Bulk Manufacturer of Controlled Substances Application: Irvine Labs Inc., 106579-106580 [2024-31293]
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ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
authorized applicants representing
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All written submissions must conform
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on_filing_procedures.pdf, elaborates
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In accordance with §§ 201.16(c) and
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Certification.—Pursuant to § 207.3 of
the Commission’s rules, any person
submitting information to the
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Authority: These investigations are
being conducted under authority of title
VII of the Tariff Act of 1930; this notice
is published pursuant to § 207.12 of the
Commission’s rules.
By order of the Commission.
Issued: December 20, 2024.
Lisa Barton,
Secretary to the Commission.
[FR Doc. 2024–31088 Filed 12–27–24; 8:45 am]
BILLING CODE 7020–02–P
JUDICIAL CONFERENCE OF THE
UNITED STATES
Advisory Committee on Evidence
Rules; Hearing of the Judicial
Conference
Judicial Conference of the
United States.
ACTION: Advisory Committee on
Evidence Rules; notice of cancellation of
open hearing.
AGENCY:
The following public hearing
on proposed amendments to the Federal
Rules of Evidence has been canceled:
Evidence Rules Hearing on January 22,
2025.
DATES: January 22, 2025.
SUMMARY:
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106579
H.
Thomas Byron III, Esq., Chief Counsel,
Rules Committee Staff, Administrative
Office of the U.S. Courts, Thurgood
Marshall Federal Judiciary Building,
One Columbus Circle NE, Suite 7–300,
Washington, DC 20544, Phone (202)
502–1820, RulesCommittee_Secretary@
ao.uscourts.gov.
FOR FURTHER INFORMATION CONTACT:
The
announcement for this hearing was
previously published in the Federal
Register on July 31, 2024 at 89 FR
61498.
SUPPLEMENTARY INFORMATION:
(Authority: 28 U.S.C. 2073.)
Dated: December 23, 2024.
Shelly L. Cox,
Management Analyst, Rules Committee Staff.
[FR Doc. 2024–31251 Filed 12–27–24; 8:45 am]
BILLING CODE 2210–55–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–1461]
Bulk Manufacturer of Controlled
Substances Application: Irvine Labs
Inc.
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
AGENCY:
Irvine Labs Inc. 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 submit
electronic comments on or objections to
the issuance of the proposed registration
on or before February 28, 2025. Such
persons may also file a written request
for a hearing on the application on or
before February 28, 2025.
ADDRESSES: The Drug Enforcement
Administration requires that all
comments be submitted electronically
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
SUMMARY:
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106580
Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices
Number, your comment has been
successfully submitted and there is no
need to resubmit the same comment.
In
accordance with 21 CFR 1301.33(a), this
is notice that on August 26, 2024, Irvine
Labs Inc., 7305 Murdy Circle,
SUPPLEMENTARY INFORMATION:
Huntington Beach, California 92647–
3533, applied to be registered as a bulk
manufacturer of the following basic
class(es) of controlled substance(s):
Controlled substance
Drug code
Lysergic acid diethylamide ......................................................................................................................................
Mescaline .................................................................................................................................................................
Peyote ......................................................................................................................................................................
Diethyltryptamine .....................................................................................................................................................
Dimethyltryptamine ..................................................................................................................................................
Psilocybin .................................................................................................................................................................
Psilocyn ....................................................................................................................................................................
The company plans to bulk
manufacture the above listed controlled
substances for research and
development purposes internally and
for distribution to its research
customers. No other activities for these
drug codes are authorized for this
registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024–31293 Filed 12–27–24; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ddrumheller on DSK120RN23PROD with NOTICES1
Soroosh Armandi, D.O.; Decision and
Order
On February 1, 2024, the Drug
Enforcement Administration (DEA or
Government) issued an Order to Show
Cause (OSC) to Soroosh Armandi, D.O.,
of San Pedro, California (Registrant).
Request for Final Agency Action
(RFAA), Attachment (RFAAX) A, at 1, 3.
The OSC proposed the revocation of
Registrant’s Certificate of Registration
No. FA0060359, alleging that
Registrant’s registration should be
revoked because Registrant is ‘‘currently
without authority to handle controlled
substances in the State of California, the
state in which [he is] registered with
DEA.’’ Id. at 2 (citing 21 U.S.C.
824(a)(3)).1
The OSC notified Registrant of his
right to file a written request for hearing,
and that if he failed to file such a
request, he would be deemed to have
waived his right to a hearing and be in
default. Id. (citing 21 CFR 1301.43).
Here, Registrant did not request a
1 According to Agency records, Registrant’s
registration expired on June 30, 2024. The fact that
a registrant allows his registration to expire during
the pendency of an OSC does not impact the
Agency’s jurisdiction or prerogative under the
Controlled Substances Act (CSA) to adjudicate the
OSC to finality. Jeffrey D. Olsen, M.D., 84 FR 68474,
68476–68479 (2019).
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hearing. RFAA, at 2.2 ‘‘A default, unless
excused, shall be deemed to constitute
a waiver of the [registrant’s] right to a
hearing and an admission of the factual
allegations of the [OSC].’’ 21 CFR
1301.43(e).
Further, ‘‘[i]n the event that a
registrant . . . is deemed to be in
default . . . DEA may then file a request
for final agency action with the
Administrator, along with a record to
support its request. In such
circumstances, the Administrator may
enter a default final order pursuant to
[21 CFR] § 1316.67.’’ Id. § 1301.43(f)(1).
Here, the Government has requested
final agency action based on Registrant’s
default pursuant to 21 CFR 1301.43(c),
(f), 1301.46. RFAA, at 1; see also 21 CFR
1316.67.
Findings of Fact
The Agency finds that, in light of
Registrant’s default, the factual
allegations in the OSC are admitted.
According to the OSC, Registrant’s
California medical license expired on
March 31, 2023. RFAAX A, at 2.
Further, effective June 29, 2023, the
2 Based on the Government’s submissions in its
RFAA dated May 24, 2024, the Agency finds that
service of the OSC on Registrant was adequate. The
included declaration from a DEA Diversion
Investigator (DI) indicates that she was ‘‘unable to
locate Registrant and [she was] under the belief that
Registrant was out of the country;’’ accordingly, on
February 2, 2024, the DI emailed a copy of the OSC
to Registrant’s registered email address. RFAAX 1,
at 2. The DI did not state that an undeliverable
message was ever received. Id. On the same date,
the DI mailed a copy of the OSC to Registrant’s
registered address. Id. On February 5, 2024,
however, the OSC was returned to the DI, along
with a notice of a forwarding address for Registrant.
Id.; see also id., Attachment B. On February 14,
2024, the DI mailed a copy of the OSC to
Registrant’s forwarding address and later received
confirmation via the certified mailing receipt that
the OSC was successfully delivered on February 17,
2024. Id. at 2; see also id., Attachment C. The
Agency finds that the DI’s efforts to serve Registrant
were ‘‘ ‘reasonably calculated, under all the
circumstances, to apprise [Registrant] of the
pendency of the action.’ ’’ Jones v. Flowers, 547 U.S.
220, 226 (2006) (quoting Mullane v. Central
Hanover Bank & Trust Co., 339 U.S. 306, 314
(1950)). Therefore, due process notice requirements
have been satisfied.
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7315
7381
7415
7434
7435
7437
7438
Schedule
I
I
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I
I
Osteopathic Medical Board of California
revoked Registrant’s California medical
license. Id. According to California
online records, of which the Agency
takes official notice, Registrant’s
California medical license remains
revoked.3 California DCA License
Search, https://search.dca.ca.gov (last
visited date of signature of this Order).4
Accordingly, the Agency finds that
Registrant is not licensed to practice
medicine in California, the state in
which he is registered with DEA.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the
Attorney General is authorized to
suspend or revoke a registration issued
under 21 U.S.C. 823 ‘‘upon a finding
that the registrant . . . has had his 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, DEA has
also 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. Gonzales v.
3 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
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,
Registrant may dispute the Agency’s finding by
filing a properly supported motion for
reconsideration of findings of fact within fifteen
calendar days of the date of this Order. Any such
motion and response shall be filed and served by
email to the other party and to Office of the
Administrator, Drug Enforcement Administration at
dea.addo.attorneys@dea.gov.
4 The OSC lists the number for Registrant’s
California medical license as 20A9741, RFAAX A,
at 1; however, the California DCA License Search
lists Registrant’s California medical license number
as 9741.
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Agencies
[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106579-106580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31293]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1461]
Bulk Manufacturer of Controlled Substances Application: Irvine
Labs Inc.
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Irvine Labs Inc. 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 submit electronic comments on or
objections to the issuance of the proposed registration on or before
February 28, 2025. Such persons may also file a written request for a
hearing on the application on or before February 28, 2025.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically 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
[[Page 106580]]
Number, your comment has been successfully submitted and there is no
need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on August 26, 2024, Irvine Labs Inc., 7305 Murdy Circle,
Huntington Beach, California 92647-3533, applied to be registered as a
bulk manufacturer of the following basic class(es) of controlled
substance(s):
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Lysergic acid diethylamide.............. 7315 I
Mescaline............................... 7381 I
Peyote.................................. 7415 I
Diethyltryptamine....................... 7434 I
Dimethyltryptamine...................... 7435 I
Psilocybin.............................. 7437 I
Psilocyn................................ 7438 I
------------------------------------------------------------------------
The company plans to bulk manufacture the above listed controlled
substances for research and development purposes internally and for
distribution to its research customers. No other activities for these
drug codes are authorized for this registration.
Matthew Strait,
Deputy Assistant Administrator.
[FR Doc. 2024-31293 Filed 12-27-24; 8:45 am]
BILLING CODE 4410-09-P