Importer of Controlled Substances Application: MMJ Biopharma Cultivation, Inc., 63583-63584 [2020-22070]
Download as PDF
<![CDATA[
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 196 / Thursday, October 8, 2020 / Notices
substances from the pharmacy. DEA
also told Registrant on three separate
occasions that there was a reasonable
basis to believe that M.B. was diverting
controlled substances. Despite these
reports, Registrant continued to employ
M.B. until at least February 2018.
There is also no evidence on the
record that Registrant took any real
measures to increase security at the
pharmacy or otherwise stop the losses.
Registrant’s owner told DEA on June 1,
2017, that Registrant was in the process
of taking additional security measures—
namely ordering a safe to store
controlled substances and taking daily
inventories of controlled substances—
and that M.B. no longer worked at
Registrant. RFAAX 15, at 2. Registrant’s
PIC, however, told DEA on July 27,
2017, that Registrant’s narcotics were
being stored in an unlocked case and
that any pharmacy employee could
change the inventory quantities in
Registrant’s computer. RFAAX 11 (text
messages between PIC and DEA TFO).
Registrant also admitted that ‘‘[n]either
of these alleged additional safeguards
were effective, as the controlled
substances continued to be stored in
such a way that all employees have
access to them, and the daily
inventories were conducted in such a
way that any employee could alter the
inventory.’’ RFAAX 12, at 2 (admitting
to the factual allegations in paragraphs
2–8 of the OSC); OSC, at 4. Furthermore,
PIC Clark told the DEA that, as of July
27, 2017, M.B. was working as a
pharmacy tech at Registrant. RFAA 11.
Registrant confirmed that M.B. was still
employed by Registrant in meetings
with DEA on January 8, 2018 and
February 7, 2018. RFAAX 15, at 4.
‘‘[A] DEA registrant is obligated at all
times to act in the public interest.’’ Peter
F. Kelly, D.P.M., 82 FR 28,676, 28,688
(2017). Registrant’s failure to take action
to stop the illicit flow of controlled
substances out of the pharmacy was a
breach of its duty as a registrant to act
in the public interest. Moreover, it likely
permitted the additional diversion of
hundreds (if not thousands) of units of
controlled substances. I, therefore, find
that Registrant’s failure to stem the
known diversion of controlled
substances from its inventory
constitutes ‘‘conduct which may
threaten the public health and safety.’’
21 U.S.C. 823(f)(5).
Having considered all of the factors, I
conclude that the evidence pertinent to
factors two, four, and five demonstrate
a prima facie showing that Registrant
‘‘has committed such acts as would
render [its] registration . . . inconsistent
with the public interest.’’ 21 U.S.C.
824(a)(4). I further conclude that
VerDate Sep<11>2014
17:48 Oct 07, 2020
Jkt 253001
Registrant has not rebutted the
Government’s prima facie case.
III. Sanction
Where, as here, the Government has
met its prima facie burden of showing
that Registrant’s continued registration
is inconsistent with the public interest,
the burden shifts to the Registrant to
show why it can be entrusted with a
registration. Garrett Howard Smith,
M.D., 83 FR 18,882, 18,910 (2018)
(collecting cases).
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 functions’ under the statute.’’
Gonzales, 546 U.S. at 259. ‘‘Because
‘past performance is the best predictor
of future performance, ALRA Labs, Inc.
v. Drug Enf’t Admin., 54 F.3d 450, 452
(7th Cir. 1995), [the Agency] has
repeatedly held that where a registrant
has committed acts inconsistent with
the public interest, the registrant must
accept responsibility for [the
registrant’s] actions and demonstrate
that [registrant] will not engage in future
misconduct.’ ’’ Jayam Krishna-Iyer, 74
FR at 463 (quoting Medicine Shoppe, 73
FR 364, 387 (2008)); see also Jackson, 72
FR at 23,853; John H. Kennnedy, M.D.,
71 FR 35,705, 35,709 (2006); Prince
George Daniels, D.D.S., 60 FR 62,884,
62,887 (1995). The issue of trust is
necessarily a fact-dependent
determination based on the
circumstances presented by the
individual registrant; therefore, the
Agency looks at factors, such as the
acceptance of responsibility, and the
credibility of that acceptance as it
relates to the probability of repeat
violations or behavior, and the nature of
the misconduct that forms the basis for
sanction, while also considering the
Agency’s interest in deterring similar
acts. See Arvinder Singh, M.D., 81 FR
8247, 8248 (2016).
Registrant accepted responsibility for
most of its misconduct in the MOA, in
which it admitted to many of the factual
allegations in the OSC in exchange for
certain agreements from the
Government. Registrant, however, did
not present any evidence of remorse for
its past misconduct and did not provide
any assurances that it would not engage
in such conduct in the future. Further,
it provided no evidence of rehabilitative
actions taken to correct its past unlawful
behavior, except an agreement from the
Owner, in her individual capacity, that
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
63583
‘‘she will not serve as an officer, partner,
stockholder, proprietor, owner, partial
owner, or pharmacist in charge of any
entity that either possesses or is seeing
a DEA Certificate of Registration’’ for so
long as the MOA between the
Government and Registrant remains in
effect. Absent such evidence and such
assurances in this matter, I find that
continued registration of Registrant is
inconsistent with the public interest.
Registrant’s silence weighs against its
continued registration. Zvi H. Perper,
M.D., 77 FR 64,131, 64,142 (2012)
(citing Med. Shoppe-Jonesborough, 73
FR at 387); see also Samuel S. Jackson,
72 FR 23,848, 23,853 (2007).
Accordingly, I find that the factors
weigh in favor of sanction and I shall
order the sanction the Government
requested, as contained in the Order
below.
IV. 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 BW8625785 issued to
Wayne Pharmacy. This Order is
effective November 9, 2020.
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020–22216 Filed 10–7–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–642]
Importer of Controlled Substances
Application: MMJ Biopharma
Cultivation, Inc.
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 November 9, 2020. Such
persons may also file a written request
for a hearing on the application on or
before November 9, 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:
DATES:
E:\FR\FM\08OCN1.SGM
08OCN1
63584
Federal Register / Vol. 85, No. 196 / Thursday, October 8, 2020 / Notices
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 February 13, 2020,
MMJ Biopharma Cultivation, Inc., 71
Margaret Terrance Memorial Way,
Akwesasne, New York, 13655, applied
to be registered as an importer of the
following basic class(es) of controlled
substances:
Controlled
substance
Drug code
Marihuana Extract.
Marihuana .........
Tetrahydrocannabinols.
Schedule
7350
I
7360
7370
I
I
The company plans to import the
listed controlled substances as mature
plants to support the manufacturing of
dosage forms for use in clinical trials.
This notice does not constitute an
evaluation or determination of the
merits of the company’s application.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–22070 Filed 10–7–20; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Federal Bureau of Investigation
Overview of This Information
Collection
[OMB Number 1110–0058]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Extension of a
Currently-Approved Collection;
National Incident-Based Reporting
System (NIBRS)
Federal Bureau of Investigation
(FBI), Department of Justice (DOJ).
ACTION: 30-Day Notice and request for
comments.
AGENCY:
The DOJ, FBI, Criminal
Justice Information Services (CJIS)
Division, will be submitting the
following information collection request
to the Office of Management and Budget
for review and approval in accordance
with the Paperwork Reduction Act
(PRA) of 1995.
DATES: Comments are encouraged and
will be accepted for 30 days until
December 7, 2020.
FOR FURTHER INFORMATION CONTACT:
Written comments and
recommendations for the proposed
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:48 Oct 07, 2020
Jkt 253001
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
SUPPLEMENTARY INFORMATION: 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 FBI, 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).
1. Type of Information Collection:
Extension of a currently-approved
collection.
2. The Title of the Form/Collection:
National Incident-Based Reporting
System.
3. The agency form number, if any,
and the applicable component of the
Department sponsoring the collection:
The form number is 1110–0058. The
applicable component within the DOJ is
the CJIS Division of the FBI.
4. Affected public who will be asked
or required to respond, as well as a brief
abstract:
Primary: Federal, state, local, and
tribal law enforcement agencies (LEAs).
Abstract: Under Title 28, United
States Code (U.S.C.), Section (§ ) 534,
subsections (a) and (c); the Uniform
Federal Crime Reporting Act of 1988, 34
U.S.C. 41303; the Hate Crime Statistics
Act, 34 U.S.C. 41305, modified by the
Matthew Shepard and James Byrd, Jr.,
Hate Crimes Prevention Act (2009),
Public Law (Pub. L.) § 4708; the Anti-
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
Arson Act of 1982, 18 U.S.C. 841 note;
the William Wilberforce Trafficking
Victims Protection Reauthorization Act
of 2008, 34 U.S.C. 41309; the USA
Patriot Improvement and
Reauthorization Act of 2005, Public Law
109–177, 307, subsection (e) Reporting
of Cargo Theft, 120 Statutes at Large
193, 240 (2006); and 34 U.S.C. 12532,
this collection requests incident data
from federal, state, local, and tribal
LEAs in order for the FBI Uniform
Crime Reporting (UCR) Program to serve
as the national clearinghouse for the
collection and dissemination of incident
data and to release these statistics in the
following publications: Crime in the
United States, Hate Crime Statistics,
Law Enforcement Officers Killed and
Assaulted, and National Incident-Based
Reporting System. The NIBRS is a data
collection which allows LEAs to collect
information on each crime occurrence.
The FBI designed NIBRS to generate
data as a byproduct of federal, state, and
local automated records management
systems (RMS). Currently, the NIBRS
collects data on each incident and arrest
within 28 crime categories comprised of
71 specific crimes called Group A
offenses. For each of the offenses
coming to the attention of law
enforcement, various details about the
crime are collected. In addition to the
Group A offenses, arrest data only are
reported for 13 Group B offense
categories. When reporting data via the
traditional Summary Reporting System
(SRS), LEAs tally the occurrences of 10
Part I crimes.
The most significant difference
between NIBRS and the traditional SRS
is the degree of detail in reporting. The
NIBRS is capable of producing more
detailed, accurate, and meaningful
information because data are collected
about when and where crime takes
place, what form it takes, and the
characteristics of its victims and
perpetrators. Although most of the
general concepts for collecting, scoring,
and reporting UCR data in SRS apply in
NIBRS (e.g., jurisdictional rules), there
are some important differences between
the two data collection systems. The
SRS employs the Hierarchy Rule, i.e., in
a multiple-offense incident, only the
most serious offense is reported, and
only 10 Part I offenses can be reported.
The many advantages NIBRS has over
SRS include, but are not limited to,
reports up to 10 offenses occurring
during the incident; revised, expanded,
and new offense definitions; more
specificity in reporting and using
offense and arrest data for 28 Group A
offense categories encompassing 71
crimes; distinguishes between
E:\FR\FM\08OCN1.SGM
08OCN1
]]>Agencies
[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Notices]
[Pages 63583-63584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22070]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-642]
Importer of Controlled Substances Application: MMJ Biopharma
Cultivation, Inc.
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 November 9,
2020. Such persons may also file a written request for a hearing on the
application on or before November 9, 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:
[[Page 63584]]
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 February 13, 2020, MMJ Biopharma Cultivation, Inc.,
71 Margaret Terrance Memorial Way, Akwesasne, New York, 13655, applied
to be registered as an importer of the following basic class(es) of
controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Marihuana Extract.................. 7350 I
Marihuana.......................... 7360 I
Tetrahydrocannabinols.............. 7370 I
------------------------------------------------------------------------
The company plans to import the listed controlled substances as
mature plants to support the manufacturing of dosage forms for use in
clinical trials. This notice does not constitute an evaluation or
determination of the merits of the company's application.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-22070 Filed 10-7-20; 8:45 am]
BILLING CODE 4410-09-P
