81 FR 54602 - Importer of Controlled Substances Application: ALMAC Clinical Services Incorp (ACSI)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 158 (August 16, 2016)

Page Range		54602-54602
FR Document		2016-19439

Federal Register, Volume 81 Issue 158 (Tuesday, August 16, 2016)

[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Page 54602]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19439]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: ALMAC Clinical 
Services Incorp (ACSI)

ACTION: Notice of application.

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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 in accordance with 21 CFR 
1301.34(a) on or before September 15, 2016. Such persons may also file 
a written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before September 15, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
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 
requests 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/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
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 Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy 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 June 
29, 2016, ALMAC Clinical Services Incorp (ACSI), 25 Fretz Road, 
Souderton, Pennsylvania 18964 applied to be registered as an importer 
of the following basic classes of controlled substances:

------------------------------------------------------------------------
                  Controlled substance                       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 for clinical trial only. 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.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-19439 Filed 8-15-16; 8:45 am]
BILLING CODE 4410-09-P

54602 Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices

development and preparation of In accordance with 21 CFR Attn: DEA Federal Register
stability batches. 1301.34(a), this is notice that on June Representative/ODW, 8701 Morrissette
29, 2016, ALMAC Clinical Services Drive, Springfield, Virginia 22152.
Louis J. Milione,
Incorp (ACSI), 25 Fretz Road, SUPPLEMENTARY INFORMATION: The
Deputy Assistant Administrator.
Souderton, Pennsylvania 18964 applied Attorney General has delegated her
[FR Doc. 2016–19434 Filed 8–15–16; 8:45 am] to be registered as an importer of the authority under the Controlled
BILLING CODE 4410–09–P following basic classes of controlled Substances Act to the Administrator of
substances: the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
DEPARTMENT OF JUSTICE Controlled substance Schedule exercise all necessary functions with
Drug Enforcement Administration respect to the promulgation and
Oxycodone (9143) ................ II
implementation of 21 CFR part 1301,
[Docket No. DEA–392] Hydromorphone (9150) ........ II
Morphine (9300) ................... II incident to the registration of
Tapentadol (9780) ................ II manufacturers, distributors, dispensers,
Importer of Controlled Substances
Fentanyl (9801) .................... II importers, and exporters of controlled
Application: ALMAC Clinical Services
substances (other than final orders in
Incorp (ACSI)
The company plans to import the connection with suspension, denial, or
ACTION: Notice of application. listed controlled substances in dosage revocation of registration) has been
form for clinical trial only. Approval of redelegated to the Deputy Assistant
DATES: Registered bulk manufacturers of permit applications will occur only Administrator of the DEA Office of
the affected basic classes, and when the registrant’s business activity is Diversion Control (‘‘Deputy Assistant
applicants therefore, may file written consistent with what is authorized Administrator’’) pursuant to section 7 of
comments on or objections to the under 21 U.S.C. 952(a)(2). Authorization 28 CFR part 0, appendix to subpart R.
issuance of the proposed registration in will not extend to the import of FDA In accordance with 21 CFR
accordance with 21 CFR 1301.34(a) on approved or non-approved finished 1301.34(a), this is notice that on May 18,
or before September 15, 2016. Such dosage forms for commercial sale. 2016, Cody Laboratories, Inc., 601
persons may also file a written request Yellowstone Avenue, Barry Baldwin,
Louis J. Milione,
for a hearing on the application Controlled Substances Manager, Cody,
pursuant to 21 CFR 1301.43 on or before Deputy Assistant Administrator. Wyoming 82414–9321 applied to be
September 15, 2016. [FR Doc. 2016–19439 Filed 8–15–16; 8:45 am] registered as an importer of the
ADDRESSES: Written comments should BILLING CODE 4410–09–P following basic classes of controlled
be sent to: Drug Enforcement substances:
Administration, Attention: DEA Federal
Register Representative/ODW, 8701 DEPARTMENT OF JUSTICE Controlled substance Schedule
Morrissette Drive, Springfield, Virginia Drug Enforcement Administration Phenylacetone (8501) .......... II
22152. All requests for hearing must be Poppy Straw Concentrate
sent to: Drug Enforcement [Docket No. DEA–392]
(9670) ................................ II
Administration, Attn: Administrator, Tapentadol (9780) ................ II
8701 Morrissette Drive, Springfield, Importer of Controlled Substances
Virginia 22152. All requests for hearing Application: Cody Laboratories, Inc. The company plans to import narcotic
should also be sent to: (1) Drug ACTION: Notice of application. raw materials to manufacture bulk
Enforcement Administration, Attn: controlled substances for distribution to
Hearing Clerk/LJ, 8701 Morrissette SUMMARY: Registered bulk its customers. The company plans to
Drive, Springfield, Virginia 22152; and manufacturers of the affected basic import an intermediate form of
(2) Drug Enforcement Administration, classes, and applicants therefore, may tapentadol (9780), to bulk manufacture
Attn: DEA Federal Register file written comments on or objections tapentadol for distribution to its
Representative/ODW, 8701 Morrissette to the issuance of the proposed customers.
Drive, Springfield, Virginia 22152. registration in accordance with 21 CFR
Louis J. Milione,
SUPPLEMENTARY INFORMATION: The 1301.34(a) on or before September 15,
Deputy Assistant Administrator.
Attorney General has delegated her 2016. Such persons may also file a
written request for a hearing on the [FR Doc. 2016–19435 Filed 8–15–16; 8:45 am]
authority under the Controlled
Substances Act to the Administrator of application pursuant to 21 CFR 1301.43 BILLING CODE 4410–09–P

the Drug Enforcement Administration on or before September 15, 2016.
(DEA), 28 CFR 0.100(b). Authority to ADDRESSES: Written comments should
DEPARTMENT OF JUSTICE
exercise all necessary functions with be sent to: Drug Enforcement
respect to the promulgation and Administration, Attention: DEA Federal Drug Enforcement Administration
implementation of 21 CFR part 1301, Register Representative/ODW, 8701
incident to the registration of Morrissette Drive, Springfield, Virginia [Docket No. DEA–392]
manufacturers, distributors, dispensers, 22152. All requests for hearing must be
Importer of Controlled Substances
importers, and exporters of controlled sent to: Drug Enforcement
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Application: Actavis Laboratories FL.,
substances (other than final orders in Administration, Attn: Administrator,
Inc.
connection with suspension, denial, or 8701 Morrissette Drive, Springfield,
revocation of registration) has been Virginia 22152. All requests for hearing ACTION: Notice of application.
redelegated to the Deputy Assistant should also be sent to: (1) Drug
Administrator of the DEA Office of Enforcement Administration, Attn: DATES: Registered bulk manufacturers of
Diversion Control (‘‘Deputy Assistant Hearing Clerk/LJ, 8701 Morrissette the affected basic classes, and
Administrator’’) pursuant to section 7 of Drive, Springfield, Virginia 22152; and applicants therefore, may file written
28 CFR part 0, appendix to subpart R. (2) Drug Enforcement Administration, comments on or objections to the

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Document Created: 2016-08-16 03:20:10
Document Modified: 2016-08-16 03:20:10

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 manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016.
FR Citation		81 FR 54602

81 FR 54602 - Importer of Controlled Substances Application: ALMAC Clinical Services Incorp (ACSI)

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 81, Issue 158 (August 16, 2016)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration