Importer of Controlled Substances Application: Sharp (Bethlehem), LLC, 539-540 [2017-28471]
Download as PDF
<![CDATA[
539
Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Notices
SOUTH DAKOTA
manufacturer of the following basic
classes of controlled substances:
Miner County
Wheeler Hotel, 101 N. Main St.,
MINNESOTA
Ramsey County
Church of St. Casimir—Catholic, 937 E.
Jessamine Ave., St. Paul, AD83000939
Authority: 60.13 of 36 CFR part 60
Dated: December 13, 2017.
J. Paul Loether,
Chief, National Register of Historic Places/
National Historic Landmarks Program and
Keeper, National Register of Historic Places.
[FR Doc. 2017–28467 Filed 1–3–18; 8:45 am]
BILLING CODE 4312–52–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Organix, Inc.
ACTION:
Notice of application.
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 5, 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
September 6, 2017, Organix, Inc., 240
Salem Street, Woburn, Massachusetts
01801 applied to be registered as a bulk
ethrower on DSK3G9T082PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:16 Jan 03, 2018
Jkt 244001
Drug
code
Controlled substance
Additional documentation has been
received for the following resource:
Gamma Hydroxybutyric
Acid.
Lysergic acid
diethylamide.
Marihuana .......................
Tetrahydrocannabinols ...
Dimethyltryptamine .........
Psilocybin .......................
Psilocyn ..........................
Heroin .............................
Morphine .........................
Schedule
2010
I
7315
I
7360
7370
7435
7437
7438
9200
9300
I
I
I
I
I
I
II
The company plans to manufacture
reference standards for distribution to
its research and forensic customers. In
reference to drug code 7360 (marihuana)
and 7370 (THC) the company plans to
manufacture these drugs as synthetic.
No other activities for these drug codes
are authorized for this registration.
Dated: December 20, 2017.
Demetra Ashley,
Acting Assistant Administrator.
DC:llll llllllllllll
DCX:llll llllllllllll
Return to ODW—Mike Lewis
DCX:llll llllllllllll
DR:llll llllllllllll
DRX:llll llllllllllll
DRW:llll lllllllllll
DRW Policy Analyst:llll llll
DRG:llll llllllllllll
DRG/A:llll llllllllll
DRGR Unit Chief:llll llllll
DRQ:llll
lllllllllll
DRGR Staff Coordinatorllll lll
DRGR–L.Mckoyllll10/25/2017
NOA—ORGANIX INC
Document#: DRGR–17–0306
DFN: 010.02.A1 General
Correspondence
DFN: 301–04 Federal Register Files
[FR Doc. 2017–28180 Filed 1–3–18; 8:45 am]
BILLING CODE 4410–09–P
Controlled substance
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Sharp (Bethlehem), LLC
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
DATES:
PO 00000
Frm 00041
Fmt 4703
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:
Sfmt 4703
3,4-Methylenedioxy
methamphetamine.
Psilocybin .......................
Drug
code
Schedule
7405
I
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-
E:\FR\FM\04JAN1.SGM
04JAN1
540
Federal Register / Vol. 83, No. 3 / Thursday, January 4, 2018 / Notices
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
DEPARTMENT OF JUSTICE
National Institute of Corrections
ethrower on DSK3G9T082PROD with NOTICES
Advisory Board; Notice of Meeting
This notice announces a forthcoming
meeting of the National Institute of
Corrections (NIC) Advisory Board. The
meeting will be open to the public.
Name of Committee: Advisory Board.
General Function of the Committee:
To aid the National Institute of
Corrections in developing long-range
plans, advise on program development,
and to support NIC’s efforts in the areas
of training, technical assistance,
information services, and policy/
program development assistance to
Federal, state, and local corrections
agencies.
Date and Time: 8:30 a.m. to 12:00
p.m. on Thursday, January 25, 2018,
8:30 a.m. to 12:00 p.m. on Friday,
January 26, 2018.
Location: National Institute of
Corrections, 500 First Street NW, 2nd
Floor, Washington, DC 20534, (202)
514–4202.
Contact Person: Shaina Vanek, Acting
Director, National Institute of
Corrections, 320 First Street NW, Room
5002, Washington, DC 20534. To contact
Ms. Vanek, please call (202) 514–4202.
Agenda: On the mornings of January
25 and 26, 2018, the Advisory Board
will discuss/address the following
topics: (1) Agency Report from the NIC
Acting Director, (2) briefings on current
activities and future goals, and (3)
updates from partner agencies and
associations.
Procedure: Then January 25 and 26,
2018 meetings are open to the public.
Interested persons may present data,
information or views, orally or in
writing, on issues pending before the
committee. Oral presentations from the
public will be scheduled between
approximately 11:15 a.m. to 11:30 a.m.
on January 25, 2018 and between 11:15
a.m. and 11:30 a.m. on January 26, 2018.
Time allotted for each presentation may
be limited. Those desiring to make
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
VerDate Sep<11>2014
16:16 Jan 03, 2018
Jkt 244001
indication of the approximate time
requested to make their presentation on
or before January 19, 2018.
General Information: NIC welcomes
the attendance of the public at its
advisory committee meetings and will
make every effort to accommodate
persons with physical disabilities or
special needs. If you require special
accommodations due to a disability,
please contact Shaina Vanek at least 7
days in advance of the meeting. Notice
of this meeting is given under the
Federal Advisory Committee Act (5
U.S.C. app. 2).
Shaina Vanek,
Acting Director, National Institute of
Corrections.
[FR Doc. 2017–28121 Filed 1–3–18; 8:45 am]
BILLING CODE 4410–36–M
DEPARTMENT OF LABOR
Authority: 44 U.S.C. 3507(a)(1)(D).
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request;
Investment Advice Participants and
Beneficiaries
Notice of availability; request
for comments.
ACTION:
The Department of Labor
(DOL) is submitting the Employee
Benefits Security Administration
(EBSA) sponsored information
collection request (ICR) titled,
‘‘Investment Advice Participants and
Beneficiaries,’’ to the Office of
Management and Budget (OMB) for
review and approval for continued use,
without change, in accordance with the
Paperwork Reduction Act of 1995
(PRA). Public comments on the ICR are
invited.
DATES: The OMB will consider all
written comments that agency receives
on or before February 5, 2018.
ADDRESSES: A copy of this ICR with
applicable supporting documentation;
including a description of the likely
respondents, proposed frequency of
response, and estimated total burden
may be obtained free of charge from the
RegInfo.gov website at https://
www.reginfo.gov/public/do/
PRAViewICR?ref_nbr=201711-1210-001
(this link will only become active on the
day following publication of this notice)
or by contacting Michel Smyth by
telephone at 202–693–4129, TTY 202–
693–8064, (these are not toll-free
numbers) or by email at DOL_PRA_
PUBLIC@dol.gov.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
This ICR
seeks to extend PRA authority for the
Investment Advice Participants and
Beneficiaries information collection.
The regulatory provision contains the
following information collection
requirements: (1) A fiduciary adviser
must furnish an initial disclosure that
provides detailed information to
participants about an advice
arrangement before initially providing
investment advice; (2) a fiduciary
adviser must annually engage an
independent auditor to audit the
investment advice arrangement for
compliance with the regulation; (3) if
the fiduciary adviser provides the
investment advice through the use of a
computer model, then—before
providing the advice—the fiduciary
adviser must obtain a written
certification from an eligible investment
expert as to the computer model’s
compliance with certain standards (e.g.,
applies generally accepted investment
theories, unbiased operation, and
objective criteria) set forth in the
regulation; and (4) a fiduciary adviser
must maintain records with respect to
the investment advice provided in
reliance on the regulation necessary to
determine whether the applicable
requirements of the regulation have
been satisfied. Employee Retirement
Income Security Act (ERISA) of 1974
sections 408(b)(14) and 408(g)
authorizes this information collection.
See 29 U.S.C. 1108(b)(14), 1108(g).
This information collection is subject
to the PRA. A Federal agency generally
cannot conduct or sponsor a collection
of information, and the public is
generally not required to respond to an
SUPPLEMENTARY INFORMATION:
Office of the Secretary
SUMMARY:
Submit comments about this request
by mail to the Office of Information and
Regulatory Affairs, Attn: OMB Desk
Officer for DOL–EBSA, Office of
Management and Budget, Room 10235,
725 17th Street NW, Washington, DC
20503; by Fax: 202–395–5806 (this is
not a toll-free number); or by email:
OIRA_submission@omb.eop.gov.
Commenters are encouraged, but not
required, to send a courtesy copy of any
comments by mail or courier to the U.S.
Department of Labor-OASAM, Office of
the Chief Information Officer, Attn:
Departmental Information Compliance
Management Program, Room N1301,
200 Constitution Avenue NW,
Washington, DC 20210; or by email:
DOL_PRA_PUBLIC@dol.gov.
FOR FURTHER INFORMATION CONTACT:
Michel Smyth by telephone at 202–693–
4129, TTY 202–693–8064, (these are not
toll-free numbers) or by email at DOL_
PRA_PUBLIC@dol.gov.
E:\FR\FM\04JAN1.SGM
04JAN1
]]>Agencies
[Federal Register Volume 83, Number 3 (Thursday, January 4, 2018)]
[Notices]
[Pages 539-540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
