Bulk Manufacturer of Controlled Substances Application: National Center for Natural Products Research (NIDA MPROJECT), 78766-78767 [2015-31669]
Download as PDF
78766
Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
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 3, 2015, Johnson Matthey,
Inc., Custom Pharmaceuticals
Department, 2003 Nolte Drive, West
Deptford, New Jersey 08066–1742
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
Schedule
Gamma
Hydroxybutyric
Acid
(2010).
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
Dihydromorphine (9145) ...............
Difenoxin (9168) ...........................
Propiram (9649) ...........................
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Nabilone (7379) ............................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Ecgonine (9180) ...........................
Hydrocodone (9193) .....................
Meperidine (9230) ........................
Methadone (9250) ........................
Methadone intermediate (9254) ...
Morphine (9300) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Noroxymorphone (9668) ..............
Alfentanil (9737) ...........................
Remifentanil (9739) ......................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
I
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
asabaliauskas on DSK5VPTVN1PROD with NOTICES
The company plans to manufacture
the listed controlled substances in bulk
for sale to its customers.
In reference to drug codes 7360
(marihuana) and 7370 (THC), the
company plans to bulk manufacture
these drugs as synthetic. No other
activities for these drug codes are
authorized for this registration.
Dated: December 9, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Fisher Clinical Services,
Inc.
ACTION:
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 1301.34(a) on
or before January 19, 2016. Such
persons may also file a written request
for a hearing on the application
pursuant to 21 CFR 1301.43 on or before
January 19, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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 August
26, 2015, Fisher Clinical Services, Inc.
7554 Schantz Road, Allentown,
Pennsylvania 18106 applied to be
registered as an importer of the
following basic classes of controlled
substances:
DATES:
Controlled substance
[FR Doc. 2015–31665 Filed 12–16–15; 8:45 am]
BILLING CODE 4410–09–P
VerDate Sep<11>2014
16:53 Dec 16, 2015
Notice of application.
Methylphenidate (1724) ................
Levorphanol (9220) ......................
Noroxymorphone (9668) ..............
Tapentadol (9780) ........................
Jkt 238001
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
Schedule
II
II
II
II
The company plans to import the
listed substances for analytical research,
testing, and clinical trials. This
authorization does not extend to the
import of a finished FDA approved or
non-approved dosage form for
commercial distribution in the United
States.
The company plans to import an
intermediate form of tapentadol (9780)
to bulk manufacture tapentadol for
distribution to its customers. Placement
of these (this) drug code (s) 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 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.
Dated: December 9, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–31672 Filed 12–16–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: National
Center for Natural Products Research
(NIDA MPROJECT)
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 16, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearing 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
DATES:
E:\FR\FM\17DEN1.SGM
17DEN1
Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices
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
27, 2015, National Center for Natural
Products Research (NIDA MPROJECT),
University of Mississippi, 135 Coy
Waller Complex, P.O. Box 1848,
University, Mississippi 38677–1848
applied to be registered as a bulk
manufacturer of the following basic
classes controlled substances:
Controlled substance
Schedule
Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
I
I
The company plans to cultivate
marihuana in support of the National
Institute on Drug Abuse for research
approved by the Department of Health
and Human Services.
Dated: December 9, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015–31669 Filed 12–16–15; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1140–0092]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Voluntary
Magazine Questionnaire for Agencies/
Entities Who Store Explosive Materials
Bureau of Alcohol, Tobacco,
Firearms and Explosives, Department of
Justice
ACTION: 60-Day notice.
AGENCY:
The Department of Justice
(DOJ), Bureau of Alcohol, Tobacco,
Firearms and Explosives (ATF), will
submit 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.
DATES: Comments are encouraged and
will be accepted for 60 days until
February 16, 2016.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:53 Dec 16, 2015
Jkt 238001
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
Anita Scheddel, Program Analyst,
Explosives Industry Programs Branch,
99 New York Ave. NE., Washington, DC
20226 at email: Anita.Scheddel@atf.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 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;
• Evaluate whether and if so how the
quality, utility, and clarity of the
information to be collected can be
enhanced; 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.
Overview of this information
collection 1140–0092:
1. Type of Information Collection
(check justification or form 83):
Extension of a currently approved
collection.
2. The Title of the Form/Collection:
Voluntary Magazine Questionnaire for
Agencies/Entities Who Store Explosive
Materials.
3. The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
Form number (if applicable): Not
Applicable.
Component: Bureau of Alcohol,
Tobacco, Firearms and Explosives,
U.S. Department of Justice.
4. Affected public who will be asked
or required to respond, as well as a brief
abstract:
Primary: Agencies/Entities Who Store
Explosive Materials.
Other (if applicable): None.
Abstract: Primary: Agencies/Entities
Who Store Explosive Materials. Other:
None. The purpose of the form is to
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
78767
identify the number and locations of
public explosives storage facilities
(magazines), including those facilities
used by State and local law
enforcement.
5. An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: An estimated 1,000
respondents will take 30 minutes to
complete the survey.
6. An estimate of the total public
burden (in hours) associated with the
collection: The estimated annual public
burden associated with this collection is
500 hours.
If additional information is required
contact: Jerri Murray, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE., Room 3E–
405B, Washington, DC 20530.
Dated: December 14, 2015.
Jerri Murray,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2015–31705 Filed 12–16–15; 8:45 am]
BILLING CODE 4410–FY–P
DEPARTMENT OF JUSTICE
[OMB Number 1121–NEW]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; New
Collection: Body Worn Camera
Supplement (BWCS) to the Law
Enforcement Management and
Administrative Statistics (LEMAS)
Survey
Bureau of Justice Statistics,
Department of Justice.
ACTION: 30-day notice.
AGENCY:
The Department of Justice
(DOJ), Office of Justice Programs,
Bureau of Justice Statistics, 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 52512, on August 31,
2015, allowing for a 60 day comment
period.
SUMMARY:
Comments are encouraged and
will be accepted for an additional 30
days until January 19, 2016.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments
especially on the estimated public
DATES:
E:\FR\FM\17DEN1.SGM
17DEN1
Agencies
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Pages 78766-78767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31669]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: National
Center for Natural Products Research (NIDA MPROJECT)
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 February 16, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152. Request for
hearing 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
[[Page 78767]]
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 27, 2015, National Center for Natural Products Research (NIDA
MPROJECT), University of Mississippi, 135 Coy Waller Complex, P.O. Box
1848, University, Mississippi 38677-1848 applied to be registered as a
bulk manufacturer of the following basic classes controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
------------------------------------------------------------------------
The company plans to cultivate marihuana in support of the National
Institute on Drug Abuse for research approved by the Department of
Health and Human Services.
Dated: December 9, 2015.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2015-31669 Filed 12-16-15; 8:45 am]
BILLING CODE 4410-09-P