81 FR 66081 - Importer of Controlled Substances Application: Catalent CTS, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 186 (September 26, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 186 (September 26, 2016)
| Page Range | 66081-66082 | |
| FR Document | 2016-23017 |
[Federal Register Volume 81, Number 186 (Monday, September 26, 2016)] [Notices] [Pages 66081-66082] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Notices 66081
Controlled substance Drug code Schedule
Para-Fluorofentanyl .................................................................................................................................................. 9812 I
3-Methylfentanyl ....................................................................................................................................................... 9813 I
Alpha-methylfentanyl ................................................................................................................................................ 9814 I
Acetyl-alpha-methylfentanyl ..................................................................................................................................... 9815 I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ....................................................................... 9821 I
Butyryl Fentanyl ....................................................................................................................................................... 9822 I
Beta-hydroxyfentanyl ................................................................................................................................................ 9830 I
Beta-hydroxy-3-methylfentanyl ................................................................................................................................. 9831 I
Alpha-methylthiofentanyl .......................................................................................................................................... 9832 I
3-Methylthiofentanyl ................................................................................................................................................. 9833 I
Thiofentanyl .............................................................................................................................................................. 9835 I
Beta-hydroxythiofentanyl .......................................................................................................................................... 9836 I
Amphetamine ........................................................................................................................................................... 1100 II
Methamphetamine .................................................................................................................................................... 1105 II
Lisdexamfetamine .................................................................................................................................................... 1205 II
Phenmetrazine ......................................................................................................................................................... 1631 II
Methylphenidate ....................................................................................................................................................... 1724 II
Amobarbital .............................................................................................................................................................. 2125 II
Pentobarbital ............................................................................................................................................................ 2270 II
Secobarbital ............................................................................................................................................................. 2315 II
Glutethimide ............................................................................................................................................................. 2550 II
Nabilone ................................................................................................................................................................... 7379 II
1-Phenylcyclohexylamine ......................................................................................................................................... 7460 II
Phencyclidine ........................................................................................................................................................... 7471 II
4-Anilino-N-phenethyl-4-piperidine (ANPP) ............................................................................................................. 8333 II
1-Piperidinocyclohexanecarbonitrile ......................................................................................................................... 8603 II
Alphaprodine ............................................................................................................................................................ 9010 II
Cocaine .................................................................................................................................................................... 9041 II
Codeine .................................................................................................................................................................... 9050 II
Dihydrocodeine ........................................................................................................................................................ 9120 II
Oxycodone ............................................................................................................................................................... 9143 II
Hydromorphone ........................................................................................................................................................ 9150 II
Diphenoxylate ........................................................................................................................................................... 9170 II
Ecgonine .................................................................................................................................................................. 9180 II
Ethylmorphine .......................................................................................................................................................... 9190 II
Hydrocodone ............................................................................................................................................................ 9193 II
Levomethorphan ...................................................................................................................................................... 9210 II
Levorphanol .............................................................................................................................................................. 9220 II
Isomethadone ........................................................................................................................................................... 9226 II
Meperidine ................................................................................................................................................................ 9230 II
Meperidine intermediate-A ....................................................................................................................................... 9232 II
Meperidine intermediate-B ....................................................................................................................................... 9233 II
Meperidine intermediate-C ....................................................................................................................................... 9234 II
Metazocine ............................................................................................................................................................... 9240 II
Noroxymorphone ...................................................................................................................................................... 9250 II
Methadone intermediate .......................................................................................................................................... 9254 II
Dextropropoxyphene, bulk (non-dosage forms) ...................................................................................................... 9273 II
Morphine .................................................................................................................................................................. 9300 II
Thebaine .................................................................................................................................................................. 9333 II
Levo-alphacetylmethadol ......................................................................................................................................... 9648 II
Oxymorphone ........................................................................................................................................................... 9652 II
Noroxymorphone ...................................................................................................................................................... 9668 II
Racemethorphan ...................................................................................................................................................... 9732 II
Alfentanil ................................................................................................................................................................... 9737 II
Remifentanil ............................................................................................................................................................. 9739 II
Sufentanil ................................................................................................................................................................. 9740 II
Carfentanil ................................................................................................................................................................ 9743 II
Tapentadol ............................................................................................................................................................... 9780 II
Fentanyl .................................................................................................................................................................... 9801 II
The company plans to manufacture DEPARTMENT OF JUSTICE DATES: Registered bulk manufacturers of
small quantities of the listed controlled the affected basic classes, and
substances to make reference standards Drug Enforcement Administration applicants therefore, may file written
mstockstill on DSK3G9T082PROD with NOTICES
which will be distributed to its comments on or objections to the
customers. [Docket No. DEA–392] issuance of the proposed registration in
Dated: September 19, 2016. accordance with 21 CFR 1301.34(a) on
Louis L. Milione, Importer of Controlled Substances or before October 26, 2016. Such
Application: Catalent CTS, LLC persons may also file a written request
Deputy Assistant Administrator.
[FR Doc. 2016–23019 Filed 9–23–16; 8:45 am] for a hearing on the application
ACTION: Notice of application.
BILLING CODE 4410–09–P
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![66082 Federal Register / Vol. 81, No. 186 / Monday, September 26, 2016 / Notices
pursuant to 21 CFR 1301.43 on or before approved finished dosage forms for for the proper performance of the
October 26, 2016. commercial sale. functions of the agency, including
ADDRESSES: Written comments should Dated: September 19, 2016. whether the information will have
be sent to: Drug Enforcement Louis J. Milione,
practical utility;
Administration, Attention: DEA Federal Deputy Assistant Administrator. (2) Evaluate the accuracy of the
Register Representative/ODW, 8701 agency’s estimate of the burden of the
[FR Doc. 2016–23017 Filed 9–23–16; 8:45 am]
Morrissette Drive, Springfield, Virginia proposed collection of information,
BILLING CODE 4410–09–P
22152. All requests for hearing must be including the validity of the
sent to: Drug Enforcement methodology and assumptions used;
Administration, Attn: Administrator, DEPARTMENT OF JUSTICE (3) Enhance the quality, utility, and
8701 Morrissette Drive, Springfield, clarity of the information to be
Virginia 22152. All requests for hearing [OMB Number 1110–0048] collected; and
should also be sent to: (1) Drug (4) Minimize the burden of the
Enforcement Administration, Attn: Agency Information Collection
collection of information on those who
Hearing Clerk/LJ, 8701 Morrissette Activities; Proposed Collection,
are to respond, including through the
Drive, Springfield, Virginia 22152; and Comments Requested; Extension of a
use of appropriate automated,
(2) Drug Enforcement Administration, Currently Approved Collection; Cargo
electronic, mechanical, or other
Attn: DEA Federal Register Theft Incident Report
technological collection techniques of
Representative/ODW, 8701 Morrissette AGENCY: Federal Bureau of other forms of information technology,
Drive, Springfield, Virginia 22152. Investigation, Department of Justice. e.g., permitting electronic submission of
SUPPLEMENTARY INFORMATION: The responses.
ACTION: 30-Day notice.
Attorney General has delegated her
authority under the Controlled Overview of This Information
SUMMARY: The Department of Justice,
Substances Act to the Administrator of Collection
Federal Bureau of Investigation,
the Drug Enforcement Administration Criminal Justice Information Services (1) Type of Information Collection:
(DEA), 28 CFR 0.100(b). Authority to (CJIS) Division will be submitting the Extension of a currently approved
exercise all necessary functions with following Information Collection collection.
respect to the promulgation and Request to the Office of Management (2) The Title of the Form/Collection:
implementation of 21 CFR part 1301, and Budget (OMB) for review and Cargo Theft Incident Report.
incident to the registration of clearance in accordance with the (3) The agency form number, if any,
manufacturers, distributors, dispensers, established review procedures of the and the applicable component of the
importers, and exporters of controlled Paperwork Reduction Act of 1995. This department sponsoring the collection:
substances (other than final orders in proposed information collection was Form Number: 1110–0048 Sponsor:
connection with suspension, denial, or previously published in the Federal Criminal Justice Information Services
revocation of registration) has been Register at 81 FR 47178, on July 20, Division, Federal Bureau of
redelegated to the Deputy Assistant 2016, allowing for a 60 day comment Investigation, Department of Justice.
Administrator of the DEA Office of period. (4) Affected public who will be asked
Diversion Control (‘‘Deputy Assistant
DATES: Comments are encouraged and or required to respond, as well as a brief
Administrator’’) pursuant to section 7 of
will be accepted for an additional 30 abstract: Primary: City, county, state,
28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR days until October 26, 2016. federal, and tribal law enforcement
1301.34(a), this is notice that on May 6, FOR FURTHER INFORMATION CONTACT: agencies.
2016, Catalent CTS., LLC., 10245 Written comments and/or suggestions Abstract: This collection is needed to
Hickman Mills Drive, Kansas City, regarding the items contained in this collect information on cargo theft
Missouri 64137 applied to be registered notice, especially the estimated public incidents committed throughout the
as an importer of the following basic burden and associated response time, United States.
classes of controlled substances: should be directed to Mr. Samuel (5) An estimate of the total number of
Berhanu, Unit Chief, Federal Bureau of respondents and the amount of time
Drug Investigation, CJIS Division, Module estimated for an average respondent to
Controlled substance Schedule
code E–3, 1000 Custer Hollow Road, respond: There are approximately
Clarksburg, West Virginia 26306; 18,439 law enforcement agency
Gamma Hydroxy- 2010 I
facsimile (304) 625–3566. Written respondents that submit monthly for a
butyric Acid.
Marihuana ................. 7360 I comments and/or suggestions can also total of 221,268 responses with an
be sent to the Office of Management and estimated response time of 5 minutes
The company plans to import finished Budget, Office of Information and per response.
dosage unit products containing gamma- Regulatory Affairs, Attention (6) An estimate of the total public
hydroxybutyric acid and cannabis Department of Justice Desk Officer, burden (in hours) associated with this
extracts for clinical trial studies. Washington, DC 20503 or sent to OIRA_ collection: There are approximately
These cannabis extracts compounds submissions@omb.eop.gov. 18,439 hours, annual burden, associated
are listed under drug code 7360. No SUPPLEMENTARY INFORMATION: Written with this information collection.
other activity for this drug code is comments and suggestions from the If additional information is required
mstockstill on DSK3G9T082PROD with NOTICES
authorized for this registration. public and affected agencies concerning contact: Jerri Murray, Department
Approval of permit applications will the proposed collection of information Clearance Officer, Policy and Planning
occur only when the registrant’s are encouraged. Comments should Staff, Justice Management Division,
business activity is consistent with what address one or more of the following United States Department of Justice,
is authorized under to 21 U.S.C. four points: Two Constitution Square, 145 N Street
952(a)(2). Authorization will not extend (1) Evaluate whether the proposed NE., Room 3E–405B, Washington, DC
to the import of FDA approved or non- collection of information is necessary 20530.
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Document Created: 2018-02-09 13:22:32
Document Modified: 2018-02-09 13:22:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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 pursuant to 21 CFR 1301.43 on or before October 26, 2016. | |
| FR Citation | 81 FR 66081 |
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