[Federal Register Volume 89, Number 180 (Tuesday, September 17, 2024)]
[Notices]
[Pages 76152-76156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21051]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 23-53]
George D. Gowder, III, M.D.; Decision and Order
On July 18, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to George Gowder, III,
M.D., of Blairsville, Georgia (Respondent). OSC, at 1, 3. The OSC
proposed the denial of Respondent's application for a DEA Certificate
of Registration (registration), Control No. W22147308C, alleging that
Respondent has been convicted of a felony relating to Federal
controlled substance laws, and that he has been excluded from
participation in Medicare, Medicaid, and all Federal health care
programs. Id. at 1-2 (citing 21 U.S.C. 823(g)(1), 824(a)(2),
824(a)(5)).
A hearing was held before DEA Administrative Law Judge Teresa A.
Wallbaum (ALJ), who, on December 1, 2023, issued her Recommended
Rulings, Findings of Fact, Conclusions of Law, and Decision
(Recommended Decision or RD). The RD recommended that
[[Page 76153]]
Respondent's application be granted with restrictions.\1\ RD, at 20-21.
The Government filed Exceptions to the RD. Having reviewed the entire
record, the Agency adopts and hereby incorporates by reference the
entirety of the ALJ's rulings, credibility findings,\2\ findings of
fact, and conclusions of law, and expands upon portions thereof herein.
However, the Agency has determined based on Respondent's unequivocal
acceptance of responsibility and his fulsome demonstration of
remediation that Respondent can be trusted with an unencumbered
registration for Schedules III through V.
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\1\ The ALJ recommended that Respondent be required to submit to
regular drug testing, refrain from taking controlled substances that
are not lawfully prescribed, and hire a practice monitor to monitor
his prescribing practices and submit regular reports to DEA. RD, at
20-21. The ALJ also recommended that Respondent's registration be
limited to Schedules III through V. Id. As noted herein, Respondent
only applied for authority in Schedules III through V.
\2\ The Agency adopts the ALJ's summary of each of the
witnesses' testimonies as well as the ALJ's assessment of each of
the witnesses' credibility. See RD, at 3-10. The Agency agrees with
the ALJ that the testimony from the DEA Diversion Investigator (DI),
which was primarily focused on the introduction of the Government's
documentary evidence, was ``sufficiently detailed, plausible, and
internally consistent to be afforded full credibility.'' Id. at 5.
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I. Findings of Fact
A. Felony Conviction
On June 10, 2020, Respondent pled guilty to one count of
``Dispensing Controlled Substances Outside Professional Practice'' in
violation of 21 U.S.C. 841(a) and 841(b)(1)(C), and he was sentenced to
18 months in prison. RX 2, at 1; RD, at 8; Tr. 8. After serving 15
months in prison, he was placed on two years of supervised release. RD,
at 8; Tr. 89-91. Respondent served one year of supervised release, but
was released from the second. RD, at 8; Tr. 91-92.
Respondent's Federal conviction was the culmination of more than a
decade of diverting controlled substances for personal use.\3\ RD, at
5-6. Respondent testified that he began taking opioids in the early
2000s after they were lawfully prescribed for a back injury. Id. at 6;
Tr. 55. Respondent testified that, after finishing that prescription,
he would occasionally ``reward'' himself by taking an opiate sample
from the emergency room where he worked. RD, at 6; Tr. 55-56, 59. He
would take an opiate once a month, which then progressed to once every
two weeks. RD, at 6; Tr. 58-59. Respondent testified that his
progression ``from a user to an addict'' took at least two or three
years. RD, at 6; Tr. 59-60. Respondent abused oxycodone and hydrocodone
in pill form. Id. Respondent testified that when he became addicted to
opiates, he ``started doing things [he] would never ha[ve] thought [he]
would do,'' including forging prescriptions and stealing drugs from
patients. RD, at 6; Tr. 60. Respondent explained that he forged
prescriptions in two different ways. RD, at 7-8; Tr. 85. First, he
wrote prescriptions for himself and forged another physician's name and
DEA number. Id. Second, he wrote prescriptions purportedly for a
homebound patient, went to the pharmacy to have the prescriptions
filled, and used the drugs himself. RD, at 8; Tr. 85-86.
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\3\ The Agency agrees with the ALJ that ``Respondent testified
clearly, candidly, and without hesitation,'' notwithstanding that he
``unarguably possesses . . . the greatest motivation to enhance,
modify, or even fabricate his testimony.'' RD, at 9. Respondent
``did not shy away from difficult questions and his answers
contained no caveats or attempts to minimize his behavior,'' and in
fact, the primary details regarding his fraudulent conduct came from
Respondent's testimony and exhibits. Id. at 9-10. Therefore, the
Agency agrees with the ALJ that Respondent's testimony should be
``afforded full credibility.'' Id. at 10.
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Respondent's misconduct led to a series of arrests by local law
enforcement in 2015 and 2016, which resulted in charges for
prescription forgery. RD, at 6-7; Tr. 62-68. After the first arrest in
April of 2015, Respondent entered a residential treatment center for
three months, and has remained drug-free since. See supra III.B; RD, at
8; Tr. 93. While in recovery, local law enforcement referred his case
to Federal law enforcement and Federal charges were brought. RD, at 7;
Tr. 69-70. Respondent ultimately pled guilty and was federally
convicted in June of 2020. RD, at 7; Tr. 64, 70, 79.
B. Exclusion From Medicare
The Department of Health and Human Services (HHS) notified
Respondent by letter on October 29, 2021, that he would be ``exclud[ed]
from participation in all Federal health care programs . . . for a
minimum period of [seven] years.'' GX 3, at 1. The letter notified
Respondent that the exclusion was a result of Respondent's ``felony
conviction . . . related to the unlawful manufacture, distribution,
prescription, or dispensing of a controlled substance.'' Id. The letter
also notified Respondent that his period of exclusion exceeded the
minimum exclusion period of five years because his criminal sentence
included prison time, and because the Georgia Composite Medical Board
(Medical Board) had taken additional adverse action against Respondent
by suspending his medical license.\4\ Id. HHS considered these factors
to be ``aggravating circumstances.'' Id. The seven-year exclusion
period became effective on November 18, 2021. Id.
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\4\ Respondent regained his state medical license in October of
2022. RD, at 6; Tr. 53.
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II. Discussion
The Government alleged two independent grounds for denial: (1) that
Respondent has been convicted of a felony relating to controlled
substances, 21 U.S.C. 824(a)(2), 823(g)(1), and (2) that Respondent has
been excluded from participation in all Federal health care programs,
id. sections 824(a)(5), 823(g)(1). OSC, at 1-2. Having reviewed the
record and the RD, the Agency agrees with the ALJ, adopts the ALJ's
analysis, and finds that the Government has satisfied its prima facie
burden of demonstrating that both grounds for denial exist. Id. at 10-
12.
A. Felony Conviction
Pursuant to 21 U.S.C. 824(a)(2), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the
Controlled Substances Act (CSA) ``upon a finding that the registrant .
. . has been convicted of a felony . . . relating to any . . .
controlled substance.'' 21 U.S.C. 824(a)(2). The Agency has
consistently held that it also may deny an application for a DEA
registration upon finding that the registrant has been convicted of a
felony relating to controlled substances. Arvinder Singh, M.D., 81 FR
8247, 8248 n.3 (2016) (quoting Kwan Bo Jin, M.D., 77 FR 35021, 35021
n.2 (2012)) (``[W]here a registration can be revoked under [21 U.S.C.]
824, it can, a fortiori, be denied under [21 U.S.C. ] 823 since the law
would not require an agency to indulge in the useless act of granting a
license on one day only to withdraw it on the next.''). Here, the
undisputed and substantial record evidence demonstrates that Respondent
has been convicted of a felony relating to controlled substances. OSC,
at 10-11. RD, at 11; GX 2; RX 1, at 3-4; Tr. 87-88.
B. Exclusion From Medicare
Respondent's application also may be denied ``upon a finding that
the registrant . . . has been excluded (or directed to be excluded)
from participation in a program pursuant to section 1320a-7(a) of Title
42.'' 21 U.S.C. 824(a)(5), 823(g)(1); Arvinder Singh, 81 FR 8248 n.3.
Here, the undisputed and substantial record evidence demonstrates that
HHS
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mandatorily excluded Registrant from ``all Federal health care
programs'' under 42 U.S.C. 1320a-7(a)(4). RD, at 11; GX 3; ALJX 14, at
2; Tr. 30-31.
III. Sanction
Where, as here, the Government has established sufficient grounds
to deny a Respondent's application, the burden shifts to the registrant
to show why he can be entrusted with the responsibility carried by a
registration. Garret Howard Smith, M.D., 83 FR 18882, 18904 (2018).
When a registrant has committed acts inconsistent with the public
interest, he must both accept responsibility and demonstrate that he
has undertaken corrective measures. Holiday CVS, L.L.C., dba CVS
Pharmacy Nos 219 and 5195, 77 FR 62316, 62339 (2012). Trust is
necessarily a fact-dependent determination based on individual
circumstances; therefore, the Agency looks at factors such as the
acceptance of responsibility, the credibility of that acceptance as it
relates to the probability of repeat violations or behavior, the nature
of the misconduct that forms the basis for sanction, and the Agency's
interest in deterring similar acts. See, e.g., Robert Wayne Locklear,
M.D., 86 FR 33738, 33746 (2021).
A. Acceptance of Responsibility
Here, the Agency agrees with the ALJ that Respondent unequivocally
accepted responsibility for his conduct. RD, at 12-14. Respondent took
every opportunity to acknowledge that his conduct was wrong and he made
no efforts to minimize it. Id. at 13. He admitted that he was guilty of
dispensing controlled substances outside of his professional practice
because he forged prescriptions and fraudulently filled his patients'
prescriptions for his own use. RD, at 13; Tr. 84-85. Respondent
testified that he did not want to defend or glorify his conduct, and
stated that ``it is a shameful, morally bad place to be.'' RD, at 13;
Tr. 56, 84-86. He also acknowledged that he ``abused the public trust
as a physician.'' RD, at 13; Tr. 83. Respondent testified that he has
``been completely honest'' about his behavior and conduct ``with every
single person that [he has] spoken to whether it's law enforcement,
whether in the legal system, [or] in treatment.'' Tr. 89-90. Respondent
testified that the judge presiding over his criminal sentencing hearing
``spoke highly'' of him, and noted his acceptance of responsibility and
willingness to cooperate.\5\ RD, at 8; Tr. 80. Accordingly, the Agency
agrees with the ALJ that Respondent unequivocally accepted
responsibility for his misconduct,\6\ RD, at 12-14, and commends
Respondent for his willingness to candidly reflect on his battle with
addiction in a public forum.
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\5\ Respondent's credible, unchallenged testimony regarding his
acceptance of responsibility in his criminal proceedings weighs in
his favor. See Michele L. Martinho, M.D., 86 FR 24012, 24020 n.*E
(2021) (citing Mohammed Asgar, 83 FR 29569, 29573 n.3 (2018)) (An
AUSA or Judge's comments regarding a respondent's acceptance of
responsibility during criminal proceedings are not binding on the
Agency, but they are relevant evidence).
\6\ The Government seems to acknowledge in its Post-hearing
Brief that Respondent accepted responsibility for his conduct. ALJX
23, at 25.
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B. Remedial Measures
Having found that Respondent has unequivocally accepted
responsibility for his conduct, the Agency considers whether Respondent
has implemented sufficient remedial measures to demonstrate that he
will not engage in future misconduct and can be trusted with a
registration. Jayam Krishna-Iyer, M.D., 74 FR 459, 463 (2009). The
Agency has acknowledged that ``[i]n self-abuse cases, . . . successful
rehabilitation efforts are an important consideration in determining
whether a respondent can be trusted with a registration.'' Trenton F.
Horst, D.O., 80 FR 41079, 41091 (2015); see also Abbas E. Sina, M.D.,
80 FR 53191, 53201 (2015) (``[T]he risk of relapse becomes critical in
determining what steps are warranted when determining the public
interest.'').
Respondent provided extensive testimony regarding his recovery and
his efforts to remain sober. RD, at 15; Tr. 106-108, 109-110. After his
first arrest in April of 2015, he entered a residential treatment
center for three months. RD, at 8; Tr. 93. He went into treatment
partially because he knew he would not be able to regain his medical
license without receiving treatment. RD, at 8; Tr. 94-95. After
completing residential treatment, Respondent entered a ``Chemical
Addiction Monitoring Agreement'' with the Georgia Professional Health
Program (PHP). RD, at 8-9; RX 2, at 1. The agreement required him to
submit to random drug tests and attend self-help meetings, small-group
counseling sessions, and meetings with other physicians in the PHP. RD,
at 9; Tr. 96-97; RX 2, at 1-3. The initial agreement lasted for five
years, and he completed it before entering Federal prison in July of
2020. RD, at 9; Tr. 107-09; RX 2, at 1. Respondent was not monitored by
the PHP during his incarceration. RD, at 9; Tr. 108-109. Respondent
entered a second agreement with the PHP in September of 2022, which
required him to continue to attend various meetings and submit to
random drug tests. RD, at 9; Tr. 107-08; RX 2, at 9-17. Respondent
testified that he entered the new agreement because he wanted ``to do
whatever [the] Georgia PHP felt was needed for [him] to be a reliable
physician,'' but that he also had an ``overwhelming desire not to fall
back into addiction.'' RD, at 15; Tr. 106. Because Respondent does ``a
good bit'' more than is required by the Georgia PHP agreement, he was
recently transitioned to a ``senior monitoring agreement,'' which still
requires him to submit to random drug tests. RD, at 9, 15; Tr. 111-12.
Respondent testified that he plans to remain under the supervision
of the Georgia PHP even if he is no longer required to do so to
maintain his medical license. RD, at 15; Tr. 112. He also plans to
continue taking random drug tests, because even though there is ``no
part of [him] that wants to take a drug[,] . . . the statistics [are]
brutal on relapses,'' so he ``[cannot] imagine what would possess [him]
to not continue to be accountable to a urine drug test.'' RD, at 15-16;
Tr. 112. Respondent testified that drug testing is one of the best
tools to reduce the likelihood of remission. RD, at 16; Tr. 112.
Respondent testified that he has taken hundreds of drug tests, and that
there has only been one one-month period since April of 2015 that he
has not been subject to random drug tests. Tr. 97. Respondent testified
that he has never failed a drug test and that he has remained drug-free
since entering treatment in April of 2015. Id.
Perhaps the most concrete remedial measure that Respondent has
taken--which addresses both his addiction and the prescription
forgery--is that he applied for a registration to dispense drugs only
in Schedules III through V. Id. at 16; Tr. 37; 114-115; GX 4, at 1.
Respondent testified that he does not want authority to prescribe
Schedule II drugs because those are the drugs that he previously
abused. RD, at 16; Tr. 85-86, 114-115.
Respondent believes that he can be trusted with a registration
because of his understanding of addiction and his understanding of how
doctors can abuse their power to write prescriptions. RD, at 16; Tr.
119. According to Respondent, with this knowledge, he is safer writing
prescriptions than the majority of physicians. Id. Respondent requests
authority to prescribe controlled substances in Schedules III through V
so that he can work in an inpatient treatment facility that manages
medical detoxification and treats patients with ongoing chronic
illnesses, such as
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diabetes or mental health issues. RD, at 6; Tr. 58, 124. Respondent
currently volunteers as a physician at a long-term recovery center
where he is not required to possess a DEA registration. RD, at 5; Tr.
57, 123.
Analysis of Respondent's remedial measures is particularly complex.
On one hand, the weight of the remedial evidence is reduced because the
measures were not implemented until after Respondent was arrested, and
many of these measures are mandatory under an agreement with the
Medical Board.\7\ RD, at 15; Tr. 107. On the other hand, Respondent has
made a sincere commitment to remaining drug-free for himself and for
his family, and has gone above and beyond the Medical Board's
requirements to ensure he does so. RD, at 15; Tr. 111. For example,
Respondent's application seeks only to handle drugs in Schedules III
through V to ensure that he does not have access to the Schedule II
drugs that he abused in the past. RD, at 16; Tr. 85-86, 114-115. With
these extensive remedial measures Respondent has remained sober for
approximately nine years. Accordingly, the ALJ found, and the Agency
agrees, that Respondent can be trusted with a DEA registration. RD, at
16.
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\7\ The Agency has held that remedial measures are given
``limited-to-no-weight'' when they are implemented after enforcement
begins. See, e.g., Morris & Dickson Co., LLC, 88 FR 34523, 34539-40
(2023) (citing Mireille Lalanne, M.D., 78 FR 47750, 47777 (2013)
(``The Agency has recognized that a cessation of illegal behavior
only when `DEA comes knocking at one's door,' can be afforded a
diminished weight borne of its own opportunistic timing.'');
Southwood Pharmaceuticals, Inc., 72 FR 36487, 36503 (2007) (giving
no weight to respondent's ``stroke-of-midnight decision'' to cease
supplying suspect pharmacies with controlled substances and to
employ a compliance officer). This principle applies in even greater
force here, where the remedial measures that Respondent has
implemented appear to be mandatory under an agreement with the state
medical board, rather than voluntary.
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C. Deterrent Effect and Egregiousness
Acceptance of responsibility and remedial measures are assessed in
the context of the ``egregiousness of the violations and the [DEA's]
interest in deterring similar misconduct by [the] Respondent in the
future as well as on the part of others.'' Daniel A. Glick, D.D.S., 80
FR 74800, 74810 (2015); OakmontScript Limited Partnership, 87 FR 21516,
21545 (2022). Because these administrative proceedings are intended to
be remedial, rather than punitive, the Agency has previously found
that, under appropriate circumstances, ``criminal convictions and
sanctions by state licensing authorities can sufficiently deter
physicians from engaging in misconduct, making the denial of an
application . . . unnecessary to achieve the goal of general
deterrence.'' Gilbert Y. Kim, D.D.S., 87 FR 21139, 21145 (2022) (citing
Kansky J. Delisma, M.D., 85 FR 23845, 23854 (2020)). The Agency has
also held that, sometimes, ``such punitive measures can suffice to
deter the registrant or applicant from future misconduct, making
revocation or denial of an application unnecessary to achieve specific
deterrence.'' Id.
Here, the Agency does not find that imposing a sanction is
necessary to deter Respondent from engaging in future misconduct.
Respondent has already faced significant legal consequences for his
misconduct, including multiple arrests, jailtime, supervised release,
and the loss of his state medical license and DEA registration.
Respondent has also undergone significant monitoring to recover and
maintain his state medical license, including taking hundreds of random
drug tests and attending frequent substance abuse meetings. RD, at 9;
Tr. 96-97; RX 2, at 1-3. Respondent testified that the consequences of
his unlawful behavior have hurt him and his family. Tr. 131. Thus, the
Agency finds that the punitive, remedial, and personal consequences
that Respondent has suffered are sufficient to deter him from engaging
in future misconduct, especially given Respondent's strong personal and
professional commitment to remaining drug-free. Respondent's commitment
to sobriety is a strong deterrent to future misconduct, as Respondent
testified that the only reason that he engaged in the fraudulent
conduct that led to the felony conviction and Medicare exclusion was to
feed his personal addiction. RD, at 6; Tr. 60. Respondent's decision
not to request authority to prescribe the Schedule II drugs that he
previously abused is also a significant deterrent. RD, at 16; Tr. 85-
86, 114-115. Moreover, there is no evidence that Respondent has
committed any additional CSA violations since entering treatment in
April of 2015, which bolsters the Agency's conclusion that Respondent
has been sufficiently deterred from future violations.
The Agency also finds that the significant consequences that
Respondent has faced are sufficient to deter the general registrant
community from committing similar misconduct of forging prescriptions
and diverting controlled substances for personal use. This Decision
should signal to the registrant community that CSA violations are
likely to result in serious legal consequences--as Respondent
confronted a protracted legal battle with local and Federal law
enforcement, state regulators, and DEA as a result of his misconduct.
But this Decision should also demonstrate to registrants recovering
from addiction that, by accepting responsibility, remediating their
actions, demonstrating sustained success with sobriety and conveying a
strong commitment to remaining sober, cooperating with state and
Federal enforcers, and demonstrating candor during enforcement
proceedings, they may be shown leniency.
Regarding egregiousness, there is no dispute that the conduct that
led to Respondent's conviction and subsequent exclusion from all
Federal health care programs was egregious.\8\ RD, at 17. Respondent
admitted to using extra samples at the hospital where he worked,
forging prescriptions using other physicians' DEA registrations, and
writing prescriptions with his own DEA registration purportedly for
home-bound patients. Id. Indeed, such cases of fraud and forgery are
particularly egregious because Respondent used his knowledge as a DEA
registrant to circumvent the closed system of distribution, and he
diverted powerful Schedule II controlled substances. Id. ``These are
actions that strike at the very heart of the responsibilities entrusted
to a DEA registrant . . . .'' Id. (citing Jana Marjenhoff, D.O., 80 FR
29067, 29095 (2015)).
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\8\ The Government argues in its Exceptions that ``the
egregiousness of Respondent's conduct supports denial and outweighs
any acceptance of responsibility or proposed remedial measures.''
Government's Exceptions, at 4. The Agency agrees with the Government
that Respondent's conduct was egregious, but finds that other
factors discussed throughout this Decision obviate the need for a
sanction in this case.
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However, the evidence overwhelmingly suggests that Respondent has
unequivocally accepted responsibility, is remorseful for his conduct,
has taken efforts to help others recover from addiction, and
rehabilitated himself even before he was convicted and required to
serve his time. He has also taken steps to reduce the likelihood of
recurrence by limiting his application to drugs in Schedules III
through V that he has never abused. In other words, Respondent has
presented convincing evidence to demonstrate that the Agency can trust
him with a registration.\9\ Therefore, the Agency will grant his
application.
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\9\ For all of the reasons set forth herein, the Agency finds
that it can fully trust Respondent with a registration. The Agency
therefore finds that the ALJ's recommended conditions on
Respondent's registration are unnecessary. RD, at 20-21. However,
the Agency's trust can be lost in the event of a relapse, so the
Agency encourages Respondent to stick to his plan to continue taking
random drug tests. As Respondent testified, ``the statistics [are]
brutal on relapses,'' and drug testing is one of the best tools to
reduce the likelihood of remission. RD, at 15-16; Tr. 112.
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[[Page 76156]]
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823 and 824, I hereby dismiss the Order to Show Cause issued to
George Gowder, III, M.D., and grant Respondent's application number
W22147308C in Schedules III through V. This Order is effective
immediately.
Signing Authority
This document of the Drug Enforcement Administration was signed on
September 11, 2024, by Administrator Anne Milgram. That document with
the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2024-21051 Filed 9-16-24; 8:45 am]
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