Federal Register / Vol. 88, No. 211 / Thursday, November 2, 2023 / Notices 75309 

1A record of the Commissioners’ votes, the 

Commission’s statement on adequacy, and any 

individual Commissioner’s statements will be 

available from the Office of the Secretary and at the 

Commission’s website. 

2Commissioner Stayin did not participate in the 

vote on these reviews. 

3The Commission has found the response 

submitted on behalf of the Cast Iron Soil Pipe 

Institute and its two individual members to be 

individually adequate. Comments from other 

interested parties will not be accepted (see 19 CFR 

207.62(d)(2)). 

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. 

2See footnotes 4 and 6, infra. 

3The Agency adopts the Chief ALJ’s summary of 

each of the witnesses’ testimonies as well as the 

Chief ALJ’s assessment of each of the witnesses’ 

credibility. See RD, at 3–10. The Agency agrees 

with the Chief ALJ that the Diversion Investigator’s 

(DI) testimony, which focused on the investigative 

steps completed in the case and establishing the 

foundations for exhibits received into the record, 

was sufficiently detailed, plausible, and internally 

consistent to be afforded full credibility. See id. at 

3–4. The Agency also agrees with the Chief ALJ’s 

assessment of the testimony provided by a Task 

Force Agent (TFA) on investigative assistance 

provided to DEA and non-controversial 

introduction of documentary evidence. See id. at 4. 

The testimony was sufficiently detailed, plausible, 

and internally consistent to be afforded full 

credibility. Id. M.L., mother of Patient K.L, 

primarily testified about her observations of K.L. 

during the time period in which Respondent issued 

K.L. controlled substance prescriptions, as well as 

an interaction with Respondent at his medical 

office. Id. at 5–6. Despite M.L.’s apparent anger 

toward Respondent for the role that she believed he 

played in her daughter’s addiction to pain 

medication, the Agency agrees with the Chief ALJ 

that M.L.’s testimony was sufficiently consistent, 

plausible, and detailed to be afforded credibility. 

See id. at 6. Further, the Agency agrees with the 

Chief ALJ that Dr. Mark Rubenstein, M.D., the 

Government’s expert witness, provided opinions on 

Continued 

recurrence of material injury within a 

reasonably foreseeable time. 

DATES: October 6, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Alexis Yim (202–708–1446), Office of 

Investigations, U.S. International Trade 

Commission, 500 E Street SW, 

Washington, DC 20436. Hearingimpaired persons can obtain 

information on this matter by contacting 

the Commission’s TDD terminal on 202– 

205–1810. Persons with mobility 

impairments who will need special 

assistance in gaining access to the 

Commission should contact the Office 

of the Secretary at 202–205–2000. 

General information concerning the 

Commission may also be obtained by 

accessing its internet server (https://

www.usitc.gov). The public record for 

this proceeding may be viewed on the 

Commission’s electronic docket (EDIS) 

at https://edis.usitc.gov. 

SUPPLEMENTARY INFORMATION: 

Background.—On October 6, 2023, 

the Commission determined that the 

domestic interested party group 

response to its notice of institution (88 

FR 42753, July 3, 2023) of the subject 

five-year reviews was adequate and that 

the respondent interested party group 

response was inadequate. The 

Commission did not find any other 

circumstances that would warrant 

conducting full reviews.1 Accordingly, 

the Commission determined that it 

would conduct expedited reviews 

pursuant to section 751(c)(3) of the Act 

(19 U.S.C. 1675(c)(3)).2

For further information concerning 

the conduct of these reviews and rules 

of general application, consult the 

Commission’s Rules of Practice and 

Procedure, part 201, subparts A and B 

(19 CFR part 201), and part 207, 

subparts A, D, E, and F (19 CFR part 

207). 

Staff report.—A staff report 

containing information concerning the 

subject matter of the reviews has been 

placed in the nonpublic record, and will 

be made available to persons on the 

Administrative Protective Order service 

list for these reviews on November 21, 

2023. A public version will be issued 

thereafter, pursuant to § 207.62(d)(4) of 

the Commission’s rules. 

Written submissions.—As provided in 

§ 207.62(d) of the Commission’s rules, 

interested parties that are parties to the 

reviews and that have provided 

individually adequate responses to the 

notice of institution,3 and any party 

other than an interested party to the 

reviews may file written comments with 

the Secretary on what determination the 

Commission should reach in the 

reviews. Comments are due on or before 

5:15 p.m. on November 30, 2023, and 

may not contain new factual 

information. Any person that is neither 

a party to the five-year reviews nor an 

interested party may submit a brief 

written statement (which shall not 

contain any new factual information) 

pertinent to the reviews by November 

30, 2023. However, should the 

Department of Commerce (‘‘Commerce’’) 

extend the time limit for its completion 

of the final results of its reviews, the 

deadline for comments (which may not 

contain new factual information) on 

Commerce’s final results is three 

business days after the issuance of 

Commerce’s results. If comments 

contain business proprietary 

information (BPI), they must conform 

with the requirements of §§ 201.6, 

207.3, and 207.7 of the Commission’s 

rules. The Commission’s Handbook on 

Filing Procedures, available on the 

Commission’s website at https://

www.usitc.gov/documents/handbook_

on_filing_procedures.pdf, elaborates 

upon the Commission’s procedures with 

respect to filings. 

In accordance with §§ 201.16(c) and 

207.3 of the rules, each document filed 

by a party to the reviews must be served 

on all other parties to the reviews (as 

identified by either the public or BPI 

service list), and a certificate of service 

must be timely filed. The Secretary will 

not accept a document for filing without 

a certificate of service. 

Determination.—The Commission has 

determined these reviews are 

extraordinarily complicated and 

therefore has determined to exercise its 

authority to extend the review period by 

up to 90 days pursuant to 19 U.S.C. 

1675(c)(5)(B). 

Authority: These reviews are being 

conducted under authority of title VII of the 

Act; this notice is published pursuant to 

§ 207.62 of the Commission’s rules. 

By order of the Commission. 

Issued: October 27, 2023. 

Katherine Hiner, 

Supervisory Attorney. 

[FR Doc. 2023–24183 Filed 11–1–23; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 22–36] 

Osmin A. Morales, M.D.; Decision and 

Order 

On May 25, 2022, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause (OSC) to Osmin A. Morales, M.D., 

(Respondent) of Florida seeking to deny 

his application for a DEA Certificate of 

Registration, Control No. W20125906C, 

and alleging that his registration ‘‘would 

be inconsistent with the public 

interest.’’ OSC, at 1 (citing 21 U.S.C. 

823(g)(1) 1). 

A hearing was held before DEA Chief 

Administrative Law Judge John J. 

Mulrooney, II (the Chief ALJ). On 

February 8, 2023, the Chief ALJ issued 

his Recommended Rulings, Findings of 

Fact, Conclusions of Law, and Decision 

(RD), which recommended that the 

Agency deny Respondent’s application. 

RD, at 22. Respondent did not file 

exceptions to the RD. Having reviewed 

the entire record, the Agency adopts and 

hereby incorporates by reference the 

entirety 2 of the Chief ALJ’s rulings, 

credibility findings,3 findings of fact, 


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Florida’s standard of care and Respondent’s 

prescribing history that ‘‘gave every appearance of 

being comprehensive and well-reasoned,’’ were 

unrefuted and uncontroverted, and merited 

controlling weight. Id. at 10. Respondent did not 

present a case. Id. at 3; Tr. 1,124–25. 

4 In addition to the misconduct discussed in this 

Decision, the Chief ALJ found misconduct related 

to 23 prescriptions Respondent issued to patients 

on November 18, 2020, that the Government alleged 

were either (a) signed and dated prior to their 

issuance date, (b) fraudulently written by 

Respondent’s staff, and/or (c) issued after 

Respondent surrendered his prior DEA registration. 

RD, at 4, 18–19. Based on the overwhelming nature 

of the evidence establishing Respondent’s other 

misconduct in his prescribing of controlled 

substances, the Agency need not reach a factual 

finding with regard to these 23 prescriptions. 

5The Agency adopts and incorporates by 

reference the entirety of the Chief ALJ’s findings 

regarding the standard of care in Florida and the 

related summary of Dr. Rubenstein’s expert 

testimony. 

6Based on the overwhelming evidence of 

misconduct related to Respondent’s prescribing to 

K.L., the Agency need not issue findings regarding 

prescriptions issued to K.L. on July 5, 2016, and 

July 15, 2016. 

conclusions of law, and recommended 

sanction in the RD and summarizes and 

expands upon portions thereof herein. 

I. Findings of Fact 

The Agency finds from clear, 

unequivocal, convincing, and 

unrebutted evidence that Respondent 

committed numerous failures in his 

prescribing conduct that fell below the 

standard of care in Florida. Overall, the 

Agency finds that Respondent issued at 

least 252 prescriptions 4 to patients from 

September 27, 2017, through November 

25, 2020, without a legitimate medical 

purpose, outside the usual course of 

professional practice, and beneath the 

standard of care in Florida. See RD, at 

18–19. 

Florida Standard of Care 

Dr. Rubenstein provided expert 

testimony on the applicable standard of 

care for prescribing controlled 

substances in Florida.5 RD, at 7–8; Tr. 

637. According to Dr. Rubenstein, a 

physician is required to conduct ‘‘an 

appropriate history and physical 

examination to establish an appropriate 

medical diagnosis, [and] review 

appropriate medical records,’’ prior to 

prescribing a controlled substance. RD, 

at 7 (quoting Tr. 638). Dr. Rubenstein 

further explained that while the nature 

and depth of the physical examination 

may vary depending on the location of 

the pain, it should include an 

assessment tailored to the patient’s 

particular complaints. RD, at 7; Tr. 639– 

40. He clarified that while the physical 

examination at the initial visit is usually 

the most thorough, physicians must still 

conduct additional physical 

examinations at subsequent visits. RD, 

at 7; Tr. 641. Dr. Rubenstein emphasized 

that ‘‘[t]o prescribe controlled 

substances, you must establish an 

appropriate and valid medical 

diagnosis.’’ RD, at 7 (quoting Tr. 646). 

Dr. Rubenstein also testified that prior 

to issuing a controlled substance 

prescription, a physician should query 

the state prescription monitoring 

program (PMP), which, in Florida, is the 

Electronic-Florida Online Reporting of 

Controlled Substance Evaluation 

Program (E–FORCSE). RD, at 7–8; Tr. 

638, 650, 835–36. The physician should 

also assess and document signs of 

misuse or noncompliance. RD, at 8; Tr. 

647, 651–52. Notably, Dr. Rubenstein 

stressed the importance of maintaining 

‘‘full and appropriate records’’ that 

include patient history, physical 

examinations, medical records, 

diagnostic studies, and controlled 

substance prescriptions. RD, at 8 

(quoting Tr. 646); Tr. 650, 813. 

The Patients 

Patient K.L. 

Regarding Patient K.L., the Agency 

finds that Respondent issued at least 

110 controlled substance prescriptions 

from July 9, 2018, through November 

25, 2020, without a legitimate medical 

purpose, outside the usual course of 

professional practice, and beneath the 

applicable standard of care.6 See RD, at 

18–19; GX 7, 12; Tr. 670–71, 852–54. 

Based on Dr. Rubenstein’s testimony 

and the record as a whole, these 

prescriptions were issued without a 

legitimate medical purpose, outside the 

usual course of professional practice, 

and beneath the standard of care 

because Respondent failed to 

appropriately establish or document a 

medical indication (RD, at 8; GX 11; Tr. 

689–90, 705, 708–10, 714, 719, 722, 725, 

736–37, 853), altered prescriptions 

without any documented justification 

(RD, at 8; GX 11; Tr. 825–34), 

maintained Patient K.L. on high doses 

and high-risk combinations of 

controlled substances without any 

established or documented medical 

indication (RD, at 8–9; GX 11; Tr. 671, 

687, 706, 710, 712–13, 717–19, 725–26, 

729, 737, 853), issued prescriptions on 

dates prior to correlating patient visits 

(RD, at 9; GX 11–12; Tr. 758–61, 801– 

810), failed to resolve or adequately 

address signs of potential diversion 

prior to issuing prescriptions (RD, at 9; 

GX 11; Tr. 825–27, 839, 841, 843–48, 

853–54), failed to document and 

maintain copies of certain prescriptions 

(RD, at 9; GX 11–12; Tr. 814–19) created 

patient records with inconsistent 

information (RD, at 9; GX 11–12; Tr. 

745–50, 756–58, 851–52, 957–58), and/ 

or failed to conduct in-person 

examinations of the patient, including a 

purported office visit noted in Patient 

K.L.’s file when evidence indicated that 

Respondent was not in the country (RD, 

at 9; GX 11–12, 20; Tr. 542, 745–50, 

756–58, 851–52, 957–58). 

Patient R.J. 

Regarding Patient R.J., the Agency 

finds that Respondent issued at least 83 

controlled substance prescriptions from 

August 2, 2018, to October 26, 2020, 

without a legitimate medical purpose, 

outside the usual course of professional 

practice, and beneath the standard of 

care in Florida. See RD, at 18–19; GX 14; 

857, 925–26. Based on Dr. Rubenstein’s 

testimony and the record as a whole, 

these prescriptions were issued beneath 

the standard of care and outside the 

usual course of professional practice 

because Respondent failed to 

appropriately establish or document a 

medical indication (RD, at 8; GX 13; Tr. 

863, 868–69, 885, 896–97, 904–06), 

maintained Patient R.J. on high doses 

and high-risk combinations of 

controlled substances without any 

established or documented medical 

indication (RD, at 8–9; GX 13; Tr. 866– 

67, 898, 905–06, 925), issued 

prescriptions on dates prior to 

correlating patient visits (RD, at 9; GX 

13–14; Tr. 914–17), failed to resolve or 

adequately address signs of potential 

diversion prior to issuing prescriptions 

(RD, at 9; GX 13; Tr. 920–23, 925), failed 

to document and maintain copies of 

certain prescriptions (RD, at 9; GX 13– 

14; Tr. 917–20), and/or created patient 

records with inconsistent information 

(RD, at 9; GX 13–14; Tr. 882, 911, 914). 

Patient A.H. 

Regarding Patient A.H., the Agency 

finds that Respondent issued at least 19 

controlled substance prescriptions from 

June 26, 2019, through November 11, 

2020, without a legitimate medical 

purpose, outside the usual course of 

professional practice, and beneath the 

standard of care in Florida. See RD, at 

18–19; GX 16; Tr. 927–28, 931. Based on 

Dr. Rubenstein’s testimony and the 

record as a whole, these prescriptions 

were issued beneath the standard of care 

and outside the usual course of 

professional practice because 

Respondent failed to appropriately 

establish or document a medical 

indication (RD, at 8; GX 15; Tr. 927–29), 

maintained Patient A.H. on high doses 

and high-risk combinations of 

controlled substances without any 

established or documented medical 

indication (RD, at 8–9; GX 15; Tr. 927– 


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7Respondent also issued four controlled 

substance prescriptions to Patient K.L. when 

Respondent was not in the country. See supra, 

Patient K.L. 

29), and/or failed to conduct and 

document a physical examination, 

obtain and document a medical history, 

monitor and document compliance, 

and/or create and document a treatment 

plan (RD, at 9–10; GX 15; Tr. 928–31). 

Patient R.H. 

Regarding Patient R.H., the Agency 

finds that Respondent issued at least 37 

controlled substance prescriptions from 

September 27, 2017, through November 

4, 2020, without a legitimate medical 

purpose, outside the usual course of 

professional practice, and beneath the 

standard of care in Florida. See RD, at 

18–19; GX 18; Tr. 934, 941. Based on Dr. 

Rubenstein’s testimony and the record 

as a whole, these prescriptions were 

issued beneath the standard of care and 

outside the usual course of professional 

practice because Respondent failed to 

appropriately establish or document a 

medical indication (RD, at 8; GX 17; Tr. 

939), maintained Patient R.H. on high 

doses and high-risk combinations of 

controlled substances without any 

established or documented medical 

indication (RD, at 8–9; GX 17; Tr. 712, 

933–34), and/or failed to conduct and 

document a physical examination, 

obtain and document a medical history, 

monitor and document compliance, 

and/or create and document a treatment 

plan (RD, at 9–10; GX 17; Tr. 934–35, 

939–41). 

Patients M.P., C.C., and C.A. 

The Agency finds that Respondent 

issued one controlled substance 

prescription each to Patients M.P., C.C., 

and C.A.—on January 3, 2019, January 

2, 2019, and December 26, 2018, 

respectively—without a legitimate 

medical purpose, outside the usual 

course of professional practice, and 

beneath the standard of care in 

Florida.7 See RD, at 18–19; Tr. 945–46, 

949–50, 956, 959–60. Although office 

visit notes indicated that Respondent 

had conducted in-person examinations 

of these patients, testimony by the DI 

and TFA, as well as U.S. Customs and 

Border Protection records, established 

that Respondent was not in the United 

States when he issued these controlled 

substance prescriptions. RD, at 5; GX 20, 

22–27; Tr. 141–48, 608–25. Based on 

this evidence and related testimony by 

Dr. Rubenstein, these controlled 

substance prescriptions were issued to 

M.P., C.C., and C.A. without a legitimate 

medical purpose, outside the usual 

course of professional practice, and 

beneath the standard of care in Florida. 

RD, at 9; Tr. 941–56, 960. 

II. Discussion 

According to the CSA, a practitioner’s 

application for a DEA registration may 

be denied upon a determination that 

‘‘the issuance of such registration . . . 

would be inconsistent with the public 

interest.’’ 21 U.S.C. 823(g)(1). In the case 

of a practitioner, the CSA requires that 

the Agency consider the following 

factors in determining whether an 

applicant’s registration would be 

inconsistent with the public interest: 

(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 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). 

DEA considers these public interest 

factors in the disjunctive. Robert A. 

Leslie, M.D., 68 FR 15227, 15230 (2003). 

Each factor is weighed on a case-by-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). 

The Government has the burden of 

proof in this proceeding. 21 CFR 

1301.44. While the Agency has 

considered all of the public interest 

factors in 21 U.S.C. 823(g)(1), the 

Government’s evidence in support of its 

prima facie case for denying 

Respondent’s application is confined to 

Factors B and D. See RD, at 13, n.24 

(finding that Factors A, C, and E do not 

weigh for or against the sanction sought 

by the Government). 

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). DEA 

regulations require that for a 

prescription for a controlled substance 

to be effective, it must be issued for a 

legitimate medical purpose by an 

individual practitioner acting in the 

usual course of professional practice. 21 

CFR 1306.04(a); see also 21 U.S.C. 829. 

Based on Dr. Rubenstein’s 

uncontroverted expert opinion, the 

Agency finds that Respondent issued 

more than 250 prescriptions outside of 

the usual course of professional practice 

and beneath the Florida standard of care 

in violation of Federal law. See supra I. 

Additionally, the Agency finds that 

Respondent violated Fla. Stat. section 

456.44(3) with regard to patients K.L., 

R.J., A.H., and R.H., by failing to obtain 

and/or document a medical history, 

establish and/or document a medical 

indication for prescribing, conduct and/ 

or document a physical examination, 

create and/or document a treatment 

plan, monitor and document 

compliance, and/or maintain accurate 

and complete medical records. 

The Agency finds that for each of the 

seven patients at issue, Respondent 

failed to maintain sufficiently detailed 

medical records that were accurate and 

complete and, among other things, 

justified the course of medical 

treatment, thereby violating Fla. Stat. 

section 456.44(3), Fla. Stat. section 

458.331(1)(m), and Fla. Admin. Code r. 

64B8–9.003. Lastly, the Agency finds 

that Respondent violated Fla. Stat. 

section 458.331(1)(k) by preparing office 

visit notes stating that he had conducted 

in-person examinations of patients K.L., 

M.P., C.C., and C.A., when in fact he 

was not in the United States. This 

conduct violated Florida law and 

further rendered Respondent’s 

dispensing outside the usual course of 

professional practice. 

In sum, and in agreement with the 

RD, the Agency finds that the record 

contains substantial evidence that 

Respondent prescribed and dispensed 

controlled substances in violation of 

both Federal and State law. RD, at 18; 

see 21 U.S.C. 829; 21 CFR 1306.04(a); 

Fla. Stat. sections 456.44(3), 

458.331(1)(k), 458.331(1)(m); Fla. 

Admin. Code r. 64B8–9.003. In 

weighing Factors B and D, the Agency 

finds that the Government has 

established a prima facie case that 

Respondent committed acts that render 

his registration inconsistent with the 

public interest and support denial of his 

registration application. See 21 U.S.C. 

823(g)(1). 

III. Sanction 

Where, as here, the Government has 

established grounds to deny 

Respondent’s application, the burden 

shifts to the respondent 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 respondent has committed acts 

inconsistent with the public interest, he 

must both accept responsibility and 


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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). 

When a respondent declines to testify 

and ‘‘neither [takes] responsibility for 

his misconduct nor provid[es] any 

assurances that he has implemented 

remedial measures to ensure such 

conduct is not repeated,’’ the 

respondent’s silence weighs against 

registration. Zvi H. Perper, M.D., 77 FR 

64131, 64142 (2012) (citing Medicine 

Shoppe-Jonesborough, 73 FR 364, 387 

(2008)); see also Jeanne E. Germeil, 

M.D., 85 FR 73786, 73803 (2020). Such 

silence also warrants an adverse 

inference against the respondent. 

MacKay v. Drug Enf’t Admin, 664 F.3d 

808, 820 (10th Cir. 2011) (upholding the 

Agency’s finding that a respondent’s 

failure to testify warranted an adverse 

inference because there was ‘‘no 

evidence that [respondent] recognized 

the extent of his misconduct and was 

prepared to remedy his prescribing 

practices’’); T.J. McNichol, M.D., 77 FR 

57133, 57153–54 (2012) (stating that ‘‘it 

is appropriate to draw an adverse 

inference from Respondent’s failure to 

testify’’). 

Here, Respondent has failed to accept 

responsibility or offer any basis for the 

Agency to trust him, despite his past 

misconduct, with the responsibility of a 

registration. RD, at 21. In light of 

Respondent’s silence, he has not 

sufficiently demonstrated that he can be 

entrusted with a DEA registration. See 

id.; MacKay, 664 F.3d at 820; Jeanne E. 

Germeil, M.D., 85 FR at 73803; Zvi H. 

Perper, M.D., 77 FR at 64142. 

In addition to acceptance of 

responsibility, the Agency looks to the 

egregiousness and extent of the 

misconduct, Garrett Howard Smith, 

M.D., 83 FR at 18910 (collecting cases), 

and considers both specific and general 

deterrence when determining an 

appropriate sanction. Daniel A. Glick, 

D.D.S., 80 FR 74800, 74810 (2015). Here, 

Respondent’s blatant and repeated 

disregard for the laws relating to 

controlled substances warrants a 

sanction. Respondent’s inappropriate 

and unlawful prescribing of controlled 

substances placed multiple patients, 

and the public, at risk of harm. In this 

case, the Agency believes that denial of 

Respondent’s application would deter 

Respondent and the general registrant 

community from disregarding 

controlled substance laws and engaging 

in the pattern of misconduct that 

permeated Respondent’s actions as a 

registrant. See RD, at 22. As the Chief 

ALJ noted, ‘‘[t]he misconduct 

established was sufficiently egregious 

that a denial is strongly supported.’’ RD, 

at 22. Further, there is no evidence that 

Respondent’s behavior is unlikely to 

recur in the future such that the Agency 

can entrust him with a registration. 

In sum, the public interest factors 

weigh in favor of denial as a sanction; 

accordingly, the Agency shall order the 

sanctions the Government requested, as 

contained in the Order below. 

Order 

Pursuant to 28 CFR 0.100(b) and the 

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

823(g)(1), I hereby deny the DEA 

registration application of Osmin A. 

Morales, M.D. (Control No. 

W20125906C) and any other pending 

application of Osmin A. Morales, M.D., 

for a DEA registration in Florida. This 

Order is effective December 4, 2023. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on October 25, 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. 2023–24151 Filed 11–1–23; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1228P] 

Proposed Aggregate Production 

Quotas for Schedule I and II Controlled 

Substances and Assessment of 

Annual Needs for the List I Chemicals 

Ephedrine, Pseudoephedrine, and 

Phenylpropanolamine for 2024 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Notice with request for 

comments. 

SUMMARY: The Drug Enforcement 

Administration (DEA) proposes to 

establish the 2024 aggregate production 

quotas (APQ) for controlled substances 

in schedules I and II of the Controlled 

Substances Act (CSA) and the 

assessment of annual needs (AAN) for 

the list I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. For the 2024 

quota year, DEA intends to allocate 

procurement quotas to DEA-registered 

manufacturers of schedule II controlled 

substances on a quarterly basis. In order 

to address domestic drug shortages of 

controlled substances, procurement 

quota allocations will be divided 

between quantities authorized for 

domestic sales and quantities 

authorized for export sales. 

DATES: Electronic comments must be 

submitted, and written comments must 

be postmarked, on or before December 

4, 2023. Interested persons may file 

written comments on this notice in 

accordance with 21 CFR 1303.11(c) and 

1315.11(d). Commenters should be 

aware that the electronic Federal Docket 

Management System will not accept 

comments after 11:59 p.m. Eastern Time 

on the last day of the comment period. 

Based on comments received in 

response to this notice, the 

Administrator may hold a public 

hearing on one or more issues raised. In 

the event the Administrator decides in 

her sole discretion to hold such a 

hearing, the Administrator will publish 

a notice of any such hearing in the 

Federal Register. After consideration of 

any comments or objections, or after a 

hearing, if one is held, the 

Administrator will publish in the 

Federal Register a final order 

establishing the 2024 aggregate 

production quotas for schedule I and II 

controlled substances, and an 

assessment of annual needs for the list 

I chemicals ephedrine, 

pseudoephedrine, and 

phenylpropanolamine. 


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