83 FR 16901 - Importer of Controlled Substances Application: Clinical Supplies Management Holdings, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 74 (April 17, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 74 (April 17, 2018)
| Page Range | 16901-16902 | |
| FR Document | 2018-07978 |
[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)] [Notices] [Pages 16901-16902] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices 16901
5:15 p.m., May 1, 2018. All written Commission including under 5 U.S.C. proposed registration on or before May
submissions must conform with the Appendix 3; or (ii) by U.S. government 17, 2018. Such persons may also file a
provisions of section 201.8 of the employees and contract personnel for written request for a hearing on the
Commission’s Rules of Practice and cybersecurity purposes. The application on or before May 17, 2018.
Procedure (19 CFR 201.8). Section 201.8 Commission will not otherwise disclose
and the Commission’s Handbook on any confidential business information in ADDRESSES: Written comments should
Filing Procedures require that interested a manner that would reveal the be sent to: Drug Enforcement
parties file documents electronically on operations of the firm supplying the Administration, Attention: DEA Federal
or before the filing deadline and submit information. Register Representative/DRW, 8701
eight (8) true paper copies by 12:00 p.m. Summaries Of Written Submissions: Morrissette Drive, Springfield, Virginia
eastern time on the next business day. The Commission intends to publish 22152. All requests for hearing must be
In the event that confidential treatment summaries of the positions of interested sent to: Drug Enforcement
of a document is requested, interested persons in an appendix to its report. Administration, Attn: Administrator,
parties must file, at the same time as the Persons wishing to have a summary of 8701 Morrissette Drive, Springfield,
eight paper copies, at least four (4) their position included in the appendix Virginia 22152. All request for hearing
additional true paper copies in which should include a summary with their should also be sent to: (1) Drug
the confidential information must be written submission. The summary may Enforcement Administration, Attn:
deleted (see the following paragraph for not exceed 500 words, should be in Hearing Clerk/LJ, 8701 Morrissette
further information regarding MSWord format or a format that can be Drive, Springfield, Virginia 22152; and
confidential business information). easily converted to MSWord, and (2) Drug Enforcement Administration,
Persons with questions regarding should not include any CBI. The Attn: DEA Federal Register
electronic filing should contact the summary will be included in the report Representative/DRW, 8701 Morrissette
Office of the Secretary, Docket Services as provided if it meets these Drive, Springfield, Virginia 22152.
Division (202–205–1802). requirements and is germane to the Comments and requests for hearings on
Confidential Business Information: subject matter of the investigation. In applications to import narcotic raw
Any submissions that contain the appendix, the Commission will material are not appropriate. 72 FR
confidential business information must identify the name of the organization 3417, (January 25, 2007)
also conform with the requirements of furnishing the summary and will SUPPLEMENTARY INFORMATION: The
section 201.6 of the Commission’s Rules include a link to the Commission’s Attorney General has delegated his
of Practice and Procedure (19 CFR Electronic Document Information authority under the Controlled
201.6). Section 201.6 of the rules System (EDIS) where the full written Substances Act to the Administrator of
requires that the cover of the document submission can be found. the Drug Enforcement Administration
and the individual pages be clearly
By order of the Commission. (DEA), 28 CFR 0.100(b). Authority to
marked as to whether they are the
Issued: April 12, 2018. exercise all necessary functions with
‘‘confidential’’ or ‘‘non-confidential’’
Lisa Barton, respect to the promulgation and
version, and that the confidential
Secretary to the Commission.
implementation of 21 CFR part 1301,
business information is clearly
incident to the registration of
identified by means of brackets. All [FR Doc. 2018–08015 Filed 4–16–18; 8:45 am]
manufacturers, distributors, dispensers,
written submissions, except for those BILLING CODE 7020–02–P
importers, and exporters of controlled
containing CBI, will be made available
substances (other than final orders in
for inspection by interested parties.
The Commission may include some or connection with suspension, denial, or
DEPARTMENT OF JUSTICE revocation of registration) has been
all of the confidential business
information submitted in the course of redelegated to the Assistant
Drug Enforcement Administration
this investigation in the report it sends Administrator of the DEA Diversion
to the USTR. Additionally, all [Docket No. DEA–392] Control Division (‘‘Assistant
information, including CBI, submitted Administrator’’) pursuant to section 7 of
Importer of Controlled Substances 28 CFR part 0, appendix to subpart R.
in this investigation may be disclosed to Application: Clinical Supplies
and used: (i) By the Commission, its Management Holdings, Inc. In accordance with 21 CFR
employees and Offices, and contract 1301.34(a), this is notice that on March
personnel (a) for developing or ACTION: Notice of application. 14, 2018, Clinical Supplies Management
maintaining the records of this or a Holdings, Inc., 342 42nd Street South,
related proceeding, or (b) in internal DATES: Registered bulk importers of the Fargo, ND 58103 applied to be
investigations, audits, reviews, and affected basic classes, and applicants registered as an importer of the
evaluations relating to the programs, therefore, may file written comments on following basic classes of controlled
personnel, and operations of the or objections to the issuance of the substances:
Controlled substance Drug code Schedule
Marihuana ........................................................................................................................................................................ 7360 I
Tetrahydrocannabinols .................................................................................................................................................... 7370 I
daltland on DSKBBV9HB2PROD with NOTICES
The company plans to import automatic approval of subsequent under 21 U.S.C. 952(a)(2). Authorization
analytical reference standards for permit applications to import controlled will not extend to the import of FDA
distribution to its customers for research substances. Approval of permit approved or non-approved finished
and analytical purposes. Placement of applications will occur only when the dosage forms for commercial sale.
these drug codes onto the company’s registrant’s business activity is
registration does not translate into consistent with what is authorized
VerDate Sep<11>2014 21:16 Apr 16, 2018 Jkt 244001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\17APN1.SGM 17APN1](https://thefederalregister.org/doc/83_FR_16975/page/1.svg)
![16902 Federal Register / Vol. 83, No. 74 / Tuesday, April 17, 2018 / Notices
Dated: April 10, 2018. additional information, please contact 2. Title of the Form/Collection:
Susan A. Gibson, Michael J. Lewis, Diversion Control Application for Registration,
Deputy Assistant Administrator. Division, Drug Enforcement Application for Registration Renewal.
[FR Doc. 2018–07978 Filed 4–16–18; 8:45 am] Administration; Mailing Address: 8701 3. The agency form number, if any,
BILLING CODE 4410–09–P
Morrissette Drive, Springfield, Virginia and the applicable component of the
22152; Telephone: (202) 598–6812 or Department sponsoring the collection:
sent to OIRA_submission@omb.eop.gov. The form numbers are DEA Forms 363,
DEPARTMENT OF JUSTICE SUPPLEMENTARY INFORMATION: Written 363a. The applicable component within
comments and suggestions from the the Department of Justice is the Drug
[OMB Number 1117–0015]
public and affected agencies concerning Enforcement Administration, Diversion
Agency Information Collection the proposed collection of information Control Division.
Activities; Proposed eCollection, are encouraged. Your comments should 4. Affected public who will be asked
eComments Requested; Extension address one or more of the following or required to respond, as well as a brief
Without Change of a Previously four points: abstract:
Approved Collection; Application for Affected public: Business or other for-
—Evaluate whether the proposed profit.
Registration, Application for collection of information is necessary
Registration Renewal; DEA Forms 363, Affected public (Other): Not-for-profit
for the proper performance of the institutions, Federal, State, local, and
363a functions of the agency, including tribal governments.
AGENCY: Drug Enforcement whether the information will have Abstract: The Controlled Substances
Administration, Department of Justice. practical utility; Act requires practitioners who dispense
ACTION: 30-Day Notice. —Evaluate the accuracy of the agency’s narcotic drugs to individuals for
estimate of the burden of the maintenance or detoxification treatment
SUMMARY: The Department of Justice proposed collection of information, to register annually with DEA.1 21
(DOJ), Drug Enforcement including the validity of the U.S.C. 822, 823; 21 CFR 1301.11 and
Administration (DEA), will be methodology and assumptions used; 1301.13. Registration is a necessary
submitting the following information —Evaluate whether and if so how the control measure and helps to prevent
collection request to the Office of quality, utility, and clarity of the diversion by ensuring the closed system
Management and Budget (OMB) for information proposed to be collected of distribution of controlled substances
review and approval in accordance with can be enhanced; and can be monitored by DEA and the
the Paperwork Reduction Act of 1995. —Minimize the burden of the collection businesses and individuals handling
The proposed information collection of information on those who are to controlled substances are qualified to do
was previously published in the Federal respond, including through the use of so and are accountable.
Register, on February 21, 2018, allowing appropriate automated, electronic, 5. An estimate of the total number of
for a 60 day comment period. mechanical, or other forms of respondents and the amount of time
DATES: Comments are encouraged and information technology, e.g., estimated for an average respondent to
will be accepted for 30 days until May permitting electronic submission of respond: DEA Form 363 is submitted on
17, 2018. responses. an as needed basis by persons seeking
FOR FURTHER INFORMATION CONTACT: If to become registered; DEA Form 363a is
Overview of This Information
you have comments on the estimated submitted on an annual basis thereafter
Collection
public burden or associated response to renew existing registrations. The
time, suggestions, or need a copy of the 1. Type of Information Collection: below table presents information
proposed information collection Extension of a currently approved regarding the number of respondents,
instrument with instructions or collection. responses and associated burden hours.
Number of Total annual
annual Average time per response hours
respondents
DEA Form 363 (paper) ................................................. 15 0.30 hours (18 minutes) ............................................... 5
DEA Form 363 (online) ................................................ 223 0.13 hours (8 minutes) ................................................. 30
DEA Form 363a (paper) ............................................... 51 0.22 hours (13 minutes) ............................................... 11
DEA Form 363a (online) .............................................. 1,437 0.10 hours (6 minutes) ................................................. 144
Total ....................................................................... 1,726 ....................................................................................... 189
Figures are rounded.
6. An estimate of the total public Department Clearance Officer, United Dated: April 11, 2018.
burden (in hours) associated with the States Department of Justice, Justice Melody Braswell,
proposed collection: The DEA estimates Management Division, Policy and Department Clearance Officer for PRA, U.S.
that this collection takes 189 annual Planning Staff, Two Constitution Department of Justice.
daltland on DSKBBV9HB2PROD with NOTICES
burden hours. Square, 145 N Street NE, Suite 3E.405B, [FR Doc. 2018–07904 Filed 4–16–18; 8:45 am]
If additional information is required Washington, DC 20530. BILLING CODE 4410–09–P
please contact: Melody Braswell,
1 This registration requirement is waived for
certain practitioners under specified circumstances.
See 21 U.S.C. 823(g)(2).
VerDate Sep<11>2014 19:20 Apr 16, 2018 Jkt 244001 PO 00000 Frm 00080 Fmt 4703 Sfmt 9990 E:\FR\FM\17APN1.SGM 17APN1](https://thefederalregister.org/doc/83_FR_16975/page/2.svg)
Document Created: 2018-04-17 02:52:55
Document Modified: 2018-04-17 02:52:55
| 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 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. | |
| FR Citation | 83 FR 16901 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR