Bulk Manufacturer of Controlled Substances Application: AMRI Renesselaer, Inc., 44640-44641 [2019-18323]
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44640
Federal Register / Vol. 84, No. 165 / Monday, August 26, 2019 / Notices
applicants therefore, may file written
comments on or objections to the
issuance of the proposed registration on
or before October 25, 2019.
ADDRESS: Written comments should be
sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
In
accordance with 21 CFR 1301.33(a), this
is notice that on June 19, 2019, Cambrex
High Point, Inc., 4180 Mendenhall Oaks
Parkway, High Point, North Carolina
27265–8017 applied to be registered as
a bulk manufacturer of the following
basic classes of controlled substances:
SUPPLEMENTARY INFORMATION:
Controlled
substance
Oxymorphone ................
Noroxymorphone ...........
Drug
code
9652
9668
Schedule
II
II
The company plans to manufacture
the above listed controlled substances in
bulk for distribution to its customers.
No other activities for these drug codes
are authorized for this registration.
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
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 5, 2019, Clinical
Supplies Management Holdings, Inc.,
342 42nd Street South, Fargo, North
Dakota 58103 applied to be registered as
an importer of the following basic
classes of controlled substances:
Drug
code
Controlled substance
Marihuana .....................
Tetrahydrocannabinols
7360
7370
Schedule
I
I
The company plans to import listed
controlled substances in their finished
dosage form for use in clinical trials
only. Drug codes 7350 (marihuana
extract) and 7360 (marihuana) will be
used for the manufacture of cannabidiol
only.
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
[FR Doc. 2019–18325 Filed 8–23–19; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
[FR Doc. 2019–18320 Filed 8–23–19; 8:45 am]
BILLING CODE 4410–09–P
[FR Doc. 2019–18324 Filed 8–23–19; 8:45 am]
manufacture the applicable various
basic classes of controlled substances is
consistent with the public interest and
with United States obligations under
international treaties, conventions, or
protocols in effect on May 1, 1971. The
DEA investigated the company’s
maintenance of effective controls
against diversion by inspecting and
testing the company’s physical security
systems, verifying the company’s
compliance with state and local laws,
and reviewing the company’s
background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the DEA has granted a
registration as a bulk manufacturer to
the above listed company.
BILLING CODE 4410–09–P
Bulk Manufacturer of Controlled
Substances Application: AMRI
Renesselaer, Inc.
ACTION:
DEPARTMENT OF JUSTICE
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Drug Enforcement Administration
[Docket No. DEA–392]
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Registration AMPAC Fine
Chemicals Virginia, LLC
Importer of Controlled Substances
Application: Clinical Supplies
Management Holdings, Inc.
ACTION:
VerDate Sep<11>2014
16:09 Aug 23, 2019
Jkt 247001
Notice of registration.
The registrant listed below
have applied for and been granted a
registration by the Drug Enforcement
Administration (DEA) as a bulk
manufacturer of various basic classes of
schedule II controlled substances.
SUPPLEMENTARY INFORMATION: The
company listed below applied to be
registered as a bulk manufacturer of
various basic classes of scheduled II
controlled substances. Information on a
previously published notice is listed
below. No comments or objections were
submitted for this notice.
SUMMARY:
Registered bulk importers 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
September 25, 2019. Such persons may
also file a written request for a hearing
on the application on or before
September 25, 2019.
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
DATES:
khammond on DSKBBV9HB2PROD with NOTICES
ACTION:
Notice of application.
Company
FR docket
Published
AMPAC Fine Chemicals Virginia, LLC.
84 FR 21810
May 15, 2019.
The DEA has considered the factors in
21 U.S.C. 823(a) and determined that
the registration of this registrant to
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Notice of application.
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 October 25, 2019.
ADDRESS: 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 March 15, 2019, AMRI
Rensselaer, Inc., 33 Riverside Avenue,
Rennselaer, New York 12144–2951
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
DATES:
Controlled substance
Marihuana ......................
Tetrahydrocannabinols ..
Amphetamine ................
Lisdexamfetamine .........
Pentobarbital .................
4-Anilino-N-phenethyl-4piperidine (ANPP).
Codeine .........................
E:\FR\FM\26AUN1.SGM
26AUN1
Drug
code
Schedule
7360
7370
1100
1205
2270
8333
I
I
II
II
II
II
9050
II
Federal Register / Vol. 84, No. 165 / Monday, August 26, 2019 / Notices
Controlled substance
Oxycodone ....................
Hydromorphone .............
Hydrocodone .................
Meperidine .....................
Morphine ........................
Fentanyl .........................
Drug
code
9143
9150
9193
9230
9300
9801
Schedule
II
II
II
II
II
II
Controlled
substance
The company plans to manufacture
bulk controlled substances for use in
product development and for
distribution to its customers. In
reference to drug codes 7360
(marihuana) and 7370
(tetrahydrocannabinols), the company
plans to bulk manufacture these drugs
as synthetics. No other activities for
these drug codes are authorized for this
registration.
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
The company plans to import the
listed controlled substance for research
purposes.
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
[FR Doc. 2019–18321 Filed 8–23–19; 8:45 am]
BILLING CODE 4410–09–P
Executive Office of the
President, Office of Management and
Budget.
ACTION: Notice of availability of the
OMB Sequestration Update Report to
the President and Congress for FY 2020.
AGENCY:
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: Cambrex High Point, Inc.
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 September 25, 2019. Such
persons may also file a written request
for a hearing on the application on or
before September 25, 2019.
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 19, 2019, Cambrex
High Point, Inc., 4180 Mendenhall Oaks
Jkt 247001
OMB is issuing the OMB
Sequestration Update Report to the
President and Congress for Fiscal Year
2020 to report on the status of the
discretionary caps and on the
compliance of pending discretionary
appropriations legislation with those
caps.
SUMMARY:
Notice of application.
DATES:
khammond on DSKBBV9HB2PROD with NOTICES
II
below the caps after accounting for
enacted supplemental appropriations.
For fiscal years 2020 and 2021, the
report formally updates the caps for the
revisions enacted in the Bipartisan
Budget Act of 2019. The report also
finds that actions to date by the House
of Representatives for the 12 annual
appropriations bills for fiscal year 2020
would breach the non-defense cap
under OMB estimates if they were
enacted into law. The Senate has not yet
begun consideration of its 2020
appropriations bills; therefore, an
evaluation of Senate compliance cannot
be made at this time. Finally, the report
contains OMB’s Preview Estimate of the
Disaster Relief Funding Adjustment for
FY 2020.
Russell T. Vought,
Acting Director.
[FR Doc. 2019–18442 Filed 8–23–19; 8:45 am]
BILLING CODE 3110–01–P
DEPARTMENT OF JUSTICE
16:09 Aug 23, 2019
9670
Schedule
OMB Sequestration Update Report to
the President and Congress for Fiscal
Year 2020
BILLING CODE 4410–09–P
VerDate Sep<11>2014
Poppy Straw Concentrate.
Drug
code
OFFICE OF MANAGEMENT AND
BUDGET
[FR Doc. 2019–18323 Filed 8–23–19; 8:45 am]
ACTION:
Parkway, High Point, North Carolina
27265–8017 applied to be registered as
an importer of the following basic class
of controlled substance:
44641
August 20, 2019.
The OMB Sequestration
Reports to the President and Congress is
available on-line on the OMB home
page at: https://www.whitehouse.gov/
omb/legislative/sequestration-reportsorders/.
FOR FURTHER INFORMATION CONTACT:
Thomas Tobasko, 6202 New Executive
Office Building, Washington, DC 20503,
Email address: ttobasko@omb.eop.gov,
telephone number: (202) 395–5745, FAX
number: (202) 395–4768. Because of
delays in the receipt of regular mail
related to security screening,
respondents are encouraged to use
electronic communications.
SUPPLEMENTARY INFORMATION: Section
254 of the Balanced Budget and
Emergency Deficit Control Act of 1985
requires the Office of Management and
Budget (OMB) to issue a Sequestration
Update Report by August 20th of each
year. For fiscal year 2019, the report
finds enacted appropriations to be at or
DATES:
ADDRESSES:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
NATIONAL ARCHIVES AND RECORDS
ADMINISTRATION
[NARA–2019–035]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
National Archives and Records
Administration (NARA).
ACTION: Notice.
AGENCY:
NARA is proposing to request
that the Office of Management and
Budget (OMB) renew approval of an
information collection our Office of
Government Information Services
(OGIS) uses to obtain customer intake
information and consent as part of its
mediation services program. OGIS
collects customer name, contact
information, case number, information
on the customer’s concern areas/
resolution goals, and documents relating
to the underlying Freedom of
Information Act/Privacy Act request or
appeal as part of its intake process in
order to provide mediation services. In
some cases, customers also complete a
privacy consent form, NA Form 10003,
authorizing OGIS to make inquiries on
the customer’s behalf and authorizing
agencies to release to OGIS information
and records related to their FOIA/
Privacy Act requests and appeals. We
invite you to comment on this proposed
information collection.
DATES: We must receive written
comments on or before October 25,
2019.
SUMMARY:
Send comments to
Paperwork Reduction Act Comments
ADDRESSES:
E:\FR\FM\26AUN1.SGM
26AUN1
]]>Agencies
[Federal Register Volume 84, Number 165 (Monday, August 26, 2019)]
[Notices]
[Pages 44640-44641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18323]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: AMRI
Renesselaer, Inc.
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 October 25, 2019.
ADDRESS: 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 March 15, 2019, AMRI Rensselaer, Inc., 33 Riverside
Avenue, Rennselaer, New York 12144-2951 applied to be registered as a
bulk manufacturer of the following basic classes of controlled
substances:
------------------------------------------------------------------------
Drug
Controlled substance code Schedule
------------------------------------------------------------------------
Marihuana.............................. 7360 I
Tetrahydrocannabinols.................. 7370 I
Amphetamine............................ 1100 II
Lisdexamfetamine....................... 1205 II
Pentobarbital.......................... 2270 II
4-Anilino-N-phenethyl-4-piperidine 8333 II
(ANPP).
Codeine................................ 9050 II
[[Page 44641]]
Oxycodone.............................. 9143 II
Hydromorphone.......................... 9150 II
Hydrocodone............................ 9193 II
Meperidine............................. 9230 II
Morphine............................... 9300 II
Fentanyl............................... 9801 II
------------------------------------------------------------------------
The company plans to manufacture bulk controlled substances for use
in product development and for distribution to its customers. In
reference to drug codes 7360 (marihuana) and 7370
(tetrahydrocannabinols), the company plans to bulk manufacture these
drugs as synthetics. No other activities for these drug codes are
authorized for this registration.
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
[FR Doc. 2019-18323 Filed 8-23-19; 8:45 am]
BILLING CODE 4410-09-P
