Importer of Controlled Substances Application: Catalent CTS, LLC, 66081-66082 [2016-23017]
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66081
Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Notices
Controlled substance
Drug code
mstockstill on DSK3G9T082PROD with NOTICES
Para-Fluorofentanyl ..................................................................................................................................................
3-Methylfentanyl .......................................................................................................................................................
Alpha-methylfentanyl ................................................................................................................................................
Acetyl-alpha-methylfentanyl .....................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) .......................................................................
Butyryl Fentanyl .......................................................................................................................................................
Beta-hydroxyfentanyl ................................................................................................................................................
Beta-hydroxy-3-methylfentanyl .................................................................................................................................
Alpha-methylthiofentanyl ..........................................................................................................................................
3-Methylthiofentanyl .................................................................................................................................................
Thiofentanyl ..............................................................................................................................................................
Beta-hydroxythiofentanyl ..........................................................................................................................................
Amphetamine ...........................................................................................................................................................
Methamphetamine ....................................................................................................................................................
Lisdexamfetamine ....................................................................................................................................................
Phenmetrazine .........................................................................................................................................................
Methylphenidate .......................................................................................................................................................
Amobarbital ..............................................................................................................................................................
Pentobarbital ............................................................................................................................................................
Secobarbital .............................................................................................................................................................
Glutethimide .............................................................................................................................................................
Nabilone ...................................................................................................................................................................
1-Phenylcyclohexylamine .........................................................................................................................................
Phencyclidine ...........................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) .............................................................................................................
1-Piperidinocyclohexanecarbonitrile .........................................................................................................................
Alphaprodine ............................................................................................................................................................
Cocaine ....................................................................................................................................................................
Codeine ....................................................................................................................................................................
Dihydrocodeine ........................................................................................................................................................
Oxycodone ...............................................................................................................................................................
Hydromorphone ........................................................................................................................................................
Diphenoxylate ...........................................................................................................................................................
Ecgonine ..................................................................................................................................................................
Ethylmorphine ..........................................................................................................................................................
Hydrocodone ............................................................................................................................................................
Levomethorphan ......................................................................................................................................................
Levorphanol ..............................................................................................................................................................
Isomethadone ...........................................................................................................................................................
Meperidine ................................................................................................................................................................
Meperidine intermediate-A .......................................................................................................................................
Meperidine intermediate-B .......................................................................................................................................
Meperidine intermediate-C .......................................................................................................................................
Metazocine ...............................................................................................................................................................
Noroxymorphone ......................................................................................................................................................
Methadone intermediate ..........................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ......................................................................................................
Morphine ..................................................................................................................................................................
Thebaine ..................................................................................................................................................................
Levo-alphacetylmethadol .........................................................................................................................................
Oxymorphone ...........................................................................................................................................................
Noroxymorphone ......................................................................................................................................................
Racemethorphan ......................................................................................................................................................
Alfentanil ...................................................................................................................................................................
Remifentanil .............................................................................................................................................................
Sufentanil .................................................................................................................................................................
Carfentanil ................................................................................................................................................................
Tapentadol ...............................................................................................................................................................
Fentanyl ....................................................................................................................................................................
The company plans to manufacture
small quantities of the listed controlled
substances to make reference standards
which will be distributed to its
customers.
Dated: September 19, 2016.
Louis L. Milione,
Deputy Assistant Administrator.
BILLING CODE 4410–09–P
19:40 Sep 23, 2016
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Catalent CTS, LLC
[FR Doc. 2016–23019 Filed 9–23–16; 8:45 am]
VerDate Sep<11>2014
Drug Enforcement Administration
Jkt 238001
ACTION:
PO 00000
Notice of application.
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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 October 26, 2016. Such
persons may also file a written request
for a hearing on the application
DATES:
DEPARTMENT OF JUSTICE
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Schedule
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26SEN1
66082
Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Notices
pursuant to 21 CFR 1301.43 on or before
October 26, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be
sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing
should also be sent to: (1) Drug
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/ODW, 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 6,
2016, Catalent CTS., LLC., 10245
Hickman Mills Drive, Kansas City,
Missouri 64137 applied to be registered
as an importer of the following basic
classes of controlled substances:
Controlled substance
mstockstill on DSK3G9T082PROD with NOTICES
Gamma Hydroxybutyric Acid.
Marihuana .................
Drug
code
Schedule
2010
I
7360
I
The company plans to import finished
dosage unit products containing gammahydroxybutyric acid and cannabis
extracts for clinical trial studies.
These cannabis extracts compounds
are listed under drug code 7360. No
other activity for this drug code is
authorized for this registration.
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 non-
VerDate Sep<11>2014
19:40 Sep 23, 2016
Jkt 238001
approved finished dosage forms for
commercial sale.
Dated: September 19, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–23017 Filed 9–23–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1110–0048]
Agency Information Collection
Activities; Proposed Collection,
Comments Requested; Extension of a
Currently Approved Collection; Cargo
Theft Incident Report
Federal Bureau of
Investigation, Department of Justice.
ACTION: 30-Day notice.
AGENCY:
The Department of Justice,
Federal Bureau of Investigation,
Criminal Justice Information Services
(CJIS) Division will be submitting the
following Information Collection
Request to the Office of Management
and Budget (OMB) for review and
clearance in accordance with the
established review procedures of the
Paperwork Reduction Act of 1995. This
proposed information collection was
previously published in the Federal
Register at 81 FR 47178, on July 20,
2016, allowing for a 60 day comment
period.
SUMMARY:
Comments are encouraged and
will be accepted for an additional 30
days until October 26, 2016.
FOR FURTHER INFORMATION CONTACT:
Written comments and/or suggestions
regarding the items contained in this
notice, especially the estimated public
burden and associated response time,
should be directed to Mr. Samuel
Berhanu, Unit Chief, Federal Bureau of
Investigation, CJIS Division, Module
E–3, 1000 Custer Hollow Road,
Clarksburg, West Virginia 26306;
facsimile (304) 625–3566. Written
comments and/or suggestions can also
be sent 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. Comments should
address one or more of the following
four points:
(1) Evaluate whether the proposed
collection of information is necessary
DATES:
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) 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;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) 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 of
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of This Information
Collection
(1) Type of Information Collection:
Extension of a currently approved
collection.
(2) The Title of the Form/Collection:
Cargo Theft Incident Report.
(3) The agency form number, if any,
and the applicable component of the
department sponsoring the collection:
Form Number: 1110–0048 Sponsor:
Criminal Justice Information Services
Division, Federal Bureau of
Investigation, Department of Justice.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: City, county, state,
federal, and tribal law enforcement
agencies.
Abstract: This collection is needed to
collect information on cargo theft
incidents committed throughout the
United States.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: There are approximately
18,439 law enforcement agency
respondents that submit monthly for a
total of 221,268 responses with an
estimated response time of 5 minutes
per response.
(6) An estimate of the total public
burden (in hours) associated with this
collection: There are approximately
18,439 hours, annual burden, associated
with this information collection.
If additional information is required
contact: Jerri Murray, Department
Clearance Officer, Policy and Planning
Staff, Justice Management Division,
United States Department of Justice,
Two Constitution Square, 145 N Street
NE., Room 3E–405B, Washington, DC
20530.
E:\FR\FM\26SEN1.SGM
26SEN1
]]>Agencies
[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)]
[Notices]
[Pages 66081-66082]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23017]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Catalent CTS, LLC
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
1301.34(a) on or before October 26, 2016. Such persons may also file a
written request for a hearing on the application
[[Page 66082]]
pursuant to 21 CFR 1301.43 on or before October 26, 2016.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for hearing should also be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/ODW, 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 6,
2016, Catalent CTS., LLC., 10245 Hickman Mills Drive, Kansas City,
Missouri 64137 applied to be registered as an importer of the following
basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............. 2010 I
Marihuana............................. 7360 I
------------------------------------------------------------------------
The company plans to import finished dosage unit products
containing gamma-hydroxybutyric acid and cannabis extracts for clinical
trial studies.
These cannabis extracts compounds are listed under drug code 7360.
No other activity for this drug code is authorized for this
registration. 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 non-approved finished dosage forms for
commercial sale.
Dated: September 19, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-23017 Filed 9-23-16; 8:45 am]
BILLING CODE 4410-09-P
