83 FR 13520 - Importer of Controlled Substances Application: Novitium Pharma, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 61 (March 29, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 61 (March 29, 2018)
| Page Range | 13520-13520 | |
| FR Document | 2018-06318 |
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)] [Notices] [Page 13520] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06318] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Novitium Pharma, 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 on or before April 30, 2018. Such persons may also file a written request for a hearing on the application on or before April 30, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: 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 1301.34(a), this is notice that on January 8, 2018, Novitium Pharma, LLC., 70 Lake Drive, East Windsor, NJ 08520 applied to be registered as an importer of the Schedule II controlled substance Levorphanol (9220). The company plans to import the controlled substance to develop the manufacturing process for a drug product that will in turn be used to produce a tablet equivalent to the current brand product. Dated: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018-06318 Filed 3-28-18; 8:45 am] BILLING CODE 4410-09-P
![13520 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices
respect to the promulgation and 22152. All requests for hearing must be applicants therefore, may file written
implementation of 21 CFR part 1301, sent to: Drug Enforcement comments on or objections to the
incident to the registration of Administration, Attn: Administrator, issuance of the proposed registration on
manufacturers, distributors, dispensers, 8701 Morrissette Drive, Springfield, or before April 30, 2018. Such persons
importers, and exporters of controlled Virginia 22152. All requests for hearing may also file a written request for a
substances (other than final orders in should also be sent to: (1) Drug hearing on the application on or before
connection with suspension, denial, or Enforcement Administration, Attn: April 30, 2018.
revocation of registration) has been Hearing Clerk/LJ, 8701 Morrissette
redelegated to the Assistant Drive, Springfield, Virginia 22152; and ADDRESSES: Written comments should
Administrator of the DEA Diversion (2) Drug Enforcement Administration, be sent to: Drug Enforcement
Control Division (‘‘Assistant Attn: DEA Federal Register Administration, Attention: DEA Federal
Administrator’’) pursuant to section 7 of Representative/DRW, 8701 Morrissette Register Representative/DRW, 8701
28 CFR part 0, appendix to subpart R. Drive, Springfield, Virginia 22152. Morrissette Drive, Springfield, Virginia
In accordance with 21 CFR SUPPLEMENTARY INFORMATION: The 22152. All requests for hearing must be
1301.34(a), this is notice that on June 5, Attorney General has delegated his sent to: Drug Enforcement
2017, Fisher Clinical Services, Inc., 700 authority under the Controlled Administration, Attn: Administrator,
A–C Nestle Way, Breinigsville, Substances Act to the Administrator of 8701 Morrissette Drive, Springfield,
Pennsylvania 18031–1522 applied to be the Drug Enforcement Administration Virginia 22152. All request for hearing
registered as an importer of the (DEA), 28 CFR 0.100(b). Authority to should also be sent to: (1) Drug
following basic classes of controlled exercise all necessary functions with Enforcement Administration, Attn:
substances: respect to the promulgation and Hearing Clerk/LJ, 8701 Morrissette
implementation of 21 CFR part 1301, Drive, Springfield, Virginia 22152; and
Controlled incident to the registration of
Drug code Schedule (2) Drug Enforcement Administration,
substance
manufacturers, distributors, dispensers, Attn: DEA Federal Register
Methylphenidate ..... 1724 II importers, and exporters of controlled Representative/DRW, 8701 Morrissette
Levorphanol ............ 9220 II substances (other than final orders in Drive, Springfield, Virginia 22152.
Noroxymorphone .... 9668 II connection with suspension, denial, or
Tapentadol .............. 9780 II revocation of registration) has been SUPPLEMENTARY INFORMATION:
redelegated to the Assistant The Attorney General has delegated
The company plans to import the Administrator of the DEA Diversion his authority under the Controlled
listed controlled substances in finished Control Division (‘‘Assistant Substances Act to the Administrator of
dosage form for testing, and clinical Administrator’’) pursuant to section 7 of the Drug Enforcement Administration
trials purposes only. This authorization 28 CFR part 0, appendix to subpart R. (DEA), 28 CFR 0.100(b). Authority to
does not extend to the import of a In accordance with 21 CFR
finished Food and Drug Administration exercise all necessary functions with
1301.34(a), this is notice that on respect to the promulgation and
(FDA) approved or non-approved February 24, 2014, Lannett Company,
dosage form for commercial distribution implementation of 21 CFR part 1301,
Inc., 9001 Torresdale Avenue,
in the United States. incident to the registration of
Philadelphia, Pennsylvania 19136
applied to be registered as an importer manufacturers, distributors, dispensers,
Dated: March 15, 2018.
of tetrahydrocannabinols (7370), a basic importers, and exporters of controlled
Susan A. Gibson,
class of controlled substance listed in substances (other than final orders in
Deputy Assistant Administrator. connection with suspension, denial, or
[FR Doc. 2018–06321 Filed 3–28–18; 8:45 am]
schedule I.
The company plans to import the revocation of registration) has been
BILLING CODE 4410–09–P redelegated to the Assistant
finished dosage forms to support their
abbreviated new drug application Administrator of the DEA Diversion
(ANDA) submission to the U.S. Food Control Division (‘‘Assistant
DEPARTMENT OF JUSTICE
and Drug Administration (FDA). No Administrator’’) pursuant to section 7 of
Drug Enforcement Administration other activity for this drug code is 28 CFR part 0, appendix to subpart R.
authorized for this registration. In accordance with 21 CFR
[Docket No. DEA–392]
Dated: March 15, 2018. 1301.34(a), this is notice that on January
Importer of Controlled Substances Susan A. Gibson, 8, 2018, Novitium Pharma, LLC., 70
Application: Lannett Company, Inc. Deputy Assistant Administrator. Lake Drive, East Windsor, NJ 08520
[FR Doc. 2018–06313 Filed 3–28–18; 8:45 am] applied to be registered as an importer
ACTION: Notice of application. of the Schedule II controlled substance
BILLING CODE 4410–09–P
Levorphanol (9220).
DATES: Registered bulk manufacturers of
the affected basic classes and applicants The company plans to import the
DEPARTMENT OF JUSTICE controlled substance to develop the
therefore, may file written comments on
or objections to the issuance of the Drug Enforcement Administration manufacturing process for a drug
proposed registration on or before April product that will in turn be used to
30, 2018. Such persons may also file a [Docket No. DEA–392] produce a tablet equivalent to the
sradovich on DSK3GMQ082PROD with NOTICES
written request for a hearing on the current brand product.
application on or before April 30, 2018. Importer of Controlled Substances
Application: Novitium Pharma, LLC Dated: March 15, 2018.
ADDRESSES: Written comments should
Susan A. Gibson,
be sent to: Drug Enforcement ACTION: Notice of application.
Administration, Attention: DEA Federal Deputy Assistant Administrator.
Register Representative/DRW, 8701 DATES: Registered bulk manufacturers of [FR Doc. 2018–06318 Filed 3–28–18; 8:45 am]
Morrissette Drive, Springfield, Virginia the affected basic classes, and BILLING CODE 4410–09–P
VerDate Sep<11>2014 19:09 Mar 28, 2018 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 9990 E:\FR\FM\29MRN1.SGM 29MRN1](https://thefederalregister.org/doc/83_FR_13581/page/1.svg)
Document Created: 2018-03-29 00:26:07
Document Modified: 2018-03-29 00:26:07
| 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 April 30, 2018. Such persons may also file a written request for a hearing on the application on or before April 30, 2018. | |
| FR Citation | 83 FR 13520 |
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