Notice2025-19576
Grace S. Joanita, N.P.; Decision and Order
Primary source
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Published
October 17, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 90 Issue 199 (Friday, October 17, 2025)</title>
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[Federal Register Volume 90, Number 199 (Friday, October 17, 2025)]
[Notices]
[Pages 48344-48346]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19576]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Grace S. Joanita, N.P.; Decision and Order
On February 6, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Grace S. Joanita,
N.P., of Cincinnati, Ohio (Registrant). Request for Final Agency Action
(RFAA), Exhibit (RFAAX) 1, Attachment (Attach.) F, at 1, 4. The OSC
proposed the revocation of Registrant's DEA registration, No.
MJ5209677, alleging that Registrant materially falsified her December
7, 2021 renewal application for registration. Id. at 2 (citing 21
U.S.C. 824(a)(1)).\1\
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\1\ The Government further alleged that Registrant committed
acts inconsistent with the public interest. RFAAX 1, Attach. F, at
1-2 (citing 21 U.S.C. 823(g)(1)(E)). However, due to the Agency's
finding that Registrant submitted a materially false application,
which serves as an independent basis for sanction under 21 U.S.C.
824(a)(1), the Agency declines to analyze the public interest
allegation.
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On July 5, 2023, the Government submitted an RFAA to the
Administrator requesting that the Agency issue a default final order
revoking Registrant's registration. RFAA, at 1-3. After carefully
reviewing the entire record and conducting the analysis as set forth in
detail below, the Agency finds that Registrant is in default and finds
that Registrant materially falsified her renewal application.
Accordingly, the Agency grants the Government's RFAA and revokes
Registrant's registration.
I. Default Determination
Under 21 CFR 1301.43, a registrant entitled to a hearing who fails
to file a timely hearing request ``within 30 days after the date of
receipt of the [OSC] . . . shall be deemed to have waived their right
to a hearing and to be in default'' unless ``good cause'' is
established for the failure. 21 CFR 1301.43(a), (c)(1). In the absence
of a demonstration of good cause, a registrant who fails to timely file
an answer also is ``deemed to have waived their right to a hearing and
to be in default.'' 21 CFR 1301.43(c)(2).
The OSC notified Registrant of her right to file a written request
for a hearing and an answer, and that if she failed to file such a
request and answer, she would be deemed to have waived her right to a
hearing and be in default.\2\ RFAAX 1, Attach. F, at 2-3 (citing 21 CFR
1301.43). Registrant did not request a hearing, file an answer, or
respond to the OSC in any way. RFAA, at 1-3. Accordingly, Registrant is
in default. 21 CFR 1301.43(c)(1); RFAA, at 1-3.
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\2\ Based on the Government's submissions in its RFAA dated July
5, 2023, the Agency finds substantial record evidence that service
of the OSC on Registrant was adequate. Specifically, the Declaration
from a DEA Diversion Investigator (DI) indicates that on February
10, 2023, DI served the OSC on Registrant in-person. RFAAX 1, at 3.
In addition to DI's Declaration regarding service, the
Government attached to the RFAA several substantive evidentiary
exhibits that relate to the OSC allegations. Because this matter is
a default, only the facts in the OSC are deemed to be admitted, and
any facts found based on supplementary information submitted by the
Government must be established by record evidence that meets the
appropriate evidentiary standard. See Victor Augusto Silva, M.D., 90
FR 16002, 16002 n.4 (2025) (finding that ``a registrant's deemed
admission of the factual allegations based on a default applies to
the facts in the OSC only''); see also Hayriye Gok, M.D., 90 FR
30266, 30266 n.2 (2025).
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``A default, unless excused, shall be deemed to constitute a waiver
of the [registrant's] right to a hearing and an admission of the
factual allegations of the [OSC].'' 21 CFR 1301.43(e). Because
Registrant is in default and has not moved to excuse the default, the
Agency finds that Registrant has admitted to the factual allegations in
the OSC. 21 CFR 1301.43(c)(1), (e), (f)(1).
Further, ``[i]n the event that [a registrant] . . . is deemed to be
in default . . . DEA may then file a request for final agency action
with the Administrator, along with a record to support its request. In
such circumstances, the Administrator may enter a default final order
pursuant to
[[Page 48345]]
[21 CFR] 1316.67.'' 21 CFR 1301.43(f)(1). Here, the Government has
requested final agency action based on Registrant's default pursuant to
21 CFR 1301.43(c), (f), and 1301.46. RFAA, at 1-3; see also 21 CFR
1316.67.
II. Material Falsification
A. Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are deemed admitted. 21 CFR 1301.43(e).
Accordingly, Registrant is deemed to have admitted to each of the
following facts.\3\ On or about December 7, 2021, Registrant submitted
a timely renewal application for her DEA registration, No. MJ5209677.
RFAAX 1, Attach. F, at 1. The renewal application requested information
regarding Registrant's fee exemption status. Id. at 1-2. Specifically,
the application requested the name, title, phone number, and email
address of a certifying official, and the name of a fee exempt
institution. Id. at 2. Registrant responded to the fee exemption
prompts, and provided the name of a certifying official for whom she
had not worked since November 20, 2019. Id. Based on the information
Registrant provided in response to the fee exemption prompts, her
registration was granted ``fee exempt'' status and she therefore did
not pay the required fee to renew her registration. Id. In December
2021, January 2022, and August 2022, DEA provided Registrant
opportunities to pay the required registration fee and fill out a
Change of DEA Fee Exemption Status form. Id. At the time the OSC was
issued, Registrant had not paid the required fee or filled out the
Change of DEA Fee Exemption Status form. Id.
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\3\ According to the Controlled Substances Act (CSA),
``[f]indings of fact by the [DEA Administrator], if supported by
substantial evidence, shall be conclusive.'' 21 U.S.C. 877. Here,
where Registrant is found to be in default, all the factual
allegations in the OSC are deemed to be admitted. These uncontested
and deemed admitted facts constitute evidence that exceeds the
``substantial evidence'' standard of 21 U.S.C. 877; it is unrebutted
evidence.
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B. Discussion
A DEA registration may be denied, suspended, or revoked upon a
finding that the applicant or registrant materially falsified any
application filed pursuant to or required by the Controlled Substances
Act (CSA). 21 U.S.C. 824(a)(1).\4\ To present a prima facie case for
material falsification, the Government's record evidence must show (1)
the submission of an application, (2) containing a false statement and/
or omitting information that the application requires, (3) when the
submitter knew or should have known that the statement is false and/or
that the omitted information existed and the application required its
disclosure, and (4) the false statement and/or required but omitted
information is material, that is, it ``connect[s] to at least one of
[the section 823] factors that, according to the CSA, [the
Administrator] `shall' consider'' when analyzing ``whether issuing a
registration `would be inconsistent with the public interest.' '' Frank
Joseph Stirlacci, M.D., 85 FR 45229, 45238 (2020) (citing 21 U.S.C. 823
and Kungys, 485 U.S. at 771); see also Sasha Melissa Ikramelahai, 90 FR
32017, 32019 (2025); Michael Bouknight, 90 FR 31247, 31249 (2025).
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\4\ A statutory basis to deny an application pursuant to section
823 is also a basis to revoke or suspend a registration pursuant to
section 824, and vice versa, because doing ``otherwise would mean
that all applications would have to be granted only to be revoked
the next day . . . .'' Robert Wayne Locklear, M.D., 86 FR 33738,
33744-45 (2021) (collecting cases).
The Supreme Court's decision in Kungys v. United States, 485
U.S. 759 (1988), and its progeny, guide the Agency's implementation
of these CSA provisions.
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Regarding materiality, Kungys holds that a statement is material if
it is ``predictably capable of affecting, i.e., had a natural tendency
to affect, the [Agency's] official decision,'' or stated differently,
``had a natural tendency to influence the decision.'' Kungys, 485 U.S.
at 771-72. As already discussed, materiality, for the purposes of the
CSA, is tied to the factors that the Administrator ``shall'' consider
when determining whether issuance of a registration ``would be
inconsistent with the public interest.'' 21 U.S.C. 823; Kungys, 485
U.S. at 771-72; Stirlacci, 85 FR at 45234, 45238.
The Government has the burden of proof in this proceeding. 21 CFR
1301.44. The Government must establish material falsification with
record evidence that is clear, unequivocal, and convincing. Kungys, 485
U.S. at 772; Stirlacci, 85 FR at 45230-39. Here, the Agency finds that
the Government's clear, unequivocal, and convincing record evidence
presents a prima facie case that Registrant submitted a materially
false application. 21 U.S.C. 823, 824(a)(1).
As the Agency finds above, Registrant submitted a renewal
application for DEA registration and the application requested
information regarding exemption from paying the required fee. RFAAX 1,
Attach. F, at 2; see also 21 CFR 1301.13(e) (setting forth the fee
schedule); 21 CFR 1301.21 (setting forth the conditions for fee
exemption). Registrant responded to the fee exemption prompts and
provided employment information--specifically, the name of a certifying
official--that was false at the time she submitted her renewal
application, because she had not worked for that certifying official in
over two years. RFAAX 1, Attach. F, at 2. By responding to the fee
exemption prompts, Registrant falsely represented that she was entitled
to fee exemption. Id. In other words, on her renewal application,
Registrant claimed to meet the regulatory requirements for a fee
exemption by representing that she worked for a certifying official for
whom she did not work for at the time, and she knew or should have
known that she did not work for the certifying official when she
submitted her application. Id.; see also Ikramelahai, 90 FR at 32020
(finding registrant created the false impression that she possessed a
state license when, in fact, it belonged to a different practitioner).
Thus, Registrant's renewal application contained false statements.
In addition, the false statements were material. Specifically,
Registrant's falsities are connected to public interest factor D, under
which DEA considers an applicant's compliance or non-compliance with
Federal laws relating to controlled substances. 21 U.S.C. 823(g)(1)(D).
DEA's registration and renewal process are governed by the CSA and its
implementing regulations--in other words, Federal laws which relate to
controlled substances. In applying for a DEA registration or renewing a
DEA registration, an applicant or registrant must comply with Federal
laws that govern the issuance and renewal of controlled substance
registrations. See, e.g., 21 U.S.C. 821 (authorizing the Attorney
General to promulgate regulations and charge fees relating to the
registration and dispensing of controlled substances); 21 U.S.C.
822(a)(2) (``Every person who dispenses, or who proposes to dispense,
any controlled substance, shall obtain from the Attorney General a
registration issued in accordance with the rules and regulations
promulgated by him.''); 21 U.S.C. 823(g)(1) (setting forth the factors
that the Attorney General must consider when determining whether to
grant or deny a registration); 21 CFR 1301.13 (establishing application
requirements, including registration fees tied to specific regulated
activities); 21 CFR 1301.21 (setting forth conditions for fee
exemption); Gonzales v. Raich, 545 U.S. 1, 14 (2005) (``The CSA and its
implementing regulations set forth strict requirements regarding
registration
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. . . .''). Thus, evaluating an applicant's or registrant's compliance
with the Federal laws that govern registration and renewal, including
DEA's fee schedule and fee exemptions, is appropriately considered
under factor D.\5\ 21 U.S.C. 823(g)(1)(D).
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\5\ To be clear, the Agency is not finding that Registrant
violated the above-referenced portions of the CSA or its
implementing regulations. This information is presented to give
context to the materiality of Registrant's falsification. The
Agency's only finding against Registrant is that she materially
falsified a renewal application which is grounds for revocation
under 21 U.S.C. 824(a)(1).
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Accordingly, making a false statement regarding entitlement to fee
exemption has a natural tendency to influence the Agency's decision
regarding whether issuance of a registration ``would be inconsistent
with the public interest.'' 21 U.S.C. 823; Kungys, 485 U.S. at 771-72;
Stirlacci, 85 FR at 45234, 45238; RFAAX 1, Attach. F, at 1-2.
Therefore, the falsities in Registrant's application were ``predictably
capable of affecting'' DEA's decision to renew her registration, and
therefore the Agency finds that they were material. Kungys, 485 U.S. at
771-72.
In sum, the Agency finds clear, unequivocal, and convincing record
evidence, based on Registrant's admissions, that she submitted a
materially false renewal application for registration. 21 U.S.C.
824(a)(1); 21 CFR 1301.43(e).
As a result of this established violation, the Agency finds that
the Government has established a prima facie case for sanction, that
Registrant did not rebut that prima facie case, and that there is
clear, unequivocal, and convincing record evidence supporting the
revocation of Registrant's registration. 21 U.S.C. 824(a)(1).
C. Sanction
Where, as here, the Government has presented a prima facie case
showing that Registrant submitted a materially false application for
registration renewal, the burden shifts to Registrant to show why she
can be trusted with a registration. Morall v. Drug Enf't Admin., 412
F.3d 165, 181 (D.C. Cir. 2005); Jones Total Health Care Pharmacy, LLC
v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Garrett
Howard Smith, M.D., 83 FR 18882, 18904 (2018). The issue of trust is a
fact-dependent determination based on the circumstances presented by
the individual practitioner. Jeffrey Stein, M.D., 84 FR 46968, 46972
(2019); see also Jones Total Health Care Pharmacy, 881 F.3d at 833.
Historically, the Agency has considered acceptance of responsibility,
egregiousness, and deterrence when making this assessment.
Specifically, the Agency requires the practitioner to accept
responsibility for his or her violation. Jones Total Health Care
Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't Admin., 54
F.3d 450, 452 (7th Cir. 1995). Acceptance of responsibility must be
unequivocal. Janet S. Pettyjohn, D.O., 89 FR 82639, 82641 (2024);
Mohammed Asgar, M.D., 83 FR 29569, 29573 (2018); see also Jones Total
Health Care Pharmacy, 881 F.3d at 830-31.
In addition, the Agency considers the egregiousness and extent of
the misconduct in determining the appropriate sanction. Jones Total
Health Care Pharmacy, 881 F.3d at 834 & n.4. The Agency also considers
the need to deter similar acts by Registrant, by current registrants,
and by future applicants for registration. Stein, 84 FR at 46972-73.
Here, Registrant did not timely request a hearing, or timely or
properly answer the allegations, and was therefore deemed to be in
default. 21 CFR 1301.43(c)(1), (e), (f)(1); RFAA, at 1-3. To date,
Registrant has not filed a motion with the Office of the Administrator
to excuse the default. 21 CFR 1301.43(c)(1). Registrant has thus failed
to answer the allegations contained in the OSC and has not otherwise
availed herself of the opportunity to refute the Government's case. As
such, Registrant has not accepted responsibility for the proven
violations, has made no representations regarding her future compliance
with the CSA, and has not made any demonstration that she can be
trusted with registration.
Moreover, the evidence presented by the Government shows that
Registrant provided false information regarding her fee exempt status.
Providing false information as part of an application process for
controlled substance privileges governed by Federal law calls into
question Registrant's honesty, trustworthiness, and ability or
willingness to comply with the laws governing controlled substances. To
permit Registrant to maintain a registration under these circumstances
would send a dangerous message that DEA does not expect compliance with
its registration requirements and that the registration fees required
by statute and regulation can be circumvented without consequence by
making false statements. Registrant and the regulated community must be
on notice that DEA's registration and renewal process, to include the
required fees, is governed by Federal law, that DEA will strictly
enforce those Federal laws, and that DEA expects applicants and
registrants to adhere to those Federal laws.
Accordingly, the Agency will order the revocation of Registrant's
registration.
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 No.
MJ5209677 issued to Grace S. Joanita, N.P. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Grace S. Joanita, N.P., to
renew or modify this registration, as well as any other pending
application of Grace S. Joanita, N.P., for additional registration in
Ohio. This Order is effective November 17, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
October 1, 2025, by Administrator Terrance Cole. 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. 2025-19576 Filed 10-16-25; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on October 17, 2025.
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