Manufacturer of Controlled Substances; Notice of Registration, 23627-23628 [2011-10144]
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23627
Federal Register / Vol. 76, No. 81 / Wednesday, April 27, 2011 / Notices
Drug
Schedule
Ecgonine (9180) ..........................................................................................................................................................................................
Ethylmorphine (9190) ..................................................................................................................................................................................
Hydrocodone (9193) ....................................................................................................................................................................................
Levorphanol (9220) .....................................................................................................................................................................................
Meperidine (9230) .......................................................................................................................................................................................
Methadone (9250) .......................................................................................................................................................................................
Morphine (9300) ..........................................................................................................................................................................................
Thebaine (9333) ..........................................................................................................................................................................................
Opium, powdered (9639) .............................................................................................................................................................................
Levo-alphacetylmethadol (9648) .................................................................................................................................................................
Oxymorphone (9652) ...................................................................................................................................................................................
Fentanyl (9801) ...........................................................................................................................................................................................
The company plans to import the
listed controlled substances for sale to
research facilities for drug testing and
analysis.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and 952(a),
and determined that the registration of
Sigma Aldrich Manufacturing LLC. to
import 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, at this time. DEA has
investigated Sigma Aldrich
Manufacturing LLC. to ensure that the
company’s registration is consistent
with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of 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
the basic classes of controlled
substances listed.
By Notice dated October 6, 2010, and
published in the Federal Register on
October 14, 2010, 75 FR 63203, PCASNanosyn, LLC, 3331–B Industrial Drive,
Santa Rosa, California 95403, made
application to the Drug Enforcement
Administration (DEA) to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
BILLING CODE 4410–09–P
Manufacturer of Controlled
Substances; Notice of Registration
BILLING CODE 4410–09–P
Manufacturer of Controlled
Substances; Notice of Application
Pursuant to § 1301.33(a) Title 21 of
the Code of Federal Regulations (CFR),
this is notice that on March 31, 2011,
Cedarburg Pharmaceuticals, Inc., 870
Badger Circle, Grafton, Wisconsin
53024, made application by letter to the
Drug Enforcement Administration
Jkt 223001
[FR Doc. 2011–10139 Filed 4–26–11; 8:45 am]
Drug Enforcement Administration
[FR Doc. 2011–10145 Filed 4–26–11; 8:45 am]
15:36 Apr 26, 2011
Dated: April 15, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
DEPARTMENT OF JUSTICE
Dated: April 15, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
VerDate Mar<15>2010
(DEA) to be registered as a bulk
manufacturer of 4-Anilino-N-phenethyl4-Piperidine (8333), a basic class of
controlled substance listed in schedule
II.
The company plans to use this
controlled substance in the manufacture
of another controlled substance.
Any other such applicant, and any
person who is presently registered with
DEA to manufacture such substances,
may file comments or objections to the
issuance of the proposed registration
pursuant to 21 CFR 1301.33(a).
Any such written comments or
objections should be addressed, in
quintuplicate, to the Drug Enforcement
Administration, Office of Diversion
Control, Federal Register Representative
(ODL), 8701 Morrissette Drive,
Springfield, Virginia 22152; and must be
filed no later than June 27, 2011.
Drug
Schedule
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Methylphenidate (1724) ................
Phencyclidine (7471) ....................
Codeine (9050) .............................
PO 00000
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II
II
II
II
II
Drug
Diprenorphine (9058) ...................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Methadone (9250) ........................
Morphine (9300) ...........................
Oxymorphone (9652) ...................
Fentanyl (9801) ............................
II
II
II
II
II
II
II
II
II
II
II
II
Schedule
II
II
II
II
II
II
II
II
The company is a contract
manufacturer. At the request of the
company’s customers, it manufactures
derivatives of controlled substances in
bulk form only. The primary service
provided by the company to its
customers is the development of the
process of manufacturing the derivative.
As part of its service to its customers,
the company distributes the derivatives
of the controlled substances it
manufactures to those customers. The
company’s customers use the newlycreated processes and the manufactured
derivatives in furtherance of
formulation processes and dosage form
manufacturing; pre-clinical studies,
including toxicological studies; clinical
studies supporting investigational Drug
Applications; and use in stability
studies.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of
PCAS-Nanosyn, LLC to manufacture the
listed basic classes of controlled
substances is consistent with the public
interest at this time. DEA has
investigated PCAS-Nanosyn, LLC to
ensure that the company’s registration is
consistent with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with State and
local laws, and a review of 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
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Federal Register / Vol. 76, No. 81 / Wednesday, April 27, 2011 / Notices
the basic classes of controlled
substances listed.
Dated: April 15, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2011–10144 Filed 4–26–11; 8:45 am]
BILLING CODE 4410–09–P
NUCLEAR REGULATORY
COMMISSION
[Docket No. NRC–2010–0377]
Agency Information Collection
Activities: Submission for the Office of
Management and Budget (OMB)
Review; Comment Request
Nuclear Regulatory
Commission (NRC).
ACTION: Notice of the OMB review of
information collection and solicitation
of public comment.
AGENCY:
The NRC has recently
submitted to OMB for review the
following proposal for the collection of
information under the provisions of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). The NRC hereby
informs potential respondents that an
agency may not conduct or sponsor, and
that a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. The NRC published a Federal
Register Notice with a 60-day comment
period on this information collection on
December 23, 2010.
1. Type of submission, new, revision,
or extension: Extension.
2. The title of the information
collection: NUREG/BR–0238, Materials
Annual Fee Billing Handbook; NRC
Form 628, ‘‘Financial EDI
Authorization;’’ NUREG/BR–0254,
Payment Methods; and NRC Form 629,
‘‘Authorization for Payment by Credit
Card.’’
3. Current OMB approval number:
3150–0190.
4. The form number if applicable:
NRC Form 628, ‘‘Financial EDI
Authorization’’ and NRC Form 629,
‘‘Authorization for Payment by Credit
Card.
5. How often the collection is
required: On occasion (as needed to pay
invoices).
6. Who will be required or asked to
report: Anyone doing business with the
Nuclear Regulatory Commission
including licensees, applicants and
individuals who are required to pay a
fee for inspections and licenses.
7. An estimate of the number of
annual responses: 583 (11 for NRC form
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
15:36 Apr 26, 2011
Jkt 223001
628 and 572 for NRC form 629 and
NUREG/BR–0254).
8. The estimated number of annual
respondents: 583 (11 for NRC form 628
and 572 for NRC form 629 and NUREG/
BR–0254).
9. An estimate of the total number of
hours needed annually to complete the
requirement or request: 47 hours (.9
hour for NRC form 628 and 46 hours for
NRC form 629 and NUREG/BR–0254).
10. Abstract: The U.S. Department of
the Treasury encourages the public to
pay monies owed the government
through use of the Automated
Clearinghouse Network and credit
cards. These two methods of payment
are used by licensees, applicants, and
individuals to pay civil penalties, full
cost licensing fees, and inspection fees
to the NRC.
The public may examine and have
copied for a fee publicly available
documents, including the final
supporting statement, at the NRC’s
Public Document Room, Room O–1F21,
One White Flint North, 11555 Rockville
Pike, Rockville, Maryland 20852. OMB
clearance requests are available at the
NRC worldwide Web site: https://
www.nrc.gov/public-involve/doccomment/omb/. The document will be
available on the NRC home page site for
60 days after the signature date of this
notice.
Comments and questions should be
directed to the OMB reviewer listed
below by May 27, 2011. Comments
received after this date will be
considered if it is practical to do so, but
assurance of consideration cannot be
given to comments received after this
date.
Christine J. Kymn, Desk Officer,
Office of Information and Regulatory
Affairs (3150–0190), NEOB–10202,
Office of Management and Budget,
Washington, DC 20503.
Comments can also be e-mailed to
Christine_J._Kymn@omb.eop.gov or
submitted by telephone at 202–395–
4638.
The NRC Clearance Officer is
Tremaine Donnell, 301–415–6258.
Dated at Rockville, Maryland, this 21st day
of April, 2011.
For the Nuclear Regulatory Commission.
Tremaine Donnell,
NRC Clearance Officer, Office of Information
Services.
[FR Doc. 2011–10162 Filed 4–26–11; 8:45 am]
BILLING CODE 7590–01–P
PO 00000
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NUCLEAR REGULATORY
COMMISSION
[Docket No. NRC–2011–0056]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Nuclear Regulatory
Commission (NRC).
ACTION: Notice of pending NRC action to
submit an information collection
request to the Office of Management and
Budget (OMB) and solicitation of public
comment.
AGENCY:
The NRC invites public
comment about our intention to request
the OMB’s approval for renewal of an
existing information collection that is
summarized below. We are required to
publish this notice in the Federal
Register under the provisions of the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35).
Information pertaining to the
requirement to be submitted:
1. The title of the information
collection: 10 CFR part 81, ‘‘Standard
Specifications for Granting of Patent
Licenses.’’
2. Current OMB approval number:
3150–0121.
3. How often the collection is
required: Applications for licenses are
submitted once. Other reports are
submitted annually or as other events
require.
4. Who is required or asked to report:
Applicants for and holders of NRC
licenses to NRC inventions.
5. The number of annual respondents:
1.
6. The number of hours needed
annually to complete the requirement or
request: 37; however, no applications
are anticipated during the next 3 years.
7. Abstract: As specified in 10 CFR
part 81, the NRC may grant nonexclusive licenses or limited exclusive
licenses to its patent inventions to
responsible applicants. Applicants for
licenses to NRC inventions are required
to provide information which may
provide the basis for granting the
requested license. In addition, all
license holders must submit periodic
reports on efforts to bring the invention
to a point of practical application and
the extent to which they are making the
benefits of the invention reasonably
accessible to the public. Exclusive
license holders must submit additional
information if they seek to extend their
licenses, issue sublicenses, or transfer
the licenses. In addition, if requested,
exclusive license holders must promptly
supply to the United States Government
copies of all pleadings and other papers
SUMMARY:
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]]>Agencies
[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Notices]
[Pages 23627-23628]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10144]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration
By Notice dated October 6, 2010, and published in the Federal
Register on October 14, 2010, 75 FR 63203, PCAS-Nanosyn, LLC, 3331-B
Industrial Drive, Santa Rosa, California 95403, made application to the
Drug Enforcement Administration (DEA) to be registered as a bulk
manufacturer of the following basic classes of controlled substances:
------------------------------------------------------------------------
Drug Schedule
------------------------------------------------------------------------
Amphetamine (1100)......................... II
Methamphetamine (1105)..................... II
Methylphenidate (1724)..................... II
Phencyclidine (7471)....................... II
Codeine (9050)............................. II
Diprenorphine (9058)....................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Methadone (9250)........................... II
Morphine (9300)............................ II
Oxymorphone (9652)......................... II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
The company is a contract manufacturer. At the request of the
company's customers, it manufactures derivatives of controlled
substances in bulk form only. The primary service provided by the
company to its customers is the development of the process of
manufacturing the derivative. As part of its service to its customers,
the company distributes the derivatives of the controlled substances it
manufactures to those customers. The company's customers use the newly-
created processes and the manufactured derivatives in furtherance of
formulation processes and dosage form manufacturing; pre-clinical
studies, including toxicological studies; clinical studies supporting
investigational Drug Applications; and use in stability studies.
No comments or objections have been received. DEA has considered
the factors in 21 U.S.C. 823(a) and determined that the registration of
PCAS-Nanosyn, LLC to manufacture the listed basic classes of controlled
substances is consistent with the public interest at this time. DEA has
investigated PCAS-Nanosyn, LLC to ensure that the company's
registration is consistent with the public interest. The investigation
has included inspection and testing of the company's physical security
systems, verification of the company's compliance with State and local
laws, and a review of 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
[[Page 23628]]
the basic classes of controlled substances listed.
Dated: April 15, 2011.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2011-10144 Filed 4-26-11; 8:45 am]
BILLING CODE 4410-09-P
