81 FR 20418 - Bulk Manufacturer of Controlled Substances Application: Navinta, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 67 (April 7, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 67 (April 7, 2016)
| Page Range | 20418-20419 | |
| FR Document | 2016-07948 |
[Federal Register Volume 81, Number 67 (Thursday, April 7, 2016)] [Notices] [Pages 20418-20419] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07948] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Navinta, 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 1301.33(a) on or before June 6, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: 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 1301.33(a), this is notice that on September 10, 2015, Navinta, LLC, 1499 Lower Ferry Road, Ewing, New Jersey 08618-1414 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Pentobarbital (2270)..................... II 4-Anilino-N-phenethyl-4-piperidine (ANPP) II (8333). Remifentanil (9739)...................... II Fentanyl (9801).......................... II ------------------------------------------------------------------------ The company plans initially to manufacture API quantities of the listed controlled substances for validation purposes and FDA approval, then eventually upon FDA approval to produce commercial size batches for distribution to dosage form manufacturers. [[Page 20419]] Dated: March 28, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-07948 Filed 4-6-16; 8:45 am] BILLING CODE 4410-09-P
![20418 Federal Register / Vol. 81, No. 67 / Thursday, April 7, 2016 / Notices
SUPPLEMENTARY INFORMATION: The The DEA has considered the factors in DEPARTMENT OF JUSTICE
Attorney General has delegated her 21 U.S.C. 823, 952(a) and 958(a) and
authority under the Controlled determined that the registration of Drug Enforcement Administration
Substances Act to the Administrator of Fisher Clinical Services, Inc. to import
the Drug Enforcement Administration the basic classes of controlled [Docket No. DEA–392]
(DEA), 28 CFR 0.100(b). Authority to substances is consistent with the public
exercise all necessary functions with interest and with United States Bulk Manufacturer of Controlled
respect to the promulgation and obligations under international treaties, Substances Application: Navinta, LLC
implementation of 21 CFR part 1301, conventions, or protocols in effect on
incident to the registration of ACTION: Notice of application.
May 1, 1971. The DEA investigated the
manufacturers, distributors, dispensers, company’s maintenance of effective
importers, and exporters of controlled DATES: Registered bulk manufacturers of
controls against diversion by inspecting
substances (other than final orders in the affected basic classes, and
and testing the company’s physical applicants therefore, may file written
connection with suspension, denial, or
security systems, verifying the comments on or objections to the
revocation of registration) has been
redelegated to the Deputy Assistant company’s compliance with state and issuance of the proposed registration in
Administrator of the DEA Office of local laws, and reviewing the company’s accordance with 21 CFR 1301.33(a) on
Diversion Control (‘‘Deputy Assistant background and history. or before June 6, 2016.
Administrator’’) pursuant to section 7 of Therefore, pursuant to 21 U.S.C. ADDRESSES: Written comments should
28 CFR part 0, appendix to subpart R. 952(a) and 958(a), and in accordance be sent to: Drug Enforcement
In accordance with 21 CFR with 21 CFR 1301.34, the above-named Administration, Attention: DEA Federal
1301.34(a), this is notice that on company is granted registration as an Register Representative/ODW, 8701
February 12, 2016, Stepan Company, importer of the following basic classes Morrissette Drive, Springfield, Virginia
Natural Products Dept., 100 W. Hunter of controlled substances: 22152.
Avenue, Maywood, New Jersey 07607
applied to be registered as an importer Controlled substance Schedule SUPPLEMENTARY INFORMATION: The
of coca leaves (9040), a basic class of Attorney General has delegated her
controlled substance listed in schedule Methylphenidate (1724) ............. II authority under the Controlled
II. Levorphanol (9220) ................... II Substances Act to the Administrator of
The company plans to import the Noroxymorphone (9668) ............ II the Drug Enforcement Administration
listed controlled substance in bulk for Tapentadol (9780) ..................... II (DEA), 28 CFR 0.100(b). Authority to
the manufacture of controlled substance exercise all necessary functions with
for distribution to its customers. The company plans to import the respect to the promulgation and
implementation of 21 CFR part 1301,
Dated: March 28, 2016. listed substances for analytical research,
incident to the registration of
Louis J. Milione, testing, and clinical trials. This
manufacturers, distributors, dispensers,
Deputy Assistant Administrator. authorization does not extend to the
importers, and exporters of controlled
[FR Doc. 2016–07944 Filed 4–6–16; 8:45 am] import of a finished FDA approved or substances (other than final orders in
BILLING CODE 4410–09–P non-approved dosage form for connection with suspension, denial, or
commercial distribution in the United revocation of registration) has been
States. redelegated to the Deputy Assistant
DEPARTMENT OF JUSTICE The company plans to import an Administrator of the DEA Office of
intermediate form of tapentadol (9780) Diversion Control (‘‘Deputy Assistant
Drug Enforcement Administration
to bulk manufacture tapentadol for Administrator’’) pursuant to section 7 of
[Docket No. DEA–392] distribution to its customers. Placement 28 CFR part 0, appendix to subpart R.
of these (this) drug code (s) onto the In accordance with 21 CFR
Importer of Controlled Substances company’s registration does not 1301.33(a), this is notice that on
Registration: Fisher Clinical Services, September 10, 2015, Navinta, LLC, 1499
translate into automatic approval of
Inc. Lower Ferry Road, Ewing, New Jersey
subsequent permit applications to
ACTION: Notice of registration. import controlled substances. Approval 08618–1414 applied to be registered as
of permit applications will occur only a bulk manufacturer of the following
SUMMARY: Fisher Clinical Services, Inc. when the registrant’s business activity is basic classes of controlled substances:
applied to be registered as an importer consistent with what is authorized
of certain basic classes of controlled Controlled substance Schedule
under to 21 U.S.C. 952(a)(2).
substances. The Drug Enforcement Authorization will not extend to the Pentobarbital (2270) ............... II
Administration (DEA) grants Fisher import of FDA approved or non- 4-Anilino-N-phenethyl-4-piper- II
Clinical Services, Inc. registration as an approved finished dosage forms for idine (ANPP) (8333).
importer of those controlled substances. commercial sale. Remifentanil (9739) ................. II
SUPPLEMENTARY INFORMATION: By notice Fentanyl (9801) ....................... II
Dated: March 28, 2016.
dated December 9, 2015, and published
Louis J. Milione,
mstockstill on DSK4VPTVN1PROD with NOTICES
in the Federal Register on December 17, The company plans initially to
2015, 80 FR 78766, Fisher Clinical Deputy Assistant Administrator. manufacture API quantities of the listed
Services, Inc., 7554 Schantz Road, [FR Doc. 2016–07945 Filed 4–6–16; 8:45 am] controlled substances for validation
Allentown, Pennsylvania 18106 applied BILLING CODE 4410–09–P purposes and FDA approval, then
to be registered as an importer of certain eventually upon FDA approval to
basic classes of controlled substances. produce commercial size batches for
No comments or objections were distribution to dosage form
submitted for this notice. manufacturers.
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![Federal Register / Vol. 81, No. 67 / Thursday, April 7, 2016 / Notices 20419
Dated: March 28, 2016. local laws, and reviewing the company’s SUMMARY: VHG Labs DBA LGC
Louis J. Milione, background and history. Standards Warehouse applied to be
Deputy Assistant Administrator. Therefore, pursuant to 21 U.S.C. registered as an importer of certain basic
[FR Doc. 2016–07948 Filed 4–6–16; 8:45 am] 952(a) and 958(a), and in accordance classes of controlled substances. The
BILLING CODE 4410–09–P
with 21 CFR 1301.34, the above-named Drug Enforcement Administration
company is granted registration as an (DEA) grants VHG Labs DBA LGC
importer of the following basic classes Standards Warehouse registration as an
DEPARTMENT OF JUSTICE of controlled substances: importer of those controlled substances.
Drug Enforcement Administration Controlled substance Schedule SUPPLEMENTARY INFORMATION: By notice
[Docket No. DEA–392]
dated November 19, 2015, and
Amphetamine (1100) .................... II published in the Federal Register on
Lisdexamfetamine (1205) ............. II
Importer of Controlled Substances Methylphenidate (1724) ................ II
November 25, 2015, 80 FR 73830, VHG
Registration: Mylan Pharmaceuticals, Pentobarbital (2270) ..................... II Labs DBA LGC Standards Warehouse 3
Inc. Oxycodone (9143) ........................ II Perimeter Road, Manchester, New
Hydromorphone (9150) ................ II Hampshire 03103 applied to be
ACTION: Notice of registration. Hydrocodone (9193) ..................... II registered as an importer of certain basic
Levorphanol (9220) ...................... II classes of controlled substances. No
SUMMARY: Mylan Pharmaceuticals, Inc. Morphine (9300) ........................... II
applied to be registered as an importer comments or objections were submitted
Oxymorphone (9652) ................... II
of certain basic classes of controlled Remifentanil (9739) ...................... II for this notice.
substances. The Drug Enforcement Fentanyl (9801) ............................ II The DEA has considered the factors in
Administration (DEA) grants Mylan 21 U.S.C. 823, 952(a) and 958(a) and
Pharmaceuticals, Inc. registration as an The company plans to import the determined that the registration of VHG
importer of those controlled substances. listed controlled substances in finished Labs DBA LGC Standards Warehouse to
SUPPLEMENTARY INFORMATION: By notice dosage form (FDF) from foreign sources import the basic classes of controlled
dated December 4, 2015, and published for analytical testing and clinical trials substances is consistent with the public
in the Federal Register on December 10, in which the foreign FDF will be interest and with United States
2015, 80 FR 76709, Mylan compared to the company’s own
obligations under international treaties,
Pharmaceuticals, Inc., 3711 Collins domestically-manufactured FDF. This
conventions, or protocols in effect on
Ferry Road, Morgantown, West Virginia analysis is required to allow the
May 1, 1971. The DEA investigated the
26505 applied to be registered as an company to export domestically-
importer of certain basic classes of manufactured FDF to foreign markets. company’s maintenance of effective
controlled substances. No comments or controls against diversion by inspecting
Dated: March 28, 2016. and testing the company’s physical
objections were submitted for this Louis J. Milione,
notice. security systems, verifying the
Deputy Assistant Administrator. company’s compliance with state and
The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and [FR Doc. 2016–07946 Filed 4–6–16; 8:45 am] local laws, and reviewing the company’s
determined that the registration of BILLING CODE 4410–09–P background and history.
Mylan Pharmaceuticals, Inc. to import Therefore, pursuant to 21 U.S.C.
the basic classes of controlled 952(a) and 958(a), and in accordance
substances is consistent with the public DEPARTMENT OF JUSTICE
with 21 CFR 1301.34, the above-named
interest and with United States company is granted registration as an
Drug Enforcement Administration
obligations under international treaties, importer of the following basic classes
conventions, or protocols in effect on [Docket No. DEA–392]
of controlled substances:
May 1, 1971. The DEA investigated the
company’s maintenance of effective Importer of Controlled Substances
controls against diversion by inspecting Registration: VHG Labs DBA LGC
and testing the company’s physical Standards Warehouse
security systems, verifying the ACTION: Notice of registration.
company’s compliance with state and
Controlled substance Schedule
3-Fluoro-N-methylcathinone (3-FMC) (1233) .............................................................................................................................................. I
Cathinone (1235) ......................................................................................................................................................................................... I
Methcathinone (1237) .................................................................................................................................................................................. I
4-Fluoro-N-methylcathinone (4-FMC) (1238) .............................................................................................................................................. I
Pentedrone (a-methylaminovalerophenone) (1246) .................................................................................................................................... I
Mephedrone (4-Methyl-N-methylcathinone) (1248) .................................................................................................................................... I
4-Methyl-N-ethylcathinone (4-MEC) (1249) ................................................................................................................................................ I
Naphyrone (1258) ........................................................................................................................................................................................ I
N-Ethylamphetamine (1475) ........................................................................................................................................................................ I
mstockstill on DSK4VPTVN1PROD with NOTICES
N,N-Dimethylamphetamine (1480) .............................................................................................................................................................. I
Fenethylline (1503) ...................................................................................................................................................................................... I
4-Methylaminorex (cis isomer) (1590) ......................................................................................................................................................... I
Gamma Hydroxybutyric Acid (2010) ........................................................................................................................................................... I
Methaqualone (2565) .................................................................................................................................................................................. I
Mecloqualone (2572) ................................................................................................................................................................................... I
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) (6250) ................................................................................................................... I
SR-18 (Also known as RCS-8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) (7008) .................................................................. I
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Document Created: 2016-04-06 23:43:47
Document Modified: 2016-04-06 23:43:47
| 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 June 6, 2016. | |
| FR Citation | 81 FR 20418 |
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