Importer of Controlled Substances Application: Caligor Coghlan Pharma Services, 59824 [2020-21009]
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59824
Federal Register / Vol. 85, No. 185 / Wednesday, September 23, 2020 / Notices
On December 19, 2019, the Center for
Regulatory Effectiveness commented
that BOEM should withdraw its petition
to the National Marine Fisheries Service
to issue a regulation governing the
taking of marine mammals in the Gulf
of Mexico.
BOEM Response: This comment is
outside the scope of this information
collection renewal. NMFS has the
authority to authorize incidental take
under the Marine Mammal Protection
Act and the Endangered Species Act.
BOEM has petitioned NMFS for the
development of regulations governing
incidental take of marine mammals
related to conducting geophysical
surveys during oil and gas exploration
activities in the GOM. BOEM has
identified areas where there is the
potential to impact its mission under
OCSLA in the GOM, and potentially
other regions and programs, and its
ability to manage the development of
OCS energy and mineral resources in an
environmentally responsible and
practical way.
The NMFS proposed Incidental Take
rulemaking, which is a separate process
from this information collection
renewal, allowed for public comments.
On October 25, 2019, a private citizen
commented that far too much
exploration is being allowed, explosions
and high sonar work needs to be
stopped, and would like BOEM to cut
exploration back by seventy percent.
BOEM Response: OCSLA mandates
that all G&G activities on the OCS be
conducted in a safe and
environmentally sound manner. BOEM
uses information received to best
understand and evaluate the proposed
activity and equipment to be used,
which helps to ensure that the
appropriate site/activity environmental
analysis is conducted in order to fulfill
its statutory obligations.
BOEM is again soliciting comments
on the proposed ICR that is described
below. BOEM is especially interested in
public comment addressing the
following issues: (1) Is the collection
necessary to the proper functions of
BOEM; (2) what can BOEM do to ensure
this information will be processed and
used in a timely manner; (3) is the
estimate of burden accurate; (4) how
might BOEM enhance the quality,
utility, and clarity of the information to
be collected; and (5) how might BOEM
minimize the burden of this collection
on the respondents, including
minimizing the burden through the use
of information technology?
Comments that you submit in
response to this notice are a matter of
public record. BOEM will include or
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summarize each comment in its request
to the Office of Management and Budget
(OMB) for approval of this ICR. You
should be aware that your entire
comment—including your address,
phone number, email address, or other
personal identifying information—may
be made publicly available at any time.
In order for BOEM to withhold from
disclosure your personally identifiable
information, you must identify any
information contained in the submittal
of your comments that, if released,
would clearly constitute an
unwarranted invasion of your personal
privacy. You must also briefly describe
any possible harmful consequences of
the disclosure of your information, such
as embarrassment, injury, or other harm.
While you can ask BOEM in your
comment to withhold your personally
identifiable information from public
review, BOEM cannot guarantee that it
will be able to do so.
BOEM protects proprietary
information in accordance with the
Freedom of Information Act (5 U.S.C.
552) and the Department of the
Interior’s implementing regulations (43
CFR part 2), and under regulations at 30
CFR parts 551 promulgated pursuant to
the Outer Continental Shelf Lands Act
(OCSLA) at 43 U.S.C. 1352(c).
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number.
The authority for this action is the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Deanna Meyer-Pietruszka,
Chief, Office of Policy, Regulation, and
Analysis.
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 October 23, 2020. Such
persons may also file a written request
for a hearing on the application on or
before October 23, 2020.
DATES:
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.
ADDRESSES:
In
accordance with 21 CFR 1301.34(a), this
is notice that on July 21, 2020, Caligor
Coghlan Pharma Services, 1500
Business Park Drive, Unit B, Bastrop,
Texas 78602, applied to be registered as
an importer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled
substance
Drug code
Tapentadol ......
9780
Schedule
II
[FR Doc. 2020–20948 Filed 9–22–20; 8:45 am]
BILLING CODE 4310–MR–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–723]
Importer of Controlled Substances
Application: Caligor Coghlan Pharma
Services
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Caligor Coghlan Pharma
Services 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:
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
The company plans to import the
listed controlled substance in finished
dosage form to be used in pediatric
clinical trials. 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 a Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–21009 Filed 9–22–20; 8:45 am]
BILLING CODE 4410–09–P
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]]>Agencies
[Federal Register Volume 85, Number 185 (Wednesday, September 23, 2020)]
[Notices]
[Page 59824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21009]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-723]
Importer of Controlled Substances Application: Caligor Coghlan
Pharma Services
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Caligor Coghlan Pharma Services 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.
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 October 23,
2020. Such persons may also file a written request for a hearing on the
application on or before October 23, 2020.
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 July 21, 2020, Caligor Coghlan Pharma Services, 1500
Business Park Drive, Unit B, Bastrop, Texas 78602, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Tapentadol......................... 9780 II
------------------------------------------------------------------------
The company plans to import the listed controlled substance in
finished dosage form to be used in pediatric clinical trials. 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 a Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-21009 Filed 9-22-20; 8:45 am]
BILLING CODE 4410-09-P
