Importer of Controlled Substances Application: Almac Clinical Services Incorp (ACSI), 15634 [2018-07441]
Download as PDF
<![CDATA[
15634
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:
amozie on DSK30RV082PROD with NOTICES
Drug
code
VerDate Sep<11>2014
17:17 Apr 10, 2018
Jkt 244001
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
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\11APN1.SGM
11APN1
]]>Agencies
[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Page 15634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07441]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Almac Clinical
Services Incorp (ACSI)
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: 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.
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
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:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Oxycodone............................. 9143 II
Hydromorphone......................... 9150 II
Morphine.............................. 9300 II
Tapentadol............................ 9780 II
Fentanyl.............................. 9801 II
------------------------------------------------------------------------
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 non-
approved 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
