83 FR 5811 - Importer of Controlled Substances Application: Mylan Technologies Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 28 (February 9, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 28 (February 9, 2018)
| Page Range | 5811-5812 | |
| FR Document | 2018-02641 |
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)] [Notices] [Pages 5811-5812] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02641] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: Mylan Technologies Inc. ACTION: Notice of application. ----------------------------------------------------------------------- DATES: Registered bulk importers 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 March 12, 2018. Such persons may also file a written request for a hearing on the application on or before March 12, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and [[Page 5812]] (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007). 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 1301.34(a), this is notice that on November 10, 2017, Mylan Technologies Inc., 110 Lake St., Saint Albans, VT 05478 applied to be registered as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Drug Controlled substance code Schedule ------------------------------------------------------------------------ Methylphenidate........................ 1724 II Fentanyl............................... 9801 II ------------------------------------------------------------------------ The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company's own domestically-manufactured FDF. This analysis is required to allow the company to export domestically manufactured FDF to foreign markets. Authorization will not extend to the import of Food and Drug Administration approved or non-approved finish dosage forms for commercial sale. Dated: February 1, 2018. Susan A Gibson, Deputy Assistant Administrator. [FR Doc. 2018-02641 Filed 2-8-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices 5811
issuance of the proposed registration on Dated: January 31, 2018. Nolte Drive, West Deptford, NJ 08066–
or before March 12, 2018. Such persons Susan A. Gibson, 1742 applied to be registered as an
may also file a written request for a Deputy Assistant Administrator. importer of the following basic classes
hearing on the application March 12, [FR Doc. 2018–02647 Filed 2–8–18; 8:45 am] of controlled substances:
2018. BILLING CODE 4410–09–P
Drug
Controlled substance Schedule
ADDRESSES: Written comments should code
be sent to: Drug Enforcement DEPARTMENT OF JUSTICE Coca leaves .................. 9040 II
Administration, Attention: DEA Federal Thebaine ....................... 9333 II
Register Representative/DRW, 8701 Drug Enforcement Administration Opium, raw ................... 9600 II
Morrissette Drive, Springfield, Virginia [Docket No. DEA–392] Noroxymorophone ........ 9668 II
22152. All requests for hearing must be Poppy Straw Con- 9670 II
sent to: Drug Enforcement Importer of Controlled Substances centrate.
Administration, Attn: Administrator, Application: Johnson Matthey Inc. Fentanyl ........................ 9801 II
8701 Morrissette Drive, Springfield,
Virginia 22152. All requests for hearing ACTION: Notice of application. The company plans to import coca
should also be sent to: (1) Drug leaves (9040), raw opium (9600), and
Enforcement Administration, Attn: DATES: Registered importers of the poppy straw concentrate (9670) in order
Hearing Clerk/LJ, 8701 Morrissette affected basic classes, and applicants to bulk manufacture active
Drive, Springfield, Virginia 22152; and therefore, may file written comments on pharmaceutical ingredients (API) for
(2) Drug Enforcement Administration, or objections to the issuance of the distribution to its customers. The
proposed registration on or before company plans to also import thebaine
Attn: DEA Federal Register
March 12, 2018. Such persons may also (9333), noroxymorophone (9668), and
Representative/DRW, 8701 Morrissette
file a written request for a hearing on fentanyl (9801) to use as analytical
Drive, Springfield, Virginia 22152.
the application on or before March 12, reference standards, both internally and
SUPPLEMENTARY INFORMATION: The 2018. to be sold to their customers to support
Attorney General has delegated his ADDRESSES: Written comments should testing of Johnson Matthey Inc.’s API’s
authority under the Controlled be sent to: Drug Enforcement only.
Substances Act to the Administrator of Administration, Attention: DEA Federal Dated: January 31, 2018.
the Drug Enforcement Administration Register Representative/DRW, 8701 Susan A. Gibson,
(DEA), 28 CFR 0.100(b). Authority to Morrissette Drive, Springfield, Virginia Deputy Assistant Administrator.
exercise all necessary functions with 22152. All requests for hearing must be [FR Doc. 2018–02639 Filed 2–8–18; 8:45 am]
respect to the promulgation and sent to: Drug Enforcement BILLING CODE 4410–09–P
implementation of 21 CFR part 1301, Administration, Attn: Administrator,
incident to the registration of 8701 Morrissette Drive, Springfield,
manufacturers, distributors, dispensers, Virginia 22152. All request for hearing DEPARTMENT OF JUSTICE
importers, and exporters of controlled should also be sent to: (1) Drug
substances (other than final orders in Enforcement Administration, Attn: Drug Enforcement Administration
connection with suspension, denial, or Hearing Clerk/LJ, 8701 Morrissette
[Docket No. DEA–392]
revocation of registration) has been Drive, Springfield, Virginia 22152; and
redelegated to the Assistant (2) Drug Enforcement Administration, Importer of Controlled Substances
Administrator of the DEA Diversion Attn: DEA Federal Register Application: Mylan Technologies Inc.
Control Division (‘‘Assistant Representative/DRW, 8701 Morrissette
Administrator’’) pursuant to section 7 of Drive, Springfield, Virginia 22152. ACTION: Notice of application.
28 CFR part 0, appendix to subpart R. SUPPLEMENTARY INFORMATION: The
Attorney General has delegated his DATES: Registered bulk importers of the
In accordance with 21 CFR
authority under the Controlled affected basic classes, and applicants
1301.34(a), this is notice that on
Substances Act to the Administrator of therefore, may file written comments on
December 29, 2017, Meridian Medical
the Drug Enforcement Administration or objections to the issuance of the
Technologies Inc., 2555 Hermelin Drive,
(DEA), 28 CFR 0.100(b). Authority to proposed registration on or before
Saint Louis, Missouri 63144 applied to March 12, 2018. Such persons may also
be registered as an importer of the exercise all necessary functions with
respect to the promulgation and file a written request for a hearing on
Schedule II control substance for the application on or before March 12,
Morphine (9300) the basic class of implementation of 21 CFR part 1301,
incident to the registration of 2018.
controlled substance.
manufacturers, distributors, dispensers, ADDRESSES: Written comments should
The company plans to import the importers, and exporters of controlled be sent to: Drug Enforcement
listed controlled substance in finished substances (other than final orders in Administration, Attention: DEA Federal
dosage form for internal analytical connection with suspension, denial, or Register Representative/DRW, 8701
purposes only. No other activity for this revocation of registration) has been Morrissette Drive, Springfield, Virginia
drug code is authorized for this redelegated to the Assistant 22152. All requests for hearing must be
registration. Approval of permit Administrator of the DEA Diversion sent to: Drug Enforcement
sradovich on DSK3GMQ082PROD with NOTICES
applications will occur only when the Control Division (‘‘Assistant Administration, Attn: Administrator,
registrant’s business activity is Administrator’’) pursuant to section 7 of 8701 Morrissette Drive, Springfield,
consistent with what is authorized 28 CFR part 0, appendix to subpart R. Virginia 22152. All request for hearing
under 21 U.S.C. 952(a)(2). Authorization In accordance with 21 CFR should also be sent to: (1) Drug
will not extend to the import of FDA 1301.34(a), this is notice that on Enforcement Administration, Attn:
approved or non-approved finished November 9, 2017, Johnson Matthey Hearing Clerk/LJ, 8701 Morrissette
dosage forms for commercial sale. Inc., Pharmaceutical Materials, 2003 Drive, Springfield, Virginia 22152; and
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![5812 Federal Register / Vol. 83, No. 28 / Friday, February 9, 2018 / Notices
(2) Drug Enforcement Administration, DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE
Attn: DEA Federal Register
Drug Enforcement Administration [OMB Number 1103–0098]
Representative/DRW, 8701 Morrissette
Drive, Springfield, Virginia 22152. Agency Information Collection
Comments and requests for hearings on [Docket No. DEA–392] Activities; Proposed eCollection
applications to import narcotic raw eComments Requested; COPS
material are not appropriate. 72 FR Bulk Manufacturer of Controlled Application Package
3417, (January 25, 2007). Substances Application: Siemens
Healthcare Diagnostics Inc. AGENCY: Community Oriented Policing
SUPPLEMENTARY INFORMATION: The Services, Department of Justice.
Attorney General has delegated his ACTION: Notice of application. ACTION: 30-Day notice.
authority under the Controlled
Substances Act to the Administrator of DATES: Registered bulk manufacturers of SUMMARY: The Department of Justice
the Drug Enforcement Administration the affected basic classes, and (DOJ) Office of Community Oriented
(DEA), 28 CFR 0.100(b). Authority to applicants therefore, may file written Policing Services (COPS) will be
exercise all necessary functions with comments on or objections to the submitting the following information
issuance of the proposed registration on collection request to the Office of
respect to the promulgation and
or before April 10, 2018. Management and Budget (OMB) for
implementation of 21 CFR part 1301,
review and approval in accordance with
incident to the registration of ADDRESSES: Written comments should the Paperwork Reduction Act of 1995.
manufacturers, distributors, dispensers, be sent to: Drug Enforcement The proposed information collection
importers, and exporters of controlled Administration, Attention: DEA Federal was previously published in the Federal
substances (other than final orders in Register Representative/DRW, 8701 Register on December 1, 2017, to obtain
connection with suspension, denial, or Morrissette Drive, Springfield, Virginia comments from the public and affected
revocation of registration) has been 22152. agencies.
redelegated to the Assistant SUPPLEMENTARY INFORMATION: The DATES: The purpose of this notice is to
Administrator of the DEA Diversion Attorney General has delegated his allow for an additional 30 days for
Control Division (‘‘Assistant authority under the Controlled public comment March 12, 2018.
Administrator’’) pursuant to section 7 of Substances Act to the Administrator of FOR FURTHER INFORMATION CONTACT: If
28 CFR part 0, appendix to subpart R. the Drug Enforcement Administration you have comments especially on the
In accordance with 21 CFR (DEA), 28 CFR 0.100(b). Authority to estimated public burden or associated
1301.34(a), this is notice that on exercise all necessary functions with response time, suggestions, or need a
November 10, 2017, Mylan respect to the promulgation and copy of the proposed information
Technologies Inc., 110 Lake St., Saint implementation of 21 CFR part 1301, collection instrument with instructions
Albans, VT 05478 applied to be incident to the registration of or additional information, please
registered as an importer of the manufacturers, distributors, dispensers, contact Lashon M. Hilliard, Department
following basic classes of controlled importers, and exporters of controlled of Justice Office of Community Oriented
substances: substances (other than final orders in Policing Services, 145 N Street NE,
connection with suspension, denial, or Washington, DC 20530 or at (202) 514–
Drug revocation of registration) has been 6563. Written comments and/or
Controlled substance Schedule redelegated to the Assistant suggestions can also be directed to the
code
Administrator of the DEA Diversion Office of Management and Budget,
Methylphenidate ........... 1724 II Control Division (‘‘Assistant Office of Information and Regulatory
Fentanyl ........................ 9801 II Administrator’’) pursuant to section 7 of Affairs, Attention Department of Justice
28 CFR part 0, appendix to subpart R. Desk Officer, Washington, DC 20530 or
The company plans to import the In accordance with 21 CFR sent to OIRA_submissions@
listed controlled substances in finished 1301.33(a), this is notice that on omb.eop.gov.
dosage form (FDF) from foreign sources December 13, 2017, Siemens Healthcare SUPPLEMENTARY INFORMATION: Written
for analytical testing and clinical trials Diagnostics Inc., 100 GBC Drive, comments and suggestions from the
in which the foreign FDF will be Mailstop 514, Newark, DE 19702 public and affected agencies concerning
compared to the company’s own applied to be registered as a bulk the proposed collection of information
domestically-manufactured FDF. This manufacturer of the following basic are encouraged. Your comments should
analysis is required to allow the class of controlled substance: address one or more of the following
company to export domestically four points:
Drug
manufactured FDF to foreign markets. Controlled substance Schedule —Evaluate whether the proposed
code
Authorization will not extend to the collection of information is necessary
import of Food and Drug Ecgonine ....................... 9180 II for the proper performance of the
Administration approved or non- functions of the agency, including
The company plans to bulk whether the information will have
approved finish dosage forms for
manufacture a material used in the practical utility;
commercial sale.
sradovich on DSK3GMQ082PROD with NOTICES
manufacture of reagents for a Cocaine in —Evaluate the accuracy of the agency’s
Dated: February 1, 2018. vitro diagnostic test system. estimate of the burden of the
Susan A Gibson, proposed collection of information,
Dated: February 1, 2018.
Deputy Assistant Administrator. including the validity of the
Susan A. Gibson,
[FR Doc. 2018–02641 Filed 2–8–18; 8:45 am]
methodology and assumptions used;
Deputy Assistant Administrator. —Enhance the quality, utility, and
BILLING CODE 4410–09–P [FR Doc. 2018–02642 Filed 2–8–18; 8:45 am] clarity of the information to be
BILLING CODE 4410–09–P collected; and
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Document Created: 2018-02-09 00:11:45
Document Modified: 2018-02-09 00:11:45
| 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 importers 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 March 12, 2018. Such persons may also file a written request for a hearing on the application on or before March 12, 2018. | |
| FR Citation | 83 FR 5811 |
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