83 FR 27632 - Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 114 (June 13, 2018)

Page Range		27632-27632
FR Document		2018-12685

Federal Register, Volume 83 Issue 114 (Wednesday, June 13, 2018)

[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Page 27632]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12685]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Johnson 
Matthey Pharmaceutical Materials Inc.

ACTION: Notice of application.

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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 on or before August 13, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his 
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 Assistant Administrator of the DEA Diversion Control Division 
(``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 
January 1, 2018, Johnson Matthey Pharmaceutical Materials Inc., 25 
Patton Road, Devens, MA 01434 applied to be registered as a bulk 
manufacturer for the basic classes of controlled substances:

------------------------------------------------------------------------
           Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
Amphetamine..............................            1100  II
Methylphenidate..........................            1724  II
Nabilone.................................            7379  II
Hydrocodone..............................            9193  II
Levorphanol..............................            9220  II
Alfentanil...............................            9737  II
Remifentanil.............................            9739  II
Sufentanil...............................            9740  II
------------------------------------------------------------------------

    The company plans to utilize this facility to manufacture small 
quantities of the listed controlled substances in bulk for distribution 
to its customers as well as to conduct analytical testing in support of 
the company's primary manufacturing facility in West Deptford, New 
Jersey.

    Dated: June 6, 2018.
John J. Martin,
 Assistant Administrator.
[FR Doc. 2018-12685 Filed 6-12-18; 8:45 am]
 BILLING CODE 4410-09-P

27632 Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices

Dated: June 1, 2018. applicants therefore, may file written incident to the registration of
Robert W. Patterson, comments on or objections to the manufacturers, distributors, dispensers,
Acting Administrator. issuance of the proposed registration on importers, and exporters of controlled
[FR Doc. 2018–12686 Filed 6–12–18; 8:45 am] or before August 13, 2018. substances (other than final orders in
BILLING CODE 4410–09–P ADDRESSES: Written comments should connection with suspension, denial, or
be sent to: Drug Enforcement revocation of registration) has been
Administration, Attention: DEA Federal redelegated to the Assistant
DEPARTMENT OF JUSTICE Register Representative/DRW, 8701 Administrator of the DEA Diversion
Morrissette Drive, Springfield, Virginia Control Division (‘‘Assistant
Drug Enforcement Administration 22152. Administrator’’) pursuant to section 7 of
[Docket No. DEA–392] SUPPLEMENTARY INFORMATION: The 28 CFR part 0, appendix to subpart R.
Attorney General has delegated his In accordance with 21 CFR
Bulk Manufacturer of Controlled
authority under the Controlled 1301.33(a), this is notice that on January
Substances Application: Johnson
Substances Act to the Administrator of 1, 2018, Johnson Matthey
Matthey Pharmaceutical Materials Inc.
the Drug Enforcement Administration Pharmaceutical Materials Inc., 25 Patton
ACTION: Notice of application. (DEA), 28 CFR 0.100(b). Authority to Road, Devens, MA 01434 applied to be
exercise all necessary functions with registered as a bulk manufacturer for the
DATES: Registered bulk manufacturers of respect to the promulgation and basic classes of controlled substances:
the affected basic classes, and implementation of 21 CFR part 1301,

Controlled substance Drug code Schedule

Amphetamine ................................................................................................................................................................... 1100 II
Methylphenidate .............................................................................................................................................................. 1724 II
Nabilone ........................................................................................................................................................................... 7379 II
Hydrocodone ................................................................................................................................................................... 9193 II
Levorphanol ..................................................................................................................................................................... 9220 II
Alfentanil .......................................................................................................................................................................... 9737 II
Remifentanil ..................................................................................................................................................................... 9739 II
Sufentanil ......................................................................................................................................................................... 9740 II

The company plans to utilize this DEPARTMENT OF JUSTICE various classes of schedule I or II
facility to manufacture small quantities controlled substances.
of the listed controlled substances in Drug Enforcement Administration
bulk for distribution to its customers as SUPPLEMENTARY INFORMATION: The
[Docket No. DEA–392] companies listed below applied to be
well as to conduct analytical testing in
support of the company’s primary registered as importers of various basic
Importer of Controlled Substances
manufacturing facility in West Deptford, classes of controlled substances.
Registration
New Jersey. Information on previously published
ACTION: Notice of registration. notices is listed in the table below. No
Dated: June 6, 2018.
comments or objections were submitted
John J. Martin, SUMMARY: Registrants listed below have and no requests for hearing were
Assistant Administrator. applied for and been granted submitted for these notices.
[FR Doc. 2018–12685 Filed 6–12–18; 8:45 am] registration by-the Drug Enforcement
BILLING CODE 4410–09–P Administration (DEA) as importers of

Company FR docket Published

PerkinElmer, Inc ................................................................................................................................................... 83 FR 9337 March 5, 2018.
Stepan Company .................................................................................................................................................. 83 FR 9337 March 5, 2018.
Noramco, Inc ........................................................................................................................................................ 83 FR 12408 March 21, 2018.
Sanyal Biotechnology ........................................................................................................................................... 83 FR 12407 March 21, 2018.
S&B Pharma, Inc .................................................................................................................................................. 83 FR 13523 March 29, 2018.
Siegfried USA, LLC .............................................................................................................................................. 83 FR 13521 March 29, 2018.
Lannett Company, Inc .......................................................................................................................................... 83 FR 13520 March 29, 2018.

The Drug Enforcement protocols in effect on May 1, 1971. The Therefore, pursuant to 21 U.S.C.
Administration (DEA) has considered DEA investigated each company’s 952(a) and 958(a), and in accordance
the factors in 21 U.S.C. 823, 952(a) and maintenance of effective controls with 21 CFR 1301.34, the DEA has
amozie on DSK3GDR082PROD with NOTICES1

958(a) and determined that the against diversion by inspecting and granted a registration as an importer for
registration of the listed registrants to testing each company’s physical schedule I or II controlled substances to
import the applicable basic classes of security systems, verifying each the above listed companies.
schedule I or II controlled substances is company’s compliance with state and
consistent with the public interest and local laws, and reviewing each
with United States obligations under company’s background and history.
international treaties, conventions, or

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Document Created: 2018-06-12 23:59:13
Document Modified: 2018-06-12 23:59:13

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 on or before August 13, 2018.
FR Citation		83 FR 27632

83 FR 27632 - Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Pharmaceutical Materials Inc.

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 83, Issue 114 (June 13, 2018)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration