83 FR 5810 - Importer of Controlled Substances Application: Meridian Medical Technologies Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 28 (February 9, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 28 (February 9, 2018)
| Page Range | 5810-5811 | |
| FR Document | 2018-02647 |
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)] [Notices] [Pages 5810-5811] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02647] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Meridian Medical Technologies 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 [[Page 5811]] issuance of the proposed registration on or before March 12, 2018. Such persons may also file a written request for a hearing on the application March 12, 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 requests 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 December 29, 2017, Meridian Medical Technologies Inc., 2555 Hermelin Drive, Saint Louis, Missouri 63144 applied to be registered as an importer of the Schedule II control substance for Morphine (9300) the basic class of controlled substance. The company plans to import the listed controlled substance in finished dosage form for internal analytical purposes only. No other activity for this drug code is authorized for this registration. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale. Dated: January 31, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018-02647 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
![5810 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
Dated: February 2, 2018. In accordance with 21 CFR Register Representative/DRW, 8701
Susan A Gibson, 1301.34(a), this is notice that on July 6, Morrissette Drive, Springfield, Virginia
Deputy Assistant Administrator. 2017, Noramco, Inc., 1550 Olympic 22152.
[FR Doc. 2018–02637 Filed 2–8–18; 8:45 am] Drive, Athens, Georgia 30601 applied to SUPPLEMENTARY INFORMATION: The
BILLING CODE 4410–09–P
be registered as an importer of the Attorney General has delegated his
following basic controlled substances: authority under the Controlled
Substances Act to the Administrator of
DEPARTMENT OF JUSTICE Drug
Controlled substance code Schedule the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
Drug Enforcement Administration Marihuana Extract ........ 7350 I exercise all necessary functions with
[Docket No. DEA–392] Marihuana ..................... 7360 I respect to the promulgation and
Tetrahydrocannabinols 7370 I implementation of 21 CFR part 1301,
Importer of Controlled Substances Nabilone ....................... 7379 II incident to the registration of
Application: Noramco, Inc. Phenylacetone .............. 8501 II manufacturers, distributors, dispensers,
Thebaine ....................... 9333 II
Opium, raw ................... 9600 II
importers, and exporters of controlled
ACTION: Notice of application. substances (other than final orders in
Poppy Straw Con- 9670 II
centrate. connection with suspension, denial, or
DATES: Registered bulk manufacturer of Tapentadol .................... 9780 II revocation of registration) has been
the affected basic classes and applicants redelegated to the Deputy Assistant
therefore, may file written comments on The company plans to import Administrator of the DEA Office of
or objections to the issuance of the phenylacetone (8501), opium, raw Diversion Control (‘‘Deputy Assistant
proposed registration on or before (9600), and poppy straw concentrate Administrator’’) pursuant to section 7 of
March 12, 2018. Such persons may also (9670) to bulk manufacture other 28 CFR part 0, appendix to subpart R.
file a written request for a hearing on controlled substances for distribution to In accordance with 21 CFR
the application on or before March 12, its customers. The company plans to 1301.33(a), this is notice that on
2018. import an intermediate form of November 13, 2017, INSYS
ADDRESSES: Written comments should tapentadol (9780) to bulk manufacture Manufacturing LLC, 811 Paloma Drive,
be sent to: Drug Enforcement tapentadol (9780) for distribution to its Suite C, Round Rock, TX 78665–2402
Administration, Attention: DEA Federal customers. Placement of these drug applied to be registered as a bulk
Register Representative/DRW, 8701 codes onto the company’s registration manufacturer of the following basic
Morrissette Drive, Springfield, Virginia does not translate into automatic classes of controlled substances:
22152. All requests for hearing must be approval of subsequent permit
sent to: Drug Enforcement applications to import controlled Controlled substance Drug Schedule
Administration, Attn: Administrator, substances. Approval of permit code
8701 Morrissette Drive, Springfield, applications will occur only when the Marihuana ..................... 7360 I
Virginia 22152. All requests for hearing registrant’s business activity is Tetrahydrocannabinols 7370 I
should also be sent to: (1) Drug consistent with what is authorized
Enforcement Administration, Attn: under 21 U.S.C. 952(a)(2). Authorization The company plans to manufacture
Hearing Clerk/LJ, 8701 Morrissette will not extend to the import of FDA the above listed controlled substances in
Drive, Springfield, Virginia 22152; and approved or non-approved finished bulk for distribution to its customers.
(2) Drug Enforcement Administration, dosage forms for commercial sale. In reference to drug codes 7360
Attn: DEA Federal Register Dated: January 31, 2018. (marihuana), and 7370 (THC), the
Representative/DRW, 8701 Morrissette Susan A. Gibson, company plans to bulk manufacture
Drive, Springfield, Virginia 22152. these drugs as synthetics. No other
Deputy Assistant Administrator.
Comments and requests for hearings on activities for these drug codes are
[FR Doc. 2018–02646 Filed 2–8–18; 8:45 am]
applications to import narcotic raw authorized for this registration.
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material are not appropriate. 72 FR 3417 Dated: January 31, 2018.
(January 25, 2007).
Susan A. Gibson,
SUPPLEMENTARY INFORMATION: The DEPARTMENT OF JUSTICE Deputy Assistant Administrator.
Attorney General has delegated his
[FR Doc. 2018–02643 Filed 2–8–18; 8:45 am]
authority under the Controlled Drug Enforcement Administration
BILLING CODE 4410–09–P
Substances Act to the Administrator of
[Docket No. DEA–392]
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to Bulk Manufacturer of Controlled DEPARTMENT OF JUSTICE
exercise all necessary functions with Substances Application: INSYS
respect to the promulgation and Manufacturing LLC Drug Enforcement Administration
implementation of 21 CFR part 1301,
incident to the registration of ACTION: Notice of application. [Docket No. DEA–392]
manufacturers, distributors, dispensers, Importer of Controlled Substances
importers, and exporters of controlled DATES: Registered bulk manufacturers of
the affected basic classes, and Application: Meridian Medical
substances (other than final orders in
sradovich on DSK3GMQ082PROD with NOTICES
applicants therefore, may file written Technologies Inc.
connection with suspension, denial, or
revocation of registration) has been comments on or objections to the ACTION: Notice of application.
redelegated to the Assistant issuance of the proposed registration on
Administrator of the DEA Diversion or before April 10, 2018. DATES: Registered bulk manufacturers of
Control Division (‘‘Assistant ADDRESSES: Written comments should the affected basic classes, and
Administrator’’) pursuant to section 7 of be sent to: Drug Enforcement applicants therefore, may file written
28 CFR part 0, appendix to subpart R. Administration, Attention: DEA Federal comments on or objections to the
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![Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5811
issuance of the proposed registration on Dated: January 31, 2018. Nolte Drive, West Deptford, NJ 08066–
or before March 12, 2018. Such persons Susan A. Gibson, 1742 applied to be registered as an
may also file a written request for a Deputy Assistant Administrator. importer of the following basic classes
hearing on the application March 12, [FR Doc. 2018–02647 Filed 2–8–18; 8:45 am] of controlled substances:
2018. BILLING CODE 4410–09–P
Drug
Controlled substance Schedule
ADDRESSES: Written comments should code
be sent to: Drug Enforcement DEPARTMENT OF JUSTICE Coca leaves .................. 9040 II
Administration, Attention: DEA Federal Thebaine ....................... 9333 II
Register Representative/DRW, 8701 Drug Enforcement Administration Opium, raw ................... 9600 II
Morrissette Drive, Springfield, Virginia [Docket No. DEA–392] Noroxymorophone ........ 9668 II
22152. All requests for hearing must be Poppy Straw Con- 9670 II
sent to: Drug Enforcement Importer of Controlled Substances centrate.
Administration, Attn: Administrator, Application: Johnson Matthey Inc. Fentanyl ........................ 9801 II
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing ACTION: Notice of application. The company plans to import coca
should also be sent to: (1) Drug leaves (9040), raw opium (9600), and
Enforcement Administration, Attn: DATES: Registered importers of the poppy straw concentrate (9670) in order
Hearing Clerk/LJ, 8701 Morrissette affected basic classes, and applicants to bulk manufacture active
Drive, Springfield, Virginia 22152; and therefore, may file written comments on pharmaceutical ingredients (API) for
(2) Drug Enforcement Administration, or objections to the issuance of the distribution to its customers. The
proposed registration on or before company plans to also import thebaine
Attn: DEA Federal Register
March 12, 2018. Such persons may also (9333), noroxymorophone (9668), and
Representative/DRW, 8701 Morrissette
file a written request for a hearing on fentanyl (9801) to use as analytical
Drive, Springfield, Virginia 22152.
the application on or before March 12, reference standards, both internally and
SUPPLEMENTARY INFORMATION: The 2018. to be sold to their customers to support
Attorney General has delegated his ADDRESSES: Written comments should testing of Johnson Matthey Inc.’s API’s
authority under the Controlled be sent to: Drug Enforcement only.
Substances Act to the Administrator of Administration, Attention: DEA Federal Dated: January 31, 2018.
the Drug Enforcement Administration Register Representative/DRW, 8701 Susan A. Gibson,
(DEA), 28 CFR 0.100(b). Authority to Morrissette Drive, Springfield, Virginia Deputy Assistant Administrator.
exercise all necessary functions with 22152. All requests for hearing must be [FR Doc. 2018–02639 Filed 2–8–18; 8:45 am]
respect to the promulgation and sent to: Drug Enforcement BILLING CODE 4410–09–P
implementation of 21 CFR part 1301, Administration, Attn: Administrator,
incident to the registration of 8701 Morrissette Drive, Springfield,
manufacturers, distributors, dispensers, Virginia 22152. All request for hearing DEPARTMENT OF JUSTICE
importers, and exporters of controlled should also be sent to: (1) Drug
substances (other than final orders in Enforcement Administration, Attn: Drug Enforcement Administration
connection with suspension, denial, or Hearing Clerk/LJ, 8701 Morrissette
[Docket No. DEA–392]
revocation of registration) has been Drive, Springfield, Virginia 22152; and
redelegated to the Assistant (2) Drug Enforcement Administration, Importer of Controlled Substances
Administrator of the DEA Diversion Attn: DEA Federal Register Application: Mylan Technologies Inc.
Control Division (‘‘Assistant Representative/DRW, 8701 Morrissette
Administrator’’) pursuant to section 7 of Drive, Springfield, Virginia 22152. ACTION: Notice of application.
28 CFR part 0, appendix to subpart R. SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his DATES: Registered bulk importers of the
In accordance with 21 CFR
authority under the Controlled affected basic classes, and applicants
1301.34(a), this is notice that on
Substances Act to the Administrator of therefore, may file written comments on
December 29, 2017, Meridian Medical
the Drug Enforcement Administration or objections to the issuance of the
Technologies Inc., 2555 Hermelin Drive,
(DEA), 28 CFR 0.100(b). Authority to proposed registration on or before
Saint Louis, Missouri 63144 applied to March 12, 2018. Such persons may also
be registered as an importer of the exercise all necessary functions with
respect to the promulgation and file a written request for a hearing on
Schedule II control substance for the application on or before March 12,
Morphine (9300) the basic class of implementation of 21 CFR part 1301,
incident to the registration of 2018.
controlled substance.
manufacturers, distributors, dispensers, ADDRESSES: Written comments should
The company plans to import the importers, and exporters of controlled be sent to: Drug Enforcement
listed controlled substance in finished substances (other than final orders in Administration, Attention: DEA Federal
dosage form for internal analytical connection with suspension, denial, or Register Representative/DRW, 8701
purposes only. No other activity for this revocation of registration) has been Morrissette Drive, Springfield, Virginia
drug code is authorized for this redelegated to the Assistant 22152. All requests for hearing must be
registration. Approval of permit Administrator of the DEA Diversion sent to: Drug Enforcement
sradovich on DSK3GMQ082PROD with NOTICES
applications will occur only when the Control Division (‘‘Assistant Administration, Attn: Administrator,
registrant’s business activity is Administrator’’) pursuant to section 7 of 8701 Morrissette Drive, Springfield,
consistent with what is authorized 28 CFR part 0, appendix to subpart R. Virginia 22152. All request for hearing
under 21 U.S.C. 952(a)(2). Authorization In accordance with 21 CFR should also be sent to: (1) Drug
will not extend to the import of FDA 1301.34(a), this is notice that on Enforcement Administration, Attn:
approved or non-approved finished November 9, 2017, Johnson Matthey Hearing Clerk/LJ, 8701 Morrissette
dosage forms for commercial sale. Inc., Pharmaceutical Materials, 2003 Drive, Springfield, Virginia 22152; and
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Document Created: 2018-02-09 00:11:59
Document Modified: 2018-02-09 00:11:59
| 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 March 12, 2018. Such persons may also file a written request for a hearing on the application March 12, 2018. | |
| FR Citation | 83 FR 5810 |
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