Manufacturer of Controlled Substances Registration: Cambrex Charles City, 46336-46337 [2015-19111]
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Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices
Controlled substance
Fentanyl (9801) ............................
II
The company plans to import small
quantities of the listed controlled
substances in dosage form to conduct
clinical trials.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–19109 Filed 8–3–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration: Meridian Medical
Technologies
ACTION:
The company plans to manufacture
the listed controlled substance as an
active pharmaceutical ingredient (API)
for clinical trials.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–19164 Filed 8–3–15; 8:45 am]
Meridian Medical
Technologies applied to be registered as
an importer of a certain basic class of
controlled substance. The Drug
Enforcement Administration (DEA)
grants Meridian Medical Technologies
registration as an importer of this
controlled substance.
SUPPLEMENTARY INFORMATION: By notice
dated April 14, 2015, and published in
the Federal Register on April 22, 2015,
80 FR 22553, Meridian Medical
Technologies, 2555 Hermelin Drive, St.
Louis, Missouri 63144 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
Meridian Medical Technologies 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 morphine (9300), a basic
class controlled substance listed in
schedule II.
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local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the basic classes of
controlled substances:
Controlled substance
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Schedule
II
II
[FR Doc. 2015–19099 Filed 8–3–15; 8:45 am]
BILLING CODE 4410–09–P
BILLING CODE 4410–09–P
Notice of registration.
SUMMARY:
tkelley on DSK3SPTVN1PROD with NOTICES
The company manufactures a product
containing morphine in the United
States. The company exports this
product to customers around the world.
The company has been asked to ensure
that its product, which is sold to
European customers, meets the
standards established by the European
Pharmacopeia, administered by the
Directorate for the Quality of Medicines
(EDQM). In order to ensure that its
product will meet European
specifications, the company seeks to
import morphine supplied by EDQM for
use as reference standards.
This is the sole purpose for which the
company will be authorized by the DEA
to import morphine.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Schedule
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Pharmacore,
Inc.
Manufacturer of Controlled
Substances Registration: Cambrex
Charles City
ACTION:
ACTION:
Notice of registration.
Pharmacore, Inc. applied to
be registered as a manufacturer of
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants
Pharmacore, Inc. registration as a
manufacturer of those controlled
substances.
SUPPLEMENTARY INFORMATION: By notice
dated April 14, 2015, and published in
the Federal Register on April 22, 2015,
80 FR 22554, Pharmacore, Inc., 4180
Mendenhall Oaks Parkway, High Point,
North Carolina 27265 applied to be
registered as a manufacturer of certain
basic classes of controlled substances.
No comments or objections were
submitted for this notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Pharmacore, Inc. to
manufacture the basic classes of
controlled substances 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
SUMMARY:
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Sfmt 4703
Notice of registration.
Cambrex Charles City applied
to be registered as a manufacturer of
certain basic classes of controlled
substances. The Drug Enforcement
Administration (DEA) grants Cambrex
Charles City registration as a
manufacturer of those controlled
substances.
SUMMARY:
By notice
dated April 14, 2015, and published in
the Federal Register on April 22, 2015,
80 FR 22555, Cambrex Charles City,
1205 11th Street, Charles City, Iowa
50616 applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Cambrex Charles City
to manufacture the basic classes of
controlled substances 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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\04AUN1.SGM
04AUN1
Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the basic classes of
controlled substances listed:
Controlled substance
Schedule
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333).
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Morphine (9300) ...........................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Opium, raw (9600) .......................
Opium extracts (9610) ..................
Opium fluid extract (9620) ............
Opium tincture (9630) ..................
Opium, powdered (9639) .............
Opium, granulated (9640) ............
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Poppy Straw Concentrate (9670)
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Fentanyl (9801) ............................
II
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II
II
II
II
II
II
II
II
II
II
II
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The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers, for dosage form
development, for clinical trials, and for
use in stability qualification studies.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015–19111 Filed 8–3–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Employment and Training
Administration
Comment Request for Proposed
Information Collection for Employment
and Training Administration Financial
Report Form #9130 (OMB Control No.
1205–0461), Extension With Changes
Employment and Training
Administration (ETA), Labor.
ACTION: Notice.
tkelley on DSK3SPTVN1PROD with NOTICES
AGENCY:
The Department of Labor, as
part of its continuing effort to reduce
paperwork and respondent burden
conducts a preclearance consultation
program to provide the general public
and Federal agencies with an
SUMMARY:
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18:45 Aug 03, 2015
Jkt 235001
opportunity to comment on proposed
and/or continuing collections of
information in accordance with the
Paperwork Reduction Act of 1995
(PRA95) [44 U.S.C. 3506(c)(2)(A)]. This
program helps to ensure that requested
data can be provided in the desired
format, reporting burden (time and
financial resources) is minimized,
collection instruments are clearly
understood, and the impact of collection
requirements on respondents can be
properly assessed. Currently, the
Employment and Training
Administration is soliciting comments
concerning the collection of data for
quarterly financial reporting on
federally funded programs, on Form
ETA–9130 (currently due to expire
December 31, 2015).
A copy of the proposed information
collection request (ICR) can be obtained
by contacting the office listed below in
the addressee section of this notice.
DATES: Submit written comments to the
office listed in the addresses section
below on or before October 5, 2015.
ADDRESSES: Send written comments to
Maggie Ewell, Division of Policy,
Review, and Resolution, Office of Grants
Management, Room N–4716,
Employment and Training
Administration, U.S. Department of
Labor, 200 Constitution Avenue NW.,
Washington, DC 20210. Telephone
number: 202–693–3160 (this is not a
toll-free number). Individuals with
hearing or speech impairments may
access the telephone number above via
TTY by calling the toll-free Federal
Information Relay Service at 1–877–
889–5627 (TTY/TDD). Fax: 202–693–
2705. Email: Ewell.Maggie@dol.gov. To
obtain a copy of the proposed
information collection request (ICR),
please contact the person listed above.
SUPPLEMENTARY INFORMATION:
I. Background
ETA awards approximately $8 billion
in formula and discretionary grants each
year to an average of 1,000 recipients.
Financial reports for each of these grants
must be submitted quarterly on the
financial report form ETA–9130.
Recipients include but are not limited
to: State Employment Security Agencies
which are comprised of three
components: Wagner Peyser
Employment Service, Unemployment
Insurance program, and Trade Program
Grant Agreements; as well as Workforce
Innovation and Opportunity Act
(WIOA) Youth, Adult, and Dislocated
Worker programs; National Dislocated
Worker Grants; National Farmworker
Jobs Program (NFJP); Indian and Native
American programs; the Senior
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46337
Community Service Employment
Program; Workforce Innovation and
Opportunity Act discretionary grants;
and H–1B Job Training Grants.
Financial reporting requirements for
Federal programs prescribed by the
Office of Management and Budget
(OMB) have changed with the
implementation of the Uniform
Guidance, which went into effect on
December 26, 2014, replacing numerous
previously applicable Circulars. These
changes affect both the ETA–9130
reporting form and its instructions.
However, they do not affect the
collection burden, but instead only
update certain key terms and
definitions.
Additionally, with the passage of
WIOA, there are numerous new
statutory requirements that impact
financial reporting, including but not
limited to new and/or revised
limitations and baselines that require
the addition of new and modification of
existing reporting line items on ETA–
9130 Financial Reports, as outlined in
this TEGL. Other reporting line items
have been added and removed in an
effort to streamline Federal financial
reporting and make form ETA–9130
more closely resemble the SF–425 (OMB
0348–0061), which is the standard
financial reporting form for Federal
grant recipients.
ETA has utilized the data collected to
assess the effectiveness of ETA
programs and to monitor and analyze
the financial activity of its grantees.
Grantees are provided with predesigned software to reflect the
requirements of ETA Form 9130 so that
the required data will be reported
electronically. ETA strives to reduce
reporting time for our recipients.
Several sections of the 9130 have prefilled line items or automatically
calculated line items, which is
convenient and time saving for our
recipients.
This data collection format permits
ETA to evaluate program effectiveness
and to monitor and analyze financial
activity, while complying with OMB
efforts to streamline Federal financial
reporting.
II. Review Focus
The Department is particularly
interested in comments which:
• 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,
E:\FR\FM\04AUN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Pages 46336-46337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-19111]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Cambrex
Charles City
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Cambrex Charles City applied to be registered as a
manufacturer of certain basic classes of controlled substances. The
Drug Enforcement Administration (DEA) grants Cambrex Charles City
registration as a manufacturer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and
published in the Federal Register on April 22, 2015, 80 FR 22555,
Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616
applied to be registered as a manufacturer of certain basic classes of
controlled substances. No comments or objections were submitted for
this notice.
The DEA has considered the factors in 21 U.S.C. 823(a) and
determined that the registration of Cambrex Charles City to manufacture
the basic classes of controlled substances 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
[[Page 46337]]
local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21
CFR 1301.33, the above-named company is granted registration as a bulk
manufacturer of the basic classes of controlled substances listed:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
4-Anilino-N-phenethyl-4-piperidine (ANPP) II
(8333).
Phenylacetone (8501)....................... II
Cocaine (9041)............................. II
Codeine (9050)............................. II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Morphine (9300)............................ II
Oripavine (9330)........................... II
Thebaine (9333)............................ II
Opium, raw (9600).......................... II
Opium extracts (9610)...................... II
Opium fluid extract (9620)................. II
Opium tincture (9630)...................... II
Opium, powdered (9639)..................... II
Opium, granulated (9640)................... II
Oxymorphone (9652)......................... II
Noroxymorphone (9668)...................... II
Poppy Straw Concentrate (9670)............. II
Alfentanil (9737).......................... II
Remifentanil (9739)........................ II
Sufentanil (9740).......................... II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
in bulk for sale to its customers, for dosage form development, for
clinical trials, and for use in stability qualification studies.
Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-19111 Filed 8-3-15; 8:45 am]
BILLING CODE 4410-09-P
