, the Government has proposed the denial of the 
application based on three sets of circumstances: (1) The alleged 
findings of an investigation conducted in 2000; (2) his 2010 conviction 
for violating 21 U.S.C. 846; and (3) the state board orders that were 
issued following his 2010 conviction. Id. at 6-8. However, in the event 
Applicant was to reapply, his conviction is not subject to relitigation 
in this proceeding and the Government can again rely on it as a basis 
to deny the application. See 21 U.S.C. 823(f)(3); Robert L. Dougherty, 
76 FR 16823, 16830 (2011) (discussing Robert A. Leslie, 60 FR 14004, 
14005 (1995); Robert A. Leslie, 64 FR 25908 (1999); and Robert A. 
Leslie, 68 FR 15227 (2003)). So too, the Government can rely on the 
state board orders, to the extent they add anything that is probative 
of whether granting a new application would be consistent with the 
public interest.
    Indeed, the only potential prejudice that could accrue to the 
Government would be that with the passage of additional time, it would 
be unable to produce reliable evidence probative of the violations 
allegedly found in the investigation, which was conducted fourteen 
years ago, when Applicant was practicing in Pittsburgh, Pennsylvania. 
The Government cannot, however, claim prejudice, because the evidence 
it submitted with its Request for Final Agency Action to support the 
allegations does not rise to the level of substantial evidence. Here, 
the evidence on these allegations was limited to an affidavit of a 
Diversion Investigator, with the Phoenix Office, who was assigned to 
the current matter in December 2012. While the DI's affidavit states 
that ``[t]he matters contained in this declaration are based upon my 
personal knowledge, training, and experience,'' and then makes several 
factual assertions regarding the 2000 investigation, the affidavit does 
not establish that the DI was personally involved in that 
investigation. See DI's Declaration, at 1-3. Moreover, the affidavit 
does not cite any documentary evidence that supports these factual 
assertions and the investigative record submitted by the Government 
contains no such evidence. Thus, were I to proceed to the merits of the 
Government's Request for Final Agency Action, I would be required to 
conclude that these allegations are not supported by substantial 
evidence.
    Accordingly, I conclude that granting Applicant's withdrawal 
request will not prejudice the Government. Moreover, while some agency 
resources have been expended in the review of this matter, this was 
occasioned by the need to set forth the factors to be considered in 
determining whether the granting of a withdrawal request, which is made 
after the issuance of a show cause order, ``is in the public 
interest.'' 21 CFR 1301.16(a). Because I conclude that granting 
Applicant's request to withdraw his application ``is in the public 
interest,'' I grant his request. And because there is no longer an 
application to act upon, I hold that this case is now moot and dismiss 
the Order to Show Cause.
    It is so ordered.

    Dated: April 4, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-08244 Filed 4-11-14; 8:45 am]
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