Importer of Controlled Substances Application: Clinical Supplies Management Holdings, Inc., 16901-16902 [2018-07978]
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Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
5:15 p.m., May 1, 2018. All written
submissions must conform with the
provisions of section 201.8 of the
Commission’s Rules of Practice and
Procedure (19 CFR 201.8). Section 201.8
and the Commission’s Handbook on
Filing Procedures require that interested
parties file documents electronically on
or before the filing deadline and submit
eight (8) true paper copies by 12:00 p.m.
eastern time on the next business day.
In the event that confidential treatment
of a document is requested, interested
parties must file, at the same time as the
eight paper copies, at least four (4)
additional true paper copies in which
the confidential information must be
deleted (see the following paragraph for
further information regarding
confidential business information).
Persons with questions regarding
electronic filing should contact the
Office of the Secretary, Docket Services
Division (202–205–1802).
Confidential Business Information:
Any submissions that contain
confidential business information must
also conform with the requirements of
section 201.6 of the Commission’s Rules
of Practice and Procedure (19 CFR
201.6). Section 201.6 of the rules
requires that the cover of the document
and the individual pages be clearly
marked as to whether they are the
‘‘confidential’’ or ‘‘non-confidential’’
version, and that the confidential
business information is clearly
identified by means of brackets. All
written submissions, except for those
containing CBI, will be made available
for inspection by interested parties.
The Commission may include some or
all of the confidential business
information submitted in the course of
this investigation in the report it sends
to the USTR. Additionally, all
information, including CBI, submitted
in this investigation may be disclosed to
and used: (i) By the Commission, its
employees and Offices, and contract
personnel (a) for developing or
maintaining the records of this or a
related proceeding, or (b) in internal
investigations, audits, reviews, and
evaluations relating to the programs,
personnel, and operations of the
Commission including under 5 U.S.C.
Appendix 3; or (ii) by U.S. government
employees and contract personnel for
cybersecurity purposes. The
Commission will not otherwise disclose
any confidential business information in
a manner that would reveal the
operations of the firm supplying the
information.
Summaries Of Written Submissions:
The Commission intends to publish
summaries of the positions of interested
persons in an appendix to its report.
Persons wishing to have a summary of
their position included in the appendix
should include a summary with their
written submission. The summary may
not exceed 500 words, should be in
MSWord format or a format that can be
easily converted to MSWord, and
should not include any CBI. The
summary will be included in the report
as provided if it meets these
requirements and is germane to the
subject matter of the investigation. In
the appendix, the Commission will
identify the name of the organization
furnishing the summary and will
include a link to the Commission’s
Electronic Document Information
System (EDIS) where the full written
submission can be found.
By order of the Commission.
Issued: April 12, 2018.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2018–08015 Filed 4–16–18; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Clinical Supplies
Management Holdings, Inc.
ACTION:
Notice of application.
Registered bulk importers of the
affected basic classes, and applicants
therefore, may file written comments on
or objections to the issuance of the
DATES:
proposed registration on or before May
17, 2018. Such persons may also file a
written request for a hearing on the
application on or before May 17, 2018.
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 request 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.
Comments and requests for hearings on
applications to import narcotic raw
material are not appropriate. 72 FR
3417, (January 25, 2007)
ADDRESSES:
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 March
14, 2018, Clinical Supplies Management
Holdings, Inc., 342 42nd Street South,
Fargo, ND 58103 applied to be
registered as an importer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
daltland on DSKBBV9HB2PROD with NOTICES
Marihuana ........................................................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
The company plans to import
analytical reference standards for
distribution to its customers for research
and analytical purposes. Placement of
these drug codes onto the company’s
registration does not translate into
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21:16 Apr 16, 2018
Jkt 244001
automatic approval of subsequent
permit applications to import controlled
substances. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
7360
7370
Schedule
I
I
under 21 U.S.C. 952(a)(2). Authorization
will not extend to the import of FDA
approved or non-approved finished
dosage forms for commercial sale.
E:\FR\FM\17APN1.SGM
17APN1
16902
Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
Dated: April 10, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–07978 Filed 4–16–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1117–0015]
Agency Information Collection
Activities; Proposed eCollection,
eComments Requested; Extension
Without Change of a Previously
Approved Collection; Application for
Registration, Application for
Registration Renewal; DEA Forms 363,
363a
Drug Enforcement
Administration, Department of Justice.
ACTION: 30-Day Notice.
AGENCY:
The Department of Justice
(DOJ), Drug Enforcement
Administration (DEA), will be
submitting the following information
collection request to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995.
The proposed information collection
was previously published in the Federal
Register, on February 21, 2018, allowing
for a 60 day comment period.
DATES: Comments are encouraged and
will be accepted for 30 days until May
17, 2018.
FOR FURTHER INFORMATION CONTACT: If
you have comments on the estimated
public burden or associated response
time, suggestions, or need a copy of the
proposed information collection
instrument with instructions or
SUMMARY:
additional information, please contact
Michael J. Lewis, Diversion Control
Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812 or
sent to OIRA_submission@omb.eop.gov.
SUPPLEMENTARY INFORMATION: Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
address one or more of the following
four points:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
—Evaluate the accuracy of the agency’s
estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
—Evaluate whether and if so how the
quality, utility, and clarity of the
information proposed to be collected
can be enhanced; and
—Minimize the burden of the collection
of information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other forms of
information technology, e.g.,
permitting electronic submission of
responses.
Overview of This Information
Collection
1. Type of Information Collection:
Extension of a currently approved
collection.
Number of
annual
respondents
DEA
DEA
DEA
DEA
Form
Form
Form
Form
2. Title of the Form/Collection:
Application for Registration,
Application for Registration Renewal.
3. The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
The form numbers are DEA Forms 363,
363a. The applicable component within
the Department of Justice is the Drug
Enforcement Administration, Diversion
Control Division.
4. Affected public who will be asked
or required to respond, as well as a brief
abstract:
Affected public: Business or other forprofit.
Affected public (Other): Not-for-profit
institutions, Federal, State, local, and
tribal governments.
Abstract: The Controlled Substances
Act requires practitioners who dispense
narcotic drugs to individuals for
maintenance or detoxification treatment
to register annually with DEA.1 21
U.S.C. 822, 823; 21 CFR 1301.11 and
1301.13. Registration is a necessary
control measure and helps to prevent
diversion by ensuring the closed system
of distribution of controlled substances
can be monitored by DEA and the
businesses and individuals handling
controlled substances are qualified to do
so and are accountable.
5. An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: DEA Form 363 is submitted on
an as needed basis by persons seeking
to become registered; DEA Form 363a is
submitted on an annual basis thereafter
to renew existing registrations. The
below table presents information
regarding the number of respondents,
responses and associated burden hours.
Average time per response
hours
hours
hours
hours
Total annual
hours
363 (paper) .................................................
363 (online) ................................................
363a (paper) ...............................................
363a (online) ..............................................
15
223
51
1,437
0.30
0.13
0.22
0.10
(18 minutes) ...............................................
(8 minutes) .................................................
(13 minutes) ...............................................
(6 minutes) .................................................
5
30
11
144
Total .......................................................................
1,726
.......................................................................................
189
daltland on DSKBBV9HB2PROD with NOTICES
Figures are rounded.
6. An estimate of the total public
burden (in hours) associated with the
proposed collection: The DEA estimates
that this collection takes 189 annual
burden hours.
If additional information is required
please contact: Melody Braswell,
Department Clearance Officer, United
States Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE, Suite 3E.405B,
Washington, DC 20530.
Dated: April 11, 2018.
Melody Braswell,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2018–07904 Filed 4–16–18; 8:45 am]
BILLING CODE 4410–09–P
1 This registration requirement is waived for
certain practitioners under specified circumstances.
See 21 U.S.C. 823(g)(2).
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17APN1
]]>Agencies
[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Notices]
[Pages 16901-16902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07978]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Clinical Supplies
Management Holdings, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk importers 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 May 17, 2018. Such
persons may also file a written request for a hearing on the
application on or before May 17, 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
request 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. Comments and requests for hearings on
applications to import narcotic raw material are not appropriate. 72 FR
3417, (January 25, 2007)
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 March
14, 2018, Clinical Supplies Management Holdings, Inc., 342 42nd Street
South, Fargo, ND 58103 applied to be registered as an importer of the
following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana.......................... 7360 I
Tetrahydrocannabinols.............. 7370 I
------------------------------------------------------------------------
The company plans to import analytical reference standards for
distribution to its customers for research and analytical purposes.
Placement of these drug codes onto the company's registration does not
translate into automatic approval of subsequent permit applications to
import controlled substances. 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 FDA approved or non-approved finished dosage
forms for commercial sale.
[[Page 16902]]
Dated: April 10, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-07978 Filed 4-16-18; 8:45 am]
BILLING CODE 4410-09-P
