Importer of Controlled Substances Application: MP Pharma Services, 44406-44407 [2021-17186]
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44406
Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before September 13, 2021. Such
persons may also file a written request
for a hearing on the application on or
before September 13, 2021.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for a 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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on May 7, 2021, Globyz
Pharma, LLC., 2101 Market Street, Suite
5, Upper Chichester, Pennsylvania
19061–4001, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
Lisdexamfetamine .........
I
1205
Schedule
II
lotter on DSK11XQN23PROD with NOTICES1
The company plans to import finished
dosage unit products of
Lisdexamfetamine for the one time need
of analytical testing. No other activity
for this drug codes is authorized for this
registration.
Approval of permit 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
Drug Enforcement Administration
[Docket No. DEA–881]
Drug Enforcement Administration
Notice of application.
[Docket No. DEA–882]
Cambrex High Point, Inc., has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to Supplemental
Information listed below for further
drug information.
Importer of Controlled Substances
Application: MP Pharma Services
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before September 13, 2021. Such
persons may also file a written request
for a hearing on the application on or
before September 13, 2021.
SUMMARY:
SUMMARY:
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on July 9, 2021, Cambrex
High Point, Inc., 4180 Mendenhall Oaks
Parkway, High Point, North Carolina
27265–8017, applied to renew as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
Poppy Straw Concentrate.
Schedule
9670
I
II
I
The company plans to import Poppy
Straw Concentrate to develop its own
portfolio of generic products. Approval
of permit applications will occur only
when the registrant’s business activity is
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20:11 Aug 11, 2021
Jkt 253001
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–17185 Filed 8–11–21; 8:45 am]
Importer of Controlled Substances
Application: Cambrex High Point, Inc.
[FR Doc. 2021–17181 Filed 8–11–21; 8:45 am]
VerDate Sep<11>2014
consistent with what is authorized
under 21 U.S.C. 952(a)(2).
DEPARTMENT OF JUSTICE
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
MP Pharma Services has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to Supplemental
Information listed below for further
drug information.
DATES: Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before September 13, 2021. Such
persons may also file a written request
for a hearing on the application on or
before September 13, 2021.
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 a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for a 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: In
accordance with 21 CFR 1301.34(a), this
is notice that on June 30, 2021, MP
Pharma Services, 4222 Emperor
Boulevard, Suite 320, Durham, North
Carolina 27703–9455, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
Drug
code
Controlled substance
5-Methoxy-N-NDimethyltryptamine.
E:\FR\FM\12AUN1.SGM
12AUN1
Schedule
7431
I
I
I
Federal Register / Vol. 86, No. 153 / Thursday, August 12, 2021 / Notices
The company plans to import 5Methoxy-N–N-Dimethyltryptamine as
raw material and as a formulated drug
for analytical as well as research and
development purposes. No other
activity for this drug code is authorized
for this registration.
Approval of permit 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–17186 Filed 8–11–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–880]
Curium US LLC has applied
to be registered as an importer of basic
class(es) of controlled substance(s).
Refer to Supplemental Information
listed below for further drug
information.
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before September 13, 2021. Such
persons may also file a written request
for a hearing on the application on or
before September 13, 2021.
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 a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for a 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.
lotter on DSK11XQN23PROD with NOTICES1
Jkt 253001
9180
Schedule
II
The company plans to import small
quantities of the above listed controlled
substance to be used in diagnostic
testing. No other activity for these drug
codes is authorized for this registration.
Approval of permit 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
BILLING CODE P
SUMMARY:
20:11 Aug 11, 2021
Ecgonine ........................
Drug
code
[FR Doc. 2021–17183 Filed 8–11–21; 8:45 am]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
VerDate Sep<11>2014
Controlled substance
Brian S. Besser,
Acting Assistant Administrator.
Importer of Controlled Substances
Application: Curium US, LLC
DATES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on July 15, 2021, Curium
US, LLC., 2703 Wagner Place, Maryland
Heights, Missouri 63043, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF LABOR
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request;
Telecommunications Standard
Notice of availability; request
for comments.
ACTION:
The Department of Labor
(DOL) is submitting this Occupational
Safety and Health Administration
(OSHA)-sponsored information
collection request (ICR) to the Office of
Management and Budget (OMB) for
review and approval 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 September 13, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
Comments are invited on: (1) Whether
the collection of information is
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
44407
necessary for the proper performance of
the functions of the Department,
including whether the information will
have practical utility; (2) if the
information will be processed and used
in a timely manner; (3) the accuracy of
the agency’s estimates of the burden and
cost of the collection of information,
including the validity of the
methodology and assumptions used; (4)
ways to enhance the quality, utility and
clarity of the information collection; and
(5) ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
automated collection techniques or
other forms of information technology.
FOR FURTHER INFORMATION CONTACT:
Crystal Rennie by telephone at 202–
693–0456 or by email at DOL_PRA_
PUBLIC@dol.gov.
SUPPLEMENTARY INFORMATION: Under the
paperwork requirement specified by
paragraph (c) of the Standard,
employers must certify that his or her
workers have been trained as specified
by the training provision of the
Standard. Specifically, employers must
prepare a certification record that
includes the identity of the person
trained, the signature of the employer or
the person who conducted the training,
and the date the training was
completed. The certification record
shall be prepared at the completion of
training and shall be maintained on file
for the duration of the worker’s
employment. The information collected
would be used by employers as well as
compliance officers to determine
whether workers have been trained
according to the requirements set forth
in 29 CFR 1910.268(c). For additional
substantive information about this ICR,
see the related notice published in the
Federal Register on May 4, 2021 (86 FR
23742).
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
information collection, unless the OMB
approves it and displays a currently
valid OMB Control Number. In addition,
notwithstanding any other provisions of
law, no person shall generally be subject
to penalty for failing to comply with a
collection of information that does not
display a valid OMB Control Number.
See 5 CFR 1320.5(a) and 1320.6.
DOL seeks PRA authorization for this
information collection for three (3)
years. OMB authorization for an ICR
cannot be for more than three (3) years
without renewal. The DOL notes that
information collection requirements
submitted to the OMB for existing ICRs
E:\FR\FM\12AUN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 153 (Thursday, August 12, 2021)]
[Notices]
[Pages 44406-44407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17186]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-882]
Importer of Controlled Substances Application: MP Pharma Services
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: MP Pharma Services has applied to be registered as an importer
of basic class(es) of controlled substance(s). Refer to Supplemental
Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before September 13,
2021. Such persons may also file a written request for a hearing on the
application on or before September 13, 2021.
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 a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
request for a 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: In accordance with 21 CFR 1301.34(a), this
is notice that on June 30, 2021, MP Pharma Services, 4222 Emperor
Boulevard, Suite 320, Durham, North Carolina 27703-9455, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
5-Methoxy-N-N-Dimethyltryptamine....... 7431 I
------------------------------------------------------------------------
[[Page 44407]]
The company plans to import 5-Methoxy-N-N-Dimethyltryptamine as raw
material and as a formulated drug for analytical as well as research
and development purposes. No other activity for this drug code is
authorized for this registration.
Approval of permit 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 Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-17186 Filed 8-11-21; 8:45 am]
BILLING CODE 4410-09-P
