40636 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

respondent’s attempts to minimize 

misconduct undermined acceptance of 

responsibility); Medicine ShoppeJonesborough, 73 FR 364, 387 (2008) 

(noting that the respondent did not 

acknowledge recordkeeping problems, 

let alone more serious violations of 

federal law, and concluding that 

revocation was warranted). 

The issue of trust is necessarily a factdependent determination based on the 

circumstances presented by the 

individual respondent; therefore, the 

Agency looks at factors, such as the 

acceptance of responsibility and the 

credibility of that acceptance as it 

relates to the probability of repeat 

violations. Jeffrey Stein, M.D., 84 FR 

46,968, 46,972 (2019). A registrant’s 

candor during the investigation and 

hearing is an important factor in 

determining acceptance of 

responsibility and the appropriate 

sanction, Garret Howard Smith, M.D., 83 

FR at 18,910 (collecting cases); as is 

whether the registrant’s acceptance of 

responsibility is unequivocal, Lon F. 

Alexander, M.D., 82 FR 49,704, 49,728 

(2017) (collecting cases). In determining 

whether and to what extent a sanction 

is appropriate, consideration must be 

given to both the egregiousness of the 

offense established by the Government’s 

evidence and the Agency’s interest in 

both specific and general deterrence. 

Wesley Pope, 82 FR 14,944, 14,985 

(2017) (citing Joseph Gaudio, 74 FR 

10,083, 10,095 (2009)); David A. Ruben, 

M.D., 78 FR 38,363, 38,364 (2013). Cf. 

McCarthy v. SEC, 406 F.3d 179, 188–89 

(2d Cir. 2005) (upholding SEC’s express 

adoption of ‘‘deterrence, both specific 

and general as a component in 

analyzing the remedial efficacy of 

sanctions.’’). 

Here, Respondent Pharmacy has 

presented no evidence on the record 

that I could consider as accepting 

responsibility. I have considered the 

written response, which denies any 

misconduct, stating multiple times that 

it ‘‘would be impossible’’ for ‘‘the 

medications [to be] short of the original 

count[s],’’ and asserting that ‘‘we were 

far from deceit when we talked to 

[DEA].’’ RFAAX 3, at 2–3. The written 

response further seems to pass blame for 

the findings of violations against 

Respondent Pharmacy onto the DEA— 

claiming that DEA ‘‘raided the 

pharmacy,’’ on a ‘‘witch hunt waged 

against [Respondent] Pharmacy’’ arising 

from ‘‘hatred toward the owner.’’ Id. at 

2. It is clear from the written response 

that Respondent Pharmacy has not 

accepted responsibility for its actions. 

I have also considered the proposed 

Corrective Action Plan that the 

Government submitted into the record. 

RFAAX 4. The proposed Corrective 

Action Plan does not include any 

acceptance of responsibility; rather it 

proposes policies that essentially mirror 

the requirements already existing in 

law. Id. Even if I were to consider 

remedial measures, in spite of 

Respondent Pharmacy’s complete lack 

of acceptance of responsibility, these 

proposed remedial measures are 

insufficient to convince me to entrust 

Respondent Pharmacy with a 

registration. 21 U.S.C. 824(c)(3); see also 

Melanie Baker, N.P., 86 FR 23,998, 

24,011 (2021) (citing Jones Total Health 

Care Pharmacy, L.L.C., 81 FR 79,188, 

79,202–03 2016). 

Moreover, Respondent Pharmacy’s 

found lack of candor during the 

investigation demonstrates an 

unwillingness to cooperate with this 

agency in future compliance 

inspections. Truthful cooperation with 

agency requests for information ensures 

that agency officials can easily monitor 

and ensure compliance with the CSA 

and help to correct violations. See 

Jeffrey Stein, M.D., 84 FR 46,968, 46,973 

(2019) (finding that a registrant’s 

honesty during law enforcement 

regulations is ‘‘crucial to the Agency’s 

ability to complete its mission of 

preventing diversion within such a large 

regulated population’’). In order to 

entrust Respondent Pharmacy with a 

registration, I need to know that its 

personnel will not repeat their 

dishonest behavior, and in this case, 

Respondent Pharmacy has given me no 

reason to believe that I can trust it with 

a registration. 

In sanction determinations, the 

Agency has historically considered its 

interest in deterring similar acts, both 

with respect to the respondent in a 

particular case and the community of 

registrants. See Joseph Gaudio, M.D., 74 

FR 10,083, 10,095 (2009); Singh, 81 FR 

at 8248. I find that considerations of 

both specific and general deterrence 

weigh in favor of revocation in this case. 

There is simply no evidence that 

Respondent Pharmacy’s egregious 

behavior is not likely to recur in the 

future such that I can entrust it with a 

CSA registration; in other words, the 

factors weigh in favor of revocation as 

a sanction. Accordingly, 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. 

824(a), I hereby revoke DEA Certificate 

of Registration FL4375730 issued to 

Creekbend Community Pharmacy. 

Further, pursuant to 28 CFR 0.100(b) 

and the authority vested in me by 21 

U.S.C. 823(f), I hereby deny any pending 

application of Creekbend Community 

Pharmacy to renew or modify this 

registration. This order is effective 

August 27, 2021. 

Anne Milgram, 

Administrator. 

[FR Doc. 2021–16000 Filed 7–27–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

William Ralph Kinkaid, M.D.; Decision 

and Order 

On November 7, 2018, the Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause to William Ralph Kinkaid, M.D. 

(hereinafter, Respondent), of Johnson 

City, Tennessee. Order to Show Cause 

(hereinafter, OSC), at 1. The OSC 

proposed the denial of Respondent’s 

application for DEA Certificate of 

Registration, Control No. W18085586C, 

because Respondent was ‘‘mandatorily 

excluded . . . from participation in 

Medicare, Medicaid, and all Federal 

health care programs pursuant to 42 

U.S.C. 1320a–7(a)’’ and that such 

exclusion ‘‘warrants denial of 

[Respondent’s] application pursuant to 

21 U.S.C. 824(a)(5).’’ Id. at 1–2 (citing 

Richard Hauser, M.D., 83 FR 26,308 

(2018)). 

Specifically, the OSC alleged that, on 

June 24, 2013, the United States District 

Court for the Eastern District of 

Tennessee (hereinafter, E.D. Tenn.) 

issued a judgment against Respondent 

‘‘after [Respondent] pled guilty to one 

count of ‘Receiving in Interstate 

Commerce a Misbranded Drug with 

Intent to Defraud or Mislead,’ in 

violation of 21 U.S.C. 331(c).’’ Id. at 2 

(citing U.S. v. William Ralph Kinkaid, 

No. 2:12–CR–116 (E.D. Tenn. June 24, 

2013)). The OSC further alleged that 

‘‘based on [Respondent’s] conviction, 

the U.S. Department of Health and 

Human Services, Office of Inspector 

General (‘‘HHS/OIG’’), mandatorily 

excluded [Respondent] from 

participation in Medicare, Medicaid, 

and all Federal health care programs 

pursuant to 42 U.S.C. 1320a–7(a)’’ 

effective June 28, 2013, for a period of 

ten years. Id. 

The OSC notified Respondent 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 


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option, and the consequences for failing 

to elect either option. Id. (citing 21 CFR 

1301.43). The OSC also notified 

Respondent of the opportunity to 

submit a corrective action plan. Id. at 2– 

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

Respondent submitted a Waiver of 

Hearing, Statement/Response to Order 

to Show Cause, and Corrective Action 

Plan dated December 5, 2018 

(hereinafter, Response to the OSC). 

Request for Final Agency Action Exhibit 

(hereinafter, RFAAX) 7. On January 10, 

2019, DEA issued a letter to Respondent 

denying his proposed Corrective Action 

Plan. RFAAX 8. 

The Government submitted a Request 

for Final Agency Action (hereinafter, 

RFAA), along with Respondent’s 

Response to the OSC and the 

evidentiary record, for adjudication on 

May 30, 2019. I issue this Decision and 

Order based on the record submitted by 

the Government, which includes 

Respondent’s Response to the OSC, and 

constitutes the entire record before me. 

21 CFR 1301.43(e). 

I. Findings of Fact 

a. Respondent’s Application for DEA 

Registration 

On August 6, 2018, Respondent 

submitted an application (Application 

Control No. W18085586C) for a DEA 

Certificate of Registration, at the 

proposed registered location of 193 

Keefauver Road, Johnson City, TN 

37615 for a practitioner with drug 

schedules II–V. RFAAX 1 (Certification 

of Registration Status). The application 

is in pending status. Id. Respondent 

previously held DEA Certificates of 

Registration Nos. BK2452819 and 

FK2770320, which are in retired status. 

Id. 

b. Respondent’s Criminal Conviction 

The evidence in the record 

demonstrates that, on June 24, 2013, 

judgment was entered against 

Respondent following a guilty plea in 

E.D. Tenn. based on one count of 

‘‘Receiving in Interstate Commerce a 

Misbranded Drug With Intent to Defraud 

or Mislead’’ in violation of 21 U.S.C. 

331(c). RFAAX 4 (Judgment, U.S. v. 

William Ralph Kinkaid, No. 2:12–CR– 

116 (E.D. Tenn. June 24, 2013)). In 

Respondent’s guilty plea, he stipulated 

to a number of facts, which satisfied the 

offense elements. RFAAX 3 (Plea 

Agreement, U.S. v. William Ralph 

Kinkaid, No. 2:12–CR–116 (E.D. Tenn. 

June 24, 2013)). In summary, 

Respondent admitted that he was 

majority owner and managing partner of 

McLeod Cancer and Blood Center in 

Johnson City, Tennessee (hereinafter, 

McLeod Cancer). Id. at 2. McLeod 

Cancer bought misbranded, unapproved 

prescription drugs, which were 

prescribed by Respondent and other 

doctors and administered to patients at 

McLeod Cancer from approximately 

September 2007 to early 2008 and from 

August 2009 to February 2012. Id. at 2, 

5. The drugs were from foreign sources 

that were not inspected and approved 

by the U.S. Food and Drug 

Administration for distribution or use in 

the United States. Id. at 2–5. McLeod 

Cancer sought reimbursement for the 

drugs and their administration from 

Medicare, Medicaid, and other health 

benefit programs. Id. at 2. After nurses 

at McLeod Cancer raised concerns that 

the drugs were not approved for use in 

the United States, McLeod Cancer 

briefly stopped purchasing the drugs. Id. 

at 5–6. When McLeod Cancer resumed 

purchasing the unapproved drugs, they 

had the drugs shipped to a storage 

business that Respondent owned to 

prevent the nurses from learning 

McLeod Cancer was again purchasing 

unapproved foreign drugs. Id. at 6. 

As a result of his conviction, 

Respondent was sentenced to 24 months 

in federal detention, followed by a year 

of supervised release. RFAAX 4, at 2–3. 

He was also fined $10,000 and assessed 

$100 in costs. Id. at 4. 

c. Respondent’s Exclusion 

In June 2013, Respondent entered into 

a Settlement Agreement with the United 

States of America, in which he agreed 

‘‘to be excluded under [42 U.S.C. 

1320a–7(a)(1) and 42 U.S.C. 1320a– 

7(b)(7)] from Medicare, Medicaid, and 

all Federal health care programs, as 

defined in 42 U.S.C. 1320a–7b(f), for a 

period of ten (10) years.’’ RFAAX 5 

(Settlement Agreement), at 7. 

Respondent also agreed to pay 

$2,550,000 to the United States and to 

the State of Tennessee in damages and 

penalties. Id. at 3. 

d. Respondent’s State Medical License 

On July 22, 2015, the Tennessee 

Department of Health held a hearing 

regarding Respondent’s state medical 

license. Response to the OSC, Ex. 10 

(Deliberations and Decision of the 

Panel, State of Tennessee Board of 

Medical Examiners v. William Kincaid, 

M.D.). At the hearing, the panel voted to 

revoke Respondent’s license. Id. In the 

transcript from the hearing, the two 

panelists who voted to revoke 

Respondent’s license explained that 

they were voting for revocation because 

Respondent had knowingly violated the 

law, id. at 4, 8, 13; had placed business 

interests ahead of his responsibilities to 

his patients, id. at 5–6; and the 

discipline ‘‘should reflect the severity of 

what he did,’’ id. at 14. The panel, 

however, did not vote for a permanent 

revocation. One of the panelists 

explained her vote for non-permanent 

revocation this way, ‘‘I believe that the 

doctor is a good doctor who should be 

rehabilitated, but it’s up to him to 

rehabilitate himself for at least a year 

and come back.’’ Id. at 13. 

Respondent reapplied for a state 

medical license, and the State of 

Tennessee decided to grant him a 

limited medical license under a 

preceptorship on October 4, 2017. 

Response to the OSC, Ex. 12 (Oct. 4, 

2017 Letter from Tennessee Board of 

Medical Examiners). The State of 

Tennessee subsequently granted 

Respondent a medical license on July 

24, 2018. Response to the OSC, Ex. 13 

(Respondent’s Medical License). 

II. Discussion 

a. The Parties’ Positions 

i. Government’s Position 

The OSC’s sole allegation is that 

Respondent’s exclusion from all federal 

health care programs pursuant to 42 

U.S.C. 1320a–7(a) warrants denying his 

application under 21 U.S.C. 824(a)(5). 

OSC, at 2. The Government alleges that 

Respondent’s exclusion was based on 

his guilty plea to one count of 

‘‘Receiving in Interstate Commerce a 

Misbranded Drug With Intent to Defraud 

or Mislead’’ in violation of 21 U.S.C. 

331(c). RFAA, at 1. The Government 

further alleges that Respondent’s 

exclusion from Medicare, Medicaid, and 

all Federal health care programs 

warrants denial of his application 

notwithstanding the fact that the 

underlying conduct that led to his 

exclusion did not have a nexus to 

controlled substances. OSC, at 2. 

The Government argues that 21 U.S.C. 

824(a)(5) should be read ‘‘as requiring 

revocation (or denial) of a respondent’s 

DEA certificate of registration (or 

application), upon an adequate showing 

of the factual predicate, at least for the 

duration of the mandatory exclusion.’’ 

RFAA, at 4. Accordingly, the 

Government has presented evidence 

that Respondent is excluded from 

participation in Federal health care 

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

7(a) but has not presented any 

additional evidence or arguments 

regarding why Respondent’s application 

for registration should be denied. 

ii. Respondent’s Position 

Respondent filed a written statement 

in response to the Government’s OSC. 

Respondent’s Response to the OSC 

included a number of exhibits with 


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1Respondent also included descriptions of the 

Department of Justice’s conduct during its 

investigation and prosecution of his criminal case 

and dedicated a full page of his seven-page 

Response to the OSC (and attached dozens of pages 

of exhibits) to a criminal case that is unrelated, but 

Respondent states is factually similar, to 

Respondent’s criminal case. Respondent presented 

documentation that, in this unrelated case, the 

Department of Justice moved to dismiss the case 

with prejudice when the defendants appealed their 

conviction. See Response to the OSC, at 3–5; Ex. 9 

(Motion to Vacate Judgments of Conviction and 

Remand for Dismissal of Indictment with Prejudice, 

United States of America v. Patricia Posey Sen and 

Anindya Kumar Sen, Nos. 14–5786 (6th Cir. 

December 15, 2014). I am not addressing these 

portions of Respondent’s Response to the OSC 

because this is not the proper forum to appeal 

Respondent’s criminal conviction or to address any 

grievances Respondent may have regarding actions 

taken by the Department of Justice in relation to 

Respondent’s criminal case. 

documentary evidence to support his 

arguments, a first-person statement 

written from Respondent to the 

Tennessee Board of Medical Examiners, 

and dozens of letters that members of 

Respondent’s community wrote on 

Respondent’s behalf to the judge in 

Respondent’s criminal case prior to 

sentencing. Respondent does not contest 

the Government’s allegation that he is 

excluded from Federal health care 

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

7(a). Respondent acknowledges that on 

June 24, 2013, he was convicted of 

receiving in interstate commerce a 

misbranded drug in violation of 21 

U.S.C. 331(c) and that as a result of that 

conviction, he was ‘‘mandatorily 

excluded from all Federal healthcare 

programs by HHS/OIG for ten years 

from the date of conviction.’’ Response 

to the OSC, at 1. Respondent argues, 

however, that DEA should grant his 

application for a controlled substances 

registration in spite of his exclusion. 

Respondent’s Response to the OSC 

outlines his education and employment 

history, provides ‘‘background’’ 

information on his criminal offense, and 

discusses the loss of his state medical 

license and his re-licensure.1 In his firstperson statement, Respondent briefly 

described how he came to be the senior 

partner and business manager for his 

clinic, McLeod Cancer. Respondent 

stated that he was ‘‘ill-equipped as the 

business manager’’ and that when the 

clinic hired a business manager, he 

thought ‘‘[his] management problems 

were over.’’ Response to the OSC, Ex. 1. 

Respondent then stated, however, 

‘‘[l]ittle did I know I was sowing the 

seeds of my own destruction. I let [the 

business manager] do as he pleased, not 

realizing the full extent of the 

consequences and the depth of his 

treachery.’’ Id. 

Respondent states that after hiring the 

business manager, McLeod Cancer 

decided to purchase drugs from a 

particular supplier because they were 

‘‘cost-effective,’’ but stopped because 

‘‘of concerns about applicable FDA 

regulations and laws.’’ Response to the 

OSC, at 3. The McLeod Cancer 

physicians and business manager then 

sought a legal opinion from a private 

attorney ‘‘on whether purchasing drugs 

from Canada for use in the United States 

was illegal.’’ Id. Respondent submitted 

the attorney’s response to the record as 

an exhibit to his Response to the OSC. 

Id. at Ex. 3. After receiving the 

attorney’s opinion, Respondent decided 

to resume purchasing drugs from the 

supplier. Id. at Ex. 4, at 3. Respondent 

states that he ‘‘interpreted the opinion 

paper as approving the practice,’’ but 

now admits ‘‘he was wrong and did not 

understand the possible significance of 

a ‘technical violation’ and resulting 

consequences.’’ Id. 

b. Analysis of Respondent’s Application 

for Registration 

In this matter, the OSC calls for my 

adjudication of the application for 

registration based on the charge that 

Respondent was excluded from 

participation in a program pursuant to 

section 1320a–7(a) of Title 42, which is 

a basis for revocation or suspension 

under 21 U.S.C. 824(a)(2). OSC, at 1–2. 

The OSC does not allege that granting 

Respondent’s application would be 

inconsistent with the public interest 

based on consideration of the factors in 

21 U.S.C. 823(f)(1) through (5) 

(hereinafter, the public interest factors). 

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 forty-five years, 

Agency decisions have concluded that it 

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

33,738, 33,744–45 (2021) (collecting 

cases). In the recent decision Robert 

Wayne Locklear, M.D., the former 

Acting Administrator stated his 

agreement with the results of these past 

decisions and reaffirmed that a 

provision of section 824 may be the 

basis for the denial of a practitioner 

registration application. 86 FR at 33,745. 

He also clarified that allegations related 

to section 823 remain relevant to the 

adjudication of a practitioner 

registration application when a 

provision of section 824 is involved. Id. 

Accordingly, when considering an 

application for a registration, I will 

consider any allegations related to the 

grounds for denial of an application 

under 823 and will also consider any 

allegations that the applicant meets one 

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). 

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

Interest Factors 

Pursuant to section 303(f) of 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 making the public interest 

determination, the CSA requires 

consideration of the following factors: 

(1) The recommendation of the appropriate 

State licensing board or professional 

disciplinary authority. 

(2) The applicant’s experience in 

dispensing, or conducting research with 

respect to 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. 

21 U.S.C. 823(f). 

In this case, it is undisputed that 

Respondent holds a valid state medical 

license and is authorized to dispense 

controlled substances in the State of 

Tennessee where he practices. Response 

to the OSC, Ex. 12, 13. The Government 

did not allege that Respondent’s 

registration would be inconsistent with 

the public interest pursuant to section 

823 in the OSC and did not advance any 

arguments or present any evidence 

under the public interest factors in its 

RFAA. See RFAA; RFAAX 2. Instead, 

the Government based its case in section 

824 alleging that Respondent’s 

conviction of receiving a misbranded 

drug with intent to defraud or mislead 

and his subsequent exclusion from 

federal health care programs by the U.S. 

Department of Health and Human 

Services merit the denial of his 

registration under 21 U.S.C. 824(a)(5). 

RFAA, at 1–4. Because the Government 

has not alleged that Respondent’s 

registration is inconsistent with the 

public interest under section 823, I will 

not deny Respondent’s application 

based on section 823, and although I 

have considered 823, I will not analyze 

Respondent’s application under the 


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2The Government correctly argues, and 

Respondent did not rebut, that the underlying 

conviction forming the basis for a registrant’s 

mandatory exclusion from participation in federal 

health care programs need not involve controlled 

substances to provide the grounds for revocation or 

denial pursuant to section 824(a)(5). Jeffrey Stein, 

M.D., 84 FR 46,968, 46,971–72 (2019); see also 

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

KK Pharmacy, 64 FR 49,507, 49,510 (1999) 

(collecting cases); Melvin N. Seglin, M.D., 63 FR 

70,431, 70,433 (1998); Stanley Dubin, D.D.S., 61 FR 

60,727, 60,728 (1996). 

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 II.b. 

ii. 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 

Controlled Substances Act (hereinafter, 

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, 

there is no dispute in the record that 

Registrant is mandatorily excluded from 

federal health care programs under 42 

U.S.C. 1320a–7(a). The Government has 

presented substantial evidence of 

Respondent’s exclusion and the 

underlying criminal conviction that led 

to that exclusion, and Respondent has 

admitted to the same. RFAAX 4, 5; 

Response to the OSC, at 1. I will, 

therefore, sustain the Government’s 

allegation that Respondent 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 exists 

upon which a registration could be 

revoked pursuant to 21 U.S.C. 

824(a)(5).2

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. Robert Wayne 

Locklear, M.D., 86 FR at 33,745–46; 

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 a 

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’’). Accordingly, Respondent’s 

exclusion from participation in a 

program under 42 U.S.C. 1320a–7(a) 

serves as an independent basis for 

denying his application for DEA 

registration. 21 U.S.C. 824(a)(5). 

III. Sanction 

The Government can meet its burden 

in a case involving a registrant who has 

been excluded from federal health care 

programs simply by showing evidence 

of the exclusion and the underlying 

conviction. Further, DEA has long held 

that the underlying conviction forming 

the basis of a registrant’s mandatory 

exclusion from participation in Federal 

health care programs need not involve 

controlled substances for DEA to issue 

a sanction pursuant to 21 U.S.C. 

824(a)(5). Jeffrey Stein, M.D., 84 FR 

46,968, 46,971–71 (2019); Richard 

Hauser, M.D., 83 FR at 26,310. 

The Government argues that in cases 

brought pursuant to 21 U.S.C. 824(a)(5), 

the statutory language requires DEA to 

revoke a respondent’s registration (or 

deny a respondent’s application) once 

the Government has proven that a 

respondent is mandatorily excluded 

from participation in Federal health care 

programs and that DEA should not 

permit a respondent to have a DEA 

registration for as long as the respondent 

is excluded. RFAA, at 4. Since the 

Government filed the RFAA, however, 

the Agency issued a Decision and Order 

in another exclusion case, in which the 

Government made the same argument, 

Jeffrey Stein, M.D., that directly 

addressed and rejected the 

Government’s argument. 84 FR 46,968 

(2019); see also Kansky J. Delisma, M.D., 

85 FR 23,845 (2020). 

The clear language of 21 U.S.C. 

824(a)—‘‘[a] registration . . . may be 

suspended or revoked by the Attorney 

General’’—gives the Administrator the 

discretion to revoke the registration of a 

registrant who has been excluded from 

participation in Federal health 

programs. Jeffrey Stein, M.D., 84 FR at 

46,970–71 (providing detailed analysis 

of the language and legislative history of 

21 U.S.C. 824(a)(5)). It does not require 

automatic revocation or denial on that 

ground. Id. Accordingly, although 

section 824(a) provides DEA with the 

authority to revoke a respondent’s 

registration (or deny an application) 

upon a finding of one or more of the five 

listed grounds, if a respondent presents 

evidence, either in a written statement 

or in the context of a hearing, I will 

review the evidence provided by the 

respondent to determine whether 

revocation or suspension (or denial) is 

appropriate given the particular facts. 

See 5 U.S.C. 556(d) (‘‘A party is entitled 

to present his case or defense by oral or 

documentary evidence.’’); 21 CFR 

1301.43(c) (permitting a Respondent to 

file ‘‘a waiver of an opportunity for a 

hearing . . . together with a written 

statement regarding such person’s 

position on the matters of fact and law 

involved in such hearing.’’); Jones Total 

Health Care Pharmacy, LLC v. Drug 

Enf’t Admin., 881 F.3d 823, 829 (11th 

Cir. 2018) (‘‘[W]e may set aside a 

decision as ‘arbitrary and capricious 

when, among other flaws, the agency 

has . . . entirely failed to consider an 

important aspect of the problem.’ ’’); 

Morall v. Drug Enf’t Admin., 412 F.3d 

165, 177 (D.C. Cir. 2005) (‘‘To uphold 

DEA’s decision, . . . we must satisfy 

ourselves ‘that the agency ‘‘examine[d] 

the relevant data and articulate[d] a 

satisfactory explanation for its action 

including a rational connection between 

the facts found and the choice made.’ ’’). 

Where, as in the instant case, the 

Government has established a ground to 

deny a registration, I will review any 

evidence and argument the respondent 

submitted to determine whether or not 

respondent has presented ‘‘sufficient 

mitigating evidence to assure the 

Administrator that [he] can be trusted 

with the responsibility carried by such 

a registration.’’ Samuel S. Jackson, 

D.D.S., 72 FR 23,848, 23,853 (2007) 

(quoting Leo R. Miller, M.D., 53 FR 

21,931, 21,932 (1988)). ‘‘ ‘Moreover, 

because ‘‘past performance is the best 

predictor of future performance,’’ ALRA 

Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th 

Cir. 1995), [the Agency] has repeatedly 

held that where a registrant has 

committed acts inconsistent with the 

public interest, the registrant must 

accept responsibility for [the 

registrant’s] actions and demonstrate 

that [registrant] will not engage in future 

misconduct.’ ’’ Jayam Krishna-Iyer, 74 

FR 459, 463 (2009) (quoting Medicine 

Shoppe, 73 FR 364, 387 (2008)); see also 

Samuel S. Jackson, D.D.S., 72 FR at 

23,853; John H. Kennnedy, M.D., 71 FR 

35,705, 35,709 (2006); Prince George 

Daniels, D.D.S., 60 FR 62,884, 62,887 

(1995). The issue of trust is necessarily 

a fact-dependent determination based 

on the circumstances presented by the 

individual respondent; therefore, the 

Agency looks at factors, such as the 

acceptance of responsibility and the 

credibility of that acceptance as it 

relates to the probability of repeat 

violations or behavior and the nature of 

the misconduct that forms the basis for 

sanction, while also considering the 

Agency’s interest in deterring similar 

acts. See Arvinder Singh, M.D., 81 FR 

8247, 8248 (2016). 

In evaluating the degree required of a 

respondent’s acceptance of 

responsibility to entrust him with a 


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40640 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

3See DEA FY2020 Budget Request available at 

https://www.justice.gov/jmd/page/file/1142431/ 

download. 

registration, in Mohammed Asgar, M.D., 

the Agency looked for ‘‘unequivocal 

acceptance of responsibility when a 

respondent has committed knowing or 

intentional misconduct.’’ 83 FR 29,569, 

29,572 (2018) (citing Lon F. Alexander, 

M.D., 82 FR 49,704, 49,728). Here, 

Respondent pled guilty to a criminal 

charge involving intentional 

misconduct—‘‘Receiving in Interstate 

Commerce a Misbranded Drug with 

Intent to Defraud or Mislead.’’ I will, 

therefore, look for a clear acceptance of 

responsibility from Respondent. 

Respondent took concrete actions to 

accept responsibility for his misconduct 

while his criminal case was ongoing. He 

did so by pleading guilty to the charge 

in Federal Court and entering into a 

settlement agreement with the United 

States of America and the State of 

Tennessee. Respondent’s Response to 

the OSC also states, ‘‘[Respondent] has 

admitted his mistakes and taken 

responsibility for his actions with his 

freedom and money.’’ Response to the 

OSC, at 6. 

During the pendency of this matter, 

however, Respondent has not made any 

statements accepting responsibility or 

expressed remorse for his actions. See 

id. To the contrary, Respondent made 

arguments in his Response to the OSC 

that deflect or minimize responsibility 

for his actions. In a first-person 

statement, which he attached as an 

exhibit to his Response to the OSC, 

Respondent appeared to place the blame 

for the actions leading to his criminal 

conviction on his clinic’s business 

manager. See id. at Ex. 1. In reference 

to hiring the business manager for the 

clinic, Respondent stated, ‘‘[l]ittle did I 

know I was sowing the seeds of my own 

destruction. I let [the business manager] 

do as he pleased, not realizing the full 

extent of the consequences and the 

depth of his treachery.’’ Id. I am 

troubled by this statement and its 

implications for Respondent’s 

acceptance of responsibility. 

Respondent’s guilty plea and 

evidence entered into the record by 

Respondent himself demonstrate that 

Respondent was not an unknowing and 

naive participant in the scheme that led 

to his conviction. Respondent admitted 

as part of his plea that clinic nurses 

raised concerns about the misbranded 

drugs, which led to the clinic doctors 

deciding to stop ordering the drugs. 

Later, Respondent ‘‘decided McLeod 

Cancer would resume purchasing 

misbranded unapproved drugs . . . [and 

that] [t]o prevent the nurses from 

learning that McLeod Cancer was again 

purchasing unapproved foreign drugs, 

[Respondent] directed [the clinic’s 

business manager] to have the drugs 

shipped to a storage business in Johnson 

City which [Respondent] owned in 

part.’’ RFAAX 3 (Plea Agreement, U.S. 

v. William Ralph Kinkaid, No. 2:12–CR– 

116 (E.D. Tenn. June 24, 2013)). 

Respondent also submitted to the record 

a letter written by an attorney 

addressing whether Respondent’s clinic 

was ‘‘breaking federal law by importing 

foreign prescription drugs for use in the 

United States.’’ Response to the OSC, 

Ex. 3. While the attorney greatly 

downplayed the significance of the legal 

violation, particularly focusing on the 

lack of enforcement by the Food and 

Drug Administration (hereinafter, FDA) 

and referencing the importation of the 

drugs as ‘‘a technical violation,’’ he did 

state the FDA could enforce if it chose 

to do so. Id. Respondent decided to 

resume purchasing the misbranded 

unapproved drugs after receiving this 

opinion. 

Respondent’s decision to resume 

purchasing the misbranded unapproved 

drugs after receiving an opinion that 

doing so was a ‘‘technical violation’’ 

that the FDA was unlikely to enforce 

creates concern about whether 

Respondent can be entrusted with the 

responsibilities of a controlled 

substances registration. If Respondent 

were to violate part of the CSA that he 

considered to be a ‘‘technical violation,’’ 

based on a perception of limited Agency 

enforcement, it could impact the 

Agency’s mission in preventing the 

diversion and misuse of controlled 

substances. DEA budgets for 

approximately 1,625 Diversion positions 

involved in regulating more than 1.8 

million registrants overall.3 Ensuring 

that a registrant is trustworthy to 

comply with all relevant aspects of the 

CSA without constant oversight is 

crucial to the Agency’s ability to 

complete its mission of preventing 

diversion within such a large regulated 

population. Jeffrey Stein, M.D., 84 FR at 

46,974. 

Had there been a hearing on the OSC, 

it is possible that Respondent could 

have clarified his statements regarding 

his business manager and his reasoning 

for presenting the private attorney’s 

opinion regarding purchasing the 

misbranded drugs. But with such 

limited information from Respondent, 

his statements and presentation of the 

attorney’s opinion that purchasing the 

misbranded drugs was a ‘‘technical 

violation’’ appear to be aimed at 

minimizing the egregiousness of his 

conduct, which the Agency has 

previously weighed against a finding of 

acceptance of full responsibility. See 

Ronald Lynch, M.D., 75 FR 78,745, 

78,754 (2010) (Respondent did not 

accept responsibility noting that he 

‘‘repeatedly attempted to minimize his 

[egregious] misconduct’’; see also 

Michael White, M.D., 79 FR 62,957, 

62,967 (2014) (finding that Respondent’s 

‘‘acceptance of responsibility was 

tenuous at best’’ and that he 

‘‘minimized the severity of his 

misconduct by suggesting that he thinks 

the requirements for prescribing 

Phentermine are too strict.’’). In light of 

Respondent’s minimization of his crime 

and his role in the crime, and the lack 

of a hearing to determine if 

Respondent’s previous guilty plea and 

settlement agreement does, in fact, 

translate to sincere remorse and 

acceptance of responsibility, I cannot 

characterize Respondent’s acceptance of 

responsibility as unequivocal. 

In addition to acceptance of 

responsibility, the Agency also gives 

consideration to both specific and 

general deterrence when determining an 

appropriate sanction. Daniel A. Glick, 

D.D.S., 80 FR 74,800, 74,810 (2015). 

Specific deterrence is the DEA’s interest 

in ensuring that a registrant complies 

with the laws and regulations governing 

controlled substances in the future. Id. 

General deterrence concerns the DEA’s 

responsibility to deter conduct similar 

to the proven allegations against the 

respondent for the protection of the 

public at large. Id. Where a respondent 

has committed a crime with no nexus to 

controlled substances, it is sometimes 

difficult to demonstrate that a sanction 

will have a useful deterrent effect. In 

this case, I believe a sanction would 

deter Respondent and the general 

registrant community from committing 

‘‘technical violations’’ of the CSA or its 

implementing regulations and thinking 

that they could do so without serious 

consequence. 

In Respondent’s favor, Respondent 

has been held accountable for receiving 

misbranded drugs with intent to defraud 

or mislead, having been sentenced to 

prison, paying substantial financial 

penalties, and temporarily losing his 

medical license. I find that such 

significant consequences are likely to 

have some deterrent effect on 

Respondent repeating similar 

misconduct in the future. Additionally, 

according to Respondent’s unrebutted 

claims, he has fully satisfied all 

requirements imposed upon him by the 

Federal courts and all terms of his 

settlement agreement with the United 

States of America and the State of 

Tennessee. Response to the OSC, at 3– 

4. He also satisfied all requirements 

imposed upon him by the state licensing 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40641 

1RFAAX 12 is the DEA Assistant Administrator’s 

letter to Respondent, dated January 29, 2019, 

rejecting her proposed CAP. 

2 In addition, the RFAA represents that 

‘‘Respondent acknowledged service of a copy of the 

. . . [OSC] in a telephone conversation with [a] 

DEA Diversion Investigator.’’ RFAA, at 3 (citing 

RFAAX 9 (Declaration of Diversion Investigator 

(hereinafter, DI), dated October 1, 2018), at 2). 

3Respondent’s Written Statement is dated 

September 21, 2018. It appears that Respondent 

transmitted her proposed CAP along with her 

Written Statement. The OSC is dated August 24, 

2018; therefore, Respondent’s submissions are 

Continued 

authorities to regain his medical license, 

including at least three months of 

practice under a preceptorship and the 

completion of forty hours of continuing 

medical education. See Response to the 

OSC, Ex. 12, 13. However, it is difficult 

to determine the amount of deterrence 

these consequences will have on 

Respondent due to the fact that he 

deflected responsibility for the 

underlying conduct. 

Finally, Respondent submitted dozens 

of letters from former patients, 

colleagues, and community members 

regarding his aptitude as a physician 

and compassionate nature. Response to 

the OSC, Ex. 14. While these character 

references do not diminish 

Respondent’s bad acts, I find the letters 

to be personal and sincere in their 

written form. They can be of limited 

weight in this proceeding, however, 

because I have limited ability to assess 

the actual credibility of the references 

given their written form. See Michael S. 

Moore, M.D., 76 FR 45,867, 45,873 

(2011) (evaluating the weight to be 

attached to letters provided by the 

respondent’s hospital administrators 

and peers in light of the fact that the 

authors were not subjected to the rigors 

of cross examination). They also were 

not written for the purposes of 

recommending that Respondent be 

granted a controlled substances 

registration, and, therefore, they offer 

little value in assessing the 

Respondent’s suitability to discharge the 

duties of a DEA registrant. Further, 

absent Respondent’s unequivocal 

acceptance of responsibility, what little 

value the letters might have offered me 

in evaluating my ability to trust 

Respondent is nullified by the fact that 

he himself has not shown me that he 

can be so entrusted. 

As discussed above, to receive a 

registration when grounds for denial 

exist, a respondent must convince the 

Administrator that his acceptance of 

responsibility and remorse are 

sufficiently credible to demonstrate that 

the misconduct will not recur and that 

he can be entrusted with a registration. 

Having reviewed the record in its 

entirety, I find that Respondent has not 

met this burden. Although Respondent 

did take some responsibility for his 

actions through his guilty plea and 

settlement agreement with the United 

States and the State of Tennessee, his 

acceptance of responsibility was not 

unequivocal. Respondent’s 

minimization and deflection of 

responsibility for his criminal conduct 

raises concern that he would perhaps 

also be willing to circumvent CSA 

requirements that he deemed 

‘‘technical’’ to the detriment of its 

effective implementation. I am also 

concerned that granting his registration 

absent a full acceptance of 

responsibility for his criminal actions 

would send the message to the 

registered community that they could 

violate so-called ‘‘technical’’ provisions 

of the CSA or its regulations without 

serious consequence. Unless and until 

Respondent is willing to credibly accept 

full responsibility for his unlawful 

conduct, I find that I cannot entrust him 

with a controlled substances 

registration. Accordingly, I will order 

the Agency to deny Respondent’s 

application for a certificate of 

registration. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

authority vested in me by 21 U.S.C. 823, 

I hereby order that the pending 

application for a Certificate of 

Registration, Control Number 

W18085586C, submitted by William 

Ralph Kincaid, M.D., is denied. This 

Order is effective August 27, 2021. 

Anne Milgram, 

Administrator. 

[FR Doc. 2021–16004 Filed 7–27–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Erica N. Grant, M.D.; Decision and 

Order 

I. Introduction 

On August 24, 2018, the Assistant 

Administrator, Diversion Control 

Division, Drug Enforcement 

Administration (hereinafter, DEA or 

Government), issued an Order to Show 

Cause (hereinafter, OSC) to Erica N. 

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

Irving, Texas. OSC, at 1. The OSC 

proposed the revocation of 

Respondent’s Certificate of Registration 

No. FG2374053 for three reasons. Id. 

First, it alleged that Respondent was 

‘‘convicted of a felony under State law 

relating to a controlled substance.’’ Id. 

(citing 21 U.S.C. 824(a)(2)). Second, it 

alleged that it was ‘‘inconsistent with 

the public interest’’ for Respondent to 

maintain her registration. OSC, at 1 

(citing 21 U.S.C. 824(a)(4) in 

conjunction with 21 U.S.C. 823(f)). 

Third, the OSC alleged that Respondent 

‘‘materially falsified the application’’ for 

renewal of her registration. OSC, at 1 

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

Specifically, the OSC alleged that 

Respondent’s ‘‘no contest’’ plea to a 

second-degree felony in Texas, 

‘‘Attempting to Possess a Controlled 

Substance by Fraud in violation of 

Texas Health and Safety Code 

§ 481.129,’’ ‘‘is a conviction providing a 

sufficient basis for the revocation’’ of 

her registration. OSC, at 2, 3. Further, 

the OSC alleged that, ‘‘[t]o determine 

what is in the ‘public interest,’ DEA 

considers, among other things, the 

registrant’s ‘conviction record under 

Federal or State laws relating to the 

manufacture, distribution, or dispensing 

of controlled substances.’ ’’ Id. at 2. 

Finally, according to the OSC, ‘‘DEA 

may revoke a registrant’s DEA . . . 

[registration] upon a finding that the 

registrant materially falsified any 

application filed pursuant to, or 

required by, the Controlled Substances 

Act’’ (hereinafter, CSA), such as by a 

‘‘failure to report . . . [an] arrest for a 

controlled substance felony.’’ Id. at 2, 3. 

The OSC notified Respondent 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 3 (citing 21 

CFR 1301.43). The OSC also notified 

Respondent of the opportunity to 

submit a corrective action plan. OSC, at 

3–4 (citing 21 U.S.C. 824(c)(2)(C)). 

By transmittal dated September 21, 

2018, Respondent waived her right to a 

hearing and filed a written statement 

and a proposed Corrective Action Plan. 

Request for Final Agency Action 

(hereinafter, RFAA) Exhibit (hereinafter, 

collectively, RFAAX) 10 (Respondent’s 

Hearing Waiver and Written Statement 

in Response to the OSC (hereinafter, 

Written Statement)) and RFAAX 11 

(Respondent’s Request for Corrective 

Action Plan (hereinafter, CAP)).1

Respondent’s written statement 

explicitly references her receipt of the 

OSC.2 RFAAX 10, at 1. 

Based on all of the evidence in the 

record, I find that the Government’s 

service of the OSC was legally 

sufficient. In addition, also based on all 

of the evidence in the record, I find that 

Respondent timely filed her Written 

Statement and proposed CAP.3


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