Bulk Manufacturer of Controlled Substances Application: Alcami Wisconsin Corporation, 27628 [2018-12684]
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27628
Federal Register / Vol. 83, No. 114 / Wednesday, June 13, 2018 / Notices
statement of the reasons why the
Commission should grant such
treatment. See 19 CFR 201.6. Documents
for which confidential treatment by the
Commission is properly sought will be
treated accordingly. All such requests
should be directed to the Secretary to
the Commission and must include a full
statement of the reasons why the
Commission should grant such
treatment. See 19 CFR 201.6. Documents
for which confidential treatment by the
Commission is properly sought will be
treated accordingly. 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,2 solely for cybersecurity
purposes. All nonconfidential written
submissions will be available for public
inspection at the Office of the Secretary
and on EDIS.3
This action is taken under the
authority of section 337 of the Tariff Act
of 1930, as amended (19 U.S.C. 1337),
and of §§ 201.10 and 210.8(c) of the
Commission’s Rules of Practice and
Procedure (19 CFR 201.10, 210.8(c)).
Registered bulk manufacturers of
the affected basic classes, and
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before August 13, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DRW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
The
Attorney General has delegated his
authority under the Controlled
Substances Act to the Administrator of
the Drug Enforcement Administration
(DEA), 28 CFR 0.100(b). Authority to
exercise all necessary functions with
respect to the promulgation and
implementation of 21 CFR part 1301,
incident to the registration of
manufacturers, distributors, dispensers,
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
delegated to the Assistant Administrator
of the DEA Diversion Control Division
(‘‘Assistant Administrator’’) pursuant to
section 7 of 28 CFR part 0, appendix to
subpart R.
In accordance with 21 CFR
1301.33(a), this is notice that on May
3rd, 2018, Alcami Wisconsin
Corporation, W130 N10497 Washington
Dr., Germantown, WI 53022 applied to
be registered as a bulk manufacturer of
the following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
Controlled
substance
By order of the Commission.
Issued: June 7, 2018.
Lisa Barton,
Secretary to the Commission.
Drug code
Thebaine ...........
Alfentanil ...........
[FR Doc. 2018–12651 Filed 6–12–18; 8:45 am]
BILLING CODE 7020–02–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
9333
9737
Schedule
II
II
The company plans to provide bulk
active pharmaceutical ingredient to
support clinical trials.
Dated: June 6, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–12684 Filed 6–12–18; 8:45 am]
[Docket No. DEA–392]
BILLING CODE 4410–09–P
amozie on DSK3GDR082PROD with NOTICES1
Bulk Manufacturer of Controlled
Substances Application: Alcami
Wisconsin Corporation
ACTION:
Notice of application.
2 All
contract personnel will sign appropriate
nondisclosure agreements.
3 Electronic Document Information System
(EDIS): https://edis.usitc.gov.
VerDate Sep<11>2014
18:01 Jun 12, 2018
Jkt 244001
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Gazelle A. Craig, D.O.; Decision and
Order
Control Division, Drug Enforcement
Administration (hereinafter, DEA or
Government), issued an Order to Show
Cause to Gazelle A. Craig, D.O.
(hereinafter, Respondent), of Houston,
Texas. GX 2 (Order to Show Cause). The
Show Cause Order proposed the
revocation of Respondent’s Certificate of
Registration on the ground that she does
‘‘not have authority to handle controlled
substances in the State of Texas, the
[S]tate in which . . . [she is] registered
with the DEA.’’ Id. at 1 (citing 21 U.S.C.
823(f) and 824(a)(3)).
As to the Agency’s jurisdiction, the
Show Cause Order alleged that
Respondent holds DEA Certificate of
Registration No. FC1384306, which
authorizes her to dispense controlled
substances in schedules II through V as
a practitioner, at the registered address
of Gulfton Community Health Center,
6306 Gulfton St., Suite 101, Houston,
Texas 77081. Id. The Show Cause Order
alleged that this registration expires on
August 31, 2018. Id.
As the substantive ground for the
proceeding, the Show Cause Order
alleged that Respondent is ‘‘without
authority to handle controlled
substances in the State of Texas, the
[S]tate in which . . . [she is] registered
. . . with the DEA.’’ Id. It further
alleged that, on July 28, 2017, the Texas
Medical Board temporarily suspended
Respondent’s medical license and that
the Texas Medical Board order remains
in effect. Id. The Show Cause Order
asserted that Respondent is ‘‘required to
possess authority from a [S]tate in order
to obtain or retain a DEA
Registration. . . . [and c]onsequently,
the DEA must revoke . . . [her
registration] based upon [her] lack of
authority to handle controlled
substances in the State of Texas.’’ Id. at
1–2.
The Show Cause Order notified
Respondent of her right to request a
hearing on the allegations or to submit
a written statement while waiving her
right to a hearing, the procedures for
electing each option, and the
consequences for failing to elect either
option. Id. at 2 (citing 21 CFR 1301.43).
The Show Cause Order also notified
Respondent of the opportunity to
submit a Corrective Action Plan. Id. at
2–3 (citing 21 U.S.C. 824(c)(2)(C)).
On September 20, 2017, the Acting
Assistant Administrator, Diversion
PO 00000
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[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Page 27628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12684]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: Alcami
Wisconsin Corporation
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before August 13, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DRW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: The Attorney General has delegated his
authority under the Controlled Substances Act to the Administrator of
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority
to exercise all necessary functions with respect to the promulgation
and implementation of 21 CFR part 1301, incident to the registration of
manufacturers, distributors, dispensers, importers, and exporters of
controlled substances (other than final orders in connection with
suspension, denial, or revocation of registration) has been delegated
to the Assistant Administrator of the DEA Diversion Control Division
(``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0,
appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on May
3rd, 2018, Alcami Wisconsin Corporation, W130 N10497 Washington Dr.,
Germantown, WI 53022 applied to be registered as a bulk manufacturer of
the following basic classes of controlled substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Thebaine........................... 9333 II
Alfentanil......................... 9737 II
------------------------------------------------------------------------
The company plans to provide bulk active pharmaceutical ingredient
to support clinical trials.
Dated: June 6, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-12684 Filed 6-12-18; 8:45 am]
BILLING CODE 4410-09-P
