83 FR 48334 - Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals Virginia, LLC
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 185 (September 24, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 185 (September 24, 2018)
| Page Range | 48334-48335 | |
| FR Document | 2018-20702 |
[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)] [Notices] [Pages 48334-48335] From the Federal Register Online [www.thefederalregister.org] [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
![48334 Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Notices
When respondents complete a fillable they will also become a matter of public Morrissette Drive, Springfield, Virginia
form, they may submit it by uploading record. 22152.
it to a secure webserver, emailing it to By order of the Commission.
the study team at mtbeffects@usitc.gov, SUPPLEMENTARY INFORMATION: The
Issued: September 18, 2018.
faxing it, or mailing a hard copy to the Attorney General has delegated his
Lisa Barton, authority under the Controlled
Commission. Secretary to the Commission. Substances Act to the Administrator of
III. Request for Comments [FR Doc. 2018–20657 Filed 9–21–18; 8:45 am] the Drug Enforcement Administration
BILLING CODE P (DEA), 28 CFR 0.100(b). Authority to
Comments are invited on (1) whether exercise all necessary functions with
the proposed collection of information respect to the promulgation and
is necessary; (2) the accuracy of the DEPARTMENT OF JUSTICE implementation of 21 CFR part 1301,
agency’s estimate of the burden incident to the registration of
(including hours and cost) of the Drug Enforcement Administration manufacturers, distributors, dispensers,
proposed collection of information; (3) importers, and exporters of controlled
[Docket No. DEA–392]
ways to enhance the quality, utility, and substances (other than final orders in
clarity of the information to be Bulk Manufacturer of Controlled connection with suspension, denial, or
collected; and (4) ways to minimize the Substances Application: Halo revocation of registration) has been
burden of the collection of information Pharmaceutical, Inc. redelegated to the Assistant
on respondents, including through the Administrator of the DEA Diversion
use of automated collection techniques ACTION: Notice of application.
Control Division (‘‘Assistant
or other forms of information Administrator’’) pursuant to section 7 of
technology. DATES: Registered bulk manufacturers of
the affected basic classes, and 28 CFR part 0, appendix to subpart R.
The draft questionnaire and other applicants therefore, may file written In accordance with 21 CFR
supplementary documents may be comments on or objections to the 1301.33(a), this is notice that on July 18,
downloaded from the USITC website at issuance of the proposed registration on 2018, Halo Pharmaceutical, Inc., 30
https://www.usitc.gov/MTBEffects. or before November 23, 2018. North Jefferson Road, Whippany, New
Comments submitted in response to ADDRESSES: Written comments should Jersey 07981–1030 applied to be
this notice will be summarized and/or be sent to: Drug Enforcement registered as a bulk manufacturer of the
included in the request for OMB Administration, Attention: DEA Federal following basic classes of controlled
approval of this information collection; Register Representative/DPW, 8701 substances:
Controlled substance Drug code Schedule
Dihydromorphine ............................................................................................................................................................. 9145 I
Hydromorphone ............................................................................................................................................................... 9150 II
The company plans to manufacture DATES: Registered bulk manufacturers of importers, and exporters of controlled
Hydromorphone (9150) for distribution the affected basic classes, and substances (other than final orders in
to its customers. Dihydromorphine applicants therefore, may file written connection with suspension, denial, or
(9145) as an intermediate in the comments on or objections to the revocation of registration) has been
manufacture of Hydromorphone and is issuance of the proposed registration on redelegated to the Assistant
not for commercial distribution. or before November 23, 2018. Administrator of the DEA Diversion
Dated: September 14, 2018. ADDRESSES: Written comments should Control Division (‘‘Assistant
John J. Martin, be sent to: Drug Enforcement Administrator’’) pursuant to section 7 of
Assistant Administrator. Administration, Attention: DEA Federal 28 CFR part 0, appendix to subpart R.
[FR Doc. 2018–20701 Filed 9–21–18; 8:45 am] Register Representative/DPW, 8701 In accordance with 21 CFR
Morrissette Drive, Springfield, Virginia
BILLING CODE 4410–09–P 1301.33(a), this is notice that on April
22152.
19, 2018, AMPAC Fine Chemicals
SUPPLEMENTARY INFORMATION: The Virginia, LLC, 2820 North Normandy
DEPARTMENT OF JUSTICE Attorney General has delegated his Drive, Petersburg, Virginia 23805–2380
authority under the Controlled applied to be registered as a bulk
Drug Enforcement Administration Substances Act to the Administrator of manufacturer of the following basic
[Docket No. DEA–392] the Drug Enforcement Administration classes of controlled substances:
(DEA), 28 CFR 0.100(b). Authority to
Bulk Manufacturer of Controlled exercise all necessary functions with
Substances Application: AMPAC Fine respect to the promulgation and
Chemicals Virginia, LLC implementation of 21 CFR part 1301,
incident to the registration of
ACTION: Notice of application.
amozie on DSK3GDR082PROD with NOTICES1
manufacturers, distributors, dispensers,
Controlled substance Drug code Schedule
Phenylacetone ................................................................................................................................................................. 8501 II
Morphine .......................................................................................................................................................................... 9300 II
Thebaine .......................................................................................................................................................................... 9333 II
Noroxymorphone ............................................................................................................................................................. 9668 II
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![Federal Register / Vol. 83, No. 185 / Monday, September 24, 2018 / Notices 48335
Controlled substance Drug code Schedule
Tapentadol ....................................................................................................................................................................... 9780 II
The company plans to manufacture Resources Management Section, changes in technology and workload,
the above-listed controlled substances Criminal Justice Information Services the FBI conducted an extensive business
in bulk for distribution to its customers. (CJIS) Division, FBI, 1000 Custer Hollow review of the automation portion of the
Dated: September 14, 2018. Road, Module D–3, Clarksburg, WV FBI CJIS user fee rate. As a result of the
John J. Martin,
26306. Telephone number 304–625– review, an updated methodology for the
3700. calculation of the automation portion of
Assistant Administrator.
SUPPLEMENTAL INFORMATION: Pursuant to the FBI CJIS user fee rate has been
[FR Doc. 2018–20702 Filed 9–21–18; 8:45 am]
the authority in Public Law 101–515, as adopted.
BILLING CODE 4410–09–P
amended, the FBI has established user The FBI is implementing a flat rate
fees for authorized agencies requesting methodology for the automation portion
noncriminal justice fingerprint-based of the FBI CJIS user fee rate. The initial
DEPARTMENT OF JUSTICE
and name-based CHRI checks. In flat rate is based on historical
Federal Bureau of Investigation accordance with the requirements of automation fund usage divided by
Title 28, Code of Federal Regulations historical volume for the same time
[Docket No. FBI] (CFR), Section 20.31(e), the FBI period. The resulting per unit cost is
periodically reviews the process of rounded to the nearest whole dollar to
FBI Criminal Justice Information providing fingerprint-based and name- arrive at a flat rate. Each time the FBI
Services Division; User Fee Schedule based CHRI checks to determine the conducts a user fee study under 28 CFR
AGENCY: Federal Bureau of Investigation proper fee amounts which should be 20.31 (e)(2), the amount of the flat rate
(FBI), Justice. collected, and the FBI publishes any will be re-evaluated to determine if an
resulting fee adjustments in the Federal adjustment is warranted. In making this
ACTION: Notice.
Register. determination, consideration will be
SUMMARY: The FBI is authorized to A fee study was conducted in keeping given to the following factors: Program
establish and collect fees for providing with 28 CFR 20.31(e)(2). The fee study fluctuations, available funding levels,
fingerprint-based and name-based results recommend an increase in the and/or changes in legal authority. This
Criminal History Record Information fingerprint-based CHRI checks from the methodology achieves the FBI’s
(CHRI) checks submitted by authorized current user fees published in the overarching objectives for program
users for noncriminal justice purposes Federal Register on July 14, 2016, solvency, rate stability, and predictable
including employment and licensing. A which have been in effect since October revenue with regard to the automation
portion of the fee is intended to 1, 2016. The FBI reviewed the results of portion of the fee.
the independently conducted User Fee
reimburse the FBI for the cost of Pursuant to the recommendations of
Study, compared the recommendations
providing fingerprint-based and name- the study and the revised automation
to the current fee schedule, and
based CHRI checks (‘‘cost methodology, the fees for fingerprint-
determined the revised fee
reimbursement portion’’ of the fee). The based CHRI checks will be increased
recommendation amounts for the cost
FBI is also authorized to charge an and the fee for name-based CHRI checks
reimbursement portion of the fee were
additional amount to defray expenses will remain the same for federal
reasonable and in consonance with the
for the automation of fingerprint agencies specifically authorized by
underlying legal authorities.
identification and criminal justice For the automation portion of the FBI statute, e.g., pursuant to the Security
information services and associated CJIS user fee rate, the current Clearance Information Act, Title 5,
costs (‘‘automation portion’’ of the fee). methodology has been in place since United States Code, Section 9101.
The notice explains the methodology 2008. This method used the The following tables detail the new
used to calculate revised fees and depreciation value of select capital fee amounts for authorized users
provides the revised fee schedule. information technology assets as the requesting fingerprint-based and name-
APPLICABLE DATE: This revised fee basis for the calculation. Given the based CHRI checks for noncriminal
schedule is effective January 1, 2019. considerable transformation in the justice purposes, including the
FOR FURTHER INFORMATION CONTACT: Mr. business and operational environments difference from the fee schedule
John A. Traxler, Section Chief, within the FBI CJIS Division, to include currently in effect.
FINGERPRINT-BASED CHRI CHECKS
Fee currently
Fee currently Change in Revised fee
Service in effect for Revised fee
in effect fee amount for CBSPs
CBSPs 1
Fingerprint-based Submission ............................................. $12.00 $10.00 $1.25 $13.25 2 $11.25
Fingerprint-based Volunteer Submission (See e.g., 75 FR
amozie on DSK3GDR082PROD with NOTICES1
18752) 3 ............................................................................ 10.75 8.75 .50 11.25 4 9.25
1 CentralizedBilling Service Providers, see 75 FR 18753.
2 Cost Recovery = $5.25; Automation = $6.
3 Volunteers providing care for children, the elderly, or individuals with disabilities.
4 Cost Recovery = $5.25; Automation = $4.
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Document Created: 2018-09-22 00:32:40
Document Modified: 2018-09-22 00:32:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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. | |
| FR Citation | 83 FR 48334 |
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