82 FR 45613 - Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 82, Issue 188 (September 29, 2017)
Drug Enforcement Administration
Federal Register Volume 82, Issue 188 (September 29, 2017)
| Page Range | 45613-45613 | |
| FR Document | 2017-20947 |
[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)] [Notices] [Page 45613] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20947] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute 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 November 28, 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 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 March 31, 2017, Research Triangle Institute, 3040 East Cornwallis Road, Hermann Building, Room 106, Research Triangle Park, North Carolina 27709-2194 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ Marihuana.............................. 7360 I Tetrahydrocannabinols.................. 7370 I ------------------------------------------------------------------------ The company will manufacture marihuana (7360) and tetrahydrocannabinols (7370) for use by their researchers under the above listed controlled substances as Active Pharmaceutical Ingredient (API) for clinical trials. In reference to drug code (7370) the company plans to bulk manufacture a synthetic tetrahydrocannabinol. No other activities for this drug code are authorized for this registration. Dated: September 21, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017-20947 Filed 9-28-17; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 45613
DEPARTMENT OF JUSTICE Drug Control Division (‘‘Assistant
Controlled substance Schedule
code Administrator’’) pursuant to section 7 of
Drug Enforcement Administration 28 CFR part 0, appendix to subpart R.
Amphetamine ............... 1100 II In accordance with 21 CFR
Methylphenidate ........... 1724 II 1301.33(a), this is notice that on March
[Docket No. DEA–392] Oxycodone ................... 9143 II
31, 2017, Research Triangle Institute,
Importer of Controlled Substances 3040 East Cornwallis Road, Hermann
The company plans to import the
Application: Bellwyck Clinical Services Building, Room 106, Research Triangle
listed controlled substances in finished
dosage form (FDF) from foreign sources Park, North Carolina 27709–2194
ACTION: Notice of application. applied to be registered as a bulk
for analytical testing and clinical trials
in which the foreign FDF will be manufacturer of the following basic
DATES: Registered bulk manufacturers of compared to the company’s own classes of controlled substances:
the affected basic classes, and domestically-manufactured FDF. This
applicants therefore, may file written Drug
analysis is required to allow the Controlled substance Schedule
code
comments on or objections to the company to export domestically-
issuance of the proposed registration in manufactured FDF to foreign markets. Marihuana ..................... 7360 I
accordance with 21 CFR 1301.34(a) on Authorization will not extend to the Tetrahydrocannabinols 7370 I
or before October 30, 2017. Such import of FDA approved or non-
persons may also file a written request approved finished dosage forms for The company will manufacture
for a hearing on the application commercial sale. marihuana (7360) and
pursuant to 21 CFR 1301.43 on or before tetrahydrocannabinols (7370) for use by
October 30, 2017. Dated: September 21, 2017.
their researchers under the above listed
Demetra Ashley,
ADDRESSES: Written comments should controlled substances as Active
Acting Assistant Administrator. Pharmaceutical Ingredient (API) for
be sent to: Drug Enforcement
[FR Doc. 2017–20941 Filed 9–28–17; 8:45 am] clinical trials.
Administration, Attention: DEA Federal
Register Representative/DRW, 8701 BILLING CODE 4410–09–P In reference to drug code (7370) the
Morrissette Drive, Springfield, Virginia company plans to bulk manufacture a
22152. All requests for hearing must be synthetic tetrahydrocannabinol. No
DEPARTMENT OF JUSTICE other activities for this drug code are
sent to: Drug Enforcement
Administration, Attn: Administrator, authorized for this registration.
Drug Enforcement Administration
8701 Morrissette Drive, Springfield, Dated: September 21, 2017.
Virginia 22152. All request for hearing [Docket No. DEA–392]
Demetra Ashley,
should also be sent to: (1) Drug Bulk Manufacturer of Controlled Acting Assistant Administrator.
Enforcement Administration, Attn: Substances Application: Research [FR Doc. 2017–20947 Filed 9–28–17; 8:45 am]
Hearing Clerk/LJ, 8701 Morrissette Triangle Institute BILLING CODE 4410–09–P
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration, ACTION: Notice of application.
Attn: DEA Federal Register DEPARTMENT OF JUSTICE
Representative/DRW, 8701 Morrissette DATES: Registered bulk manufacturers of
Drive, Springfield, Virginia 22152. the affected basic classes, and Notice of Lodging of Proposed
SUPPLEMENTARY INFORMATION: The applicants therefore, may file written Consent Decree Under the Clean Air
Attorney General has delegated his comments on or objections to the Act
authority under the Controlled issuance of the proposed registration on
On September 19, 2017, the
Substances Act to the Administrator of or before November 28, 2017.
Department of Justice lodged a proposed
the Drug Enforcement Administration ADDRESSES: Written comments should Consent Decree with the United States
(DEA), 28 CFR 0.100(b). Authority to be sent to: Drug Enforcement District Court for the District of South
exercise all necessary functions with Administration, Attention: DEA Federal Carolina in the lawsuit entitled United
respect to the promulgation and Register Representative/DRW, 8701 States v. JW Aluminum Company, Civil
implementation of 21 CFR part 1301, Morrissette Drive, Springfield, Virginia Action No. 17–cv–02490–DCN.
incident to the registration of 22152. The United States filed this lawsuit
manufacturers, distributors, dispensers, SUPPLEMENTARY INFORMATION: The under the Clean Air Act. The United
importers, and exporters of controlled Attorney General has delegated his States’ complaint seeks injunctive relief
substances (other than final orders in authority under the Controlled and civil penalties for violations of the
connection with suspension, denial, or Substances Act to the Administrator of regulations that govern secondary
revocation of registration) has been the Drug Enforcement Administration aluminum production at the defendant’s
redelegated to the Assistant (DEA), 28 CFR 0.100(b). Authority to facility in Mount Holly, South Carolina.
Administrator of the DEA Diversion exercise all necessary functions with The consent decree requires the
Control Division (‘‘Assistant respect to the promulgation and defendant to perform injunctive relief
Administrator’’) pursuant to section 7 of implementation of 21 CFR part 1301, and pay a $230,000 civil penalty.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
28 CFR part 0, appendix to subpart R. incident to the registration of The publication of this notice opens
In accordance with 21 CFR manufacturers, distributors, dispensers, a period for public comment on the
1301.34(a), this is notice that on June importers, and exporters of controlled proposed Consent Decree. Comments
30, 2017, Bellwyck Clinical Services, substances (other than final orders in should be addressed to the Assistant
8946 Global Way, West Chester, Ohio connection with suspension, denial, or Attorney General, Environment and
45069 applied to be registered as an revocation of registration) has been Natural Resources Division, and should
importer of the following basic classes redelegated to the Assistant refer to United States v. JW Aluminum
of controlled substances: Administrator of the DEA Diversion Company, D.J. Ref. No. 90–5–2–1–
VerDate Sep<11>2014 18:50 Sep 28, 2017 Jkt 241001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1](https://thefederalregister.org/doc/82_FR_45801/page/1.svg)
Document Created: 2017-09-29 03:27:22
Document Modified: 2017-09-29 03:27:22
| 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 November 28, 2017. | |
| FR Citation | 82 FR 45613 |
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