Importer of Controlled Substances Application: Curia New York, Inc., 106589-106590 [2024-31292]

Download as PDF Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 Discussion Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act (CSA) ‘‘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. Gonzales v. Oregon, 546 U.S. 243, 270 (2006) (‘‘The Attorney General can register a physician to dispense controlled substances ‘if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.’ . . . The very definition of a ‘practitioner’ eligible to prescribe includes physicians ‘licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices’ to dispense controlled substances. § 802(21).’’). The Agency has applied these principles consistently. See, e.g., James L. Hooper, M.D., 76 FR 71371, 71372 (2011), pet. for rev. denied, 481 F. App’x 826 (4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27616, 27617 (1978).4 Under Louisiana statute, ‘‘dispense’’ means ‘‘to deliver a controlled dangerous substance to the ultimate user or human research subject by or pursuant to the lawful order of a practitioner, including the packaging, labeling, or compounding necessary to 4 This rule derives from the text of two provisions of the 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, M.D., 76 FR 71371–72; Sheran Arden Yeates, M.D., 71 FR 39130, 39131 (2006); Dominick A. Ricci, M.D., 58 FR 51104, 51105 (1993); Bobby Watts, M.D., 53 FR 11919, 11920 (1988); Frederick Marsh Blanton, M.D., 43 FR 27617. VerDate Sep<11>2014 23:58 Dec 27, 2024 Jkt 265001 prepare the substance for such delivery.’’ La. Stat. Ann. section 40:961(14) (2024). A ‘‘practitioner’’ means ‘‘a physician . . . or other person licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or administer a controlled dangerous substance in the course of professional practice or research in th[e] state.’’ Id. section 40:961(35). Further, Louisiana statute states that ‘‘[e]very person who . . . distributes, procures, possesses, prescribes, or dispenses any controlled dangerous substance within th[e] state . . . shall obtain a controlled dangerous substance license issued by the Louisiana Board of Pharmacy in accordance with the rules and regulations promulgated by the board prior to engaging in such activity.’’ Id. section 40:973(A)(1). Here, the undisputed evidence in the record is that Respondent currently lacks authority to handle controlled substances in Louisiana because Respondent’s Louisiana medical license is suspended, and Respondent’s Louisiana controlled substance license is lapsed. As discussed above, an individual must be a licensed practitioner and must hold a Louisiana controlled substance license to dispense controlled substances in Louisiana. Thus, because Respondent lacks authority to practice medicine in Louisiana, as well as lacks authority to handle controlled substances in Louisiana, Respondent is not eligible to maintain a DEA registration. RD, at 5– 6. Accordingly, the Agency will order that Respondent’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. BA7786013 issued to Shiva Akula, 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 Shiva Akula, M.D., to renew or modify this registration, as well as any other pending application of Shiva Akula, M.D., for additional registration in Louisiana. This Order is effective January 29, 2025. Signing Authority This document of the Drug Enforcement Administration was signed on December 20, 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 PO 00000 Frm 00184 Fmt 4703 Sfmt 4703 106589 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. 2024–31320 Filed 12–27–24; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–1463] Importer of Controlled Substances Application: Curia New York, Inc. Drug Enforcement Administration, Justice. ACTION: Notice of application. AGENCY: Curia New York, Inc. has 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 January 29, 2025. Such persons may also file a written request for a hearing on the application on or before January 29, 2025. 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 SUMMARY: E:\FR\FM\30DEN1.SGM 30DEN1 106590 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 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. In accordance with 21 CFR 1301.34(a), this is notice that on November 13, 2024, SUPPLEMENTARY INFORMATION: Curia New York, Inc., 33 Riverside Avenue, Rensselaer, New York 12144, applied to be registered as an importer of the following basic class(es) of controlled substance(s): Controlled substance Drug code Gamma Hydroxybutyric Acid ................................................................................................................................... The company plans to import the listed controlled substances for bulk manufacturing into other controlled substances to be distributed to their customers. No other activity for this drug code is 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. Matthew Strait, Deputy Assistant Administrator. [FR Doc. 2024–31292 Filed 12–27–24; 8:45 am] 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 September 1, 2023, the Dental Board of BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration ddrumheller on DSK120RN23PROD with NOTICES1 Samreen Riaz, D.D.S.; Decision and Order On February 27, 2024, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause (OSC) to Samreen Riaz, D.D.S., of Hawthorne, California (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 2, at 1, 3. The OSC proposed the revocation of Registrant’s Certificate of Registration No. FR4257792, alleging that Registrant’s registration should be revoked because Registrant is ‘‘currently without authority to prescribe, administer, dispense, or otherwise handle controlled substances in the State of California, the state in which [she is] registered with DEA.’’ Id. at 2 (citing 21 U.S.C. 824(a)(3)). The OSC notified Registrant of her right to file a written request for hearing, and that if she failed to file such a request, she would be deemed to have waived her right to a hearing and be in default. Id. (citing 21 CFR 1301.43). Here, Registrant did not request a VerDate Sep<11>2014 23:58 Dec 27, 2024 Jkt 265001 hearing. RFAA, at 3.1 ‘‘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. 1 Based on the Government’s submissions in its RFAA dated May 23, 2024, the Agency finds that service of the OSC on Registrant was adequate. The included declaration from a DEA Diversion Investigator (DI) indicates that on March 12, 2024, the DI attempted to serve Registrant with the OSC at Registrant’s registered address, a clinic. RFAAX 1, at 1. However, the clinic manager who was at the registered location claimed to not know Registrant, despite working at the location for nearly five years. Id. The DI then left several voicemails with the clinic’s Human Resources department, which went unanswered. Id. at 2. On March 19, 2024, the DI mailed a copy of the OSC to a different address Registrant had on file with DEA; however, as of April 5, 2024, the mailing was never claimed by Registrant and was scheduled to be returned to DEA. Id. Finally, on April 5, 2024, the DI emailed a copy of the OSC to Registrant’s registered email address. Id.; see also id., Attachment A. The DI did not receive any error message in response to the email. Id. at 2. Accordingly, the Agency finds that Registrant was successfully served the OSC by email. 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). Further, the Agency finds that 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. PO 00000 Frm 00185 Fmt 4703 Sfmt 4703 2010 Schedule I California revoked Registrant’s California dental license. RFAAX 2, at 2. According to California online records, of which the Agency takes official notice, Registrant’s California dental 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 as a dentist in California, the state in which she is registered with DEA. 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. Gonzales v. Oregon, 546 U.S. 243, 270 (2006) (‘‘The Attorney General can register a physician to dispense controlled substances ‘if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.’ . . . The very definition of a ‘practitioner’ eligible to 2 Under 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. E:\FR\FM\30DEN1.SGM 30DEN1

Agencies

[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106589-106590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31292]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1463]


Importer of Controlled Substances Application: Curia New York, 
Inc.

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Notice of application.

-----------------------------------------------------------------------

SUMMARY: Curia New York, Inc. has 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 
January 29, 2025. Such persons may also file a written request for a 
hearing on the application on or before January 29, 2025.

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

[[Page 106590]]

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 November 13, 2024, Curia New York, Inc., 33 Riverside 
Avenue, Rensselaer, New York 12144, applied to be registered as an 
importer of the following basic class(es) of controlled substance(s):

------------------------------------------------------------------------
          Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid...............            2010               I
------------------------------------------------------------------------

    The company plans to import the listed controlled substances for 
bulk manufacturing into other controlled substances to be distributed 
to their customers. No other activity for this drug code is 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 non-approved finished 
dosage forms for commercial sale.

Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-31292 Filed 12-27-24; 8:45 am]
BILLING CODE P
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