Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 84613 

1According to Agency records, Registrant’s 

registration expired on April 30, 2024. The fact that 

a registrant allows his registration to expire during 

the pendency of an OSC does not impact the 

Agency’s jurisdiction or prerogative under the 

Controlled Substances Act (CSA) to adjudicate the 

OSC to finality. Jeffrey D. Olsen, M.D., 84 FR 

68,474, 68,476–68,479 (2019). 

2Based on the Government’s submissions in its 

RFAA dated December 5, 2023, the Agency finds 

that service of the OSC on Registrant was adequate. 

Specifically, the RFAA indicates that on October 

16, 2023, Registrant was personally served with the 

OSC by a DEA Diversion Investigator. RFAA, at 1; 

RFAAX 2. 

3The Agency need not adjudicate the criminal 

violations alleged in the instant OSC. Ruan v. 

United States, 142 S. Ct. 2,370 (2022) (decided in 

the context of criminal proceedings). 

affiliation is reasonably identified by the 

geographical location or acquisition 

history of the human remains described 

in this notice. 

Determinations 

The Eastern Washington University 

has determined that: 

• The human remains described in 

this notice represent the physical 

remains of two individuals of Native 

American ancestry. 

• There is a connection between the 

human remains described in this notice 

and the Suquamish Indian Tribe of the 

Port Madison Reservation. 

Requests for Repatriation 

Written requests for repatriation of the 

human remains in this notice must be 

sent to the authorized representative 

identified in this notice under 

ADDRESSES. Requests for repatriation 

may be submitted by: 

1. Any one or more of the Indian 

Tribes or Native Hawaiian organizations 

identified in this notice. 

2. Any lineal descendant, Indian 

Tribe, or Native Hawaiian organization 

not identified in this notice who shows, 

by a preponderance of the evidence, that 

the requestor is a lineal descendant or 

an Indian Tribe or Native Hawaiian 

organization with cultural affiliation. 

Repatriation of the human remains 

described in this notice to a requestor 

may occur on or after November 22, 

2024. If competing requests for 

repatriation are received, the Eastern 

Washington University must determine 

the most appropriate requestor prior to 

repatriation. Requests for joint 

repatriation of the human remains are 

considered a single request and not 

competing requests. The Eastern 

Washington University is responsible 

for sending a copy of this notice to the 

Indian Tribes and Native Hawaiian 

organizations identified in this notice. 

Authority: Native American Graves 

Protection and Repatriation Act, 25 

U.S.C. 3003, and the implementing 

regulations, 43 CFR 10.10. 

Dated: October 11, 2024. 

Melanie O’Brien, 

Manager, National NAGPRA Program. 

[FR Doc. 2024–24417 Filed 10–22–24; 8:45 am] 

BILLING CODE 4312–52–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

David Carlos Rodriguez, M.D.; 

Decision and Order 

On September 11, 2023, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause (OSC) to David Carlos Rodriguez, 

M.D. (Registrant), of Lake City, South 

Carolina. Request for Final Agency 

Action (RFAA), Exhibit (RFAAX) 1, at 1, 

7. The OSC proposed the revocation of 

Registrant’s DEA Certificate of 

Registration (registration) No. 

BR6910803, alleging that Registrant has 

committed such acts as would render 

his registration inconsistent with the 

public interest. Id. at 3 (citing 21 U.S.C. 

823(g)(1), 824(a)(4)).1

The OSC notified Registrant 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 5–6 (citing 21 CFR 

1301.43). Here, Registrant did not 

request a hearing. RFAA, at 2.2 ‘‘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 . . . 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 Registrant’s 

default pursuant to 21 CFR 1301.43(c), 

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

1316.67. 

I. Findings of Fact 

The Agency finds that, in light of 

Registrant’s default, the factual 

allegations in the OSC are admitted.3

Registrant is deemed to have admitted 

and the Agency finds that from at least 

January 2018 through at least January 

2019, Registrant issued multiple 

controlled substance prescriptions to 

five patients that lacked a legitimate 

medical purpose and were issued 

outside the usual course of professional 

practice. RFAAX 1, at 3, 5. 

A. Prescribing to C.R. 

Registrant is deemed to have admitted 

that between May 2018 and December 

2018, on approximately a monthly basis, 

Registrant issued prescriptions for 

various quantities of oxycodone 30 mg 

(a Schedule II opioid) to C.R. RFAAX 1, 

at 3. Registrant issued these controlled 

substance prescriptions without 

conducting an appropriate evaluation, 

without making a proper diagnosis, 

without providing a therapeutic plan, 

and without discussing the risks, 

benefits, and treatment options with the 

patient. Id. Further, during several of 

C.R.’s visits to Registrant’s office, 

Registrant engaged in sexual conduct 

with C.R. prior to issuing C.R. the 

prescriptions. Id. 

B. Prescribing to K.D. 

Registrant is deemed to have admitted 

that between January 2018 and 

December 2018, on an approximately 

monthly basis, Registrant issued 

prescriptions for various quantities of 

alprazolam 2 mg (a Schedule IV 

benzodiazepine), zolpidem tartrate 10 

mg (a Schedule IV sedative), and 

dextroamphetamine-amphetamine 20 

mg (a Schedule II stimulant) to K.D. Id. 

at 4. Registrant issued these controlled 

substance prescriptions without 

conducting an appropriate evaluation, 

without making a proper diagnosis, 

without providing a therapeutic plan, 

and without discussing the risks, 

benefits, and treatment options with the 

patient. Id. 

C. Prescribing to R.R. 

Registrant is deemed to have admitted 

that between October 2018 and 

December 2018, on an approximately 

monthly basis, Registrant issued 

prescriptions for various quantities of 

alprazolam 0.5 mg and acetaminophenhydrocodone 325/10 mg (a Schedule II 

opioid) to R.R. Id. Again, Registrant 

issued these controlled substance 

prescriptions without conducting an 

appropriate evaluation, without making 

a proper diagnosis, without providing a 

therapeutic plan, and without 

discussing the risks, benefits, and 

treatment options with the patient. Id. 

On several of these occasions, Registrant 

prescribed opioids with a 

benzodiazepine, which Registrant is 

deemed to have admitted is a drug 

cocktail that is associated with 

diversion, without adequately 

documenting his reasoning for issuing 


khammond on DSKJM1Z7X2PROD with NOTICES
84614 Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 

4The OSC also alleges that Registrant’s combined 

prescribing of an opioid and a benzodiazepine 

‘‘disregarded the Centers for Disease Control and 

Prevention (CDC) guidance to ‘use particular 

caution when prescribing opioid pain medication 

and benzodiazepines concurrently.’ ’’ Id. (citing 

CDC Guidelines for Prescribing Opioids for Chronic 

Pain, 71 Morbidity and Mortality Weekly Report, 3, 

16 (2022)). The Summary for the CDC Guidance 

carefully states that its ‘‘[r]ecommendations should 

not be applied as inflexible standards of care across 

patient populations.’’ CDC Guidelines for 

Prescribing Opioids for Chronic Pain, at 1. 

Accordingly, the Agency’s decision relies not on the 

CDC Guidelines, but on the Government’s Expert, 

who opined that Registrant had ‘‘numerous 

deviations from the standard of care.’’ RFAAX 1, at 

5. 

5As 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 the 

[registrant’s] 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 Registrant 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). Agency cases have found that ‘‘the 

absence of such a conviction is of considerably less 

consequence in the public interest inquiry’’ and is 

therefore not dispositive. Dewey C. MacKay, M.D., 

75 FR 49956, 49973 (2010). 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 

Registrant. 

prescriptions for an opioid and 

benzodiazepine.4 Id. at 4. 

D. Prescribing to T.F. 

Registrant is deemed to have admitted 

that between April 2018 and November 

2018, on an approximately monthly 

basis, Registrant issued prescriptions for 

various quantities of oxycodone 10 mg, 

oxycodone 15 mg, and alprazolam 1 mg 

to T.F. Id. Registrant also issued a 

prescription for testosterone 200 mg (a 

Schedule III steroid) to T.F. Id. 

Registrant issued these controlled 

substance prescriptions without 

conducting an appropriate evaluation, 

without making a proper diagnosis, 

without providing a therapeutic plan, 

and without discussing the risks, 

benefits, and treatment options with the 

patient. Id. Registrant admits that he 

increased the oxycodone dosage from 10 

mg to 15 mg without medical 

justification. Id. As with R.R., on several 

of these occasions, Registrant prescribed 

opioids with a benzodiazepine to T.F. 

without adequately documenting his 

reasoning. Id. at 4–5. 

E. Prescribing to B.P. 

Between March 2018 and December 

2018, on an approximately monthly 

basis, Registrant issued prescriptions for 

various quantities of acetaminophenoxycodone 325/10 mg (a Schedule II 

opioid), lisdexamfetamine 30 mg (a 

Schedule II stimulant), and 

lisdexamfetamine 40 mg to Patient B.P. 

Id. at 5. Registrant issued these 

controlled substance prescriptions 

without conducting an appropriate 

evaluation, without making a proper 

diagnosis, without providing a 

therapeutic plan, and without 

discussing the risks, benefits, and 

treatment options with the patient. Id. 

Furthermore, Registrant admits that he 

increased the lisdexamfetamine dosage 

from 30 mg to 40 mg without medical 

justification. Id. 

F. Inadequate and Fraudulent Patient 

Records 

In addition to his improper 

prescribing detailed above, Registrant is 

deemed to have admitted that on 

December 11, 2018, in response to a 

subpoena, his office represented to the 

South Carolina Department of Labor, 

Licensing and Regulation Office of 

Investigations and Enforcement that his 

office had no documentation for 

patients C.R, K.D., R.R., T.F., and B.P. 

Id. Registrant is also deemed to have 

admitted that on August 15, 2019, 

pursuant to a search and seizure warrant 

from the South Carolina Department of 

Health and Environmental Control, his 

office provided fraudulent and doctored 

patient records. Id. 

G. The Government’s Expert 

According to the OSC, DEA retained 

an independent medical expert to 

review information regarding all of the 

controlled substance prescriptions 

detailed above, as well as Registrant’s 

patient files for Patients C.R., K.D., R.R., 

T.F., and B.P. Id. Based on Registrant’s 

numerous deviations from the standard 

of care, the medical expert concluded, 

and Registrant is deemed to have 

admitted, that the prescriptions were 

not issued for a legitimate medical 

purpose by an individual practitioner 

acting in the usual course of his 

professional practice. Id. Accordingly, 

Registrant is deemed to have admitted 

and the Agency finds that the abovelisted controlled substance prescriptions 

were issued beneath the standard of 

care. Id. 

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 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),5 the Government’s evidence 

in support of its prima facie case for 

revocation of Registrant’s registration is 

confined to Factors B and D. See 

RFAAX 1, at 3. 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 

Registrant’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 Registrant violated both 

federal and state law regulating 

controlled substances. RFAAX 1, at 1– 

3. Specifically, under federal 

regulations, a prescription for a 

controlled substance is valid only if 

‘‘issued for a legitimate medical purpose 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 205 / Wednesday, October 23, 2024 / Notices 84615 

6South Carolina Code of Regulations § 81–60, 

entitled Principles of Medical Ethics, states in 

subsection A that ‘‘a physician shall be dedicated 

to providing competent medical service with 

compassion and respect for human dignity.’’ 

by an individual practitioner acting in 

the usual course of his professional 

practice.’’ 21 CFR 1306.04(a). 

As for South Carolina state law, 

grounds for disciplinary action against a 

physician include when the physician 

has: ‘‘engaged in dishonorable, 

unethical, or unprofessional conduct 

that is likely either to deceive, defraud, 

or harm the public’’; ‘‘violated the code 

of medical ethics adopted by the [State 

Board of Medical Examiners] or has 

been found by the [State Board of 

Medical Examiners] to lack the ethical 

or professional competence to practice’’; 

‘‘failed to prepare or maintain an 

adequate patient record of care 

provided’’; ‘‘engaged in behavior that 

exploits the physician-patient 

relationship in a sexual way’’; and 

‘‘improperly managed medical records, 

including failure to maintain timely, 

legible, accurate, and complete medical 

records.’’ S.C. Code Ann. § 40–47–110. 

Further, South Carolina regulations 

require that prior to prescribing to a 

patient, a physician must establish a 

proper physician-patient relationship, 

which entails that the physician ‘‘make 

an informed medical judgment based on 

the circumstances of the situation and 

on the [physician’s] training and 

experience’’; ‘‘personally perform and 

document an appropriate history and 

physical examination, make a diagnosis, 

and formulate a therapeutic plan’’; 

‘‘discuss with the patient the diagnosis 

and the evidence for it, and the risks 

and benefits of various treatment 

options’’; and ‘‘ensure the availability of 

the [physician] or coverage for the 

patient for appropriate follow-up care.’’ 

Id. § 40–47–113(A).6

Here, consistent with Registrant’s 

admissions, the Agency finds that 

Registrant repeatedly issued 

prescriptions for controlled substances 

without conducting an appropriate 

evaluation, without making a proper 

diagnosis, without providing a 

therapeutic plan, and without 

discussing the risks, benefits and 

treatment options with his patients. 

RFAAX 1, at 3–5. Registrant has also 

admitted and the Agency finds that 

Registrant: engaged in sexual conduct 

with a patient prior to issuing the 

patient prescriptions for controlled 

substances; issued a cocktail 

prescription of opioids and a 

benzodiazepine to multiple patients on 

multiple occasions while failing to 

document his reasoning for so doing; 

and increased the dosages of controlled 

substance prescriptions for multiple 

patients without medical justification 

for so doing. Id. Based on Registrant’s 

numerous deviations from the standard 

of care, DEA’s medical expert 

concluded, and the Agency finds, that 

these prescriptions were not issued for 

a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice. Id. at 5. Registrant has further 

admitted that he failed to provide 

adequate patient records to one group of 

state officials, then provided fraudulent 

patient records to another group of state 

officials. Id. As such, the Agency finds 

that Registrant violated 21 CFR 

1306.04(a) and South Carolina Code 

§§ 40–47–110 and 40–47–113. 

Accordingly, the Agency finds that 

Factors B and D weigh in favor of 

revocation of Registrant’s registration 

and thus finds Registrant’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 Registrant failed to 

provide any evidence to rebut the 

Government’s prima facie case. 

III. Sanction 

Where, as here, the Government has 

established grounds for revocation, 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); 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 33738, 

33746 (2021). 

Here, Registrant failed to answer the 

allegations contained in the OSC and 

did not otherwise avail himself of the 

opportunity to refute the Government’s 

case. As such, Registrant has made no 

representations as to his future 

compliance with the CSA nor made any 

demonstration that he can be entrusted 

with registration. Moreover, the 

evidence presented by the Government 

shows that Registrant violated the CSA, 

further indicating that Registrant cannot 

be entrusted. 

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. BR6910803 issued to 

David Carlos Rodriguez, M.D. 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 David Carlos Rodriguez, 

M.D., to renew or modify this 

registration, as well as any other 

pending application of David Carlos 

Rodriguez, M.D., for additional 

registration in South Carolina. This 

Order is effective November 22, 2024. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 15, 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. 2024–24575 Filed 10–22–24; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1438] 

Bulk Manufacturer of Controlled 

Substances Application: Irvine Labs, 

Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Irvine Labs, Inc. has applied 

to be registered as a bulk manufacturer 

of basic class(es) of controlled 

substance(s). Refer to Supplementary 

Information listed below for further 

drug information. 


khammond on DSKJM1Z7X2PROD with NOTICES