Importer of Controlled Substances Application: Indigenous Peyote Conservation Initiative, 59198-59199 [2021-23281]
Download as PDF
<![CDATA[
59198
Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices
2. Applicant’s Felony Conviction
Pursuant to section 304(a)(2) of the
CSA, the Attorney General is authorized
to suspend or revoke a registration
‘‘upon a finding that the registrant . . .
has been convicted of a felony under
this subchapter or subchapter II of this
chapter or any other law of the United
States, or of any State, relating to any
substance defined in this subchapter as
a controlled substance or a list I
chemical.’’ 21 U.S.C. 824(a)(2); see also
Edward A. Ridgill, M.D., 83 FR 58599,
58600 (2018) (denying application based
on conviction under 21 U.S.C. 841 for
unlawful prescribing of controlled
substances). Each subsection of Section
824(a) provides an independent ground
to impose a sanction. Arnold E.
Feldman, M.D., 82 FR 39614, 39617
(2017).
Here, there is no dispute in the record
that Applicant was convicted of felony
counts related to unlawfully issuing
controlled substance prescriptions in
violation of California Health and Safety
Code Section 11153(a), prescription
fraud under California Health and
Safety Code Section 11173(a), and
related felony counts of conspiracy and
insurance fraud. See RFAAX 8. Two of
these state statutes specifically address
controlled substance prescriptions and
the underlying facts of the fraud and
conspiracy counts were related to
Applicant’s unlawful prescribing and
obtaining of controlled substances. See
Cal. Health & Safety Code § 11153(a) (‘‘A
prescription for a controlled substance
shall only be issued for a legitimate
medical purpose by an individual
practitioner acting in the usual course of
his or her professional practice.’’); Cal.
Health & Safety Code § 11173(a) (‘‘No
person shall obtain or attempt to obtain
controlled substances, or procure or
attempt to procure the administration of
or prescription for controlled substances
. . . by fraud, deceit, misrepresentation,
or subterfuge’’). Therefore, I find that
these provisions constitute state laws
‘‘relating to’’ controlled substances, as
those terms are defined in 21 U.S.C.
824(a)(2). See Uvienome Linda Sakor,
N.P., 86 FR 50173, 50178 (2021).
Although the Government has noted
in its RFAA that two years after
Applicant’s conviction, the state court
reduced the four felony counts to
misdemeanors and ordered summary
probation, see RFAAX 8, at 20 and
RFAA, at 6, the Agency established over
thirty years ago, and has recently
reiterated, that a deferred adjudication
is ‘‘still a ‘conviction’ within the
meaning of the . . . [CSA] even if the
proceedings are later dismissed.’’
Kimberly Maloney, N.P., 76 FR 60922,
VerDate Sep<11>2014
22:39 Oct 25, 2021
Jkt 256001
60922 (2011). In reaching this
conclusion, the Agency explained that,
‘‘[a]ny other interpretation would mean
that the conviction could only be
considered between its date and the
date of its subsequent dismissal.’’ Id.
(citing Edson W. Redard, M.D., 65 FR
30616, 30618 (2000)); see also Erica N.
Grant, M.D., 40,641, 40,650 (2021).
Thus, in accordance with prior agency
decisions, I find that the subsequent
reduction of Applicant’s charges, much
like a subsequent deferral or dismissal,
does not affect my finding that she was
convicted of a felony related to
controlled substances for purposes of 21
U.S.C. 824(a)(2).
Although the language of 21 U.S.C.
824(a)(2) discusses suspension and
revocation of a registration, for the
reasons discussed above in supra III.A,
it may also serve as the basis for the
denial of a DEA registration application.
Applicant’s felony conviction, therefore,
serves as an independent basis for
denying her application for a DEA
registration. 21 U.S.C. 824(a)(2).
IV. Sanction
Where, as here, the Government has
met its prima facie burden of showing
that a ground for revocation exists, the
burden shifts to the Applicant to show
why she can be entrusted with a
registration. See Jeffrey Stein, M.D., 84
FR 46968, 46972 (2019). Applicant, as
already discussed, waived her right to a
hearing and failed to submit a written
statement. See RFAA, at 6. Therefore,
among other things, Applicant has not
accepted responsibility for her
criminality, shown any remorse for it, or
provided any assurance that she would
not repeat it. See Jeffrey Stein, M.D., 84
FR 46972–74. Such silence weighs
against granting the Applicant’s
registration. Zvi H. Perper, M.D., 77 FR
64131, 64142 (2012) (citing Medicine
Shoppe-Jonesborough, 73 FR 264, 387
(2008); Samuel S. Jackson, 72 FR 23848,
23853 (2007)); see also Jones Total
Health Care Pharmacy, LLC v. Drug
Enf’t Admin., 881 F3d. 823, 831 (11th
Cir. 2018) (‘‘‘An agency rationally may
conclude that past performance is the
best predictor of future performance.’’’
(quoting Alra Laboratories, Inc. v. Drug
Enf’t Admin., 54 F.3d 450, 452 (7th Cir.
1995))).
Further, the CSA authorizes the
Attorney General to ‘‘promulgate and
enforce any rules, regulations, and
procedures which he may deem
necessary and appropriate for the
efficient execution of his functions
under this subchapter.’’ 21 U.S.C.
871(b). This authority specifically
relates ‘‘to ‘registration’ and ‘control,’
and ‘for the efficient execution of his
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
functions’ under the statute.’’ Gonzales
v. Oregon, 546 U.S. 243, 259 (2006). A
clear purpose of this authority is to
‘‘bar[] doctors from using their
prescription-writing powers as a means
to engage in illicit drug dealing and
trafficking . . . .’’ Id. at 270. In this
case, Applicant pled guilty to counts
directly related to issuing controlled
substance prescriptions without a
legitimate medical purpose. Applicant’s
unlawful activity is exactly the type of
activity that the CSA was intended to
prevent and she has given me no
indication that she will not repeat her
illicit behavior.
Based on the record before me, I
conclude that Applicant’s founded
criminality makes her ineligible for a
DEA registration. Accordingly, I shall
order the sanction the Government
requested, as contained in the Order
below.
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C. 823,
I hereby order that the pending
application for a Certificate of
Registration, Control Number
W18011889C, submitted by Maura
Tuso, D.M.D., is denied. This Order is
effective November 26, 2021.
Anne Milgram,
Administrator.
[FR Doc. 2021–23262 Filed 10–25–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–915]
Importer of Controlled Substances
Application: Indigenous Peyote
Conservation Initiative
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Indigenous Peyote
Conservation Initiative 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.
SUMMARY:
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 November 26, 2021. Such
persons may also file a written request
for a hearing on the application on or
before November 26, 2021.
DATES:
E:\FR\FM\26OCN1.SGM
26OCN1
Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices
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 30, 2021,
Indigenous Peyote Conservation
Initiative, 826 North FM 649,
Hebbronville, Texas 78361, applied to
be registered as an importer of the
following basic class(es) of controlled
substance(s):
ADDRESSES:
Controlled substance
Peyote .............................
Drug
code
Schedule
7415
I
Novitium Pharma LLC has
applied to be registered as a bulk
manufacturer 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 December 27, 2021. Such
persons may also file a written request
for a hearing on the application on or
before December 27, 2021.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
SUMMARY:
In
accordance with 21 CFR 1301.33(a), this
is notice that on September 8, 2021,
Novitium Pharma LLC, 70 Lake Drive,
East Windsor, New Jersey 08520,
applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
SUPPLEMENTARY INFORMATION:
Controlled substance
Drug
code
Schedule
7437
7438
9220
I
I
II
The above controlled substance will
be imported as live plants for research,
analytical purposes, enhancing the plant
population, and improving conservation
strategies of the plant in situ in its
native habit. 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 Food and Drug
Administration-approved or nonapproved finished dosage forms for
commercial sale.
The company plans to bulk
manufacture drug codes 7438 and 7437
to produce Active Pharmaceutical
Ingredient (API) and finished dosage
forms for use in clinical trial studies
only. In reference to drug code 9220, the
company plans to bulk manufacture this
drug code to support commercial drug
product manufacturing and drug
development purposes. No other
activities for these drug codes are
authorized for this registration.
Brian S. Besser,
Acting Assistant Administrator.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–23281 Filed 10–25–21; 8:45 am]
Psilocybin ........................
Psilocyn ...........................
Levorphanol .....................
[FR Doc. 2021–23282 Filed 10–25–21; 8:45 am]
BILLING CODE P
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
NATIONAL SCIENCE FOUNDATION
Drug Enforcement Administration
Request for Information:
Undergraduate Training in Biology
Mathematics and Computer Science
(UBMC)
[Docket No. DEA–916]
Bulk Manufacturer of Controlled
Substances Application: Novitium
Pharma LLC
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
VerDate Sep<11>2014
22:39 Oct 25, 2021
Jkt 256001
National Science Foundation.
Request for information.
AGENCY:
ACTION:
The National Science
Foundation’s (NSF) Division of
Undergraduate Education (DUE), the
SUMMARY:
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
59199
Division of Biological Infrastructure
(DBI), the Division of Mathematical
Sciences (DMS) and the Division of
Computer and Information Science and
Engineering (CISE) request input from
interested parties the value and need for
an interdisciplinary program that trains
undergraduate students at the
intersections of biological science,
mathematics and computer sciences.
This RFI will help inform NSF as it
considers programs for educating the
workforce of tomorrow.
DATES: Interested persons are invited to
submit comments on or before
December 31, 2021.
ADDRESSES: Submit comments to Mary
L. Crowe, mcrowe@nsf.gov. Submissions
should include the ‘‘RFI Response:
Undergraduate Training Program in
Biological, Mathematical and Computer
Science UBMC’’ in the subject line of
the message. Phone calls can be made to
Mary L. Crowe at the following number:
703–292–7177.
FOR FURTHER INFORMATION CONTACT:
Suzanne H. Plimpton, Reports Clearance
Officer, National Science Foundation,
2415 Eisenhower Avenue, Suite
W18200, Alexandria, Virginia 22314;
telephone (703) 292–7556; or send email
to splimpto@nsf.gov. Individuals who
use a telecommunications device for the
deaf (TDD) may call the Federal
Information Relay Service (FIRS) at 1–
800–877–8339, which is accessible 24
hours a day, 7 days a week, 365 days a
year (including Federal holidays).
SUPPLEMENTARY INFORMATION:
Instructions: Response to this RFI is
voluntary. Each individual or institution
is requested to submit only one
response. Responses should include the
name of the person(s) or organization(s)
filing the comment. Please include the
number of the question or questions to
which you are responding. Please limit
your response to no more than six
pages.
In accordance with FAR 15.202(3),
responses to this notice are not offers
and cannot be accepted by the
Government to form a binding contract.
Responders are solely responsible for all
expenses associated with responding to
this RFI.
Background Information: The
National Science Foundation (NSF)
plays a critical role in establishing U.S.
leadership in science and engineering
(S&E), creating innovations that drive
the nation’s economy and educating the
next generation of scientists and
engineers. The NSF 10 Big Ideas support
this role through ideas such as the
Future of Work at the Human
Technology Frontier, Harnessing the
Data Revolution, and others, that foster
E:\FR\FM\26OCN1.SGM
26OCN1
]]>Agencies
[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59198-59199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23281]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-915]
Importer of Controlled Substances Application: Indigenous Peyote
Conservation Initiative
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Indigenous Peyote Conservation Initiative 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 November 26,
2021. Such persons may also file a written request for a hearing on the
application on or before November 26, 2021.
[[Page 59199]]
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 30, 2021, Indigenous Peyote Conservation
Initiative, 826 North FM 649, Hebbronville, Texas 78361, applied to be
registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Peyote.................................. 7415 I
------------------------------------------------------------------------
The above controlled substance will be imported as live plants for
research, analytical purposes, enhancing the plant population, and
improving conservation strategies of the plant in situ in its native
habit. 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 Food and Drug Administration-approved or non-approved finished
dosage forms for commercial sale.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021-23281 Filed 10-25-21; 8:45 am]
BILLING CODE 4410-09-P
