Bulk Manufacturer of Controlled Substances Application: AMRI Rensselaer, Inc., 61250-61251 [2016-21242]
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Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices
Register Representative/ODW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DEPARTMENT OF JUSTICE
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 May 3,
2016, Isosciences, LLC, 1017 West Ninth
Avenue, Building 10, Suite B, King of
Prussia, Pennsylvania 19406 applied to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
[Docket No. DEA–392]
SUPPLEMENTARY INFORMATION:
Controlled substance
Schedule
Cathinone (1235) ..........................
Methcathinone (1237) ..................
Lysergic acid diethylamide (7315)
3,4-Methylenedioxyamphetamine
(7400).
3,4-Methylenedioxy-Nethylamphetamine (7404).
3,4Methylenedioxymethamphetamine (7405).
Amphetamine (1100) ....................
Methamphetamine (1105) ............
Codeine (9050) .............................
Morphine (9300) ...........................
I
I
I
I
I
I
II
II
II
II
The company plans to manufacture
small quantities of the listed controlled
substances to make reference standards
which will be distributed to their
customers.
Louis J. Milione,
Deputy Assistant Administrator.
mstockstill on DSK3G9T082PROD with NOTICES
[FR Doc. 2016–21241 Filed 9–2–16; 8:45 am]
BILLING CODE 4410–09–P
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17:04 Sep 02, 2016
Jkt 238001
Drug Enforcement Administration
Importer of Controlled Substances
Application: Unither Manufacturing,
LLC
ACTION:
Notice of application.
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–21239 Filed 9–2–16; 8:45 am]
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 1301.34(a) on
or before October 6, 2016. Such persons
may also file a written request for a
hearing on the application pursuant to
21 CFR 1301.43 on or before October 6,
2016.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODW, 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/LJ, 8701 Morrissette
Drive, Springfield, Virginia 22152; and
(2) Drug Enforcement Administration,
Attn: 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
1301.34(a), this is notice that on May 6,
2016, Unither Manufacturing, LLC., 331
Clay Road, Rochester, New York 14623
applied to be registered as an importer
of methylphenidate (1724), a basic class
of controlled substance listed in
schedule II.
DATES:
The company plans to import the
listed substance solely for updated
analytical testing purposes for EU
customer requirements.
This analysis is required to allow the
company to export domesticallymanufactured FDF to foreign markets.
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: AMRI
Rensselaer, Inc.
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 in
accordance with 21 CFR 1301.33(a) on
or before November 7, 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 May 19,
2016, AMRI Rensselaer, Inc., 33
Riverside Avenue, Rensselaer, New
York 12144 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
DATES:
Controlled substance
Marihuana (7360) .........................
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Schedule
I
Federal Register / Vol. 81, No. 172 / Tuesday, September 6, 2016 / Notices
Controlled substance
Schedule
Tetrahydrocannabinols (7370) .....
Amphetamine (1100) ....................
Lisdexamfetamine (1205) .............
Methylphenidate (1724) ................
Pentobarbital (2270) .....................
4-Anilino-N-phenethyl-4-piperidine
(ANPP) (8333) ..............................
Meperidine (9230) ........................
Fentanyl (9801) ............................
I
II
II
II
II
II
The company plans to manufacture
bulk controlled substances for use in
product development and for
distribution to its customers.
In reference to drug codes 7360
(marihuana) and 7370 (THC), the
company plans to bulk manufacture
these drugs as synthetics. No other
activities for these drug codes are
authorized for this registration.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016–21242 Filed 9–2–16; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1117–0010]
Agency Information Collection
Activities; Proposed eCollection,
eComments Requested; Extension
Without Change of a Previously
Approved Collection U.S. Official Order
Forms for Schedules I and II Controlled
Substances DEA Form 222
Drug Enforcement
Administration, Department of Justice.
ACTION: 30-day notice.
AGENCY:
The Department of Justice
(DOJ), Drug Enforcement
Administration (DEA), will submit the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. This proposed
information collection was previously
published in the Federal Register at 81
FR 42726, June 30, 2016, allowing for a
60 day comment period.
DATES: Comments are encouraged and
will be accepted for an additional 30
days until October 6, 2016.
FOR FURTHER INFORMATION CONTACT: If
you have comments on the estimated
public burden or associated response
time, suggestions, or need a copy of the
proposed information collection
instrument with instructions or
additional information, please contact
Michael J. Lewis, Office of Diversion
Control, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
mstockstill on DSK3G9T082PROD with NOTICES
VerDate Sep<11>2014
17:04 Sep 02, 2016
Jkt 238001
Written
comments and suggestions from the
public and affected agencies concerning
the proposed collection of information
are encouraged. Your comments should
address one or more of the following
four points:
—Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
—Evaluate the accuracy of the agency’s
estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
—Evaluate whether and if so how the
quality, utility, and clarity of the
information proposed to be collected
can be enhanced; and
—Minimize the burden of the collection
of information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other forms of
information technology, e.g.,
permitting electronic submission of
responses.
SUPPLEMENTARY INFORMATION:
II
II
SUMMARY:
22152; Telephone: (202) 598–6812 or
sent to OIRA_submissions@
omb.eop.gov.
Overview of This Information
Collection
Frm 00071
Fmt 4703
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states it ‘‘shall be unlawful for any
person to distribute a controlled
substance in schedules I or II to another
except in pursuance of a written order
of the person to whom such substance
is distributed, made on a form to be
issued by the Attorney General in blank
in accordance with subsection (d) of this
section..’’ 21 U.S.C. 828(a).
5. An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: The DEA estimates that
125,435 registrants participate in this
information collection, taking an
estimated 11.6 hours per registrant
annually.
6. An estimate of the total public
burden (in hours) associated with the
proposed collection: The DEA estimates
that this collection takes 1,453,348
annual burden hours.
If additional information is required
please contact: Jerri Murray, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE., Suite 3E.405B,
Washington, DC 20530.
Dated: August 31, 2016.
Jerri Murray,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2016–21297 Filed 9–2–16; 8:45 am]
BILLING CODE 4410–09–P
1. Type of Information Collection:
Extension of a currently approved
collection.
2. Title of the Form/Collection: U.S.
Official Order Forms for Schedules I
and II Controlled Substances.
3. The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
DEA Form: 222. The applicable
component within the Department of
Justice is the Drug Enforcement
Administration, Office of Diversion
Control.
4. Affected public who will be asked
or required to respond, as well as a brief
abstract:
Affected public (Primary): Business or
other for-profit.
Affected public (Other): Not-for-profit
institutions; Federal, State, local, and
tribal governments.
Abstract: The Controlled Substances
Act (CSA) (21 U.S.C. 801–971)
establishes a closed system of
distribution for controlled substances.
To this end, controlled substances are
closely monitored and tightly regulated
as they are distributed through the
supply chain. One tool that helps to
maintain the closed system of
distribution is the CSA provision that
PO 00000
61251
DEPARTMENT OF JUSTICE
[OMB Number 1190–NEW]
Agency Information Collection
Activities; Proposed eCollection;
eComments Requested; Approval of a
New Collection; Assessing Potential
Benefits of Accessible Web Content
for Individuals Who Are Blind
Civil Rights Division,
Department of Justice.
ACTION: 30-day notice.
AGENCY:
The Department of Justice
(DOJ), Civil Rights Division, Disability
Rights Section, will submit the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995 (PRA). This
proposed information collection was
previously published in the Federal
Register on June 30, 2016 at 81 FR
43249, on July 1, 2016, allowing for a 60
day public comment period.
DATES: Comments are encouraged and
will be accepted for an additional 30
days until October 6, 2016.
SUMMARY:
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]]>Agencies
[Federal Register Volume 81, Number 172 (Tuesday, September 6, 2016)]
[Notices]
[Pages 61250-61251]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21242]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: AMRI
Rensselaer, 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 November 7, 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 May
19, 2016, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New
York 12144 applied to be registered as a bulk manufacturer of the
following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Schedule
------------------------------------------------------------------------
Marihuana (7360)........................... I
[[Page 61251]]
Tetrahydrocannabinols (7370)............... I
Amphetamine (1100)......................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Pentobarbital (2270)....................... II
4-Anilino-N-phenethyl-4-piperidine......... II
(ANPP) (8333)..............................
Meperidine (9230).......................... II
Fentanyl (9801)............................ II
------------------------------------------------------------------------
The company plans to manufacture bulk controlled substances for use
in product development and for distribution to its customers.
In reference to drug codes 7360 (marihuana) and 7370 (THC), the
company plans to bulk manufacture these drugs as synthetics. No other
activities for these drug codes are authorized for this registration.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-21242 Filed 9-2-16; 8:45 am]
BILLING CODE 4410-09-P
