83 FR 13521 - Bulk Manufacturer of Controlled Substances Application: Navinta 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 | 13521-13521 | |
| FR Document | 2018-06325 |
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)] [Notices] [Page 13521] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06325] ----------------------------------------------------------------------- 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 class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before May 29, 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 September 13, 2017, Navinta LLC, 1499 Lower Ferry Rd. Ewing, NJ 08618 applied to be registered as a bulk manufacturer for the basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Drug code Schedule ------------------------------------------------------------------------ Pentobarbital...................... 2270 II 4-Anilino-N-phenethyl-4-piperidine 8333 II (ANPP). Levorphanol........................ 9220 II Remifentanil....................... 9739 II Fentanyl........................... 9801 II ------------------------------------------------------------------------ The company plans to initially manufacture API quantities of the listed controlled substances for validation purposes and FDA approval. Dated: March 15, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018-06325 Filed 3-28-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices 13521
DEPARTMENT OF JUSTICE Morrissette Drive, Springfield, Virginia (DEA), 28 CFR 0.100(b). Authority to
22152. All requests for hearing must be exercise all necessary functions with
Drug Enforcement Administration sent to: Drug Enforcement respect to the promulgation and
Administration, Attn: Administrator, implementation of 21 CFR part 1301,
[Docket No. DEA–392]
8701 Morrissette Drive, Springfield, incident to the registration of
Importer of Controlled Substances Virginia 22152. All request for hearing manufacturers, distributors, dispensers,
Application: Sharp Clinical Services, should also be sent to: (1) Drug importers, and exporters of controlled
INC. Enforcement Administration, Attn: substances (other than final orders in
Hearing Clerk/LJ, 8701 Morrissette connection with suspension, denial, or
ACTION: Notice of application. Drive, Springfield, Virginia 22152; and revocation of registration) has been
(2) Drug Enforcement Administration, redelegated to the Assistant
DATES: Registered bulk importers of the Attn: DEA Federal Register Administrator of the DEA Diversion
affected basic classes, and applicants Representative/DRW, 8701 Morrissette Control Division (‘‘Assistant
therefore, may file written comments on Drive, Springfield, Virginia 22152. Administrator’’) pursuant to section 7 of
or objections to the issuance of the Comments and requests for hearings on 28 CFR part 0, appendix to subpart R.
proposed registration on or before April applications to import narcotic raw In accordance with 21 CFR
30, 2018. Such persons may also file a material are not appropriate. 72 FR 1301.34(a), this is notice that on
written request for a hearing on the 3417, (January 25, 2007) February 2, 2018, Sharp Clinical
application on or before April 30, 2018. SUPPLEMENTARY INFORMATION: Services INC., 300 Kimberton Rd.,
ADDRESSES: Written comments should The Attorney General has delegated Phoenixville, PA 19460 applied to be
be sent to: Drug Enforcement his authority under the Controlled registered as an importer of the
Administration, Attention: DEA Federal Substances Act to the Administrator of following basic classes of controlled
Register Representative/DRW, 8701 the Drug Enforcement Administration substances:
Controlled substance Drug code Schedule
Gamma Hydroxybutyric Acid ........................................................................................................................................... 2010 I
Marihuana ........................................................................................................................................................................ 7360 I
3,4-Methylenedioxymethamphetamine ............................................................................................................................ 7405 I
Psilocybin ......................................................................................................................................................................... 7437 I
The company plans to import the ADDRESSES: Written comments should Controlled sub- Drug code Schedule
listed controlled substances for be sent to: Drug Enforcement stance
analytical research, testing, and clinical Administration, Attention: DEA Federal
trials. No other activity for these drug Pentobarbital .... 2270 II
Register Representative/DRW, 8701
codes is authorized for this registration. 4-Anilino-N- 8333 II
Morrissette Drive, Springfield, Virginia phenethyl-4-
Approval of permit applications will 22152. piperidine
occur only when the registrant’s (ANPP).
business activity is consistent with what SUPPLEMENTARY INFORMATION: The Levorphanol ...... 9220 II
is authorized under 21 U.S.C. 952(a)(2). Attorney General has delegated his Remifentanil ...... 9739 II
Authorization will not extend to the authority under the Controlled Fentanyl ............ 9801 II
import of FDA approved or non- Substances Act to the Administrator of
approved finished dosage forms for the Drug Enforcement Administration The company plans to initially
commercial sale. (DEA), 28 CFR 0.100(b). Authority to manufacture API quantities of the listed
Dated: March 15, 2018. exercise all necessary functions with controlled substances for validation
Susan A. Gibson, respect to the promulgation and purposes and FDA approval.
Deputy Assistant Administrator. implementation of 21 CFR part 1301, Dated: March 15, 2018.
[FR Doc. 2018–06319 Filed 3–28–18; 8:45 am] incident to the registration of Susan A. Gibson,
BILLING CODE 4410–09–P
manufacturers, distributors, dispensers, Deputy Assistant Administrator.
importers, and exporters of controlled [FR Doc. 2018–06325 Filed 3–28–18; 8:45 am]
substances (other than final orders in BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE connection with suspension, denial, or
revocation of registration) has been
Drug Enforcement Administration redelegated to the Assistant DEPARTMENT OF JUSTICE
[Docket No. DEA–392] Administrator of the DEA Diversion
Control Division (‘‘Assistant Drug Enforcement Administration
Bulk Manufacturer of Controlled Administrator’’) pursuant to section 7 of [Docket No. DEA–392]
Substances Application: Navinta LLC 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR Importer of Controlled Substances
sradovich on DSK3GMQ082PROD with NOTICES
ACTION: Notice of application. Application: Siegfried USA, LLC
1301.33(a), this is notice that on
DATES: Registered bulk manufacturers of September 13, 2017, Navinta LLC, 1499 ACTION: Notice of application.
the affected basic class, and applicants Lower Ferry Rd. Ewing, NJ 08618
therefore, may file written comments on applied to be registered as a bulk DATES: Registered bulk manufacturers of
or objections to the issuance of the manufacturer for the basic classes of the affected basic classes, and
proposed registration on or before May controlled substances: applicants therefore, may file written
29, 2018. comments on or objections to the
VerDate Sep<11>2014 19:09 Mar 28, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\29MRN1.SGM 29MRN1](https://thefederalregister.org/doc/83_FR_13582/page/1.svg)
Document Created: 2018-03-29 00:25:17
Document Modified: 2018-03-29 00:25:17
| 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 class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before May 29, 2018. | |
| FR Citation | 83 FR 13521 |
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