Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City, 36617 [2020-13009]
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Federal Register / Vol. 85, No. 117 / Wednesday, June 17, 2020 / Notices
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
Foreign Claims Settlement
Commission
[Docket No. DEA–668]
[F.C.S.C. Meeting and Hearing Notice No.
05–20]
[Docket No. DEA–667]
Importer of Controlled Substances
Application: Woodfield Distribution,
LLC
ACTION:
Bulk Manufacturer of Controlled
Substances Application: Cambrex
Charles City
Notice of application.
ACTION:
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 July 17, 2020. Such persons
may also file a written request for a
hearing on the application on or before
July 17, 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:
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 June 3, 2020,
Woodfield Distribution, LLC, 951 Clint
Moore Road, Suite A, Boca Raton,
Florida 33487–2804, applied to be
registered as an importer of the
following basic class(es) of controlled
substance:
Notice of application.
DATES:
khammond on DSKJM1Z7X2PROD with NOTICES
36617
Controlled substance
Drug
code
Schedule
Nabilone ..................................
7379
II
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 August 17, 2020.
DATES:
Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
ADDRESSES:
In
accordance with 21 CFR 1301.33(a), this
is notice that on May 6, 2020, Cambrex
Charles City, 1205 11th Street, Charles
City, Iowa 50616–3466, applied to be
registered as a bulk manufacturer of the
following basic class(es) of controlled
substances:
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
Gamma Hydroxybutyric Acid ..
Amphetamine ..........................
Lisdexamfetamine ...................
Methylphenidate ......................
ANPP (4-Anilino-N-phenethyl4-piperidine).
Phenylacetone ........................
Codeine ...................................
Oxycodone ..............................
Hydromorphone ......................
Hydrocodone ...........................
Morphine .................................
Oripavine .................................
Thebaine .................................
Opium extracts ........................
Opium fluid extract ..................
Opium tincture ........................
Opium, powdered ...................
Oxymorphone .........................
Noroxymorphone ....................
Fentanyl ..................................
Schedule
2010
1100
1205
1724
8333
I
II
II
II
II
8501
9050
9143
9150
9193
9300
9330
9333
9610
9620
9630
9639
9652
9668
9801
II
II
II
II
II
II
II
II
II
II
II
II
II
II
II
The company plans to import this
controlled substance for phase I of a
clinical study. Approval of permit
applications will occur only when the
registrant’s 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 (FDA)-approved or nonapproved finished dosage forms for
commercial sale.
The company plans to manufacture
the above-listed controlled substances
in bulk for conversion to other
controlled substances and sales to its
customers for dosage form development,
clinical trials and use in stability
qualification studies. No other activities
for these drug codes are authorized for
this registration.
William T. McDermott,
Assistant Administrator.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–13008 Filed 6–16–20; 8:45 am]
[FR Doc. 2020–13009 Filed 6–16–20; 8:45 am]
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Sunshine Act Meeting
The Foreign Claims
Settlement Commission, pursuant to its
regulations and the Government in the
Sunshine Act, hereby gives notice in
regard to the scheduling of open
meetings as follows:
DATES: Thursday, June 25, 2020, at 10
a.m.
PLACE: This meeting will be held by
teleconference. There will be no
physical meeting place.
STATUS: Open. Members of the public
who wish to observe the meeting via
teleconference should contact Patricia
M. Hall, Foreign Claims Settlement
Commission, Tele: (202) 616–6975, two
business days in advance of the
meeting. Individuals will be given callin information upon notice of
attendance to the Commission.
MATTERS TO BE CONSIDERED: 10:00
a.m.—Issuance of Proposed Decisions
under the Guam World War II Loyalty
Recognition Act, Title XVII, Public Law
114–328.
CONTACT PERSON FOR MORE INFORMATION:
Requests for information, advance
notices of intention to observe an open
meeting, and requests for teleconference
dial-in information may be directed to:
Patricia M. Hall, Foreign Claims
Settlement Commission, 441 G St NW,
Room 6234, Washington, DC 20579.
Telephone: (202) 616–6975.
SUMMARY:
Brian M. Simkin,
Chief Counsel.
[FR Doc. 2020–13131 Filed 6–15–20; 4:15 pm]
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DEPARTMENT OF JUSTICE
[OMB Number 1122–0029]
Agency Information Collection
Activities; Proposed eCollection
eComments Requested; Extension of a
Currently Approved Collection
Office on Violence Against
Women, Department of Justice.
ACTION: 30-Day notice.
AGENCY:
The Department of Justice,
Office on Violence Against Women
(OVW) will be submitting the following
information collection request to the
Office of Management and Budget
(OMB) for review and approval in
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Page 36617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13009]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-668]
Bulk Manufacturer of Controlled Substances Application: Cambrex
Charles City
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 August 17, 2020.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on May 6, 2020, Cambrex Charles City, 1205 11th Street,
Charles City, Iowa 50616-3466, applied to be registered as a bulk
manufacturer of the following basic class(es) of controlled substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid............... 2010 I
Amphetamine............................. 1100 II
Lisdexamfetamine........................ 1205 II
Methylphenidate......................... 1724 II
ANPP (4-Anilino-N-phenethyl-4- 8333 II
piperidine).
Phenylacetone........................... 8501 II
Codeine................................. 9050 II
Oxycodone............................... 9143 II
Hydromorphone........................... 9150 II
Hydrocodone............................. 9193 II
Morphine................................ 9300 II
Oripavine............................... 9330 II
Thebaine................................ 9333 II
Opium extracts.......................... 9610 II
Opium fluid extract..................... 9620 II
Opium tincture.......................... 9630 II
Opium, powdered......................... 9639 II
Oxymorphone............................. 9652 II
Noroxymorphone.......................... 9668 II
Fentanyl................................ 9801 II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances in bulk for conversion to other controlled substances and
sales to its customers for dosage form development, clinical trials and
use in stability qualification studies. No other activities for these
drug codes are authorized for this registration.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020-13009 Filed 6-16-20; 8:45 am]
BILLING CODE 4410-09-P
