Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc., 48334 [2018-20701]

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

Agencies

[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)]
[Notices]
[Page 48334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20701]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Halo 
Pharmaceutical, Inc.

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 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:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Dihydromorphine....................            9145  I
Hydromorphone......................            9150  II
------------------------------------------------------------------------

    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