Bulk Manufacturer of Controlled Substances Application: American Radiolabeled Chemicals, 31960-31961 [2016-11938]
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31960
Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices
Controlled substance
Schedule
Morphine-N-oxide (9307) .............................................................................................................................................................................
Normorphine (9313) ....................................................................................................................................................................................
Norlevorphanol (9634) .................................................................................................................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) (9821) ...............................................................................................
Amphetamine (1100) ...................................................................................................................................................................................
Methamphetamine (1105) ...........................................................................................................................................................................
Lisdexamfetamine (1205) ............................................................................................................................................................................
Methylphenidate (1724) ...............................................................................................................................................................................
Nabilone (7379) ...........................................................................................................................................................................................
4-Anilino-N-phenethyl-4-piperidine (ANPP) (8333) .....................................................................................................................................
Codeine (9050) ............................................................................................................................................................................................
Dihydrocodeine (9120) ................................................................................................................................................................................
Oxycodone (9143) .......................................................................................................................................................................................
Hydromorphone (9150) ...............................................................................................................................................................................
Diphenoxylate (9170) ..................................................................................................................................................................................
Ecgonine (9180) ..........................................................................................................................................................................................
Hydrocodone (9193) ....................................................................................................................................................................................
Levorphanol (9220) .....................................................................................................................................................................................
Meperidine (9230) .......................................................................................................................................................................................
Methadone (9250) .......................................................................................................................................................................................
Methadone intermediate (9254) ..................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) (9273) ..............................................................................................................................
Morphine (9300) ..........................................................................................................................................................................................
Oripavine (9330) ..........................................................................................................................................................................................
Thebaine (9333) ..........................................................................................................................................................................................
Opium tincture (9630) ..................................................................................................................................................................................
Opium, powdered (9639) .............................................................................................................................................................................
Oxymorphone (9652) ...................................................................................................................................................................................
Noroxymorphone (9668) ..............................................................................................................................................................................
Alfentanil (9737) ..........................................................................................................................................................................................
Remifentanil (9739) .....................................................................................................................................................................................
Sufentanil (9740) .........................................................................................................................................................................................
Tapentadol (9780) .......................................................................................................................................................................................
Fentanyl (9801) ...........................................................................................................................................................................................
The company plans to manufacturer
bulk active pharmaceutical ingredients
(APIs) for distribution to its customers.
Drug Enforcement Administration
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 July 19, 2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
[Docket No. DEA–392]
SUPPLEMENTARY INFORMATION:
Dated: May 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–11940 Filed 5–19–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Bulk Manufacturer of Controlled
Substances Application: American
Radiolabeled Chemicals
ACTION:
Notice of application.
DATES:
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 March
3, 2016, American Radiolabeled
Chemicals, 101 Arc Drive, Saint Louis,
Missouri 63146 applied to be registered
as a bulk manufacturer of the following
basic classes of controlled substances:
mstockstill on DSK3G9T082PROD with NOTICES
Controlled substance
Schedule
Gamma Hydroxybutyric Acid (2010) ...........................................................................................................................................................
Ibogaine (7260) ...........................................................................................................................................................................................
Lysergic Acid Diethylamide (7315) ..............................................................................................................................................................
Tetrahydrocannabinols (7370) .....................................................................................................................................................................
Dimethyltryptamine (7435) ..........................................................................................................................................................................
1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ...............................................................................................................................................
Dihydromorphine (9145) ..............................................................................................................................................................................
Heroin (9200) ...............................................................................................................................................................................................
Normorphine (9313) ....................................................................................................................................................................................
Amphetamine (1100) ...................................................................................................................................................................................
Methamphetamine (1105) ...........................................................................................................................................................................
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31961
Federal Register / Vol. 81, No. 98 / Friday, May 20, 2016 / Notices
Controlled substance
Schedule
Amobarbital (2125) ......................................................................................................................................................................................
Phencyclidine (7471) ...................................................................................................................................................................................
Phenylacetone (8501) .................................................................................................................................................................................
Cocaine (9041) ............................................................................................................................................................................................
Codeine (9050) ............................................................................................................................................................................................
Dihydrocodeine (9120) ................................................................................................................................................................................
Oxycodone (9143) .......................................................................................................................................................................................
Hydromorphone (9150) ...............................................................................................................................................................................
Ecgonine (9180) ..........................................................................................................................................................................................
Hydrocodone (9193) ....................................................................................................................................................................................
Meperidine (9230) .......................................................................................................................................................................................
Metazocine (9240) .......................................................................................................................................................................................
Methadone (9250) .......................................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) (9273) ..............................................................................................................................
Morphine (9300) ..........................................................................................................................................................................................
Oripavine (9330) ..........................................................................................................................................................................................
Thebaine (9333) ..........................................................................................................................................................................................
Oxymorphone (9652) ...................................................................................................................................................................................
Phenazocine (9715) ....................................................................................................................................................................................
Carfentanil (9743) ........................................................................................................................................................................................
Fentanyl (9801) ...........................................................................................................................................................................................
The company plans to manufacture
small quantities of the listed controlled
substances as radiolabeled compounds
for biochemical research.
Dated: May 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–11938 Filed 5–19–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–372]
Exempt Chemical Preparations Under
the Controlled Substances Act
Drug Enforcement
Administration, Department of Justice.
ACTION: Order with opportunity for
comment.
AGENCY:
The applications for exempt
chemical preparations received by the
Drug Enforcement Administration
(DEA) between January 1, 2016, and
March 31, 2016, as listed below, were
accepted for filing and have been
approved or denied as indicated.
DATES: Interested persons may file
written comments on this order in
accordance with 21 CFR 1308.23(e).
Electronic comments must be
submitted, and written comments must
be postmarked, on or before July 19,
2016. Commenters should be aware that
the electronic Federal Docket
Management System will not accept
comments after 11:59 p.m. Eastern Time
on the last day of the comment period.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–372’’ on all correspondence,
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:40 May 19, 2016
Jkt 238001
including any attachments. The Drug
Enforcement Administration (DEA)
encourages that all comments be
submitted through the Federal
eRulemaking Portal, which provides the
ability to type short comments directly
into the comment field on the Web page
or to attach a file for lengthier
comments. Please go to https://
www.regulations.gov and follow the
online instructions at that site for
submitting comments. Upon completion
of your submission you will receive a
Comment Tracking Number for your
comment. Please be aware that
submitted comments are not
instantaneously available for public
view on Regulations.gov. If you have
received a comment tracking number,
your comment has been successfully
submitted and there is no need to
resubmit the same comment. Paper
comments that duplicate the electronic
submission are not necessary and are
discouraged. Should you wish to mail a
comment in lieu of an electronic
comment, it should be sent via regular
or express mail to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
FOR FURTHER INFORMATION CONTACT:
Barbara J. Boockholdt, Office of
Diversion Control, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments
received are considered part of the
public record and made available for
public inspection online at https://
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www.regulations.gov and in the DEA’s
public docket. Such information
includes personal identifying
information (such as your name,
address, etc.) voluntarily submitted by
the commenter.
If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also place
all the personal identifying information
you do not want posted online or made
available in the public docket in the first
paragraph of your comment and identify
what information you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify confidential
business information to be redacted
within the comment.
Comments containing personal
identifying information and confidential
business information identified as
directed above will generally be made
publicly available in redacted form. If a
comment has so much confidential
business information that it cannot be
effectively redacted, all or part of that
comment may not be made publicly
available. Comments posted to https://
www.regulations.gov may include any
personal identifying information (such
as name, address, and phone number)
included in the text of your electronic
E:\FR\FM\20MYN1.SGM
20MYN1
]]>Agencies
[Federal Register Volume 81, Number 98 (Friday, May 20, 2016)]
[Notices]
[Pages 31960-31961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11938]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: American
Radiolabeled Chemicals
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 July 19, 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 March
3, 2016, American Radiolabeled Chemicals, 101 Arc Drive, Saint Louis,
Missouri 63146 applied to be registered as a bulk manufacturer of the
following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)............ I
Ibogaine (7260)............................. I
Lysergic Acid Diethylamide (7315)........... I
Tetrahydrocannabinols (7370)................ I
Dimethyltryptamine (7435)................... I
1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) I
Dihydromorphine (9145)...................... I
Heroin (9200)............................... I
Normorphine (9313).......................... I
Amphetamine (1100).......................... II
Methamphetamine (1105)...................... II
[[Page 31961]]
Amobarbital (2125).......................... II
Phencyclidine (7471)........................ II
Phenylacetone (8501)........................ II
Cocaine (9041).............................. II
Codeine (9050).............................. II
Dihydrocodeine (9120)....................... II
Oxycodone (9143)............................ II
Hydromorphone (9150)........................ II
Ecgonine (9180)............................. II
Hydrocodone (9193).......................... II
Meperidine (9230)........................... II
Metazocine (9240)........................... II
Methadone (9250)............................ II
Dextropropoxyphene, bulk (non-dosage forms) II
(9273).
Morphine (9300)............................. II
Oripavine (9330)............................ II
Thebaine (9333)............................. II
Oxymorphone (9652).......................... II
Phenazocine (9715).......................... II
Carfentanil (9743).......................... II
Fentanyl (9801)............................. II
------------------------------------------------------------------------
The company plans to manufacture small quantities of the listed
controlled substances as radiolabeled compounds for biochemical
research.
Dated: May 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-11938 Filed 5-19-16; 8:45 am]
BILLING CODE 4410-09-P
