81_FR_8279 81 FR 8247 - Arvinder Singh, M.D.; Decision and Order

81 FR 8247 - Arvinder Singh, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 32 (February 18, 2016)

Page Range8247-8251
FR Document2016-03361

Federal Register, Volume 81 Issue 32 (Thursday, February 18, 2016)
[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8247-8251]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03361]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 15-1]


Arvinder Singh, M.D.; Decision and Order

    On October 16, 2014, the Deputy Assistant Administrator, Office of 
Diversion Control, issued an Order to Show Cause to Arvinder Singh, 
M.D. (Respondent), of Clifton Park, New York. ALJ Ex. 1. The Show Cause 
Order proposed the denial of Respondent's application for a DEA 
Certificate of Registration as a practitioner on three grounds.
    First, the Show Cause Order alleged that on August 4, 2003, 
Respondent, following a jury trial, was convicted on 16 counts of 
health care fraud in violation of 18 U.S.C. 1347, one count of 
conspiracy to distribute controlled substances in violation of 21 
U.S.C. 846, and 24 counts of unlawful distribution of controlled 
substances in violations of 21 U.S.C. 841(a)(1) and 18 U.S.C. 2. Id. at 
1-2. (citing 21 U.S.C. 824(a)(2)).
    Second, the Show Cause Order alleged that Respondent's convictions 
for violating the Controlled Substances Act ``were based on a scheme in 
which [he] left pre-signed but otherwise blank prescriptions for [his] 
nursing staff to fill in and issue Schedule II controlled substances 
prescriptions to patients when neither [he] nor any other physician saw 
the patient at the time such prescriptions were issued.'' Id. at 2. The 
Show Cause Order alleged that Respondent's scheme also violated 21 CFR 
1306.04(a) and 1306.05(a), and that this conduct constituted acts 
inconsistent with the public interest. Id. (citing 21 U.S.C. 824(a)(4) 
and 823(f)).
    Third, the Show Cause Order alleged that on May 8, 2004, the U.S. 
Department of Health and Human Services (HHS) excluded Respondent from 
participation in federal health care programs for a period of 15 years 
based on his convictions for Health Care Fraud and for violating the 
Controlled Substances Act. Id. The Government further alleged that 
because ``the amount of the financial loss'' was in excess of $5,000; 
the time period of Respondent's illegal activity exceeded more than one 
year; and Respondent had been convicted of the CSA violations; HHS 
imposed a 15-year exclusion, which was three times the minimum 
exclusion period. Id. (citing 21 U.S.C. 824(a)(5)).
    Following service of the Show Cause Order, Respondent requested a 
hearing on the allegations. The matter was placed on the docket of the 
Office of Administrative Law Judges and assigned to Chief 
Administrative Law Judge (hereinafter, CALJ) John J. Mulrooney, II. 
Following pre-hearing procedures, the CALJ conducted a hearing at which 
both parties introduced documentary evidence and called witnesses to 
testify. Thereafter, both parties submitted briefs containing their 
proposed findings of fact, conclusions of law, and arguments regarding 
the ultimate disposition of this matter.
    On February 10, 2015, the CALJ issued his Recommended Decision. 
Therein, the CALJ found that the Government had established a prima 
facie case to deny Respondent's application for registration as a 
practitioner on multiple grounds.\1\ R.D. at 37.
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    \1\ Pursuant to 21 U.S.C. 823(f), ``[t]he Attorney General may 
deny an application for [a practitioner's] registration . . . if 
[she] determines that the issuance of such registration . . . would 
be inconsistent with the public interest.'' In making this 
determination, section 823(f) directs the Agency to consider 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. Sec.  823(f).
    ``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 a registration 
should be revoked. Id.; see also MacKay v. DEA, 664 F.3d 808, 816 
(10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); 
Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I 
am required to consider each of the factors, I ``need not make 
explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting 
Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).
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    These included that Respondent had been convicted of twenty-four 
counts of

[[Page 8248]]

violating 21 U.S.C. 841(a)(1) in that he unlawfully caused and aided 
and abetted the illegal distribution of schedule II controlled 
substances by providing pre-signed but otherwise blank prescriptions to 
nurses who worked for him, who filled in the prescriptions with the 
name of the patient, the name of the drug, the quantity and dosing 
instructions, and provided the prescriptions to the patients, 
notwithstanding that the nurses were not legally authorized to dispense 
controlled substance prescriptions and Respondent did not see the 
patients. R.D. at 32-33. As discussed in the Recommended Decision, this 
conduct implicated three of the public interest factors and supports 
the conclusion that granting Respondent's application ``would be 
inconsistent with the public interest.'' 21 U.S.C. 823(f); see also 
R.D. at 32-37; \2\ 21 CFR 1306.05(a) (``All prescriptions for 
controlled substances shall be dated as of, and signed on, the day when 
issued and shall bear the full name and address of the patient, the 
drug name, strength, dosage form, quantity prescribed, directions for 
use, and the name, address and registration number of the 
practitioner.'').
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    \2\ See R.D. at 32-33 (discussing application of factor three--
``the applicant's conviction record under Federal . . . laws 
relating to the . . . distribution[ ] or dispensing of controlled 
substances.''); id. at 33-36 (discussing application of factor two--
``[t]he applicant's experience in dispensing . . . controlled 
substances''--and factor four--``[c]ompliance with applicable laws . 
. . related to controlled substances'').
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    In addition to the above, the evidence also shows that Respondent 
``has been excluded . . . from participation in'' federal health care 
programs pursuant to the mandatory exclusion provisions of 42 U.S.C. 
1320a-7(a). See 21 U.S.C. 824(a)(5) (``[a] registration pursuant to 
section 823 of this title to . . . dispense a controlled substance . . 
. may be suspended or revoked by the Attorney General upon a finding 
that the registrant . . . has been excluded (or directed to be 
excluded) from participation in a program pursuant to section 1320a-
7(a) of Title 42'').\3\ More specifically, the evidence shows that on 
May 28, 2004, the Office of Inspector General, Department of Health and 
Human Services, excluded Respondent ``from participat[ing] in the 
Medicare, Medicaid, and all Federal health care programs . . . for a 
minimum period of 15 years.'' GX 6. The exclusion was based on 
Respondent's convictions ``of criminal offense[s] related to'': (1) 
``the delivery of an item or service under the Medicare program''; (2) 
``fraud, theft, embezzlement, breach of fiduciary responsibility, or 
other financial misconduct in connection with the delivery of a health 
care item or service or any act or omission in a health care program 
operated or financed by any Federal, State, or local government 
agency''; and (3) ``the unlawful manufacture, distribution, 
prescription or dispensing of a controlled substance.'' Id. (citing 42 
U.S.C. 1320a-7(a)(1), (3), (4)). As the ALJ found, these convictions 
fall within the mandatory exclusion provisions of 42 U.S.C. 1320a-7(a).
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    \3\ Notwithstanding that 21 U.S.C. 824(a)(5) addresses the 
Agency's authority to suspend or revoke a registration upon a 
finding that a registrant has been excluded from participation in 
federal health care programs under the mandatory exclusion 
provisions of 42 U.S.C. 1320a-7(a), DEA `` `has consistently held 
that where a registration can be revoked under section 824, it can, 
a fortiori, be denied under section 823 since the law would not 
require an agency to indulge in the useless act of granting a 
license on one day only to withdraw it on the next.' '' Kwan Bo Jin, 
77 FR 35021, 35021 n.2 (2012) (quoting Serling Drug Co. v. Detroit 
Prescription Wholesaler, Inc., 40 FR 11918, 11919 (1975)). See also 
John R. Amato, 40 FR 22852 (1975) (Denying application where 
practitioner's state license had been revoked, holding that section 
823(f) ``must logically give the Administrator the authority to deny 
a registration if the practitioner is not authorized by the State to 
dispense controlled substances. . . . To hold otherwise would mean 
that all applications would have to be granted only to be revoked 
the next day under 21 U.S.C. 824(a)(3). This [A]gency has 
consistently held that where a registration can be revoked under 
section 824, it can, a fortiori, be denied under section 823.'').
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    Turning to whether Respondent had produced sufficient evidence to 
rebut the Government's prima facie case, the CALJ found that 
``Respondent continues to dispute the nature of the criminal charges 
and their severity.'' R.D. 38. The CALJ further found that ``instead of 
accepting responsibility for the crimes for which he was convicted, he 
has emphasized isolated excerpts from orders and transcripts where he 
perceives he has been `exonerated,' and/or occasions when DEA or the 
state licensing agency `had no problems' with him.'' Id. (citations 
omitted). Continuing, the CALJ explained that ``[t]he Respondent has 
not accepted responsibility for his actions, persuasively expressed 
remorse for his conduct, or presented evidence that could reasonably 
support a finding that the Administrator should entrust him with a 
registration.'' Id.
    The CALJ also found that Respondent's misconduct was egregious and 
``militates persuasively in favor of denial of his application.'' Id. 
at 39. On the other hand, because Respondent's misconduct ``ended 
nearly fifteen years earlier'' and he ``has paid his debt to society,'' 
the CALJ found that granting his application would not ``adversely 
impact compliance expectations on the regulated community in a 
significant way,'' and thus, the Agency's interest in ``general 
deterrence should not, standing alone, constitute an insurmountable 
impediment to granting'' his application. Id.
    However, the CALJ then found that ``[t]he issue of specific 
deterrence . . . is a dramatically different issue.'' Id. The CALJ 
explained that ``virtually every documentary, testimonial, and 
argumentative contribution made by the Respondent in these proceedings 
makes it overwhelmingly clear that he does not believe he was mistaken 
in any way.'' Id. The CALJ thus concluded that ``until . . . Respondent 
can convincingly show he accepts the authority of the law and those 
bodies charged with enforcing it and regulating his activities, 
granting him a DEA registration will gravely endanger the public.'' Id. 
at 40. The CALJ thus recommended that Respondent's application be 
denied. Id.
    Respondent filed Exceptions to the Recommended Decision and the 
Government filed a response to Respondent's Exceptions. Thereafter, the 
record was forwarded to my Office for Final Agency Action.
    Having considered the record in its entirety (including 
Respondent's Exceptions), I adopt the CALJ's findings of fact and 
conclusions of law to the extent they are discussed herein. Because I 
agree with the CALJ's ultimate findings that: (1) Multiple grounds 
exist to deny Respondent's application, (2) Respondent has failed to 
adequately acknowledge his misconduct, (3) Respondent's misconduct was 
egregious, and (4) the Agency's interest in specific deterrence 
supports the denial of his application, I will adopt the CALJ's 
recommendation that I deny Respondent's application. A discussion of 
Respondent's Exceptions follows.
    Invoking Gonzales v. Oregon, 546 U.S. 243 (2006), Respondent's 
first contention is that ``the [A]gency has relied on factors which 
Congress has not intended it to consider.'' Exceptions, at 1. Fleshing 
out his argument, Respondent contends that during the hearing, ``[t]he 
Government has not shown a single case of [d]iversion.'' Id. at 2. He 
argues that the Government ``failed to even scratch the surface of the 
case where it is apparent that billing issues were criminalized through 
the use of [the] CSA despite no evidence of [d]iversion or [p]ublic 
[s]afety [i]ssues, by creating a [sic] interpretive rule, as in 
Gonzales'' and that ``Congress does not allow DEA to use its policing 
power to regulate Medical Practices or make its own rules to prosecute 
doctors.'' Id.

[[Page 8249]]

    Gonzales, however, offers no comfort to Respondent because here, 
the Government's case is based on his convictions for aiding and 
abetting violations of a duly enacted statute--21 U.S.C. 841(a)(1).\4\ 
Moreover, while most prosecutions under 21 U.S.C. 841(a)(1) are based 
on allegations of drug dealing, the statute encompasses any knowing or 
intentional distribution or dispensing of a controlled substance, 
``[e]xcept as authorized by'' the Controlled Substances Act. 21 U.S.C. 
841(a)(1). As the Court of Appeals explained in affirming his 
convictions:
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    \4\ In discussing Respondent's conviction record for the 
unlawful distribution of controlled substances under factor three, 
the Recommended Decision refers to 18 U.S.C. 841(a)(1) in several 
places. See R.D. 32. The correct provision is 21 U.S.C. 841(a)(1).

[n]urses are not authorized by law to write [Schedule II controlled 
substance] prescriptions, which must be written in triplicate by 
licensed physicians only.\5\ [Respondent] developed a scheme that 
enabled nurses to see patients alone, to issue prescriptions for 
Schedule II [c]ontrolled [s]ubstances, and to bill for such 
services. He and the other physicians would pre-sign the triplicate 
forms and provide them to non-physician personnel to use during 
patient visits. These employees, although not trained or legally 
authorized to do so, filled in all the required prescription 
information--drug type, dosage, and quantity--and provided the 
prescriptions to the patients.
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    \5\ The CSA leaves to state law the determination of the classes 
of health care providers that are authorized to prescribe controlled 
substances. See 21 U.S.C. 823(f) (``The Attorney General shall 
register [a] practitioner[ ] . . . to dispense . . . controlled 
substances . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.''); id. Sec.  802(21) (``The term `practitioner' means a 
physician, dentist, veterinarian . . . or other person licensed, 
registered, or otherwise permitted, by the United States or the 
jurisdiction in which he practices . . . to dispense . . . a 
controlled substance in the course of professional practice. . . 
.''). See also 21 CFR 1306.03(a) (``A prescription for a controlled 
substance may be issued only by an individual practitioner who is . 
. . [a]uthorized to prescribe controlled substances by the 
jurisdiction in which he is licensed to practice his profession and 
. . . [e]ither registered or exempted from registration . . . .'').

United States v. Singh, 390 F.3d 168, 176 (2d Cir. 2004). Indeed, the 
Court of Appeals noted that ``[d]ata extracted from Singh's office 
records revealed that the nurses issued prescriptions for at least 
76,000 tablets of Schedule II Controlled Substances when Singh was not 
present in the Practice suite.'' Id.
    Contrary to Respondent's contention, the Government was not 
required to show that any of the drugs obtained through these 
prescriptions were diverted. See Exceptions, at 2. As the Supreme Court 
recognized in Gonzales, one of the purposes of the CSA's prescription 
regulation (21 CFR 1306.04(a)) is to ``ensure[ ] patients use 
controlled substances under the supervision of a doctor so as to 
prevent addiction and recreational abuse.'' 546 U.S. at 274. 
Respondent's nurses lacked the necessary training in medicine to 
properly supervise his patients and to determine whether additional 
prescriptions were warranted. Thus, by providing his nurses with pre-
signed and otherwise blank prescriptions, Respondent's conduct created 
a substantial risk that the drugs would be diverted and abused. 
Moreover, as Respondent did not see the patients on those occasions 
when his nurses provided the prescriptions to the patients, he has no 
idea whether any of the drugs were abused or diverted. Yet, as the CALJ 
found, Respondent still does not understand this. R.D. 37-38.
    Respondent also argues ``that billing issues were criminalized 
through the use of [the] CSA despite no evidence of Diversion or Public 
Safety Issues.'' Exceptions, at 2. However, in affirming his 
convictions for health care fraud, see 18 U.S.C. 1347, the Second 
Circuit reviewed the sufficiency of the evidence presented at trial and 
found that there were numerous instances in which Respondent billed for 
office visits as if he had seen the patients when, in fact, the 
patients were seen only by his nurses. See Singh, 390 F.3d at 187-89. 
Not only are Respondent's convictions res judicata, the crime of health 
care fraud does not require proof of either diversion or public safety 
issues. See 18 U.S.C. 1347(a).
    Respondent further argues that the CALJ ignored substantial 
evidence in concluding that he failed to acknowledge his misconduct. 
Exceptions, at 3. Respondent argues that:

    I admitted right from the start in 1999 that I made the mistake 
of leaving Pre-Signed Prescriptions for legitimate patients of the 
practice with treatment plan spelled [out] in the chart, and not for 
Diversion. I never tried to trivialize it. . . . I admitted to the 
truth. The Agency wants me to admit Diversion (drug trafficking) 
when there was none.

Id.

    My review of the record finds no instance of the Agency attempting 
to elicit from Respondent an admission that he engaged in drug 
trafficking. What the record does show, however, is that Respondent 
still fails to acknowledge the risk of diversion created by his 
practice of providing pre-signed but otherwise blank prescriptions to 
his nurses and authorizing them to issue the prescriptions to the 
patients he did not see.\6\
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    \6\ At one point, Respondent testified ``that there was no 
medical safety issue. And, yes, as you [the CALJ] now present it to 
me--and I apologize for that. This prescription could have been 
diverted, yes. There is no doubt about that.'' Tr. 269. However, on 
further questioning by the CALJ as to whether pre-signing the 
prescriptions was a safety issue, Respondent testified: ``No. 
Safety, I also--no, I didn't mean no safety issue with blank 
prescription, no, not at all.'' Id. Respondent then explained that 
``[t]here was no public safety [issue] in the sense that there was 
no issue that patient could be harmed. I was thinking entirely 
differently.'' Id.
    The CALJ then asked: ``[s]o there was no safety issue with some 
patient who you didn't know was going to get the prescription, with 
whatever drugs that were written on it that you didn't know, . . . 
there was no way in your view that any of those patients could be 
harmed?'' Tr. 269-70. Respondent answered: ``They were following my 
previous protocol.'' Id. at 270.
     Later, the CALJ asked: ``[s]he [the Nurse] was exercising her 
judgment for patients that you didn't know for medications that you 
had no idea because you signed them?'' Id. at 278. Respondent 
answered: ``I knew the patients Your Honor. I knew the patients were 
coming in.'' Id. In response, the CALJ asked: ``Back to that 
again?'' Id. Respondent answered: ``No. I get back, yes, Your Honor. 
I apologize. I fully agree that, yes, it could be a great hazard. It 
could have been a great hazard.'' Id.
     In response, the CALJ stated: ``I know those are your words, 
but they're not very convincing the way that you say it. I must say 
that your tenor, it's not very convincing that you think that.'' Id. 
I find no reason to reject the CALJ's assessment of Respondent's 
demeanor and the credibility of his testimony. See Universal Camera, 
340 U.S. at 496.
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    Moreover, at the hearing, Respondent continued to dispute the 
extent of his misconduct in pre-signing prescriptions. Respondent 
testified that he engaged in this practice only after November 25, 
1997, when another physician suddenly left his practice, and ``I left a 
few, you know, eight or 10 prescriptions pre[-]signed without any 
patient name.'' Tr. 250. The CALJ then asked Respondent: ``So your 
testimony is that there were--in the entire practice that you had there 
were only eight to 10 times that you pre[-]signed prescriptions?'' Id. 
Respondent answered: ``That's right, Your Honor.'' Id.
    The CALJ again asked: ``And that's your testimony under oath?'' Id. 
at 250-51. Respondent answered: ``Yes, that's my testimony under oath. 
And all other prescriptions nurses handed were pre[-]filled and then 
handed to the patient. Even if I was not there they can give that 
because after that we learned our lesson. We cannot do this.'' Id. at 
251.
    After Respondent asserted that the difference between pre-signed 
and pre-filled prescriptions was that the former did not have a 
patient's name, the CALJ again asked: ``So . . . it's your recollection 
that there were only eight to 10 times that this occurred?'' Id.

[[Page 8250]]

Respondent answered: ``That's correct, Your Honor.'' Id. Following up, 
the CALJ asked: ``there were only eight to 10 total pre[-]signed 
prescriptions that you ever made in your life?'' Id. After Respondent 
ascertained that the CALJ meant that the prescriptions had been signed 
but otherwise ``left blank,'' Respondent answered ``[y]es.'' Id. 252.
    The evidence further shows that on December 2, 1997, Investigators 
from the New York State Bureau of Controlled Substances went to his 
office at Albany Memorial Hospital and found six blank pre-signed 
prescriptions in the possession of his nurse. RX 12, at 2. At the 
hearing, Respondent testified that ``[a]fter the investigation, we 
stopped doing that.'' \7\ Tr. 398. Yet later in his testimony, 
Respondent testified that this practice continued until some 
unspecified date in February 1998, when he hired another doctor for the 
practice, id. at 405-6, before returning to his original story and 
asserting that he had provided pre-signed prescriptions only on 
December 2, 1997 and had ``stopped that right away'' after the State's 
Investigator had come to his office. Id. at 411-12.
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    \7\ According to the Investigator's Report, Respondent's wife 
was present at his Albany office and ``called his attorney, who 
showed up at the office within minutes'' but ``would not allow the 
[Investigator] to make photocopies of those blanks on'' that date. 
RX 12, at 2. (The pre-signed prescriptions were, however, 
surrendered several days later. Id.) I therefore find that 
Respondent was aware of the investigation on December 2, 1997.
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    Respondent, however, was convicted of twenty-four counts of causing 
an act to be done and aiding and abetting the unlawful distribution of 
schedule II controlled substances based on his having provided pre-
signed but otherwise blank prescriptions to his employees. See GX 2, at 
21-24 (Superseding Indictment); GX 5, at 1 (District Court's Judgment). 
Moreover, Respondent was convicted of having committed this offense 
beginning as early as November 25, 1996, and was convicted of nineteen 
such offenses before November 25, 1997, the date on which his 
physician-employee quit the practice. See GX 2, at 21-24; GX 5, at 1.
    As for his testimony that he stopped providing pre-signed 
prescriptions after becoming aware of the investigation, Respondent was 
convicted of having committed the offense on five occasions in January 
1998, more than a month after he became aware of the investigation. See 
GX 2, at 23-24; GX 5, at 1. Moreover, the Court of Appeals found that 
on July 27, 1999--nearly 18 months after the visit by the State 
Investigator--federal agents executed search warrants at Respondent's 
offices in Albany and Port Chester, as well as his home, and found 
still more pre-signed prescriptions. See 390 F.3d at 178.
    Likewise, with respect to his convictions for health care fraud, 
Respondent asserted that there were only 15 or 20 times when he billed 
an office visit as if he had seen the patient when the patient had only 
been seen by a nurse. Id. at 254. While Respondent admitted that ``the 
billing mistake was actually a big mistake'' and ``was stupid of me,'' 
id. at 255, here too, he attempted to minimize his misconduct 
asserting, in essence, that he was confused because ``in some states . 
. . if [the] doctor has set a plan, the nurse can do it as to this 
doctor's plan, [and the visit] can be billed under [the] doctor.'' Id. 
at 257. Unexplained is why, if Respondent had overbilled only 15 to 20 
times, the District Court ordered him to pay more than $227,000 in 
restitution to approximately 250 payees.\8\ See GX 5, at 7-13. The 
amount of the restitution he was ordered to pay likewise refutes his 
assertion that the overbilling was not motivated by money. See Tr. 262 
(Respondent's testimony denying that the overbilling was financially 
motivated).
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    \8\ Of further note, the Court of Appeals also rejected 
Respondent's challenge to his convictions for health care fraud, 
explaining that his ``contention that the billing codes and rules 
were sufficiently ambiguous to preclude a finding of fraudulent 
intent on his part is belied by the evidence. There are in fact no 
ambiguities in the billing requirements.'' 390 F.3d at 187. See also 
id. at 187-88 (``Nor could a rational jury find ambiguities 
sufficient to negate fraudulent intent . . . in the Medicare rules 
that allow billing for services performed by registered nurses when 
those services are `incident to' a physician's services. The 
requirements for `incident to' billing are that the physician must 
be present in the office suite and available to provide assistance. 
This requirement is plain enough, and there is ample proof that 
Singh did not comply with it.'').
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    Finally, Respondent argues that the CALJ improperly ignored the 
State's recommendation; he also provides a laundry list of exhibits 
that he believes the CALJ ignored. As for the decision of the Peer 
Committee of the New York State Department of Education Committee in 
the Professions, the State has not made a recommendation to the Agency 
as to whether to grant a new registration to Respondent. While the 
State's decision to issue Respondent a new medical license establishes 
that he again holds authority under state law to dispense controlled 
substances and thereby satisfies the CSA's prerequisite for obtaining a 
practitioner's registration, this ``Agency has long held that `the 
Controlled Substances Act requires that the Administrator . . . make an 
independent determination [from that made by state officials] as to 
whether the granting of controlled substance privileges would be in the 
public interest.' '' David A. Ruben, 78 FR 38363, 38379 n.35 (2013) 
(quoting Mortimer Levin, 57 FR 8680, 8681 (1992)).
    Notably, under New York law, ``an applicant . . . does not have to 
admit past wrongdoing the applicant does not believe he committed . . . 
in order to be readmitted to his profession.'' GX 9F, at 12 (citation 
omitted). To be sure, in exercising its sovereign power to regulate the 
medical profession, the State of New York may follow this policy. See 
Ruben, 78FR at 38837 n.53. However, DEA is charged with protecting the 
public interest, see 21 U.S.C. 823(f), and based on the threat to 
public health and safety caused by intentional and knowing misconduct 
involving controlled substances, it is fully within DEA's authority to 
require an applicant for registration to acknowledge the full extent of 
his misconduct which has been proven on the record of the proceeding. 
See MacKay v. DEA, 664 F.3d 808, 821 (10th Cir. 2011) (discussing Jayam 
Krishna-Iyer, 74 FR 459, 462 (2009)). And while both MacKay and 
Krishna-Iyer involved practitioners who engaged in intentional 
diversion (i.e., drug trafficking), the same consideration applies 
here, where, even though there is no evidence that the drugs the 
patients obtained using the pre-signed prescriptions were diverted, 
Respondent engaged in intentional or knowing misconduct which created a 
substantial risk of diversion.
    Thus, while Respondent has put forward evidence of his remedial 
measures, his continued refusal to acknowledge the full scope of his 
criminal conduct precludes a finding that his registration would be 
consistent with the public interest. See R.D. at 37-38. Indeed, in his 
post-hearing brief, Respondent goes so far as to characterize his 
convictions for violating 21 U.S.C. 841(a)(1) as ``technical 
convictions.'' Resp. Post-Hrng. Br., at 12. They were not.
    Moreover, as I have previously explained, the record contains no 
support for Respondent's assertion (Exceptions at 4) that he was 
required to admit to having issued prescriptions outside of the usual 
course of professional practice and for other than a legitimate medical 
purpose (i.e., drug trafficking). See 21 CFR 1306.04(a). What he was 
required to acknowledge was the full scope of his criminal behavior and 
the risk of diversion it created, which, as established by his

[[Page 8251]]

convictions and the Second Circuit's opinion, went on for a far longer 
period and to a far greater extent than he was willing to acknowledge 
during this proceeding.
    Accordingly, I find the CALJ's conclusion that Respondent has not 
accepted responsibility for his misconduct to be fully supported by the 
record and that he has not put forward sufficient evidence ``that could 
reasonably support a finding that'' he can be entrusted with a 
registration. R.D. at 38. Because I also agree with the CALJ's finding 
that Respondent's misconduct was egregious and that he still ``does not 
believe he was mistaken in any way,'' I also agree that these factors 
support the denial of his application. See id. at 39. I therefore adopt 
the CALJ's recommendation that I deny Respondent's application.

Order

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

    Dated: February 10, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-03361 Filed 2-17-16; 8:45 am]
BILLING CODE 4410-09-P



                                                                              Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices                                                      8247

                                                  registrant’s business activity is                       importer of butylone (7541), a basic                  programs for a period of 15 years based
                                                  consistent with what is authorized                      class of controlled substance listed in               on his convictions for Health Care Fraud
                                                  under to 21 U.S.C. 952(a)(2).                           schedule I.                                           and for violating the Controlled
                                                  Authorization will not extend to the                      The company plans to import the                     Substances Act. Id. The Government
                                                  import of FDA approved or non-                          above listed controlled substance for                 further alleged that because ‘‘the
                                                  approved finished dosage forms for                      analytical research and testing of                    amount of the financial loss’’ was in
                                                  commercial sale.                                        equipment. This authorization does not                excess of $5,000; the time period of
                                                    Dated: February 10, 2016.                             extend to the import of a finished FDA                Respondent’s illegal activity exceeded
                                                                                                          approved or non-approved dosage form                  more than one year; and Respondent
                                                  Louis J. Milione,
                                                                                                          for commercial sale.                                  had been convicted of the CSA
                                                  Deputy Assistant Administrator.                                                                               violations; HHS imposed a 15-year
                                                  [FR Doc. 2016–03358 Filed 2–17–16; 8:45 am]               Dated: February 10, 2016.
                                                                                                                                                                exclusion, which was three times the
                                                                                                          Louis J. Milione,
                                                  BILLING CODE 4410–09–P                                                                                        minimum exclusion period. Id. (citing
                                                                                                          Deputy Assistant Administrator.                       21 U.S.C. 824(a)(5)).
                                                                                                          [FR Doc. 2016–03353 Filed 2–17–16; 8:45 am]              Following service of the Show Cause
                                                  DEPARTMENT OF JUSTICE                                   BILLING CODE 4410–09–P                                Order, Respondent requested a hearing
                                                                                                                                                                on the allegations. The matter was
                                                  Drug Enforcement Administration                                                                               placed on the docket of the Office of
                                                  [Docket No. DEA–392]                                    DEPARTMENT OF JUSTICE                                 Administrative Law Judges and assigned
                                                                                                                                                                to Chief Administrative Law Judge
                                                  Importer of Controlled Substances                       Drug Enforcement Administration                       (hereinafter, CALJ) John J. Mulrooney,
                                                  Registration: Sigma Aldrich                             [Docket No. 15–1]                                     II. Following pre-hearing procedures,
                                                  International GMBH-Sigma Aldrich Co.                                                                          the CALJ conducted a hearing at which
                                                  LLC                                                     Arvinder Singh, M.D.; Decision and                    both parties introduced documentary
                                                                                                          Order                                                 evidence and called witnesses to testify.
                                                  ACTION:   Notice of registration.                                                                             Thereafter, both parties submitted briefs
                                                                                                             On October 16, 2014, the Deputy
                                                  SUMMARY:   Sigma Aldrich International                                                                        containing their proposed findings of
                                                                                                          Assistant Administrator, Office of
                                                  GMBH-Sigma Aldrich Co. LLC applied                                                                            fact, conclusions of law, and arguments
                                                                                                          Diversion Control, issued an Order to                 regarding the ultimate disposition of
                                                  to be registered as an importer of a basic              Show Cause to Arvinder Singh, M.D.
                                                  class of controlled substance. The Drug                                                                       this matter.
                                                                                                          (Respondent), of Clifton Park, New                       On February 10, 2015, the CALJ
                                                  Enforcement Administration (DEA)                        York. ALJ Ex. 1. The Show Cause Order                 issued his Recommended Decision.
                                                  grants Sigma Aldrich International                      proposed the denial of Respondent’s                   Therein, the CALJ found that the
                                                  GMBH-Sigma Aldrich Co. LLC                              application for a DEA Certificate of                  Government had established a prima
                                                  registration as an importer of this                     Registration as a practitioner on three               facie case to deny Respondent’s
                                                  controlled substance.                                   grounds.                                              application for registration as a
                                                  SUPPLEMENTARY INFORMATION: By notice                       First, the Show Cause Order alleged                practitioner on multiple grounds.1 R.D.
                                                  dated October 13, 2015, and published                   that on August 4, 2003, Respondent,                   at 37.
                                                  in the Federal Register on October 21,                  following a jury trial, was convicted on                 These included that Respondent had
                                                  2015, 80 FR 63839, Sigma Aldrich                        16 counts of health care fraud in                     been convicted of twenty-four counts of
                                                  International GMBH-Sigma Aldrich Co.                    violation of 18 U.S.C. 1347, one count
                                                  LLC, 3500 Dekalb Street, Saint Louis,                   of conspiracy to distribute controlled                   1 Pursuant to 21 U.S.C. 823(f), ‘‘[t]he Attorney

                                                  Missouri 63118 applied to be registered                 substances in violation of 21 U.S.C. 846,             General may deny an application for [a
                                                  as an importer of a certain basic class of              and 24 counts of unlawful distribution                practitioner’s] registration . . . if [she] determines
                                                                                                                                                                that the issuance of such registration . . . would be
                                                  controlled substance. No comments or                    of controlled substances in violations of             inconsistent with the public interest.’’ In making
                                                  objections were submitted for this                      21 U.S.C. 841(a)(1) and 18 U.S.C. 2. Id.              this determination, section 823(f) directs the
                                                  notice.                                                 at 1–2. (citing 21 U.S.C. 824(a)(2)).                 Agency to consider the following factors:
                                                    The DEA has considered the factors in                    Second, the Show Cause Order                          (1) The recommendation of the appropriate State
                                                                                                                                                                licensing board or professional disciplinary
                                                  21 U.S.C. 823, 952(a) and 958(a) and                    alleged that Respondent’s convictions                 authority.
                                                  determined that the registration of                     for violating the Controlled Substances                  (2) The applicant’s experience in dispensing . . .
                                                  Sigma Aldrich International GMBH-                       Act ‘‘were based on a scheme in which                 controlled substances.
                                                  Sigma Aldrich Co. LLC, to import the                    [he] left pre-signed but otherwise blank                 (3) The applicant’s conviction record under
                                                  basic class of controlled substance is                  prescriptions for [his] nursing staff to              Federal or State laws relating to the manufacture,
                                                                                                                                                                distribution, or dispensing of controlled substances.
                                                  consistent with the public interest and                 fill in and issue Schedule II controlled                 (4) Compliance with applicable State, Federal, or
                                                  with United States obligations under                    substances prescriptions to patients                  local laws relating to controlled substances.
                                                  international treaties, conventions, or                 when neither [he] nor any other                          (5) Such other conduct which may threaten the
                                                  protocols in effect on May 1, 1971. The                 physician saw the patient at the time                 public health and safety.
                                                  DEA investigated the company’s                          such prescriptions were issued.’’ Id. at                 Id. § 823(f).
                                                                                                                                                                   ‘‘These factors are . . . considered in the
                                                  maintenance of effective controls                       2. The Show Cause Order alleged that                  disjunctive.’’ Robert A. Leslie, M.D., 68 FR 15227,
                                                  against diversion by inspecting and                     Respondent’s scheme also violated 21                  15230 (2003). I ‘‘may rely on any one or a
                                                  testing the company’s physical security                 CFR 1306.04(a) and 1306.05(a), and that               combination of factors[,] and may give each factor
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                                                  systems, verifying the company’s                        this conduct constituted acts                         the weight [I] deem[ ] appropriate in determining
                                                                                                                                                                whether a registration should be revoked. Id.; see
                                                  compliance with state and local laws,                   inconsistent with the public interest. Id.            also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir.
                                                  and reviewing the company’s                             (citing 21 U.S.C. 824(a)(4) and 823(f)).              2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir.
                                                  background and history.                                    Third, the Show Cause Order alleged                2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir.
                                                    Therefore, pursuant to 21 U.S.C.                      that on May 8, 2004, the U.S.                         2005). Moreover, while I am required to consider
                                                                                                                                                                each of the factors, I ‘‘need not make explicit
                                                  952(a) and 958(a), and in accordance                    Department of Health and Human                        findings as to each one.’’ MacKay, 664 F.3d at 816
                                                  with 21 CFR 1301.34, the above-named                    Services (HHS) excluded Respondent                    (quoting Volkman, 567 F.3d at 222 (quoting Hoxie,
                                                  company is granted registration as an                   from participation in federal health care             419 F.3d at 482)).



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                                                  8248                         Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices

                                                  violating 21 U.S.C. 841(a)(1) in that he                 specifically, the evidence shows that on                impact compliance expectations on the
                                                  unlawfully caused and aided and                          May 28, 2004, the Office of Inspector                   regulated community in a significant
                                                  abetted the illegal distribution of                      General, Department of Health and                       way,’’ and thus, the Agency’s interest in
                                                  schedule II controlled substances by                     Human Services, excluded Respondent                     ‘‘general deterrence should not,
                                                  providing pre-signed but otherwise                       ‘‘from participat[ing] in the Medicare,                 standing alone, constitute an
                                                  blank prescriptions to nurses who                        Medicaid, and all Federal health care                   insurmountable impediment to
                                                  worked for him, who filled in the                        programs . . . for a minimum period of                  granting’’ his application. Id.
                                                  prescriptions with the name of the                       15 years.’’ GX 6. The exclusion was                        However, the CALJ then found that
                                                  patient, the name of the drug, the                       based on Respondent’s convictions ‘‘of                  ‘‘[t]he issue of specific deterrence . . .
                                                  quantity and dosing instructions, and                    criminal offense[s] related to’’: (1) ‘‘the             is a dramatically different issue.’’ Id.
                                                  provided the prescriptions to the                        delivery of an item or service under the                The CALJ explained that ‘‘virtually
                                                  patients, notwithstanding that the                       Medicare program’’; (2) ‘‘fraud, theft,                 every documentary, testimonial, and
                                                  nurses were not legally authorized to                    embezzlement, breach of fiduciary                       argumentative contribution made by the
                                                  dispense controlled substance                            responsibility, or other financial                      Respondent in these proceedings makes
                                                  prescriptions and Respondent did not                     misconduct in connection with the                       it overwhelmingly clear that he does not
                                                  see the patients. R.D. at 32–33. As                      delivery of a health care item or service               believe he was mistaken in any way.’’
                                                  discussed in the Recommended                             or any act or omission in a health care                 Id. The CALJ thus concluded that ‘‘until
                                                  Decision, this conduct implicated three                  program operated or financed by any                     . . . Respondent can convincingly show
                                                  of the public interest factors and                       Federal, State, or local government                     he accepts the authority of the law and
                                                  supports the conclusion that granting                    agency’’; and (3) ‘‘the unlawful                        those bodies charged with enforcing it
                                                  Respondent’s application ‘‘would be                      manufacture, distribution, prescription                 and regulating his activities, granting
                                                  inconsistent with the public interest.’’                 or dispensing of a controlled                           him a DEA registration will gravely
                                                  21 U.S.C. 823(f); see also R.D. at 32–37; 2              substance.’’ Id. (citing 42 U.S.C. 1320a–               endanger the public.’’ Id. at 40. The
                                                  21 CFR 1306.05(a) (‘‘All prescriptions                   7(a)(1), (3), (4)). As the ALJ found, these             CALJ thus recommended that
                                                  for controlled substances shall be dated                 convictions fall within the mandatory                   Respondent’s application be denied. Id.
                                                  as of, and signed on, the day when                       exclusion provisions of 42 U.S.C.                          Respondent filed Exceptions to the
                                                  issued and shall bear the full name and                  1320a–7(a).                                             Recommended Decision and the
                                                  address of the patient, the drug name,                      Turning to whether Respondent had                    Government filed a response to
                                                  strength, dosage form, quantity                          produced sufficient evidence to rebut                   Respondent’s Exceptions. Thereafter,
                                                  prescribed, directions for use, and the                  the Government’s prima facie case, the
                                                                                                                                                                   the record was forwarded to my Office
                                                  name, address and registration number                    CALJ found that ‘‘Respondent continues
                                                                                                                                                                   for Final Agency Action.
                                                  of the practitioner.’’).                                 to dispute the nature of the criminal
                                                                                                                                                                      Having considered the record in its
                                                     In addition to the above, the evidence                charges and their severity.’’ R.D. 38. The
                                                                                                                                                                   entirety (including Respondent’s
                                                  also shows that Respondent ‘‘has been                    CALJ further found that ‘‘instead of
                                                                                                           accepting responsibility for the crimes                 Exceptions), I adopt the CALJ’s findings
                                                  excluded . . . from participation in’’                                                                           of fact and conclusions of law to the
                                                  federal health care programs pursuant to                 for which he was convicted, he has
                                                                                                           emphasized isolated excerpts from                       extent they are discussed herein.
                                                  the mandatory exclusion provisions of                                                                            Because I agree with the CALJ’s ultimate
                                                  42 U.S.C. 1320a–7(a). See 21 U.S.C.                      orders and transcripts where he
                                                                                                           perceives he has been ‘exonerated,’ and/                findings that: (1) Multiple grounds exist
                                                  824(a)(5) (‘‘[a] registration pursuant to                                                                        to deny Respondent’s application, (2)
                                                                                                           or occasions when DEA or the state
                                                  section 823 of this title to . . . dispense                                                                      Respondent has failed to adequately
                                                                                                           licensing agency ‘had no problems’ with
                                                  a controlled substance . . . may be                                                                              acknowledge his misconduct, (3)
                                                                                                           him.’’ Id. (citations omitted).
                                                  suspended or revoked by the Attorney                                                                             Respondent’s misconduct was
                                                                                                           Continuing, the CALJ explained that
                                                  General upon a finding that the                                                                                  egregious, and (4) the Agency’s interest
                                                                                                           ‘‘[t]he Respondent has not accepted
                                                  registrant . . . has been excluded (or                                                                           in specific deterrence supports the
                                                                                                           responsibility for his actions,
                                                  directed to be excluded) from                                                                                    denial of his application, I will adopt
                                                                                                           persuasively expressed remorse for his
                                                  participation in a program pursuant to                                                                           the CALJ’s recommendation that I deny
                                                                                                           conduct, or presented evidence that
                                                  section 1320a–7(a) of Title 42’’).3 More                                                                         Respondent’s application. A discussion
                                                                                                           could reasonably support a finding that
                                                                                                           the Administrator should entrust him                    of Respondent’s Exceptions follows.
                                                      2 See R.D. at 32–33 (discussing application of
                                                                                                           with a registration.’’ Id.                                 Invoking Gonzales v. Oregon, 546
                                                  factor three—‘‘the applicant’s conviction record
                                                  under Federal . . . laws relating to the . . .              The CALJ also found that                             U.S. 243 (2006), Respondent’s first
                                                  distribution[ ] or dispensing of controlled              Respondent’s misconduct was egregious                   contention is that ‘‘the [A]gency has
                                                  substances.’’); id. at 33–36 (discussing application     and ‘‘militates persuasively in favor of                relied on factors which Congress has not
                                                  of factor two—‘‘[t]he applicant’s experience in                                                                  intended it to consider.’’ Exceptions, at
                                                  dispensing . . . controlled substances’’—and factor
                                                                                                           denial of his application.’’ Id. at 39. On
                                                  four—‘‘[c]ompliance with applicable laws . . .           the other hand, because Respondent’s                    1. Fleshing out his argument,
                                                  related to controlled substances’’).                     misconduct ‘‘ended nearly fifteen years                 Respondent contends that during the
                                                      3 Notwithstanding that 21 U.S.C. 824(a)(5)
                                                                                                           earlier’’ and he ‘‘has paid his debt to                 hearing, ‘‘[t]he Government has not
                                                  addresses the Agency’s authority to suspend or           society,’’ the CALJ found that granting                 shown a single case of [d]iversion.’’ Id.
                                                  revoke a registration upon a finding that a registrant
                                                  has been excluded from participation in federal          his application would not ‘‘adversely                   at 2. He argues that the Government
                                                  health care programs under the mandatory                                                                         ‘‘failed to even scratch the surface of the
                                                  exclusion provisions of 42 U.S.C. 1320a–7(a), DEA        license had been revoked, holding that section          case where it is apparent that billing
                                                  ‘‘ ‘has consistently held that where a registration
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                                                                                                           823(f) ‘‘must logically give the Administrator the      issues were criminalized through the
                                                  can be revoked under section 824, it can, a fortiori,    authority to deny a registration if the practitioner
                                                  be denied under section 823 since the law would          is not authorized by the State to dispense controlled
                                                                                                                                                                   use of [the] CSA despite no evidence of
                                                  not require an agency to indulge in the useless act      substances. . . . To hold otherwise would mean          [d]iversion or [p]ublic [s]afety [i]ssues,
                                                  of granting a license on one day only to withdraw        that all applications would have to be granted only     by creating a [sic] interpretive rule, as in
                                                  it on the next.’ ’’ Kwan Bo Jin, 77 FR 35021, 35021      to be revoked the next day under 21 U.S.C.              Gonzales’’ and that ‘‘Congress does not
                                                  n.2 (2012) (quoting Serling Drug Co. v. Detroit          824(a)(3). This [A]gency has consistently held that
                                                  Prescription Wholesaler, Inc., 40 FR 11918, 11919        where a registration can be revoked under section
                                                                                                                                                                   allow DEA to use its policing power to
                                                  (1975)). See also John R. Amato, 40 FR 22852 (1975)      824, it can, a fortiori, be denied under section        regulate Medical Practices or make its
                                                  (Denying application where practitioner’s state          823.’’).                                                own rules to prosecute doctors.’’ Id.


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                                                                               Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices                                                      8249

                                                     Gonzales, however, offers no comfort                  1306.04(a)) is to ‘‘ensure[ ] patients use           prescriptions to the patients he did not
                                                  to Respondent because here, the                          controlled substances under the                      see.6
                                                  Government’s case is based on his                        supervision of a doctor so as to prevent                Moreover, at the hearing, Respondent
                                                  convictions for aiding and abetting                      addiction and recreational abuse.’’ 546              continued to dispute the extent of his
                                                  violations of a duly enacted statute—21                  U.S. at 274. Respondent’s nurses lacked              misconduct in pre-signing prescriptions.
                                                  U.S.C. 841(a)(1).4 Moreover, while most                  the necessary training in medicine to                Respondent testified that he engaged in
                                                  prosecutions under 21 U.S.C. 841(a)(1)                   properly supervise his patients and to               this practice only after November 25,
                                                  are based on allegations of drug dealing,                determine whether additional                         1997, when another physician suddenly
                                                  the statute encompasses any knowing or                   prescriptions were warranted. Thus, by               left his practice, and ‘‘I left a few, you
                                                  intentional distribution or dispensing of                providing his nurses with pre-signed                 know, eight or 10 prescriptions
                                                  a controlled substance, ‘‘[e]xcept as                    and otherwise blank prescriptions,                   pre[-]signed without any patient name.’’
                                                  authorized by’’ the Controlled                           Respondent’s conduct created a                       Tr. 250. The CALJ then asked
                                                  Substances Act. 21 U.S.C. 841(a)(1). As                  substantial risk that the drugs would be             Respondent: ‘‘So your testimony is that
                                                  the Court of Appeals explained in                        diverted and abused. Moreover, as                    there were—in the entire practice that
                                                  affirming his convictions:                               Respondent did not see the patients on               you had there were only eight to 10
                                                  [n]urses are not authorized by law to write              those occasions when his nurses                      times that you pre[-]signed
                                                  [Schedule II controlled substance]                       provided the prescriptions to the                    prescriptions?’’ Id. Respondent
                                                  prescriptions, which must be written in                  patients, he has no idea whether any of              answered: ‘‘That’s right, Your Honor.’’
                                                  triplicate by licensed physicians only.5                 the drugs were abused or diverted. Yet,              Id.
                                                  [Respondent] developed a scheme that                                                                             The CALJ again asked: ‘‘And that’s
                                                  enabled nurses to see patients alone, to issue           as the CALJ found, Respondent still
                                                                                                                                                                your testimony under oath?’’ Id. at 250–
                                                  prescriptions for Schedule II [c]ontrolled               does not understand this. R.D. 37–38.
                                                                                                                                                                51. Respondent answered: ‘‘Yes, that’s
                                                  [s]ubstances, and to bill for such services. He             Respondent also argues ‘‘that billing             my testimony under oath. And all other
                                                  and the other physicians would pre-sign the              issues were criminalized through the
                                                  triplicate forms and provide them to non-
                                                                                                                                                                prescriptions nurses handed were
                                                  physician personnel to use during patient
                                                                                                           use of [the] CSA despite no evidence of              pre[-]filled and then handed to the
                                                  visits. These employees, although not trained            Diversion or Public Safety Issues.’’                 patient. Even if I was not there they can
                                                  or legally authorized to do so, filled in all the        Exceptions, at 2. However, in affirming              give that because after that we learned
                                                  required prescription information—drug                   his convictions for health care fraud, see           our lesson. We cannot do this.’’ Id. at
                                                  type, dosage, and quantity—and provided the              18 U.S.C. 1347, the Second Circuit                   251.
                                                  prescriptions to the patients.                           reviewed the sufficiency of the evidence                After Respondent asserted that the
                                                  United States v. Singh, 390 F.3d 168,                    presented at trial and found that there              difference between pre-signed and pre-
                                                  176 (2d Cir. 2004). Indeed, the Court of                 were numerous instances in which                     filled prescriptions was that the former
                                                  Appeals noted that ‘‘[d]ata extracted                    Respondent billed for office visits as if            did not have a patient’s name, the CALJ
                                                  from Singh’s office records revealed that                he had seen the patients when, in fact,              again asked: ‘‘So . . . it’s your
                                                  the nurses issued prescriptions for at                   the patients were seen only by his                   recollection that there were only eight to
                                                  least 76,000 tablets of Schedule II                      nurses. See Singh, 390 F.3d at 187–89.               10 times that this occurred?’’ Id.
                                                  Controlled Substances when Singh was                     Not only are Respondent’s convictions
                                                  not present in the Practice suite.’’ Id.                 res judicata, the crime of health care                  6 At one point, Respondent testified ‘‘that there

                                                     Contrary to Respondent’s contention,                  fraud does not require proof of either               was no medical safety issue. And, yes, as you [the
                                                                                                                                                                CALJ] now present it to me—and I apologize for
                                                  the Government was not required to                       diversion or public safety issues. See 18            that. This prescription could have been diverted,
                                                  show that any of the drugs obtained                      U.S.C. 1347(a).                                      yes. There is no doubt about that.’’ Tr. 269.
                                                  through these prescriptions were                            Respondent further argues that the                However, on further questioning by the CALJ as to
                                                  diverted. See Exceptions, at 2. As the                                                                        whether pre-signing the prescriptions was a safety
                                                                                                           CALJ ignored substantial evidence in                 issue, Respondent testified: ‘‘No. Safety, I also—no,
                                                  Supreme Court recognized in Gonzales,                    concluding that he failed to                         I didn’t mean no safety issue with blank
                                                  one of the purposes of the CSA’s                         acknowledge his misconduct.                          prescription, no, not at all.’’ Id. Respondent then
                                                  prescription regulation (21 CFR                          Exceptions, at 3. Respondent argues                  explained that ‘‘[t]here was no public safety [issue]
                                                                                                                                                                in the sense that there was no issue that patient
                                                     4 In discussing Respondent’s conviction record
                                                                                                           that:                                                could be harmed. I was thinking entirely
                                                  for the unlawful distribution of controlled                I admitted right from the start in 1999 that       differently.’’ Id.
                                                  substances under factor three, the Recommended                                                                   The CALJ then asked: ‘‘[s]o there was no safety
                                                                                                           I made the mistake of leaving Pre-Signed             issue with some patient who you didn’t know was
                                                  Decision refers to 18 U.S.C. 841(a)(1) in several
                                                  places. See R.D. 32. The correct provision is 21         Prescriptions for legitimate patients of the         going to get the prescription, with whatever drugs
                                                  U.S.C. 841(a)(1).                                        practice with treatment plan spelled [out] in        that were written on it that you didn’t know, . . .
                                                     5 The CSA leaves to state law the determination       the chart, and not for Diversion. I never tried      there was no way in your view that any of those
                                                  of the classes of health care providers that are         to trivialize it. . . . I admitted to the truth.     patients could be harmed?’’ Tr. 269–70. Respondent
                                                  authorized to prescribe controlled substances. See                                                            answered: ‘‘They were following my previous
                                                                                                           The Agency wants me to admit Diversion               protocol.’’ Id. at 270.
                                                  21 U.S.C. 823(f) (‘‘The Attorney General shall
                                                  register [a] practitioner[ ] . . . to dispense . . .     (drug trafficking) when there was none.                 Later, the CALJ asked: ‘‘[s]he [the Nurse] was
                                                  controlled substances . . . if the applicant is          Id.                                                  exercising her judgment for patients that you didn’t
                                                  authorized to dispense . . . controlled substances                                                            know for medications that you had no idea because
                                                  under the laws of the State in which he practices.’’);      My review of the record finds no                  you signed them?’’ Id. at 278. Respondent
                                                  id. § 802(21) (‘‘The term ‘practitioner’ means a                                                              answered: ‘‘I knew the patients Your Honor. I knew
                                                  physician, dentist, veterinarian . . . or other person
                                                                                                           instance of the Agency attempting to                 the patients were coming in.’’ Id. In response, the
                                                  licensed, registered, or otherwise permitted, by the     elicit from Respondent an admission                  CALJ asked: ‘‘Back to that again?’’ Id. Respondent
                                                  United States or the jurisdiction in which he            that he engaged in drug trafficking.                 answered: ‘‘No. I get back, yes, Your Honor. I
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                                                  practices . . . to dispense . . . a controlled           What the record does show, however, is               apologize. I fully agree that, yes, it could be a great
                                                  substance in the course of professional practice.                                                             hazard. It could have been a great hazard.’’ Id.
                                                  . . .’’). See also 21 CFR 1306.03(a) (‘‘A prescription
                                                                                                           that Respondent still fails to                          In response, the CALJ stated: ‘‘I know those are
                                                  for a controlled substance may be issued only by         acknowledge the risk of diversion                    your words, but they’re not very convincing the
                                                  an individual practitioner who is . . . [a]uthorized     created by his practice of providing pre-            way that you say it. I must say that your tenor, it’s
                                                  to prescribe controlled substances by the                signed but otherwise blank                           not very convincing that you think that.’’ Id. I find
                                                  jurisdiction in which he is licensed to practice his                                                          no reason to reject the CALJ’s assessment of
                                                  profession and . . . [e]ither registered or exempted
                                                                                                           prescriptions to his nurses and                      Respondent’s demeanor and the credibility of his
                                                  from registration . . . .’’).                            authorizing them to issue the                        testimony. See Universal Camera, 340 U.S. at 496.



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                                                  8250                        Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices

                                                  Respondent answered: ‘‘That’s correct,                  search warrants at Respondent’s offices                  make an independent determination
                                                  Your Honor.’’ Id. Following up, the                     in Albany and Port Chester, as well as                   [from that made by state officials] as to
                                                  CALJ asked: ‘‘there were only eight to 10               his home, and found still more pre-                      whether the granting of controlled
                                                  total pre[-]signed prescriptions that you               signed prescriptions. See 390 F.3d at                    substance privileges would be in the
                                                  ever made in your life?’’ Id. After                     178.                                                     public interest.’ ’’ David A. Ruben, 78
                                                  Respondent ascertained that the CALJ                       Likewise, with respect to his                         FR 38363, 38379 n.35 (2013) (quoting
                                                  meant that the prescriptions had been                   convictions for health care fraud,                       Mortimer Levin, 57 FR 8680, 8681
                                                  signed but otherwise ‘‘left blank,’’                    Respondent asserted that there were                      (1992)).
                                                  Respondent answered ‘‘[y]es.’’ Id. 252.                 only 15 or 20 times when he billed an                       Notably, under New York law, ‘‘an
                                                     The evidence further shows that on                   office visit as if he had seen the patient               applicant . . . does not have to admit
                                                  December 2, 1997, Investigators from                    when the patient had only been seen by                   past wrongdoing the applicant does not
                                                  the New York State Bureau of                            a nurse. Id. at 254. While Respondent                    believe he committed . . . in order to be
                                                  Controlled Substances went to his office                admitted that ‘‘the billing mistake was                  readmitted to his profession.’’ GX 9F, at
                                                  at Albany Memorial Hospital and found                   actually a big mistake’’ and ‘‘was stupid                12 (citation omitted). To be sure, in
                                                  six blank pre-signed prescriptions in the               of me,’’ id. at 255, here too, he                        exercising its sovereign power to
                                                  possession of his nurse. RX 12, at 2. At                attempted to minimize his misconduct                     regulate the medical profession, the
                                                  the hearing, Respondent testified that                  asserting, in essence, that he was                       State of New York may follow this
                                                  ‘‘[a]fter the investigation, we stopped                 confused because ‘‘in some states . . . if               policy. See Ruben, 78FR at 38837 n.53.
                                                  doing that.’’ 7 Tr. 398. Yet later in his               [the] doctor has set a plan, the nurse can               However, DEA is charged with
                                                  testimony, Respondent testified that this               do it as to this doctor’s plan, [and the                 protecting the public interest, see 21
                                                  practice continued until some                           visit] can be billed under [the] doctor.’’               U.S.C. 823(f), and based on the threat to
                                                  unspecified date in February 1998,                      Id. at 257. Unexplained is why, if                       public health and safety caused by
                                                  when he hired another doctor for the                    Respondent had overbilled only 15 to 20                  intentional and knowing misconduct
                                                  practice, id. at 405–6, before returning                times, the District Court ordered him to                 involving controlled substances, it is
                                                  to his original story and asserting that                pay more than $227,000 in restitution to                 fully within DEA’s authority to require
                                                  he had provided pre-signed                              approximately 250 payees.8 See GX 5, at                  an applicant for registration to
                                                  prescriptions only on December 2, 1997                  7–13. The amount of the restitution he                   acknowledge the full extent of his
                                                  and had ‘‘stopped that right away’’ after               was ordered to pay likewise refutes his                  misconduct which has been proven on
                                                  the State’s Investigator had come to his                assertion that the overbilling was not                   the record of the proceeding. See
                                                  office. Id. at 411–12.                                  motivated by money. See Tr. 262                          MacKay v. DEA, 664 F.3d 808, 821 (10th
                                                     Respondent, however, was convicted                   (Respondent’s testimony denying that                     Cir. 2011) (discussing Jayam Krishna-
                                                  of twenty-four counts of causing an act                 the overbilling was financially                          Iyer, 74 FR 459, 462 (2009)). And while
                                                  to be done and aiding and abetting the                  motivated).                                              both MacKay and Krishna-Iyer involved
                                                  unlawful distribution of schedule II                       Finally, Respondent argues that the                   practitioners who engaged in intentional
                                                  controlled substances based on his                      CALJ improperly ignored the State’s                      diversion (i.e., drug trafficking), the
                                                  having provided pre-signed but                          recommendation; he also provides a                       same consideration applies here, where,
                                                  otherwise blank prescriptions to his                    laundry list of exhibits that he believes                even though there is no evidence that
                                                  employees. See GX 2, at 21–24                           the CALJ ignored. As for the decision of                 the drugs the patients obtained using
                                                  (Superseding Indictment); GX 5, at 1                    the Peer Committee of the New York                       the pre-signed prescriptions were
                                                  (District Court’s Judgment). Moreover,                  State Department of Education                            diverted, Respondent engaged in
                                                  Respondent was convicted of having                      Committee in the Professions, the State                  intentional or knowing misconduct
                                                  committed this offense beginning as                     has not made a recommendation to the                     which created a substantial risk of
                                                  early as November 25, 1996, and was                     Agency as to whether to grant a new                      diversion.
                                                                                                          registration to Respondent. While the                       Thus, while Respondent has put
                                                  convicted of nineteen such offenses
                                                                                                          State’s decision to issue Respondent a                   forward evidence of his remedial
                                                  before November 25, 1997, the date on
                                                                                                          new medical license establishes that he                  measures, his continued refusal to
                                                  which his physician-employee quit the
                                                                                                          again holds authority under state law to                 acknowledge the full scope of his
                                                  practice. See GX 2, at 21–24; GX 5, at
                                                                                                          dispense controlled substances and                       criminal conduct precludes a finding
                                                  1.
                                                                                                          thereby satisfies the CSA’s prerequisite                 that his registration would be consistent
                                                     As for his testimony that he stopped
                                                                                                          for obtaining a practitioner’s                           with the public interest. See R.D. at 37–
                                                  providing pre-signed prescriptions after
                                                                                                          registration, this ‘‘Agency has long held                38. Indeed, in his post-hearing brief,
                                                  becoming aware of the investigation,
                                                                                                          that ‘the Controlled Substances Act                      Respondent goes so far as to
                                                  Respondent was convicted of having
                                                                                                          requires that the Administrator . . .                    characterize his convictions for
                                                  committed the offense on five occasions
                                                                                                                                                                   violating 21 U.S.C. 841(a)(1) as
                                                  in January 1998, more than a month
                                                                                                             8 Of further note, the Court of Appeals also          ‘‘technical convictions.’’ Resp. Post-
                                                  after he became aware of the
                                                                                                          rejected Respondent’s challenge to his convictions       Hrng. Br., at 12. They were not.
                                                  investigation. See GX 2, at 23–24; GX 5,                for health care fraud, explaining that his                  Moreover, as I have previously
                                                  at 1. Moreover, the Court of Appeals                    ‘‘contention that the billing codes and rules were       explained, the record contains no
                                                  found that on July 27, 1999—nearly 18                   sufficiently ambiguous to preclude a finding of
                                                                                                                                                                   support for Respondent’s assertion
                                                  months after the visit by the State                     fraudulent intent on his part is belied by the
                                                                                                          evidence. There are in fact no ambiguities in the        (Exceptions at 4) that he was required to
                                                  Investigator—federal agents executed                    billing requirements.’’ 390 F.3d at 187. See also id.    admit to having issued prescriptions
                                                                                                          at 187–88 (‘‘Nor could a rational jury find
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                                                     7 According to the Investigator’s Report,
                                                                                                                                                                   outside of the usual course of
                                                                                                          ambiguities sufficient to negate fraudulent intent
                                                  Respondent’s wife was present at his Albany office      . . . in the Medicare rules that allow billing for
                                                                                                                                                                   professional practice and for other than
                                                  and ‘‘called his attorney, who showed up at the         services performed by registered nurses when those       a legitimate medical purpose (i.e., drug
                                                  office within minutes’’ but ‘‘would not allow the       services are ‘incident to’ a physician’s services. The   trafficking). See 21 CFR 1306.04(a).
                                                  [Investigator] to make photocopies of those blanks      requirements for ‘incident to’ billing are that the      What he was required to acknowledge
                                                  on’’ that date. RX 12, at 2. (The pre-signed            physician must be present in the office suite and
                                                  prescriptions were, however, surrendered several        available to provide assistance. This requirement is
                                                                                                                                                                   was the full scope of his criminal
                                                  days later. Id.) I therefore find that Respondent was   plain enough, and there is ample proof that Singh        behavior and the risk of diversion it
                                                  aware of the investigation on December 2, 1997.         did not comply with it.’’).                              created, which, as established by his


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                                                                              Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Notices                                                8251

                                                  convictions and the Second Circuit’s                    approximately 10–11 grants of                         DEPARTMENT OF LABOR
                                                  opinion, went on for a far longer period                approximately $2,000,000 each to Local
                                                  and to a far greater extent than he was                 Workforce Development Boards                          Office of the Secretary
                                                  willing to acknowledge during this                      (LWDB). This program is designed to
                                                  proceeding.                                                                                                   Agency Information Collection
                                                                                                          provide employment-related services to
                                                     Accordingly, I find the CALJ’s                                                                             Activities; Submission for OMB
                                                                                                          eligible youth who are new entrants to
                                                  conclusion that Respondent has not                                                                            Review; Comment Request;
                                                                                                          the workforce, including those with
                                                  accepted responsibility for his                                                                               Representative Fee Request
                                                                                                          limited current or past work experience.
                                                  misconduct to be fully supported by the
                                                  record and that he has not put forward                     The program will provide youth with                ACTION:   Notice.
                                                  sufficient evidence ‘‘that could                        work experience opportunities,
                                                                                                                                                                SUMMARY:   The Department of Labor
                                                  reasonably support a finding that’’ he                  including summer and year-round
                                                                                                                                                                (DOL) is submitting the Office of
                                                  can be entrusted with a registration.                   part-time job opportunities for in-school
                                                                                                                                                                Workers’ Compensation Programs
                                                  R.D. at 38. Because I also agree with the               youth and employment and work                         (OWCP) sponsored information
                                                  CALJ’s finding that Respondent’s                        experience opportunities throughout the               collection request (ICR) titled,
                                                  misconduct was egregious and that he                    year for out-of-school youth, and                     ‘‘Representative Fee Request,’’ to the
                                                  still ‘‘does not believe he was mistaken                exposure to career pathways in                        Office of Management and Budget
                                                  in any way,’’ I also agree that these                   in-demand job sectors. The grants will                (OMB) for review and approval for
                                                  factors support the denial of his                       require partnerships between LWDBs                    continued use, without change, in
                                                  application. See id. at 39. I therefore                 and local summer employment                           accordance with the Paperwork
                                                  adopt the CALJ’s recommendation that                    programs, employers, Local Education                  Reduction Act of 1995 (PRA), 44 U.S.C.
                                                  I deny Respondent’s application.                        Agencies (LEAs), and re-engagement                    3501 et seq. Public comments on the
                                                  Order                                                   centers. Other community partners may                 ICR are invited.
                                                                                                          provide services to eligible youth that               DATES: The OMB will consider all
                                                     Pursuant to the authority vested in me
                                                                                                          assist in the development of work                     written comments that agency receives
                                                  by 21 U.S.C. 823(f) and 28 CFR 0.100(b),
                                                                                                          experience and entry into career                      on or before March 21, 2016.
                                                  I order that the application of Arvinder
                                                  Singh, M.D., for a DEA Certificate of                   pathways.                                             ADDRESSES: A copy of this ICR with
                                                  Registration as a practitioner, be, and it                 The complete FOA and any                           applicable supporting documentation;
                                                  hereby is, denied. This Order is effective              subsequent FOA amendments in                          including a description of the likely
                                                  immediately.                                            connection with this solicitation are                 respondents, proposed frequency of
                                                                                                          described in further detail on ETA’s                  response, and estimated total burden
                                                    Dated: February 10, 2016.
                                                                                                          Web site at http://www.doleta.gov/                    may be obtained free of charge from the
                                                  Chuck Rosenberg,
                                                                                                          grants/ or http://www.grants.gov. The                 RegInfo.gov Web site at http://www.
                                                  Acting Administrator.                                                                                         reginfo.gov/public/do/PRAViewICR?ref_
                                                  [FR Doc. 2016–03361 Filed 2–17–16; 8:45 am]
                                                                                                          Web sites provide application
                                                                                                          information, eligibility requirements,                nbr=201508-1240-002 or by contacting
                                                  BILLING CODE 4410–09–P
                                                                                                          review and selection procedures, and                  Michel Smyth by telephone at 202–693–
                                                                                                          other program requirements governing                  4129, TTY 202–693–8064, (these are not
                                                                                                                                                                toll-free numbers) or by email at DOL_
                                                  DEPARTMENT OF LABOR                                     this solicitation.
                                                                                                                                                                PRA_PUBLIC@dol.gov.
                                                                                                          DATES: The closing date for receipt of                   Submit comments about this request
                                                  Employment and Training                                 applications under this Announcement                  by mail or courier to the Office of
                                                  Administration                                          is March 25, 2016. We must receive                    Information and Regulatory Affairs,
                                                                                                          applications no later than 4:00:00 p.m.               Attn: OMB Desk Officer for DOL–
                                                  Notice of Availability of Funds and
                                                                                                          Eastern Time.                                         OWCP, Office of Management and
                                                  Funding Opportunity Announcement
                                                                                                                                                                Budget, Room 10235, 725 17th Street
                                                  for: Summer Jobs and Beyond: Career                     FOR FURTHER INFORMATION CONTACT:                      NW., Washington, DC 20503; by Fax:
                                                  Pathways for Youth (CPY)                                Janice Sheelor, Grants Management                     202–395–5806 (this is not a toll-free
                                                  AGENCY:  Employment and Training                        Specialist, Office of Grants                          number); or by email: OIRA_
                                                  Administration, Labor.                                  Management, at (202) 693–3538.                        submission@omb.eop.gov. Commenters
                                                  ACTION: Funding Opportunity                             Applicants should email all technical                 are encouraged, but not required, to
                                                  Announcement (FOA).                                     questions to sheelor.janice@dol.gov and               send a courtesy copy of any comments
                                                                                                          reference the Funding Opportunity                     by mail or courier to the U.S.
                                                    Funding Opportunity Number: FOA–                      Number listed in this notice.                         Department of Labor-OASAM, Office of
                                                  ETA–16–08.                                                                                                    the Chief Information Officer, Attn:
                                                  SUMMARY: The Employment and
                                                                                                            The Grant Officer for this FOA is
                                                                                                          Latifa Jeter.                                         Departmental Information Compliance
                                                  Training Administration (ETA), U.S.                                                                           Management Program, Room N1301,
                                                  Department of Labor, announces the                        Signed February 9, 2016 in Washington,              200 Constitution Avenue NW.,
                                                  availability of up to $20,000,000 in grant              DC.                                                   Washington, DC 20210; or by email:
                                                  funds authorized by section 169(c) of                   Eric D. Luetkenhaus,                                  DOL_PRA_PUBLIC@dol.gov.
                                                  the Workforce Innovation and                            Grant Officer/Division Chief, Employment              FOR FURTHER INFORMATION CONTACT:
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                                                  Opportunity Act (WIOA), Public Law                      and Training Administration.                          Michel Smyth by telephone at 202–693–
                                                  113–128, Dislocated Worker                              [FR Doc. 2016–03336 Filed 2–17–16; 8:45 am]           4129, TTY 202–693–8064, (these are not
                                                  Demonstration Projects, and the
                                                                                                          BILLING CODE 4510–FT–P                                toll-free numbers) or by email at DOL_
                                                  Consolidated Appropriation Act of
                                                                                                                                                                PRA_PUBLIC@dol.gov.
                                                  2016, Public Law 114–113 for the pilot
                                                  grant program, Summer Jobs and                                                                                  Authority: 44 U.S.C. 3507(a)(1)(D).
                                                  Beyond: Career Pathways for Youth                                                                             SUPPLEMENTARY INFORMATION:     An
                                                  (CPY). ETA plans to award                                                                                     attorney or other representative may


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Document Created: 2016-02-18 07:46:46
Document Modified: 2016-02-18 07:46:46
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 8247 

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