Bulk Manufacturer of Controlled Substances Application: Navinta LLC, 15799-15800 [2020-05750]
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Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
Issued: March 16, 2020.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2020–05767 Filed 3–18–20; 8:45 am]
Affairs, Attention Department of Justice
Desk Officer, Washington, DC 20503 or
sent to OIRA_submissions@
omb.eop.gov.
BILLING CODE 7020–02–P
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF JUSTICE
Bureau of Alcohol, Tobacco, Firearms
and Explosives
[OMB Number 1140–0020]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Firearms
Transaction Record/Registro de
Transaccio´n de Armas de Fuego—ATF
Form 4473 (5300.9)
Bureau of Alcohol, Tobacco,
Firearms and Explosives, Department of
Justice.
ACTION: 30-Day notice.
AGENCY:
The Department of Justice
(DOJ), Bureau of Alcohol, Tobacco,
Firearms and Explosives (ATF), will
submit 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 collection is being revised
to include a Continuation Sheet, as well
as changes to the content and layout of
the form. There is also a decrease in the
total respondents and burden hours
associated with this information
collection (IC). The proposed IC is also
being published to obtain comments
from the public and affected agencies.
DATES: The proposed information
collection was previously published in
the Federal Register, on December 26,
2019, allowing for a 60-day comment
period. Comments are encouraged and
will be accepted for an additional 30
days until April 20, 2020.
FOR FURTHER INFORMATION CONTACT: If
you have additional comments,
particularly with respect to the
estimated public burden or associated
response time, have suggestions, need a
copy of the proposed information
collection instrument with instructions,
or desire any other additional
information, please contact Helen
Koppe, ATF Firearms & Explosives
Industry Division either by mail at 99
New York Avenue NE, 6 N–652,
Washington, DC 20226, by email at
FederalRegisterNoticeATFF4473@
atf.gov, or by telephone at 202–648–
7173. Written comments and/or
suggestions can also be directed to the
Office of Management and Budget,
Office of Information and Regulatory
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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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
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;
—Evaluate whether and if so how the
quality, utility, and clarity of the
information to be collected can be
enhanced; and
—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.
Overview of This Information
Collection
Frm 00042
Fmt 4703
Sfmt 4703
respondents will utilize the form
annually, and it will take each
respondent 30 minutes to complete their
responses.
(6) An estimate of the total public
burden (in hours) associated with the
collection: The estimated annual public
burden associated with this collection is
8,594,551 hours, which is equal to
17,189,101 (# of respondents) * 1 (# of
responses per respondent) * .5 (30
minutes).
(7) An Explanation of the Change in
Estimates: The adjustments associated
with this information collection include
a reduction in the total respondents to
this IC by 1,086,139. Consequently, the
hourly burden for this IC has also
decreased by 543,069 hours, since the
last renewal in 2016.
If additional information is required
contact: Melody Braswell, Department
Clearance Officer, United States
Department of Justice, Justice
Management Division, Policy and
Planning Staff, Two Constitution
Square, 145 N Street NE, 3E.405A,
Washington, DC 20530.
Dated: March 13, 2020.
Melody Braswell,
Department Clearance Officer for PRA, U.S.
Department of Justice.
[FR Doc. 2020–05676 Filed 3–18–20; 8:45 am]
BILLING CODE 4410–14–P
DEPARTMENT OF JUSTICE
(1) Type of Information Collection:
Revision of a currently approved
collection.
(2) The Title of the Form/Collection:
Firearms Transaction Record/Registro
de Transaccio´n de Armas de Fuego.
(3) The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
Form number: ATF Form 4473
(5300.9).
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:
Primary: Individuals or households.
Other: Business or other for-profit.
Abstract: The Firearms Transaction
Record/Registro de Transaccio´n de
Armas de Fuego allows Federal firearms
licensees to determine the eligibility of
persons purchasing firearms. It also
alerts buyers to certain restrictions on
the receipt and possession of firearms.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: An estimated 17,189,101
PO 00000
15799
Drug Enforcement Administration
[Docket No. DEA–602]
Bulk Manufacturer of Controlled
Substances Application: Navinta LLC
ACTION:
Notice of application.
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 May 18, 2020.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on September 23, 2019,
Navinta LLC, 1499 Lower Ferry Road,
Ewing, New Jersey 08618–1414
registered as a bulk manufacturer of the
following basic class(es), of controlled
substances:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\19MRN1.SGM
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15800
Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Notices
Controlled substance
Drug code
4-Anilino-N-phenethyl-4-piperidine (ANPP) .....................................................................................................................
Levomethorphan ..............................................................................................................................................................
Levorphanol .....................................................................................................................................................................
Remifentanil .....................................................................................................................................................................
Fentanyl ...........................................................................................................................................................................
The company plans to bulk
manufacture API quantities of the listed
controlled substances for validation
purposes and FDA approval.
Dated: March 5, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–05750 Filed 3–18–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
John O. Dimowo, M.D.; Decision and
Order
jbell on DSKJLSW7X2PROD with NOTICES
On August 28, 2017, the Drug
Enforcement Administration
(hereinafter, DEA) Administrative Law
Judge Charles Wm. Dorman (hereinafter,
ALJ), issued a Recommended Rulings,
Findings of Fact, Conclusions of Law
and Decision (hereinafter, RD) on the
action to revoke the DEA Certification of
Registration of John O. Dimowo, M.D.
Neither party filed exceptions to the RD.
Having reviewed and considered the
entire administrative record before me,
I adopt the ALJ’s RD with minor
modifications, where noted herein.*A
Overall, with respect to this case, I
appreciate Respondent’s efforts to limit
DEA time and resources by stipulating
to many of the Government’s fact
allegations. However, as explained in
the findings and conclusions below, his
actions, including prescribing after a
court’s restriction and prescribing in
Texas after his convictions and
settlement in California without a DEA
registration, contradicted the credibility
of his words. The Respondent must
convince the Administrator that his
acceptance of responsibility and
remorse are sufficiently credible to
demonstrate that the misconduct will
not recur. Jeffrey Stein, M.D., 84 FR
46,968, 46,974 (2019). As described
*A I have made minor modifications to the RD. I
have substituted initials or titles for the names of
witnesses and patients to protect their privacy and
I have made minor, nonsubstantive, grammatical
changes. Where I have made substantive changes,
omitted language for brevity or relevance, or where
I have added to or modified the ALJ’s opinion, I
have noted the edits with an asterisk, and I have
included specific descriptions of the modifications
in brackets following the asterisk or in footnotes
marked with an asterisk and a letter.
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17:05 Mar 18, 2020
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herein, Respondent did not convince me
or the ALJ that he could be entrusted
with a DEA registration.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
824(a), I hereby revoke DEA Certificate
of Registration BD3755571 issued to
John O. Dimowo, M.D. Further,
pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(f), I hereby deny any pending
application of John O. Dimowo to renew
or modify this registration, as well as
any pending application of John O.
Dimowo for registration in California.
This Order is effective April 20, 2020.
Dated: March 2, 2020.
Uttam Dhillon,
Acting Administrator.
Paul E. Soeffing, Esq., for the
Government
Courtney E. Pilchman, Esq., for the
Respondent
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
Charles Wm. Dorman, Administrative
Law Judge. On July 21, 2016, the Drug
Enforcement Administration (‘‘DEA’’ or
‘‘Government’’) served John O. Dimowo,
M.D., (‘‘Respondent’’) with an Order to
Show Cause (‘‘OSC’’), seeking to revoke
his DEA Certificate of Registration
(‘‘COR’’), Number BD3755571.
Administrative Law Judge Exhibit
(‘‘ALJ–’’) 1, 6. One of the allegations
contained in the OSC was that the
Respondent lacked state authority to
handle controlled substances in
California, where he was registered. In
response to the OSC, the Respondent
timely requested a hearing before an
Administrative Law Judge. ALJ–2.
On September 2, 2016, the
Government filed a Motion for
Summary Disposition. ALJ–7. Therein,
the Government argued that the
Respondent lacked state authority in
California to handle controlled
substances, the state where the
Respondent was registered with the
DEA. ALJ–7, at 2. The Government
stated that an Interim Suspension Order
was issued against the Respondent by
the Medical Board of California
(‘‘MBC’’) on June 10, 2016. ALJ–7, at 2–
PO 00000
Frm 00043
Fmt 4703
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8333
9210
9220
9739
9801
Schedule
II
II
II
II
II
3. Attached to the Government’s Motion
was a copy of the MBC’s Interim Order
of Suspension. ALJ–7, Ex. 1. The
Government also stated that on June 28,
2016, a hearing was held before a
California administrative law judge.
ALJ–7, at 3. Following that hearing, on
July 1, 2016, the state continued the
suspension of the Respondent’s medical
license, and issued an Interim Order of
Suspension. ALJ–7, Ex. 2.
On September 16,*B 2016, the
Respondent filed a Response to the
Government Motion for Summary
Disposition (‘‘Response’’). ALJ–8.
Therein, the Respondent acknowledged
that his California medical license had
been suspended but asserted that he had
‘‘completed negotiation with the [MBC]
to resolve the accusations that resulted
in the temporary license suspension.’’
ALJ–8, at 1. Attached to the Response
was a copy of a Stipulated Settlement
and Disciplinary Order between the
Respondent and the Attorney General of
California. ALJ–8, Ex. 1. In the
Response, the Respondent requested
that ‘‘the hearing on this matter be
stayed pending the final approval of the
negotiated settlement stipulation by the
Executive Director of the [MBC].’’ ALJ–
8,*C at 1.
At that time, both parties agreed that
the Respondent currently lacked state
authority to handle controlled
substances in California. Because there
was no genuine question of fact, no
adversarial hearing was required. See,
e.g., Jesus R. Juarez, M.D., 62 FR 14,945,
14,945 (1997). Therefore, because DEA
precedent requires that a practitioner be
authorized to handle controlled
substances in the jurisdiction in which
the practitioner is registered, I granted
the Government’s Motion for Summary
Disposition on October 18, 2016. See
ALJ–14. On November 15, 2016, I
forwarded my October 18, 2016 Order
Granting Summary Disposition and
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
(‘‘Recommended Decision’’) to the
Acting Administrator of the DEA. ALJ–
15.
Subsequent to the issuance of the
Recommended Decision, the MBC
restored a substantial portion of the
*B Correction.
*C Correction.
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]]>Agencies
[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15799-15800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05750]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-602]
Bulk Manufacturer of Controlled Substances Application: Navinta
LLC
ACTION: Notice of application.
-----------------------------------------------------------------------
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 May 18, 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 September 23, 2019, Navinta LLC, 1499 Lower Ferry
Road, Ewing, New Jersey 08618-1414 registered as a bulk manufacturer of
the following basic class(es), of controlled substances:
[[Page 15800]]
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Levomethorphan..................... 9210 II
Levorphanol........................ 9220 II
Remifentanil....................... 9739 II
Fentanyl........................... 9801 II
------------------------------------------------------------------------
The company plans to bulk manufacture API quantities of the listed
controlled substances for validation purposes and FDA approval.
Dated: March 5, 2020.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-05750 Filed 3-18-20; 8:45 am]
BILLING CODE 4410-09-P
