9166 Federal Register / Vol. 90, No. 25 / Friday, February 7, 2025 / Notices 

1Commissioner Schmidtlein stepped down from 

the Commission on January 31, 2025. 

2Commissioner Kearns respectfully dissents from 

the Commission’s decision and has filed a separate 

opinion explaining his views. 

1Based on the Government’s submissions in its 

RFAA dated April 18, 2024, the Agency finds that 

service of the OSC on Registrant was adequate. 

Specifically, the Declaration from a DEA Diversion 

Investigator (DI) indicates that on February 29, 

2024, the DI successfully served the OSC via email 

to Registrant’s registered email address, as the DI’s 

email was not returned undeliverable. RFAAX 2, at 

2; Mohammed S. Aljanaby, M.D., 82 FR 34552, 

34552 (2017) (finding that service by email satisfies 

due process where the email is not returned as 

undeliverable and other methods have been 

unsuccessful). 

The DI made several other attempts to serve 

Registrant with the OSC, but they were unsucessful. 

On February 27, 2024, the DI attempted personal 

service at Registrant’s last known forwarding 

address. RFAAX 2, at 2. The DI left a copy of the 

OSC at the address and asked the current residents 

to give the documents to Registrant. Id. Also on this 

date, the DI called and texted Registrant via a 

telephone number provided by the current residents 

and received no response. Id. On February 29, 2024, 

the DI attempted to contact Registrant by his 

registered phone number and left her contact 

information with an acquaintance of Registrant who 

answered the phone. Id. at 2–3. On March 1, 2024, 

the DI sent the OSC via certified mail to four 

addresses associated with Registrant, including 

Registrant’s registered address. Id. at 3, Attachment 

C. According to the DI, all four mailings were 

returned unable to forward. Id. at 3. The DI also 

contacted the Medical Board of California in 

attempting service, but the Board was unable to 

provide a current address. Id. at 3. 

In sum, the Agency finds that Registrant was 

successfully served the OSC by email and the DI’s 

efforts to serve Registrant by other means were 

‘‘ ‘reasonably calculated, under all the 

circumstances, to apprise [Registrant] of the 

pendency of the action.’ ’’ Jones v. Flowers, 547 U.S. 

220, 226 (2006) (quoting Mullane v. Central 

Hanover Bank & Trust Co., 339 U.S. 306, 314 

(1950)). Therefore, due process notice requirements 

have been satisfied. 

infringement of claim 1 of the ’295 

patent. The Final ID included a 

recommended determination (‘‘RD’’) on 

remedy and bonding that recommended 

issuance of a limited exclusion order 

directed to the three remaining 

respondents and a cease and desist 

order directed to Summit. See Final ID 

at 73–87. 

On May 16, 2024, the Commission 

determined to review the Final ID in 

part. 89 FR 45012–15 (May 22, 2024). 

The Commission determined not to 

review the Final ID’s findings with 

respect to claim construction, 

infringement, and the technical prong of 

the domestic industry requirement. Id. 

at 45013. On July 23, 2024, the 

Commission determined to supplement 

the Final ID and to reverse-in-part Order 

No. 19 and remand the investigation to 

the CALJ for further proceedings with 

respect to the written description 

requirement. See Comm’n Notice (July 

23, 2024); Comm’n Op. (July 23, 2024); 

Remand Order (July 23, 2024). 

On remand, the parties agreed that a 

live hearing was unnecessary and the 

CALJ set a procedural schedule for the 

submission of evidence and the parties’ 

briefing and extended the target date to 

February 10, 2025. Order No. 23 (Aug. 

1, 2024), unreviewed by Comm’n Notice 

(Aug. 27, 2024). The parties conducted 

additional expert discovery and the 

CALJ admitted the resulting evidence 

into the record. Order No. 24 (Sept. 3, 

2024). 

On November 8, 2024, the CALJ 

issued the Remand ID finding that claim 

1 of the ’295 is not invalid for lack of 

written description under 35 U.S.C. 112. 

OUII filed a petition for review on 

November 21, 2024. Respondents filed a 

petition for review on November 29, 

2024. West filed a response to OUII’s 

petition for review on November 29, 

2024. West filed a response to 

Respondents’ petition for review on 

December 6, 2024. 

On December 20, 2024, the 

Commission determined to review the 

Remand ID in its entirety. On review, 

the Commission has determined to take 

no position with respect to certain 

statements in the Remand ID.1

Specifically, the Commission takes no 

position on the second sentence of the 

last paragraph on page 5 continuing to 

page 6 (‘‘The Commission concluded 

that OUII, . . .’’) and the subsequent 

citations (‘‘Id. at 18 . . .; see also; . . .; 

but cf. . . . .’’); and the Commission 

takes no position on the second 

sentence in the first full paragraph on 

page 7 (‘‘Because OUII . . . .’’). The 

Commission has determined to affirm 

the remainder of the Remand ID. 

Because the Commission previously 

determined not to review the finding on 

summary determination with respect to 

the economic prong of the domestic 

industry requirement and the findings 

in the Final ID with respect to claim 

construction, infringement, and the 

technical prong of the domestic industry 

requirement, the Commission has 

determined that there has been a 

violation of section 337 with respect to 

infringement of claim 1 of the ’295 

patent.2

For remedy, the Commission has 

determined to issue a limited exclusion 

order prohibiting further importation of 

infringing products by the three 

remaining respondents and a cease and 

desist order against Respondent 

Summit. The Commission has 

determined that the public interest 

factors do not counsel against issuing 

remedial orders. The Commission has 

determined that bond should be set in 

the amount of zero percent (0%) (i.e., no 

bond). 

The Commission vote for this 

determination took place on February 3, 

2025. 

This action is taken under the 

authority of section 337 of the Tariff Act 

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

and in Part 210 of the Commission’s 

Rules of Practice and Procedure (19 CFR 

part 210). 

By order of the Commission. 

Issued: February 3, 2025. 

Lisa Barton, 

Secretary to the Commission. 

[FR Doc. 2025–02336 Filed 2–6–25; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Massoud Amini, M.D.; Decision and 

Order 

On February 23, 2024, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause (OSC) to Massoud Amini, M.D., 

of Woodland Hills, California. 

(Registrant). Request for Final Agency 

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

3. The OSC proposed the revocation of 

Registrant’s DEA Certificate of 

Registration No. BA6612142, alleging 

that Registrant’s registration should be 

revoked because Registrant is ‘‘currently 

without authority to handle controlled 

substances in California, the state in 

which [he is] registered with DEA.’’ Id. 

at 2 (citing 21 U.S.C. 824(a)(3)). 

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. (citing 21 CFR 

1301.43). Here, Registrant did not 

request a hearing. RFAA, at 2.1 ‘‘A 

default, unless excused, shall be 

deemed to constitute a waiver of the 

[registrant’s] right to a hearing and an 

admission of the factual allegations of 

the [OSC].’’ 21 CFR 1301.43(e). 

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. 


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Federal Register / Vol. 90, No. 25 / Friday, February 7, 2025 / Notices 9167 

2Under the Administrative Procedure Act, an 

agency ‘‘may take official notice of facts at any stage 

in a proceeding—even in the final decision.’’ 

United States Department of Justice, Attorney 

General’s Manual on the Administrative Procedure 

Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 

1979). Pursuant to 5 U.S.C. 556(e), ‘‘[w]hen an 

agency decision rests on official notice of a material 

fact not appearing in the evidence in the record, a 

party is entitled, on timely request, to an 

opportunity to show the contrary.’’ Accordingly, 

Registrant may dispute the Agency’s finding by 

filing a properly supported motion for 

reconsideration of findings of fact within fifteen 

calendar days of the date of this Order. Any such 

motion and 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. 

3This rule derives from the text of two provisions 

of the Controlled Substances Act (CSA). First, 

Congress defined the term ‘‘practitioner’’ to mean 

‘‘a physician . . . or other person licensed, 

registered, or otherwise permitted, by . . . the 

jurisdiction in which he practices . . . , to 

distribute, dispense, . . . [or] administer . . . a 

controlled substance in the course of professional 

practice.’’ 21 U.S.C. 802(21). Second, in setting the 

requirements for obtaining a practitioner’s 

registration, Congress directed that ‘‘[t]he Attorney 

General shall register practitioners . . . 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). Because Congress 

has clearly mandated that a practitioner possess 

state authority in order to be deemed a practitioner 

under the CSA, DEA has held repeatedly that 

revocation of a practitioner’s registration is the 

appropriate sanction whenever he is no longer 

authorized to dispense controlled substances under 

the laws of the state in which he practices. See, e.g., 

James L. Hooper, 76 FR 71371, 71372; Sheran 

Arden Yeates, D.O., 71 FR 39130, 39131 (2006); 

Dominick A. Ricci, D.O., 58 FR 51104, 51105 (1993); 

Bobby Watts, D.O., 53 FR 11919, 11920 (1988); 

Frederick Marsh Blanton, 43 FR 27617. 

1On June 17, 2024, Respondent filed a Motion to 

Continue Show Cause Hearing to request a 

continuance on the instant proceedings, which the 

Administrative Law Judge denied. 

I. Findings of Fact 

The Agency finds that, in light of 

Registrant’s default, the factual 

allegations in the OSC are admitted. 

According to the OSC, effective January 

12, 2024, the Medical Board of 

California revoked Registrant’s 

California medical license. RFAAX 1, at 

2. According to California’s online 

records, of which the Agency takes 

official notice, Registrant’s California 

medical license remains revoked.2

California DCA License Search, https:// 

search.dca.ca.gov/ (last visited date of 

signature of this Order). Accordingly, 

the Agency finds that Registrant is not 

licensed to practice medicine in 

California, the state in which he is 

registered with DEA. 

II. Discussion 

Pursuant to 21 U.S.C. 824(a)(3), the 

Attorney General is authorized to 

suspend or revoke a registration issued 

under 21 U.S.C. 823 ‘‘upon a finding 

that the registrant . . . has had his State 

license or registration suspended . . . 

[or] revoked . . . by competent State 

authority and is no longer authorized by 

State law to engage in the . . . 

dispensing of controlled substances.’’ 

With respect to a practitioner, DEA has 

also long held that the possession of 

authority to dispense controlled 

substances under the laws of the state in 

which a practitioner engages in 

professional practice is a fundamental 

condition for obtaining and maintaining 

a practitioner’s registration. See, e.g., 

James L. Hooper, D.O., 76 FR 71371, 

71372 (2011), pet. for rev. denied, 481 

F. App’x 826 (4th Cir. 2012); Frederick 

Marsh Blanton, D.O., 43 FR 27616, 

27617 (1978).3

According to California statute, 

‘‘dispense’’ means ‘‘to deliver a 

controlled substance to an ultimate user 

or research subject by or pursuant to the 

lawful order of a practitioner, including 

the prescribing, furnishing, packaging, 

labeling, or compounding necessary to 

prepare the substance for that delivery.’’ 

Cal. Health & Safety Code section 11010 

(West 2024). Furthermore, a 

‘‘practitioner’’ means a person 

‘‘licensed, registered, or otherwise 

permitted, to distribute, dispense, 

conduct research with respect to, or 

administer, a controlled substance in 

the course of professional practice or 

research in [the] state.’’ Id. 

section 11026(c). 

Here, the undisputed evidence in the 

record is that Registrant currently lacks 

authority to practice medicine in 

California. As discussed above, a 

physician must be a licensed 

practitioner to dispense a controlled 

substance in California. Thus, because 

Registrant currently lacks authority to 

practice medicine in California and, 

therefore, is not currently authorized to 

handle controlled substances in 

California, Registrant is not eligible to 

maintain a DEA registration. 

Accordingly, the Agency will order that 

Registrant’s DEA registration be 

revoked. 

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. BA6612142 issued to 

Massoud Amini, 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 Massoud Amini, M.D., to renew or 

modify this registration, as well as any 

other pending application of Massoud 

Amini, M.D., for additional registration 

in California. This Order is effective 

March 10, 2025. 

Signing Authority 

This document of the Drug 

Enforcement Administration was signed 

on January 31, 2025, by Acting 

Administrator Derek Maltz. That 

document with the original signature 

and date is maintained by DEA. For 

administrative purposes only, and in 

compliance with requirements of the 

Office of the Federal Register, the 

undersigned DEA Federal Register 

Liaison Officer has been authorized to 

sign and submit the document in 

electronic format for publication, as an 

official document of DEA. This 

administrative process in no way alters 

the legal effect of this document upon 

publication in the Federal Register. 

Heather Achbach, 

Federal Register Liaison Officer, Drug 

Enforcement Administration. 

[FR Doc. 2025–02342 Filed 2–6–25; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 24–47] 

Herold Pierre-Louis, P.A.; Decision and 

Order 

On May 21, 2024, the Drug 

Enforcement Administration (DEA or 

Government) issued an Order to Show 

Cause (OSC) to Herold Pierre-Louis, 

P.A., of Tucson, Arizona (Respondent). 

OSC, at 1, 3. The OSC proposed the 

revocation of Respondent’s DEA 

Certificate of Registration No. 

MP7845766, alleging that Respondent’s 

DEA registration should be revoked 

because Respondent is ‘‘without 

authority to prescribe, administer, 

dispense, or otherwise handle 

controlled substances in the State of 

Arizona, the state in which [he is] 

registered with DEA.’’ Id. at 2 (citing 21 

U.S.C. 824(a)(3)). 

On May 30, 2024, Respondent 

requested a hearing and filed an Answer 

to the OSC. On June 10, 2024, the 

Government filed a Motion for 

Summary Disposition, to which 

Respondent did not respond.1 On June 

27, 2024, Administrative Law Judge 

Paul E. Soeffing (the ALJ) granted the 

Government’s Motion for Summary 

Disposition and recommended the 

revocation of Respondent’s registration, 

finding that because Respondent lacks 

state authority to handle controlled 

substances in Arizona, the state in 

which he is registered with DEA, ‘‘there 

is no other fact of consequence for this 

tribunal to decide.’’ Order Granting the 


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