Bulk Manufacturer of Controlled Substances Registration, 15633-15634 [2018-07455]
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Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
authority is contingent on Respondent
being a practitioner with a valid DEA
registration, see 21 U.S.C. 823(g)(2)(A);
21 CFR 1301.28(a), I will revoke his
DATA-Waiver authority as well.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as 28 CFR 0.100(b), I order that DEA
Certificate of Registration No.
BZ5641419 and DATA-Waiver
Identification Number XZ5641419,
issued to Witold Marek Zajewski, M.D.,
be, and they hereby are, revoked. I
further order that any pending
application of Witold Marek Zajewski to
renew or modify the above registration,
or any pending application of Witold
Marek Zajewski for any other
registration in the State of Illinois, be,
and it hereby is, denied. This Order is
effective immediately.4
Dated: April 4, 2018.
Robert W. Patterson,
Acting Administrator.
Registrants listed below have
applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as importers of
various classes of schedule I or II
controlled substances.
[FR Doc. 2018–07454 Filed 4–10–18; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4410–09–P
The companies listed below applied
to be registered as importers of various
basic classes of controlled substances.
Information on previously published
notices is listed in the table below. No
comments or objections were submitted
and no requests for hearing were
submitted for these notices.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Registration
ACTION:
Notice of registration.
Company
FR docket
Sharp (Bethlehem), LLC .....................................................
Catalent Pharma Solutions, LLC ........................................
Janssen Pharmaceuticals, Inc ............................................
Mylan Pharmaceuticals, Inc ...............................................
Meridian Medical Technologies, Inc ...................................
Noramco, Inc ......................................................................
Johnson Matthey, Inc .........................................................
Mylan Technologies, Inc .....................................................
Mylan Pharmaceuticals, Inc ...............................................
The Drug Enforcement
Administration (DEA) has considered
the factors in 21 U.S.C. 823, 952(a) and
958(a) and determined that the
registration of the listed registrants to
import the applicable basic classes of
schedule I or II controlled substances 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 each company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
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with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule I or II controlled substances to
the above listed companies.
Dated: April 4, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
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Registrants listed below have
applied for and been granted
registration by the Drug Enforcement
Administration (DEA) as bulk
manufacturers of various classes of
schedule I and II controlled substances.
SUMMARY:
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
The companies listed below applied
to be registered as bulk manufacturers of
various basic classes of controlled
substances. Information on previously
published notices is listed in the table
below. No comments or objections were
submitted for these notices.
Bulk Manufacturer of Controlled
Substances Registration
ACTION:
Notice of registration.
FR docket
4 For the same reasons which led the IDFPR to
revoke Respondent’s controlled substance license, I
January 4, 2018.
January 16, 2018.
January 16, 2018.
February 9, 2018.
February 9, 2018.
February 9, 2018.
February 9, 2018.
February 9, 2018.
February 23, 2018.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2018–07444 Filed 4–10–18; 8:45 am]
Nanosyn, Inc .......................................................................
Janssen Pharmaceutical, Inc .............................................
Cambrex High Point, Inc ....................................................
AMPAC Fine Chemicals LLC .............................................
Organix, Inc ........................................................................
Johnson Matthey Inc ..........................................................
Chemtos, LLC .....................................................................
Alcami Wisconsin Corporation ...........................................
17:17 Apr 10, 2018
Published
539 ..........................................................................
2215 ........................................................................
2214 ........................................................................
5809 ........................................................................
5810 ........................................................................
5810 ........................................................................
5811 ........................................................................
5811 ........................................................................
8107 ........................................................................
Company
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SUMMARY:
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56993 ......................................................................
58027 ......................................................................
61795 ......................................................................
61795 ......................................................................
150 ..........................................................................
2215 ........................................................................
2671 ........................................................................
2675 ........................................................................
conclude that the public interest necessitates that
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December 1, 2017.
December 8, 2017.
December 29, 2017.
December 29, 2017.
January 2, 2018.
January 16, 2018.
January 18, 2018.
January 18, 2018.
this Order be effective immediately. 21 CFR
1316.67.
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Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of these registrants to
manufacture the applicable basic classes
of controlled substances 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 each of the company’s
maintenance of effective controls
against diversion by inspecting and
testing each company’s physical
security systems, verifying each
company’s compliance with state and
local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed companies.
Dated: April 3, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–07455 Filed 4–10–18; 8:45 am]
BILLING CODE 4410–09–P
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
7, 2018, Almac Clinical Services Incorp
(ACSI) 25 Fretz Road, Souderton, PA
18964 applied to be registered as an
importer of the following basic classes
of controlled substances:
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Controlled substance
[Docket No. DEA–392]
Oxycodone ...............
Hydromorphone ........
Morphine ...................
Tapentadol ................
Fentanyl ....................
Importer of Controlled Substances
Application: Almac Clinical Services
Incorp (ACSI)
ACTION:
9143
9150
9300
9780
9801
Schedule
II
II
II
II
II
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 May 11, 2018. Such persons
may also file a written request for a
hearing on the application on or before
May 11, 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.
DATES:
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The company plans to import the
listed controlled substances in dosage
form to conduct clinical trials.
Approval of permit applications will
occur only when the registrant’s
business activity is consistent with what
is authorized under to 21 U.S.C. 952
(a)(2).
Authorization will not extend to the
import of FDA approved or nonapproved finished dosage forms for
commercial sale.
Dated: April 3, 2018
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018–07441 Filed 4–10–18; 8:45 am]
BILLING CODE 4410–09–P
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DEPARTMENT OF JUSTICE
[OMB Number 1121–0111]
Agency Information Collection
Activities: Proposed eCollection
eComments Requested; Revision of a
Currently Approved Collection;
Comments Requested: National Crime
Victimization Survey (NCVS)
Bureau of Justice Statistics,
Department of Justice.
ACTION: 30-day notice.
AGENCY:
The Department of Justice
(DOJ), Office of Justice Programs,
Bureau of Justice Statistics, will be
submitting a request to the Office of
Management and Budget (OMB) for
review and approval of a revision to the
National Crime Victimization Survey
information collection in accordance
with the Paperwork Reduction Act of
1995. The proposed information
collection, which is currently under
OMB review, was previously published
in the Federal Register on Monday,
March 19, 2018, allowing a 30-day
comment period. The requested revision
impacts the minimum age at which
respondents will be administered
questions on their sexual orientation
and gender identity, raising the
minimum age from 16 to 18. This
revision, which will be implemented
within 6 months of OMB approval, will
not impact the burden hours associated
with the previous 30-day request.
DATES: Comments are encouraged and
will be accepted for 30 days until May
11, 2018.
FOR FURTHER INFORMATION CONTACT:
If you have additional comments
especially on the estimated public
burden or associated response time,
suggestions, or need a copy of the
proposed information collection
instrument with instructions or
additional information, please contact
Jennifer Truman, Statistician, Bureau of
Justice Statistics, 810 Seventh Street
NW, Washington, DC 20531 (email:
Jennifer.Truman@ojp.usdoj.gov;
telephone: 202–514–5083).
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 the impact of the change on
the functioning of the Bureau of
Justice Statistics;
—Evaluate the accuracy of the agency’s
estimate of the burden of the
proposed collection of information,
SUMMARY:
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[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15633-15634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07455]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Registration
ACTION: Notice of registration.
-----------------------------------------------------------------------
SUMMARY: Registrants listed below have applied for and been granted
registration by the Drug Enforcement Administration (DEA) as bulk
manufacturers of various classes of schedule I and II controlled
substances.
SUPPLEMENTARY INFORMATION:
The companies listed below applied to be registered as bulk
manufacturers of various basic classes of controlled substances.
Information on previously published notices is listed in the table
below. No comments or objections were submitted for these notices.
----------------------------------------------------------------------------------------------------------------
Company FR docket Published
----------------------------------------------------------------------------------------------------------------
Nanosyn, Inc.......................... 82 FR 56993................... December 1, 2017.
Janssen Pharmaceutical, Inc........... 82 FR 58027................... December 8, 2017.
Cambrex High Point, Inc............... 82 FR 61795................... December 29, 2017.
AMPAC Fine Chemicals LLC.............. 82 FR 61795................... December 29, 2017.
Organix, Inc.......................... 83 FR 150..................... January 2, 2018.
Johnson Matthey Inc................... 83 FR 2215.................... January 16, 2018.
Chemtos, LLC.......................... 83 FR 2671.................... January 18, 2018.
Alcami Wisconsin Corporation.......... 83 FR 2675.................... January 18, 2018.
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[[Page 15634]]
The DEA has considered the factors in 21 U.S.C. 823(a) and
determined that the registration of these registrants to manufacture
the applicable basic classes of controlled substances 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 each of the company's maintenance of
effective controls against diversion by inspecting and testing each
company's physical security systems, verifying each company's
compliance with state and local laws, and reviewing each company's
background and history.
Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21
CFR 1301.33, the DEA has granted a registration as a bulk manufacturer
to the above listed companies.
Dated: April 3, 2018.
Susan A. Gibson,
Deputy Assistant Administrator.
[FR Doc. 2018-07455 Filed 4-10-18; 8:45 am]
BILLING CODE 4410-09-P
