83 FR 60899 - Importer of Controlled Substances Application: GE Healthcare
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 228 (November 27, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 228 (November 27, 2018)
| Page Range | 60899-60899 | |
| FR Document | 2018-25864 |
[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)] [Notices] [Page 60899] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25864] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: GE Healthcare 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 December 27, 2018. Such persons may also file a written request for a hearing on the application on or before December 27, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 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/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 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 September 5, 2018, GE Healthcare, 3350 North Ridge Avenue, Arlington Heights, Illinois 60004, applied to be registered as an importer of cocaine (9041), a basic class of controlled substance listed in schedule II. The company plans to import small quantities of Ioflupane, in the form of three separate analogues of cocaine, to validate production and quality control systems, for a reference standard, and for producing material for a future investigational new drug (IND) submission. Supplies of this particular controlled substance are not available in the form needed within the current domestic supply of the United States. Dated: November 16, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018-25864 Filed 11-26-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 228 / Tuesday, November 27, 2018 / Notices 60899
Company FR Docket Published
Alcami Carolinas Corporation ............................................. 83 FR 46758 ...................................................................... September 14, 2018.
The DEA has considered the factors in Administration, Attn: Administrator, DEPARTMENT OF JUSTICE
21 U.S.C. 823, 952(a) and 958(a) and 8701 Morrissette Drive, Springfield,
determined that the registration of the Virginia 22152. All requests for hearing Drug Enforcement Administration
listed registrant to import the applicable should also be sent to: (1) Drug
basic classes of schedule I controlled Enforcement Administration, Attn: [Docket No. DEA–392]
substances is consistent with the public Hearing Clerk/OALJ, 8701 Morrissette
interest and with United States Drive, Springfield, Virginia 22152; and Bulk Manufacturer of Controlled
obligations under international treaties, (2) Drug Enforcement Administration, Substances Application: Insys
conventions, or protocols in effect on Attn: DEA Federal Register Manufacturing, LLC
May 1, 1971. The DEA investigated the Representative/DPW, 8701 Morrissette
company’s maintenance of effective Drive, Springfield, Virginia 22152. ACTION: Notice of application.
controls against diversion by inspecting SUPPLEMENTARY INFORMATION: The
the company’s physical security Attorney General has delegated his
systems, verifying the company’s DATES: Registered bulk manufacturers of
authority under the Controlled
compliance with state and local laws, Substances Act to the Administrator of the affected basic classes, and
and reviewing the company’s the Drug Enforcement Administration applicants therefore, may file written
background and history. (DEA), 28 CFR 0.100(b). Authority to comments on or objections to the
Therefore, pursuant to 21 U.S.C. exercise all necessary functions with issuance of the proposed registration on
952(a) and 958(a), and in accordance respect to the promulgation and or before January 28, 2019.
with 21 CFR 1301.34, the DEA has implementation of 21 CFR part 1301,
granted a registration as an importer for ADDRESSES: Written comments should
incident to the registration of be sent to: Drug Enforcement
schedule I controlled substances to the manufacturers, distributors, dispensers,
above listed company. Administration, Attention: DEA Federal
importers, and exporters of controlled Register Representative/DPW, 8701
Dated: November 16, 2018. substances (other than final orders in Morrissette Drive, Springfield, Virginia
John J. Martin, connection with suspension, denial, or 22152.
Assistant Administrator. revocation of registration) has been
[FR Doc. 2018–25863 Filed 11–26–18; 8:45 am] redelegated to the Assistant SUPPLEMENTARY INFORMATION: The
BILLING CODE 4410–09–P Administrator of the DEA Diversion Attorney General has delegated his
Control Division (‘‘Assistant authority under the Controlled
Administrator’’) pursuant to section 7 of Substances Act to the Administrator of
DEPARTMENT OF JUSTICE 28 CFR part 0, appendix to subpart R. the Drug Enforcement Administration
In accordance with 21 CFR (DEA), 28 CFR 0.100(b). Authority to
Drug Enforcement Administration 1301.34(a), this is notice that on
exercise all necessary functions with
[Docket No. DEA–392] September 5, 2018, GE Healthcare, 3350
respect to the promulgation and
North Ridge Avenue, Arlington Heights,
Illinois 60004, applied to be registered implementation of 21 CFR part 1301,
Importer of Controlled Substances
as an importer of cocaine (9041), a basic incident to the registration of
Application: GE Healthcare
class of controlled substance listed in manufacturers, distributors, dispensers,
ACTION: Notice of application. schedule II. importers, and exporters of controlled
The company plans to import small substances (other than final orders in
DATES: Registered bulk manufacturers of quantities of Ioflupane, in the form of connection with suspension, denial, or
the affected basic classes, and three separate analogues of cocaine, to revocation of registration) has been
applicants therefore, may file written validate production and quality control delegated to the Assistant Administrator
comments on or objections to the systems, for a reference standard, and of the DEA Diversion Control Division
issuance of the proposed registration on for producing material for a future (‘‘Assistant Administrator’’) pursuant to
or before December 27, 2018. Such investigational new drug (IND) section 7 of 28 CFR part 0, appendix to
persons may also file a written request submission. Supplies of this particular subpart R.
for a hearing on the application on or controlled substance are not available in
before December 27, 2018. In accordance with 21 CFR
the form needed within the current 1301.33(a), this is notice that on October
ADDRESSES: Written comments should domestic supply of the United States.
be sent to: Drug Enforcement 4, 2018, Insys Manufacturing, LLC, 811
Dated: November 16, 2018. Paloma Drive, Suite C, Round Rock,
Administration, Attention: DEA Federal
Register Representative/DPW, 8701 John J. Martin, Texas 78665, applied to be registered as
Morrissette Drive, Springfield, Virginia Assistant Administrator. a bulk manufacturer of the following
22152. All requests for hearing must be [FR Doc. 2018–25864 Filed 11–26–18; 8:45 am] basic classes of controlled substances:
sent to: Drug Enforcement BILLING CODE 4410–09–P
amozie on DSK3GDR082PROD with NOTICES1
Controlled substance Drug code Schedule
Marihuana ................................................................................................................................................................ 7360 I
Tetrahydrocannabinols ............................................................................................................................................ 7370 I
VerDate Sep<11>2014 17:45 Nov 26, 2018 Jkt 247001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\27NON1.SGM 27NON1](https://thefederalregister.org/doc/83_FR_61127/page/1.svg)
Document Created: 2018-11-27 01:25:01
Document Modified: 2018-11-27 01:25:01
| 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 December 27, 2018. Such persons may also file a written request for a hearing on the application on or before December 27, 2018. | |
| FR Citation | 83 FR 60899 |
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