Importer of Controlled Substances Application: Myoderm, 66751 [2018-28081]
Download as PDF
<![CDATA[
66751
Federal Register / Vol. 83, No. 247 / Thursday, December 27, 2018 / Notices
Dated: December 8, 2018.
John J. Martin,
Assistant Administrator.
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
November 2, 2018, Myoderm, 48 East
Main Street, Norristown, Pennsylvania
19401–4915 applied to be registered as
an importer of the following basic
classes of controlled substances:
[FR Doc. 2018–28078 Filed 12–26–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Myoderm
ACTION:
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 January 28, 2019. Such
persons may also file a written request
for a hearing on the application on or
before January 28, 2019.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 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/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 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
Controlled
substance
DATES:
Drug code
Amphetamine ........
Lisdexamfetamine
Methylphenidate ...
Nabilone ................
Oxycodone ............
Hydromorphone ....
Hydrocodone ........
Morphine ...............
Oxymorphone .......
Fentanyl ................
Schedule
1100
1205
1724
7379
9143
9150
9193
9300
9652
9801
II
II
II
II
II
II
II
II
II
II
The company plans to import the
listed controlled substances for clinical
trials, research, and analytical purposes.
Approval of permit applications will
occur only when the registrant’s 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: December 8, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–28081 Filed 12–26–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Agilent Technologies
ACTION:
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 January 28, 2019. Such
persons may also file a written request
for a hearing on the application on or
before January 28, 2019.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 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/OALJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette
Drive, Springfield, Virginia 22152.
ADDRESSES:
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.
SUPPLEMENTARY INFORMATION:
In accordance with 21 CFR
1301.34(a), this is notice that on August
13, 2018, Agilent Technologies, 250
Smith Street, North Kingstown, Rhode
Island 02852 applied to be registered as
an importer of the following basic
classes of controlled substances:
khammond on DSK30JT082PROD with NOTICES
Controlled substance
Drug code
Marihuana ................................................................................................................................................................
Tetrahydrocannabinols ............................................................................................................................................
VerDate Sep<11>2014
17:14 Dec 26, 2018
Jkt 247001
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
E:\FR\FM\27DEN1.SGM
27DEN1
7360
7370
Schedule
I
I
]]>Agencies
[Federal Register Volume 83, Number 247 (Thursday, December 27, 2018)]
[Notices]
[Page 66751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-28081]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Myoderm
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 January 28, 2019.
Such persons may also file a written request for a hearing on the
application on or before January 28, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
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/OALJ, 8701 Morrissette Drive,
Springfield, Virginia 22152; and (2) Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 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
November 2, 2018, Myoderm, 48 East Main Street, Norristown,
Pennsylvania 19401-4915 applied to be registered as an importer of the
following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Amphetamine..................................... 1100 II
Lisdexamfetamine................................ 1205 II
Methylphenidate................................. 1724 II
Nabilone........................................ 7379 II
Oxycodone....................................... 9143 II
Hydromorphone................................... 9150 II
Hydrocodone..................................... 9193 II
Morphine........................................ 9300 II
Oxymorphone..................................... 9652 II
Fentanyl........................................ 9801 II
------------------------------------------------------------------------
The company plans to import the listed controlled substances for
clinical trials, research, and analytical purposes.
Approval of permit applications will occur only when the
registrant's 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: December 8, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-28081 Filed 12-26-18; 8:45 am]
BILLING CODE 4410-09-P
