Federal Register / Vol. 89, No. 197 / Thursday, October 10, 2024 / Notices 82259 

2All contract personnel will sign appropriate 

nondisclosure agreements. 

3Electronic Document Information System 

(EDIS): https://edis.usitc.gov 

1Effective December 2, 2022, the Medical 

Marijuana and Cannabidiol Research Expansion 

Act, Pub. L. 117–215, 136 Stat. 2257 (2022) 

(Marijuana Research Amendments or MRA), 

amended the Controlled Substances Act (CSA) and 

other statutes. Relevant to this matter, the MRA 

redesignated 21 U.S.C. 823(f), cited in the OSC, as 

21 U.S.C. 823(g)(1). Accordingly, this Decision cites 

to the current designation, 21 U.S.C. 823(g)(1), and 

to the MRA-amended CSA throughout. 

2Prior Agency decisions have addressed whether 

it is appropriate to consider a provision of 21 U.S.C. 

824(a) when determining whether to grant a 

practitioner registration application. For over fortyfive years, Agency decisions have concluded that it 

is. Robert Wayne Locklear, M.D., 86 FR 33738, 

33744–45 (2021) (collecting cases); see also Dinorah 

Drug Store, Inc., 61 FR 15972, 15973–74 (1996). 

3Based on the Government’s submissions in its 

RFAA dated July 3, 2023, the Agency finds that 

service of the OSC on Applicant was adequate. 

Specifically, the included Declaration of a DEA 

Diversion Investigator indicates that on January 30, 

2023, Applicant was personally served with the 

OSC. RFAAX 1, at 2. 

4Within the document where Applicant 

withdrew his request for hearing, Applicant’s 

counsel indicated that Applicant would ‘‘continue 

with the Corrective Action Plan route that was 

parallel to the litigation path, but unrelated to the 

hearing.’’ Id. at 1. 

5See also 21 CFR 1301.43(f)(3) (‘‘A party held to 

be in default may move to set aside a default final 

order issued by the Administrator by filing a motion 

no later than 30 days from the day of issuance by 

the Administrator of a default final order. Any such 

motion shall be granted only upon a showing of 

good cause to excuse the default.’’) Any motion to 

set aside a default and any response shall be filed 

and served by email to the other party and to Office 

of the Administrator, Drug Enforcement 

Administration at dea.addo.attorneys@dea.gov. 

personnel,2 solely for cybersecurity 

purposes. All nonconfidential written 

submissions will be available for public 

inspection at the Office of the Secretary 

and on EDIS.3

This action is taken under the 

authority of section 337 of the Tariff Act 

of 1930, as amended (19 U.S.C. 1337), 

and of §§ 201.10 and 210.8(c) of the 

Commission’s Rules of Practice and 

Procedure (19 CFR 201.10, 210.8(c)). 

By order of the Commission. 

Issued: October 7, 2024. 

Lisa Barton, 

Secretary to the Commission. 

[FR Doc. 2024–23444 Filed 10–9–24; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Salman Akbar, M.D.; Decision and 

Order 

On January 27, 2023, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause (OSC) to Salman Akbar, M.D., of 

Richmond, Virginia (Applicant). 

Request for Final Agency Action 

(RFAA), Exhibit (RFAAX) 1, Attachment 

E, at 1, 4. The OSC proposed the denial 

of Applicant’s application for a DEA 

Certificate of Registration (registration), 

Control No. W22109452C, alleging that 

Applicant has committed acts that 

would render his registration 

inconsistent with the public interest. Id. 

at 1, 2 (citing 21 U.S.C. 823(g)(1),1

824(a)(4) 2). 

The OSC notified Applicant of his 

right to file with DEA a written request 

for hearing, and that if he failed to file 

such a request, he would be deemed to 

have waived his right to a hearing and 

be in default. Id. at 2 (citing 21 CFR 

1301.43). Here, Applicant filed a timely 

answer and request for hearing on 

February 28, 2023,3 but ultimately 

withdrew his request for hearing on 

March 27, 2023. See RFAAX 1, 

Attachment F.4 On March 27, 2023, 

Chief Administrative Law Judge John J. 

Mulrooney, II, (the Chief ALJ) issued a 

Termination Order that terminated the 

proceedings. 21 CFR 1301.43(c) 

provides that, ‘‘[i]n the event . . . a 

person who has requested a hearing fails 

to plead . . . or otherwise defend, said 

party shall be deemed to be in default 

. . . .’’ By voluntarily withdrawing his 

hearing request, Respondent ‘‘fail[ed] to 

. . . otherwise defend.’’ 21 CFR 

1301.43(c). Accordingly, Respondent is 

‘‘deemed to be in default.’’ Id.; Default 

Provisions for Hearing Proceedings 

Relating to the Revocation, Suspension, 

or Denial of a Registration, 87 FR 68036 

(Nov. 14, 2022).5 See RFAAX 1, 

Attachment G. ‘‘A default, unless 

excused, shall be deemed to constitute 

a waiver of the registrant’s/applicant’s 

right to a hearing and an admission of 

the factual allegations of the [OSC].’’ 21 

CFR 1301.43(e). 

Further, ‘‘[i]n the event that a 

[registrant/applicant] . . . 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 

[21 CFR] § 1316.67.’’ Id. § 1301.43(f)(1). 

Here, the Government has requested 

final agency action based on Applicant’s 

default pursuant to 21 CFR 1301.43(c), 

(d), 1301.46. RFAA, at 1; see also 21 

CFR 1316.67. 

I. Findings of Fact 

The Agency finds that, in light of 

Applicant’s default, the factual 

allegations in the OSC are admitted. 

Applicant is deemed to have admitted 

that on March 2, 2020, DEA issued 

Applicant an Immediate Suspension 

Order and Order to Show Cause that 

suspended Applicant’s previous DEA 

registration, Control No. BA5092856, 

and immediately rendered Applicant 

without authority to issue prescriptions 

for controlled substances. RFAAX 1, 

Attachment E, at 1–2; see also RFAAX 

1, Attachment B. Further, on October 

20, 2021, by Order of the then-Acting 

Administrator, Applicant’s DEA 

registration, Control No. BA5092856, 

was revoked. RFAAX 1, Attachment E, 

at 2; see also RFAAX 1, Attachment C. 

Nonetheless, Applicant is deemed to 

have admitted, and the Agency finds, 

that between on or about January 15, 

2021, and on or about January 6, 2022, 

Applicant issued at least 17 

prescriptions for controlled substances, 

including four prescriptions for 

oxycodone (a Schedule II controlled 

substance), two prescriptions for 

hydrocodone (a Schedule II controlled 

substance), five prescriptions for 

lorazepam (a Schedule IV controlled 

substance), two prescriptions for 

zolpidem (a Schedule IV controlled 

substance), one prescription for 

clonazepam (a Schedule IV controlled 

substance), two prescriptions for 

pregabalin (a Schedule V controlled 

substance), and one prescription for 

diazepam (a Schedule IV controlled 

substance). RFAAX 1, Attachment E, at 

2; see also RFAAX 1, Attachment D. 

Applicant is deemed to have admitted, 

and the Agency finds, that each of these 

17 prescriptions was issued without a 

DEA registration and outside the usual 

course of professional practice. Id. 

II. Discussion 

A. The Five Public Interest Factors 

Pursuant to section 303(g)(1) of the 

CSA, ‘‘[t]he Attorney General shall 

register practitioners . . . to dispense 

. . . controlled substances . . . if the 

applicant is authorized to dispense . . . 

controlled substances under the laws of 

the State in which he practices.’’ 21 

U.S.C. 823(g)(1). Section 303(g)(1) 

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: 

(A) The recommendation of the 

appropriate State licensing board or 

professional disciplinary authority. 

(B) The applicant’s experience in 

dispensing, or conducting research with 

respect to controlled substances. 

(C) The applicant’s conviction record 

under Federal or State laws relating to the 


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82260 Federal Register / Vol. 89, No. 197 / Thursday, October 10, 2024 / Notices 

6As to Factor A, the record contains no evidence 

of a recommendation from any State licensing board 

or professional disciplinary authority. 21 U.S.C. 

823(g)(1)(A). Nonetheless, an absence of such 

evidence ‘‘does not weigh for or against a 

determination as to whether continuation of [or 

granting of a] DEA certification is consistent with 

the public interest.’’ Roni Dreszer, M.D., 76 FR 

19434, 19444 (2011). As to Factor C, there is no 

evidence in the record that Applicant has been 

convicted of an offense under either Federal or 

State law ‘‘relating to the manufacture, distribution, 

or dispensing of controlled substances.’’ 21 U.S.C. 

823(g)(1)(C). However, as Agency cases have noted, 

there are a number of reasons why a person who 

has engaged in criminal misconduct may never 

have been convicted of an offense under this factor. 

Dewey C. MacKay, M.D., 75 FR 49956, 49973 (2010). 

Agency cases have therefore found that ‘‘the 

absence of such a conviction is of considerably less 

consequence in the public interest inquiry’’ and is 

therefore not dispositive. Id. Finally, as to Factor E, 

the Government’s evidence fits squarely within the 

parameters of Factors B and D and does not raise 

‘‘other conduct which may threaten the public 

health and safety.’’ 21 U.S.C. 823(g)(1)(E). 

Accordingly, Factor E does not weigh for or against 

Applicant. 

7The Agency need not adjudicate the criminal 

violations alleged in the instant OSC. Ruan v. 

United States, 142 S. Ct. 2370 (2022) (decided in 

the context of criminal proceedings). 

manufacture, distribution, or dispensing of 

controlled substances. 

(D) Compliance with applicable State, 

Federal, or local laws relating to controlled 

substances. 

(E) Such other conduct which may threaten 

the public health and safety. 

21 U.S.C. 823(g)(1). 

The Agency considers these public 

interest factors in the disjunctive. Robert 

A. Leslie, M.D., 68 FR 15227, 15230 

(2003). Each factor is weighed on a caseby-case basis. Morall v. Drug Enf’t 

Admin., 412 F.3d 165, 173–74 (D.C. Cir. 

2005). Any one factor, or combination of 

factors, may be decisive. David H. Gillis, 

M.D., 58 FR 37507, 37508 (1993). 

While the Agency has considered all 

of the public interest factors in 21 U.S.C. 

823(g)(1),6 the Government’s evidence 

in support of its prima facie case for 

denial of Applicant’s application for 

registration is confined to Factors B and 

D. See RFAAX 1, Attachment E, at 1. 

Moreover, the Government has the 

burden of proof in this proceeding. 21 

CFR 1301.44. Here, the Agency finds 

that the Government’s evidence satisfies 

its prima facie burden of showing that 

Applicant’s registration would be 

‘‘inconsistent with the public interest.’’ 

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

B. Factors B and D 

Evidence is considered under Public 

Interest Factors B and D when it reflects 

compliance (or non-compliance) with 

laws related to controlled substances 

and experience dispensing controlled 

substances. See Sualeh Ashraf, M.D., 88 

FR 1095, 1097 (2023); Kareem Hubbard, 

M.D., 87 FR 21156, 21162 (2022). In the 

current matter, the Government has 

alleged that Applicant violated both 

Federal and State law regulating 

controlled substances. RFAAX 1, 

Attachment E, at 2.7 Specifically, 

Federal law states that ‘‘[a] prescription 

for a controlled substance may be issued 

only by an individual practitioner who 

is: (1) [a]uthorized to prescribe 

controlled substances by the jurisdiction 

in which he is licensed to practice his 

profession and (2) [e]ither registered or 

exempted from registration pursuant to 

§§ 1301.22(c) and 1301.23 . . . .’’ 21 

CFR 1306.03(a)(1–2). As for State law, 

Virginia statute requires that ‘‘[e]very 

person who manufactures, distributes or 

dispenses any substance that is 

controlled in [s]chedules I through V 

. . . except . . . those persons who are 

licensed practitioners of medicine . . . 

shall obtain annually a controlled 

substances registration certificate issued 

by the [Board of Pharmacy]. This 

registration shall be in addition to other 

licensing or permitting requirements 

enumerated in [Virginia’s Drug Control 

Act] or otherwise required by law.’’ Va. 

Code. Ann. section 54.1–3422(A). 

Here, Applicant has admitted that he 

repeatedly issued prescriptions for 

controlled substances while his DEA 

registration was suspended as well as 

after his DEA registration was revoked. 

As such, the Agency finds that 

Applicant violated 21 CFR 

1306.03(a)(1–2) and Virginia Code 

section 54.1–3422(A). 

Accordingly, the Agency finds that 

Factors B and D weigh in favor of denial 

of Applicant’s application and thus 

finds Applicant’s continued registration 

to be inconsistent with the public 

interest in balancing the factors of 21 

U.S.C. 823(g)(1). The Agency further 

finds that Applicant failed to provide 

any evidence to rebut the Government’s 

prima facie case. 

III. Sanction 

Where, as here, the Government has 

established grounds to deny Applicant’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, 18910 (2018). To 

establish that he can be entrusted with 

registration, a registrant 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) (internal quotations 

omitted); see also Michele L. Martinho, 

M.D., 86 FR 24012, 24019 (2021); George 

D. Gowder, III, M.D., 89 FR 76152, 

76154 (2024). Trust is necessarily a factdependent 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 at 33746. 

Here, although Applicant initially 

requested a hearing, he ultimately 

withdrew his hearing request and did 

not otherwise avail himself of the 

opportunity to refute the Government’s 

case. As such, Applicant has made no 

representations as to his future 

compliance with the CSA nor 

demonstrated that he can be entrusted 

with registration. Moreover, the 

evidence presented by the Government 

shows that Applicant violated the CSA, 

further indicating that Applicant cannot 

be entrusted. Accordingly, the Agency 

will order the denial of Applicant’s 

application. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

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

823(g)(1) and 21 U.S.C. 824(a), I hereby 

deny the pending application for a 

Certificate of Registration, Control No. 

W22109452C, submitted by Salman 

Akbar, M.D., as well as any other 

pending application of Salman Akbar, 

M.D., for additional registration in 

Virginia. This Order is effective 

November 12, 2024. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 4, 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. 2024–23504 Filed 10–9–24; 8:45 am] 

BILLING CODE 4410–09–P 


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