Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals Virginia, LLC, 48334-48335 [2018-20702]

Download as PDF 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]


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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.

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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