Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc., 63838-63839 [2015-26675]
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63838
Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
Controlled substance
Schedule
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Betacetylmethadol (9607) ............................................................................................................................................................................
Betameprodine (9608) .................................................................................................................................................................................
Betamethadol (9609) ...................................................................................................................................................................................
Betaprodine (9611) ......................................................................................................................................................................................
Dextromoramide (9613) ...............................................................................................................................................................................
Dipipanone (9622) .......................................................................................................................................................................................
Hydroxypethidine (9627) .............................................................................................................................................................................
Noracymethadol (9633) ...............................................................................................................................................................................
Norlevorphanol (9634) .................................................................................................................................................................................
Normethadone (9635) .................................................................................................................................................................................
Racemoramide (9645) .................................................................................................................................................................................
Trimeperidine (9646) ...................................................................................................................................................................................
1-Methyl-4-phenyl-4-propionoxypiperidine (9661) .......................................................................................................................................
Tilidine (9750) ..............................................................................................................................................................................................
Para-Fluorofentanyl (9812) ..........................................................................................................................................................................
3-Methylfentanyl (9813) ...............................................................................................................................................................................
Alpha-Methylfentanyl (9814) ........................................................................................................................................................................
Acetyl-alpha-methylfentanyl (9815) .............................................................................................................................................................
Beta-hydroxyfentanyl (9830) .......................................................................................................................................................................
Beta-hydroxy-3-methylfentanyl (9831) ........................................................................................................................................................
Alpha-methylthiofentanyl (9832) ..................................................................................................................................................................
3-Methylthiofentanyl (9833) .........................................................................................................................................................................
Thiofentanyl (9835) ......................................................................................................................................................................................
Methamphetamine (1105) ...........................................................................................................................................................................
Methylphenidate (1724) ...............................................................................................................................................................................
Amobarbital (2125) ......................................................................................................................................................................................
Pentobarbital (2270) ....................................................................................................................................................................................
Secobarbital (2315) .....................................................................................................................................................................................
Glutethimide (2550) .....................................................................................................................................................................................
Nabilone (7379) ...........................................................................................................................................................................................
1-Phenylcyclohexylamine (7460) .................................................................................................................................................................
Phencyclidine (7471) ...................................................................................................................................................................................
Phenylacetone (8501) .................................................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile (8603) ................................................................................................................................................
Alphaprodine (9010) ....................................................................................................................................................................................
Dihydrocodeine (9120) ................................................................................................................................................................................
Ecgonine (9180) ..........................................................................................................................................................................................
Ethylmorphine (9190) ..................................................................................................................................................................................
Levomethorphan (9210) ..............................................................................................................................................................................
Levorphanol (9220) .....................................................................................................................................................................................
Meperidine (9230) .......................................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) (9273) ..............................................................................................................................
Levo-alphacetylmethadol (9648) .................................................................................................................................................................
Noroxymorphone (9668) ..............................................................................................................................................................................
Racemethorphan (9732) ..............................................................................................................................................................................
Alfentanil (9737) ..........................................................................................................................................................................................
Remifentanil (9739) .....................................................................................................................................................................................
Sufentanil (9740) .........................................................................................................................................................................................
Carfentanil (9743) ........................................................................................................................................................................................
Tapentadol (9780) .......................................................................................................................................................................................
The company plans to import small
quantities of the listed controlled
substances for the manufacture of
analytical reference standards and
distribution to their research and
forensic customers.
In reference to drug code 7360 the
company plans to import a synthetic
cannabidiol. No other activity for this
drug code 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
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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.
DEPARTMENT OF JUSTICE
Dated: October 13, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
Bulk Manufacturer of Controlled
Substances Application: Halo
Pharmaceutical, Inc.
Drug Enforcement Administration
[Docket No. DEA–392]
[FR Doc. 2015–26674 Filed 10–20–15; 8:45 am]
ACTION:
BILLING CODE 4410–09–P
PO 00000
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 in
accordance with 21 CFR 1301.33(a) on
or before December 21, 2015.
DATES:
Frm 00102
Fmt 4703
Sfmt 4703
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Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152.
DEPARTMENT OF JUSTICE
The
Attorney General has delegated her
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 Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy 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 July 24,
2015, Halo Pharmaceutical, Inc., 30
North Jefferson Road, Whippany, New
Jersey 07981 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
ACTION:
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Controlled substance
Schedule
Dihydromorphine (9145) ...............
Hydromorphone (9150) ................
I
II
The company plans to manufacture
Hydromorphone HCl for sale to other
manufacturers and to manufacture other
controlled substances for distribution to
its customers. Dihydromorphine is an
intermediate in the manufacture of
Hydromorphone and is not for
commercial distribution.
Dated: October 13, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–26675 Filed 10–20–15; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4410–09–P
VerDate Sep<11>2014
22:39 Oct 20, 2015
Jkt 238001
Drug Enforcement Administration
63839
Dated: October 13, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–26668 Filed 10–20–15; 8:45 am]
[Docket No. DEA–392]
BILLING CODE 4410–09–P
Importer of Controlled Substances
Application: Sigma-Aldrich
International GMBH—Sigma Aldrich Co
LLC
DEPARTMENT OF JUSTICE
Notice of application.
Registered bulk manufacturers of
the affected basic class, and applicants
therefore, may file written comments on
or objections to the issuance of the
proposed registration in accordance
with 21 CFR 1301.34(a) on or before
November 20, 2015. Such persons may
also file a written request for a hearing
on the application pursuant to 21 CFR
1301.43 on or before November 20,
2015.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODXL, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The
Attorney General has delegated her
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 Deputy Assistant
Administrator of the DEA Office of
Diversion Control (‘‘Deputy 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 May 29,
2015, Sigma-Aldrich International
GMBH—Sigma Aldrich Co. LLC, Sigma
Aldrich Company LLC, 3500 Dekalb
Street, Saint Louis, Missouri 63118
applied to be registered as an importer
of Butylone (7541), a basic class of
controlled substance listed in schedule
I.
The company plans to import the
above listed controlled substance for
analytical research and testing of
equipment.
ADDRESSES:
PO 00000
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[OMB Number 1105–0096]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Extension
With Change, of a Previously
Approved Collection Sequestered
Juror Information Form
U.S. Marshals Service,
Department of Justice.
ACTION: 30-Day notice.
AGENCY:
The Department of Justice
(DOJ), U.S. Marshals Service (USMS),
will be submitting the following
information collection request to the
Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. This proposed
information collection was previously
published in the Federal Register at 80
FR 50872, on August 21, 2015, allowing
for a 60 day comment period.
DATES: Comments are encouraged and
will be accepted for an additional 30
days until November 20, 2015.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments
especially on the estimated public
burden or associated response time,
suggestions, or need a copy of the
proposed information collection
instrument with instructions or
additional information, please contact
Nicole Feuerstein, Publications
Specialist, U.S. Marshals Service, CS–3,
10th Floor, Washington, DC 20530–0001
(phone: 202–307–5168). Written
comments and/or suggestions can also
be directed to the Office of Management
and Budget, Office of Information and
Regulatory Affairs, Attention
Department of Justice Desk Officer,
Washington, DC 20503 or sent to OIRA_
submissions@omb.eop.gov.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
address one or more of the following
four points:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the US Marshals Service,
including whether the information
will have practical utility;
SUMMARY:
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]]>Agencies
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Notices]
[Pages 63838-63839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26675]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Halo
Pharmaceutical, Inc.
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 in accordance with 21 CFR
1301.33(a) on or before December 21, 2015.
[[Page 63839]]
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODXL,
8701 Morrissette Drive, Springfield, Virginia 22152. Request for
hearings should be sent to: Drug Enforcement Administration, Attention:
Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated her
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 Deputy Assistant Administrator of the DEA Office of Diversion
Control (``Deputy 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 July
24, 2015, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany,
New Jersey 07981 applied to be registered as a bulk manufacturer of the
following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Dihydromorphine (9145)..................... I
Hydromorphone (9150)....................... II
------------------------------------------------------------------------
The company plans to manufacture Hydromorphone HCl for sale to
other manufacturers and to manufacture other controlled substances for
distribution to its customers. Dihydromorphine is an intermediate in
the manufacture of Hydromorphone and is not for commercial
distribution.
Dated: October 13, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-26675 Filed 10-20-15; 8:45 am]
BILLING CODE 4410-09-P
