81 FR 27472 - Importer of Controlled Substances Registration: Sharp Clinical Services, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 88 (May 6, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 88 (May 6, 2016)
| Page Range | 27472-27473 | |
| FR Document | 2016-10728 |
[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)] [Notices] [Pages 27472-27473] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10728] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration: Sharp Clinical Services, Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Sharp Clinical Services, Inc. applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Sharp Clinical Services, Inc. registration as an importer of this controlled substance. SUPPLEMENTARY INFORMATION: By notice dated January 4, 2016, and published in the Federal Register on January 11, 2016, 81 FR 1207, Sharp Clinical Services, Inc., 300 Kimberton Road, Phoenixville, Pennsylvania 19460 applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Sharp Clinical Services, Inc. to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's [[Page 27473]] maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of marihuana (7360), a basic class of controlled substance listed in schedule I. The company plans to import finished pharmaceutical products containing cannabis extracts in dosage form for clinical trial studies. This compound is listed under drug code 7360. No other activity for this drug code 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- approved finished dosage forms for commercial sale. Dated: April 29, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-10728 Filed 5-5-16; 8:45 am] BILLING CODE 4410-09-P
![27472 Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices
public and affected agencies concerning collection: The estimated annual public Controlled substance Schedule
the proposed collection of information burden associated with this collection is
are encouraged. Your comments should 228.75 hours. Amphetamine (1100) .................... II
address one or more of the following If additional information is required Lisdexamfetamine (1205) ............. II
four points: Methylphenidate (1724) ................ II
contact: Jerri Murray, Department
• Evaluate whether the proposed Clearance Officer, United States
Oxycodone (9143) ........................ II
collection of information is necessary Hydromorphone (9150) ................ II
Department of Justice, Justice Hydrocodone (9193) ..................... II
for the proper performance of the Management Division, Policy and Morphine (9300) ........................... II
functions of the agency, including Planning Staff, Two Constitution Oxymorphone (9652) ................... II
whether the information will have Square, 145 N Street NE., Room 3E– Fentanyl (9801) ............................ II
practical utility; 405B, Washington, DC 20530.
• Evaluate the accuracy of the The company plans to import the
agency’s estimate of the burden of the Dated: May 3, 2016.
listed controlled substances in finished
proposed collection of information, Jerri Murray,
dosage form for clinical trials, research,
including the validity of the Department Clearance Officer for PRA, U.S. and analytical purposes.
methodology and assumptions used; Department of Justice.
The import of the above listed basic
• Evaluate whether and if so how the [FR Doc. 2016–10683 Filed 5–5–16; 8:45 am] classes of controlled substances will be
quality, utility, and clarity of the BILLING CODE 4410–FY–P granted only for analytical testing,
information to be collected can be research, and clinical trials. This
enhanced; and authorization does not extend to the
• Minimize the burden of the DEPARTMENT OF JUSTICE import of a finished FDA approved or
collection of information on those who
Drug Enforcement Administration non-approved dosage form for
are to respond, including through the
commercial sale.
use of appropriate automated,
electronic, mechanical, or other [Docket No. DEA–392] Dated: April 29, 2016.
technological collection techniques or Louis J. Milione,
other forms of information technology, Importer of Controlled Substances Deputy Assistant Administrator.
e.g., permitting electronic submission of Registration: Myoderm [FR Doc. 2016–10727 Filed 5–5–16; 8:45 am]
responses. BILLING CODE 4410–09–P
ACTION: Notice of registration.
Overview of This Information
Collection SUMMARY: Myoderm applied to be
DEPARTMENT OF JUSTICE
1. Type of Information Collection: registered as an importer of certain basic
Extension, without change, of a classes of controlled substances. The Drug Enforcement Administration
currently approved collection. Drug Enforcement Administration
2. The Title of the Form/Collection: (DEA) grants Myoderm registration as an [Docket No. DEA–392]
FFL Out of Business Records Request importer of those controlled substances.
Importer of Controlled Substances
3. The agency form number, if any, SUPPLEMENTARY INFORMATION: By notice Registration: Sharp Clinical Services,
and the applicable component of the dated January 4, 2016, and published in
Department sponsoring the collection: Inc.
the Federal Register on January 11,
Form number: ATF F 5300.3A 2016, 81 FR 1207, Myoderm, 48 East ACTION: Notice of registration.
Component: Bureau of Alcohol, Main Street, Norristown, Pennsylvania
Tobacco, Firearms and Explosives, U.S. 19401 applied to be registered as an SUMMARY: Sharp Clinical Services, Inc.
Department of Justice. importer of certain basic classes of applied to be registered as an importer
4. Affected public who will be asked controlled substances. No comments or of a certain basic class of controlled
or required to respond, as well as a brief substance. The Drug Enforcement
objections were submitted for this
abstract: Administration (DEA) grants Sharp
notice.
Primary: Business or other for-profit. Clinical Services, Inc. registration as an
Other (if applicable): None. The DEA has considered the factors in
21 U.S.C. 823, 952(a) and 958(a) and importer of this controlled substance.
Abstract: The form is used by ATF to
notify licensees that go out of business determined that the registration of SUPPLEMENTARY INFORMATION: By notice
to send their firearms related business Myoderm to import the basic classes of dated January 4, 2016, and published in
records to the ATF, if the business controlled substances is consistent with the Federal Register on January 11,
discontinuance is absolute, or to allow the public interest and with United 2016, 81 FR 1207, Sharp Clinical
the licensee to notify ATF of the States obligations under international Services, Inc., 300 Kimberton Road,
successor who will be maintaining treaties, conventions, or protocols in Phoenixville, Pennsylvania 19460
control of their firearms related records. effect on May 1, 1971. The DEA applied to be registered as an importer
The questions are simple and a return investigated the company’s maintenance of a certain basic class of controlled
address is supplied. The format is easy of effective controls against diversion by substance. No comments or objections
for the user to list the required inspecting and testing the company’s were submitted for this notice.
information ATF needs to perform its physical security systems, verifying the The DEA has considered the factors in
company’s compliance with state and 21 U.S.C. 823, 952(a) and 958(a) and
asabaliauskas on DSK3SPTVN1PROD with NOTICES
functions in regard to the law.
5. An estimate of the total number of local laws, and reviewing the company’s determined that the registration of
respondents and the amount of time background and history. Sharp Clinical Services, Inc. to import
estimated for an average respondent to Therefore, pursuant to 21 U.S.C. the basic class of controlled substance is
respond: An estimated 2,745 952(a) and 958(a), and in accordance consistent with the public interest and
respondents will take 5 minutes to with 21 CFR 1301.34, the above-named with United States obligations under
complete the survey. company is granted registration as an international treaties, conventions, or
6. An estimate of the total public importer of the following basic classes protocols in effect on May 1, 1971. The
burden (in hours) associated with the of controlled substances: DEA investigated the company’s
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![Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices 27473
maintenance of effective controls manufacture the basic classes of grants Almac Clinical Services Incorp
against diversion by inspecting and controlled substances is consistent with (ACSI) registration as an importer of this
testing the company’s physical security the public interest and with United controlled substance.
systems, verifying the company’s States obligations under international SUPPLEMENTARY INFORMATION: By notice
compliance with state and local laws, treaties, conventions, or protocols in dated December 15, 2015, and
and reviewing the company’s effect on May 1, 1971. The DEA published in the Federal Register on
background and history. investigated the company’s maintenance December 24, 2015, 80 FR 80387, Almac
Therefore, pursuant to 21 U.S.C. of effective controls against diversion by Clinical Services Incorp (ACSI), 25 Fretz
952(a) and 958(a), and in accordance inspecting and testing the company’s Road, Souderton, Pennsylvania 18964
with 21 CFR 1301.34, the above-named physical security systems, verifying the applied to be registered as an importer
company is granted registration as an company’s compliance with state and of a certain basic class of controlled
importer of marihuana (7360), a basic local laws, and reviewing the company’s substance. No comments or objections
class of controlled substance listed in background and history. were submitted for this notice.
schedule I. Therefore, pursuant to 21 U.S.C. The DEA has considered the factors in
The company plans to import finished 823(a), and in accordance with 21 CFR 21 U.S.C. 823, 952(a) and 958(a) and
pharmaceutical products containing 1301.33, the above-named company is determined that the registration of
cannabis extracts in dosage form for granted registration as a bulk Almac Clinical Services Incorp (ACSI)
clinical trial studies. manufacturer of the following basic to import the basic class of controlled
This compound is listed under drug classes of controlled substances: substance is consistent with the public
code 7360. No other activity for this interest and with United States
drug code is authorized for this Controlled substance Schedule obligations under international treaties,
registration. Approval of permits conventions, or protocols in effect on
applications will occur only when the Codeine-N-oxide (9053) ............... I
Dihydromorphine (9145) ............... I May 1, 1971. The DEA investigated the
registrant’s business activity is Morphine-N-oxide (9307) ............. I company’s maintenance of effective
consistent with what is authorized Amphetamine (1100) .................... II controls against diversion by inspecting
under 21 U.S.C. 952(a)(2). Authorization Methylphenidate (1724) ................ II and testing the company’s physical
will not extend to the import of FDA Phenylacetone (8501) .................. II security systems, verifying the
approved or non-approved finished Codeine (9050) ............................. II company’s compliance with state and
dosage forms for commercial sale. Dihydrocodeine (9120) ................. II
local laws, and reviewing the company’s
Oxycodone (9143) ........................ II
Dated: April 29, 2016. Hydromorphone (9150) ................ II background and history.
Louis J. Milione, Hydrocodone (9193) ..................... II Therefore, pursuant to 21 U.S.C.
Deputy Assistant Administrator. Morphine (9300) ........................... II 952(a) and 958(a), and in accordance
[FR Doc. 2016–10728 Filed 5–5–16; 8:45 am] Oripavine (9330) ........................... II with 21 CFR 1301.34, the above-named
BILLING CODE 4410–09–P
Thebaine (9333) ........................... II company is granted registration as an
Opium extracts (9610) .................. II importer of Morphine (9300), a basic
Opium fluid extract (9620) ............ II class of controlled substance listed in
Opium tincture (9630) .................. II schedule II.
DEPARTMENT OF JUSTICE Opium, powdered (9639) ............. II The company plans to import the
Opium, granulated (9640) ............ II
Drug Enforcement Administration Oxymorphone (9652) ................... II
listed controlled substance in dosage
Noroxymorphone (9668) .............. II form for clinical trial only. Approval of
[Docket No. DEA–392]
Tapentadol (9780) ........................ II permit applications will occur only
Manufacturer of Controlled when the registrant’s business activity is
Substances Registration: Noramco, The company plans to manufacture consistent with what is authorized
Inc. the above-listed controlled substances under 21 U.S.C. 952(a)(2). Authorization
in bulk for distribution to its customers. will not extend to the import of FDA
ACTION: Notice of registration. Dated: April 29, 2016.
approved or non-approved finished
dosage forms for commercial sale.
SUMMARY: Noramco, Inc. applied to be Louis J. Milione,
Deputy Assistant Administrator. Dated: April 29, 2016.
registered as a manufacturer of certain
basic classes of controlled substances. [FR Doc. 2016–10731 Filed 5–5–16; 8:45 am] Louis J. Milione,
The Drug Enforcement Administration BILLING CODE 4410–09–P Deputy Assistant Administrator.
(DEA) grants Noramco, Inc. registration [FR Doc. 2016–10730 Filed 5–5–16; 8:45 am]
as a manufacturer of those controlled BILLING CODE 4410–09–P
substances. DEPARTMENT OF JUSTICE
SUPPLEMENTARY INFORMATION: By notice Drug Enforcement Administration DEPARTMENT OF JUSTICE
dated November 23, 2015, and
published in the Federal Register on [Docket No. DEA–392]
Drug Enforcement Administration
December 3, 2015, 80 FR 75692,
Noramco, Inc., 500 Swedes Landing Importer of Controlled Substances [Docket No. DEA–392]
Road, Wilmington, Delaware 19801– Registration: Almac Clinical Services
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Incorp (ACSI) Importer of Controlled Substances
4417 applied to be registered as a
Registration: Noramco, Inc.
manufacturer of certain basic classes of ACTION: Notice of registration.
controlled substances. No comments or ACTION: Notice of registration.
objections were submitted for this SUMMARY: Almac Clinical Services
notice. Incorp (ACSI) applied to be registered as SUMMARY: Noramco, Inc. applied to be
The DEA has considered the factors in an importer of a certain basic class of registered as an importer of certain basic
21 U.S.C. 823(a) and determined that controlled substance. The Drug classes of controlled substances. The
the registration of Noramco, Inc. to Enforcement Administration (DEA) Drug Enforcement Administration
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Document Created: 2016-05-06 00:29:39
Document Modified: 2016-05-06 00:29:39
| 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 registration. | |
| FR Citation | 81 FR 27472 |
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