81 FR 95640 - Bulk Manufacturer of Controlled Substances Application: Navinta LLC
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 | 95640-95641 | |
| FR Document | 2016-31282 |
[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)] [Notices] [Pages 95640-95641] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-31282] ----------------------------------------------------------------------- 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 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 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 19, 2016, Navinta LLC, 1499 [[Page 95641]] Lower Ferry Road, Ewing, New Jersey 08618-1414 applied to be registered as a bulk manufacturer of the following basic classes controlled substances: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ Pentobarbital...................... 2270 II 4-Anilino-N-phenethyl-4-piperidine 8333 II (ANPP). Remifentanil....................... 9739 II Fentanyl........................... 9801 II ------------------------------------------------------------------------ The company plans to initially to manufacture API quantities of the listed controlled substances for validation purposes and FDA approval, then eventually up FDA approval to produce commercial size batches for distribution to dosage form manufacturers. Dated: December 19, 2016. Louis J. Milione, Assistant Administrator. [FR Doc. 2016-31282 Filed 12-27-16; 8:45 am] BILLING CODE 4410-09-P
![95640 Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices
Controlled substance Drug code Schedule
Codeine ........................................................................................................................................................................... 9050 II
Oxycodone ....................................................................................................................................................................... 9143 II
Hydromorphone ............................................................................................................................................................... 9150 II
Hydrocodone ................................................................................................................................................................... 9193 II
Morphine .......................................................................................................................................................................... 9300 II
The company plans to manufacture or before January 27, 2017. Such SUPPLEMENTARY INFORMATION: The
bulk controlled substances for use in persons may also file a written request Attorney General has delegated her
product development and for for a hearing on the application authority under the Controlled
distribution to its customers. pursuant to 21 CFR 1301.43 on or before Substances Act to the Administrator of
Dated: December 20, 2016. January 27, 2017. the Drug Enforcement Administration
Louis J. Milione, ADDRESSES: Written comments should (DEA), 28 CFR 0.100(b). Authority to
be sent to: Drug Enforcement exercise all necessary functions with
Assistant Administrator.
Administration, Attention: DEA Federal respect to the promulgation and
[FR Doc. 2016–31284 Filed 12–27–16; 8:45 am]
Register Representative/DRW, 8701 implementation of 21 CFR part 1301,
BILLING CODE 4410–09–P incident to the registration of
Morrissette Drive, Springfield, Virginia
22152. All requests for hearing must be manufacturers, distributors, dispensers
sent to: Drug Enforcement importers, and exporters of, controlled
DEPARTMENT OF JUSTICE
Administration, Attn: Administrator, substances (other than final orders in
Drug Enforcement Administration 8701 Morrissette Drive, Springfield, connection with suspension, denial, or
Virginia 22152. All requests for hearing revocation of registration) has been
[Docket No. DEA–392] redelegated to the Assistant
should also be sent to: (1) Drug
Enforcement Administration, Attn: Administrator of the DEA Diversion
Importer of Controlled Substances Control Division (‘‘Assistant
Application: Noramco, Inc. Hearing Clerk/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and Administrator’’) pursuant to section 7 of
ACTION: Notice of application. (2) Drug Enforcement Administration, 28 CFR part 0, appendix to subpart R.
Attn: DEA Federal Register In accordance with 21 CFR
DATES: Registered bulk manufacturers of Representative/DRW, 8701 Morrissette 1301.34(a), this is notice that on October
the affected basic classes, and Drive, Springfield, Virginia 22152. 14, 2016, Noramco, Inc., 1440 Olympic
applicants therefore, may file written Comments and request for hearing on Drive, Athens, Georgia 30601 applied to
comments on or objections to the applications to import narcotic raw be registered as an importer of the
issuance of the proposed registration in material are not appropriate. 72 FR 3417 following basic classes of controlled
accordance with 21 CFR 1301.34(a) on (January 25, 2007). substances:
Controlled substance Drug code Schedule
Phenylacetone ................................................................................................................................................................. 8501 II
Thebaine .......................................................................................................................................................................... 9333 II
Poppy Straw Concentrate ............................................................................................................................................... 9670 II
Tapentadol ....................................................................................................................................................................... 9780 II
The company plans to import DEPARTMENT OF JUSTICE SUPPLEMENTARY INFORMATION: The
thebaine derivatives (9333) as reference Attorney General has delegated her
standards. The company plans to import Drug Enforcement Administration authority under the Controlled
an intermediate form of tapentadol Substances Act to the Administrator of
[Docket No. DEA–392] the Drug Enforcement Administration
(9780) to bulk manufacture tapentadol
for distribution to its customers. The (DEA), 28 CFR 0.100(b). Authority to
Bulk Manufacturer of Controlled
company plans to import phenylacetone exercise all necessary functions with
Substances Application: Navinta LLC
(8501) and poppy straw concentrate respect to the promulgation and
(9670) to manufacture other controlled ACTION: Notice of application. implementation of 21 CFR part 1301,
substances. incident to the registration of
DATES: Registered bulk manufacturers of manufacturers, distributors, dispensers,
Dated: December 19, 2016. importers, and exporters of controlled
the affected basic classes, and
Louis J. Milione, applicants therefore, may file written substances (other than final orders in
Assistant Administrator. comments on or objections to the connection with suspension, denial, or
[FR Doc. 2016–31281 Filed 12–27–16; 8:45 am] issuance of the proposed registration in revocation of registration) has been
accordance with 21 CFR 1301.33(a) on redelegated to the Deputy Assistant
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4410–09–P
or before February 27, 2017. Administrator of the DEA Office of
ADDRESSES: Written comments should Diversion Control (‘‘Deputy Assistant
be sent to: Drug Enforcement Administrator’’) pursuant to section 7 of
Administration, Attention: DEA Federal 28 CFR part 0, appendix to subpart R.
Register Representative/DRW, 8701 In accordance with 21 CFR
Morrissette Drive, Springfield, Virginia 1301.33(a), this is notice that on
22152. September 19, 2016, Navinta LLC, 1499
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![Federal Register / Vol. 81, No. 249 / Wednesday, December 28, 2016 / Notices 95641
Lower Ferry Road, Ewing, New Jersey a bulk manufacturer of the following
08618–1414 applied to be registered as basic classes controlled substances:
Controlled substance Drug code Schedule
Pentobarbital .................................................................................................................................................................... 2270 II
4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... 8333 II
Remifentanil ..................................................................................................................................................................... 9739 II
Fentanyl ........................................................................................................................................................................... 9801 II
The company plans to initially to DEPARTMENT OF JUSTICE Administration (DEA) as bulk
manufacture API quantities of the listed manufacturers of various classes of
controlled substances for validation Drug Enforcement Administration controlled substances.
purposes and FDA approval, then
[Docket No. DEA–392] SUPPLEMENTARY INFORMATION: The
eventually up FDA approval to produce
commercial size batches for distribution companies listed below applied to be
Bulk Manufacturer of Controlled registered as manufacturers of various
to dosage form manufacturers. Substances Registration basic classes of controlled substances.
Dated: December 19, 2016.
ACTION: Notice of registration. Information on previously published
Louis J. Milione, notices is listed in the table below. No
Assistant Administrator. SUMMARY: Registrants listed below have comments or objections were submitted
[FR Doc. 2016–31282 Filed 12–27–16; 8:45 am] applied for and been granted for these notices.
BILLING CODE 4410–09–P registration by the Drug Enforcement
Company FR docket Published
National Center for Natural Products Research (NIDA MPROJECT) .............. 80 FR 78766 ............................................ December 17, 2015.
Cambrex Charles City ....................................................................................... 81 FR 46956 ............................................ July 19, 2016.
Chemtos, LLC .................................................................................................... 81 FR 54604 ............................................ August 16, 2016.
Stepan Company ............................................................................................... 81 FR 54849 ............................................ August 17, 2016.
Chattem Chemicals ........................................................................................... 81 FR 57932 ............................................ August 24, 2016.
The DEA has considered the factors in DEPARTMENT OF JUSTICE Substances Act to the Administrator of
21 U.S.C. 823(a) and determined that the Drug Enforcement Administration
the registration of these registrants to Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to
manufacture the applicable basic classes [Docket No. DEA–392] exercise all necessary functions with
of controlled substances is consistent respect to the promulgation and
with the public interest and with United Bulk Manufacturer of Controlled implementation of 21 CFR part 1301,
States obligations under international Substances Application: Synthcon, incident to the registration of
treaties, conventions, or protocols in LLC manufacturers, distributors, dispensers,
effect on May 1, 1971. The DEA importers, and exporters of controlled
investigated each of the company’s ACTION: Notice of application. substances (other than final orders in
maintenance of effective controls
DATES: Registered bulk manufacturers of connection with suspension, denial, or
against diversion by inspecting and
testing each company’s physical the affected basic classes, and revocation of registration) has been
security systems, verifying each applicants therefore, may file written redelegated to the Assistant
company’s compliance with state and comments on or objections to the Administrator of the DEA Diversion
local laws, and reviewing each issuance of the proposed registration in Control Division (‘‘Assistant
company’s background and history. accordance with 21 CFR 1301.33(a) on Administrator’’) pursuant to section 7 of
Therefore, pursuant to 21 U.S.C. or before February 27, 2017. 28 CFR part 0, appendix to subpart R.
823(a), and in accordance with 21 CFR ADDRESSES: Written comments should In accordance with 21 CFR
1301.33, the DEA has granted a be sent to: Drug Enforcement 1301.33(a), this is notice that on
registration as a bulk manufacturer to Administration, Attention: DEA Federal December 16, 2015, Synthcon, LLC, 770
the above listed persons. Register Representative/DRW, 8701 Wooten Road, Unit 101, Colorado
Dated: December 19, 2016. Morrissette Drive, Springfield, Virginia Springs, Colorado 80915 applied to be
Louis J. Milione, 22152. registered as a bulk manufacturer of the
Assistant Administrator. SUPPLEMENTARY INFORMATION: following basic classes of controlled
[FR Doc. 2016–31280 Filed 12–27–16; 8:45 am] The Attorney General has delegated substances:
BILLING CODE 4410–09–P her authority under the Controlled
sradovich on DSK3GMQ082PROD with NOTICES
Controlled substance Drug code 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
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Document Created: 2016-12-28 02:16:50
Document Modified: 2016-12-28 02:16:50
| 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 95640 |
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