80 FR 75692 - Importer of Controlled Substances Registration: Catalent CTS, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 232 (December 3, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 232 (December 3, 2015)
| Page Range | 75692-75693 | |
| FR Document | 2015-30551 |
[Federal Register Volume 80, Number 232 (Thursday, December 3, 2015)] [Notices] [Pages 75692-75693] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30551] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration: Catalent CTS, LLC ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Catalent CTS, LLC applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Catalent CTS, LLC registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated August 21, 2015, and published in the Federal Register on August 31, 2015, 80 FR 52509, Catalent CTS, LLC, 10245 Hickman Mills Drive, Kansas City, Missouri 64137 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 Catalent CTS, LLC 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 marihuana (7360), a basic class of controlled substance listed in schedule I. The company plans to import finished pharmaceutical products containing cannabis extracts in dosage form for clinical trial studies. This compound is listed under drug code 7360. No other activity for this drug code is authorized for this registration. Approval of permits 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. [[Page 75693]] Dated: November 27, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015-30551 Filed 12-2-15; 8:45 am] BILLING CODE 4410-09-P
![75692 Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices
exercise all necessary functions with Administration, Attention: DEA Federal DEPARTMENT OF JUSTICE
respect to the promulgation and Register Representative/OD/D, 8701
implementation of 21 CFR part 1301, Morrissette Drive, Springfield, Virginia Drug Enforcement Administration
incident to the registration of 22152. Request for hearings should be
manufacturers, distributors, dispensers, sent to: Drug Enforcement [Docket No. DEA–392]
importers, and exporters of controlled Administration, Attention: Hearing
substances (other than final orders in Clerk/LJ, 8701 Morrissette Drive, Importer of Controlled Substances
connection with suspension, denial, or Springfield, Virginia 22152. Registration: Catalent CTS, LLC
revocation of registration) has been
SUPPLEMENTARY INFORMATION: The ACTION: Notice of registration.
redelegated to the Deputy Assistant
Attorney General has delegated her
Administrator of the DEA Office of
authority under the Controlled SUMMARY: Catalent CTS, LLC applied to
Diversion Control (‘‘Deputy Assistant
Substances Act to the Administrator of be registered as an importer of a certain
Administrator’’) pursuant to section 7 of
the Drug Enforcement Administration basic class of controlled substance. The
28 CFR part 0, appendix to subpart R.
(DEA), 28 CFR 0.100(b). Authority to Drug Enforcement Administration
In accordance with 21 CFR
exercise all necessary functions with (DEA) grants Catalent CTS, LLC
1301.33(a), this is notice that on
respect to the promulgation and registration as an importer of this
September 7, 2015, Organix, Inc., 240
implementation of 21 CFR part 1301, controlled substance.
Salem Street, Woburn, Massachusetts
incident to the registration of
01801 applied to be registered as a bulk SUPPLEMENTARY INFORMATION: By notice
manufacturers, distributors, dispensers,
manufacturer of the following basic dated August 21, 2015, and published in
importers, and exporters of controlled
classes of controlled substances: the Federal Register on August 31,
substances (other than final orders in
2015, 80 FR 52509, Catalent CTS, LLC,
connection with suspension, denial, or
Controlled substance Schedule 10245 Hickman Mills Drive, Kansas
revocation of registration) has been
City, Missouri 64137 applied to be
Gamma Hydroxybutyric Acid I redelegated to the Deputy Assistant
registered as an importer of a certain
(2010). Administrator of the DEA Office of
basic class of controlled substance. No
Lysergic acid diethylamide (7315) I Diversion Control (‘‘Deputy Assistant
Marihuana (7360) ......................... I comments or objections were submitted
Administrator’’) pursuant to section 7 of
Tetrahydrocannabinols (7370) ..... I for this notice.
28 CFR part 0, appendix to subpart R.
Psilocybin (7437) .......................... I The DEA has considered the factors in
Psilocyn (7438) ............................. I In accordance with 21 CFR 21 U.S.C. 823, 952(a) and 958(a) and
Heroin (9200) ............................... I 1301.33(a), this is notice that on October determined that the registration of
Morphine (9300) ........................... II 6, 2015, Noramco, Inc., 500 Swedes Catalent CTS, LLC to import the basic
Landing Road, Wilmington, Delaware class of controlled substance is
The company plans to manufacture 19801–4417 applied to be registered as consistent with the public interest and
reference standards for distribution to a bulk manufacturer of the following with United States obligations under
its research and forensics customers. In basic classes of controlled substances: international treaties, conventions, or
reference to drug codes 7360 protocols in effect on May 1, 1971. The
(marihuana) and 7370 (THC) the Controlled substance Schedule DEA investigated the company’s
company plans to manufacture these maintenance of effective controls
drugs as synthetic. No other activities Codeine-N-oxide (9053) ............... I
Dihydromorphine (9145) ............... I against diversion by inspecting and
for these drug codes are authorized for Morphine-N-oxide (9307) ............. I testing the company’s physical security
this registration. Amphetamine (1100) .................... II systems, verifying the company’s
Dated: November 27, 2015. Methylphenidate (1724) ................ II compliance with state and local laws,
Louis J. Milione, Phenylacetone (8501) .................. II and reviewing the company’s
Codeine (9050) ............................. II background and history.
Deputy Assistant Administrator.
Dihydrocodeine (9120) ................. II
[FR Doc. 2015–30554 Filed 12–2–15; 8:45 am] Therefore, pursuant to 21 U.S.C.
Oxycodone (9143) ........................ II
BILLING CODE 4410–09–P Hydromorphone (9150) ................ II 952(a) and 958(a), and in accordance
Hydrocodone (9193) ..................... II with 21 CFR 1301.34, the above-named
Morphine (9300) ........................... II company is granted registration as an
DEPARTMENT OF JUSTICE Oripavine (9330) ........................... II importer of marihuana (7360), a basic
Thebaine (9333) ........................... II class of controlled substance listed in
Drug Enforcement Administration Opium extracts (9610) .................. II schedule I.
Opium fluid extract (9620) ............ II The company plans to import finished
[Docket No. DEA–392] Opium tincture (9630) .................. II pharmaceutical products containing
Opium, powdered (9639) ............. II
Bulk Manufacturer of Controlled Opium, granulated (9640) ............ II
cannabis extracts in dosage form for
Substances Application: Noramco, Inc. Oxymorphone (9652) ................... II clinical trial studies.
Noroxymorphone (9668) .............. II This compound is listed under drug
ACTION: Notice of application. Tapentadol (9780) ........................ II code 7360. No other activity for this
drug code is authorized for this
DATES: Registered bulk manufacturers of registration. Approval of permits
The company plans to manufacture
the affected basic classes, and applications will occur only when the
the above-listed controlled substances
Lhorne on DSK5TPTVN1PROD with NOTICES
applicants therefore, may file written registrant’s business activity is
in bulk for distribution to its customers.
comments on or objections to the consistent with what is authorized
issuance of the proposed registration in Dated: November 23, 2015.
under to 21 U.S.C. 952(a)(2).
accordance with 21 CFR 1301.33(a) on Louis J. Milione, Authorization will not extend to the
or before February 1, 2016. Deputy Assistant Administrator. import of FDA approved or non-
ADDRESSES: Written comments should [FR Doc. 2015–30550 Filed 12–2–15; 8:45 am] approved finished dosage forms for
be sent to: Drug Enforcement BILLING CODE 4410–09–P commercial sale.
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![Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices 75693
Dated: November 27, 2015. Washington, DC 20210; or by email: receive a month-to-month extension
Louis J. Milione, DOL_PRA_PUBLIC@dol.gov. while they undergo review. For
Deputy Assistant Administrator. FOR FURTHER INFORMATION CONTACT: additional substantive information
[FR Doc. 2015–30551 Filed 12–2–15; 8:45 am] Michel Smyth by telephone at 202–693– about this ICR, see the related notice
BILLING CODE 4410–09–P 4129, TTY 202–693–8064, (these are not published in the Federal Register on
toll-free numbers) or by email at DOL_ May 21, 2015 (80 FR 29344).
PRA_PUBLIC@dol.gov.
Interested parties are encouraged to
DEPARTMENT OF LABOR Authority: 44 U.S.C. 3507(a)(1)(D). send comments to the OMB, Office of
SUPPLEMENTARY INFORMATION: This ICR Information and Regulatory Affairs at
Office of the Secretary
seeks to extend PRA authority for the the address shown in the ADDRESSES
Agency Information Collection Hazardous Waste Operations and section within thirty (30) days of
Activities; Submission for OMB Emergency Response (HAZWOPER) publication of this notice in the Federal
Review; Comment Request; Hazardous Standard information collection. The Register. In order to help ensure
Waste Operations and Emergency HAZWOPER Standard specifies a appropriate consideration, comments
Response number of information collection should mention OMB Control Number
requirements. Employers can use the 1218–0202. The OMB is particularly
AGENCY: Office of the Secretary, Labor. information collected under the interested in comments that:
ACTION: Notice. HAZWOPER rule to develop the various
• Evaluate whether the proposed
SUMMARY: On November 30, 2015 the programs the Standard requires and to
collection of information is necessary
Department of Labor (DOL) will submit ensure that their workers are trained
properly about the safety and health for the proper performance of the
the Occupational Safety and Health functions of the agency, including
Administration (OSHA) sponsored hazards associated with hazardous
waste operations and emergency whether the information will have
information collection request (ICR) practical utility;
titled, ‘‘Hazardous Waste Operations response to hazardous waste releases.
and Emergency Response,’’ to the Office The OSHA uses the records developed • Evaluate the accuracy of the
of Management and Budget (OMB) for in response to this Standard to agency’s estimate of the burden of the
review and approval for continued use, determine adequate compliance with proposed collection of information,
without change, in accordance with the the Standard’s safety and health including the validity of the
Paperwork Reduction Act of 1995 provisions. An employer’s failure to methodology and assumptions used;
collect and distribute information
(PRA), 44 U.S.C. 3501 et seq. Public
required in this standard will • Enhance the quality, utility, and
comments on the ICR are invited. clarity of the information to be
significantly affect OSHA efforts to
DATES: The OMB will consider all collected; and
control and reduce injuries and
written comments that agency receives
fatalities. Such failure would also be • Minimize the burden of the
on or before January 4, 2016.
contrary to the direction Congress collection of information on those who
ADDRESSES: A copy of this ICR with provided in the Superfund are to respond, including through the
applicable supporting documentation; Amendments and Reauthorization Act. use of appropriate automated,
including a description of the likely Occupational Safety and Health Act of electronic, mechanical, or other
respondents, proposed frequency of 1970 sections 2(b)(9), 6, and 8(c)
response, and estimated total burden technological collection techniques or
authorize this information collection. other forms of information technology,
may be obtained free of charge from the See 29 U.S.C. 651(b)(9), 655, and 657(c).
RegInfo.gov Web site at http:// e.g., permitting electronic submission of
This information collection is subject
www.reginfo.gov/public/do/ responses.
to the PRA. A Federal agency generally
PRAViewICR?ref_nbr=201511-1218-003 cannot conduct or sponsor a collection Agency: DOL–OSHA.
(this link will only become active on of information, and the public is Title of Collection: Hazardous Waste
December 1, 2015) or by contacting generally not required to respond to an Operations and Emergency Response
Michel Smyth by telephone at 202–693– information collection, unless it is Standard.
4129, TTY 202–693–8064, (these are not approved by the OMB under the PRA
toll-free numbers) or by email at DOL_ and displays a currently valid OMB OMB Control Number: 1218–0202.
PRA_PUBLIC@dol.gov. Control Number. In addition, Affected Public: Private Sector—
Submit comments about this request notwithstanding any other provisions of businesses or other for-profit.
by mail or courier to the Office of law, no person shall generally be subject Total Estimated Number of
Information and Regulatory Affairs, to penalty for failing to comply with a Respondents: 30,052.
Attn: OMB Desk Officer for DOL–OSHA, collection of information that does not
Office of Management and Budget, display a valid Control Number. See 5 Total Estimated Number of
Room 10235, 725 17th Street NW., CFR 1320.5(a) and 1320.6. The DOL Responses: 1,440,759.
Washington, DC 20503; by Fax: 202– obtains OMB approval for this Total Estimated Annual Time Burden:
395–5806 (this is not a toll-free information collection under Control 261,551 hours.
number); or by email: OIRA_ Number 1218–0202.
submission@omb.eop.gov. Commenters OMB authorization for an ICR cannot Total Estimated Annual Other Costs
are encouraged, but not required, to be for more than three (3) years without Burden: $3,124,960.
Lhorne on DSK5TPTVN1PROD with NOTICES
send a courtesy copy of any comments renewal. The DOL seeks to extend PRA Dated: November 27, 2015.
by mail or courier to the U.S. authorization for this information Michel Smyth,
Department of Labor-OASAM, Office of collection for three (3) more years, Departmental Clearance Officer.
the Chief Information Officer, Attn: without any change to existing [FR Doc. 2015–30576 Filed 12–2–15; 8:45 am]
Departmental Information Compliance requirements. The DOL notes that
BILLING CODE 4510–26–P
Management Program, Room N1301, existing information collection
200 Constitution Avenue NW., requirements submitted to the OMB
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Document Created: 2015-12-14 13:51:48
Document Modified: 2015-12-14 13:51:48
| 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 registration. | |
| FR Citation | 80 FR 75692 |
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