83 FR 22517 - Importer of Controlled Substances Application: Rhodes Technologies
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 94 (May 15, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 94 (May 15, 2018)
| Page Range | 22517-22518 | |
| FR Document | 2018-10302 |
[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)] [Notices] [Pages 22517-22518] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10302] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer 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 June 14, 2018. Such persons may also file a written request for a hearing on the application on or before June 14, 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 April 6, 2018, Rhodes Technologies, 498 Washington Street, Coventry, Rhode Island 02816 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ Tetrahydrocannabinols.................. 7370 I Methylphenidate........................ 1724 II Oxycodone.............................. 9143 II Hydromorphone.......................... 9150 II Hydrocodone............................ 9193 II Morphine............................... 9300 II Opium, raw............................. 9600 II Oxymorphone............................ 9652 II Poppy Straw Concentrate................ 9670 II ------------------------------------------------------------------------ The company plans to import opium, raw (9600) and poppy straw concentrate (9670) in order to bulk manufacture controlled substances in Active Pharmaceutical Ingredient (API) form. The company distributes the manufactured APIs in bulk to its customers. [[Page 22518]] The company plans to import the other listed controlled substances for internal reference standards use only. The comparisons of foreign reference standards to the company's domestically manufactured API will allow the company to export domestically manufactured API to foreign markets. Dated: April 25, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018-10302 Filed 5-14-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices 22517
revocation of registration) has been authority under the Controlled hearing on the application on or before
redelegated to the Assistant Substances Act to the Administrator of June 14, 2018.
Administrator of the DEA Diversion the Drug Enforcement Administration ADDRESSES: Written comments should
Control Division (‘‘Assistant (DEA), 28 CFR 0.100(b). Authority to be sent to: Drug Enforcement
Administrator’’) pursuant to section 7 of exercise all necessary functions with Administration, Attention: DEA Federal
28 CFR part 0, appendix to subpart R. respect to the promulgation and Register Representative/DRW, 8701
In accordance with 21 CFR implementation of 21 CFR part 1301, Morrissette Drive, Springfield, Virginia
1301.33(a), this is notice that on April incident to the registration of 22152. All requests for hearing must be
5, 2017, Patheon API Manufacturing, manufacturers, distributors, dispensers, sent to: Drug Enforcement
Inc., 309 Delaware Street, Building importers, and exporters of controlled Administration, Attn: Administrator,
1106, Greenville, South Carolina 29605 substances (other than final orders in 8701 Morrissette Drive, Springfield,
applied to be registered as a bulk connection with suspension, denial, or Virginia 22152. All requests for hearing
manufacturer of the following basic revocation of registration) has been should also be sent to: (1) Drug
classes of controlled substances: redelegated to the Assistant Enforcement Administration, Attn:
Administrator of the DEA Diversion Hearing Clerk/LJ, 8701 Morrissette
Thebaine ................................. 9333 II
Noroxymorphone .................... 9668 II Control Division (‘‘Assistant Drive, Springfield, Virginia 22152; and
Administrator’’) pursuant to section 7 of (2) Drug Enforcement Administration,
The company plans to manufacture 28 CFR part 0, appendix to subpart R. Attn: DEA Federal Register
the above-listed controlled substances In accordance with 21 CFR Representative/DRW, 8701 Morrissette
as Active Pharmaceutical Ingredient 1301.34(a), this is notice that on April Drive, Springfield, Virginia 22152.
(API) for supply to its customers. 18, 2018, Mylan Pharmaceuticals, Inc., Comments and requests for hearings on
Dated: May 1, 2018. 3711 Collins Ferry Road, Morgantown, applications to import narcotic raw
West Virginia 26505 applied to be material are not appropriate. 72 FR
Susan A. Gibson,
registered as an importer of the 3417, (January 25, 2007).
Deputy Assistant Administrator.
following basic classes of controlled SUPPLEMENTARY INFORMATION: The
[FR Doc. 2018–10303 Filed 5–14–18; 8:45 am]
substances: Attorney General has delegated his
BILLING CODE 4410–09–P
authority under the Controlled
Amphetamine .......................... 1100 II
Methylphenidate ...................... 1724 II Substances Act to the Administrator of
DEPARTMENT OF JUSTICE Oxycodone .............................. 9143 II the Drug Enforcement Administration
Hydromorphone ...................... 9150 II (DEA), 28 CFR 0.100(b). Authority to
Methadone .............................. 9250 II exercise all necessary functions with
Drug Enforcement Administration Morphine ................................. 9300 II
Fentanyl .................................. 9801 II respect to the promulgation and
[Docket No. DEA–392]
implementation of 21 CFR part 1301,
Importer of Controlled Substances The company plans to import the incident to the registration of
Application: Mylan Pharmaceuticals, listed controlled substances in finished manufacturers, distributors, dispensers,
Inc. dosage form (FDF) from foreign sources importers, and exporters of controlled
for analytical testing and clinical trials substances (other than final orders in
ACTION: Notice of application. in which the foreign FDF will be connection with suspension, denial, or
compared to the company’s own revocation of registration) has been
DATES: Registered bulk manufacturers of domestically-manufactured FDF. redelegated to the Assistant
the affected basic classes, and This analysis is required to allow the Administrator of the DEA Diversion
applicants therefore, may file written company to export domestically- Control Division (‘‘Assistant
comments on or objections to the manufactured FDF to foreign markets. Administrator’’) pursuant to section 7 of
issuance of the proposed registration on 28 CFR part 0, appendix to subpart R.
or before June 14, 2018. Such persons Dated: April 25, 2018.
In accordance with 21 CFR
may also file a written request for a Susan A. Gibson, 1301.34(a), this is notice that on April
hearing on the application on or before Deputy Assistant Administrator. 6, 2018, Rhodes Technologies, 498
June 14, 2018. [FR Doc. 2018–10301 Filed 5–14–18; 8:45 am] Washington Street, Coventry, Rhode
ADDRESSES: Written comments should BILLING CODE 4410–09–P Island 02816 applied to be registered as
be sent to: Drug Enforcement an importer of the following basic
Administration, Attention: DEA Federal classes of controlled substances:
Register Representative/DRW, 8701 DEPARTMENT OF JUSTICE
Morrissette Drive, Springfield, Virginia Tetrahydrocannabinols ........... 7370 I
22152. All requests for hearing must be Drug Enforcement Administration Methylphenidate ...................... 1724 II
Oxycodone .............................. 9143 II
sent to: Drug Enforcement Hydromorphone ...................... 9150 II
[Docket No. DEA–392]
Administration, Attn: Administrator, Hydrocodone ........................... 9193 II
8701 Morrissette Drive, Springfield, Importer of Controlled Substances
Morphine ................................. 9300 II
Virginia 22152. All requests for hearing Opium, raw ............................. 9600 II
Application: Rhodes Technologies Oxymorphone ......................... 9652 II
should also be sent to: (1) Drug Poppy Straw Concentrate ....... 9670 II
Enforcement Administration, Attn: ACTION: Notice of application.
Hearing Clerk/LJ, 8701 Morrissette The company plans to import opium,
daltland on DSKBBV9HB2PROD with NOTICES
Drive, Springfield, Virginia 22152; and DATES: Registered bulk manufacturers of raw (9600) and poppy straw concentrate
(2) Drug Enforcement Administration, the affected basic classes, and (9670) in order to bulk manufacture
Attn: DEA Federal Register applicants therefore, may file written controlled substances in Active
Representative/DRW, 8701 Morrissette comments on or objections to the Pharmaceutical Ingredient (API) form.
Drive, Springfield, Virginia 22152. issuance of the proposed registration on The company distributes the
SUPPLEMENTARY INFORMATION: The or before June 14, 2018. Such persons manufactured APIs in bulk to its
Attorney General has delegated his may also file a written request for a customers.
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![22518 Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
The company plans to import the The Show Cause Order notified Accordingly, I find that Respondent’s
other listed controlled substances for Respondent of his right to request a registration expired on February 28,
internal reference standards use only. hearing or to submit a written statement 2018 and that there is no application to
The comparisons of foreign reference while waiving his right to a hearing, the act upon.
standards to the company’s procedure for electing either option, and DEA has long held that ‘‘ ‘if a
domestically manufactured API will the consequence of failing to elect either registrant has not submitted a timely
allow the company to export option. Id. at 2 (citing 21 CFR 1301.43). renewal application prior to the
domestically manufactured API to The Order also notified Respondent of expiration date, then the registration
foreign markets. his right to submit a corrective action expires and there is nothing to
Dated: April 25, 2018. plan. Id. at 2–3 (citing 21 U.S.C. revoke.’ ’’ Donald Brooks Reece II, M.D.,
824(c)(2)(C)). 77 FR 35054, 35055 (2012) (quoting
Susan A. Gibson,
On November 8, 2017, Respondent Ronald J. Riegel, 63 FR 67312, 67133
Deputy Assistant Administrator. was personally served with the Show (1998)); see also Thomas E. Mitchell, 76
[FR Doc. 2018–10302 Filed 5–14–18; 8:45 am] Cause Order, and on December 8, 2018, FR 20032, 20033 (2011). ‘‘Moreover, in
BILLING CODE 4410–09–P Respondent requested a hearing. Resp. the absence of an application (whether
Hrng. Req. at 1. The matter was placed timely filed or not), there is nothing to
on the docket of the Office of act upon.’’ Reece, 77 FR at 35055.
DEPARTMENT OF JUSTICE Administrative Law Judges and assigned Accordingly, because Respondent has
to ALJ Charles Wm. Dorman, who, on allowed his registration to expire and
Drug Enforcement Administration December 11, 2017, issued an order did not file an application to renew his
setting the briefing schedule. See registration or for any other registration
[No. 18–12] Briefing Schedule for Lack of State in Pennsylvania, this case is now moot
Authority Allegations, at 1. and will be dismissed.
Donald Kenneth Shreves, D.V.M.; On January 4, 2018, the Government
Dismissal of Proceeding submitted a Motion for Summary Order
On October 31, 2017, the Acting Disposition; as support for its motion, Pursuant to the authority vested in me
Assistant Administrator, Diversion the Government attached a copy of the by 21 U.S.C. 824(a), as well as 28 CFR
Control Division, issued an Order to Board’s Suspension Order and a 0.100(b), I order that the Order to Show
Show Cause to Donald Kenneth Declaration of a DEA Task Force Office Cause issued to Donald K. Shreves,
Shreves, D.V.M. (Respondent), of that Respondent’s Veterinary License D.V.M., be, and it hereby is, dismissed.
remained suspended as of January 2, This Order is effective immediately.
Pottstown, Pennsylvania. The Show
2017, when she queried the Board’s
Cause Order proposed the revocation of Dated: May 7, 2018.
website. Mot. for Summ. Disp.,
Respondent’s Certificate of Registration Robert W. Patterson,
Attachments 3; 5; 6, at 2. On January 10,
on the ground that he does ‘‘not have Acting Administrator.
2018, Respondent filed his reply and
authority to handle controlled
admitted that he was currently without [FR Doc. 2018–10305 Filed 5–14–18; 8:45 am]
substances in the State of Pennsylvania,
authority to handle controlled BILLING CODE 4410–09–P
the [S]tate in which [he is] registered
substances in Pennsylvania. Resp.’s
with the’’ Agency. Show Cause Order, at
Reply to Govt. Mot. for Summ. Disp., at
1.
1. DEPARTMENT OF JUSTICE
With respect to the Agency’s On January 11, 2018, the ALJ issued
jurisdiction, the Show Cause Order his Recommended Decision (R.D.). Drug Enforcement Administration
alleged that Respondent is registered ‘‘as Therein, the ALJ found that there was
a practitioner in [s]chedules II–V under no dispute over the material fact that [Docket No. DEA–392]
. . . registration number BS5342934,’’ at Respondent lacks authority to dispense
the location of ‘‘1361C Farmington Ave., controlled substances in Pennsylvania. Bulk Manufacturer of Controlled
Pottstown, Pennsylvania.’’ Id. The Order Id. at 5–6. The ALJ thus granted the Substances Registration
further alleged that Respondent’s Government’s Motion for Summary
registration was due to expire on Disposition and recommended that ACTION: Notice of registration.
February 28, 2018. Id. Respondent’s registration be revoked.
As the substantive ground for the Id. SUMMARY: Registrants listed below have
proceeding, the Show Cause Order Neither party filed exceptions to the applied for and been granted
alleged that on September 28, 2017, the Recommended Decision. On February 6, registration by the Drug Enforcement
Pennsylvania Board of Veterinary 2018, the ALJ forwarded the record to Administration (DEA) as bulk
Medicine ‘‘issued an Order of my Office. manufacturers of various classes of
Temporary Suspension’’ of his Having reviewed the record, I hold schedule I and II controlled substances.
veterinary medicine license. Id. at 1–2. that this proceeding is now moot. The SUPPLEMENTARY INFORMATION: The
The Order alleged that as a consequence evidence in the record establishes that companies listed below applied to be
of the Board’s action, Respondent is Respondent’s registration was due to registered as bulk manufacturers of
currently ‘‘without to handle controlled expire on February 28, 2018, and various basic classes of controlled
substances in . . . Pennsylvania, the according to the Agency’s registration substances. Information on previously
[S]tate in which’’ he is registered, and record for Respondent of which I take published notices is listed in the table
daltland on DSKBBV9HB2PROD with NOTICES
therefore, his registration should be official notice,1 he has not submitted an below. No comments or objections were
revoked. Id. at 2. application to renew his registration. submitted for these notices.
1 Under the Administrative Procedure Act (APA), W. Gaunt & Sons, Inc., Reprint 1979). In accordance opportunity to refute the facts of which I take
an agency ‘‘may take official notice of facts at any with the APA and DEA’s regulations, Respondent official notice, Respondent may file a motion for
stage in a proceeding—even in the final decision.’’ is ‘‘entitled on timely request to an opportunity to reconsideration within fifteen calendar days of
U.S. Dept. of Justice, Attorney General’s Manual on show to the contrary.’’ 5 U.S.C. 556(e); see also 21 service of this order which shall commence on the
the Administrative Procedure Act 80 (1947) (Wm. CFR 1316.59(e). To allow Respondent the date this order is mailed.
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Document Created: 2018-05-15 00:34:28
Document Modified: 2018-05-15 00:34:28
| 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 June 14, 2018. Such persons may also file a written request for a hearing on the application on or before June 14, 2018. | |
| FR Citation | 83 FR 22517 |
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