83 FR 10523 - Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 47 (March 9, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 47 (March 9, 2018)
| Page Range | 10523-10523 | |
| FR Document | 2018-04766 |
[Federal Register Volume 83, Number 47 (Friday, March 9, 2018)] [Notices] [Page 10523] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04766] ======================================================================= ----------------------------------------------------------------------- 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 in accordance with 21 CFR 1301.33(a) on or before May 8, 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 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: March 5, 2018. Susan A. Gibson, Deputy Assistant Administrator. [FR Doc. 2018-04766 Filed 3-8-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 47 / Friday, March 9, 2018 / Notices 10523
of the allegations in the complaint. In incident to the registration of FOR FURTHER INFORMATION CONTACT:
the motion, the complainant states that manufacturers, distributors, dispensers, Information regarding this notice is
there are no other agreements, written or importers, and exporters of controlled available from the following sources:
oral, express or implied between the substances (other than final orders in Press inquiries: Contact Mr. Frank
parties concerning the subject matter of connection with suspension, denial, or Meilinger, Director, OSHA Office of
the investigation. Respondents and OUII revocation of registration) has been Communications, phone: (202) 693–
filed responses in support of the motion. redelegated to the Assistant 1999; email: meilinger.francis2@dol.gov.
The ALJ issued the subject ID on Administrator of the DEA Diversion General and technical information:
February 5, 2018, granting the Control Division (‘‘Assistant Contact Mr. Kevin Robinson, Director,
unopposed motion for termination. He Administrator’’) pursuant to section 7 of Office of Technical Programs and
found that the motion satisfied 28 CFR part 0, appendix to subpart R. Coordination Activities, Directorate of
Commission Rule 210.21(a)(1) (19 CFR In accordance with 21 CFR Technical Support and Emergency
210.21(a)(1)) and that there are no 1301.33(a), this is notice that on March Management, Occupational Safety and
extraordinary circumstances that 31, 2017, Research Triangle Institute, Health Administration, U.S. Department
warrant denying the motion. No party 3040 East Cornwallis Road, Hermann of Labor, phone: (202) 693–2110; email:
petitioned for review of the subject ID. Building, Room 106, Research Triangle robinson.kevin@dol.gov. OSHA’s web
The Commission has determined not Park, North Carolina 27709–2194 page includes information about the
to review the ID and has terminated the applied to be registered as a bulk NRTL Program (see http://
investigation. manufacturer of the following basic www.osha.gov/dts/otpca/nrtl/
The authority for the Commission’s classes of controlled substances: index.html).
determination is contained in section SUPPLEMENTARY INFORMATION:
337 of the Tariff Act of 1930, as Controlled Drug Schedule
amended, 19 U.S.C. 1337, and in part substance code I. Notice of Final Decision
210 of the Commission’s Rules of OSHA hereby gives notice of the
Marihuana ..................... 7360 I
Practice and Procedure, 19 CFR part Tetrahydrocannabinols 7370 I expansion of the scope of recognition of
210. MET Laboratories, Inc. (MET), as a
By order of the Commission. The company will manufacture NRTL. MET’s expansion covers the
Issued: March 6, 2018. marihuana (7360) and addition of four test standards to its
Lisa R. Barton, tetrahydrocannabinols (7370) for use by scope of recognition.
Secretary to the Commission. their researchers under the above-listed OSHA recognition of a NRTL signifies
controlled substances as Active that the organization meets the
[FR Doc. 2018–04794 Filed 3–8–18; 8:45 am]
Pharmaceutical Ingredient (API) for requirements specified by 29 CFR
BILLING CODE 7020–02–P
clinical trials. 1910.7. Recognition is an
In reference to drug code (7370) the acknowledgment that the organization
company plans to bulk manufacture a can perform independent safety testing
DEPARTMENT OF JUSTICE synthetic tetrahydrocannabinol. No and certification of the specific products
Drug Enforcement Administration other activities for this drug code are covered within its scope of recognition
authorized for this registration. and is not a delegation or grant of
[Docket No. DEA–392] government authority. As a result of
Dated: March 5, 2018.
recognition, employers may use
Bulk Manufacturer of Controlled Susan A. Gibson,
products properly approved by the
Substances Application: Research Deputy Assistant Administrator.
NRTL to meet OSHA standards that
Triangle Institute [FR Doc. 2018–04766 Filed 3–8–18; 8:45 am] require testing and certification of the
BILLING CODE 4410–09–P products.
ACTION: Notice of application.
The Agency processes applications by
DATES: Registered bulk manufacturers of a NRTL for initial recognition, or for
the affected basic classes, and expansion or renewal of this
DEPARTMENT OF LABOR
applicants therefore, may file written recognition, following requirements in
comments on or objections to the Occupational Safety and Health Appendix A to 29 CFR 1910.7. This
issuance of the proposed registration in Administration appendix requires that the Agency
accordance with 21 CFR 1301.33(a) on publish two notices in the Federal
or before May 8, 2018. [Docket No. OSHA–2006–0028]
Register in processing an application. In
the first notice, OSHA announces the
ADDRESSES: Written comments should
MET Laboratories, Inc.: Grant of application and provides its preliminary
be sent to: Drug Enforcement finding and, in the second notice, the
Administration, Attention: DEA Federal Expansion of Recognition
Agency provides its final decision on
Register Representative/DRW, 8701 AGENCY: Occupational Safety and Health the application. These notices set forth
Morrissette Drive, Springfield, Virginia Administration (OSHA), Labor. the NRTL’s scope of recognition or
22152. ACTION: Notice. modifications of that scope. OSHA
SUPPLEMENTARY INFORMATION: The maintains an informational web page for
Attorney General has delegated his SUMMARY: In this notice, OSHA each NRTL that details its scope of
announces its final decision to expand
amozie on DSK30RV082PROD with NOTICES
authority under the Controlled recognition. These pages are available
Substances Act to the Administrator of the scope of recognition for MET from the Agency’s website at http://
the Drug Enforcement Administration Laboratories, Inc., as a Nationally www.osha.gov/dts/otpca/nrtl/
(DEA), 28 CFR 0.100(b). Authority to Recognized Testing Laboratory (NRTL). index.html.
exercise all necessary functions with DATES: The expansion of the scope of MET submitted four applications, one
respect to the promulgation and recognition becomes effective on March dated July 7, 2015 (OSHA–2006–0028–
implementation of 21 CFR part 1301, 9, 2018. 0037), two dated December 14, 2016
VerDate Sep<11>2014 16:47 Mar 08, 2018 Jkt 244001 PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 E:\FR\FM\09MRN1.SGM 09MRN1](https://thefederalregister.org/doc/83_FR_10570/page/1.svg)
Document Created: 2018-03-09 03:48:20
Document Modified: 2018-03-09 03:48:20
| 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 in accordance with 21 CFR 1301.33(a) on or before May 8, 2018. | |
| FR Citation | 83 FR 10523 |
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