Importer of Controlled Substances Application: Myonex Inc, 11558-11559 [2021-03919]
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11558
Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
In
accordance with 21 CFR 1301.33(a), this
is notice that on July 20, 2020, Chattem
Chemicals 3801 Saint Elmo Avenue,
Chattanooga, Tennessee 37409, applied
to be registered as a bulk manufacturer
of the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug
code
Gamma Hydroxybutyric Acid ....
Marihuana .................................
Tetrahydrocannabinols .............
4-Methoxyamphetamine ...........
Dihydromorphine .......................
Norlevorphanol ..........................
Amphetamine ............................
Methamphetamine ....................
Lisdexamfetamine .....................
Methylphenidate ........................
ANPP (4-Anilino-N-phenethyl-4piperidine).
Phenylacetone ..........................
Cocaine .....................................
Codeine .....................................
Dihydrocodeine .........................
Oxycodone ................................
Hydromorphone ........................
Hydrocodone .............................
Levorphanol ..............................
Meperidine ................................
Meperidine intermediate–A .......
Meperidine intermediate–B .......
Meperidine intermediate–C .......
Methadone ................................
Methadone intermediate ...........
Morphine ...................................
Oripavine ...................................
Thebaine ...................................
Opium, powdered .....................
Opium, granulated ....................
Oxymorphone ...........................
Noroxymorphone ......................
Racemethorphan ......................
Alfentanil ...................................
Remifentanil ..............................
Sufentanil ..................................
Tapentadol ................................
Fentanyl ....................................
Schedule
2010
7360
7370
7411
9145
9634
1100
1105
1205
1724
8333
I
I
I
I
I
I
II
II
II
II
II
8501
9041
9050
9120
9143
9150
9193
9220
9230
9232
9233
9234
9250
9254
9300
9330
9333
9639
9640
9652
9668
9732
9737
9739
9740
9780
9801
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
[FR Doc. 2021–03836 Filed 2–24–21; 8:45 am]
BILLING CODE 4410–09–P
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17:04 Feb 24, 2021
Jkt 253001
Drug Enforcement Administration
[Docket No. DEA–791]
Bulk Manufacturer of Controlled
Substances Application: S&B Pharma,
Inc.
Drug Enforcement
Administration, Justice.
AGENCY:
ACTION:
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before April 26, 2021. Such persons
may also file a written request for a
hearing on the application on or before
April 26, 2021.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on November 11, 2020,
S&B Pharma, Inc., 405 South Motor
Avenue, Azusa, California 91702–3232,
applied to be registered as an bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Gamma Hydroxybutyric Acid ....
Tetrahydrocannabinols .............
Amphetamine ............................
Methamphetamine ....................
Lisdexamfetamine .....................
Methylphenidate ........................
Pentobarbital .............................
4-Anilino-N-phenethyl-4-piperidine (ANPP).
Tapentadol ................................
Fentanyl ....................................
Drug
code
Schedule
7360
7370
1100
1105
1205
1724
2270
8333
I
I
II
II
II
II
II
II
9780
9801
II
II
The company plans to manufacture
the listed controlled substances in bulk
for use in product development and for
commercial sales to its customers. In
reference to drug code 7360 (Marihuana)
and 7370 (Tetrahydrocannabinols), the
company plans to bulk manufacture
both as synthetic substances. No other
Frm 00064
Fmt 4703
DEPARTMENT OF JUSTICE
[Docket No. DEA798]
Notice of application.
Controlled substance
BILLING CODE 4410–09–P
Drug Enforcement Administration
S&B Pharma, Inc., has applied
to be registered as a bulk manufacturer
of basic class(es) of controlled
substance(s). Refer to Supplemental
Information listed below for further
drug information.
PO 00000
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–03837 Filed 2–24–21; 8:45 am]
SUMMARY:
The company plans to manufacturer
the listed controlled substances in bulk
for distribution and sale to its
customers.
In reference to drug code 7360
(Marihuana) and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as a synthetic. No other activities for
this drug code are authorized for this
registration.
William T. McDermott,
Assistant Administrator.
activity for these drug codes is
authorized for this registration.
DEPARTMENT OF JUSTICE
Sfmt 4703
Importer of Controlled Substances
Application: Myonex Inc
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Myonex Inc has applied to be
registered as an importer of basic
class(es) of controlled substance(s).
Refer to Supplemental Information
listed below for further drug
information.
SUMMARY:
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before March 29, 2021. Such persons
may also file a written request for a
hearing on the application on or before
March 29, 2021.
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 a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All request for a 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: In
accordance with 21 CFR 1301.34(a), this
is notice that on January 6, 2021,
Myonex Inc, 48 East Main Street,
Norristown, Pennsylvania 19401–4915,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
DATES:
Controlled substance
Amphetamine .................
Lisdexamfetamine ..........
Methylphenidate .............
E:\FR\FM\25FEN1.SGM
25FEN1
Drug
code
Schedule
1100
1205
1724
II
II
II
Federal Register / Vol. 86, No. 36 / Thursday, February 25, 2021 / Notices
Controlled substance
Nabilone .........................
Oxycodone .....................
Hydromorphone ..............
Hydrocodone ..................
Morphine .........................
Oxymorphone .................
Fentanyl ..........................
Drug
code
Schedule
7379
9143
9150
9193
9300
9652
9801
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
business activity is consistent with what
is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the
import of the Food and Drug
Administration (FDA)-approved or nonapproved finished dosage forms for
commercial sale. No other activity for
these drug codes is authorized for this
registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021–03919 Filed 2–24–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the
Comprehensive Environmental
Response, Compensation, and Liability
Act
On February 18, 2021, the Department
of Justice lodged a proposed consent
decree with the United States District
Court for the Eastern District of
Wisconsin in the lawsuit entitled
United States v. Wisconsin Public
Service Corporation, Civil Action No.
21–cv–00211.
The United States filed this lawsuit
under the Comprehensive
Environmental Response, Compensation
and Liability Act (‘‘CERCLA’’). The
complaint names Wisconsin Public
Service Corporation (‘‘WPSC’’) as the
defendant. The complaint requests
recovery of costs that the United States
incurred responding to releases of
hazardous substances at the Wisconsin
Public Service Corporation Manitowoc
MGP Superfund Alternative Site in
Manitowoc, Wisconsin. The complaint
also seeks injunctive relief at operable
unit 1 of the Site. In return, the United
States agrees not to sue WPSC under
sections 106 and 107 of CERCLA and
Section 7003 of the Solid Waste
Disposal Act, 42 U.S.C. 6901–6992 (also
known as the Resource Conservation
and Recovery Act (‘‘RCRA’’)).
Commentors may request an
VerDate Sep<11>2014
17:04 Feb 24, 2021
Jkt 253001
opportunity for a public meeting in the
affected area, in accordance with
Section 7003(d) of RCRA.
The publication of this notice opens
a period for public comment on the
consent decree. Comments should be
addressed to the Assistant Attorney
General, Environment and Natural
Resources Division, and should refer to
United States v. Wisconsin Public
Service Corporation, D.J. Ref. No. 90–
11–3–12152. All comments must be
submitted no later than thirty (30) days
after the publication date of this notice.
Comments may be submitted either by
email or by mail:
To submit
comments:
Send them to:
By email .......
pubcomment-ees.enrd@
usdoj.gov.
Assistant Attorney General,
U.S. DOJ—ENRD, P.O.
Box 7611, Washington,
D.C. 20044–7611.
By mail .........
During the public comment period,
the consent decree may be examined
and downloaded at this Justice
Department website: https://
www.usdoj.gov/enrd/Consent_
Decrees.html. We will provide a paper
copy of the consent decree upon written
request and payment of reproduction
costs. Please mail your request and
payment to: Consent Decree Library,
U.S. DOJ—ENRD, P.O. Box 7611,
Washington, DC 20044–7611.
Please enclose a check or money order
for $43.50 (25 cents per page
reproduction cost) payable to the United
States Treasury. For a paper copy
without the exhibits and signature
pages, the cost is $11.50.
Patricia McKenna,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2021–03880 Filed 2–24–21; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
[OMB Number NEW]
Agency Information Collection
Activities; Proposed eCollection,
eComments Requested; Law
Enforcement Public Contact Data
Collection
Federal Bureau of
Investigation, Department of Justice.
ACTION: 60-Day notice.
AGENCY:
The Department of Justice,
Federal Bureau of Investigation,
Criminal Justice Information Services
SUMMARY:
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
11559
Division, will be submitting the
following information collection request
to the Office of Management and Budget
for review and approval in accordance
with the Paperwork Reduction Act of
1995.
DATES: Comments are encouraged and
will be accepted for 60 days until April
26, 2021.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments
especially 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
Mrs. Amy C. Blasher, Unit Chief,
Federal Bureau of Investigation,
Criminal Justice Information Services
Division, Module E–3, 1000 Custer
Hollow Road, Clarksburg, West Virginia
26306; acblasher@fbi.gov.
SUPPLEMENTARY INFORMATION: 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 Federal Bureau of
Investigation, 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 how the quality, utility, and
clarity of the information 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 technological
collection techniques or other forms
of information technology, e.g.,
permitting electronic submission of
responses.
Overview of This Information
Collection
1. Type of Information Collection:
Establishment of a New Collection.
2. The Title of the Form/Collection:
Law Enforcement Public Contact Data
Collection.
3. The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
There is no form number for this
collection. The applicable component
within the Department of Justice is the
Criminal Justice Information Services
E:\FR\FM\25FEN1.SGM
25FEN1
]]>Agencies
[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Notices]
[Pages 11558-11559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03919]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA798]
Importer of Controlled Substances Application: Myonex Inc
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Myonex Inc has applied to be registered as an importer of
basic class(es) of controlled substance(s). Refer to Supplemental
Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may file written comments on or objections to
the issuance of the proposed registration on or before March 29, 2021.
Such persons may also file a written request for a hearing on the
application on or before March 29, 2021.
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 a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
request for a 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: In accordance with 21 CFR 1301.34(a), this
is notice that on January 6, 2021, Myonex Inc, 48 East Main Street,
Norristown, Pennsylvania 19401-4915, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................ 1100 II
Lisdexamfetamine....................... 1205 II
Methylphenidate........................ 1724 II
[[Page 11559]]
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 business activity is
consistent with what is authorized under 21 U.S.C. 952(a)(2).
Authorization will not extend to the import of the Food and Drug
Administration (FDA)-approved or non-approved finished dosage forms for
commercial sale. No other activity for these drug codes is authorized
for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-03919 Filed 2-24-21; 8:45 am]
BILLING CODE P
