Importer of Controlled Substances Application: Unither Manufacturing LLC, 26944 [2021-10407]
Download as PDF
<![CDATA[
26944
Federal Register / Vol. 86, No. 94 / Tuesday, May 18, 2021 / Notices
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.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–836]
Importer of Controlled Substances
Application: Lipomed
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
William T. McDermott,
Assistant Administrator.
Lipomed 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.
SUMMARY:
[FR Doc. 2021–10420 Filed 5–17–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before June 17, 2021. Such persons
may also file a written request for a
hearing on the application on or before
June 17, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on March 29, 2021,
Lipomed, 150 Cambridgepark Drive,
Suite 705, Cambridge, Massachusetts
02140–2300, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
DATES:
Controlled substance
jbell on DSKJLSW7X2PROD with NOTICES
Ethylone ..........................
Drug
code
Schedule
I 7547 II
The company plans to import the
above controlled substance as analytical
reference standards for distribution to
its customers for research and analytical
purposes. Placement of this drug code
onto the company’s registration does not
translate into automatic approval of
subsequent permit applications to
import controlled substance. No other
VerDate Sep<11>2014
16:40 May 17, 2021
Jkt 253001
Drug Enforcement Administration
[Docket No. DEA–833]
Importer of Controlled Substances
Application: Unither Manufacturing
LLC
be registered as an importer of the
following basic class(es) of controlled
substance(s):
Drug
code
Controlled substance
Methylphenidate ..............
Schedule
I 1724 III
The company plans to import the
listed controlled substance solely for
updated analytical testing purposes for
European customer requirements. This
analysis is required to allow the
company to export domesticallymanufactured finished dosage forms to
foreign markets.
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.
William T. McDermott,
Assistant Administrator.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
[FR Doc. 2021–10407 Filed 5–17–21; 8:45 am]
BILLING CODE P
Unither Manufacturing 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 file written
comments on or objections to the
issuance of the proposed registration on
or before June 17, 2021. Such persons
may also file a written request for a
hearing on the application on or before
June 17, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152. All requests for a hearing must
be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for a
hearing should also 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.
SUPPLEMENTARY INFORMATION: In
accordance with 21 CFR 1301.34(a), this
is notice that on April 16, 2021, Unither
Manufacturing LLC, 331 Clay Road,
Rochester, New York 14623, applied to
SUMMARY:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
DEPARTMENT OF JUSTICE
Office of Justice Programs
[OMB Number 1121–0334]
Agency Information Collection
Activities; Proposed Collection
Comments Requested; Reinstatement,
With Change, of a Previously
Approved Collection for Which
Approval Has Expired: 2021 Survey of
Campus Law Enforcement Agencies
(SCLEA)
Bureau of Justice Statistics,
Office of Justice Programs, Department
of Justice.
ACTION: 60-Day notice.
AGENCY:
The Bureau of Justice
Statistics, Office of Justice Programs,
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 July
19, 2021.
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
SUMMARY:
E:\FR\FM\18MYN1.SGM
18MYN1
]]>Agencies
[Federal Register Volume 86, Number 94 (Tuesday, May 18, 2021)]
[Notices]
[Page 26944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10407]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-833]
Importer of Controlled Substances Application: Unither
Manufacturing LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Unither Manufacturing 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 file written comments on or objections to
the issuance of the proposed registration on or before June 17, 2021.
Such persons may also file a written request for a hearing on the
application on or before June 17, 2021.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for a hearing should also 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.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on April 16, 2021, Unither Manufacturing LLC, 331 Clay
Road, Rochester, New York 14623, applied to be registered as an
importer of the following basic class(es) of controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Methylphenidate........................ 1724 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance solely
for updated analytical testing purposes for European customer
requirements. This analysis is required to allow the company to export
domestically-manufactured finished dosage forms to foreign markets.
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.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-10407 Filed 5-17-21; 8:45 am]
BILLING CODE P
