83 FR 12407 - Bulk Manufacturer of Controlled Substances Application: Rhodes Technologies
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 55 (March 21, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 55 (March 21, 2018)
| Page Range | 12407-12408 | |
| FR Document | 2018-05745 |
[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)] [Notices] [Pages 12407-12408] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Notices 12407
request a hearing and ‘‘has not Order revocation of registration) has been
otherwise corresponded or Pursuant to the authority vested in me redelegated to the Assistant
communicated with [the Agency] by 21 U.S.C. 824(a), as well as 28 CFR Administrator of the DEA Diversion
regarding the Order . . . including the 0.100(b), I hereby order that the Order Control Division (‘‘Assistant
filing of any written statement in lieu of to Show Cause issued to Keith F. Administrator’’) pursuant to section 7 of
a hearing.’’ RFAA, at 1–2. Based on the Ostrosky, D.D.S., be, and it hereby is, 28 CFR part 0, appendix to subpart R.
Government’s representation I find that In accordance with 21 CFR
dismissed. This Order is effective
more than 30 days have now passed 1301.34(a), this is notice that on
immediately.
since Registrant was served with the December 29, 2017, Sanyal
Show Cause Order and that he has not Dated: March 13, 2018. Biotechnology LLC, 700 West Olney
requested a hearing or filed a written Robert W. Patterson, Road, Marioneaux Lab—Room 3159,
statement of position; I further find that Acting Administrator. Norfolk, Virginia 23507–1607 applied to
Registrant has not filed a Corrective [FR Doc. 2018–05746 Filed 3–20–18; 8:45 am] be registered as an importer the
Action Plan. Accordingly, I find that BILLING CODE 4410–09–P following basic classes of controlled
Registrant has waived his right to a substances:
hearing or to submit a written statement
while waiving his right to a hearing; I DEPARTMENT OF JUSTICE Controlled Drug Schedule
substance code
also find that Registrant has waived his
right to submit a Corrective Action Plan. Drug Enforcement Administration
Marihuana Extract ........ 7350 I
21 CFR 1301.43(d). [Docket No. DEA–392] Tetrahydrocannabinols 7370 I
In the RFAA, the Government seeks a
final order revoking Registrant’s Importer of Controlled Substances This company plans to import
registration. As support for the proposed Application: Sanyal Biotechnology finished dosage unit products
sanction, the Government’s evidence LLC containing gamma-hydroxybutyric acid
includes a copy of the Stipulation and and cannabis extracts for clinical trial
Order issued by the Minnesota Board on ACTION: Notice of application. studies.
February 3, 2017, pursuant to which it This cannabis extracts compounds are
DATES: Registered bulk manufacturers of listed under drug code 7350. No other
accepted Registrant’s voluntary
the affected basic classes, and activity for these drug codes is
surrender of his dental license. GX 3.
applicants therefore, may file written authorized for this registration.
The Government also submitted a comments on or objections to the Approval of permit applications will
Certification of Registration History, issuance of the proposed registration on occur only when the registrant’s
which was sworn to on October 30, or before April 20, 2018. Such persons business activity is consistent with what
2017. GX 1. Therein, the Associate Chief may also file a written request for a is authorized under to 21 U.S.C.
of the Registration and Program Support hearing on the application on or before 952(a)(2). Authorization will not extend
Section states that Registration No. April 20, 2018. to the import of FDA approved or non-
BO1259983 ‘‘expires on December 31, ADDRESSES: Written comments should approved finished dosage forms for
2017,’’ and that ‘‘Keith F. Ostrosky, be sent to: Drug Enforcement commercial sale.
D.D.S., has no other pending or valid Administration, Attention: DEA Federal
DEA registration(s) in Minnesota.’’ Id. at Dated: March 15, 2018.
Register Representative/DRW, 8701 Susan A. Gibson,
1–2. Morrissette Drive, Springfield, Virginia Deputy Assistant Administrator.
Pursuant to 5 U.S.C. § 556(e), I take 22152. All requests for hearing must be
official notice of Registrant’s registration [FR Doc. 2018–05724 Filed 3–20–18; 8:45 am]
sent to: Drug Enforcement
record with Agency. According to that BILLING CODE 4410–09–P
Administration, Attn: Administrator,
record, Registration No. BO1259983 8701 Morrissette Drive, Springfield,
expired on December 31, 2017 and Virginia 22152. All requests for hearing
Registrant has not filed an application, DEPARTMENT OF JUSTICE
should also be sent to: (1) Drug
whether timely or not, to renew his Enforcement Administration, Attn: Drug Enforcement Administration
registration or for any other registration Hearing Clerk/LJ, 8701 Morrissette
in the State of Minnesota. Drive, Springfield, Virginia 22152; and [Docket No. DEA–392]
DEA has long held that ‘‘ ‘if a (2) Drug Enforcement Administration,
Bulk Manufacturer of Controlled
registrant has not submitted a timely Attn: DEA Federal Register
Substances Application: Rhodes
renewal application prior to the Representative/DRW, 8701 Morrissette
Technologies
expiration date, then the registration Drive, Springfield, Virginia 22152.
expires and there is nothing to revoke.’ ’’ SUPPLEMENTARY INFORMATION: The ACTION: Notice of application.
Donald Brooks Reece II, M.D., 77 FR Attorney General has delegated his
35054, 35055 (2012) (quoting Ronald J. authority under the Controlled DATES: Registered bulk manufacturers of
Riegel, 63 FR 67312, 67133 (1998)); see Substances Act to the Administrator of the affected basic classes, and
also Thomas E. Mitchell, 76 FR 20032, the Drug Enforcement Administration applicants therefore, may file written
20033 (2011). ‘‘Moreover, in the absence (DEA), 28 CFR 0.100(b). Authority to comments on or objections to the
of an application (whether timely filed exercise all necessary functions with issuance of the proposed registration on
sradovich on DSK3GMQ082PROD with NOTICES
or not), there is nothing to act upon.’’ respect to the promulgation and or before May 21, 2018.
Reece, 77 FR at 35055. Accordingly, implementation of 21 CFR part 1301, ADDRESSES: Written comments should
because Registrant has allowed his incident to the registration of be sent to: Drug Enforcement
registration to expire and has not filed manufacturers, distributors, dispensers, Administration, Attention: DEA Federal
any application for registration in importers, and exporters of controlled Register Representative/DRW, 8701
Minnesota, this case is now moot and substances (other than final orders in Morrissette Drive, Springfield, Virginia
will be dismissed. connection with suspension, denial, or 22152.
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![12408 Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Notices
SUPPLEMENTARY INFORMATION: The DEPARTMENT OF JUSTICE Drug
Controlled substance Schedule
Attorney General has delegated his code
authority under the Controlled Drug Enforcement Administration
Marihuana ..................... 7360 I
Substances Act to the Administrator of [Docket No. DEA–392] Tetrahydrocannabinols 7370 I
the Drug Enforcement Administration Nabilone ....................... 7379 II
(DEA), 28 CFR 0.100(b). Authority to Importer of Controlled Substances Phenylacetone .............. 8501 II
exercise all necessary functions with Application: Noramco, Inc. Opium, raw ................... 9600 II
respect to the promulgation and Poppy Straw Con- 9670 II
implementation of 21 CFR part 1301, ACTION: Notice of application. centrate.
Tapentadol .................... 9780 II
incident to the registration of
DATES: Registered bulk manufacturers of
manufacturers, distributors, dispensers, the affected basic classes, and The company plans to import
importers, and exporters of controlled applicants therefore, may file written phenylacetone (8501), opium, raw
substances (other than final orders in comments on or objections to the (9600), and poppy straw concentrate
connection with suspension, denial, or issuance of the proposed registration on (9670) to bulk manufacture other
revocation of registration) has been or before April 20, 2018. Such persons controlled substances for distribution to
redelegated to the Assistant may also file a written request for a its customers. The company plans to
Administrator of the DEA Diversion hearing on the application on or before import an intermediate form of
Control Division (‘‘Assistant April 20, 2018. tapentadol (9780) to bulk manufacture
Administrator’’) pursuant to section 7 of ADDRESSES: Written comments should tapentadol (9780) for distribution to its
28 CFR part 0, appendix to subpart R. be sent to: Drug Enforcement customers.
Administration, Attention: DEA Federal In reference to drug codes 7360 and
In accordance with 21 CFR
Register Representative/DRW, 8701 7370, the company plans to import a
1301.33(a), this is notice that on March synthetic cannabidiol and a synthetic
17, 2017, Rhodes Technologies, 498 Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be tetrahydrocannabinol. No other activity
Washington Street, Coventry, Rhode for these drug codes is authorized for
Island 02816 applied to be registered as sent to: Drug Enforcement
Administration, Attn: Administrator, this registration. Placement of these
a bulk manufacturer the following basic drug codes onto the company’s
classes of controlled substances: 8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing registration does not translate into
should also be sent to: (1) Drug automatic approval of subsequent
Drug permit applications to import controlled
Controlled substance Schedule Enforcement Administration, Attn:
code
Hearing Clerk/LJ, 8701 Morrissette substances. Approval of permit
Marihuana ..................... 7360 I Drive, Springfield, Virginia 22152; and applications will occur only when the
Tetrahydrocannabinols 7370 I (2) Drug Enforcement Administration, registrant’s business activity is
Dihydromorphine .......... 9145 I Attn: DEA Federal Register consistent with what is authorized
Methylphenidate ........... 1724 II Representative/DRW, 8701 Morrissette under 21 U.S.C 952(a)(2). Authorization
Codeine ........................ 9050 II Drive, Springfield, Virginia 22152. will not extend to the import of FDA
Dihydrocodeine ............. 9120 II Comments and requests for hearings on approved or non-approved finished
Oxycodone ................... 9143 II applications to import narcotic raw dosage forms for commercial sale.
Hydromorphone ............ 9150 II material are not appropriate. 72 FR 3417 Dated: March 15, 2018.
Hydrocodone ................ 9193 II (January 25, 2007). Susan A. Gibson,
Levorphanol .................. 9220 II Deputy Assistant Administrator.
SUPPLEMENTARY INFORMATION: The
Morphine ....................... 9300 II
Attorney General has delegated his [FR Doc. 2018–05725 Filed 3–20–18; 8:45 am]
Oripavine ...................... 9330 II
authority under the Controlled BILLING CODE 4410–09–P
Thebaine ....................... 9333 II
Oxymorphone ............... 9652 II
Substances Act to the Administrator of
Noroxymorphone .......... 9668 II
the Drug Enforcement Administration
Tapentadol .................... 9780 II
(DEA), 28 CFR 0.100(b). Authority to DEPARTMENT OF LABOR
Fentanyl ........................ 9801 II exercise all necessary functions with
respect to the promulgation and Employment and Training
implementation of 21 CFR part 1301, Administration
The company plans to manufacture incident to the registration of
the listed controlled substances in bulk manufacturers, distributors, dispensers, Agency Information Collection
for conversion and sale to finished importers, and exporters of controlled Activities; Comment Request; Senior
dosage form manufacturers. substances (other than final orders in Community Service Employment
connection with suspension, denial, or Program (SCSEP)
In reference to drug code 7360 and
7370, the company plans to bulk revocation of registration) has been ACTION: Notice of information collection;
manufacture a synthetic CBD and redelegated to the Assistant request for comment.
tetrahydrocannabinol. Administrator of the DEA Diversion
Control Division (‘‘Assistant SUMMARY: The Department of Labor
No other activity for drug code 7360 (DOL), Employment and Training
Administrator’’) pursuant to section 7 of
and 7370 are authorized for this 28 CFR part 0, appendix to subpart R. Administration (ETA) is soliciting
sradovich on DSK3GMQ082PROD with NOTICES
registration. In accordance with 21 CFR 1301.34(a), comments concerning a proposed
Dated: March 15, 2018. this is notice that on July 6, 2017, extension for the authority to conduct
Susan A. Gibson, Noramco, Inc., 500 Swedes Landing the information collection request (ICR)
Deputy Assistant Administrator. Road, Wilmington, Delaware 19801– titled, ‘‘Senior Community Service
4417 applied to be registered as an Employment Program (SCSEP).’’ This
[FR Doc. 2018–05745 Filed 3–20–18; 8:45 am]
importer of the following basic comment request is part of continuing
BILLING CODE 4410–09–P
controlled substances: Departmental efforts to reduce
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Document Created: 2018-03-21 00:45:32
Document Modified: 2018-03-21 00:45:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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. | |
| FR Citation | 83 FR 12407 |
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