81 FR 95647 - Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 249 (December 28, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 249 (December 28, 2016)
| Page Range | 95647-95648 | |
| FR Document | 2016-31283 |
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)] [Notices] [Pages 95647-95648] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31283] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Johnson Matthey Inc. 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 27, 2017. 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 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 95648]] 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 September 5, 2016, Johnson Matthey Inc., Pharmaceuticals Materials, 900 River Road, Conshohocken, Pennsylvania 19428, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ Gamma Hydroxybutyric Acid.......... 2010 I Amphetamine........................ 1100 II Methylphenidate.................... 1724 II Codeine............................ 9050 II Oxycodone.......................... 9143 II Diphenoxylate...................... 9170 II Hydrocodone........................ 9193 II Meperidine......................... 9230 II Methadone.......................... 9250 II Methadone intermediate............. 9254 II Morphine........................... 9300 II Thebaine........................... 9333 II Opium tincture..................... 9630 II ------------------------------------------------------------------------ The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers. Thebaine (9333) will be used to manufacture other controlled substances for sale in bulk to its customers. Dated: December 20, 2016. Louis J. Milione, Assistant Administrator. [FR Doc. 2016-31283 Filed 12-27-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices 95647
Controlled substance Drug code Schedule
Meperidine ............................................................................................................................................................... 9230 II.
Meperidine intermediate-B ....................................................................................................................................... 9233 II.
Methadone ............................................................................................................................................................... 9250 II.
Dextropropoxyphene, bulk (non-dosage forms) ...................................................................................................... 9273 II.
Morphine .................................................................................................................................................................. 9300 II.
Thebaine .................................................................................................................................................................. 9333 II.
Oxymorphone .......................................................................................................................................................... 9652 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 Administration (DEA) as importers of
bulk controlled substances for use in various classes of schedule I or II
product development of analytical Drug Enforcement Administration controlled substances.
reference standards, for distribution to [Docket No. DEA–392] SUPPLEMENTARY INFORMATION:
its customers. The companies listed below applied
Dated: December 20, 2016. Importer of Controlled Substances to be registered as importers of various
Registration basic classes of controlled substances.
Louis J. Milione,
Assistant Administrator. ACTION: Notice of registration. Information on previously published
notices is listed in the table below. No
[FR Doc. 2016–31285 Filed 12–27–16; 8:45 am]
SUMMARY: Registrants listed below have comments or objections were submitted
BILLING CODE 4410–09–P
applied for and been granted and no requests for hearing were
registration by the Drug Enforcement submitted for these notices.
Company FR docket Published
Rhodes Technologies ........................................................... 81 FR 46956 ........................................................................ July 19, 2016.
Bellwyck Clinical Services .................................................... 81 FR 54603 ........................................................................ August 16, 2016.
Cerilliant Corporation ............................................................ 81 FR 57933 ........................................................................ August 24, 2016.
Noramco, Inc ........................................................................ 81 FR 57932 ........................................................................ August 24, 2016.
Cody Laboratories, Inc ......................................................... 81 FR 54602 ........................................................................ August 16, 2016.
AMRI Rensselaer, Inc .......................................................... 81 FR 54603 ........................................................................ August 16, 2016.
ALMAC Clinical Services Incorp (ACSI) .............................. 81 FR 54602 ........................................................................ August 16, 2016.
Fresenius Kabi USA, LLC .................................................... 81 FR 54601 ........................................................................ August 16, 2016.
Akorn, Inc ............................................................................. 81 FR 57935 ........................................................................ August 24, 2016.
Actavis Laboratories FL, Inc ................................................ 81 FR 54602 ........................................................................ August 16, 2016.
Unither Manufacturing LLC .................................................. 81 FR 61250 ........................................................................ September 6, 2016.
Cambrex Charles City .......................................................... 81 FR 63222 ........................................................................ September 14, 2016.
United States Pharmacopeial Convention ........................... 81 FR 63220 ........................................................................ September 14, 2016.
R & D Systems, Inc .............................................................. 81 FR 64509 ........................................................................ September 20, 2016.
Catalent CTS, LLC ............................................................... 81 FR 66081 ........................................................................ September 26, 2016.
The DEA has considered the factors in granted a registration as an importer for DATES: Registered bulk manufacturers of
21 U.S.C. 823, 952(a) and 958(a) and schedule I or II controlled substances to the affected basic classes, and
determined that the registration of the the above listed persons. applicants therefore, may file written
listed registrants to import the Dated: December 19, 2016. comments on or objections to the
applicable basic classes of schedule I or Louis J. Milione,
issuance of the proposed registration in
II controlled substances is consistent accordance with 21 CFR 1301.33(a) on
Assistant Administrator.
with the public interest and with United or before February 27, 2017.
[FR Doc. 2016–31273 Filed 12–27–16; 8:45 am]
States obligations under international
BILLING CODE 4410–09–P ADDRESSES: Written comments should
treaties, conventions, or protocols in
be sent to: Drug Enforcement
effect on May 1, 1971. The DEA
Administration, Attention: DEA Federal
investigated each company’s
DEPARTMENT OF JUSTICE Register Representative/DRW, 8701
maintenance of effective controls
Morrissette Drive, Springfield, Virginia
against diversion by inspecting and Drug Enforcement Administration 22152.
testing each company’s physical
sradovich on DSK3GMQ082PROD with NOTICES
security systems, verifying each [Docket No. DEA–392] SUPPLEMENTARY INFORMATION: The
company’s compliance with state and Attorney General has delegated her
local laws, and reviewing each Bulk Manufacturer of Controlled authority under the Controlled
company’s background and history. Substances Application: Johnson Substances Act to the Administrator of
Therefore, pursuant to 21 U.S.C. Matthey Inc. the Drug Enforcement Administration
952(a) and 958(a), and in accordance (DEA), 28 CFR 0.100(b). Authority to
ACTION: Notice of application.
with 21 CFR 1301.34, the DEA has exercise all necessary functions with
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![95648 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
respect to the promulgation and revocation of registration) has been September 5, 2016, Johnson Matthey
implementation of 21 CFR part 1301, redelegated to the Assistant Inc., Pharmaceuticals Materials, 900
incident to the registration of Administrator of the DEA Diversion River Road, Conshohocken,
manufacturers, distributors, dispensers, Control Division (‘‘Assistant Pennsylvania 19428, applied to be
importers, and exporters of controlled Administrator’’) pursuant to section 7 of registered as a bulk manufacturer of the
substances (other than final orders in 28 CFR part 0, appendix to subpart R. following basic classes of controlled
connection with suspension, denial, or In accordance with 21 CFR substances:
1301.33(a), this is notice that on
Controlled substance Drug code Schedule
Gamma Hydroxybutyric Acid ........................................................................................................................................... 2010 I
Amphetamine ................................................................................................................................................................... 1100 II
Methylphenidate .............................................................................................................................................................. 1724 II
Codeine ........................................................................................................................................................................... 9050 II
Oxycodone ....................................................................................................................................................................... 9143 II
Diphenoxylate .................................................................................................................................................................. 9170 II
Hydrocodone ................................................................................................................................................................... 9193 II
Meperidine ....................................................................................................................................................................... 9230 II
Methadone ....................................................................................................................................................................... 9250 II
Methadone intermediate .................................................................................................................................................. 9254 II
Morphine .......................................................................................................................................................................... 9300 II
Thebaine .......................................................................................................................................................................... 9333 II
Opium tincture ................................................................................................................................................................. 9630 II
The company plans to manufacture respondents, proposed frequency of et seq.). The information collected helps
the listed controlled substances in bulk response, and estimated total burden determine compensation benefits
for distribution and sale to its may be obtained free of charge from the awarded for pneumoconiosis. The
customers. Thebaine (9333) will be used RegInfo.gov Web site at http:// information collection has been
to manufacture other controlled www.reginfo.gov/public/do/ classified as a revision, because the
substances for sale in bulk to its PRAViewICR?ref_nbr=201607-1240-002 OWCP proposes to make a series of
customers. (this link will only become active on the cosmetic and minor changes to Form
Dated: December 20, 2016. day following publication of this notice) CM–905. The changes provide clearer
or by contacting Michel Smyth by language, so that Federal/State workers’
Louis J. Milione,
telephone at 202–693–4129 (this is not compensation officials clearly
Assistant Administrator.
a toll-free number) or sending an email understand which portion of the form
[FR Doc. 2016–31283 Filed 12–27–16; 8:45 am] to DOL_PRA_PUBLIC@dol.gov. they should complete and what
BILLING CODE 4410–09–P Submit comments about this request information to provide. Other changes
to the Office of Information and update the form to reflect current
Regulatory Affairs, Attn: OMB Desk organizational structure within the DOL.
DEPARTMENT OF LABOR Officer for DOL–OWCP, Office of For additional substantive information
Management and Budget, Room 10235, about this ICR, see the related notice
Office of the Secretary 725 17th Street NW., Washington, DC published in the Federal Register on
20503, Fax: 202–395–6881 (this is not a July 27, 2016 (81 FR 49270).
Agency Information Collection toll-free number), email: OIRA_
Activities; Submission for OMB submission@omb.eop.gov. Commenters This information collection is subject
Review; Comment Request; Request are encouraged, but not required, to to the PRA. A Federal agency generally
for State or Federal Workers’ send a courtesy copy of any comments cannot conduct or sponsor a collection
Compensation Information to the U.S. Department of Labor- of information, and the public is
OASAM, Office of the Chief Information generally not required to respond to an
ACTION: Notice. Officer, Attn: Compliance Management information collection, unless it is
Program, Room N1301, 200 Constitution approved by the OMB under the PRA
SUMMARY: The Department of Labor and displays a currently valid OMB
(DOL) is submitting the Office of Avenue NW., Washington, DC 20210,
email: DOL_PRA_PUBLIC@dol.gov. Control Number. In addition,
Workers’ Compensation Programs notwithstanding any other provisions of
(OWCP) sponsored information FOR FURTHER INFORMATION CONTACT:
Contact Michel Smyth by telephone at law, no person shall generally be subject
collection request (ICR) revision titled, to penalty for failing to comply with a
‘‘Request for State or Federal Workers’ 202–693–4129 (this is not a toll-free
number) or by email at DOL_PRA_ collection of information that does not
Compensation Information,’’ to the display a valid Control Number. See 5
Office of Management and Budget PUBLIC@dol.gov.
CFR 1320.5(a) and 1320.6. The DOL
(OMB) for review and approval for use Authority: 44 U.S.C. 3507(a)(1)(D). obtains OMB approval for this
in accordance with the Paperwork SUPPLEMENTARY INFORMATION: This ICR information collection under Control
sradovich on DSK3GMQ082PROD with NOTICES
Reduction Act (PRA) of 1995 (44 U.S.C. seeks approval under the PRA for Number 1240–0032. The current
3501 et seq.). revisions to the Request for State or approval for this collection is scheduled
DATES: Submit comments on or before Federal Workers’ Compensation to expire on December 31, 2016;
January 27, 2017. Information (Form CM–905) information however, the DOL notes that existing
ADDRESSES: A copy of this ICR with collection. Form CM–905 collects information collection requirements
applicable supporting documentation; information to process a claim under the submitted to the OMB receive a month-
including a description of the likely Black Lung Benefits Act (30 U.S.C. 901 to-month extension while they undergo
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Document Created: 2016-12-28 02:17:08
Document Modified: 2016-12-28 02:17:08
| 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 1301.33(a) on or before February 27, 2017. | |
| FR Citation | 81 FR 95647 |
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