76856 Federal Register / Vol. 88, No. 214 / Tuesday, November 7, 2023 / Notices 

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. 

2By letter dated March 14, 2022, Respondent 

requested a hearing. RFAAX 15, at 1. On May 16, 

2022, Respondent withdrew his hearing request and 

Chief Administrative Law Judge John J. Mulrooney, 

II, issued an Order Terminating Proceedings. 

RFAAX 16; RFAAX 17. 

3On June 6, 2021, Respondent emailed the DI a 

document titled ‘‘Controlled Drug Inventory 5–25– 

2021.’’ Declaration, at 4; see also RFAAX 6. 

4As noted by the DI, the most recent invoice 

indicated that Respondent himself purchased 100 

tablets of 2 mg alprazolam under his own DEA 

registration; all of the other invoices for the 

controlled substance purchases in question showed 

that the controlled substances were shipped to 

another practitioner at the Pet Hospital, G.K. Id. at 

2–3; see also RFAAX 2, at 66; RFAAX 8, at 1; 

RFAAX 9, at 3. Respondent also admitted that his 

wife paid for all of the controlled substances 

ordered for the Pet Hospital. Declaration, at 3. 

5Though unable to produce dispensing records 

for the controlled substances in question, 

Respondent was able to produce dispensing records 

for other controlled substances. Id. at 3; see also 

RFAAX 4. According to the DI, these other 

dispensing records were commingled with records 

of other practitioners, including G.K., and because 

the records lacked detail, the DI was unable to 

determine which controlled substances had been 

dispensed by Respondent. Id. Because there were 

no records showing the disposition of the 

oxycodone, alprazolam, or zolpidem in question, 

the DI was unable to confirm whether the drugs had 

been purchased for a legitimate medical purpose; 

moreover, there was no evidence that Respondent 

had contacted any law enforcement agency to report 

the diversion of any oxycodone, alprazolam, or 

zolpidem. Declaration, at 3. 

6Respondent admitted to DI that he observed 

G.K. receiving a shipment of alprazolam in 2019; 

specifically, Respondent observed G.K. meet a 

delivery driver outside the Pet Hospital who gave 

G.K. several boxes that G.K. then placed in his 

personal vehicle. Id. Respondent stated that he then 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. All 

requests for a hearing must be sent to: 

(1) Drug Enforcement Administration, 

Attn: Hearing Clerk/OALJ, 8701 

Morrissette Drive, Springfield, Virginia 

22152; and (2) Drug Enforcement 

Administration, Attn: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for a hearing should 

also be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on September 19, 2023, 

Groff NA Hemplex LLC, 100 Redco 

Avenue, Suite A, Red Lion, 

Pennsylvania 17356–1436, applied to be 

registered as an importer of the 

following basic class(es) of controlled 

substance(s): 

Controlled substance Drug code Schedule 

Marihuana Extract .................................................................................................................................................... 7350 I 

Marihuana ................................................................................................................................................................ 7360 I 

Tetrahydrocannabinols ............................................................................................................................................ 7370 I 

The company plans to import the 

listed controlled substances in bulk 

form to manufacture research grade 

material for clinical trial studies. 

Several types of Marihuana Extract 

compounds are listed under drug code 

7350. No other activities for these drug 

codes are authorized for this 

registration. 

Approval of permit applications will 

occur only when the registrant’s 

business activity is consistent with what 

is authorized under 21 U.S.C. 952(a)(2). 

Authorization will not extend to the 

import of Food and Drug 

Administration-approved or nonapproved finished dosage forms for 

commercial sale. 

Claude Redd, 

Acting Deputy Assistant Administrator. 

[FR Doc. 2023–24575 Filed 11–6–23; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Jagjit Kaleka, D.V.M.; Decision and 

Order 

On February 25, 2022, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause (OSC) to Jagjit Kaleka, D.V.M. 

(Respondent), of Mauston, Wisconsin. 

Request for Final Agency Action 

(RFAA), Government Exhibit (RFAAX) 

13, at 1, 5. The OSC proposed the 

revocation of Respondent’s DEA 

Certificate of Registration (registration), 

Control No. AK7830640, alleging that 

Respondent has ‘‘committed such acts 

as would render [his] registration 

inconsistent with the public interest.’’ 

Id. at 1, 2 (citing 21 U.S.C. 824(a)(4), 

823(g)(1) 1). 

The Agency makes the following 

findings of fact based on the 

uncontroverted evidence submitted by 

the Government in its RFAA dated April 

6, 2023.2

I. Findings of Fact 

According to the Declaration of a DEA 

Diversion Investigator (the DI), 

Respondent was the owner of and a 

veterinarian at Mauston Pet Hospital 

(the Pet Hospital). RFAA, Declaration of 

Diversion Investigator (Declaration), at 

2. From June 21, 2019, through February 

22, 2021, the Pet Hospital purchased 

500 tablets of 10 mg oxycodone 

(Schedule II), 1000 tablets of 2 mg 

alprazolam (Schedule IV), and 100 

tablets of 5 mg zolpidem (Schedule IV). 

Id.; see also RFAAX 2; RFAAX 9. On 

June 8, 2021, the DI served a Notice of 

Inspection at the Pet Hospital, and 

Respondent consented to an inspection 

of the premises. Declaration, at 2; see 

also RFAAX 7. Prior to the inspection, 

the DI asked Respondent to take an 

inventory of all controlled substances at 

the Pet Hospital,3 and on the day of the 

inspection, the DI asked Respondent to 

produce a biennial inventory, which 

Respondent was unable to produce. 

Declaration, at 2, 4. 

During the inspection, Respondent 

denied personally ordering the 

controlled substances in question, 

namely, oxycodone, alprazolam, and 

zolpidem. Declaration, at 2.4 The DI 

explained that despite the Pet Hospital’s 

purchases, ‘‘[n]one of these drugs could 

be located on the premises and there 

were no records showing that the drugs 

had been dispensed, lost, stolen, or 

otherwise disposed of.’’ Id. at 2, 3.5

Further, ‘‘[t]hough Respondent denied 

knowledge that [G.K., another 

practitioner at the Pet Hospital,] had 

been using the Pet Hospital’s account to 

purchase and obtain controlled 

substances for other than a legitimate 

medical purpose in the usual course of 

veterinary practice, Respondent 

[admitted that he] was aware of at least 

one incident during which [G.K.] 

purchased and received alprazolam.’’ 

Id.6 Notably, Respondent admitted that 


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Federal Register / Vol. 88, No. 214 / Tuesday, November 7, 2023 / Notices 76857 

instructed an employee, S.T., to retrieve the boxes 

and bring them inside Pet Hospital where 

Respondent confirmed that they contained 

alprazolam. Id. In addition, S.T. admitted to filling 

out a DEA form 222 for the purchase of oxycodone 

at G.K.’s request. Id. at 4; see also RFAAX 2, at 3; 

RFAAX 3. 

7The DI referenced 21 CFR 1317.90(a) once more 

in noting that ‘‘because Respondent was not the 

‘ultimate user[]’ or ‘[a] person[] lawfully entitled to 

dispose of an ultimate user’s decedent’s property,’[] 

he did not dispose of the controlled substances ‘in 

compliance with applicable Federal, State, tribal[], 

and local laws and regulations.’ ’’ Id. at 4. 

8The DI also described how Respondent had been 

previously notified of violations in 2017, with 

Respondent at that time cited by DEA for failing to 

keep a biennial inventory, failing to maintain 

separate and readily retrievable records of 

controlled substances, failing to keep controlled 

substances in a securely locked, substantially 

constructed cabinet, and accepting controlled 

substances from end users without being licensed 

as a collector. Id. at 2, 4–5; see also RFAAX 10. 

Respondent was also subject to disciplinary action 

by the State of Wisconsin Veterinary Examining 

Board in 2018 following findings that Respondent 

had failed to store controlled substances in a 

securely locked, substantially constructed cabinet, 

had failed to keep a biennial inventory, and had 

sold a Schedule III controlled substance to an 

unregistered individual who had previously 

surrendered his DEA registration and was not 

authorized to possess or purchase controlled 

substances. Declaration, at 2, 5; see also RFAAX 11. 

9As to Factor A, the Agency considers the 

recommendation of the appropriate state licensing 

board. Here, the state licensing board has taken 

disciplinary action against Respondent’s veterinary 

license arising out of similar misconduct as that 

which forms the basis for the OSC in the current 

matter. See RFAAX 11; RFAAX 14, at 3. 

Nonetheless, because the Government has not made 

any representations as to Factor A in its RFAA, the 

Agency finds that Factor A weighs neither for nor 

against Respondent’s continued registration. As to 

Factor C, there is no evidence in the record that 

Respondent 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 

Respondent. 

10 In its RFAA, the Government noted that if the 

Agency were to find that Factors B and D did not 

weigh against Respondent’s continued registration, 

it would rely on Factor E in the alternative. Id. at 

6. 

11Federal law also prohibits an individual from 

accepting controlled substances from end users 

without being authorized as a collector. 21 U.S.C. 

822(g)(1)(A) (incorrectly cited in the OSC as 21 

U.S.C. 821(g)(1)(A), see RFAAX 14, at 3); 21 CFR 

1317.30 and 1317.40. 

neither alprazolam nor zolpidem have 

ever been used at the Pet Hospital for 

veterinary purposes. Declaration, at 3. 

Although Respondent denied that he 

had any expired controlled substances, 

the DI found expired controlled 

substances in an unsecured area in the 

Pet Hospital’s basement. Id. at 4; see 

also RFAAX 12. Respondent had no 

records of any disposal of expired or 

unwanted controlled substances, but 

Respondent told the DI that he disposed 

of expired or unwanted controlled 

substances by giving them to the police 

or placing them in the garbage, which 

the DI noted was an unacceptable 

method that does not render the 

controlled substances ‘‘ ‘nonretrievable’ ’’ pursuant to Federal 

regulations. Declaration, at 2, 4 (citing 

21 CFR 1317.90(a)).7 8

II. Discussion 

A. The Five Public Interest Factors 

Under the CSA, ‘‘[a] registration . . . 

to . . . dispense a controlled substance 

. . . may be suspended or revoked by 

the Attorney General upon a finding 

that the registrant . . . has committed 

such acts as would render his 

registration under section 823 of this 

title inconsistent with the public 

interest as determined under such 

section.’’ 21 U.S.C. 824(a). 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 [registrant]’s experience in 

dispensing, or conducting research with 

respect to controlled substances. 

(C) The [registrant]’s conviction 

record under Federal or State laws 

relating to the 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 DEA considers these public 

interest factors in the disjunctive. Robert 

A. Leslie, M.D., 68 FR 15,227, 15,230 

(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),9 the Government’s evidence 

in support of its prima facie case for 

revocation of Respondent’s registration 

is confined to Factors B and D. See 

RFAA, at 6–10.10 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 

Respondent’s continued 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 Respondent violated 

numerous Federal laws regulating 

controlled substances. RFAAX 14, at 2– 

3. Specifically, Federal law requires that 

registrants (1) keep a biennial inventory 

of any controlled substances on hand; 

(2) keep controlled substances in a 

‘‘securely locked, substantially 

constructed cabinet’’; (3) dispose of 

controlled substances properly so as to 

comply with applicable regulations and 

render the controlled substances nonretrievable; (4) keep records of the 

disposal of controlled substances; and 

(5) timely report any loss of controlled 

substances. 21 U.S.C. 827(a)–(b); 21 CFR 

1301.75(b), 1301.76(b), 1304.11(a), 

1304.11(c), 1304.21(e), 1317.90, and 

1317.95.11

Here, the record demonstrates that 

Respondent, among other things, failed 

to conduct a biennial inventory of 

controlled substances, failed to properly 

store controlled substances in a securely 

locked, substantially constructed 

cabinet, failed to dispose of controlled 

substances properly so as to comply 

with applicable regulations and render 

the controlled substances nonretrievable, failed to keep records of the 

disposal of controlled substances, and 

failed to timely report the loss of 

controlled substances. As Respondent’s 

conduct displays clear violations of the 

various Federal regulations described 

above, the Agency hereby sustains the 

Government’s allegations that 

Respondent repeatedly violated Federal 

law relating to controlled substances. 

Accordingly, the Agency finds that 

Factors B and D weigh in favor of 

revocation of Respondent’s registration 

and thus finds Respondent’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 Respondent failed to 

provide sufficient evidence to rebut the 

Government’s prima facie case. 


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76858 Federal Register / Vol. 88, No. 214 / Tuesday, November 7, 2023 / Notices 

III. Sanction 

Where, as here, the Government has 

established grounds to revoke 

Respondent’s registration, 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). 

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) 

(internal quotations omitted). 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). 

Here, although Respondent initially 

requested a hearing, he withdrew his 

hearing request and did not otherwise 

avail himself of the opportunity to 

refute the Government’s case. As such, 

Respondent has made no 

representations as to his future 

compliance with the CSA nor made any 

demonstration that he can be entrusted 

with registration. In fact, despite having 

already been subject to state action and 

a Federal citation in 2017 and thus put 

on notice of the impropriety of his 

actions, Respondent failed to change his 

ways and continued to commit much of 

the same misconduct. Moreover, the 

evidence presented by the Government 

clearly shows that Respondent violated 

the CSA, further indicating that 

Respondent cannot be entrusted. 

Accordingly, the Agency will order the 

revocation of Respondent’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. AK7830640 issued to 

Jagjit Kaleka, D.V.M. 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 Jagjit Kaleka, D.V.M., to renew or 

modify this registration, as well as any 

other pending application of Jagjit 

Kaleka, D.V.M., for additional 

registration in Wisconsin. This Order is 

effective December 7, 2023. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 31, 2023, 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. 2023–24524 Filed 11–6–23; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1285] 

Importer of Controlled Substances 

Application: Mylan Technologies Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Mylan Technologies Inc. as 

applied to be registered as an importer 

of basic class(es) of controlled 

substance(s). Refer to SUPPLEMENTARY

INFORMATION listed below for further 

drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before December 7, 2023. Such 

persons may also file a written request 

for a hearing on the application on or 

before December 7, 2023. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. All 

requests for a hearing must be sent to: 

(1) Drug Enforcement Administration, 

Attn: Hearing Clerk/OALJ, 8701 

Morrissette Drive, Springfield, Virginia 

22152; and (2) Drug Enforcement 

Administration, Attn: DEA Federal 

Register Representative/DPW, 8701 

Morrissette Drive, Springfield, Virginia 

22152. All requests for a hearing should 

also be sent to: Drug Enforcement 

Administration, Attn: Administrator, 

8701 Morrissette Drive, Springfield, 

Virginia 22152. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.34(a), this 

is notice that on October 5, 2023, Mylan 

Technologies Inc. 110 Lake Street, Saint 

Albans, Vermont 05478–2266 applied to 

be registered as an importer of the 

following basic class(es) of controlled 

substance(s) 

Controlled substance Drug 

code Schedule 

Fentanyl ........................ 9801 II 

Methylphenidate ........... 1724 II 

The company plans to import the 

listed controlled substances in finished 

dosage form (FDF) from foreign sources 

for analytical testing and clinical trials 

in which the foreign FDF will be 

compared to the company’s own 

domestically manufactured FDF to 

foreign markets. No other activities for 

these drug codes are authorized for this 

registration. 

Approval of permit applications will 

occur only when the registrant’s 

business activity is consistent with what 

is authorized under 21 U.S.C. 952(a)(2). 

Authorization will not extend to the 

import of Food and Drug 

Administration-approved or nonapproved finished dosage forms for 

commercial sale. 

Claude Redd, 

Acting Deputy Assistant Administrator. 

[FR Doc. 2023–24573 Filed 11–6–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Notice of Lodging of Proposed 

Modification to Consent Decree Under 

the Clean Water Act 

On October 25, 2023, the Department 

of Justice lodged a proposed a Material 

Modification to the Consent Decrees’ 

Wet Weather Improvement Program 

(‘‘Modification’’) with the United States 

District Court for the Southern District 


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I I