Notice of Application - 2012
[Federal Register Volume 77, Number 218 (Friday, November 9, 2012)]
[Notices]
[Pages 67396-67397]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27437]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Application, Fisher
Clinical Services, Inc.
Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this
is notice that on August 20, 2012, Fisher Clinical Services, Inc., 7554
Schantz Road,
[[Page 67397]]
Allentown, Pennsylvania 18106, made application to the Drug Enforcement
Administration (DEA) for registration as an importer of Tapentadol
(9780), a basic class of controlled substance listed in schedule II.
The company plans to import the listed controlled substance to
conduct clinical trials.
Any bulk manufacturer who is presently, or is applying to be,
registered with DEA to manufacture such basic class of controlled
substance listed in schedule II, which falls under the authority of
section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)) may, in the
circumstances set forth in 21 U.S.C. 958(i), 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 Sec. 1301.43 and in such form as prescribed by 21
CFR Sec. 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 December 10, 2012.
This procedure is to be conducted simultaneously with, and
independent of, the procedures described in 21 CFR Sec. 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 a basic class of any controlled substances
in schedules 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 Sec. 1301.34(b), (c), (d), (e), and (f) are satisfied.
Dated: November 1, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2012-27437 Filed 11-8-12; 8:45 am]
BILLING CODE 4410-09-P
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