80 FR 63838 - Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 203 (October 21, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 203 (October 21, 2015)
| Page Range | 63838-63839 | |
| FR Document | 2015-26675 |
[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)] [Notices] [Pages 63838-63839] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-26675] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, 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 in accordance with 21 CFR 1301.33(a) on or before December 21, 2015. [[Page 63839]] ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (``Deputy 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 24, 2015, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey 07981 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance Schedule ------------------------------------------------------------------------ Dihydromorphine (9145)..................... I Hydromorphone (9150)....................... II ------------------------------------------------------------------------ The company plans to manufacture Hydromorphone HCl for sale to other manufacturers and to manufacture other controlled substances for distribution to its customers. Dihydromorphine is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution. Dated: October 13, 2015. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2015-26675 Filed 10-20-15; 8:45 am] BILLING CODE 4410-09-P
![63838 Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices
Controlled substance Schedule
Betacetylmethadol (9607) ............................................................................................................................................................................ I
Betameprodine (9608) ................................................................................................................................................................................. I
Betamethadol (9609) ................................................................................................................................................................................... I
Betaprodine (9611) ...................................................................................................................................................................................... I
Dextromoramide (9613) ............................................................................................................................................................................... I
Dipipanone (9622) ....................................................................................................................................................................................... I
Hydroxypethidine (9627) ............................................................................................................................................................................. I
Noracymethadol (9633) ............................................................................................................................................................................... I
Norlevorphanol (9634) ................................................................................................................................................................................. I
Normethadone (9635) ................................................................................................................................................................................. I
Racemoramide (9645) ................................................................................................................................................................................. I
Trimeperidine (9646) ................................................................................................................................................................................... I
1-Methyl-4-phenyl-4-propionoxypiperidine (9661) ....................................................................................................................................... I
Tilidine (9750) .............................................................................................................................................................................................. I
Para-Fluorofentanyl (9812) .......................................................................................................................................................................... I
3-Methylfentanyl (9813) ............................................................................................................................................................................... I
Alpha-Methylfentanyl (9814) ........................................................................................................................................................................ I
Acetyl-alpha-methylfentanyl (9815) ............................................................................................................................................................. I
Beta-hydroxyfentanyl (9830) ....................................................................................................................................................................... I
Beta-hydroxy-3-methylfentanyl (9831) ........................................................................................................................................................ I
Alpha-methylthiofentanyl (9832) .................................................................................................................................................................. I
3-Methylthiofentanyl (9833) ......................................................................................................................................................................... I
Thiofentanyl (9835) ...................................................................................................................................................................................... I
Methamphetamine (1105) ........................................................................................................................................................................... II
Methylphenidate (1724) ............................................................................................................................................................................... II
Amobarbital (2125) ...................................................................................................................................................................................... II
Pentobarbital (2270) .................................................................................................................................................................................... II
Secobarbital (2315) ..................................................................................................................................................................................... II
Glutethimide (2550) ..................................................................................................................................................................................... II
Nabilone (7379) ........................................................................................................................................................................................... II
1-Phenylcyclohexylamine (7460) ................................................................................................................................................................. II
Phencyclidine (7471) ................................................................................................................................................................................... II
Phenylacetone (8501) ................................................................................................................................................................................. II
1-Piperidinocyclohexanecarbonitrile (8603) ................................................................................................................................................ II
Alphaprodine (9010) .................................................................................................................................................................................... II
Dihydrocodeine (9120) ................................................................................................................................................................................ II
Ecgonine (9180) .......................................................................................................................................................................................... II
Ethylmorphine (9190) .................................................................................................................................................................................. II
Levomethorphan (9210) .............................................................................................................................................................................. II
Levorphanol (9220) ..................................................................................................................................................................................... II
Meperidine (9230) ....................................................................................................................................................................................... II
Dextropropoxyphene, bulk (non-dosage forms) (9273) .............................................................................................................................. II
Levo-alphacetylmethadol (9648) ................................................................................................................................................................. II
Noroxymorphone (9668) .............................................................................................................................................................................. II
Racemethorphan (9732) .............................................................................................................................................................................. II
Alfentanil (9737) .......................................................................................................................................................................................... II
Remifentanil (9739) ..................................................................................................................................................................................... II
Sufentanil (9740) ......................................................................................................................................................................................... II
Carfentanil (9743) ........................................................................................................................................................................................ II
Tapentadol (9780) ....................................................................................................................................................................................... II
The company plans to import small is authorized under 21 U.S.C. 952(a)(2). DEPARTMENT OF JUSTICE
quantities of the listed controlled Authorization will not extend to the
substances for the manufacture of import of FDA approved or non- Drug Enforcement Administration
analytical reference standards and approved finished dosage forms for
distribution to their research and commercial sale. [Docket No. DEA–392]
forensic customers.
Dated: October 13, 2015.
In reference to drug code 7360 the Bulk Manufacturer of Controlled
company plans to import a synthetic Louis J. Milione, Substances Application: Halo
cannabidiol. No other activity for this Deputy Assistant Administrator. Pharmaceutical, Inc.
drug code is authorized for this [FR Doc. 2015–26674 Filed 10–20–15; 8:45 am]
registration. BILLING CODE 4410–09–P
ACTION: Notice of application.
Placement of these drug codes onto
tkelley on DSK3SPTVN1PROD with NOTICES
the company’s registration does not DATES: Registered bulk manufacturers of
translate into automatic approval of the affected basic classes, and
subsequent permit applications to applicants therefore, may file written
import controlled substances. comments on or objections to the
Approval of permit applications will issuance of the proposed registration in
occur only when the registrant’s accordance with 21 CFR 1301.33(a) on
business activity is consistent with what or before December 21, 2015.
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![Federal Register / Vol. 80, No. 203 / Wednesday, October 21, 2015 / Notices 63839
ADDRESSES: Written comments should DEPARTMENT OF JUSTICE Dated: October 13, 2015.
be sent to: Drug Enforcement Louis J. Milione,
Administration, Attention: DEA Federal Drug Enforcement Administration Deputy Assistant Administrator.
Register Representative/ODXL, 8701 [FR Doc. 2015–26668 Filed 10–20–15; 8:45 am]
Morrissette Drive, Springfield, Virginia [Docket No. DEA–392] BILLING CODE 4410–09–P
22152. Request for hearings should be
sent to: Drug Enforcement Importer of Controlled Substances
Administration, Attention: Hearing Application: Sigma-Aldrich DEPARTMENT OF JUSTICE
International GMBH—Sigma Aldrich Co
Clerk/LJ, 8701 Morrissette Drive, [OMB Number 1105–0096]
LLC
Springfield, Virginia 22152.
ACTION: Notice of application. Agency Information Collection
SUPPLEMENTARY INFORMATION: The
Activities; Proposed eCollection
Attorney General has delegated her eComments Requested; Extension
authority under the Controlled DATES: Registered bulk manufacturers of
the affected basic class, and applicants With Change, of a Previously
Substances Act to the Administrator of Approved Collection Sequestered
the Drug Enforcement Administration therefore, may file written comments on
or objections to the issuance of the Juror Information Form
(DEA), 28 CFR 0.100(b). Authority to
proposed registration in accordance AGENCY: U.S. Marshals Service,
exercise all necessary functions with
with 21 CFR 1301.34(a) on or before Department of Justice.
respect to the promulgation and November 20, 2015. Such persons may
implementation of 21 CFR part 1301, ACTION: 30-Day notice.
also file a written request for a hearing
incident to the registration of on the application pursuant to 21 CFR SUMMARY: The Department of Justice
manufacturers, distributors, dispensers, 1301.43 on or before November 20, (DOJ), U.S. Marshals Service (USMS),
importers, and exporters of controlled 2015. will be submitting the following
substances (other than final orders in information collection request to the
connection with suspension, denial, or ADDRESSES: Written comments should
be sent to: Drug Enforcement Office of Management and Budget
revocation of registration) has been (OMB) for review and approval in
Administration, Attention: DEA Federal
redelegated to the Deputy Assistant accordance with the Paperwork
Register Representative/ODXL, 8701
Administrator of the DEA Office of Reduction Act of 1995. This proposed
Morrissette Drive, Springfield, Virginia
Diversion Control (‘‘Deputy Assistant 22152. Request for hearings should be information collection was previously
Administrator’’) pursuant to section 7 of sent to: Drug Enforcement published in the Federal Register at 80
28 CFR part 0, appendix to subpart R. Administration, Attention: Hearing FR 50872, on August 21, 2015, allowing
In accordance with 21 CFR Clerk/LJ, 8701 Morrissette Drive, for a 60 day comment period.
1301.33(a), this is notice that on July 24, Springfield, Virginia 22152. DATES: Comments are encouraged and
2015, Halo Pharmaceutical, Inc., 30 SUPPLEMENTARY INFORMATION: The
will be accepted for an additional 30
North Jefferson Road, Whippany, New Attorney General has delegated her days until November 20, 2015.
Jersey 07981 applied to be registered as authority under the Controlled FOR FURTHER INFORMATION CONTACT: If
a bulk manufacturer of the following Substances Act to the Administrator of you have additional comments
basic classes of controlled substances: the Drug Enforcement Administration especially on the estimated public
(DEA), 28 CFR 0.100(b). Authority to burden or associated response time,
Controlled substance Schedule exercise all necessary functions with suggestions, or need a copy of the
respect to the promulgation and proposed information collection
Dihydromorphine (9145) ............... I implementation of 21 CFR part 1301, instrument with instructions or
Hydromorphone (9150) ................ II incident to the registration of additional information, please contact
manufacturers, distributors, dispensers, Nicole Feuerstein, Publications
The company plans to manufacture importers, and exporters of controlled Specialist, U.S. Marshals Service, CS–3,
Hydromorphone HCl for sale to other substances (other than final orders in 10th Floor, Washington, DC 20530–0001
manufacturers and to manufacture other connection with suspension, denial, or (phone: 202–307–5168). Written
controlled substances for distribution to revocation of registration) has been comments and/or suggestions can also
redelegated to the Deputy Assistant be directed to the Office of Management
its customers. Dihydromorphine is an
Administrator of the DEA Office of and Budget, Office of Information and
intermediate in the manufacture of
Diversion Control (‘‘Deputy Assistant Regulatory Affairs, Attention
Hydromorphone and is not for
Administrator’’) pursuant to section 7 of Department of Justice Desk Officer,
commercial distribution. Washington, DC 20503 or sent to OIRA_
28 CFR part 0, appendix to subpart R.
Dated: October 13, 2015. In accordance with 21 CFR submissions@omb.eop.gov.
Louis J. Milione, 1301.34(a), this is notice that on May 29, SUPPLEMENTARY INFORMATION: Written
Deputy Assistant Administrator. 2015, Sigma-Aldrich International comments and suggestions from the
[FR Doc. 2015–26675 Filed 10–20–15; 8:45 am] GMBH—Sigma Aldrich Co. LLC, Sigma public and affected agencies concerning
Aldrich Company LLC, 3500 Dekalb the proposed collection of information
BILLING CODE 4410–09–P
Street, Saint Louis, Missouri 63118 are encouraged. Your comments should
applied to be registered as an importer address one or more of the following
tkelley on DSK3SPTVN1PROD with NOTICES
of Butylone (7541), a basic class of four points:
controlled substance listed in schedule —Evaluate whether the proposed
I. collection of information is necessary
The company plans to import the for the proper performance of the
above listed controlled substance for functions of the US Marshals Service,
analytical research and testing of including whether the information
equipment. will have practical utility;
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Document Created: 2018-02-27 08:54:09
Document Modified: 2018-02-27 08:54:09
| 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 in accordance with 21 CFR 1301.33(a) on or before December 21, 2015. | |
| FR Citation | 80 FR 63838 |
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