Importer of Controlled Substances Application: Catalent CTS, LLC, 54613-54614 [2018-23686]

Download as PDF 54613 Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Sigma Aldrich Research ACTION: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: DEPARTMENT OF JUSTICE Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 31, 2018. DATES: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of SUPPLEMENTARY INFORMATION: manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been delegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on June 14, 2018, Sigma Aldrich Research, 1–3 Strathmore Road, Natick, Massachusetts 01760–2447 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Drug code Cathinone ........................................................................................................................................................................ Mephedrone (4-Methyl-N-methylcathinone) .................................................................................................................... Lysergic acid diethylamide .............................................................................................................................................. 3,4-Methylenedioxymethamphetamine ............................................................................................................................ Dimethyltryptamine .......................................................................................................................................................... 5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................................. MDPV (3,4-Methylenedioxypyrovalerone) ....................................................................................................................... Heroin .............................................................................................................................................................................. Normorphine .................................................................................................................................................................... Norlevorphanol ................................................................................................................................................................ Amphetamine ................................................................................................................................................................... Nabilone ........................................................................................................................................................................... Cocaine ............................................................................................................................................................................ Codeine ........................................................................................................................................................................... Ecgonine .......................................................................................................................................................................... Levorphanol ..................................................................................................................................................................... Meperidine ....................................................................................................................................................................... Methadone ....................................................................................................................................................................... Morphine .......................................................................................................................................................................... Thebaine .......................................................................................................................................................................... Levo-alphacetylmethadol ................................................................................................................................................. Remifentanil ..................................................................................................................................................................... Sufentanil ......................................................................................................................................................................... Carfentanil ....................................................................................................................................................................... Fentanyl ........................................................................................................................................................................... issuance of the proposed registration on or before November 29, 2018. Such persons may also file a written request for a hearing on the application on or before November 29, 2018. The company plans to manufacture reference standards. Dated: October 11, 2018. John J. Martin, Assistant Administrator. BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration khammond on DSK30JT082PROD with NOTICES [Docket No. DEA–392] Importer of Controlled Substances Application: Catalent CTS, LLC ACTION: Notice of application. Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the DATES: VerDate Sep<11>2014 17:34 Oct 29, 2018 Jkt 247001 Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also 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. ADDRESSES: [FR Doc. 2018–23695 Filed 10–29–18; 8:45 am] PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 1235 1248 7315 7405 7435 7439 7535 9200 9313 9634 1100 7379 9041 9050 9180 9220 9230 9250 9300 9333 9648 9739 9740 9743 9801 Schedule I I I I I I I I I I II II II II II II II II II II II II II II II SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (‘‘Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on July 17, 2018, Catalent CTS, LLC, 10245 Hickman Mills Drive, Kansas City, E:\FR\FM\30OCN1.SGM 30OCN1 54614 Federal Register / Vol. 83, No. 210 / Tuesday, October 30, 2018 / Notices [FR Doc. 2018–23686 Filed 10–29–18; 8:45 am] dispense controlled substances in schedules II through V as a practitioner. Id. The OSC alleges that this registration expires on December 31, 2018. Id. The substantive ground for the proceeding, as alleged in the OSC, is that Registrant is ‘‘without authority to handle controlled substances in New Hampshire, the state in which [he is] registered with the DEA.’’ Id. Specifically, the OSC alleges that the State of New Hampshire Board of Medicine (hereinafter, Board) issued an Order of Emergency License Suspension and Notice of Hearing on September 25, 2017. Id. at 1–2. On the following day, September 26, 2017, Registrant entered into a written agreement ‘‘not to practice medicine [including the writing of] prescriptions . . . until further order of the Board.’’ Id. at 2. The OSC notifies Registrant of his right to request a hearing on the allegations or to submit a written statement while waiving his right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option. Id. (citing 21 CFR 1301.43). The OSC also notifies Registrant of the opportunity to submit a corrective action plan. OSC, at 2–3 (citing 21 U.S.C. 824(c)(2)(C)). BILLING CODE 4410–09–P Adequacy of Service Missouri 64137–1418 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Gamma Hydroxybutyric Acid. Marihuana Extract ............. Marihuana ......................... Tetrahydrocannabinols ..... Drug code Schedule 2010 I 7350 7360 7370 I I I The company plans to import finished dosage unit products containing gammahydroxybutryic acid and marihuana extracts for clinical trial studies. These marihuana extracts compounds are listed under drug code 7350. No other activity for these drug codes 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 FDA-approved or nonapproved finished dosage forms for commercial sale. Dated: October 19, 2018. John J. Martin, Assistant Administrator. DEPARTMENT OF JUSTICE Drug Enforcement Administration khammond on DSK30JT082PROD with NOTICES Eric Lee Knight, M.D.; Decision and Order On February 6, 2018, the Acting Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause to Eric Lee Knight, M.D. (hereinafter, Registrant), of Derry, New Hampshire. Order to Show Cause (hereinafter, OSC), at 1. The OSC proposes the revocation of Registrant’s Certificate of Registration on the ground that he does ‘‘not have authority to handle controlled substances in the State of New Hampshire, the state in which . . . [he is] registered with the DEA.’’ Id. (citing 21 U.S.C. 823(f) and 824(a)(3)). Regarding jurisdiction, the OSC alleges that Registrant holds DEA Certificate of Registration No. BK7282940 at the registered address of 93 1⁄2 Walnut Hill Road, Derry, New Hampshire 03038.1 OSC, at 1. This registration authorizes Registrant to 1 The OSC erroneously lists the number of Registrant’s address on Walnut Hill Road as 92 1⁄2. VerDate Sep<11>2014 17:34 Oct 29, 2018 Jkt 247001 In a Declaration dated April 27, 2018, a Diversion Investigator (hereinafter, DI), who describes herself as being assigned to the DEA Boston Field Division-Manchester (New Hampshire) District Office, states that after two unsuccessful attempts at serving the OSC on Registrant, she and two Task Force Officers traveled to the residence of Registrant on February 16, 2018, and ‘‘[a]fter displaying our credentials to Dr. Knight, I presented the original copy of the . . . [OSC] to Dr. Knight.’’ (Government Exhibit (hereinafter, GX) 8 at 2–3 (Declaration of DEA Diversion Investigator). In its Request for Final Agency Action dated May 3, 2018, the Government represents that ‘‘[m]ore than 30-days have passed since Registrant received the . . . [OSC]; however, Registrant has not submitted to DEA a request for hearing.’’ Request for Final Agency Action, at 2. In its Request for Final Agency Action—Addendum dated September 26, 2018, the Government represents that Registrant has not ‘‘corresponded in writing or otherwise with regard to his position on a hearing before DEA.’’ Request for Final Agency Action—Addendum, at 2. The Government requests the issuance of a Final Order revoking Registrant’s DEA registration. Id. at 4. PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 Based on the DI’s Declaration, the Government’s written representations, and my review of the record, I find that the Government personally served the OSC on Registrant on February 16, 2018. I also find that more than 30 days have now passed since the date the Government served the OSC. Further, based on the Government’s written representations, I find that neither Registrant, nor anyone purporting to represent him, requested a hearing, submitted a written statement while waiving Registrant’s right to a hearing, or submitted a corrective action plan. Accordingly, I find that Registrant has waived his right to a hearing and his right to submit a written statement and corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this Decision and Order based on the record submitted by the Government, which constitutes the entire record before me. 21 CFR 1301.43(e). Findings of Fact Registrant’s DEA Registration Registrant is the holder of DEA Certificate of Registration No. BK7282940 at the registered address of 93 1⁄2 Walnut Hill Road, Derry, New Hampshire 03038. GX 1 (Certification of Registration), at 1. Pursuant to this registration, Registrant is authorized to dispense controlled substances in schedules II through V as a practitioner. Id. Registrant’s registration expires on December 31, 2018. Id. The Status of Registrant’s State License In this case, the Board issued an Order of Emergency License Suspension and Notice of Hearing on September 25, 2017. The Board’s Order suspended Registrant’s New Hampshire medical license until further order of the Board. GX 3 (Order of Emergency License Suspension and Notice of Hearing), at 13. On October 9, 2017, the Board accepted Registrant’s agreement ‘‘not to practice medicine . . . [including the writing of] prescriptions . . . until further order of the Board.’’ GX 4 (Preliminary Agreement Not to Practice), at 1. According to New Hampshire’s online records, of which I take official notice, Registrant’s license to practice medicine is still suspended.2 New Hampshire 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 E:\FR\FM\30OCN1.SGM 30OCN1

Agencies

[Federal Register Volume 83, Number 210 (Tuesday, October 30, 2018)]
[Notices]
[Pages 54613-54614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23686]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Catalent CTS, LLC

ACTION: Notice of application.

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

DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before November 29, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before November 29, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
requests for hearing should also 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.

SUPPLEMENTARY INFORMATION: 
    The Attorney General has delegated his authority under the 
Controlled Substances Act to the Administrator of the Drug Enforcement 
Administration (DEA), 28 CFR 0.100(b). Authority to exercise all 
necessary functions with respect to the promulgation and implementation 
of 21 CFR part 1301, incident to the registration of manufacturers, 
distributors, dispensers, importers, and exporters of controlled 
substances (other than final orders in connection with suspension, 
denial, or revocation of registration) has been redelegated to the 
Assistant Administrator of the DEA Diversion Control Division 
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, 
appendix to subpart R.
    In accordance with 21 CFR 1301.34(a), this is notice that on July 
17, 2018, Catalent CTS, LLC, 10245 Hickman Mills Drive, Kansas City,

[[Page 54614]]

Missouri 64137-1418 applied to be registered as an importer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
         Controlled substance           Drug code         Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid.............       2010  I
Marihuana Extract.....................       7350  I
Marihuana.............................       7360  I
Tetrahydrocannabinols.................       7370  I
------------------------------------------------------------------------

    The company plans to import finished dosage unit products 
containing gamma-hydroxybutryic acid and marihuana extracts for 
clinical trial studies. These marihuana extracts compounds are listed 
under drug code 7350. No other activity for these drug codes 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 FDA-approved or non-approved finished dosage 
forms for commercial sale.

    Dated: October 19, 2018.
 John J. Martin,
Assistant Administrator.
[FR Doc. 2018-23686 Filed 10-29-18; 8:45 am]
 BILLING CODE 4410-09-P