Bulk Manufacturer of Controlled Substances Application: Eli-Elsohly Laboratories, 27661-27662 [2019-12505]
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Federal Register / Vol. 84, No. 114 / Thursday, June 13, 2019 / Notices
controlled substances in amounts not
reasonably related to the proper medical
management of patients’ illnesses or
conditions. Id. at Att. 2. In her
Voluntary Surrender, Respondent
stated: ‘‘I understand and acknowledge
I will have no authority to order,
dispense, distribute, administer or
prescribe controlled substances in the
state of Alabama.’’ Id. Thus, there is no
dispute that Respondent voluntarily
surrendered her authority to handle
controlled substances in Alabama.
Further, as recorded by the State Board,
the status of Respondent’s CSC is
‘‘Inactive-Failed to Renew.’’ Id. at Att. 4.
Based on my review of the website of
the State Board and the Medical
Licensure Commission of Alabama, the
status of Respondent’s CSC has not
changed.2 Alabama Board of Medical
Examiners and Medical Licensure
Commission of Alabama Online License
Verification, https://
abme.igovsolution.com/online/Lookups/
Individual_Lookup.aspx (last visited
May 22, 2019).
Accordingly, I find that Respondent
currently is without authority to
dispense controlled substances in
Alabama, the State in which she is
registered.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under section 823 of the Controlled
Substances Act (hereinafter, CSA),
‘‘upon a finding that the registrant . . .
has had [her] State license or
registration suspended . . . [or] revoked
. . . by competent State authority and is
no longer authorized by State law to
engage in the . . . dispensing of
controlled substances.’’ With respect to
a practitioner, the DEA has long held
that the possession of authority to
dispense controlled substances under
the laws of the State in which a
practitioner engages in professional
practice is a fundamental condition for
obtaining and maintaining a
practitioner’s registration. See, e.g.,
James L. Hooper, M.D., 76 FR 71,371
(2011), pet. for rev. denied, 481 Fed.
Appx. 826 (4th Cir. 2012); Frederick
Marsh Blanton, M.D., 43 FR 27,616,
27,617 (1978).
This rule derives from the text of two
provisions of the CSA. First, Congress
defined the term ‘‘practitioner’’ to mean
‘‘a physician . . . or other person
licensed, registered, or otherwise
permitted, by . . . the jurisdiction in
which [s]he practices . . ., to distribute,
dispense, . . . [or] administer . . . a
controlled substance in the course of
professional practice.’’ 21 U.S.C.
§ 802(21). Second, in setting the
requirements for obtaining a
practitioner’s registration, Congress
directed that ‘‘[t]he Attorney General
shall register practitioners . . . if the
applicant is authorized to dispense . . .
controlled substances under the laws of
the State in which [s]he practices.’’ 21
U.S.C. § 823(f). Because Congress has
clearly mandated that a practitioner
possess State authority in order to be
deemed a practitioner under the CSA,
the DEA has held repeatedly that
revocation of a practitioner’s registration
is the appropriate sanction whenever a
practitioner is no longer authorized to
dispense controlled substances under
the laws of the State in which she
practices. See, e.g., Hooper, supra, 76
FR at 71,371–72; Sheran Arden Yeates,
M.D., 71 FR 39,130, 39,131 (2006);
Dominick A. Ricci, M.D., 58 FR 51,104,
51,105 (1993); Bobby Watts, M.D., 53 FR
11,919, 11,920 (1988), Blanton, supra,
43 FR at 27,617.
Here, the undisputed evidence in the
record is that Respondent voluntarily
surrendered her Alabama CSC. The fact
that Respondent may, some day, regain
her State registration to dispense
controlled substances does not change
the salient fact that Respondent is not
currently authorized to handle
controlled substances in the State in
which she is registered. Mehdi
Nikparvarfard, M.D., 83 FR 14,503,
14,504 (2018). Respondent, therefore, is
not eligible for a DEA COR.
Accordingly, I will order that
Respondent’s DEA COR be revoked and
that any pending application for the
renewal or modification of that COR be
denied. 21 U.S.C. §§ 823(f) and
824(a)(3).
Order
Pursuant to 28 CFR § 0.100(b) and the
authority vested in me by 21 U.S.C.
§ 824(a), I order that DEA COR No.
FK0505428 issued to Elizabeth C. Korcz,
M.D., be, and it hereby is, revoked.
Pursuant to 28 CFR § 0.100(b) and the
authority vested in me by 21 U.S.C.
§ 823(f), I further order that any pending
application of Elizabeth C. Korcz, M.D.,
to renew or modify this registration, as
well as any other pending application
by her for registration in the State of
Alabama be, and it hereby is, denied.
This Order is effective July 15, 2019.
Dated: May 22, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019–12506 Filed 6–12–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Eli-Elsohly
Laboratories
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 August 12, 2019.
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 March 14, 2019, EliElsohly Laboratories, Mahmoud A.
Elsohly Ph.D., 5 Industrial Park Drive,
Oxford, Mississippi 38655 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
khammond on DSKBBV9HB2PROD with NOTICES
Controlled substance
Drug code
Marihuana Extract ...........................................................................................................................................................
Marihuana ........................................................................................................................................................................
2 Under the Administrative Procedure Act, an
agency ‘‘may take official notice of facts at any stage
in a proceeding—even in the final decision.’’
United States Department of Justice, Attorney
General’s Manual on the Administrative Procedure
Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint
1979). Pursuant to 5 U.S.C. § 556(e), ‘‘[w]hen an
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agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a
party is entitled, on timely request, to an
opportunity to show the contrary.’’ Accordingly,
Respondent may dispute my finding by filing a
properly supported motion for reconsideration
within 15 calendar days of the date of this Order.
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7360
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Any such motion shall be filed with the Office of
the Administrator and a copy shall be served on the
Government; in the event Respondent files a
motion, the Government shall have 15 calendar
days to file a response.
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Federal Register / Vol. 84, No. 114 / Thursday, June 13, 2019 / Notices
Controlled substance
Drug code
Tetrahydrocannabinols ....................................................................................................................................................
Dihydromorphine .............................................................................................................................................................
Amphetamine ...................................................................................................................................................................
Methamphetamine ...........................................................................................................................................................
Cocaine ............................................................................................................................................................................
Codeine ...........................................................................................................................................................................
Dihydrocodeine ................................................................................................................................................................
Oxycodone .......................................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
Ecgonine ..........................................................................................................................................................................
Hydrocodone ...................................................................................................................................................................
Morphine ..........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Oxymorphone ..................................................................................................................................................................
The company plans to manufacture
the listed controlled substances for
product development and reference
standards. In reference to drug codes
7360 (marihuana) and 7370 (THC), the
company plans to isolate these
controlled substances from procured
7350 (marihuana extract). In reference to
drug code 7360, no cultivation activities
are authorized for this registration. No
other activities for these drug codes are
authorized for this registration.
process. ACRS reviews do not normally
encompass matters pertaining to
environmental impacts other than those
related to radiological safety.
The ACRS meetings are not
adjudicatory hearings such as those
conducted by the NRC’s Atomic Safety
and Licensing Board Panel as part of the
Commission’s licensing process.
Dated: June 3, 2019.
John J. Martin,
Assistant Administrator.
An agenda will be published in the
Federal Register for each full
Committee meeting. There may be a
need to make changes to the agenda to
facilitate the conduct of the meeting.
The Chairman of the Committee is
empowered to conduct the meeting in a
manner that, in his/her judgment, will
facilitate the orderly conduct of
business, including making provisions
to continue the discussion of matters
not completed on the scheduled day on
another day of the same meeting.
Persons planning to attend the meeting
may contact the Designated Federal
Officer (DFO) specified in the Federal
Register notice prior to the meeting to
be advised of any changes to the agenda
that may have occurred.
The following requirements shall
apply to public participation in ACRS
Full Committee meetings:
(a) Persons who plan to submit
written comments at the meeting should
provide 35 copies to the DFO at the
beginning of the meeting. Persons who
cannot attend the meeting, but wish to
submit written comments regarding the
agenda items may do so by sending a
readily reproducible copy addressed to
the DFO specified in the Federal
Register notice, care of the Advisory
Committee on Reactor Safeguards, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001.
Comments should be limited to items
being considered by the Committee.
Comments should be in the possession
of the DFO 5 days prior to the meeting
[FR Doc. 2019–12505 Filed 6–12–19; 8:45 am]
BILLING CODE 4410–09–P
NUCLEAR REGULATORY
COMMISSION
khammond on DSKBBV9HB2PROD with NOTICES
Advisory Committee on Reactor
Safeguards; Procedures for Meetings
Background
This notice describes procedures to be
followed with respect to meetings
conducted by the U.S. Nuclear
Regulatory Commission’s (NRC’s)
Advisory Committee on Reactor
Safeguards (ACRS) pursuant to the
Federal Advisory Committee Act
(FACA). These procedures are set forth
so that they may be incorporated by
reference in future notices for
individual meetings.
The ACRS is a statutory advisory
Committee established by Congress to
review and report on nuclear safety
matters and applications for the
licensing of nuclear facilities. The
Committee’s reports become a part of
the public record.
The ACRS meetings are conducted in
accordance with FACA; they are
normally open to the public and provide
opportunities for oral or written
statements from members of the public
to be considered as part of the
Committee’s information gathering
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General Rules Regarding ACRS Full
Committee Meetings
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to allow time for reproduction and
distribution.
(b) Persons desiring to make oral
statements at the meeting should make
a request to do so to the DFO; if
possible, the request should be made 5
days before the meeting, identifying the
topic(s) on which oral statements will
be made and the amount of time needed
for presentation so that orderly
arrangements can be made. The
Committee will hear oral statements on
topics being reviewed at an appropriate
time during the meeting as scheduled by
the Chairman.
(c) Information regarding topics to be
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whether the meeting has been canceled
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(d) The use of still, motion picture,
and television cameras will be
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(e) A transcript will be kept for certain
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Room (PDR), One White Flint North,
Room O–1F21, 11555 Rockville Pike,
Rockville, Maryland 20852–2738. A
copy of the certified minutes of the
meeting will be available at the same
location three months following the
meeting. Copies may be obtained upon
payment of appropriate reproduction
charges. ACRS meeting agendas,
transcripts, and letter reports are
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]]>Agencies
[Federal Register Volume 84, Number 114 (Thursday, June 13, 2019)]
[Notices]
[Pages 27661-27662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12505]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Eli-
Elsohly Laboratories
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 August 12, 2019.
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 March 14, 2019, Eli-Elsohly Laboratories, Mahmoud A.
Elsohly Ph.D., 5 Industrial Park Drive, Oxford, Mississippi 38655
applied to be registered as a bulk manufacturer of the following basic
classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana Extract........................ 7350 I
Marihuana................................ 7360 I
[[Page 27662]]
Tetrahydrocannabinols.................... 7370 I
Dihydromorphine.......................... 9145 I
Amphetamine.............................. 1100 II
Methamphetamine.......................... 1105 II
Cocaine.................................. 9041 II
Codeine.................................. 9050 II
Dihydrocodeine........................... 9120 II
Oxycodone................................ 9143 II
Hydromorphone............................ 9150 II
Ecgonine................................. 9180 II
Hydrocodone.............................. 9193 II
Morphine................................. 9300 II
Thebaine................................. 9333 II
Oxymorphone.............................. 9652 II
------------------------------------------------------------------------
The company plans to manufacture the listed controlled substances
for product development and reference standards. In reference to drug
codes 7360 (marihuana) and 7370 (THC), the company plans to isolate
these controlled substances from procured 7350 (marihuana extract). In
reference to drug code 7360, no cultivation activities are authorized
for this registration. No other activities for these drug codes are
authorized for this registration.
Dated: June 3, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-12505 Filed 6-12-19; 8:45 am]
BILLING CODE 4410-09-P
