Bulk Manufacturer of Controlled Substances Application: Rhodes Technologies, 12407-12408 [2018-05745]

Download as PDF 12407 sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Notices request a hearing and ‘‘has not otherwise corresponded or communicated with [the Agency] regarding the Order . . . including the filing of any written statement in lieu of a hearing.’’ RFAA, at 1–2. Based on the Government’s representation I find that more than 30 days have now passed since Registrant was served with the Show Cause Order and that he has not requested a hearing or filed a written statement of position; I further find that Registrant has not filed a Corrective Action Plan. Accordingly, I find that Registrant has waived his right to a hearing or to submit a written statement while waiving his right to a hearing; I also find that Registrant has waived his right to submit a Corrective Action Plan. 21 CFR 1301.43(d). In the RFAA, the Government seeks a final order revoking Registrant’s registration. As support for the proposed sanction, the Government’s evidence includes a copy of the Stipulation and Order issued by the Minnesota Board on February 3, 2017, pursuant to which it accepted Registrant’s voluntary surrender of his dental license. GX 3. The Government also submitted a Certification of Registration History, which was sworn to on October 30, 2017. GX 1. Therein, the Associate Chief of the Registration and Program Support Section states that Registration No. BO1259983 ‘‘expires on December 31, 2017,’’ and that ‘‘Keith F. Ostrosky, D.D.S., has no other pending or valid DEA registration(s) in Minnesota.’’ Id. at 1–2. Pursuant to 5 U.S.C. § 556(e), I take official notice of Registrant’s registration record with Agency. According to that record, Registration No. BO1259983 expired on December 31, 2017 and Registrant has not filed an application, whether timely or not, to renew his registration or for any other registration in the State of Minnesota. DEA has long held that ‘‘ ‘if a registrant has not submitted a timely renewal application prior to the expiration date, then the registration expires and there is nothing to revoke.’ ’’ Donald Brooks Reece II, M.D., 77 FR 35054, 35055 (2012) (quoting Ronald J. Riegel, 63 FR 67312, 67133 (1998)); see also Thomas E. Mitchell, 76 FR 20032, 20033 (2011). ‘‘Moreover, in the absence of an application (whether timely filed or not), there is nothing to act upon.’’ Reece, 77 FR at 35055. Accordingly, because Registrant has allowed his registration to expire and has not filed any application for registration in Minnesota, this case is now moot and will be dismissed. VerDate Sep<11>2014 18:34 Mar 20, 2018 Jkt 244001 Order Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well as 28 CFR 0.100(b), I hereby order that the Order to Show Cause issued to Keith F. Ostrosky, D.D.S., be, and it hereby is, dismissed. This Order is effective immediately. Dated: March 13, 2018. Robert W. Patterson, Acting Administrator. [FR Doc. 2018–05746 Filed 3–20–18; 8:45 am] BILLING CODE 4410–09–P 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 December 29, 2017, Sanyal Biotechnology LLC, 700 West Olney Road, Marioneaux Lab—Room 3159, Norfolk, Virginia 23507–1607 applied to be registered as an importer the following basic classes of controlled substances: Controlled substance DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Sanyal Biotechnology 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 issuance of the proposed registration on or before April 20, 2018. Such persons may also file a written request for a hearing on the application on or before April 20, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 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 DATES: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 Marihuana Extract ........ Tetrahydrocannabinols Drug code 7350 7370 Schedule I I This company plans to import finished dosage unit products containing gamma-hydroxybutyric acid and cannabis extracts for clinical trial studies. This cannabis 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 to 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: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–05724 Filed 3–20–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Rhodes Technologies ACTION: 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 May 21, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: E:\FR\FM\21MRN1.SGM 21MRN1 12408 Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Notices 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 1301.33(a), this is notice that on March 17, 2017, Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island 02816 applied to be registered as a bulk manufacturer the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: Controlled substance sradovich on DSK3GMQ082PROD with NOTICES Marihuana ..................... Tetrahydrocannabinols Dihydromorphine .......... Methylphenidate ........... Codeine ........................ Dihydrocodeine ............. Oxycodone ................... Hydromorphone ............ Hydrocodone ................ Levorphanol .................. Morphine ....................... Oripavine ...................... Thebaine ....................... Oxymorphone ............... Noroxymorphone .......... Tapentadol .................... Fentanyl ........................ Drug code Schedule 7360 7370 9145 1724 9050 9120 9143 9150 9193 9220 9300 9330 9333 9652 9668 9780 9801 I I I II II II II II II II II II II II II II II The company plans to manufacture the listed controlled substances in bulk for conversion and sale to finished dosage form manufacturers. In reference to drug code 7360 and 7370, the company plans to bulk manufacture a synthetic CBD and tetrahydrocannabinol. No other activity for drug code 7360 and 7370 are authorized for this registration. Dated: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–05745 Filed 3–20–18; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 18:34 Mar 20, 2018 Jkt 244001 DEPARTMENT OF JUSTICE Controlled substance Drug code Schedule Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Noramco, Inc. ACTION: 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 April 20, 2018. Such persons may also file a written request for a hearing on the application on or before April 20, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (January 25, 2007). 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 6, 2017, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801– 4417 applied to be registered as an importer of the following basic controlled substances: Marihuana ..................... Tetrahydrocannabinols Nabilone ....................... Phenylacetone .............. Opium, raw ................... Poppy Straw Concentrate. Tapentadol .................... 7360 7370 7379 8501 9600 9670 I I II II II II 9780 II DATES: PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 The company plans to import phenylacetone (8501), opium, raw (9600), and poppy straw concentrate (9670) to bulk manufacture other controlled substances for distribution to its customers. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol (9780) for distribution to its customers. In reference to drug codes 7360 and 7370, the company plans to import a synthetic cannabidiol and a synthetic tetrahydrocannabinol. No other activity for these drug codes is authorized for this registration. Placement of these drug codes onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. 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: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018–05725 Filed 3–20–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF LABOR Employment and Training Administration Agency Information Collection Activities; Comment Request; Senior Community Service Employment Program (SCSEP) Notice of information collection; request for comment. ACTION: The Department of Labor (DOL), Employment and Training Administration (ETA) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, ‘‘Senior Community Service Employment Program (SCSEP).’’ This comment request is part of continuing Departmental efforts to reduce SUMMARY: E:\FR\FM\21MRN1.SGM 21MRN1

Agencies

[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Notices]
[Pages 12407-12408]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05745]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Rhodes 
Technologies

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 May 21, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

[[Page 12408]]


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 1301.33(a), this is notice that on March 
17, 2017, Rhodes Technologies, 498 Washington Street, Coventry, Rhode 
Island 02816 applied to be registered as a bulk manufacturer the 
following basic classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana..............................     7360  I
Tetrahydrocannabinols..................     7370  I
Dihydromorphine........................     9145  I
Methylphenidate........................     1724  II
Codeine................................     9050  II
Dihydrocodeine.........................     9120  II
Oxycodone..............................     9143  II
Hydromorphone..........................     9150  II
Hydrocodone............................     9193  II
Levorphanol............................     9220  II
Morphine...............................     9300  II
Oripavine..............................     9330  II
Thebaine...............................     9333  II
Oxymorphone............................     9652  II
Noroxymorphone.........................     9668  II
Tapentadol.............................     9780  II
Fentanyl...............................     9801  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for conversion and sale to finished dosage form manufacturers.
    In reference to drug code 7360 and 7370, the company plans to bulk 
manufacture a synthetic CBD and tetrahydrocannabinol.
    No other activity for drug code 7360 and 7370 are authorized for 
this registration.

     Dated: March 15, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-05745 Filed 3-20-18; 8:45 am]
 BILLING CODE 4410-09-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.