Bulk Manufacturer of Controlled Substances Application: PCI Synthesis, 63622-63623 [2023-19989]
Download as PDF
<![CDATA[
63622
Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1266]
Importer of Controlled Substances
Application: Benuvia Operations, LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Benuvia Operations, LLC 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
SUMMARY:
on or before October 16, 2023. Such
persons may also file a written request
for a hearing on the application on or
before October 16, 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,
8701 Morrissette Drive, Springfield,
Virginia 22152.
In
accordance with 21 CFR 1301.34(a), this
is notice that on August 10, 2023,
Benuvia Operations, LLC, 3950 North
Mays Street, Round Rock, Texas 78665–
2729, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug code
Ibogaine ...........................................................................................................................................................................
Tetrahydrocannabinols ....................................................................................................................................................
Mescaline .........................................................................................................................................................................
3,4-Methylenedioxyamphetamine ....................................................................................................................................
3,4-Methylenedioxymethamphetamine ............................................................................................................................
5-Methoxy-N,N-dimethyltryptamine .................................................................................................................................
Dimethyltryptamine ..........................................................................................................................................................
Psilocybin .........................................................................................................................................................................
Psilocyn ...........................................................................................................................................................................
5-Methoxy-N,N-diisopropyltryptamine .............................................................................................................................
Dronabinol in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration
The company plans to import the
listed controlled substances for clinical
trial manufacturing and analytical
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.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–19998 Filed 9–14–23; 8:45 am]
ddrumheller on DSK120RN23PROD with NOTICES1
BILLING CODE P
VerDate Sep<11>2014
17:05 Sep 14, 2023
Jkt 259001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1248]
Bulk Manufacturer of Controlled
Substances Application: PCI Synthesis
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
PCI Synthesis 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 November 14, 2023. Such
persons may also file a written request
for a hearing on the application on or
before November 14, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
SUMMARY:
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
7260
7370
7381
7400
7405
7431
7435
7437
7438
7439
7365
Schedule
I
I
I
I
I
I
I
I
I
I
II
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 March 30, 2023, PCI
Synthesis, 9 Opportunity Way,
Newburyport, Massachusetts 01950–
0195, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Amphetamine ...............
E:\FR\FM\15SEN1.SGM
15SEN1
Drug
code
1100
Schedule
II
Federal Register / Vol. 88, No. 178 / Friday, September 15, 2023 / Notices
Controlled substance
Methamphetamine ........
Drug
code
Schedule
1105
II
The company plans to develop
manufacturing processes, conduct
analytical method validation and
conduct bulk product stability studies.
No other activities for these drug codes
are authorized for this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023–19989 Filed 9–14–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
[OMB Number 1140–0017]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Annual
Firearms Manufacturing and
Exportation Report (AFMER)
Bureau of Alcohol, Tobacco,
Firearms and Explosives, Department of
Justice.
ACTION: 30-Day notice.
AGENCY:
The Bureau of Alcohol,
Tobacco, Firearms and Explosives
(ATF), 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.
The proposed information collection
was previously published in the Federal
Register, on July 6, 2023, allowing a 60day comment period.
DATES: Comments are encouraged and
will be accepted for 30 days until
October 16, 2023.
FOR FURTHER INFORMATION CONTACT: If
you have 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: Leslie Anderson, by email at
Leslie.anderson@atf.gov, or by
telephone at 301–616–4634.
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 agency, including
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:05 Sep 14, 2023
Jkt 259001
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 or the OMB
Control Number 1140–0017. 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.
Overview of This Information
Collection
1. Type of Information Collection:
Revision of a previously approved
collection.
2. Title of the Form/Collection:
Annual Firearms Manufacturing and
Exportation Report (AFMER).
3. Agency form number, if any, and
the applicable component of the
Department of Justice sponsoring the
collection: ATF Form 5300.11.
Component: Bureau of Alcohol,
Tobacco, Firearms and Explosives, U.S.
Department of Justice.
4. Affected public who will be asked
or required to respond, as well as a brief
abstract: Private Sector—Businesses or
other for-profit.
Abstract: The information collected is
used to compile statistics on the
PO 00000
Frm 00074
Fmt 4703
Sfmt 9990
63623
manufacture and exportation of
firearms. The furnishing of this
information is mandatory under 18
U.S.C. 923(g)(5)(A). This form must be
submitted annually for every Type 07
and Type 10 Federal Firearms Licensees
(FFLs), even if no firearms were
exported or distributed into commerce.
The information collection (IC) OMB
#1140–0017 is being revised due to
material and non-material changes to
the form, such as added instructions,
definitions, formatting changes (to
adjust form length), bolded lines (to
fillable boxes), grammatical changes
(sentence rephrasing/statement
modification), and instruction
clarification.
5. Obligation to Respond: Mandatory.
The statutory requirements are
implemented under 18 U.S.C. chapter
44.
6. Total Estimated Number of
Respondents: 19,200 respondents.
7. Estimated Time per Respondent: 20
minutes.
8. Frequency: Once annually.
9. Total Estimated Annual Time
Burden: 6,400 hours.
10. Total Estimated Annual Other
Costs Burden: No new cost is associated
with this collection. All respondents
can electronically submit the AFMER to
ATF free of charge, however, it is
estimated that half the respondents
submit the form to the Federal Firearms
Licensing Center by mail. The annual
cost has increased due to a change in
the postal rate from $0.55 during the last
renewal in 2020, to $0.63 in 2023.
Consequently, the new public cost
burden will be reported as $6,048.00,
which is equal to $0.63 (mailing cost per
respondent) * 19,200 (# of respondents)
* 50% (percentage of responses
submitted by mail).
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: September 11, 2023.
Darwin Arceo,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2023–19941 Filed 9–14–23; 8:45 am]
BILLING CODE 4410–14–P
E:\FR\FM\15SEN1.SGM
15SEN1
]]>Agencies
[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63622-63623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-19989]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1248]
Bulk Manufacturer of Controlled Substances Application: PCI
Synthesis
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: PCI Synthesis 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
November 14, 2023. Such persons may also file a written request for a
hearing on the application on or before November 14, 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on March 30, 2023, PCI Synthesis, 9 Opportunity Way,
Newburyport, Massachusetts 01950-0195, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................ 1100 II
[[Page 63623]]
Methamphetamine........................ 1105 II
------------------------------------------------------------------------
The company plans to develop manufacturing processes, conduct
analytical method validation and conduct bulk product stability
studies. No other activities for these drug codes are authorized for
this registration.
Claude Redd,
Acting Deputy Assistant Administrator.
[FR Doc. 2023-19989 Filed 9-14-23; 8:45 am]
BILLING CODE P
