Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals Virginia, LLC, 48334-48335 [2018-20702]
Download as PDF
<![CDATA[
48334
Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Notices
When respondents complete a fillable
form, they may submit it by uploading
it to a secure webserver, emailing it to
the study team at mtbeffects@usitc.gov,
faxing it, or mailing a hard copy to the
Commission.
III. Request for Comments
they will also become a matter of public
record.
By order of the Commission.
Issued: September 18, 2018.
Lisa Barton,
Secretary to the Commission.
BILLING CODE P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: Halo
Pharmaceutical, Inc.
ACTION:
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
redelegated 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 July 18,
2018, Halo Pharmaceutical, Inc., 30
North Jefferson Road, Whippany, New
Jersey 07981–1030 applied to be
registered as a bulk manufacturer of the
following basic classes of controlled
substances:
SUPPLEMENTARY INFORMATION:
[FR Doc. 2018–20657 Filed 9–21–18; 8:45 am]
Comments are invited on (1) whether
the proposed collection of information
is necessary; (2) the accuracy of the
agency’s estimate of the burden
(including hours and cost) of the
proposed collection of information; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
The draft questionnaire and other
supplementary documents may be
downloaded from the USITC website at
https://www.usitc.gov/MTBEffects.
Comments submitted in response to
this notice will be summarized and/or
included in the request for OMB
approval of this information collection;
Morrissette Drive, Springfield, Virginia
22152.
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 November 23, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
DATES:
Controlled substance
Drug code
Dihydromorphine .............................................................................................................................................................
Hydromorphone ...............................................................................................................................................................
The company plans to manufacture
Hydromorphone (9150) for distribution
to its customers. Dihydromorphine
(9145) as an intermediate in the
manufacture of Hydromorphone and is
not for commercial distribution.
Dated: September 14, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–20701 Filed 9–21–18; 8:45 am]
BILLING CODE 4410–09–P
Drug Enforcement Administration
[Docket No. DEA–392]
Bulk Manufacturer of Controlled
Substances Application: AMPAC Fine
Chemicals Virginia, LLC
amozie on DSK3GDR082PROD with NOTICES1
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,
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF JUSTICE
ACTION:
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 November 23, 2018.
ADDRESSES: Written comments should
be sent to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/DPW, 8701
Morrissette Drive, Springfield, Virginia
22152.
DATES:
Notice of application.
Drug code
Phenylacetone .................................................................................................................................................................
Morphine ..........................................................................................................................................................................
Thebaine ..........................................................................................................................................................................
Noroxymorphone .............................................................................................................................................................
17:40 Sep 21, 2018
Jkt 244001
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
I
II
importers, and exporters of controlled
substances (other than final orders in
connection with suspension, denial, or
revocation of registration) has been
redelegated 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 April
19, 2018, AMPAC Fine Chemicals
Virginia, LLC, 2820 North Normandy
Drive, Petersburg, Virginia 23805–2380
applied to be registered as a bulk
manufacturer of the following basic
classes of controlled substances:
Controlled substance
VerDate Sep<11>2014
9145
9150
Schedule
E:\FR\FM\24SEN1.SGM
24SEN1
8501
9300
9333
9668
Schedule
II
II
II
II
48335
Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Notices
Controlled substance
Drug code
Tapentadol .......................................................................................................................................................................
The company plans to manufacture
the above-listed controlled substances
in bulk for distribution to its customers.
Dated: September 14, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–20702 Filed 9–21–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Federal Bureau of Investigation
[Docket No. FBI]
FBI Criminal Justice Information
Services Division; User Fee Schedule
Federal Bureau of Investigation
(FBI), Justice.
ACTION: Notice.
AGENCY:
The FBI is authorized to
establish and collect fees for providing
fingerprint-based and name-based
Criminal History Record Information
(CHRI) checks submitted by authorized
users for noncriminal justice purposes
including employment and licensing. A
portion of the fee is intended to
reimburse the FBI for the cost of
providing fingerprint-based and namebased CHRI checks (‘‘cost
reimbursement portion’’ of the fee). The
FBI is also authorized to charge an
additional amount to defray expenses
for the automation of fingerprint
identification and criminal justice
information services and associated
costs (‘‘automation portion’’ of the fee).
The notice explains the methodology
used to calculate revised fees and
provides the revised fee schedule.
APPLICABLE DATE: This revised fee
schedule is effective January 1, 2019.
FOR FURTHER INFORMATION CONTACT: Mr.
John A. Traxler, Section Chief,
SUMMARY:
Resources Management Section,
Criminal Justice Information Services
(CJIS) Division, FBI, 1000 Custer Hollow
Road, Module D–3, Clarksburg, WV
26306. Telephone number 304–625–
3700.
SUPPLEMENTAL INFORMATION: Pursuant to
the authority in Public Law 101–515, as
amended, the FBI has established user
fees for authorized agencies requesting
noncriminal justice fingerprint-based
and name-based CHRI checks. In
accordance with the requirements of
Title 28, Code of Federal Regulations
(CFR), Section 20.31(e), the FBI
periodically reviews the process of
providing fingerprint-based and namebased CHRI checks to determine the
proper fee amounts which should be
collected, and the FBI publishes any
resulting fee adjustments in the Federal
Register.
A fee study was conducted in keeping
with 28 CFR 20.31(e)(2). The fee study
results recommend an increase in the
fingerprint-based CHRI checks from the
current user fees published in the
Federal Register on July 14, 2016,
which have been in effect since October
1, 2016. The FBI reviewed the results of
the independently conducted User Fee
Study, compared the recommendations
to the current fee schedule, and
determined the revised fee
recommendation amounts for the cost
reimbursement portion of the fee were
reasonable and in consonance with the
underlying legal authorities.
For the automation portion of the FBI
CJIS user fee rate, the current
methodology has been in place since
2008. This method used the
depreciation value of select capital
information technology assets as the
basis for the calculation. Given the
considerable transformation in the
business and operational environments
within the FBI CJIS Division, to include
Schedule
9780
II
changes in technology and workload,
the FBI conducted an extensive business
review of the automation portion of the
FBI CJIS user fee rate. As a result of the
review, an updated methodology for the
calculation of the automation portion of
the FBI CJIS user fee rate has been
adopted.
The FBI is implementing a flat rate
methodology for the automation portion
of the FBI CJIS user fee rate. The initial
flat rate is based on historical
automation fund usage divided by
historical volume for the same time
period. The resulting per unit cost is
rounded to the nearest whole dollar to
arrive at a flat rate. Each time the FBI
conducts a user fee study under 28 CFR
20.31 (e)(2), the amount of the flat rate
will be re-evaluated to determine if an
adjustment is warranted. In making this
determination, consideration will be
given to the following factors: Program
fluctuations, available funding levels,
and/or changes in legal authority. This
methodology achieves the FBI’s
overarching objectives for program
solvency, rate stability, and predictable
revenue with regard to the automation
portion of the fee.
Pursuant to the recommendations of
the study and the revised automation
methodology, the fees for fingerprintbased CHRI checks will be increased
and the fee for name-based CHRI checks
will remain the same for federal
agencies specifically authorized by
statute, e.g., pursuant to the Security
Clearance Information Act, Title 5,
United States Code, Section 9101.
The following tables detail the new
fee amounts for authorized users
requesting fingerprint-based and namebased CHRI checks for noncriminal
justice purposes, including the
difference from the fee schedule
currently in effect.
FINGERPRINT-BASED CHRI CHECKS
Fee currently
in effect
amozie on DSK3GDR082PROD with NOTICES1
Service
Fingerprint-based Submission .............................................
Fingerprint-based Volunteer Submission (See e.g., 75 FR
18752) 3 ............................................................................
Fee currently
in effect for
CBSPs 1
Change in
fee amount
$10.00
$1.25
$13.25
2 $11.25
10.75
8.75
.50
11.25
4 9.25
Billing Service Providers, see 75 FR 18753.
Recovery = $5.25; Automation = $6.
3 Volunteers providing care for children, the elderly, or individuals with disabilities.
4 Cost Recovery = $5.25; Automation = $4.
2 Cost
17:40 Sep 21, 2018
Jkt 244001
PO 00000
Frm 00062
Revised fee
for CBSPs
$12.00
1 Centralized
VerDate Sep<11>2014
Revised fee
Fmt 4703
Sfmt 4703
E:\FR\FM\24SEN1.SGM
24SEN1
]]>Agencies
[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)]
[Notices]
[Pages 48334-48335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20702]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application: AMPAC
Fine Chemicals Virginia, LLC
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 November 23, 2018.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
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 redelegated
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 April
19, 2018, AMPAC Fine Chemicals Virginia, LLC, 2820 North Normandy
Drive, Petersburg, Virginia 23805-2380 applied to be registered as a
bulk manufacturer of the following basic classes of controlled
substances:
------------------------------------------------------------------------
Controlled substance Drug code Schedule
------------------------------------------------------------------------
Phenylacetone...................... 8501 II
Morphine........................... 9300 II
Thebaine........................... 9333 II
Noroxymorphone..................... 9668 II
[[Page 48335]]
Tapentadol......................... 9780 II
------------------------------------------------------------------------
The company plans to manufacture the above-listed controlled
substances in bulk for distribution to its customers.
Dated: September 14, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-20702 Filed 9-21-18; 8:45 am]
BILLING CODE 4410-09-P
