83 FR 539 - Importer of Controlled Substances Application: Sharp (Bethlehem), LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 3 (January 4, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 3 (January 4, 2018)
| Page Range | 539-540 | |
| FR Document | 2017-28471 |
[Federal Register Volume 83, Number 3 (Thursday, January 4, 2018)] [Notices] [Pages 539-540] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-28471] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Sharp (Bethlehem), LLC 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 February 5, 2018. Such persons may also file a written request for a hearing on the application pursuant on or before February 5, 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 June 15, 2017, Sharp (Bethlehem), LLC, 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ 3,4-Methylenedioxy methamphetamine..... 7405 I Psilocybin............................. 7437 I ------------------------------------------------------------------------ The company plans to import the listed controlled substances for clinical trials. No other activity for these drug codes is authorized for this registration. Approval of permits 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- [[Page 540]] approved finished dosage forms for commercial sale. Dated: December 28, 2017. Neil D. Doherty, Deputy Assistant Administrator. [FR Doc. 2017-28471 Filed 1-3-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Notices 539
SOUTH DAKOTA manufacturer of the following basic issuance of the proposed registration on
Miner County classes of controlled substances: or before February 5, 2018. Such
persons may also file a written request
Wheeler Hotel, 101 N. Main St.,
Drug for a hearing on the application
Controlled substance Schedule
Additional documentation has been code pursuant on or before February 5, 2018.
received for the following resource:
Gamma Hydroxybutyric 2010 I ADDRESSES: Written comments should
MINNESOTA Acid. be sent to: Drug Enforcement
Ramsey County Lysergic acid 7315 I Administration, Attention: DEA Federal
diethylamide. Register Representative/DRW, 8701
Church of St. Casimir—Catholic, 937 E.
Marihuana ....................... 7360 I Morrissette Drive, Springfield, Virginia
Jessamine Ave., St. Paul, AD83000939
Tetrahydrocannabinols ... 7370 I 22152. All requests for hearing must be
Authority: 60.13 of 36 CFR part 60 Dimethyltryptamine ......... 7435 I sent to: Drug Enforcement
Psilocybin ....................... 7437 I
Dated: December 13, 2017. Administration, Attn: Administrator,
Psilocyn .......................... 7438 I
J. Paul Loether, Heroin ............................. 9200 I 8701 Morrissette Drive, Springfield,
Chief, National Register of Historic Places/ Morphine ......................... 9300 II Virginia 22152. All requests for hearing
National Historic Landmarks Program and should also be sent to: (1) Drug
Keeper, National Register of Historic Places. The company plans to manufacture Enforcement Administration, Attn:
[FR Doc. 2017–28467 Filed 1–3–18; 8:45 am] reference standards for distribution to Hearing Clerk/LJ, 8701 Morrissette
BILLING CODE 4312–52–P its research and forensic customers. In Drive, Springfield, Virginia 22152; and
reference to drug code 7360 (marihuana) (2) Drug Enforcement Administration,
and 7370 (THC) the company plans to Attn: DEA Federal Register
DEPARTMENT OF JUSTICE manufacture these drugs as synthetic. Representative/DRW, 8701 Morrissette
No other activities for these drug codes Drive, Springfield, Virginia 22152.
Drug Enforcement Administration are authorized for this registration. SUPPLEMENTARY INFORMATION: The
[Docket No. DEA–392] Dated: December 20, 2017. Attorney General has delegated his
Demetra Ashley,
authority under the Controlled
Bulk Manufacturer of Controlled Substances Act to the Administrator of
Acting Assistant Administrator.
Substances Application: Organix, Inc. the Drug Enforcement Administration
DC:llll llllllllllll (DEA), 28 CFR 0.100(b). Authority to
ACTION: Notice of application. DCX:llll llllllllllll exercise all necessary functions with
respect to the promulgation and
DATES: Registered bulk manufacturers of Return to ODW—Mike Lewis implementation of 21 CFR part 1301,
the affected basic classes, and DCX:llll llllllllllll incident to the registration of
applicants therefore, may file written manufacturers, distributors, dispensers,
comments on or objections to the DR:llll llllllllllll
DRX:llll llllllllllll importers, and exporters of controlled
issuance of the proposed registration on substances (other than final orders in
or before March 5, 2018. DRW:llll lllllllllll connection with suspension, denial, or
ADDRESSES: Written comments should DRW Policy Analyst:llll llll revocation of registration) has been
be sent to: Drug Enforcement DRG:llll llllllllllll redelegated to the Assistant
Administration, Attention: DEA Federal Administrator of the DEA Diversion
DRG/A:llll llllllllll
Register Representative/DRW, 8701 Control Division (‘‘Assistant
Morrissette Drive, Springfield, Virginia DRGR Unit Chief:llll llllll
Administrator’’) pursuant to section 7 of
22152. DRQ:llll lllllllllll 28 CFR part 0, appendix to subpart R.
SUPPLEMENTARY INFORMATION: The DRGR Staff Coordinatorllll lll In accordance with 21 CFR
Attorney General has delegated his DRGR–L.Mckoyllll10/25/2017 1301.34(a), this is notice that on June
authority under the Controlled NOA—ORGANIX INC 15, 2017, Sharp (Bethlehem), LLC, 2400
Substances Act to the Administrator of Document#: DRGR–17–0306 Baglyos Circle, Bethlehem,
the Drug Enforcement Administration DFN: 010.02.A1 General Pennsylvania 18020 applied to be
(DEA), 28 CFR 0.100(b). Authority to Correspondence registered as an importer of the
exercise all necessary functions with DFN: 301–04 Federal Register Files following basic classes of controlled
respect to the promulgation and substances:
[FR Doc. 2017–28180 Filed 1–3–18; 8:45 am]
implementation of 21 CFR part 1301, BILLING CODE 4410–09–P
incident to the registration of Drug
Controlled substance Schedule
code
manufacturers, distributors, dispensers,
importers, and exporters of controlled DEPARTMENT OF JUSTICE 3,4-Methylenedioxy 7405 I
substances (other than final orders in methamphetamine.
connection with suspension, denial, or Drug Enforcement Administration Psilocybin ....................... 7437 I
revocation of registration) has been
[Docket No. DEA–392] The company plans to import the
redelegated to the Assistant
Administrator of the DEA Diversion Importer of Controlled Substances listed controlled substances for clinical
Control Division (‘‘Assistant Application: Sharp (Bethlehem), LLC trials. No other activity for these drug
ethrower on DSK3G9T082PROD with NOTICES
Administrator’’) pursuant to section 7 of codes is authorized for this registration.
28 CFR part 0, appendix to subpart R. ACTION: Notice of application. Approval of permits applications will
In accordance with 21 CFR occur only when the registrant’s
1301.33(a), this is notice that on DATES: Registered bulk manufacturers of business activity is consistent with what
September 6, 2017, Organix, Inc., 240 the affected basic classes, and is authorized under 21 U.S.C. 952(a)(2).
Salem Street, Woburn, Massachusetts applicants therefore, may file written Authorization will not extend to the
01801 applied to be registered as a bulk comments on or objections to the import of FDA approved or non-
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![540 Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Notices
approved finished dosage forms for indication of the approximate time Submit comments about this request
commercial sale. requested to make their presentation on by mail to the Office of Information and
Dated: December 28, 2017. or before January 19, 2018. Regulatory Affairs, Attn: OMB Desk
Neil D. Doherty, General Information: NIC welcomes Officer for DOL–EBSA, Office of
the attendance of the public at its Management and Budget, Room 10235,
Deputy Assistant Administrator.
advisory committee meetings and will 725 17th Street NW, Washington, DC
[FR Doc. 2017–28471 Filed 1–3–18; 8:45 am] 20503; by Fax: 202–395–5806 (this is
make every effort to accommodate
BILLING CODE 4410–09–P
persons with physical disabilities or not a toll-free number); or by email:
special needs. If you require special OIRA_submission@omb.eop.gov.
accommodations due to a disability, Commenters are encouraged, but not
DEPARTMENT OF JUSTICE required, to send a courtesy copy of any
please contact Shaina Vanek at least 7
National Institute of Corrections days in advance of the meeting. Notice comments by mail or courier to the U.S.
of this meeting is given under the Department of Labor-OASAM, Office of
Advisory Board; Notice of Meeting Federal Advisory Committee Act (5 the Chief Information Officer, Attn:
U.S.C. app. 2). Departmental Information Compliance
This notice announces a forthcoming Management Program, Room N1301,
meeting of the National Institute of Shaina Vanek, 200 Constitution Avenue NW,
Corrections (NIC) Advisory Board. The Acting Director, National Institute of Washington, DC 20210; or by email:
meeting will be open to the public. Corrections. DOL_PRA_PUBLIC@dol.gov.
Name of Committee: Advisory Board. [FR Doc. 2017–28121 Filed 1–3–18; 8:45 am] FOR FURTHER INFORMATION CONTACT:
General Function of the Committee: BILLING CODE 4410–36–M Michel Smyth by telephone at 202–693–
To aid the National Institute of 4129, TTY 202–693–8064, (these are not
Corrections in developing long-range toll-free numbers) or by email at DOL_
plans, advise on program development, PRA_PUBLIC@dol.gov.
and to support NIC’s efforts in the areas DEPARTMENT OF LABOR
of training, technical assistance, Authority: 44 U.S.C. 3507(a)(1)(D).
information services, and policy/ Office of the Secretary SUPPLEMENTARY INFORMATION: This ICR
program development assistance to seeks to extend PRA authority for the
Federal, state, and local corrections Agency Information Collection Investment Advice Participants and
agencies. Activities; Submission for OMB Beneficiaries information collection.
Date and Time: 8:30 a.m. to 12:00 Review; Comment Request; The regulatory provision contains the
p.m. on Thursday, January 25, 2018, Investment Advice Participants and following information collection
8:30 a.m. to 12:00 p.m. on Friday, Beneficiaries requirements: (1) A fiduciary adviser
January 26, 2018. must furnish an initial disclosure that
Location: National Institute of ACTION:Notice of availability; request provides detailed information to
Corrections, 500 First Street NW, 2nd for comments. participants about an advice
Floor, Washington, DC 20534, (202) arrangement before initially providing
SUMMARY: The Department of Labor
514–4202. investment advice; (2) a fiduciary
(DOL) is submitting the Employee
Contact Person: Shaina Vanek, Acting adviser must annually engage an
Benefits Security Administration
Director, National Institute of independent auditor to audit the
(EBSA) sponsored information
Corrections, 320 First Street NW, Room investment advice arrangement for
collection request (ICR) titled,
5002, Washington, DC 20534. To contact compliance with the regulation; (3) if
‘‘Investment Advice Participants and
Ms. Vanek, please call (202) 514–4202. the fiduciary adviser provides the
Beneficiaries,’’ to the Office of
Agenda: On the mornings of January investment advice through the use of a
Management and Budget (OMB) for
25 and 26, 2018, the Advisory Board computer model, then—before
review and approval for continued use,
will discuss/address the following providing the advice—the fiduciary
without change, in accordance with the
topics: (1) Agency Report from the NIC adviser must obtain a written
Paperwork Reduction Act of 1995
Acting Director, (2) briefings on current certification from an eligible investment
(PRA). Public comments on the ICR are
activities and future goals, and (3) expert as to the computer model’s
invited.
updates from partner agencies and compliance with certain standards (e.g.,
associations. DATES: The OMB will consider all applies generally accepted investment
Procedure: Then January 25 and 26, written comments that agency receives theories, unbiased operation, and
2018 meetings are open to the public. on or before February 5, 2018. objective criteria) set forth in the
Interested persons may present data, ADDRESSES: A copy of this ICR with regulation; and (4) a fiduciary adviser
information or views, orally or in applicable supporting documentation; must maintain records with respect to
writing, on issues pending before the including a description of the likely the investment advice provided in
committee. Oral presentations from the respondents, proposed frequency of reliance on the regulation necessary to
public will be scheduled between response, and estimated total burden determine whether the applicable
approximately 11:15 a.m. to 11:30 a.m. may be obtained free of charge from the requirements of the regulation have
on January 25, 2018 and between 11:15 RegInfo.gov website at http:// been satisfied. Employee Retirement
a.m. and 11:30 a.m. on January 26, 2018. www.reginfo.gov/public/do/ Income Security Act (ERISA) of 1974
Time allotted for each presentation may PRAViewICR?ref_nbr=201711-1210-001 sections 408(b)(14) and 408(g)
ethrower on DSK3G9T082PROD with NOTICES
be limited. Those desiring to make (this link will only become active on the authorizes this information collection.
formal oral presentations should notify day following publication of this notice) See 29 U.S.C. 1108(b)(14), 1108(g).
the contact person and submit a brief or by contacting Michel Smyth by This information collection is subject
statement of the general nature of the telephone at 202–693–4129, TTY 202– to the PRA. A Federal agency generally
evidence or arguments they wish to 693–8064, (these are not toll-free cannot conduct or sponsor a collection
present, the names and addresses of numbers) or by email at DOL_PRA_ of information, and the public is
proposed participants, and an PUBLIC@dol.gov. generally not required to respond to an
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Document Created: 2018-01-04 02:02:01
Document Modified: 2018-01-04 02:02:01
| 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 February 5, 2018. Such persons may also file a written request for a hearing on the application pursuant on or before February 5, 2018. | |
| FR Citation | 83 FR 539 |
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