Importer of Controlled Substances Application: ANI Pharmaceuticals Inc., 53926-53927 [2023-17034]
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Federal Register / Vol. 88, No. 152 / Wednesday, August 9, 2023 / Notices
Controlled substance
Drug code
Normethadone .................................................................................................................................................................
Racemoramide ................................................................................................................................................................
Trimeperidine ...................................................................................................................................................................
1-Methyl-4-phenyl-4-propionoxypiperidine ......................................................................................................................
Tilidine .............................................................................................................................................................................
Para-Fluorofentanyl .........................................................................................................................................................
3-Methylfentanyl ..............................................................................................................................................................
Alpha-methylfentanyl .......................................................................................................................................................
Acetyl-alpha-methylfentanyl .............................................................................................................................................
Beta-hydroxyfentanyl .......................................................................................................................................................
Beta-hydroxy-3-methylfentanyl ........................................................................................................................................
Alpha-methylthiofentanyl .................................................................................................................................................
3-Methylthiofentanyl .........................................................................................................................................................
Thiofentanyl .....................................................................................................................................................................
Fentanyl related-compounds as defined in 21 CFR 1308.11(h) .....................................................................................
Methamphetamine ...........................................................................................................................................................
Methylphenidate ..............................................................................................................................................................
Amobarbital ......................................................................................................................................................................
Pentobarbital ....................................................................................................................................................................
Secobarbital .....................................................................................................................................................................
Glutethimide .....................................................................................................................................................................
Nabilone ...........................................................................................................................................................................
1-Phenylcyclohexylamine ................................................................................................................................................
Phencyclidine ...................................................................................................................................................................
Phenylacetone .................................................................................................................................................................
1-Piperidinocyclohexanecarbonitrile ................................................................................................................................
Alphaprodine ....................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Ethylmorphine ..................................................................................................................................................................
Levomethorphan ..............................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Meperidine .......................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ..............................................................................................................
Levo-alphacetylmethadol .................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
Racemethorphan .............................................................................................................................................................
Alfentanil ..........................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Sufentanil .........................................................................................................................................................................
Carfentanil .......................................................................................................................................................................
Tapentadol .......................................................................................................................................................................
lotter on DSK11XQN23PROD with NOTICES1
The company plans to import the
listed controlled substances for the
manufacturing of analytical reference
standards and distribution to their
research and forensic customers. No
other activities for these drug codes are
authorized for this registration.
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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–17037 Filed 8–8–23; 8:45 am]
BILLING CODE P
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Jkt 259001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1235]
Importer of Controlled Substances
Application: ANI Pharmaceuticals Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
ANI Pharmaceuticals 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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before September 8, 2023. Such
persons may also file a written request
SUMMARY:
PO 00000
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Fmt 4703
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9635
9645
9646
9661
9750
9812
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9830
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9835
9850
1105
1724
2125
2270
2315
2550
7379
7460
7471
8501
8603
9010
9120
9180
9190
9210
9220
9230
9273
9648
9668
9732
9737
9739
9740
9743
9780
Schedule
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
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II
for a hearing on the application on or
before September 8, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or 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 submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.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. All
requests for a hearing must be sent to:
(1) Drug Enforcement Administration,
Attn: Hearing Clerk/OALJ, 8701
Morrissette Drive, Springfield, Virginia
E:\FR\FM\09AUN1.SGM
09AUN1
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Federal Register / Vol. 88, No. 152 / Wednesday, August 9, 2023 / Notices
22152; and (2) Drug Enforcement
Administration, Attn: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on June 16, 2023, ANI
Pharmaceuticals Inc., 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
Drug
code
Controlled substance
Tapentadol ....................
Schedule
9780
II
The substance Tapentadol (9780) will
be used in small quantities in support
of the development of a drug product for
Abbreviated New Drug submission and
eventual marketing. No other activity for
these drug codes are authorized for this
registration.
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 Food Drug Administrationapproved or non-approved finished
dosage forms for commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–17034 Filed 8–8–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
[OMB Number 1125–0005]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Revision of a
Previously Approved Collection;
Notice of Entry of Appearance as
Attorney or Representative Before the
Board of Immigration Appeals
Executive Office for
Immigration Review, Department of
Justice.
AGENCY:
ACTION:
60-Day notice.
The Executive Office for
Immigration Review (EOIR), Department
of Justice (DOJ), will be submitting 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.
DATES: Comments are encouraged and
will be accepted for 60 days until
October 10, 2023.
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
Lauren Alder Reid, Assistant Director,
Office of Policy, Executive Office for
Immigration Review, 5107 Leesburg
Pike, Suite 2500, Falls Church, VA
22041, telephone: (703) 305–0289 or
lauren.alder.reid@usdoj.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 Bureau of Justice
Statistics, 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 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.,
SUMMARY:
Number of
respondents
lotter on DSK11XQN23PROD with NOTICES1
Activity
EOIR–27 ..............................................................................
If additional information is required
contact: Darwin Arceo, Department
Clearance Officer, United States
VerDate Sep<11>2014
18:19 Aug 08, 2023
Jkt 259001
Frequency
42,126
1/annually
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
permitting electronic submission of
responses.
Abstract: This information collection
is necessary to allow a practitioner of
record to notify the Board that he or she
is representing a party before the Board.
EOIR is updating the information
regarding how to obtain automated case
information. In addition, EOIR is
clarifying that a practitioner of record is
authorized to file a notice of entry of
appearance before the Board of
Immigration Appeals, as distinguished
from the entry of a limited appearance.
Overview of This Information
Collection
1. Type of Information Collection:
Revision of a previously approved
collection.
2. The Title of the Form/Collection:
Notice of Entry of Appearance as
Attorney or Representative Before the
Board of Immigration Appeals.
3. The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
EOIR–27. The sponsoring business
component: EOIR.
4. Affected public who will be asked
or required to respond, as well as the
obligation to respond: Affected Public:
Individuals or households. The
obligation to respond is mandatory per
8 CFR 1003.38(g) and 8 CFR
1003.2(g)(1).
5. An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: It is estimated that 42,126
respondents will complete each form
within approximately 6 minutes.
6. An estimate of the total annual
burden (in hours) associated with the
collection: 4,213 annual burden hours.
7. An estimate of the total annual cost
burden associated with the collection:
$331,732.
Total annual
responses
42,126
Time per
response
Total annual
burden
(hours)
6 min
Square, 145 N Street NE, 4W–218,
Washington, DC.
E:\FR\FM\09AUN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 152 (Wednesday, August 9, 2023)]
[Notices]
[Pages 53926-53927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17034]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1235]
Importer of Controlled Substances Application: ANI
Pharmaceuticals Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: ANI Pharmaceuticals 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 submit electronic comments on or
objections to the issuance of the proposed registration on or before
September 8, 2023. Such persons may also file a written request for a
hearing on the application on or before September 8, 2023.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or 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
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.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. All
requests for a hearing must be sent to: (1) Drug Enforcement
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive,
Springfield, Virginia
[[Page 53927]]
22152; and (2) Drug Enforcement Administration, Attn: DEA Federal
Register Representative/DPW, 8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a hearing should also be sent to: Drug
Enforcement Administration, Attn: Administrator, 8701 Morrissette
Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on June 16, 2023, ANI Pharmaceuticals Inc., 70 Lake
Drive, East Windsor, New Jersey 08520, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Tapentadol............................. 9780 II
------------------------------------------------------------------------
The substance Tapentadol (9780) will be used in small quantities in
support of the development of a drug product for Abbreviated New Drug
submission and eventual marketing. No other activity for these drug
codes are authorized for this registration.
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 Food Drug
Administration-approved or non-approved finished dosage forms for
commercial sale.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-17034 Filed 8-8-23; 8:45 am]
BILLING CODE P
