3340 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 

CHART I—Continued 

Supplier Product name Form Application 

date 

o2si Smart Solutions ......................... Oxycodone Solution, 2,000 mg/L—Parent Stock Solution—Not For Sale Glass cryule: 2 mL ........................... 5/28/2021 

o2si Smart Solutions ......................... Pentazocine Solution, 2,000 mg/L—Parent Stock Solution ....................... Glass cryule: 2 mL ........................... 5/28/2021 

Restek Corporation ........................... Custom D-Methamphetamine Standard ..................................................... Glass Ampule: 1.3 mL ..................... 4/15/2021 

UTAK Laboratories, Inc ..................... DAU High Cutoff 1 Urine Control ............................................................... Kit: 4 bottles, 10 mL each ................ 4/16/2021 

UTAK Laboratories, Inc ..................... DAU High Cutoff 2 Urine Control ............................................................... Kit: 4 bottles, 10 mL each ................ 4/16/2021 

UTAK Laboratories, Inc ..................... DAU Low Cutoff 1 Urine Control ................................................................ Kit: 4 bottles, 10 mL each ................ 4/16/2021 

UTAK Laboratories, Inc ..................... DAU Low Cutoff 2 Urine Control ................................................................ Kit: 4 bottles, 10 mL each ................ 4/16/2021 

UTAK Laboratories, Inc ..................... Drugs of Abuse Level 1 Whole Blood Control ........................................... Kit: 5 bottles, 5 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... Fentanyl Analogues 2 NG/ML Whole Blood Control ................................. Kit: 5 bottles, 3 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... Fentanyl Analogues 5 NG/ML Urine Control ............................................. Kit: 5 bottles, 3 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... PM 100 Urine Control ................................................................................. Kit: 5 bottles, 5 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... PM 100 Whole Blood Control ..................................................................... Kit: 5 bottles, 5 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... PM Plus High Urine Control ....................................................................... Kit: 5 bottles, 5 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... PM Plus Low Urine Control ........................................................................ Kit: 5 bottles, 5 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... SAMHSA Confirm Level 1 SMX Oral Fluid Control ................................... Kit: 5 bottles, 3 mL each .................. 4/16/2021 

UTAK Laboratories, Inc ..................... SAMHSA Confirm Level 2 SMX Oral Fluid Control ................................... Kit: 5 bottles, 3 mL each .................. 4/16/2021 

The Assistant Administrator has 

found that each of the compounds, 

mixtures, and preparations described in 

Chart II below is not consistent with the 

criteria stated in 21 U.S.C. 811(g)(3)(B) 

and in 21 CFR 1308.23. Accordingly, the 

Assistant Administrator has determined 

that the chemical preparations or 

mixtures generally described in Chart II 

below and specifically described in the 

application materials received by DEA, 

are not exempt from application of any 

part of the CSA or from application of 

any part of the CFR, with regard to the 

requested exemption pursuant to 21 

CFR 1308.23, as of the date that was 

provided in the determination letters to 

the individual requesters. 

CHART II 

Supplier Product name Form Application 

date 

Aalto Scientific, Ltd ............................ Immunoassy Base (Level A–E) .................................................................. Glass vial, bottle, or flask: 500 mL– 

1L.

4/1/2021 

Aalto Scientific, Ltd ............................ Immunoassy Base (Level A–E) .................................................................. Glass vial, bottle, or flask: 100mL– 

500 mL.

4/1/2021 

Aalto Scientific, Ltd ............................ Immunoassy Base (Level A–E) .................................................................. Glass vial, bottle, or flask: 100 mL .. 4/1/2021 

Opportunity for Comment 

Pursuant to 21 CFR 1308.23(e), any 

interested person may submit written 

comments on or objections to any 

chemical preparation in this order that 

has been approved or denied as exempt. 

If any comments or objections raise 

significant issues regarding any finding 

of fact or conclusion of law upon which 

this order is based, the Assistant 

Administrator will immediately 

suspend the effectiveness of any 

applicable part of this order until he 

may reconsider the application in light 

of the comments and objections filed. 

Thereafter, the Assistant Administrator 

shall reinstate, revoke, or amend his 

original order as he determines 

appropriate. 

Approved Exempt Chemical 

Preparations Are Posted on the DEA’s 

Website 

A list of all current exemptions, 

including those listed in this order, is 

available on the DEA’s website at http:// 

www.DEAdiversion.usdoj.gov/ 

schedules/exempt/exempt_chemlist.pdf. 

The dates of applications of all current 

exemptions are posted for easy 

reference. 

* * * * * 

Brian S. Besser, 

Acting Assistant Administrator. 

[FR Doc. 2022–01125 Filed 1–20–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Daniel R. Nevarre, M.D.; Decision and 

Order 

On June 7, 2021, a former Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause to Daniel R. Nevarre, M.D., 

(hereinafter, Applicant), of South 

Jordan, Utah. Order to Show Cause 

(hereinafter, OSC), at 1. The OSC 

proposed the denial of Applicant’s 

application No. H21079595C for a DEA 

Certificate of Registration, because the 

United States Department of Health and 

Human Services, Office of Inspector 

General (hereinafter, HHS/OIG) 

mandatorily excluded Applicant from 

participation in Medicare, Medicaid, 

and all Federal health care programs for 

a minimum period of 10 years pursuant 

to 42 U.S.C. 1320a–7(a); and such 

exclusion ‘‘warrants denial of 

[Applicant’s] application for DEA 

registration pursuant to 21 U.S.C. 

824(a)(5).’’ Id. at 2. The OSC also alleged 

that Applicant’s application ‘‘contains 

material false statements’’ and thus 

forms an independent ground for denial. 

Id. at 2 (citing 21 U.S.C. 824(a)(1)). 

The OSC alleged that on May 25, 

2018, Applicant ‘‘pled guilty to one 

count of medical assistance fraud in 

violation of 62 P.S. § 1407(a)(1), and to 

one count of insurance fraud, in 

violation of 18 Pa.C.S. § 4117(a)(2).’’ Id. 

at 1–2 (citing Commonwealth of Pa. v. 

Daniel Raymond Nevarre, No. CP–11– 

CR–0000717–2018 (Pa. Ct. Comm. Pl. 

May 25, 2018)). The OSC further alleged 

that, based on such conviction, HHS/ 

OIG ‘‘mandatorily excluded [Applicant] 

from participation in Medicare, 

Medicaid, and all Federal health care 

programs’’ for a minimum period of 10 

years pursuant to 42 U.S.C. 1320a–7(a), 

effective November 20, 2018. Id. The 

OSC therefore proposed denial of 

Applicant’s application based on 21 

U.S.C. 824(a)(5). 


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1Applicant only applied for schedule II nonnarcotic (IIN). 

2Although Applicant submitted evidence in his 

application related to his conviction and the 

circumstances of his surrender for cause of his 

previous DEA registrations, he did not include any 

discernable information on the HHS/OIG exclusion. 

RFAAX 1, App. 1 (Application). 

The OSC also proposed denial of 

Applicant’s application based on 21 

U.S.C. 824(a)(1), because Applicant 

responded ‘‘no’’ to Liability Question 1 

on his DEA application, which asks 

whether Applicant has ever been 

excluded from participation in a 

medicare program. Id. The OSC 

therefore proposed denial of Applicant’s 

application because his ‘‘failure to 

disclose [his] exclusion from Medicare 

constitutes material falsification of [his] 

application for a DEA [registration].’’ Id. 

The Show Cause Order notified 

Applicant of the right to request a 

hearing on the allegations or to submit 

a written statement, while waiving the 

right to a hearing, the procedures for 

electing each option, and the 

consequences for failing to elect either 

option. Id. at 2–3 (citing 21 CFR 

1301.43). The OSC also notified 

Applicant of the opportunity to submit 

a corrective action plan. OSC, at 3 

(citing 21 U.S.C. 824(c)(2)(C)). 

Adequacy of Service 

In a signed and sworn Declaration, a 

Diversion Investigator (hereinafter, DI 2) 

assigned to the Pittsburg District Office, 

Philadelphia Field Division, stated that, 

on June 21, 2021, after receiving a 

request from the Salt Lake City District 

Office to assist with service of the OSC, 

he and a Narcotics Agent from the 

Pennsylvania Office of the Attorney 

General traveled to Applicant’s 

residential address in Johnstown, 

Pennsylvania, where he ‘‘personally 

served [the Applicant] with a copy of 

the [OSC].’’ Request for Final Agency 

Action, dated November 9, 2021 

(hereinafter, RFAA), Exhibit 

(hereinafter, RFAAX) 3 (DI 2 

Declaration), at 1–2. 

The Government forwarded its RFAA, 

along with the evidentiary record, to 

this office on November 9, 2021. In its 

RFAA, the Government represents that 

‘‘neither [Applicant] nor any attorney 

representing [Applicant] has requested a 

hearing’’ or filed a written statement. 

RFAA, at 2; see also RFAAX 3, at 2 & 

RFAAX 1, at 4. The Government 

requests ‘‘Final Agency Action denying 

the Application on the grounds that 

[Applicant] materially falsified his 

Application and has been excluded 

from participation in Medicare, 

Medicaid, and all Federal health care 

programs pursuant to 42 U.S.C. 1320a– 

7(a).’’ Id. 

Based on the DI’s Declaration, the 

Government’s written representations, 

and my review of the record, I find that 

the Government accomplished service 

of the OSC on Applicant on June 21, 

2021. I also find that more than thirty 

days have now passed since the 

Government accomplished service of 

the OSC. Further, based on the 

Government’s written representations, I 

find that neither Applicant, nor anyone 

purporting to represent the Applicant, 

requested a hearing, submitted a written 

statement while waiving Applicant’s 

right to a hearing, or submitted a 

corrective action plan. Accordingly, I 

find that Applicant has waived the right 

to a hearing and the right to submit a 

written statement and corrective action 

plan. 21 CFR 1301.43(d) and 21 U.S.C. 

824(c)(2)(C). I, therefore, issue this 

Decision and Order based on the record 

submitted by the Government, which 

constitutes the entire record before me. 

21 CFR 1301.43(e). 

A. Findings of Fact 

1. Applicant’s DEA Application and 

Former Registrations 

On February 1, 2021, DEA received an 

application from Applicant for a DEA 

Certificate of Registration as a 

practitioner in Schedules IIN 1 through 

V with a proposed registered address of 

881 Baxter Drive, Suite 100, South 

Jordan, Utah 84095. RFAAX 1 (DI 1 

Declaration) (Appendix, hereinafter, 

App.) 1 (Applicant’s Application). 

Applicant’s application was assigned 

Control No. H21079595C. RFAAX 1, at 

1. 

DI 1 submitted a Declaration, dated 

September 13, 2021, which stated that 

Applicant had previously surrendered 

for cause DEA Certificates of 

Registration numbered FN7029487 and 

BN5130290 on September 5, 2018, and 

October 15, 2018, respectively, after 

losing his state authority to practice 

medicine in Pennsylvania. RFAAX 1 (DI 

1 Declaration) at 2. DI 1 further stated 

that Applicant’s third previous DEA 

Certificate of Registration numbered 

FN5716420 in New York expired on 

October 31, 2018. Id. at 2–3. 

2. Applicant’s Exclusion (21 U.S.C. 

824(a)(5)) 

The Government’s uncontroverted 

evidence demonstrates that Applicant 

pled guilty to false information/claims 

and insurance fraud on or about May 25, 

2018, in the Court of County Pleas in 

Cambria County, Pennsylvania. RFAAX 

1, at App. C (Applicant’s Guilty plea). 

In a letter from the HHS/OIG, dated 

October 31, 2018, HHS excluded 

Applicant from Medicare, Medicaid, 

and all federal health care programs 

under 42 U.S.C. 1320a–7(a) for a 

minimum period 10 years based on 

Applicant’s conviction. RFAAX 1, App. 

E (hereinafter, HHS Exclusion), at 1. The 

HHS Exclusion stated that the exclusion 

would become effective twenty days 

from the date of the letter. Id. at 1. 

Accordingly, I find clear, 

unequivocal, and convincing record 

evidence that HHS excluded Applicant 

from Medicare, Medicaid, and all 

federal health care programs under 42 

U.S.C. 1320a–7(a) for a minimum of 10 

years, effective November 20, 2018. 

3. Material Falsification of Applicant’s 

Application (21 U.S.C. 824(a)(1)) 

I find clear, unequivocal, and 

convincing record evidence that 

Applicant answered ‘‘N’’ to the first 

Liability question on the registration 

renewal application that was received 

by DEA on or about February 1, 2021. 

RFAAX 1, App. 1, at 2. I find clear, 

unequivocal, and convincing record 

evidence that the text of the first 

Liability question on the registration 

renewal application that Applicant 

submitted on or about February 1, 2021, 

asked whether Applicant had ‘‘ever 

been . . . excluded or directed to be 

excluded from participation in a 

medicare or state health care program, 

or is any such action pending.’’ 2 Id. 

Accordingly, I find clear, unequivocal, 

and convincing record evidence that 

Applicant’s ‘‘N’’ response to the first 

Liability question on his application 

that he submitted on or about February 

1, 2021, was false, because the record 

evidence clearly establishes that on 

October 31, 2018, Applicant was 

excluded from Medicare, Medicaid and 

all federal healthcare programs by HHS. 

See RFAAX 1, App. E. 

B. Discussion 

In its OSC, the Government relied 

upon grounds Congress provided to 

support revocation/suspension, not 

denial of an application. Prior Agency 

decisions have addressed whether it is 

appropriate to consider a provision of 

21 U.S.C. 824(a) when determining 

whether or not to grant a practitioner 

registration application. For over fortyfive years, Agency decisions have 

concluded that it is. Robert Wayne 

Locklear, M.D., 86 FR 33,738 33,744–45 

(2021) (collecting cases); see also, 

William Ralph Kincaid, M.D., 86 FR 

40,636, 40,641 (2021). A provision of 

section 824 may be the basis for the 

denial of a practitioner registration 

application and allegations related to 

section 823 remain relevant to the 

adjudication of a practitioner 


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3 It is noted that this Agency has concluded 

repeatedly that the underlying crime requiring 

exclusion from federal health care programs under 

Section 1320a–7(a) of Title 42 does not require a 

nexus to controlled substances in order to be used 

as a ground for revocation or suspension of a 

registration or denial of an application. Narciso 

Reyes, M.D., 83 FR 61,678, 61,681 (2018); KK 

Pharmacy, 64 FR at 49,510 (collecting cases); 

Melvin N. Seglin, M.D., 63 Red. Reg. 70,431, 70,433 

(1998); Stanley Dubin, D.D.S., 61 FR 60,727, 60,728 

(1996). In this case, the HHS ALJ applied 

aggravating factors to extend Applicant’s exclusion 

period due to circumstances such as, the amount of 

restitution ($288,900) and the length of the criminal 

activity, which continued over a period of 

approximately seven years. RFAAX 1, App. E, at 3. 

Applicant’s extensive unlawful activity over the 

course of seven years and his falsification on his 

application demonstrate a serious lack of honesty 

such that I cannot entrust him with a controlled 

substances registration. 

4See supra B.1 finding that a ground for 

revocation can serve as a basis for denial of an 

application. 

registration application when a 

provision of section 824 is involved. See 

Robert Wayne Locklear, M.D., 86 FR at 

33,744–45. 

Accordingly, when considering an 

application for a registration, I will 

consider any actionable allegations 

related to the grounds for denial of an 

application under 823 and will also 

consider any allegations that the 

applicant meets one or more of the five 

grounds for revocation or suspension of 

a registration under section 824. Id. See 

also Dinorah Drug Store, Inc., 61 FR 

15,972, 15,973–74 (1996). 

1. 21 U.S.C. 823(f): The Five Public 

Interest Factors 

Pursuant to section 303(f) of the 

Controlled Substances Act (hereinafter, 

the CSA), ‘‘[t]he Attorney General shall 

register practitioners . . . to dispense 

. . . controlled substances . . . if the 

applicant is authorized to dispense . . . 

controlled substances under the laws of 

the State in which he practices.’’ 21 

U.S.C. 823(f). Section 303(f) further 

provides that an application for a 

practitioner’s registration may be denied 

upon a determination that ‘‘the issuance 

of such registration . . . would be 

inconsistent with the public interest.’’ 

Id. 

In this case, there is no indication that 

Applicant does not hold a valid state 

medical license or is not authorized to 

dispense controlled substances in the 

State of Utah, where he has applied for 

a registration. 

Because the Government has not 

alleged that Applicant’s registration is 

inconsistent with the public interest 

under section 823, and although I have 

considered 823, I will not analyze 

Applicant’s application under the 

public interest factors. Therefore, in 

accordance with prior agency decisions, 

I will move to assess whether the 

Government has proven by substantial 

evidence that a ground for revocation 

exists under 21 U.S.C. 824(a). Supra B. 

2. 21 U.S.C. 824(a)(5): Mandatory 

Exclusion From Federal Health Care 

Programs Pursuant to 42 U.S.C. 1320a– 

7(a) 

Under Section 824(a) of the CSA, a 

registration ‘‘may be suspended or 

revoked’’ upon a finding of one or more 

of five grounds. 21 U.S.C. 824. The 

ground in 21 U.S.C. 824(a)(5) requires 

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.’’ Id. Here, 

the undisputed record evidence 

demonstrates that HHS mandatorily 

excluded Applicant from federal health 

care programs. RFAAX 6. Accordingly, 

I will sustain the Government’s 

allegation that Applicant has been 

excluded from participation in a 

program pursuant to section 1320a–7(a) 

of Title 42 and find that the Government 

has established that a ground for 

revocation exists pursuant to 21 U.S.C. 

824(a)(5).3 Although the language of 21 

U.S.C. 824(a)(5) discusses suspension 

and revocation of a registration, for the 

reasons discussed above, it may also 

serve as the basis for the denial of a DEA 

registration application. See Dinorah 

Drug Store, Inc., 61 FR at 15,973 

(interpreting 21 U.S.C. 824(a)(5) to serve 

as a basis for the denial of an 

application for registration because it 

‘‘makes little sense . . . to grant the 

application for registration, only to 

possibly turn around and propose to 

revoke or suspend that registration 

based on the registrant’s exclusion from 

a Medicare program’’). Applicant’s 

exclusion from participation in a 

program under 42 U.S.C. 1320a–7(a), 

therefore, serves as an independent 

basis for denying his application for 

DEA registration. 

3. 21 U.S.C. 824(a)(1): Material 

Falsification 

As already discussed, I find clear, 

unequivocal, and convincing evidence 

that Applicant submitted a registration 

application containing a false answer to 

the first Liability question. Supra 

section A.3. Applicant’s false 

submission implicated Applicant’s 

‘‘exclu[sion] . . . from participation in a 

program pursuant to section 1320a–7(a) 

of Title 42.’’ 21 U.S.C. 824(a)(5). As a 

result, Applicant’s false response to the 

first Liability question directly 

implicated my analysis related to the 

CSA’s statutory grounds for revocation 

of a controlled substances registration, 

which as explained in supra B.1 and 

B.2, the agency has consistently 

interpreted to be equally relevant to its 

assessment of an application for a 

controlled substances registration. See 

Robert Wayne Locklear, M.D., 86 FR at 

33,744–45 (collecting cases). Therefore, 

Applicant’s false submission affected 

my decision by depriving me of legally 

relevant facts when I evaluated 

Applicant’s registration application. 

RFAAX 2, at 1; see also Frank Joseph 

Stirlacci, M.D., 85 FR 45,229, 45,235 

(2020). Accordingly, I find, based on the 

CSA, agency decisions, and the analysis 

underlying multiple Supreme Court 

decisions explaining ‘‘materiality,’’ that 

the falsity Applicant submitted was 

material. Frank Joseph Stirlacci, M.D., 

85 FR at 45,235. 

I find that there is clear, convincing, 

and unequivocal evidence in the record 

supporting denial of Applicant’s 

application based on his having 

‘‘materially falsified any application 

filed pursuant to or required by this 

subchapter or subchapter II.’’ 21 U.S.C. 

824(a)(1).4

4. Summary of Government’s Prima 

Facie Case 

Where, in section 824(a)(5) cases, the 

applicant offers no mitigating evidence 

upon which the Administrator can 

analyze the facts, the agency has 

consistently held that revocation/ 

suspension/denial is warranted. See, 

e.g., Sassan Bassiri, D.D.S., 82 FR 

32,200, 32,201 (2017); Richard Hauser, 

M.D., 83 FR 26,308, 26,310 (2018) 

(revocation was sought under Section 

824(a)(5) and the registrant’s certificate 

of registration was revoked ‘‘based on 

the unchallenged basis for his 

mandatory exclusion’’). Additionally, in 

this case, there is evidence on the record 

that Applicant materially falsified his 

application. When the basis for 

revocation/suspension/denial is clear 

and the registrant/applicant has had 

notice and the opportunity to present 

evidence, whether in a hearing or a 

written statement in accordance with 21 

CFR 1301.43, but has chosen not to 

present any such evidence that could 

inform the Administrator’s decision, it 

is reasonable that the Administrator 

should revoke or suspend, or deny. See 

KK Pharmacy, 64 FR 49,507, 49,510 

(1999); Orlando Ortega-Ortiz, M.D. 70 

FR 15,122 (2005); Lazaro Guerra, 68 FR 

15,266 (2003) (basis for revocation was 

both (a)(3) and (a)(5)). 

Accordingly, I find that there is clear, 

convincing, and unequivocal evidence 

in the record supporting denial of 

Applicant’s application based on his 

exclusion from federal health care 

programs. 21 U.S.C. 824(a)(5). I further 


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*A I have made minor modifications to the RD. I 

have substituted initials or titles for the names of 

witnesses and patients to protect their privacy and 

I have made minor, nonsubstantive, grammatical 

changes and nonsubstantive, conforming edits. 

Where I have made substantive changes, omitted 

language for brevity or relevance, or where I have 

added to or modified the ALJ’s opinion, I have 

noted the edits with an asterisk, and I have 

included specific descriptions of the modifications 

in brackets following the asterisk or in footnotes 

marked with a letter and an asterisk. Within those 

brackets and footnotes, the use of the personal 

pronoun ‘‘I’’ refers to myself—the Administrator. 

*B I have omitted a section of the RD’s discussion 

of the procedural history to avoid repetition with 

my introduction. 

1Respondent was advised during the Prehearing 

Conference that, under 21 CFR 1316.50, he had the 

right to seek representation by a qualified attorney 

at his own expense. Respondent was also advised 

that, if he continued to represent himself, he would 

be held to the same standards and procedural 

requirements of an attorney, including adherence to 

the procedural orders and rulings of this tribunal 

and to the procedural rules set forth in 21 CFR 

1316.41–1316.68. ALJ Ex. 13 at 2, n.3. During the 

merits hearing, Respondent acknowledged that he 

had been so advised and confirmed that he wanted 

to proceed pro se. Tr. 7–8. 

2Respondent failed to submit a Prehearing 

Statement by the December 29, 2020, deadline set 

out in this tribunal’s Order for Prehearing 

Statements. ALJ Ex. 3. The tribunal then issued an 

Order Directing Compliance, which gave 

Respondent until January 4, 2021, to show good 

cause as to why he did not comply with the Order 

for Prehearing Statements. ALJ Ex. 7. Respondent 

then filed a Prehearing Statement on January 4, 

2021, but did not offer any attempt to show good 

cause for his late filing. ALJ Ex. 8. The tribunal 

issued a Second Order Directing Compliance on 

January 4, 2021, requiring Respondent to show good 

cause. ALJ Ex. 9. Respondent then filed a document 

styled ‘‘Requisite Good Cause for Late Filing,’’ in 

which he purported to show good cause. ALJ Ex. 

10. Thereafter, the tribunal issued an Order 

Regarding Respondent’s Late Filed Prehearing 

Statement, which set out several of Respondent’s 

failures to comply with the Order for Prehearing 

Statements, including late filings and at least two 

failures to serve pleadings on opposing counsel. 

ALJ Ex. 11. The Order also directed Respondent to 

file a Prehearing Statement in compliance with the 

Order for Prehearing Statements by January 11, 

2021. Id. Respondent finally did file a compliant 

Prehearing Statement on January 10, 2021. ALJ Ex. 

12. 

find that there is clear, convincing, and 

unequivocal evidence in the record 

supporting denial of Applicant’s 

application based on his material 

falsification of his application. 21 U.S.C. 

824(a)(1). 

C. Sanction 

Here, there is no dispute in the record 

that Applicant is mandatorily excluded 

pursuant to Section 1320a–7(a) of Title 

42, and, further that Applicant 

materially falsified his application for a 

controlled substance registration, and 

therefore, that grounds for the denial of 

Applicant’s application exist. Where, as 

here, the Government has met its prima 

facie burden of showing that grounds 

for denial exist, the burden shifts to the 

Applicant to show why he can be 

entrusted with a registration. Garrett 

Howard Smith, M.D., 83 FR 18,882, 

18,910 (2018) (collecting cases). 

In this case, Applicant failed to 

respond to the Government’s Order to 

Show Cause and did not avail himself 

of the opportunity to refute the 

Government’s case. See RFAA, at 2. 

Therefore, Applicant has not provided 

any remorse or assurances that he 

would implement remedial measures to 

ensure such conduct is not repeated. 

Such silence weighs against the 

Applicant’s registration. Zvi H. Perper, 

M.D., 77 FR at 64,142, citing Medicine 

Shoppe, 73 FR at 387; see also Samuel 

S. Jackson, 72 FR at 23,853. Further, due 

to the lack of a statement or testimony 

from Applicant, it is unclear whether 

Applicant can be entrusted with a DEA 

registration; and therefore, I find that 

sanction is appropriate to protect the 

public from a recurrence of Applicant’s 

unlawful actions in the context of his 

CSA registration. See Leo R. Miller, 

M.D., 53 FR 21,931, 21,932 (1988). 

Consequently, I find that the factors 

weigh in favor of sanction and I shall 

order the sanctions the Government 

requested, as contained in the Order 

below. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 

823(f) and 21 U.S.C. 824(a), I hereby 

deny the pending application for a 

Certificate of Registration, Control 

Number H21079595C, submitted by 

Daniel R. Nevarre, M.D., as well as any 

other pending application of Daniel R. 

Nevarre, M.D. for additional registration 

in Utah. This Order is effective [insert 

Date Thirty Days From the Date of 

Publication in the Federal Register]. 

Anne Milgram, 

Administrator. 

[FR Doc. 2022–01112 Filed 1–20–22; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 21–5] 

Stephen E. Owusu, D.P.M.; Decision 

and Order 

On October 22, 2020, a former 

Assistant Administrator, Diversion 

Control Division, of the Drug 

Enforcement Administration 

(hereinafter, DEA or Government), 

issued an Order to Show Cause 

(hereinafter, OSC) to Stephen E. Owusu, 

D.P.M. (hereinafter, Respondent) of 

Brooklyn, New York. Administrative 

Law Judge Exhibit (hereinafter, ALJX) 1 

(OSC), at 1. The OSC proposed the 

denial of Respondent’s application for 

DEA Certificate of Registration No. 

W19061136C (hereinafter, COR or 

registration) and the denial of any 

applications for any other DEA 

registrations pursuant to 21 U.S.C. 

824(a)(2) and 824(a)(5) because 

Respondent was convicted of a felony 

related to controlled substances and 

because Respondent has been excluded 

from participation in Medicare, 

Medicaid, and all federal health care 

programs pursuant to 42 U.S.C. 1320a– 

7(a). Id. 

On November 23, 2020, the 

Respondent timely requested a hearing, 

which commenced (and ended) on 

February 17, 2021, at the DEA Hearing 

Facility in Arlington, Virginia with the 

parties, counsel, and witnesses 

participating via video teleconference 

(VTC). On April 9, 2021, Administrative 

Law Judge Teresa A. Wallbaum 

(hereinafter, the ALJ) issued her 

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

of the Administrative Law Judge 

(hereinafter, Recommended Decision or 

RD). By letter dated May 4, 2021, the 

ALJ certified and transmitted the record 

to me for final Agency action. In the 

letter, the ALJ advised that neither party 

filed exceptions. Having reviewed the 

entire record, I adopt the ALJ’s rulings, 

findings of fact, as modified, 

conclusions of law and recommended 

sanction with minor modifications, 

where noted herein.*A

Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

of the Administrative Law Judge 

Teresa A. Wallbaum; Administrative 

Law Judge 

April 9, 2021 

*B Respondent proceeded pro se 

throughout the entire case.1 Respondent 

timely filed a Request for Hearing. A 

Prehearing Conference was conducted 

on January 12, 2021, via VTC. 2A 

hearing on the merits of the OSC 

allegations was conducted on February 

17, 2021, via VTC at the DEA Hearing 

Facility in Arlington, Virginia. The 

Government filed a Post-Hearing Brief 

on March 26, 2021. 

The issue to be ultimately decided by 

the Acting Administrator, with the 

assistance of this Recommended 

Decision, is whether Respondent’s 

application should be denied based 


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