Notice of Application - 2012
Federal Register, Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Page 24985]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10053]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application; Almac
Clinical Services, Inc., (ACSI)
Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to
issuing a registration under this Section to a bulk manufacturer of a
controlled substance in schedule I or II, and prior to issuing a
regulation under 21 U.S.C. 952(a)(2), authorizing the importation of
such a substance, provide manufacturers holding registrations for the
bulk manufacture of the substance an opportunity for a hearing.
Therefore, in accordance with 21 CFR 1301.34(a), this is notice
that on March 5, 2012, Almac Clinical Services, Inc., (ACSI), 25 Fretz
Road, Souderton, Pennsylvania 18964, made application by renewal to the
Drug Enforcement Administration (DEA) to be registered as an importer
of the following basic classes of controlled substances:
| Drug |
Schedule |
| Oxycodone (9143) |
II |
| Hydromorphone (9150) |
II |
| Tapentadol (9780) |
II |
| Fentanyl (9801) |
II |
The company plans to import small quantities of the listed
controlled substances in dosage form to conduct clinical trials.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic classes of controlled
substances may file comments or objections to the issuance of the
proposed registration and may, at the same time, file a written request
for a hearing on such application pursuant to 21 CFR 1301.43, and in
such form as prescribed by 21 CFR 1316.47.
Any such written comments or objections should be addressed, in
quintuplicate, to the Drug Enforcement Administration, Office of
Diversion Control, Federal Register Representative (ODL), 8701
Morrissette Drive, Springfield, Virginia 22152; and must be filed no
later than May 29, 2012.
This procedure is to be conducted simultaneously with, and
independent of, the procedures described in 21 CFR 1301.34(b), (c),
(d), (e), and (f). As noted in a previous notice published in the
Federal Register on September 23, 1975, 40 FR 43745-46, all applicants
for registration to import the basic class of any controlled substance
in schedule I or II are, and will continue to be, required to
demonstrate to the Deputy Assistant Administrator, Office of Diversion
Control, Drug Enforcement Administration, that the requirements for
such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and
21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied.
Dated: April 17, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-10053 Filed 4-25-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |
