Importer of Controlled Substances Application: Globyz Pharma, LLC, 59189-59190 [2021-23285]
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Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices
importers of the products at issue in this
investigation. The initial written
submissions and proposed remedial
orders must be filed no later than close
of business on Wednesday, November 3,
2021. Reply submissions must be filed
no later than the close of business on
Wednesday, November 10, 2021. No
further submissions on these issues will
be permitted unless otherwise ordered
by the Commission.
Persons filing written submissions
must file the original document
electronically on or before the deadlines
stated above. The Commission’s paper
filing requirements in 19 CFR 210.4(f)
are currently waived. 85 FR 15798
(March 19, 2020). Submissions should
refer to the investigation number (Inv.
No. 337–TA–1206) in a prominent place
on the cover page and/or the first page.
(See Handbook for Electronic Filing
Procedures, https://www.usitc.gov/
documents/handbook_on_filing_
procedures.pdf). Persons with questions
regarding filing should contact the
Secretary, (202) 205–2000.
Any person desiring to submit a
document to the Commission in
confidence must request confidential
treatment by marking each document
with a header indicating that the
document contains confidential
information. This marking will be
deemed to satisfy the request procedure
set forth in Rules 201.6(b) and
210.5(e)(2) (19 CFR 201.6(b) &
210.5(e)(2)). Documents for which
confidential treatment by the
Commission is properly sought will be
treated accordingly. A redacted nonconfidential version of the document
must also be filed simultaneously with
any confidential filing. All information,
including confidential business
information and documents for which
confidential treatment is properly
sought, submitted to the Commission for
purposes of this investigation may be
disclosed to and used: (i) By the
Commission, its employees and Offices,
and contract personnel (a) for
developing or maintaining the records
of this or a related proceeding, or (b) in
internal investigations, audits, reviews,
and evaluations relating to the
programs, personnel, and operations of
the Commission including under 5
U.S.C. Appendix 3; or (ii) by U.S.
government employees and contract
personnel, solely for cybersecurity
purposes. All contract personnel will
sign appropriate nondisclosure
agreements. All nonconfidential written
submissions will be available for public
inspection on EDIS.
The Commission vote for this
determination took place on October 20,
2021.
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22:39 Oct 25, 2021
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The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended, 19 U.S.C. 1337, and in Part
210 of the Commission’s Rules of
Practice and Procedure, 19 CFR part
210.
DEPARTMENT OF JUSTICE
By order of the Commission.
Issued: October 20, 2021.
Lisa Barton,
Secretary to the Commission.
AGENCY:
JUDICIAL CONFERENCE OF THE
UNITED STATES
Committee on Rules of Practice and
Procedure; Meeting of the Judicial
Conference
Judicial Conference of the
United States.
AGENCY:
Committee on Rules of Practice
and Procedure; revised notice of open
meeting.
ACTION:
The Committee on Rules of
Practice and Procedure will hold a
meeting in Washington, DC on January
4, 2022 rather than in Miami, FL as
previously announced. The meeting is
open to the public for observation but
not participation. An agenda and
supporting materials will be posted at
least 7 days in advance of the meeting
at: https://www.uscourts.gov/rulespolicies/records-and-archives-rulescommittees/agenda-books. The
announcement for this meeting was
previously published in the Federal
Register on June 28, 2021.
SUMMARY:
January 4, 2022.
FOR FURTHER INFORMATION CONTACT:
Scott Myers, Esq., Acting 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.
(Authority: 28 U.S.C. 2073.)
Dated: October 21, 2021.
Shelly L. Cox,
Management Analyst, Rules Committee Staff.
[FR Doc. 2021–23276 Filed 10–25–21; 8:45 am]
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Fmt 4703
Sfmt 4703
Importer of Controlled Substances
Application: Globyz Pharma, LLC
Globyz Pharma, LLC has
applied to be registered as an importer
of basic class(es) of controlled
substance(s). Refer to SUPPLEMENTAL
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.
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 August 18, 2021,
Globyz Pharma, LLC, 2101 Market
Street, Suite 5, Upper Chichester,
Pennsylvania 19061–4001, applied to be
registered as an importer of the
following basic class(es) of controlled
substance(s):
SUMMARY:
BILLING CODE 7020–02–P
BILLING CODE 2210–55–P
[Docket No. DEA–917]
Drug Enforcement
Administration, Justice.
ACTION: Notice of application.
[FR Doc. 2021–23267 Filed 10–25–21; 8:45 am]
DATES:
Drug Enforcement Administration
Controlled substance
Amphetamine ..................
Lisdexamfetamine ...........
Oxycodone ......................
I
Drug
code
Schedule
1100
1205
9143
II
II
II
I
The company plans to import finished
dosage unit products of the above
controlled substances solely for its
customers to perform analytical testing
to meet Canadian requirements. The
analysis is required to allow its
customers to export domestically
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59190
Federal Register / Vol. 86, No. 204 / Tuesday, October 26, 2021 / Notices
manufactured finished dosage forms to
foreign markets. 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.
Brian S. Besser,
Acting Assistant Administrator.
[FR Doc. 2021–23285 Filed 10–25–21; 8:45 am]
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 20–22]
Nicholas P. Roussis, M.D.; Decision
and Order
On May 27, 2020, the Assistant
Administrator, Diversion Control
Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause to Nicholas P. Roussis, M.D.
(hereinafter, Respondent), of Staten
Island, New York. Order to Show Cause
(hereinafter, OSC), at 1. The OSC
proposed the denial of Respondent’s
application for DEA Certificate of
Registration, Control No. W19115227C,
because Respondent was mandatorily
excluded from ‘‘‘participation in
Medicare, Medicaid, and all federal
health care programs for a minimum
period of 10 years’ pursuant to 42 U.S.C.
1320a–7(a)’’ and such exclusion
‘‘warrants denial of [Respondent’s]
application for a [registration] pursuant
to 21 U.S.C. 824(a)(5).’’ Id. at 1–2 (citing
Richard Hauser, M.D., 83 FR 26308
(2018)).
Specifically, the OSC alleged that, on
October 16, 2017, the United States
District Court for the District of New
Jersey issued a judgment against
Respondent ‘‘based on [Respondent’s]
plea of guilty to the charge of
Racketeering-Transporting in Aid of
Travel Act-Acceptance of Bribes, in
violation of 18 U.S.C. 1952(a)(3) & 18
U.S.C. 2, a felony.’’ Id. at 2 (citing U.S.
v. Nicholas P. Roussis, No. 2:17–cr–
00231–SRC (D.N.J.)). The OSC further
alleged that ‘‘[b]ased on [Respondent’s]
conviction, the U.S. Department of
Health and Human Services, Office of
the Inspector General (‘‘HHS/OIG’’), by
letter dated April 30, 2018, mandatorily
excluded [Respondent] from
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22:39 Oct 25, 2021
Jkt 256001
‘participation in Medicare, Medicaid,
and all federal health care programs for
a minimum period of 10 years’ pursuant
to 42 U.S.C. 1320a–7(a), effective May
20, 2018.’’ Id.
The OSC notified Respondent of the
right to request a hearing on the
allegations or to submit a written
statement, while waiving the right to a
hearing, the procedures for electing each
option, and the consequences for failing
to elect either option. Id. at 3 (citing 21
CFR 1301.43). The OSC also notified
Respondent of the opportunity to
submit a corrective action plan. Id. at 3–
4 (citing 21 U.S.C. 824(c)(2)(C)).
By letter dated June 30, 2020,
Respondent timely requested a hearing.
Administrative Law Judge Exhibit
(hereinafter, ALJX) 2. The matter was
placed on the docket of the Office of
Administrative Law Judges and was
assigned to Administrative Law Judge
Mark M. Dowd (hereinafter, the ALJ).
On July 1, 2020, the ALJ issued an Order
for Prehearing Statements. ALJX 3. The
Government timely filed its prehearing
statement (hereinafter, Govt Prehearing)
on July 13, 2020. ALJX 4. Respondent
timely filed his prehearing statement
(hereinafter, Resp Prehearing) on July
22, 2020. ALJX 5. On July 28, 2020, the
ALJ issued a prehearing ruling that,
among other things, established the
schedules and procedures for the
remaining prehearing activities and for
the hearing. ALJX 6 (Prehearing Ruling,
at 1–11).
On September 8, 2020, the
Government filed ‘‘Objections Pursuant
to 21 CFR 1316.59’’ (hereinafter, Govt
Objections), which objected to the
admission of certain evidence submitted
by Respondent on the grounds of
authenticity. ALJX 8 (Govt Objections),
at 2. The evidence in question consisted
of ‘‘Respondent’s Exhibit 1, a 38-page
document containing approximately 18
letters’’ that Respondent had submitted
on August 3, 2020. Govt Objections, at
1. According to the Govt Objections,
‘‘[m]ost of the letters [appeared] to have
been drafted . . . nearly three years
before the Government served its
[OSC].’’ Id. Further, the Government
alleged that, ‘‘[a]ll but two of the letters
[were] unsigned and four [were]
undated.’’ Id. Finally, the Government
claimed that, ‘‘[although] all but one of
the letters [appeared] to be directed
toward a Federal District Court Judge in
connection with U.S. v. Nicholas P.
Roussis . . . the letters [did] not seem
to be available for inspection as part of
the publically [sic] assessable electronic
court file.’’ Id. at 2. The Government
concluded that because ‘‘all but two of
the letters [were] unsworn and no
witness [was] disclosed to authenticate
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Fmt 4703
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and/or lay a foundation for the
documents’ admissibility’’ the letters
should not be admitted. Id. On
September 9, 2020, Respondent filed a
Reply to Government’s Objections
(hereinafter, Reply to Objections). In the
Reply to Objections, Respondent
attached an affirmation from one of the
attorneys who represented him in his
criminal case. Reply to Objections, at 1.
The affirmation stated that all 18 letters
had been submitted as exhibits to the
District of New Jersey as part of
Respondent’s sentencing submission
during his criminal case. Reply to
Objections, Attachment (Affirmation of
Angela D. Lipsman), at 1–3. In the Reply
to Objections, Respondent stated,
‘‘[p]lease consider that affirmation as a
response to the Government’s
objections.’’ Reply to Objections, at 1. At
the hearing in this matter, which took
place on September 14, 2020, the
Government further objected to the
admission of the letters on the grounds
of relevance. Tr. 41. The Government
argued that in context, the letters related
only to the sentencing of the
Respondent in his criminal case and not
to Respondent’s prescribing practices or
whether he could be entrusted with a
DEA registration. Tr. 41–42. The ALJ
ultimately overruled the Government’s
objections on both grounds of
authenticity and relevance and admitted
the letters into the record. Tr. 42–43.
The hearing in this matter took place
via video teleconference on September
14, 2020. Following the hearing, both
the Government and the Respondent
filed their post-hearing briefs on
October 21, 2020. On November 5, 2020,
the ALJ issued the Recommended
Rulings, Findings of Fact, Conclusions
of Law, and Decision (hereinafter, RD).
Neither party filed exceptions to the RD.
See generally Transmittal Letter. I have
reviewed and agree with the procedural
rulings of the ALJ during the
administration of the hearing.
Having considered the record in its
entirety, I agree with the ALJ and find
that that the record established by
substantial evidence a prima facie case
supporting the denial of Respondent’s
application. RD, at 37. I also agree with
the ALJ that the Respondent failed to
fully accept responsibility for his
misconduct, failed to demonstrate that
the Agency can entrust him to maintain
his registration, and therefore, that
denial of his application is the
appropriate sanction. Id. I make the
following findings of fact.
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]]>Agencies
[Federal Register Volume 86, Number 204 (Tuesday, October 26, 2021)]
[Notices]
[Pages 59189-59190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23285]
=======================================================================
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-917]
Importer of Controlled Substances Application: Globyz Pharma, LLC
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
-----------------------------------------------------------------------
SUMMARY: Globyz Pharma, LLC has applied to be registered as an importer
of basic class(es) of controlled substance(s). Refer to Supplemental
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.
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 August 18, 2021, Globyz Pharma, LLC, 2101 Market
Street, Suite 5, Upper Chichester, Pennsylvania 19061-4001, applied to
be registered as an importer of the following basic class(es) of
controlled substance(s):
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Amphetamine............................. 1100 II
Lisdexamfetamine........................ 1205 II
Oxycodone............................... 9143 II
------------------------------------------------------------------------
The company plans to import finished dosage unit products of the
above controlled substances solely for its customers to perform
analytical testing to meet Canadian requirements. The analysis is
required to allow its customers to export domestically
[[Page 59190]]
manufactured finished dosage forms to foreign markets. 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. 2021-23285 Filed 10-25-21; 8:45 am]
BILLING CODE P
