[Federal Register Volume 86, Number 179 (Monday, September 20, 2021)]
[Notices]
[Pages 52196-52203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20241]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 19-31]


Lisa M. Jones, N.P.; Dismissal of Proceedings

I. Introduction

    On June 28, 2019, a former Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration (hereinafter, DEA or 
Government), issued an Order to Show Cause to Lisa Mae Jones, N.P. 
(hereinafter, Applicant), of Mount Airy, North Carolina. Administrative 
Law Judge Exhibit (hereinafter, ALJX) 1 (Order to Show Cause 
(hereinafter, OSC)), at 1. The OSC proposed the denial of Applicant's 
application (Application No. W19018692M) for a DEA certificate of 
registration (hereinafter, North Carolina-based registration 
application) and ``any other applications for any other DEA 
registrations'' on the ground that she ``materially falsified'' her 
application ``in violation of 21 U.S.C. 824(a)(1) and 823(f).'' Id.
    The substantive ground for the proceeding, as more specifically 
alleged in the OSC, is that Applicant's ``failure to disclose the 
disciplinary actions taken against . . . [her] nursing licenses (viz., 
the denial of . . . [her] application in Illinois and the fact that . . 
. [her] Tennessee and Iowa nursing licenses were placed on probation) 
constitutes material falsification of . . . [her] application for a DEA 
Certificate of Registration.'' Id. at 4.
    The OSC notified Applicant of her right to request a hearing on the 
allegations or to submit a written statement while waiving her right to 
a hearing, the procedures for electing each option, and the 
consequences for failing to elect either option. Id. at 4 (citing 21 
CFR 1301.43). The OSC also notified Applicant of the opportunity to 
file a corrective action plan. OSC, at 5 (citing 21 U.S.C. 
824(c)(2)(C)). Applicant requested a hearing. ALJX 2 (Request for 
Hearing dated July 22, 2019), ALJX 4 (Order for Prehearing Statements 
dated July 23, 2019), at 1 (stating that counsel for Applicant filed a 
hearing request on July 22, 2019).\1\
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    \1\ The Request for Hearing is stamped received on July 30, 
2019.
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    The matter was placed on the docket of the Office of Administrative 
Law Judges and assigned to the Chief Administrative Law Judge 
(hereinafter, ALJ), John J. Mulrooney, II. The Chief ALJ noted thirteen 
stipulations agreed upon by the parties and ``conclusively accepted as 
fact in these proceedings.'' Recommended Rulings, Findings of Fact, 
Conclusions of Law, and Decision of the Administrative Law Judge dated 
November 21, 2019 (hereinafter, RD), at 4-5. The second and third 
stipulations state that Applicant ``is currently licensed in the State 
of North Carolina as a Nurse Practitioner under Approval No. 5011528'' 
and that her ``North Carolina Approval (license) expires by its own 
terms on May 31, 2020.'' Id. at 4.

[[Page 52197]]

    The hearing in this matter took place at the DEA Hearing Facility 
on September 17, 2019. The RD is dated November 21, 2019. The 
Government filed exceptions to the RD. The Government's Exceptions to 
the Chief Administrative Law Judge's Recommended Decision, dated 
December 11, 2019 (hereinafter, Govt Exceptions).
    Having considered the record in its entirety, I find that the 
Government has failed to establish by clear, unequivocal, and 
convincing evidence that Applicant violated 21 U.S.C. 824(a)(1) as to 
the North Carolina-based registration application. Due to the current 
``inactive'' status of Applicant's North Carolina nurse practitioner 
license, however, I am precluded by statute from ordering that the 
North Carolina-based registration application be granted. 21 U.S.C. 
823(f) (``The Attorney General shall register practitioners . . . if 
the applicant is authorized to dispense . . . controlled substances 
under the laws of the State in which [s]he practices.''). Infra section 
II.B.
    I make the following findings.

II. Findings of Fact

A. The Material Falsification Allegations

    According to the OSC's allegations, Applicant submitted an 
application for a DEA Certificate of Registration as a mid-level 
practitioner in Schedules II through V with a registered address in 
North Carolina on or about March 1, 2019. OSC, at 2. The North 
Carolina-based registration application, the OSC further alleges, was 
assigned control number W19018692M. Id. Applicant allegedly answered 
``yes'' to Liability Question 2. Id. (``Has the applicant ever 
surrendered (for cause) or had a federal controlled substance 
registration revoked, suspended, restricted or denied, or is any such 
action pending?''). Also according to the OSC, for ``nature of 
incident,'' Applicant submitted the following material: ``Failed to 
read directions/instructions correctly, I misread the part of state 
licensure being restricted.'' Id. Regarding ``incident result,'' 
Applicant allegedly wrote: ``Surrendered to DEA Agent on/about date 
stated above,'' meaning January 31, 2019. Id.
    According to the OSC, Applicant also answered ``yes'' to Liability 
Question 3. Id. (``Has the applicant ever surrendered (for cause) or 
had a state professional license or controlled substance registration 
revoked, suspended, denied, restricted or placed on probation or is any 
such action pending?''). Regarding the ``nature of the incident,'' 
Applicant allegedly stated: ``I misread the application, I failed to 
read the part about state licensure being placed on probation.'' Id. 
For ``incident result,'' according to the OSC, Applicant again 
submitted: ``Surrendered to DEA Agent on/about date stated above,'' 
meaning January 31, 2019. Id.
    There is factual agreement among the witnesses on a number of 
matters. When there is factual disagreement, I apply my credibility 
determinations and the credibility recommendations of the Chief ALJ. 
Infra sections II.D. and II.E.

B. Applicant's Current Licensure

    In the course of adjudicating this matter, it came to my 
predecessor's attention that the North Carolina Board of Nursing 
(hereinafter, NCBON) website listed the status of Applicant's North 
Carolina nurse practitioner license as ``inactive.'' https://www.ncbon.com/licensure-listing-verify-a-license. Further, Applicant 
was not listed on the North Carolina Board of Pharmacy website as being 
registered to dispense controlled substances in North Carolina. https://portal.ncbop.org/verification/search.aspx.
    My predecessor issued Applicant an (unpublished) Interim Order on 
May 21, 2021 (hereinafter, Interim Order).\2\ In the Interim Order, the 
then-Acting Administrator explained that the ``inactive'' status of 
Applicant's nurse practitioner license impacts the status of 
Applicant's North Carolina authority to dispense controlled 
substances.\3\ Interim Order, at 1. He explicitly stated that the 
status of Applicant's North Carolina nurse practitioner license ``is 
essential to . . . [his] decision about the OSC because Applicant must 
have North Carolina authority to dispense controlled substances to be 
eligible for a DEA registration in North Carolina.'' Id. My predecessor 
ordered Applicant to address the status of her North Carolina authority 
to dispense controlled substances. Id. at 2. Applicant's response was 
due over a month ago, yet the Agency has not received any response, let 
alone the information ordered, from Applicant to date. As of the date 
of this Decision/Order, I find that the NCBON website continues to show 
Applicant's nurse practitioner license as ``inactive.'' https://www.ncbon.com/licensure-listing-verify-a-license. Accordingly, as my 
predecessor advised Applicant in the Interim Order, I am crediting and 
using the current ``inactive'' information on the NCBON website and 
denying the North Carolina-based registration application. 21 U.S.C. 
823(f); 21 U.S.C. 802(21). I shall also adjudicate the OSC's 
allegations in the event Applicant submits a registration application 
in the future.
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    \2\ Applicant's attorney during the Hearing, on whom the Interim 
Order was served, orally confirmed that she received the Interim 
Order and forwarded it to Applicant.
    \3\ The Interim Order attached a copy of the website of the 
North Carolina Board of Nursing showing the status of Applicant's 
nurse practitioner license as ``inactive.''
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C. The Investigation of Applicant

    I find that Applicant submitted an online application for a DEA 
registration with a registered address in North Carolina on or about 
March 1, 2019. GX 1 (Certification of Non-Registration), at 1. I find 
that her application was assigned DEA control number W19018692M. Id. I 
find that Applicant answered ``yes'' to two of the ``Background 
Information,'' or Liability, questions. Id. at 1-2; infra II.F. I find 
that, when an application contains a ``yes'' response to a Liability 
question, it is referred for investigation. Transcript (hereinafter, 
Tr.) 38.

D. The Government's Case

    The Government called one witness, the DEA Diversion Investigator 
assigned to investigate Applicant's North Carolina-based registration 
application (hereinafter, DI), and offered eight exhibits. The eight 
Government exhibits are either DEA documents showing Applicant's DEA 
registration status and history, or documents from states showing 
Applicant's license status and history. At the beginning of the 
hearing, Applicant's attorney stipulated to the admission of all of the 
Government's eight noticed exhibits. Id. at 25-26.
    DI testified about her DEA employment, training, and duties as a DI 
at DEA's office in Greensboro, North Carolina. Id. at 24, 26-28. She 
testified that her first meeting with Applicant stemmed from a 
telephone call she received from the DEA Roanoke office in January 
2019. Id. at 28-35. From that telephone call, she stated, she learned 
that a Special Agent (hereinafter, SA) and a Task Force Officer 
(hereinafter, TFO) from the Roanoke office were traveling to North 
Carolina to interview Applicant and that DI's presence was requested at 
the meeting. Id. at 28, 31.
    DI explained that the Roanoke office found that Applicant had 
answered Liability questions inaccurately on the application she had 
submitted for the controlled substance registration under which 
Applicant was practicing in Virginia at the time. Id. at 28. DI 
described ``liability questions'' as questions about matters that ``we 
consider liabilities for that registrant'' or ``things that we would 
consider as to

[[Page 52198]]

whether or not there's a public interest reason why that individual 
should be perhaps their registration [sic] rejected for some reason.'' 
\4\ Id. at 29. Specifically, regarding Applicant, DI testified that 
Applicant ``had answered negative to all of those questions, but later 
investigation found that she did in fact have some past issues with her 
state licensing.'' \5\ Id. at 30.
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    \4\ When asked for details about completing the DEA registration 
application form, DI responded that she is ``not an expert when it 
comes to the actual application process'' and that she has ``not 
actually completed one as a registrant.'' Tr. 80, 83. Regarding 
instructions for completing the form and resources to help someone 
who is unsure about how to answer a question on the form, DI 
testified that she is ``not aware that there's any [instruction] 
form, it's just a ask a question, answer the question, ask a 
question, answer the question'' and that ``[t]here is a telephone 
number . . . to basically the Registration Program Specialist within 
the DEA . . .--there's kind of a help 800 number that they can 
contact.'' Id. at 81-82; see also id. at 83.
    \5\ Neither the Government nor Applicant offered for admission 
documentary evidence supporting or refuting the findings of the 
investigation DI referenced concerning Applicant's Virginia 
registration under which she was practicing in January 2019 and that 
she voluntarily surrendered at the January 31, 2019 meeting. This is 
consistent with the sole charge in the OSC--denial of Applicant's 
North Carolina-based registration application due to material 
falsification.
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    DI testified that, at the meeting on January 31, 2019, Applicant 
acknowledged that she completed and digitally signed an application for 
a DEA registration in September 2018, the registration under which she 
practiced in Virginia. Id. at 32-33. DI stated that SA ``then presented 
her with a copy of it and pointed to the liability questions and asked 
her to read those.'' Id. at 33. DI explained that, after Applicant read 
them once, responded affirmatively to SA's question about whether ``she 
had had any past state issues regarding her license,'' and re-read 
them, Applicant ``acknowledged that she had incorrectly answered those 
questions'' in September 2018. Id. According to DI, Applicant stated 
that she ``misunderstood'' the question. Id. at 67. DI also testified 
that, ``[t]o be honest, I recall . . . [Applicant] reviewing the 
paperwork, there actually kind of seemed to be a sense of, like, she 
was realizing what had happened as she read it. And then, she did admit 
at that point.'' Id. Indeed, according to DI, the probationary actions 
on Applicant's licenses by Tennessee and Iowa came up during the 
meeting. Id. at 79.
    According to DI, after Applicant acknowledged her incorrect 
responses, SA ``basically presented her with the option to sign a 
voluntary surrender form'' or go to a hearing. Id. at 35, 65. DI 
testified that Applicant ``read over it, . . . [SA] explained it to 
her, and she signed that voluntary surrender'' of her Virginia 
registration with TFO and DI as witnesses. Id. at 35, 68. DI identified 
GX 7 as a copy of the voluntary surrender that Applicant executed on 
January 31, 2019. Id. at 36.
    DI described the conversation that ensued after Applicant 
surrendered her Virginia registration. According to DI, Applicant 
``acknowledged that she did not plan to work in Virginia any longer and 
would be working in North Carolina.'' Id. at 68-69, 72. DI testified 
that someone from the DEA investigative team explained that, ``under 
the circumstances of her surrendering that prior registration,'' 
Applicant ``would need to reapply for a registration in the state of 
North Carolina.'' Id. at 73. DI recalled that SA told Applicant that 
``she would need to answer in the affirmative to the liability 
questions.'' Id. at 74; see also id. at 97-98 (DI testifying that ``I 
don't necessarily recall exactly if . . . [SA] said for 2 and 3, you 
need to be in the affirmative. I believe that his instruction was, 
assuming you provide the DEA with a complete and correct application, 
there won't be any issues regarding getting a new registration. I do 
recall him essentially explaining that, for Question 2, because he was 
taking a voluntary surrender, there would need to be an affirmative to 
that particular question regarding the details of that date. I don't 
necessarily remember there being any more on Question 3 . . .--other 
than a general, you will need to explain the situation.''). DI also 
testified that SA told Applicant that the voluntary surrender ``would 
not affect her state licensing.'' Id. at 74-75.
    DI testified that DEA received Applicant's North Carolina-based 
registration application. Id. at 37; see also RX 12 (showing the North 
Carolina-based registration application's submission date as February 
28, 2019). Initially, the North Carolina-based registration application 
was assigned to ``one of the brand new investigators in the office who 
was still in our training program,'' DI stated. Tr. 37. DI explained 
that the new investigator's field training officer saw Applicant's 
name, the name ``sounded familiar to him,'' so ``he kind of yelled over 
the cubicle'' to DI asking if she was familiar with the name. Id. DI 
testified that she responded in the affirmative, stating that Applicant 
``was the one . . . [she] recently had a meeting with [in] Roanoke.'' 
Id. at 37-38. DI explained how the matter was then assigned to her. Id. 
at 38.
    DI testified about Applicant's specific answers to two of the 
Liability questions on the North Carolina-based registration 
application. Id. at 83-89. First, regarding the second Liability 
question, DI confirmed that Applicant responded ``yes'' to that 
question: ``Has the applicant ever surrendered (for cause) or had a 
federal controlled substance registration revoked, suspended, 
restricted or denied, or is any such action pending?'' Id. at 83; see 
also GX 1, at 1. DI stated her ``understanding'' that Applicant's 
``yes'' answer would have caused the electronic application to drop 
down a blank box. Tr. 83. Concerning Applicant's submission for 
``incident nature'' regarding the second Liability question, ``failed 
to read directions/instructions correctly, I misread the part of state 
licensure being restricted,'' DI testified about what that response 
meant to her. GX 1, at 1. DI stated that ``[i]n this situation, it 
tells me that she has surrendered for-cause a federal controlled 
substance registration and that the explanation that she has given is 
that essentially, she misunderstood the instructions on how she was 
supposed to respond to that . . . particular question.'' Tr. 84; see 
also id. at 86. DI further testified that Applicant's submission told 
her that ``there is a state licensure being restricted'' and ``that is 
why she surrendered her DEA registration.'' Id. at 84. DI confirmed 
that Applicant's submission put DI on notice and gave DI ``some 
information regarding the potential'' that Applicant has a state 
licensure restriction. Id. at 85-86; see also id. at 103.
    Second, regarding the third Liability question, DI confirmed that 
Applicant responded ``yes'' to that question: ``Has the applicant ever 
surrendered (for cause) or had a state professional license or 
controlled substance registration revoked, suspended, denied, 
restricted, or placed on probation, or is any such action pending?'' 
Id. at 87; see also GX 1, at 2. DI consistently testified that she is 
``not aware that there's any instruction'' about how to fill out the 
drop-down box that would appear when there is a ``yes'' answer to the 
third Liability question. Tr. 87, see also id. at 93-94. Concerning 
Applicant's submission for ``incident nature'' regarding the third 
Liability question, ``I misread application. I failed to read the part 
about state licensure being placed on probation,'' DI testified about 
what that response meant to her.\6\ GX 1, at 2. DI agreed that 
Applicant's response indicated that Applicant's state licensure was 
placed on probation and that she previously surrendered her

[[Page 52199]]

DEA registration because she failed to report the probation. Tr. 88-89.
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    \6\ DI also testified that ``[i]n my reading of that, I'm not 
sure exactly what she's telling me there.'' Tr. 88.
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    DI testified that, after she received Applicant's North Carolina-
based registration application, she ``started searching under 
licensing'' for Applicant and contacted SA and TFO. Id. at 85-86. Due 
to those contacts, DI testified that SA provided her ``with some 
documentation regarding the original surrender'' on January 31, 
2019.\7\ Id. at 86.
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    \7\ DI also indicated that SA provided her the documentation 
regarding Applicant's January 2019 surrender ``because there were 
some concerns regarding if . . . [Applicant's] answer was 
complete.'' Tr. 86.
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    DI testified about the extent of her knowledge of Applicant's state 
licensing history at the time Applicant's North Carolina-based 
registration application was assigned to her. Id. at 89-92. From her 
attendance at the meeting on January 31, 2019, DI stated she was aware 
that Applicant's licenses in Tennessee and Iowa were put on probation. 
Id. at 90-92. She also testified about her investigative work after 
being assigned Applicant's North Carolina-based registration 
application. DI stated that she ``went online and . . . actually just 
started searching the nursing boards for the states for which . . . 
[she] knew . . . [Applicant] had licensing.'' Id. at 39. From this 
online research, DI testified that she learned about Applicant's 
Illinois license status ``based on information given in consent orders 
that were public information on their websites.'' Id. at 39-40; see 
also id. at 41 (DI testimony that the Iowa documentation mentioned that 
``there was a refusal to renew in Illinois . . . [a]nd so that led me 
to check Illinois as well.'').
    DI testified that her investigative work moved beyond conducting 
online research and included contacting Tennessee to ``find out the 
underlying facts, because all of them kind of pointed to Tennessee as 
sister state disciplinary action.'' Id. at 40. DI described three 
individuals and the assistance they gave her investigation. The first 
was an attorney involved in the Tennessee action against Applicant, the 
second was an individual in the Air Force Surgeon General's office 
whose name DI obtained from the Tennessee attorney, and the third was 
an individual from the Illinois Department of Professional Regulation 
who explained the meaning of ``refuse to renew'' status in Illinois. 
Id. at 47-63. From Tennessee, Iowa, and Illinois, DI obtained consent 
decrees, settlement agreements, and other records. Id. at 104. From the 
Air Force, DI obtained a ``59-page report'' and ``a packet that 
included the review of . . . [Applicant's] patient encounters.'' \8\ 
Id. DI testified that she found nothing in the states' and Air Force's 
records that ``went after her licensing.'' Id. at 106. Instead, she 
testified, ``it was actually kind of a chain reaction.'' Id. DI 
explained that ``after the Air Force took action and Tennessee took 
action, because of the action in Tennessee, then Illinois and Iowa took 
action.'' Id. DI specifically addressed the Air Force report, GX 2, and 
the Air Force's action concerning Applicant, testifying that there is 
``not anything [in GX 2] that specifically says [that Applicant 
committed] a controlled substance violation.'' Id. at 105; compare id. 
at 111-128, RD, at 24-32, and Govt Exceptions, at 4-18.
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    \8\ DI authenticated the six non-DEA Government exhibits, all of 
which she obtained through her investigative work: GX 2 (United 
States Department of the Air Force Professional Staffing Record), GX 
3 (Tennessee Board of Nursing Consent Order), GX 4 (Illinois 
Department of Financial and Professional Regulation, License Lookup 
Information), GX 5 (Iowa Board of Nursing Notice of Hearing and 
Statement of Charges), GX 6 (Iowa Board of Nursing Settlement 
Agreement and Final Order), and GX 8 (State of Illinois Department 
of Financial and Professional Regulation Consent Order dated June 8, 
2015). Tr. 41-63.
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    When asked what made her decide that Applicant made false 
statements in the North Carolina-based registration application, DI 
initially responded that her reading of Applicant's answer to the third 
Liability question ``did not actually answer the question being asked'' 
in her opinion. Tr. 94. ``The information that . . . [Applicant] 
provided seems to be an answer to Question 2 and not the answer to 
Question 3,'' she elaborated. Id. at 95. When asked whether her 
testimony was that ``the words state licensure being placed on 
probation'' are false, DI responded that ``I'm not saying that that is 
false, I'm saying that the information provided does not answer the 
question being asked.'' Id.; see also id. at 104 (``No, I wouldn't say 
that it was false.''). DI's testimony was that Applicant's words were 
``inadequate.'' Id. at 95. She also stated that ``the details . . . 
seem in conflict with one another'' because Applicant never had ``any 
state licensure that's been placed on probation in the state of North 
Carolina,'' yet Applicant listed ``Winston-Salem, North Carolina'' as 
the ``incident location.'' Id. at 95-96; see also id. at 109-111 (DI 
testifying that, to her knowledge, no action was taken against 
Applicant's state professional license on January 31, 2019, no action 
was taken against Applicant's professional license in North Carolina, 
Applicant's professional license in North Carolina was never 
disciplined for misreading or falsifying an application, and Applicant 
never surrendered a state professional license to any DEA agent).\9\ DI 
acknowledged that, if she had been in the place of the ``initial 
Diversion Investigator'' to whom the matter was assigned, she would 
have looked for every state in which Applicant was licensed. Id. at 
102. She characterized such an effort as ``due diligence.'' Id. at 104.
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    \9\ See also Tr. 98-99 (DI testifying that ``My understanding of 
what she has written, her answer to Question 3 does not answer the 
question. The facts may be true that are listed there, but it's not 
answering the question that has been asked. Question 3 is 
specifically asking about state licensure and she is telling me 
about a surrender of her DEA registration, which would be a federal 
registration. And as I said, so she's listing the date she 
surrendered her federal registration, she lists the incident result 
as the surrender of her DEA registration, and the location is when 
she did that. When it comes to--she does mention her misreading 
the--basically, she gives an explanation of why she surrendered her 
DEA registration. The information that she has provided there . . . 
I have some background knowledge on this only because I was at that 
meeting. The initial Diversion Investigator who received this 
information would not have had that information at his fingertips 
and reading that, I don't believe he would have been able to come to 
the information quite as easily or have already had some background 
knowledge of what had happened regarding her state registration.'').
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    I agree with the RD that DI presented as ``an objective, 
dispassionate regulator whose testimony was sufficiently detailed, 
internally consistent, and plausible to be afforded full credibility.'' 
RD, at 11.

E. Applicant's Case

    At the hearing, Applicant testified and succeeded in having seven 
of her exhibits admitted into evidence. Tr. 131-261.
    Applicant testified about her experience using the online 
registration application submission process for her North Carolina-
based registration application. Id. at 132-40, 141-45; RX 12, at 1. She 
stated that, when she responded ``yes'' to a Liability question, ``a 
blank box pops up'' and ``[t]here is no instructions [sic] as to what 
information to put in there.'' \10\ Tr. 133. During her testimony, she 
surmised that ``it would have solved the problem if

[[Page 52200]]

. . . [the online registration application submission process] would 
have said what State licensure, what State, what license, was it 
revoked, suspended, denied, restricted.'' Id. at 144-45. Applicant's 
testimony continued with her stating that she ``think[s] that would 
have solved the problem because . . . [she] could have answered 
Tennessee, probation, Iowa, probation.'' Id. at 145.
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    \10\ Applicant testified consistently that only a blank box 
appeared when she responded ``yes'' to Liability questions two and 
three. Tr. 239; see also id. at 239-42, 249 (Applicant testifying 
that she consulted Google for instructions and, when responding to 
questions about RX 12, at 67 showing three categories of information 
(location, nature, and disposition) under the heading of ``Answers 
to Liability Questions,'' testified that, as she recalls, she 
``independently determined that the relevant categories of 
information were location, nature, and disposition''); cf. id. at 
241-42 (Applicant testifying that ``it's possible'' there were 
prompts asking for date, nature of incident, location, and 
disposition).
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    In the context of her testimony about her suboptimal experience 
attempting to complete the online DEA registration application, 
Applicant testified that she ``took it upon . . . [herself] to answer 
the questions based on what . . . [she] was instructed to from the 
January 31st meeting as far as the yesses that needed to be in there.'' 
Id. She similarly testified in response to questioning by the Chief ALJ 
about the ``confusion . . . because it asks you if you had a State 
professional license action, essentially, against you, and the answer 
was yes and you start talking about Winston-Salem, North Carolina, and 
that really had nothing to do with the State. . . . That's what a lot 
of this comes down to.'' Id. at 136. Applicant responded that she ``put 
that down there because when . . . [she] was in the meeting on January 
31st with the three DEA agents . . . [she] was informed that . . . [DI] 
would be the investigating officer and it was already disclosed that . 
. . [she] already had . . . [her] license placed on probation, the two 
States.'' Id. at 137. After the Chief ALJ restated the question as 
``why would you answer a question dealing with State licenses with that 
date and that place,'' Applicant responded that, ``I guess that's how I 
read it, sir.'' Id. at 138-39. She elaborated that ``the DEA agents 
already knew that . . . [her] license had been placed on probation in 
the State of Tennessee and Iowa for nurse practitioner, so they already 
knew the information from . . . [the] meeting.'' Id. at 139; see also 
id. at 140 (Applicant responding ``no'' to whether she thought it was 
necessary to explain each state because DEA ``already knew about . . . 
[her] two nurse practitioner licenses already being placed on 
probation''); id. at 142 (Applicant testifying that she ``read over the 
State licensure . . . [and] immediately went to controlled substance 
registration revocation. . . . [she] just didn't grab that State 
licensure wording in there.''); id. at 142-43 (Applicant responding to 
why she thought the second and third Liability questions asked about 
the same thing, stating she ``blew past the State professional license 
words. . . . just blew through them.'').
    Applicant also testified about the meeting with the DEA 
investigative team on January 31, 2019. Id. at 140-41, 152-56. She 
stated that the meeting took place in the evening from about 6:00 to 
8:00. Id. at 152. Applicant testified that SA told her that her boss, a 
provider at the Woodlawn Pain Care Clinic where she was working at the 
time, ``was under investigation and they wanted to speak to . . . [her] 
about . . . [him].'' \11\ Id. at 152-55. She stated that ``[i]t was a 
lot of questions.'' Id. at 156.
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    \11\ Applicant testified that she was working as a nurse 
practitioner for this same provider at the North Carolina practice 
he opened after DEA investigated him in Virginia. Tr. 252-53.
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    Applicant testified that, at the conclusion of the meeting, SA 
``showed . . . [her] the questionnaire [application that she had 
submitted for her Virginia-based DEA registration], . . . [she] read it 
once, and then he had . . . [her] re-read it again and then . . . [she] 
realized . . . [she] had made a mistake, that . . . [she] had put a no 
when it should have been a yes that . . . [her] license was placed on 
probation.'' Id. at 140; see also id. at 156-57. She testified that SA 
``didn't say anything about . . . [her] licensure being placed on 
probation.'' Id. at 141. She added that SA ``didn't disclose that 
information to . . . [her, she] disclosed it to him.'' Id. She 
testified that she ``told him [SA], yes, that . . . [she] read it 
wrong, that . . . [her] license in Tennessee and Iowa had been placed 
on probation.'' Id. Applicant added that she then ``noticed under his 
[SA's] left arm he had a copy of . . . [her] Tennessee licensure 
probation information because . . . [she] saw . . . [her] signature on 
there and . . . [she] had already known what the information was.'' Id.
    According to Applicant's testimony, SA told her that she ``could 
either go in front of a judge, or . . . [she] could sign the surrender 
for cause certificate that they had already made up for . . . [her].'' 
Id. at 157-58. She testified that she signed the surrender certificate 
``[b]ecause . . . [she] realized . . . [she] had made an error.'' Id. 
at 159. Applicant stated that she asked about reapplying for ``another 
DEA number'' and that SA said she could ``but . . . [she] needed to 
make sure that . . . [she] answered yes to . . . the ones . . . [she] 
had previously answered wrong.'' Id. at 157-58. She testified that SA 
said nothing more about how to answer the second and third Liability 
questions and that SA told her it would take two to three weeks for her 
to get a new registration. Id. at 158-59. She testified that SA told 
her DI ``would be handling . . . [her] application when . . . [she] 
reapplied'' and that, at the time, DI said nothing pertaining to 
reapplication. Id. at 157, 159.
    I agree with the Chief ALJ that, ``where . . . [Applicant's] 
testimony conflicts with other objective evidence and testimony 
received during the proceedings, it must be scrutinized with great 
caution.'' RD, at 17.

F. Allegation That Applicant Submitted a Materially False Registration 
Application

    Having read and analyzed all of the record evidence, I find from 
clear, unequivocal, convincing, and unrebutted record evidence that 
Applicant answered ``yes'' to Liability questions two and three. GX 1, 
at 1-2. I further find from clear, unequivocal, convincing, and 
unrebutted record evidence that Applicant's ``yes'' answers to 
Liability questions two and three are true. See, e.g., GX 3, GX 6, and 
GX 7.
    Concerning Applicant's responses to the follow-up required due to 
her affirmative answer to the second Liability question, having read 
and analyzed all of the record evidence, I find from clear, 
unequivocal, convincing, and unrebutted record evidence that those 
responses told DI that Applicant ``surrendered for-cause a federal 
controlled substance registration,'' that Applicant's explanation was, 
``essentially, she misunderstood the instructions on how she was 
supposed to respond to that . . . particular question,'' and that 
``there is a state licensure being restricted'' and ``that is why she 
surrendered her DEA registration.'' Tr. 84, 86. I further find from 
clear, unequivocal, convincing, and unrebutted record evidence that 
Applicant's submission put DI on notice and gave DI ``some information 
regarding the potential'' that Applicant had a state licensure 
restriction. Id. at 85-86, 103. Having read and analyzed all of the 
record evidence, I also find from clear, unequivocal, convincing, and 
unrebutted record evidence that DI was one of the witnesses to 
Applicant's voluntary surrender of her Virginia-based registration on 
January 31, 2019. Id. at 35-36, 68.
    Concerning Applicant's responses to the follow-up required due to 
her affirmative answer to the third Liability question, having read and 
analyzed all of the record evidence, I find from clear, unequivocal, 
convincing, and unrebutted record evidence that DI did not consider 
those responses false; DI considered that the information Applicant 
provided ``does not answer the question being asked.'' Id. at 94. I 
further find from clear, unequivocal, convincing, and unrebutted record

[[Page 52201]]

evidence that DI ``started searching under licensing'' for Applicant 
after receiving Applicant's North Carolina-based registration 
application. Id. at 85-86. Having read and analyzed all of the record 
evidence, I also find from clear, unequivocal, convincing, and 
unrebutted record evidence that DI learned about the Tennessee and Iowa 
probationary actions on Applicant's licenses from her attendance at the 
meeting on January 31, 2019. Id. at 79, 90-92.
    Having read and analyzed all of the record evidence, I find from 
clear, unequivocal, and convincing record evidence that Applicant met 
with a DEA investigative team on January 31, 2019. See, e.g., id. at 
32-37 (DI's corrected testimony), GX 7. I also find from clear, 
unequivocal, convincing, and unrebutted record evidence that the DEA 
investigative team's meeting with Applicant took place in Winston-
Salem, North Carolina in a hotel lobby in the evening from about 6:00 
until 8:00. Tr. 71 (DI's testimony); id. at 151-52, 155 (Applicant's 
testimony). I further find from clear, unequivocal, convincing, and 
unrebutted record evidence that the outcomes of the Winston-Salem 
meeting included Applicant's voluntary surrender of her Virginia-based 
registration and the DEA investigative team's provision of input and 
instructions to Applicant about the next DEA registration application 
she might submit. See, e.g., id. at 35-36, 65-75 (DI's testimony); id. 
at 156-159 (Applicant's testimony); GX 7. I also find from unrebutted 
record evidence that the DEA investigative team advised Applicant at 
the Winston-Salem meeting that she may apply for a DEA registration at 
a registered location in North Carolina, cautioned Applicant, in the 
event she reapplies, to answer ``yes'' to the Liability questions she 
previously incorrectly answered in the negative, told Applicant that DI 
would handle any application she submitted for registration in North 
Carolina, and predicted that it would take two to three weeks for 
Applicant to get a new registration if she were to submit a complete 
and correct application. Tr. 71-75 (DI's testimony); id. at 157-59 
(Applicant's testimony).
    I already found that Applicant submitted an online application for 
a DEA registration with a registered address in North Carolina on or 
about March 1, 2019. Supra section II.C. Having read and analyzed all 
of the record evidence, I find that the unrebutted record evidence is 
that Applicant's North Carolina-based registration application was 
initially assigned to ``one of the brand new investigators in the 
office who was still in . . . [the] training program,'' that the new 
investigator's field training officer recognized Applicant's name and 
confirmed DI's familiarity with Applicant, and that Applicant's North 
Carolina-based registration application was reassigned to DI. Tr. 37-38 
(DI's testimony). I find that the unrebutted record evidence is that 
the investigation into Applicant's North Carolina-based registration 
application remained DI's responsibility and that Applicant's North 
Carolina-based registration application was not assigned away from DI. 
See, e.g., id. at 28. I find that the Government did not submit clear, 
unequivocal, and convincing evidence about the online registration 
application process, including what information the online application 
elicits after an applicant responds ``yes'' to a Liability question. 
See, e.g., id. at 87, 93 (DI's testimony).
    Having read and analyzed all of the record evidence, I do not find 
clear, unequivocal, and convincing record evidence that Applicant's 
North Carolina-based registration application was false. Having read 
and analyzed all of the record evidence, I do not find any record 
evidence rebutting Applicant's testimony that her responses to the 
second and third Liability questions' follow-up reflected the input and 
instructions she received from the DEA investigative team on January 
31, 2019.\12\
---------------------------------------------------------------------------

    \12\ The Government neither cross-examined Applicant concerning 
her testimony about the input and instructions she stated the DEA 
investigative team gave her during the Winston-Salem meeting, nor 
put on a rebuttal case after Applicant's testimony.
---------------------------------------------------------------------------

III. Discussion

A. The Controlled Substances Act and the Public Interest Factors

    Pursuant to the Controlled Substances Act (hereinafter, 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). The CSA 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 . . . controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

Id.
    These factors are considered in the disjunctive. Robert A. Leslie, 
M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or a 
combination of factors and may give each factor the weight [I] deem[ ] 
appropriate in determining whether . . . an application for 
registration [should be] denied.'' Id. Moreover, while I am required to 
consider each factor, I `` `need not make explicit findings as to each 
one,' '' and I `` `can give each factor the weight . . . [I] determine[ 
] is appropriate.' '' Jones Total Health Care Pharmacy, LLC v. Drug 
Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018) (quoting Akhtar-Zaidi 
v. Drug Enf't Admin., 841 F.3d 707, 711 (6th Cir. 2016)); see also 
MacKay v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011) 
(quoting Volkman v. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 
2009) (quoting Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir. 
2005))). In other words, the public interest determination ``is not a 
contest in which score is kept; the Agency is not required to 
mechanically count up the factors and determine how many favor the 
Government and how many favor the registrant. Rather, it is an inquiry 
which focuses on protecting the public interest; what matters is the 
seriousness of the registrant's misconduct.'' Peter A. Ahles, M.D., 71 
FR 50097, 50098-99 (2006).
    In this matter, as already discussed, the OSC calls for my 
adjudication of the North Carolina-based registration application based 
on the charge that Applicant submitted materially false responses to 
its second and third Liability questions. OSC, at 1-4; supra sections 
II.A and II.D. Material falsification, of course, is a basis for 
revocation or suspension. 21 U.S.C. 824(a)(1). While the OSC references 
21 U.S.C. 823(f), it does not specifically allege that granting 
Applicant's North Carolina-based registration application would be 
inconsistent with the public interest based on consideration of the 
factors in 21 U.S.C. 823(f)(1) through (5). Supra section III.A. In 
addition, while the Government presented some evidence and argument 
that the North Carolina-based registration application should be denied 
due to concerns about

[[Page 52202]]

Applicant's controlled substance prescribing, Government counsel 
confirmed that material falsification is the exclusive basis for the 
application denial sought by the Government. Tr. 214-16. Given the 
allegations noticed in this matter, no other conclusion is legally 
supportable. Accordingly, the sole, specific substantive basis for 
proposing the denial of Applicant's North Carolina-based registration 
application is material falsification under 21 U.S.C. 824(a)(1). OSC, 
at 1-4; see also Tr. 211-218.
    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, and as recently as a few months ago, Agency decisions have 
concluded that it is. See, e.g., Robert Wayne Locklear, 86 FR 33738 
(2021) (collecting Agency decisions). Those decisions have offered 
multiple bases and analyses for that conclusion. 86 FR at 33744-45. I 
agree with my predecessors' conclusions that a provision of 21 U.S.C. 
824 may be the basis for the denial of a practitioner registration 
application, and that the 21 U.S.C. 823 factors remain relevant to the 
adjudication of a practitioner registration application when a 
provision of 21 U.S.C. 824 is involved. Id.

B. The Material Falsification Allegations

    Regarding 21 U.S.C. 824(a)(1), the Agency recently addressed the 
elements of a material falsification concluding, among other things, 
that Kungys v. United States, 485 U.S. 759 (1988), and its recent 
progeny remain consistent with the CSA. Frank Joseph Stirlacci, M.D., 
85 FR 45229, 45238 (2020). According to the Supreme Court, material 
means having `a natural tendency to influence, or was capable of 
influencing, the decision of the decisionmaking body to which it was 
addressed.'' Id. (citing Kungys, 485 U.S. at 771).
    The Government argues that, although Applicant correctly responded 
``yes'' to the third Liability question, ``when called upon to provide 
a `complete' explanation for her answer, she provided substantive 
information that was false . . . and concealed information that was 
true.'' Government's Proposed Findings of Fact, Conclusions of Law, and 
Argument, dated November 1, 2019, at 1. According to the Government, 
the ``substantive information that was false'' was that ``her state 
license had been subject to action in North Carolina in 2019,'' and the 
``concealed information that was true'' was that ``her state licenses 
had been subject to various disciplinary actions in Tennessee, Iowa, 
and Illinois in 2015.'' Id. In other words, the Government argues that 
Applicant's responses to the follow up engendered due to her ``yes'' 
response were false, on the one hand, and did not disclose responsive 
information that was true, on the other hand. Id. Consequently, I now 
address whether the North Carolina-based registration application was 
materially false according to the Kungys definition of ``material.''
    As already discussed, I find from clear, unequivocal, convincing, 
and unrebutted record evidence that Applicant answered ``yes'' to 
Liability questions two and three. Supra section II.F. In addition, as 
already discussed, I find from clear, unequivocal, convincing, and 
unrebutted record evidence that Applicant's ``yes'' answers to 
Liability questions two and three are true. Id. According to the record 
evidence that the Government submitted regarding Applicant's responses 
to the follow-up required due to her ``yes'' answers, I also find 
clear, unequivocal, convincing, and unrebutted record evidence that DI 
did not consider those responses false, but that DI considered that the 
information Applicant provided ``does not answer the question being 
asked.'' Id. I further find the Government did not submit clear, 
unequivocal, and convincing evidence about the online registration 
application process, including what information the online application 
elicits after an applicant responds ``yes'' to a Liability question. 
Id.
    As already discussed, I find from clear, unequivocal, convincing, 
and unrebutted record evidence that the DEA investigative team provided 
input and instructions to Applicant about the next DEA registration 
application she might submit during their meeting on January 31, 2019. 
Supra section II.F. In addition, as already discussed, I find from 
unrebutted record evidence that the DEA investigative team advised 
Applicant at that time that she may apply for a DEA registration at a 
registered location in North Carolina, cautioned Applicant, in the 
event she reapplies, to answer ``yes'' to the Liability questions she 
previously incorrectly answered in the negative, told Applicant that DI 
would handle any application she submitted for registration in North 
Carolina, and predicted that it would take two to three weeks for 
Applicant to get a new registration if she were to submit a complete 
and correct application.\13\ Id. Also, as already discussed, I do not 
find any record evidence rebutting Applicant's testimony that her 
responses to the second and third Liability questions' follow-up 
reflected the input and instructions she received from the DEA 
investigative team on January 31, 2019. Id. According to the arguments 
made by Applicant's counsel during the hearing, Applicant admits that 
her responses to the follow-up were incomplete and inadequate. Tr. 199. 
Applicant's counsel argued that Applicant did her best and what she 
thought she was supposed to do based on what she had been told in 
January. Id.
---------------------------------------------------------------------------

    \13\ Applicant submitted the North Carolina-based registration 
application on or about March 1, 2019, about a month after she met 
with the DEA investigative team. GX 1, at 1.
---------------------------------------------------------------------------

    As already mentioned, the found facts of this case are unique and 
not likely ever to recur. Based on those facts, Applicant's responses 
to the follow-up that ensued from her ``yes'' responses to two 
Liability questions did not have a ``natural tendency to influence'' 
and were not ``capable of influencing'' the Agency's decision regarding 
Applicant's North Carolina-based registration application because the 
responses stemmed from Applicant's meeting with the DEA investigative 
team on January 31, 2019. In addition, the Government did not submit 
evidence rebutting Applicant's evidence about what transpired during 
her meeting with the DEA investigative team on January 31, 2019. For 
these reasons, I credit Applicant's evidence about what the DEA 
investigative team told her during that meeting and what impact that 
had on the content of the North Carolina-based registration 
application. It would, therefore, be inappropriate for me to find a 
material falsification violation when the Government submitted no 
evidence rebutting Applicant's rendition of what the DEA investigative 
team told her that impacted the content of the North Carolina-based 
registration application.\14\ Supra section II.F.
---------------------------------------------------------------------------

    \14\ Given the unique found facts in this matter, my findings 
and conclusions do not impact prior Agency decisions stating, for 
example, that misinterpretation of the application does not relieve 
an applicant of the responsibility to read the question carefully 
and answer all parts of it honestly, or that negligence and 
carelessness in completing an application could be a sufficient 
reason to revoke a registration. See, e.g., Martha Hernandez, M.D., 
62 FR 61,145, 61,147 (1997) (finding that respondent submitted 
material falsifications that are grounds for revocation, but 
concluding that revocation is not an appropriate sanction in light 
of the facts and circumstances).
---------------------------------------------------------------------------

    Accordingly, on the unique and unlikely ever to recur record 
evidence before me, I find that the follow-up

[[Page 52203]]

responses Applicant provided in her North Carolina-based registration 
application were not ``predictably capable of affecting, that is, had a 
natural tendency to affect, the official decision'' of DEA given 
Applicant's unrebutted record evidence of the input and instructions 
she said she received during her meeting with the DEA investigative 
team on January 31, 2019.
    The Government has the burden of proof in this proceeding. 21 CFR 
1301.44. For the above-stated reasons, I find that the Government has 
failed to meet its burden. The record evidence does not include clear, 
unequivocal, and convincing evidence that Applicant materially 
falsified her North Carolina-based registration application. 21 U.S.C. 
824(a)(1); Frank Joseph Stirlacci, M.D., 85 FR 45,229 (2020). 
Accordingly, I am dismissing the OSC.
    However, as explained supra section II.B., Applicant is not 
currently ``authorized to dispense controlled substances under the laws 
of the State'' of North Carolina, I have no statutory authority to 
grant Applicant's North Carolina-based registration application. 21 
U.S.C. 823(f); 21 U.S.C. 802(21); supra section II.B.

Order

    Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 
U.S.C. 823(f) and 824(a), I hereby dismiss the Order to Show Cause 
issued to Lisa Mae Jones, N.P. Further, pursuant to 28 CFR 0.100(b) and 
the authority vested in me by 21 U.S.C. 823(f), in conjunction with 21 
U.S.C. 802(21), I deny Application No. W19018692M. This Order is 
effective October 20, 2021.

Anne Milgram,
Administrator.
[FR Doc. 2021-20241 Filed 9-17-21; 8:45 am]
BILLING CODE 4410-09-P