Bulk Manufacturer of Controlled Substances Application: Apertus Pharmaceuticals, 16440 [2015-06966]
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16440
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
with the FDA including validation
batches, standards and stability studies.
No other activity for this drug code is
authorized for this registration.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Dated: March 20, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
Bulk Manufacturer of Controlled
Substances Application: Apertus
Pharmaceuticals
ACTION:
[FR Doc. 2015–06966 Filed 3–26–15; 8:45 am]
Notice of application.
BILLING CODE 4410–09–P
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 1301.33(a) on
or before May 26, 2015.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152. Request for hearings should be
sent to: Drug Enforcement
Administration, Attention: Hearing
Clerk/LJ, 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 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
1301.33(a), this is notice that on March
20, 2014, Apertus Pharmaceuticals, 331
Consort Drive, St. Louis, Missouri
63011, applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
DATES:
Controlled substance
Schedule
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Marihuana (7360) .........................
Tetrahydrocannabinols (7370) .....
I
I
The company plans to divide the
synthesized cannabidiol, with a portion
going for sale as an API in nabiximol.
The raw material will be used to
synthesize dronabinol. Therefore, they
anticipate consuming and purchasing
small quantities of CS for generating
data to support the Drug Master File
VerDate Sep<11>2014
20:59 Mar 26, 2015
Jkt 235001
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
[Docket No. OSHA–2012–0035]
Traylor/Skanska/Jay Dee Joint
Venture: Grant of a Permanent
Variance
Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Notice.
AGENCY:
In this notice, OSHA grants a
permanent variance to Traylor/Skanska/
Jay Dee Joint Venture from the
provisions of OSHA standards that
regulate work in compressed air
environments at 29 CFR 1926.803.
DATES: The permanent variance
specified by this notice becomes
effective on March 27, 2015 and shall
remain in effect until January 31, 2016.
FOR FURTHER INFORMATION CONTACT:
Information regarding this notice is
available from the following sources:
Press inquiries: Contact Mr. Frank
Meilinger, Director, OSHA Office of
Communications, U.S. Department of
Labor, 200 Constitution Avenue NW.,
Room N–3647, Washington, DC 20210;
telephone: (202) 693–1999; email:
Meilinger.francis2@dol.gov.
General and technical information:
Contact Mr. Kevin Robinson, Acting
Director, Office of Technical Programs
and Coordination Activities, Directorate
of Technical Support and Emergency
Management, Occupational Safety and
Health Administration, U.S. Department
of Labor, 200 Constitution Avenue NW.,
Room N–3655, Washington, DC 20210;
phone: (202) 693–2110 or email:
robinson.kevin@dol.gov.
SUPPLEMENTARY INFORMATION:
Copies of this Federal Register
notice. Electronic copies of this Federal
Register notice are available at https://
www.regulations.gov. This Federal
Register notice, as well as news releases
and other relevant information, also are
available at OSHA’s Web page at
https://www.osha.gov.
SUMMARY:
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
I. Notice of Application
On April 26, 2012, Traylor Bros., Inc.,
835 N. Congress Ave., Evansville, IN
47715, and Traylor/Skanska/Jay Dee
Joint Venture, Blue Plains Tunnel, 5000
Overlook Avenue SW., Washington, DC
20032, submitted under Section 6(d) of
the Occupational Safety and Health Act
of 1970 (‘‘OSH Act’’; 29 U.S.C. 655) and
29 CFR 1905.11 (‘‘Variances and other
relief under section 6(d)’’) an
application for a permanent variance
from several provisions of the OSHA
standard that regulates work in
compressed air at 29 CFR 1926.803.
OSHA is addressing this request as two
separate applications: (1) Traylor Bros.,
Inc. (‘‘Traylor’’) request for a permanent
variance for future tunneling projects;
and (2) Traylor/Skanska/Jay Dee Joint
Venture, Blue Plains Tunnel (‘‘Traylor
JV’’ or ‘‘the applicant’’). This notice only
addresses the Traylor JV application for
an interim order and permanent
variance for the Blue Plains Tunnel
project.1 This notice does not address
the Traylor application for a permanent
variance for future projects. That request
will be addressed separately.
Traylor JV also requested an interim
order pending OSHA’s decision on the
application for a variance (Ex. OSHA–
2012–0035–0008). Specifically, this
notice addresses the application
submitted by Traylor JV for the Blue
Plains Tunnel project in which the
applicant seeks a permanent variance
and interim order from the provisions of
the standard that: (1) Prohibit
compressed-air worker exposure to
pressures exceeding 50 pounds per
square inch (p.s.i.) except in an
emergency (29 CFR 1926.803(e)(5)); 2 (2)
require the use of the decompression
values specified in decompression
tables in Appendix A of the
compressed-air standard for
construction (29 CFR 1926.803(f)(1));
and (3) require the use of automated
operational controls and a special
decompression chamber (29 CFR
1926.803(g)(1)(iii) and .803(g)(1)(xvii),
respectively).
The applicant is a contractor that
works on complex tunnel projects using
recently developed equipment and
procedures for soft-ground tunneling.
The applicant’s workers engage in the
construction of tunnels using advanced
shielded mechanical excavation
1 See
Section III discussion of condition A Scope.
decompression tables in Appendix A of
subpart S express the maximum working pressures
as pounds per square inch gauge (p.s.i.g.), with a
maximum working pressure of 50 p.s.i.g. Therefore,
throughout this notice, OSHA expresses the 50 p.s.i.
value specified by § 1926.803(e)(5) as 50 p.s.i.g.,
consistent with the terminology in Appendix A,
Table 1 of subpart S.
2 The
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Page 16440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06966]
[[Page 16440]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Apertus
Pharmaceuticals
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
1301.33(a) on or before May 26, 2015.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/ODW,
8701 Morrissette Drive, Springfield, Virginia 22152. Request for
hearings should be sent to: Drug Enforcement Administration, Attention:
Hearing Clerk/LJ, 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 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 1301.33(a), this is notice that on March
20, 2014, Apertus Pharmaceuticals, 331 Consort Drive, St. Louis,
Missouri 63011, applied to be registered as a bulk manufacturer of the
following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
Tetrahydrocannabinols (7370)............... I
------------------------------------------------------------------------
The company plans to divide the synthesized cannabidiol, with a
portion going for sale as an API in nabiximol. The raw material will be
used to synthesize dronabinol. Therefore, they anticipate consuming and
purchasing small quantities of CS for generating data to support the
Drug Master File with the FDA including validation batches, standards
and stability studies.
No other activity for this drug code is authorized for this
registration.
Dated: March 20, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-06966 Filed 3-26-15; 8:45 am]
BILLING CODE 4410-09-P
