Importer of Controlled Substances Application: Aurobindo Pharma USA, Inc., 44404-44405 [2023-14759]
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Federal Register / Vol. 88, No. 132 / Wednesday, July 12, 2023 / Notices
Controlled Substance
Drug Code
Meperidine .............................................................................................................................................................................
Meperidine-intermediate-A ....................................................................................................................................................
Meperidine intermediate-B ....................................................................................................................................................
Meperidine intermediate-C ....................................................................................................................................................
Metazocine ............................................................................................................................................................................
Oliceridine ..............................................................................................................................................................................
Methadone .............................................................................................................................................................................
Methadone intermediate ........................................................................................................................................................
Metopon .................................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ....................................................................................................................
Morphine ................................................................................................................................................................................
Oripavine ...............................................................................................................................................................................
Thebaine ................................................................................................................................................................................
Dihydroetorphine ...................................................................................................................................................................
Opium, raw ............................................................................................................................................................................
Opium extracts ......................................................................................................................................................................
Opium fluid extract ................................................................................................................................................................
Opium tincture .......................................................................................................................................................................
Opium, powdered ..................................................................................................................................................................
Opium, granulated .................................................................................................................................................................
Levo-alphacetylmethadol .......................................................................................................................................................
Opium poppy .........................................................................................................................................................................
Oxymorphone ........................................................................................................................................................................
Noroxymorphone ...................................................................................................................................................................
Poppy Straw Concentrate .....................................................................................................................................................
Phenazocine ..........................................................................................................................................................................
Thiafentanil ............................................................................................................................................................................
Piminodine .............................................................................................................................................................................
Racemethorphan ...................................................................................................................................................................
Racemorphan ........................................................................................................................................................................
Alfentanil ................................................................................................................................................................................
Remifentanil ...........................................................................................................................................................................
Sufentanil ...............................................................................................................................................................................
Carfentanil .............................................................................................................................................................................
Tapentadol .............................................................................................................................................................................
Bezitramide ............................................................................................................................................................................
Fentanyl .................................................................................................................................................................................
Moramide-intermediate ..........................................................................................................................................................
The company plans to import
analytical reference standards for
distribution to its customers for research
and analytics purposes. Placement of
these drug codes onto the company’s
registration does not translate into
automatic approval of subsequent
permit applications to import controlled
substances. Approval of permit
applications will occur only when the
registrant’s business activity is
consistent with what is authorized in 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–14728 Filed 7–11–23; 8:45 am]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1225]
Importer of Controlled Substances
Application: Aurobindo Pharma USA,
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Aurobindo Pharma USA, Inc.
has applied to be registered as an
importer of basic class(es) of controlled
substance(s). Refer to Supplementary
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 August 11, 2023. Such
persons may also file a written request
for a hearing on the application on or
before August 11, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
SUMMARY:
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9232
9233
9234
9240
9245
9250
9254
9260
9273
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9330
9333
9334
9600
9610
9620
9630
9639
9640
9648
9650
9652
9668
9670
9715
9729
9730
9732
9733
9737
9739
9740
9743
9780
9800
9801
9802
Schedule
II
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II
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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
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,
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Federal Register / Vol. 88, No. 132 / Wednesday, July 12, 2023 / Notices
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on April 18, 2023,
Aurobindo Pharma USA, Inc., 6
Wheeling Road, Dayton, New Jersey
08810–1526, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
Controlled
substance
Drug
code
Remifentanil ..................
9739
Schedule
II
The company plans to import
Remifentanil (9739) in bulk form for
research and development. 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–14759 Filed 7–11–23; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1110–0NEW]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Lawful Access
Data Collection
Federal Bureau of
Investigation, Department of Justice.
ACTION: 30-Day notice.
AGENCY:
The Department of Justice
(DOJ), Federal Bureau of Investigation
(FBI), Criminal Justice Information
Services (CJIS) Division 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.
The proposed information collection
was previously published in the Federal
Register on April 24, 2023, allowing a
60-day comment period.
DATES: Comments are encouraged and
will be accepted for 30 days until
August 11, 2023.
FOR FURTHER INFORMATION CONTACT: If
you have comments especially on the
estimated public burden or associated
response time, suggestions, or need a
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copy of the proposed information
collection instrument with instructions
or additional information, please
contact: Mr. Edward L. Abraham, Unit
Chief, FBI, CJIS Division, Module D–1,
1000 Custer Hollow Road, Clarksburg,
West Virginia 26306, phone number
304–625–4830.
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:
SUPPLEMENTARY INFORMATION:
—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;
—Enhance the quality, utility, and
clarity of the information to be
collected; and/or
—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.
Written comments and
recommendations for this information
collection should be submitted within
30 days of the publication of this notice
on the following website
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
30-day Review—Open for Public
Comments’’ or by using the search
function and entering either the title of
the information collection. This
information collection request may be
viewed at www.reginfo.gov. Follow the
instructions to view Department of
Justice, information collections
currently under review by OMB.
DOJ seeks PRA authorization for this
information collection for three (3)
years. OMB authorization for an ICR
cannot be for more than three (3) years
without renewal. The DOJ notes that
information collection requirements
submitted to the OMB for existing ICRs
receive a month-to-month extension
while they undergo review.
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44405
Overview of This Information
Collection
1. Type of Information Collection:
New collection.
2. Title of the Form/Collection: Lawful
Access Data Collection.
3. Agency form number, if any, and
the applicable component of the
Department of Justice sponsoring the
collection: There is no form number for
this collection. The applicable
component within the Department of
Justice is the CJIS Division, in the FBI.
4. Affected public who will be asked
or required to respond, as well as a brief
abstract:
Affected Public: (State, Local and
Tribal Governments) Law enforcement
agencies and state/local digital forensic
laboratories.
Abstract: This collection is needed to
collect data on the volume of law
enforcement investigations that are
negatively impacted by device and
software encryption.
5. Obligation to Respond: Voluntary.
6. Total Estimated Number of
Respondents: 19,000.
7. Estimated Time per Respondent: 3
minutes, 12 seconds.
8. Frequency: 50 times annually.
9. Total Estimated Annual Time
Burden: 50,967 hours.
Total annual responses = 950,000
[19,000 × 50]
Annual burden = ([(950,000 × 192
seconds)/60]/60) = 50,667 hours
10. Total Estimated Annual Other
Costs Burden: $0.
If additional information is required,
contact: Darwin Arceo, Department
Clearance Officer, Policy and Planning
Staff, Justice Management Division,
United States Department of Justice,
Two Constitution Square, 145 N Street
NE, 4W–218 Washington, DC 20530.
Dated: July 7, 2023.
Darwin Arceo,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2023–14755 Filed 7–11–23; 8:45 am]
BILLING CODE 4410–02–P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the
Comprehensive Environmental
Response, Compensation, and Liability
Act
On July 7, 2023, the Department of
Justice lodged a proposed consent
decree with the United States District
Court for the District of Massachusetts
in United States and Commonwealth of
Massachusetts v. Massachusetts Electric
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]]>Agencies
[Federal Register Volume 88, Number 132 (Wednesday, July 12, 2023)]
[Notices]
[Pages 44404-44405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14759]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1225]
Importer of Controlled Substances Application: Aurobindo Pharma
USA, Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Aurobindo Pharma USA, Inc. has applied to be registered as an
importer of basic class(es) of controlled substance(s). Refer to
Supplementary 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
August 11, 2023. Such persons may also file a written request for a
hearing on the application on or before August 11, 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 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,
[[Page 44405]]
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on April 18, 2023, Aurobindo Pharma USA, Inc., 6
Wheeling Road, Dayton, New Jersey 08810-1526, applied to be registered
as an importer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Remifentanil........................... 9739 II
------------------------------------------------------------------------
The company plans to import Remifentanil (9739) in bulk form for
research and development. 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 non-approved finished
dosage forms for commercial sale.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023-14759 Filed 7-11-23; 8:45 am]
BILLING CODE 4410-09-P
