Importer of Controlled Substances Application: Epic Pharma, LLC, 48693-48694 [2022-17178]
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48693
Federal Register / Vol. 87, No. 153 / Wednesday, August 10, 2022 / Notices
Controlled substance
Thebaine .......................
Opium extracts .............
Opium fluid extract .......
Opium tincture ..............
Opium, powdered .........
Oxymorphone ...............
Noroxymorphone ..........
Fentanyl ........................
Drug
code
Schedule
9333
9610
9620
9630
9639
9652
9668
9801
II
II
II
II
II
II
II
II
The company plans to manufacture
the listed controlled substances in bulk
for conversion to other controlled
substances and sales to its customers for
dosage form development, clinical trials
and use in stability qualification
studies.
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.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–17175 Filed 8–9–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
[Docket No. DEA–1057]
Tetrahydrocannabinols
Importer of Controlled Substances
Application: VA Cooperative Studies
Program
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
VA Cooperative Studies
Program 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 September 9, 2022. Such
persons may also file a written request
for a hearing on the application on or
before September 9, 2022.
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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
17:26 Aug 09, 2022
Jkt 256001
Drug
code
Controlled substance
Drug Enforcement Administration
VerDate Sep<11>2014
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 June 9, 2022, VA
Cooperative Studies Program, 2401
Centre Avenue SE, Albuquerque, New
Mexico 87106, applied to be registered
as an importer of the following basic
class(es) of controlled substance(s):
I
7370
Schedule
II
The company plans to import finished
dosage unit products containing
Tetrahydrocannabinols drug code (7370)
for research and clinical trial studies.
No other activity for this drug code is
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.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–17177 Filed 8–9–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
ACTION:
Notice of application.
Epic Pharma, 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
on or before September 9, 2022. Such
persons may also file a written request
for a hearing on the application on or
before September 9, 2022.
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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on July 19, 2022, Epic
Pharma, LLC, 22715 North Conduit
Avenue, Laurelton, New York 11413–
3134, applied to be registered as an
importer of the following basic class(es)
of controlled substance(s):
SUMMARY:
Controlled substance
Drug
code
Schedule
Drug Enforcement Administration
Methadone ....................
[Docket No. DEA–1066]
Importer of Controlled Substances
Application: Epic Pharma, LLC
Drug Enforcement
Administration, Justice.
AGENCY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
9250
II
The company plans to import the
listed controlled substance for research
and development purposes. No other
activity for this drug code is authorized
for this registration.
E:\FR\FM\10AUN1.SGM
10AUN1
48694
Federal Register / Vol. 87, No. 153 / Wednesday, August 10, 2022 / Notices
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.
Kristi O’Malley,
Assistant Administrator.
[FR Doc. 2022–17178 Filed 8–9–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Amendment to Consent Decree Under
the Clean Water Act
khammond on DSKJM1Z7X2PROD with NOTICES
On August 5, 2022, the Department of
Justice lodged a proposed third
amendment to a consent decree with the
United States District Court for the
Eastern District of Missouri in the
lawsuit entitled in United States, et al.
v. Metropolitan St. Louis Sewer District,
Civil Action No. 4:07–CV–01120.
Under the original 2012 consent
decree, the Metropolitan St. Louis
Sewer District (‘‘MSD’’) agreed to
undertake numerous measures to come
into compliance with the Clean Water
Act, including constructing three
combined sewer overflow (‘‘CSO’’)
storage tunnels. MSD still is in the
process of complying with the 2012
decree. The proposed amendment
would allow MSD to replace two of
these CSO storage tunnels with one
larger CSO storage tunnel to
accommodate overflows from all of the
outfalls related to the original two CSO
storage tunnels.
The publication of this notice opens
a period of public comment on the
proposed amendment. Comments
should be addressed to the Assistant
Attorney General, Environment and
Natural Resources Division, and should
refer to United States, et al. v.
Metropolitan St. Louis Sewer District,
D.J. Ref. No. 90–5–1–1–08111. 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, DC
20044–7611.
By mail .........
VerDate Sep<11>2014
17:26 Aug 09, 2022
Jkt 256001
During the public comment period,
the proposed amendment may be
examined and downloaded at this
Department of Justice website: https://
www.justice.gov/enrd/consent-decrees.
We will provide a paper copy of the
proposed amendment 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 in the amount
of $3.25 (25 cents per page reproduction
cost) payable to the United States
Treasury.
Susan M. Akers,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. 2022–17180 Filed 8–9–22; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
[Docket No. OSHA–2022–0002]
National Advisory Committee on
Occupational Safety and Health
(NACOSH): Notice of Meeting
Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Notice of NACOSH meeting.
AGENCY:
The National Advisory
Committee on Occupational Safety and
Health (NACOSH) will meet on
September 13, 2022. In conjunction
with the committee meeting, the
NACOSH Heat Injury and Illness
Prevention Work Group will meet
separately on September 12, 2022.
DATES:
NACOSH Work Group meeting: The
NACOSH Heat Injury and Illness
Prevention Work Group (Heat Work
Group) will meet from 1:00 p.m. to 2:00
p.m., ET, Monday, September 12, 2022.
NACOSH meeting: NACOSH will
meet from 10:00 a.m. to 4:30 p.m., ET,
Tuesday, September 13, 2022.
ADDRESSES:
Submission of comments and requests
to speak: Submit comments and
requests to speak at the NACOSH
meeting by September 6, 2022,
identified by the docket number for this
Federal Register notice (Docket No.
OSHA–2022–0002), using the following
method:
Electronically: Comments and
requests to speak, including
attachments, must be submitted
electronically at www.regulations.gov,
SUMMARY:
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
the Federal eRulemaking Portal. Follow
the online instructions for submitting
comments.
Requests for special accommodations:
Submit requests for special
accommodations for this NACOSH
meeting by September 6, 2022, to Ms.
Carla Marcellus, Directorate of
Standards and Guidance, OSHA, U.S.
Department of Labor; telephone: (202)
693–1865; email: marcellus.carla@
dol.gov.
Instructions: All submissions must
include the agency name and the OSHA
docket number for this Federal Register
notice (Docket No. OSHA–2022–0002).
OSHA will place comments and
requests to speak, including personal
information, in the public docket, which
may be available online. Therefore,
OSHA cautions interested parties about
submitting personal information such as
Social Security numbers and birthdates.
Docket: To read or download
documents in the public docket for this
NACOSH meeting, go to
www.regulations.gov. All documents in
the public docket are listed in the index;
however, some documents (e.g.,
copyrighted material) are not publicly
available to read or download through
www.regulations.gov. All submissions,
including copyrighted material, are
available for inspection through the
OSHA Docket Office. Contact the OSHA
Docket Office at (202) 693–2350 (TTY
(877) 889–5627) for assistance in
locating docket submissions.
Participation in the NACOSH Heat
Work Group meeting: Members of the
public may attend the NACOSH Heat
Work Group meeting. However, any
participation by the public will be in
listen-only mode. OSHA is not receiving
public comments or requests to speak at
the Heat Work Group meeting.
FOR FURTHER INFORMATION CONTACT:
For press inquiries: Mr. Frank
Meilinger, Director, OSHA Office of
Communications, U.S. Department of
Labor; telephone: (202) 693–1999;
email: meilinger.francis2@dol.gov.
For general information about
NACOSH: Ms. Lisa Long, Acting Deputy
Director, Directorate of Standards and
Guidance, OSHA, U.S. Department of
Labor; telephone: (202) 693–2409;
email: long.lisa@dol.gov.
Telecommunication requirements: For
additional information about the
telecommunication requirements for the
meeting, please contact Ms. Carla
Marcellus, Directorate of Standards and
Guidance, OSHA, U.S. Department of
Labor; telephone: (202) 693–1865;
email: marcellus.carla@dol.gov.
For copies of this Federal Register
Notice: Electronic copies of this Federal
E:\FR\FM\10AUN1.SGM
10AUN1
]]>Agencies
[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48693-48694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17178]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1066]
Importer of Controlled Substances Application: Epic Pharma, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Epic Pharma, 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 on or before
September 9, 2022. Such persons may also file a written request for a
hearing on the application on or before September 9, 2022.
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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on July 19, 2022, Epic Pharma, LLC, 22715 North Conduit
Avenue, Laurelton, New York 11413-3134, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methadone.............................. 9250 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance for
research and development purposes. No other activity for this drug code
is authorized for this registration.
[[Page 48694]]
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.
Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-17178 Filed 8-9-22; 8:45 am]
BILLING CODE P
