Importer of Controlled Substances Registration: Catalent CTS, LLC, 75692-75693 [2015-30551]
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Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices
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
September 7, 2015, Organix, Inc., 240
Salem Street, Woburn, Massachusetts
01801 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Schedule
Gamma
Hydroxybutyric
Acid
(2010).
Lysergic acid diethylamide (7315)
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Psilocybin (7437) ..........................
Psilocyn (7438) .............................
Heroin (9200) ...............................
Morphine (9300) ...........................
I
I
I
I
I
I
I
II
The company plans to manufacture
reference standards for distribution to
its research and forensics customers. In
reference to drug codes 7360
(marihuana) and 7370 (THC) the
company plans to manufacture these
drugs as synthetic. No other activities
for these drug codes are authorized for
this registration.
Dated: November 27, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–30554 Filed 12–2–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer 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 in
accordance with 21 CFR 1301.33(a) on
or before February 1, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Lhorne on DSK5TPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
15:11 Dec 02, 2015
Jkt 238001
Administration, Attention: DEA Federal
Register Representative/OD/D, 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 October
6, 2015, Noramco, Inc., 500 Swedes
Landing Road, Wilmington, Delaware
19801–4417 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
ACTION:
SUPPLEMENTARY INFORMATION:
Controlled substance
Codeine-N-oxide (9053) ...............
Dihydromorphine (9145) ...............
Morphine-N-oxide (9307) .............
Amphetamine (1100) ....................
Methylphenidate (1724) ................
Phenylacetone (8501) ..................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium extracts (9610) ..................
Opium fluid extract (9620) ............
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Opium, granulated (9640) ............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Tapentadol (9780) ........................
Schedule
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
Dated: November 23, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–30550 Filed 12–2–15; 8:45 am]
BILLING CODE 4410–09–P
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Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Catalent CTS, LLC
Notice of registration.
Catalent CTS, LLC applied to
be registered as an importer of a certain
basic class of controlled substance. The
Drug Enforcement Administration
(DEA) grants Catalent CTS, LLC
registration as an importer of this
controlled substance.
SUPPLEMENTARY INFORMATION: By notice
dated August 21, 2015, and published in
the Federal Register on August 31,
2015, 80 FR 52509, Catalent CTS, LLC,
10245 Hickman Mills Drive, Kansas
City, Missouri 64137 applied to be
registered as an importer of a certain
basic class of controlled substance. No
comments or objections were submitted
for this notice.
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and
determined that the registration of
Catalent CTS, LLC to import the basic
class of controlled substance is
consistent with the public interest and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971. The
DEA investigated the company’s
maintenance of effective controls
against diversion by inspecting and
testing the company’s physical security
systems, verifying the company’s
compliance with state and local laws,
and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the above-named
company is granted registration as an
importer of marihuana (7360), a basic
class of controlled substance listed in
schedule I.
The company plans to import finished
pharmaceutical products containing
cannabis extracts in dosage form for
clinical trial studies.
This compound is listed under drug
code 7360. No other activity for this
drug code is authorized for this
registration. Approval of permits
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.
SUMMARY:
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Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices
Dated: November 27, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
Washington, DC 20210; or by email:
DOL_PRA_PUBLIC@dol.gov.
FOR FURTHER INFORMATION CONTACT:
Michel Smyth by telephone at 202–693–
4129, TTY 202–693–8064, (these are not
toll-free numbers) or by email at DOL_
PRA_PUBLIC@dol.gov.
[FR Doc. 2015–30551 Filed 12–2–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Authority: 44 U.S.C. 3507(a)(1)(D).
Office of the Secretary
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Hazardous
Waste Operations and Emergency
Response
Office of the Secretary, Labor.
Notice.
AGENCY:
ACTION:
On November 30, 2015 the
Department of Labor (DOL) will submit
the Occupational Safety and Health
Administration (OSHA) sponsored
information collection request (ICR)
titled, ‘‘Hazardous Waste Operations
and Emergency Response,’’ to the Office
of Management and Budget (OMB) for
review and approval for continued use,
without change, in accordance with the
Paperwork Reduction Act of 1995
(PRA), 44 U.S.C. 3501 et seq. Public
comments on the ICR are invited.
DATES: The OMB will consider all
written comments that agency receives
on or before January 4, 2016.
ADDRESSES: A copy of this ICR with
applicable supporting documentation;
including a description of the likely
respondents, proposed frequency of
response, and estimated total burden
may be obtained free of charge from the
RegInfo.gov Web site at https://
www.reginfo.gov/public/do/
PRAViewICR?ref_nbr=201511-1218-003
(this link will only become active on
December 1, 2015) or by contacting
Michel Smyth by telephone at 202–693–
4129, TTY 202–693–8064, (these are not
toll-free numbers) or by email at DOL_
PRA_PUBLIC@dol.gov.
Submit comments about this request
by mail or courier to the Office of
Information and Regulatory Affairs,
Attn: OMB Desk Officer for DOL–OSHA,
Office of Management and Budget,
Room 10235, 725 17th Street NW.,
Washington, DC 20503; by Fax: 202–
395–5806 (this is not a toll-free
number); or by email: OIRA_
submission@omb.eop.gov. Commenters
are encouraged, but not required, to
send a courtesy copy of any comments
by mail or courier to the U.S.
Department of Labor-OASAM, Office of
the Chief Information Officer, Attn:
Departmental Information Compliance
Management Program, Room N1301,
200 Constitution Avenue NW.,
Lhorne on DSK5TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
15:11 Dec 02, 2015
This ICR
seeks to extend PRA authority for the
Hazardous Waste Operations and
Emergency Response (HAZWOPER)
Standard information collection. The
HAZWOPER Standard specifies a
number of information collection
requirements. Employers can use the
information collected under the
HAZWOPER rule to develop the various
programs the Standard requires and to
ensure that their workers are trained
properly about the safety and health
hazards associated with hazardous
waste operations and emergency
response to hazardous waste releases.
The OSHA uses the records developed
in response to this Standard to
determine adequate compliance with
the Standard’s safety and health
provisions. An employer’s failure to
collect and distribute information
required in this standard will
significantly affect OSHA efforts to
control and reduce injuries and
fatalities. Such failure would also be
contrary to the direction Congress
provided in the Superfund
Amendments and Reauthorization Act.
Occupational Safety and Health Act of
1970 sections 2(b)(9), 6, and 8(c)
authorize this information collection.
See 29 U.S.C. 651(b)(9), 655, and 657(c).
This information collection is subject
to the PRA. A Federal agency generally
cannot conduct or sponsor a collection
of information, and the public is
generally not required to respond to an
information collection, unless it is
approved by the OMB under the PRA
and displays a currently valid OMB
Control Number. In addition,
notwithstanding any other provisions of
law, no person shall generally be subject
to penalty for failing to comply with a
collection of information that does not
display a valid Control Number. See 5
CFR 1320.5(a) and 1320.6. The DOL
obtains OMB approval for this
information collection under Control
Number 1218–0202.
OMB authorization for an ICR cannot
be for more than three (3) years without
renewal. The DOL seeks to extend PRA
authorization for this information
collection for three (3) more years,
without any change to existing
requirements. The DOL notes that
existing information collection
requirements submitted to the OMB
SUPPLEMENTARY INFORMATION:
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75693
receive a month-to-month extension
while they undergo review. For
additional substantive information
about this ICR, see the related notice
published in the Federal Register on
May 21, 2015 (80 FR 29344).
Interested parties are encouraged to
send comments to the OMB, Office of
Information and Regulatory Affairs at
the address shown in the ADDRESSES
section within thirty (30) days of
publication of this notice in the Federal
Register. In order to help ensure
appropriate consideration, comments
should mention OMB Control Number
1218–0202. The OMB is particularly
interested in comments that:
• Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
• Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
• Enhance the quality, utility, and
clarity of the information to be
collected; and
• Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Agency: DOL–OSHA.
Title of Collection: Hazardous Waste
Operations and Emergency Response
Standard.
OMB Control Number: 1218–0202.
Affected Public: Private Sector—
businesses or other for-profit.
Total Estimated Number of
Respondents: 30,052.
Total Estimated Number of
Responses: 1,440,759.
Total Estimated Annual Time Burden:
261,551 hours.
Total Estimated Annual Other Costs
Burden: $3,124,960.
Dated: November 27, 2015.
Michel Smyth,
Departmental Clearance Officer.
[FR Doc. 2015–30576 Filed 12–2–15; 8:45 am]
BILLING CODE 4510–26–P
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]]>Agencies
[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)]
[Notices]
[Pages 75692-75693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30551]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Registration: Catalent CTS, LLC
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Catalent CTS, LLC applied to be registered as an importer of a
certain basic class of controlled substance. The Drug Enforcement
Administration (DEA) grants Catalent CTS, LLC registration as an
importer of this controlled substance.
SUPPLEMENTARY INFORMATION: By notice dated August 21, 2015, and
published in the Federal Register on August 31, 2015, 80 FR 52509,
Catalent CTS, LLC, 10245 Hickman Mills Drive, Kansas City, Missouri
64137 applied to be registered as an importer of a certain basic class
of controlled substance. No comments or objections were submitted for
this notice.
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and
958(a) and determined that the registration of Catalent CTS, LLC to
import the basic class of controlled substance is consistent with the
public interest and with United States obligations under international
treaties, conventions, or protocols in effect on May 1, 1971. The DEA
investigated the company's maintenance of effective controls against
diversion by inspecting and testing the company's physical security
systems, verifying the company's compliance with state and local laws,
and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in
accordance with 21 CFR 1301.34, the above-named company is granted
registration as an importer of marihuana (7360), a basic class of
controlled substance listed in schedule I.
The company plans to import finished pharmaceutical products
containing cannabis extracts in dosage form for clinical trial studies.
This compound is listed under drug code 7360. No other activity for
this drug code is authorized for this registration. Approval of permits
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 non-
approved finished dosage forms for commercial sale.
[[Page 75693]]
Dated: November 27, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-30551 Filed 12-2-15; 8:45 am]
BILLING CODE 4410-09-P
