Gary Gray d/b/a Complex; Decision and Order, 33916-33917 [2023-11132]
Download as PDF
<![CDATA[
33916
Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices
Controlled substance
Drug code
Diphenoxylate ................................................................................................................................................................
Levomethorphan ............................................................................................................................................................
Levorphanol ...................................................................................................................................................................
Meperidine .....................................................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ............................................................................................................
Thebaine ........................................................................................................................................................................
Oxymorphone ................................................................................................................................................................
Noroxymorphone ...........................................................................................................................................................
Alfentanil ........................................................................................................................................................................
Sufentanil .......................................................................................................................................................................
The company plans to import the bulk
control substances for distribution as
analytical reference standards to its
customers for analytical testing of raw
materials. No other activities for these
drug codes are 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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–11166 Filed 5–24–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1198]
Importer of Controlled Substances
Application: Almac Clinical Services
Incorp. (ACSI)
In
accordance with 21 CFR 1301.34(a), this
is notice that on May 1, 2023, Almac
Clinical Services Incorp (ACSI), 25 Fretz
Road, Souderton, Pennsylvania 18964,
applied to be registered as an importer
of the following basic class(es) of
controlled substance(s):
SUPPLEMENTARY INFORMATION:
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Almac Clinical Services
Incorp (ACSI) 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:
lotter on DSK11XQN23PROD with NOTICES1
Controlled substance
Registered bulk manufacturers of
the affected basic class(es), and
applicants therefore, may submit
electronic comments on or objections to
the issuance of the proposed registration
on or before June 26, 2023. Such
persons may also file a written request
for a hearing on the application on or
before June 26, 2023.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
DATES:
VerDate Sep<11>2014
18:04 May 24, 2023
Jkt 259001
through the Federal eRulemaking Portal,
which provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon submission
of your comment, you will receive a
Comment Tracking Number. Please be
aware that submitted comments are not
instantaneously available for public
view on https://www.regulations.gov. If
you have received a Comment Tracking
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment. All
requests for a hearing must 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. All requests for a hearing should
also be sent to: Drug Enforcement
Administration, Attn: Administrator,
8701 Morrissette Drive, Springfield,
Virginia 22152.
Psilocybin ........................
Oxycodone ......................
Hydromorphone ...............
Morphine ..........................
Tapentadol ......................
Fentanyl ...........................
Drug
code
Schedule
7437
9143
9150
9300
9780
9801
I
II
II
II
II
II
The company plans to import the
listed controlled substances as finished
dosage form units for clinical trials
purposes only. No other activities for
these drug codes are authorized for this
registration.
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
9170
9210
9220
9230
9273
9333
9652
9668
9737
9740
Schedule
II
II
II
II
II
II
II
II
II
II
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.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2023–11173 Filed 5–24–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22–11]
Gary Gray d/b/a Complex; Decision
and Order
On November 22, 2021, the Drug
Enforcement Administration (DEA or
the Agency) issued an Order to Show
Cause (OSC) to Gary Gray d/b/a
Complex (hereinafter, the Respondent)
seeking to deny Respondent’s
application for a DEA Certificate of
Registration to manufacture marihuana,
Control No. W14063382E. OSC, at 1.
After a hearing, the Chief
Administrative Law Judge (Chief ALJ)
issued his Recommended Rulings,
Findings of Law, and Decision of the
Administrative Law Judge
(Recommended Decision or RD), which
recommended Respondent’s application
for a manufacturing registration be
denied because ‘‘the plain language of
the controlling regulations compels the
denial of the present application as a
matter of law.’’ RD, at 2, 11. The Agency
agrees with the Chief ALJ’s
recommendation, and, for the reasons
explained below, denies Respondent’s
application as inconsistent with the
public interest under 21 U.S.C. 823(a).1
1 Effective December 2, 2022, the Medical
Marijuana and Cannabidiol Research Expansion
Act, Public Law 117–215, 136 Stat. 2257 (2022)
(Marijuana Research Amendments or MRA),
amended the Controlled Substances Act (CSA) and
E:\FR\FM\25MYN1.SGM
25MYN1
Federal Register / Vol. 88, No. 101 / Thursday, May 25, 2023 / Notices
lotter on DSK11XQN23PROD with NOTICES1
I. Findings of Fact
On July 30, 2014, Respondent filed an
application with DEA to bulk
manufacture Schedule I controlled
substances. Government Exhibit (GX) 1.
According to Respondent, he is seeking
to obtain DEA registration as a bulk
manufacturer of marihuana ‘‘so that he
may cultivate, harvest, and package the
particular strains of marihuana required
for his research and product
development purposes.’’ Resp
Posthearing, at 4; Tr. 30. Respondent
hopes to ultimately produce products
that will treat Alzheimer’s and other
degenerative diseases. Tr. 30, 49.
Respondent is a pharmacist and has
possessed, and operated under,
pharmacy controlled substance
registrations, as well as having held
multiple state pharmacy licenses for
over 50 years. Tr. 58–61. It is
undisputed, however, that Respondent
does not currently hold any type of DEA
controlled substance registration, and at
the onset of the hearing, a certification
of Respondent’s lack of DEA registration
as a schedule 1 researcher was admitted
into the record without objection. Tr.
18; GX 1, at 2.
II. Discussion
The Controlled Substances Act (CSA)
states that the Agency shall register an
applicant to manufacture controlled
substances in schedule I or II if such
registration is determined to be
‘‘consistent with the public interest and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971.’’ 21
U.S.C. 823(a). The CSA provides six
factors DEA must consider in
determining the public interest. Id. 21
CFR 1318.05, which implements the
requirements of § 823(a) for marihuana
growers and manufacturers, further
provides that the Agency shall place
‘‘particular emphasis’’ on certain
enumerated criteria in determining the
public interest.
In situations, such as here, where ‘‘an
applicant seeks registration to grow
cannabis for its own research or product
development’’ one of the criteria of
‘‘particular emphasis’’ is that ‘‘the
applicant must possess registration as a
schedule I researcher with respect to
marihuana under § 1301.31 of this
chapter.’’ 21 CFR 1318.05(b)(3)(ii)
(emphasis added). It is undisputed that
Respondent does not possess a DEA
schedule I researcher registration under
§ 1301.31. Tr. 19; Respondent’s
Exceptions, at 3. Accordingly, under the
plain language of the regulation,
other statutes; however, the relevant provision here,
21 U.S.C. 823(a), remained the same.
VerDate Sep<11>2014
18:04 May 24, 2023
Jkt 259001
Respondent does not meet the criteria to
receive the manufacturer registration for
which he has applied, and the Agency
finds that granting his application for a
registration would not be consistent
with the public interest under § 823(a).2
33917
DEPARTMENT OF LABOR
Agency Information Collection
Activities; Submission for OMB
Review; Comment Request; Request
for State or Federal Workers’
Compensation Information
Order
Pursuant to 28 CFR 0.100(b) and the
authority vested in me by 21 U.S.C.
823(a), I hereby deny DEA registration
application No. W14063382E submitted
by Gary Gray d/b/a/Complex. This
Order is effective June 26, 2023.
Signing Authority
This document of the Drug
Enforcement Administration was signed
on May 16, 2023, by Administrator
Anne Milgram. That document with the
original signature and date is
maintained by DEA. For administrative
purposes only, and in compliance with
requirements of the Office of the Federal
Register, the undersigned DEA Federal
Register Liaison Officer has been
authorized to sign and submit the
document in electronic format for
publication, as an official document of
DEA. This administrative process in no
way alters the legal effect of this
document upon publication in the
Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug
Enforcement Administration.
[FR Doc. 2023–11132 Filed 5–24–23; 8:45 am]
BILLING CODE 4410–09–P
2 Respondent filed Exceptions to the Chief ALJ’s
Recommended Decision arguing that he is eligible
for a manufacturer registration because he applied
for the requisite researcher registration in June 2022
and that application is pending with DEA.
Respondent’s Exceptions, at 4. Respondent’s
argument is unpersuasive as the regulations clearly
state that an applicant must currently possess a
researcher registration, not just have submitted an
application for one. (Respondent’s application for a
researcher registration is also not in the record
under consideration for this matter as, based on a
declaration from Respondent’s counsel, it was
submitted after the Chief ALJ had transferred the
certified record for this matter to the DEA
Administrator). Respondent requests, in the
alternative, that any action on the instant
application be stayed pending action on his
application for registration as a schedule 1
researcher. Id. at 6–7. Respondent’s request is
denied. Respondent may submit a new application
for a manufacturer registration and that application
will be evaluated on its merits.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Notice of availability; request
for comments.
ACTION:
The Department of Labor
(DOL) is submitting this Office of
Workers’ Compensation Programs
(OWCP)-sponsored information
collection request (ICR) to the Office of
Management and Budget (OMB) for
review and approval in accordance with
the Paperwork Reduction Act of 1995
(PRA). Public comments on the ICR are
invited.
DATES: The OMB will consider all
written comments that the agency
receives on or before June 26, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
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.
Comments are invited on: (1) whether
the collection of information is
necessary for the proper performance of
the functions of the Department,
including whether the information will
have practical utility; (2) the accuracy of
the agency’s estimates of the burden and
cost of the collection of information,
including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility and
clarity of the information collection; and
(4) ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
automated collection techniques or
other forms of information technology.
FOR FURTHER INFORMATION CONTACT:
Nicole Bouchet by telephone at 202–
693–0213, or by email at DOL_PRA_
PUBLIC@dol.gov.
SUPPLEMENTARY INFORMATION: The
OWCP Form CM–981 is completed by a
school official to verify whether a Black
Lung beneficiary’s dependent, aged 18
to 23, qualifies as a full-time student.
For additional substantive information
about this ICR, see the related notice
published in the Federal Register on
January 31, 2022 (88 FR 6314).
This information collection is subject
to the PRA. A Federal agency generally
cannot conduct or sponsor a collection
of information, and the public is
SUMMARY:
E:\FR\FM\25MYN1.SGM
25MYN1
]]>Agencies
[Federal Register Volume 88, Number 101 (Thursday, May 25, 2023)]
[Notices]
[Pages 33916-33917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11132]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 22-11]
Gary Gray d/b/a Complex; Decision and Order
On November 22, 2021, the Drug Enforcement Administration (DEA or
the Agency) issued an Order to Show Cause (OSC) to Gary Gray d/b/a
Complex (hereinafter, the Respondent) seeking to deny Respondent's
application for a DEA Certificate of Registration to manufacture
marihuana, Control No. W14063382E. OSC, at 1.
After a hearing, the Chief Administrative Law Judge (Chief ALJ)
issued his Recommended Rulings, Findings of Law, and Decision of the
Administrative Law Judge (Recommended Decision or RD), which
recommended Respondent's application for a manufacturing registration
be denied because ``the plain language of the controlling regulations
compels the denial of the present application as a matter of law.'' RD,
at 2, 11. The Agency agrees with the Chief ALJ's recommendation, and,
for the reasons explained below, denies Respondent's application as
inconsistent with the public interest under 21 U.S.C. 823(a).\1\
---------------------------------------------------------------------------
\1\ Effective December 2, 2022, the Medical Marijuana and
Cannabidiol Research Expansion Act, Public Law 117-215, 136 Stat.
2257 (2022) (Marijuana Research Amendments or MRA), amended the
Controlled Substances Act (CSA) and other statutes; however, the
relevant provision here, 21 U.S.C. 823(a), remained the same.
---------------------------------------------------------------------------
[[Page 33917]]
I. Findings of Fact
On July 30, 2014, Respondent filed an application with DEA to bulk
manufacture Schedule I controlled substances. Government Exhibit (GX)
1. According to Respondent, he is seeking to obtain DEA registration as
a bulk manufacturer of marihuana ``so that he may cultivate, harvest,
and package the particular strains of marihuana required for his
research and product development purposes.'' Resp Posthearing, at 4;
Tr. 30. Respondent hopes to ultimately produce products that will treat
Alzheimer's and other degenerative diseases. Tr. 30, 49.
Respondent is a pharmacist and has possessed, and operated under,
pharmacy controlled substance registrations, as well as having held
multiple state pharmacy licenses for over 50 years. Tr. 58-61. It is
undisputed, however, that Respondent does not currently hold any type
of DEA controlled substance registration, and at the onset of the
hearing, a certification of Respondent's lack of DEA registration as a
schedule 1 researcher was admitted into the record without objection.
Tr. 18; GX 1, at 2.
II. Discussion
The Controlled Substances Act (CSA) states that the Agency shall
register an applicant to manufacture controlled substances in schedule
I or II if such registration is determined to be ``consistent with the
public interest and with United States obligations under international
treaties, conventions, or protocols in effect on May 1, 1971.'' 21
U.S.C. 823(a). The CSA provides six factors DEA must consider in
determining the public interest. Id. 21 CFR 1318.05, which implements
the requirements of Sec. 823(a) for marihuana growers and
manufacturers, further provides that the Agency shall place
``particular emphasis'' on certain enumerated criteria in determining
the public interest.
In situations, such as here, where ``an applicant seeks
registration to grow cannabis for its own research or product
development'' one of the criteria of ``particular emphasis'' is that
``the applicant must possess registration as a schedule I researcher
with respect to marihuana under Sec. 1301.31 of this chapter.'' 21 CFR
1318.05(b)(3)(ii) (emphasis added). It is undisputed that Respondent
does not possess a DEA schedule I researcher registration under Sec.
1301.31. Tr. 19; Respondent's Exceptions, at 3. Accordingly, under the
plain language of the regulation, Respondent does not meet the criteria
to receive the manufacturer registration for which he has applied, and
the Agency finds that granting his application for a registration would
not be consistent with the public interest under Sec. 823(a).\2\
---------------------------------------------------------------------------
\2\ Respondent filed Exceptions to the Chief ALJ's Recommended
Decision arguing that he is eligible for a manufacturer registration
because he applied for the requisite researcher registration in June
2022 and that application is pending with DEA. Respondent's
Exceptions, at 4. Respondent's argument is unpersuasive as the
regulations clearly state that an applicant must currently possess a
researcher registration, not just have submitted an application for
one. (Respondent's application for a researcher registration is also
not in the record under consideration for this matter as, based on a
declaration from Respondent's counsel, it was submitted after the
Chief ALJ had transferred the certified record for this matter to
the DEA Administrator). Respondent requests, in the alternative,
that any action on the instant application be stayed pending action
on his application for registration as a schedule 1 researcher. Id.
at 6-7. Respondent's request is denied. Respondent may submit a new
application for a manufacturer registration and that application
will be evaluated on its merits.
---------------------------------------------------------------------------
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 823(a), I hereby deny DEA registration application No.
W14063382E submitted by Gary Gray d/b/a/Complex. This Order is
effective June 26, 2023.
Signing Authority
This document of the Drug Enforcement Administration was signed on
May 16, 2023, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2023-11132 Filed 5-24-23; 8:45 am]
BILLING CODE 4410-09-P
