Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceuticals, Inc., 59646 [2019-24108]
Download as PDF
<![CDATA[
59646
Federal Register / Vol. 84, No. 214 / Tuesday, November 5, 2019 / Notices
each company’s compliance with state
and local laws, and reviewing each
company’s background and history.
Therefore, pursuant to 21 U.S.C.
952(a) and 958(a), and in accordance
with 21 CFR 1301.34, the DEA has
granted a registration as an importer for
schedule I and II controlled substances
to the above listed companies.
Dated: October 22, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019–24105 Filed 11–4–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–527]
Bulk Manufacturer of Controlled
Substances Application: Halo
Pharmaceuticals, Inc.
ACTION:
Notice of application.
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before January 6, 2020.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on July 19, 2019, Halo
Pharmaceutical Inc., 30 North Jefferson
Road, Whippany, New Jersey 07981–
1030 applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled substance
khammond on DSKJM1Z7X2PROD with NOTICES
Dihydromorphine ......................
Hydromorphone .......................
Drug
code
9145
9150
Schedule
I
II
The company plans to manufacture
Hydromorphone (9150) for distribution
to its customers. Dihydromorphone
(9145) is an intermediate in the
manufacture of Hydromorphone and is
not for commercial distribution.
Dated: October 22, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019–24108 Filed 11–4–19; 8:45 am]
BILLING CODE 4410–09–P
VerDate Sep<11>2014
16:34 Nov 04, 2019
Jkt 250001
DEPARTMENT OF LABOR
Agency Information Collection
Activities; Comment Request;
Requests for District Director Action
ACTION:
Notice.
The Department of Labor
(DOL) is soliciting comments
concerning a proposed extension for the
authority to conduct the information
collection request (ICR) titled, ‘‘Requests
for District Director Action.’’ This
comment request is part of continuing
Departmental efforts to reduce
paperwork and respondent burden in
accordance with the Paperwork
Reduction Act of 1995 (PRA).
DATES: Consideration will be given to all
written comments received by January
6, 2020.
ADDRESSES: A copy of this ICR with
applicable supporting documentation;
including a description of the likely
respondents, proposed frequency of
response, and estimated total burden
may be obtained free by contacting
Anjanette Suggs by telephone at 202–
354–9660 or by email at
suggs.anjanette@dol.gov.
Submit written comments about, or
requests for a copy of, this ICR by mail
or courier to the U.S. Department of
Labor, Office of Workers’ Compensation,
Division of Workers’ Compensation,
Room S3323, 200 Constitution Avenue
NW, Washington, DC 20210; by email:
suggs.anjanette@dol.gov.
FOR FURTHER INFORMATION CONTACT:
Contact Anjanette Suggs by telephone at
202–354–9660 or by email at
suggs.anjanette@dol.gov.
SUPPLEMENTARY INFORMATION: The DOL,
as part of continuing efforts to reduce
paperwork and respondent burden,
conducts a pre-clearance consultation
program to provide the general public
and Federal agencies an opportunity to
comment on proposed and/or
continuing collections of information
before submitting them to the OMB for
final approval. This program helps to
ensure requested data can be provided
in the desired format, reporting burden
(time and financial resources) is
minimized, collection instruments are
clearly understood, and the impact of
collection requirements can be properly
assessed.
The Longshore and Harbor Workers’
Compensation Act (LHWCA) requires
covered employers to secure the
payment of compensation under the Act
and its extensions by purchasing
insurance from a carrier authorized by
the Secretary of Labor to write
Longshore Act Insurance, or becoming
SUMMARY:
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
authorized self-insured employers. Each
authorized insurance carrier (or carrier
seeking authorization) is required to
establish annually that its Longshore
obligations are fully secured either
through an applicable state guaranty (or
analogous fund), a deposit of security
with the Division of Longshore and
Harbor Workers’ Compensation
(DLHWC), or a combination of both.
Similarly, each authorized self-insurer
(or employer seeking authorization) is
required to fully secure its Longshore
Act obligations by depositing security
with DLHWC. These requirements are
designed to assure the prompt and
continued payment of compensation
and other benefits by the responsible
carrier or self-insurer to injured workers
and their survivors. Forms LS–276,
Application for Security Deposit
Determination; LS–275–IC, Agreement
and Undertaking (Insurance Carrier);
and LS–275–SI, Agreement and
Undertaking (Self-Insured Employer) are
used to cover the submission of
information by insurance carriers and
self-insured employers regarding their
ability to meet their financial
obligations under the Longshore Act
and its extensions. This information is
currently approved through December
31, 2019. 33 U.S.C. 932 et seq.
authorizes this information collection.
This information collection is subject
to the PRA. A Federal agency generally
cannot conduct or sponsor a collection
of information, and the public is
generally not required to respond to an
information collection, unless the OMB
under the PRA approves it and displays
a currently valid OMB Control Number.
In addition, notwithstanding any other
provisions of law, no person shall
generally be subject to penalty for
failing to comply with a collection of
information that does not display a
valid Control Number. See 5 CFR
1320.5(a) and 1320.6.
Interested parties are encouraged to
provide comments to the contact shown
in the ADDRESSES section. Written
comments will receive consideration,
and summarized and included in the
request for OMB approval of the final
ICR. In order to help ensure appropriate
consideration, comments should
mention OMB No. 1240–0005.
Submitted comments will also be a
matter of public record for this ICR and
posted on the internet, without
redaction. The DOL encourages
commenters not to include personally
identifiable information, confidential
business data, or other sensitive
statements/information in any
comments.
The DOL is particularly interested in
comments that:
E:\FR\FM\05NON1.SGM
05NON1
]]>Agencies
[Federal Register Volume 84, Number 214 (Tuesday, November 5, 2019)]
[Notices]
[Page 59646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24108]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-527]
Bulk Manufacturer of Controlled Substances Application: Halo
Pharmaceuticals, Inc.
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before January 6, 2020.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on July 19, 2019, Halo Pharmaceutical Inc., 30 North
Jefferson Road, Whippany, New Jersey 07981-1030 applied to be
registered as a bulk manufacturer of the following basic classes of
controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Dihydromorphine......................... 9145 I
Hydromorphone........................... 9150 II
------------------------------------------------------------------------
The company plans to manufacture Hydromorphone (9150) for
distribution to its customers. Dihydromorphone (9145) is an
intermediate in the manufacture of Hydromorphone and is not for
commercial distribution.
Dated: October 22, 2019.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2019-24108 Filed 11-4-19; 8:45 am]
BILLING CODE 4410-09-P
