Bulk Manufacturer of Controlled Substances Application: Janssen Pharmaceutical, Inc., 9219 [2016-03852]
Download as PDF
<![CDATA[
9219
Federal Register / Vol. 81, No. 36 / Wednesday, February 24, 2016 / Notices
Controlled substance
Schedule
mstockstill on DSK4VPTVN1PROD with NOTICES
2-(4-chloro-2,5-dimethoxyphenyl)N-(2-methoxybenzyl)ethanamine
(25C–
NBOMe) (7537).
2-(4-iodo-2,5-dimethoxyphenyl)-N(2-methoxybenzyl)ethanamine
(25I–NBOMe) (7538).
Methylone (3,4-Methylenedioxy-Nmethylcathinone) (7540).
Butylone (7541) ............................
Pentylone (7542) ..........................
alpha-pyrrolidinopentiophenone
(a-PVP) (7545).
alpha-pyrrolidinobutiophenone (aPBP) (7546).
AM–694 (1-(5-Fluoropentyl)-3-(2iodobenzoyl)indole) (7694).
Acetyldihydrocodeine (9051) ........
Benzylmorphine (9052) ................
Codeine-N-oxide (9053) ...............
Desomorphine (9055) ...................
Dihydromorphine (9145) ...............
Heroin (9200) ...............................
Morphine-N-oxide (9307) .............
Normorphine (9313) .....................
Tilidine (9750) ...............................
Acetyl
Fentanyl
(N-(1phenethylpiperidin-4-yl)-Nphenylacetamide) (9821).
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Amobarbital (2125) .......................
Pentobarbital (2270) .....................
Secobarbital (2315) ......................
Phencyclidine (7471) ....................
Phenylacetone (8501) ..................
Cocaine (9041) .............................
Codeine (9050) .............................
Dihydrocodeine (9120) .................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Ecgonine (9180) ...........................
Ethylmorphine (9190) ...................
Hydrocodone (9193) .....................
Levomethorphan (9210) ...............
Levorphanol (9220) ......................
Meperidine (9230) ........................
Meperidine intermediate-B (9233)
Methadone (9250) ........................
Dextropropoxyphene, bulk.
(non-dosage forms) (9273) ..........
Morphine (9300) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
Sufentanil (9740) ..........................
Tapentadol (9780) ........................
Fentanyl (9801) ............................
I
17:59 Feb 23, 2016
Controlled substance
[FR Doc. 2016–03854 Filed 2–23–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
I
Drug Enforcement Administration
I
I
I
[Docket No. DEA–392]
I
Bulk Manufacturer of Controlled
Substances Application: Janssen
Pharmaceutical, Inc.
I
ACTION:
I
I
I
I
I
I
I
I
I
I
DATES:
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
Jkt 238001
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 April 25, 2016
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: 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
1301.33(a), this is notice that on
November 12, 2015, Janssen
Pharmaceutical, Inc., 1440 Olympic
Drive, Athens, Georgia 30601 applied to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
Methylphenidate (1724) ................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Hydrocodone (9193) .....................
Oripavine (9330) ...........................
Thebaine (9333) ...........................
Oxymorphone (9652) ...................
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
II
II
Dated: February 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–03852 Filed 2–23–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Notice of application.
Controlled substance
Tapentadol (9780) ........................
Fentanyl (9801) ............................
Schedule
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
I
The company plans to manufacture
reference standards for distribution to
their research and forensics customers.
In reference to drug codes 7360
(marihuana) and 7370
(tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
VerDate Sep<11>2014
Dated: February 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
Schedule
II
II
II
II
II
II
II
Drug Enforcement Administration
[Docket No. DEA–392]
Manufacturer of Controlled
Substances Registration: Cedarburg
Pharmaceuticals, Inc.
ACTION:
Notice of registration.
Cedarburg Pharmaceuticals,
Inc. applied to be registered as a
manufacturer of certain basic classes of
controlled substances. The Drug
Enforcement Administration (DEA)
grants Cedarburg Pharmaceuticals, Inc.
registration as a manufacturer of those
controlled substances.
SUPPLEMENTARY INFORMATION: By notice
dated September 16, 2015, and
published in the Federal Register on
September 23, 2015, 80 FR 57390,
Cedarburg Pharmaceuticals, Inc., 870
Badger Circle, Grafton, Wisconsin 53024
applied to be registered as a
manufacturer of certain basic classes of
controlled substances. No comments or
objections were submitted for this
notice.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of Cedarburg
Pharmaceuticals, Inc. to manufacture
the basic classes of controlled
substances is consistent with the public
interest and with United States
obligations under international treaties,
conventions, or protocols in effect on
May 1, 1971. The DEA investigated the
company’s maintenance of effective
controls against diversion by inspecting
and testing the company’s physical
security systems, verifying the
company’s compliance with state and
local laws, and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above-named company is
granted registration as a bulk
manufacturer of the following basic
classes of controlled substances:
SUMMARY:
E:\FR\FM\24FEN1.SGM
24FEN1
]]>Agencies
[Federal Register Volume 81, Number 36 (Wednesday, February 24, 2016)]
[Notices]
[Page 9219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-03852]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Janssen
Pharmaceutical, Inc.
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 April 25, 2016
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: 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 1301.33(a), this is notice that on
November 12, 2015, Janssen Pharmaceutical, Inc., 1440 Olympic Drive,
Athens, Georgia 30601 applied to be registered as a bulk manufacturer
of the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Methylphenidate (1724)..................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Oripavine (9330)........................... II
Thebaine (9333)............................ II
Oxymorphone (9652)......................... II
Tapentadol (9780).......................... II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances in bulk for distribution to its customers.
Dated: February 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-03852 Filed 2-23-16; 8:45 am]
BILLING CODE 4410-09-P
