Bulk Manufacturer of Controlled Substances Application: Isosciences, LLC, 93346-93348 [2024-27693]
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93346
Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices
Controlled substance
Drug code
Gamma Hydroxybutyric Acid .....................................................................................................................................
Lysergic acid diethylamide ........................................................................................................................................
Marihuana ..................................................................................................................................................................
Tetrahydrocannabinols ..............................................................................................................................................
3,4-Methylenedioxyamphetamine ..............................................................................................................................
3,4-Methylenedioxymethamphetamine ......................................................................................................................
5-Methoxy-N–N-dimethyltryptamine ..........................................................................................................................
Alpha-Methyltryptamine .............................................................................................................................................
Bufotenine ..................................................................................................................................................................
Diethyltryptamine .......................................................................................................................................................
Dimethyltryptamine ....................................................................................................................................................
Psilocybin ...................................................................................................................................................................
Psilocyn .....................................................................................................................................................................
2-(2,5-Dimethoxy-4-methylphenyl) ethanamine (2C–D) ............................................................................................
2-(2,5-Dimethoxyphenyl) ethanamine (2C–H) ...........................................................................................................
Heroin ........................................................................................................................................................................
Morphine ....................................................................................................................................................................
The company plans to synthesize the
listed controlled substances for
distribution to its customers. In
reference to drug codes 7360
(Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–27674 Filed 11–25–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1446]
Importer of Controlled Substances
Application: National Center for
Natural Products Research
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
National Center for Natural
Products Research 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.
SUMMARY:
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 December 26, 2024. Such
persons may also file a written request
for a hearing on the application on or
before December 26, 2024.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
lotter on DSK11XQN23PROD with NOTICES1
DATES:
VerDate Sep<11>2014
18:03 Nov 25, 2024
Jkt 265001
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,
8701 Morrissette Drive, Springfield,
Virginia 22152.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on September 16, 2024,
National Center for Natural Products
Research, 806 Hathorn Road, 135 Coy
Waller Lab, University, Mississippi
38677 applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
Drug
code
Controlled substance
Marihuana ......................
Tetrahydrocannabinols ..
I
7360
7370
Schedule
I
I
I
The company plans to acquire new
genetic materials with improved
cannabinoids for research and
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2010
7315
7360
7370
7400
7405
7431
7432
7433
7434
7435
7437
7438
7508
7517
9200
9300
Schedule
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manufacturing purposes. 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. 2024–27694 Filed 11–25–24; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1458]
Bulk Manufacturer of Controlled
Substances Application: Isosciences,
LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Isosciences, LLC has applied
to be registered as a bulk manufacturer
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 January 27, 2025. Such
persons may also file a written request
for a hearing on the application on or
before January 27, 2025.
ADDRESSES: The Drug Enforcement
Administration requires that all
SUMMARY:
E:\FR\FM\26NON1.SGM
26NON1
93347
Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices
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.
In
accordance with 21 CFR 1301.33(a), this
is notice that on October 28, 2024,
Isosciences, LLC, 340 Mathers Road,
Ambler, Pennsylvania 19002–3420
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
Controlled substance
Drug code
Cathinone .........................................................................................................................................................................
Methcathinone ..................................................................................................................................................................
Lysergic acid diethylamide ...............................................................................................................................................
Marihuana .........................................................................................................................................................................
Tetrahydrocannabinols .....................................................................................................................................................
3,4-Methylenedioxyamphetamine .....................................................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine ........................................................................................................................
3,4-Methylenedioxymethamphetamine .............................................................................................................................
5-Methoxy-N-N-dimethyltryptamine ..................................................................................................................................
Alpha-methyltryptamine ....................................................................................................................................................
Bufotenine ........................................................................................................................................................................
Diethyltryptamine ..............................................................................................................................................................
Dimethyltryptamine ...........................................................................................................................................................
Psilocybin .........................................................................................................................................................................
Psilocyn ............................................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine ..............................................................................................................................
Dihydromorphine ..............................................................................................................................................................
Heroin ...............................................................................................................................................................................
Nicocodeine ......................................................................................................................................................................
Nicomorphine ...................................................................................................................................................................
Normorphine .....................................................................................................................................................................
Thebacon ..........................................................................................................................................................................
Normethadone ..................................................................................................................................................................
Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) ..................................................................................
Para-Fluorofentanyl ..........................................................................................................................................................
3-Methylfentanyl ...............................................................................................................................................................
Alpha-methylfentanyl ........................................................................................................................................................
Acetyl-alpha-methylfentanyl .............................................................................................................................................
N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide ........................................................................................
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ................................................................................
Butyryl Fentanyl ................................................................................................................................................................
4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) ..........................................
2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide ..........................................................................................
Beta-hydroxyfentanyl ........................................................................................................................................................
Beta-hydroxy-3-methylfentanyl .........................................................................................................................................
Alpha-methylthiofentanyl ..................................................................................................................................................
3-Methylthiofentanyl .........................................................................................................................................................
Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide) ..............................................................
Thiofentanyl ......................................................................................................................................................................
Beta-hydroxythiofentanyl ..................................................................................................................................................
N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide ...........................................................................
Amphetamine ...................................................................................................................................................................
Methamphetamine ............................................................................................................................................................
Codeine ............................................................................................................................................................................
Dihydrocodeine .................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ................................................................................................................................................................
Hydrocodone ....................................................................................................................................................................
Isomethadone ...................................................................................................................................................................
Methadone ........................................................................................................................................................................
Methadone intermediate ...................................................................................................................................................
Morphine ...........................................................................................................................................................................
Thebaine ...........................................................................................................................................................................
Levo-alphacetylmethadol ..................................................................................................................................................
Oxymorphone ...................................................................................................................................................................
Thiafentanil .......................................................................................................................................................................
Alfentanil ...........................................................................................................................................................................
Sufentanil ..........................................................................................................................................................................
Carfentanil ........................................................................................................................................................................
Fentanyl ............................................................................................................................................................................
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1235
1237
7315
7360
7370
7400
7404
7405
7431
7432
7433
7434
7435
7437
7438
7439
9145
9200
9309
9312
9313
9315
9635
9811
9812
9813
9814
9815
9816
9821
9822
9824
9825
9830
9831
9832
9833
9834
9835
9836
9843
1100
1105
9050
9120
9143
9150
9193
9226
9250
9254
9300
9333
9648
9652
9729
9737
9740
9743
9801
Schedule
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93348
Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices
The company plans to bulk
manufacture the listed controlled
substances to be used in analytical
testing. In reference to drug codes 7360
(Marihuana), and 7370
(Tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetic. No other activities for these
drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–27693 Filed 11–25–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
[OMB Number 1117–0049]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Revision
Without Change of a Previously
Approved Collection Recordkeeping
for Electronic Prescriptions for
Controlled Substances
Drug Enforcement
Administration, Department of Justice.
ACTION: 60-Day notice.
AGENCY:
The Department of Justice
(DOJ), Drug Enforcement
Administration (DEA), 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
January 27, 2025.
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
Heather E. Achbach, Regulatory Drafting
and Policy Support Section, Drug
Enforcement Administration; Mailing
Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone:
(571) 776–3882; Email:
SUMMARY:
Heather.E.Achbach@dea.gov or
DEA.PRA@dea.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.,
permitting electronic submission of
responses.
Overview of This Information
Collection
1. Type of Information Collection:
Revision of a currently approved
collection.
2. Title of the Form/Collection:
Recordkeeping for Electronic
Prescriptions for Controlled Substances.
3. The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
No form number is associated with this
collection. The applicable component
within the Department of Justice is the
Drug Enforcement Administration,
Diversion Control Division.
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: DEA is requiring that each
registered practitioner apply to an
approved credential service provider
approved to obtain identity proofing
and a credential. Hospitals and other
institutional practitioners may conduct
this process in-house as part of their
credentialing. For practitioners
currently working at or affiliated with a
registered hospital or clinic, the
hospital/clinic have to check a
government-issued photographic
identification. This may be done when
the hospital/clinic issues credentials to
new hires or newly affiliated
physicians. For individual practitioners,
two people need to enter logical access
control data to grant permissions for
practitioners authorized to approve and
sign controlled substance prescriptions
using the electronic prescription
application. For institutional
practitioners, logical access control data
is entered by two people from an entity
within the hospital/clinic that is
separate from the entity that conduct
identity proofing in-house. Similarly,
pharmacies have to set logical access
controls in the pharmacy application so
that only authorized employees have
permission to annotate or alter
prescription records. Finally, if the
electronic prescription or pharmacy
application generates an incident report,
practitioners, hospitals/clinics, and
pharmacies have to review the incident
report to determine if the event
identified by the application represents
a security incident.
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
158,884 registrants participate in this
information collection, taking an
estimated 40 minutes for Practitioner,
128 minutes for Hospital/Clinic, and 20
minutes for Pharmacy.
6. An estimate of the total public
burden (in hours) associated with the
proposed collection: DEA estimates that
this collection takes 107,733 annual
burden hours.
7. An estimate of the total annual cost
burden associated with the collection, if
applicable: $0.
lotter on DSK11XQN23PROD with NOTICES1
TOTAL BURDEN HOURS
Number of
respondents
Activity
Frequency
Total annual
responses
Time per response
Total annual
burden
(hours)
Practitioner .........................................................................
Hospital/Clinic ....................................................................
Pharmacy ...........................................................................
154,571
1,526
2,787
1
1
1
154,571
1,526
2,787
0.67 (40 minutes) ...
2.13 (128 minutes)
0.33 (20 minutes) ...
103,563
1,526
2,787
Unduplicated Totals ....................................................
158,884
N/A
158,884
1.043 ......................
107,733
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18:03 Nov 25, 2024
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26NON1
]]>Agencies
[Federal Register Volume 89, Number 228 (Tuesday, November 26, 2024)]
[Notices]
[Pages 93346-93348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27693]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1458]
Bulk Manufacturer of Controlled Substances Application:
Isosciences, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Isosciences, LLC has applied to be registered as a bulk
manufacturer 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
January 27, 2025. Such persons may also file a written request for a
hearing on the application on or before January 27, 2025.
ADDRESSES: The Drug Enforcement Administration requires that all
[[Page 93347]]
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on October 28, 2024, Isosciences, LLC, 340 Mathers Road,
Ambler, Pennsylvania 19002-3420 applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Cathinone........................... 1235 I
Methcathinone....................... 1237 I
Lysergic acid diethylamide.......... 7315 I
Marihuana........................... 7360 I
Tetrahydrocannabinols............... 7370 I
3,4-Methylenedioxyamphetamine....... 7400 I
3,4-Methylenedioxy-N- 7404 I
ethylamphetamine.
3,4-Methylenedioxymethamphetamine... 7405 I
5-Methoxy-N-N-dimethyltryptamine.... 7431 I
Alpha-methyltryptamine.............. 7432 I
Bufotenine.......................... 7433 I
Diethyltryptamine................... 7434 I
Dimethyltryptamine.................. 7435 I
Psilocybin.......................... 7437 I
Psilocyn............................ 7438 I
5-Methoxy-N,N-diisopropyltryptamine. 7439 I
Dihydromorphine..................... 9145 I
Heroin.............................. 9200 I
Nicocodeine......................... 9309 I
Nicomorphine........................ 9312 I
Normorphine......................... 9313 I
Thebacon............................ 9315 I
Normethadone........................ 9635 I
Acryl fentanyl (N-(1- 9811 I
phenethylpiperidin-4-yl)-N-
phenylacrylamide).
Para-Fluorofentanyl................. 9812 I
3-Methylfentanyl.................... 9813 I
Alpha-methylfentanyl................ 9814 I
Acetyl-alpha-methylfentanyl......... 9815 I
N-(2-fluorophenyl)-N-(1- 9816 I
phenethylpiperidin-4-
yl)propionamide.
Acetyl Fentanyl (N-(1- 9821 I
phenethylpiperidin-4-yl)-N-
phenylacetamide).
Butyryl Fentanyl.................... 9822 I
4-Fluoroisobutyryl fentanyl (N-(4- 9824 I
fluorophenyl)-N-(1-
phenethylpiperidin-4-
yl)isobutyramide).
2-methoxy-N-(1-phenethylpiperidin-4- 9825 I
yl)-N-phenylacetamide.
Beta-hydroxyfentanyl................ 9830 I
Beta-hydroxy-3-methylfentanyl....... 9831 I
Alpha-methylthiofentanyl............ 9832 I
3-Methylthiofentanyl................ 9833 I
Furanyl fentanyl (N-(1- 9834 I
phenethylpiperidin-4-yl)-N-
phenylfuran-2-carboxamide).
Thiofentanyl........................ 9835 I
Beta-hydroxythiofentanyl............ 9836 I
N-(1-phenethylpiperidin-4-yl)-N- 9843 I
phenyltetrahydrofuran-2-carboxamide.
Amphetamine......................... 1100 II
Methamphetamine..................... 1105 II
Codeine............................. 9050 II
Dihydrocodeine...................... 9120 II
Oxycodone........................... 9143 II
Hydromorphone....................... 9150 II
Hydrocodone......................... 9193 II
Isomethadone........................ 9226 II
Methadone........................... 9250 II
Methadone intermediate.............. 9254 II
Morphine............................ 9300 II
Thebaine............................ 9333 II
Levo-alphacetylmethadol............. 9648 II
Oxymorphone......................... 9652 II
Thiafentanil........................ 9729 II
Alfentanil.......................... 9737 II
Sufentanil.......................... 9740 II
Carfentanil......................... 9743 II
Fentanyl............................ 9801 II
------------------------------------------------------------------------
[[Page 93348]]
The company plans to bulk manufacture the listed controlled
substances to be used in analytical testing. In reference to drug codes
7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans
to bulk manufacture these drugs as synthetic. No other activities for
these drug codes are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-27693 Filed 11-25-24; 8:45 am]
BILLING CODE 4410-09-P
