81 FR 22314 - Importer of Controlled Substances Registration: Mylan Technologies, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 73 (April 15, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 73 (April 15, 2016)
| Page Range | 22314-22314 | |
| FR Document | 2016-08846 |
[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)] [Notices] [Page 22314] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-08846] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Registration: Mylan Technologies, Inc. ACTION: Notice of registration. ----------------------------------------------------------------------- SUMMARY: Mylan Technologies, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Mylan Technologies, Inc. registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated November 27, 2015, and published in the Federal Register on December 3, 2015, 80 FR 75688, Mylan Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478 applied to be registered as an importer of certain basic classes of controlled substances. No comments or objections were submitted for this notice. The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Mylan Technologies, Inc. to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of the following basic classes of controlled substances: ------------------------------------------------------------------------ Controlled substance 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. Dated: April 11, 2016. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016-08846 Filed 4-14-16; 8:45 am] BILLING CODE 4410-09-P
![22314 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices
reply submissions, if any, are limited to Administration (DEA) grants Mylan DEPARTMENT OF JUSTICE
75 pages. Technologies, Inc. registration as an
Persons filing written submissions importer of those controlled substances. [OMB Number 1117–0038]
must file the original document
electronically on or before the deadlines SUPPLEMENTARY INFORMATION: By notice Agency Information Collection
stated above and submit 8 true paper dated November 27, 2015, and Activities; Proposed eCollection,
copies to the Office of the Secretary by published in the Federal Register on eComments Requested; Extension
noon the next day pursuant to section December 3, 2015, 80 FR 75688, Mylan Without Change of a Previously
210.4(f) of the Commission’s Rules of Technologies, Inc., 110 Lake Street, Approved Collection Reporting and
Practice and Procedure (19 CFR Saint Albans, Vermont 05478 applied to Recordkeeping for Digital Certificates
210.4(f)). Submissions should refer to be registered as an importer of certain AGENCY: Drug Enforcement
the investigation number (‘‘Inv. No. basic classes of controlled substances. Administration, Department of Justice.
337–TA–944’’) in a prominent place on No comments or objections were
ACTION: 30-Day notice.
the cover page and/or the first page. (See submitted for this notice.
Handbook for Electronic Filing The DEA has considered the factors in SUMMARY: The Department of Justice
Procedures, http://www.usitc.gov/ 21 U.S.C. 823, 952(a) and 958(a) and (DOJ), Drug Enforcement
secretary/fed_reg_notices/rules/ determined that the registration of Administration (DEA), will be
handbook_on_electronic_filing.pdf). submitting the following information
Mylan Technologies, Inc. to import the
Persons with questions regarding filing collection request to the Office of
basic classes of controlled substances is
should contact the Secretary (202–205– Management and Budget (OMB) for
consistent with the public interest and
2000). review and approval in accordance with
Any person desiring to submit a with United States obligations under
international treaties, conventions, or the Paperwork Reduction Act of 1995.
document to the Commission in This proposed information collection
confidence must request confidential protocols in effect on May 1, 1971. The
DEA investigated the company’s was previously published in the Federal
treatment. All such requests should be Register at 81 FR 7592, on February 12,
directed to the Secretary to the maintenance of effective controls
2016, allowing for a 60 day comment
Commission and must include a full against diversion by inspecting and
period.
statement of the reasons why the testing the company’s physical security
Commission should grant such systems, verifying the company’s DATES: Comments are encouraged and
treatment. See 19 CFR 201.6. Documents compliance with state and local laws, will be accepted for an additional 30
for which confidential treatment by the and reviewing the company’s days until May 16, 2016.
Commission is properly sought will be background and history. FOR FURTHER INFORMATION CONTACT: If
treated accordingly. A redacted non- you have comments on the estimated
Therefore, pursuant to 21 U.S.C.
confidential version of the document public burden or associated response
952(a) and 958(a), and in accordance
must also be filed simultaneously with time, suggestions, or need a copy of the
with 21 CFR 1301.34, the above-named
the any confidential filing. All non- proposed information collection
company is granted registration as an instrument with instructions or
confidential written submissions will be
importer of the following basic classes additional information, please contact
available for public inspection at the
Office of the Secretary and on EDIS. of controlled substances: Barbara J. Boockholdt, Office of
The authority for the Commission’s Diversion Control, Drug Enforcement
Controlled substance Schedule Administration; Mailing Address: 8701
determination is contained in section
337 of the Tariff Act of 1930, as Methylphenidate (1724) ................ II
Morrissette Drive, Springfield, Virginia
amended (19 U.S.C. 1337), and in Part Fentanyl (9801) ............................ II
22152; Telephone: (202) 598–6812.
210 of the Commission’s Rules of Written comments and/or suggestions
Practice and Procedure (19 CFR part can also be directed to the Office of
210). The company plans to import the Management and Budget, Office of
listed controlled substances in finished Information and Regulatory Affairs,
By order of the Commission.
dosage form (FDF) from foreign sources Attention Department of Justice Desk
Issued: April 11, 2016. for analytical testing and clinical trials Officer, Washington, DC 20503 or sent
Lisa R. Barton, in which the foreign FDF will be to OIRA_submissions@omb.eop.gov.
Secretary to the Commission. compared to the company’s own SUPPLEMENTARY INFORMATION: Written
[FR Doc. 2016–08680 Filed 4–14–16; 8:45 am] domestically-manufactured FDF. This comments and suggestions from the
BILLING CODE 7020–02–P analysis is required to allow the public and affected agencies concerning
company to export domestically- the proposed collection of information
manufactured FDF to foreign markets. are encouraged. Your comments should
DEPARTMENT OF JUSTICE address one or more of the following
Dated: April 11, 2016.
Louis J. Milione,
four points:
Drug Enforcement Administration
Deputy Assistant Administrator. —Evaluate whether the proposed
[Docket No. DEA–392] collection of information is necessary
[FR Doc. 2016–08846 Filed 4–14–16; 8:45 am]
for the proper performance of the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Importer of Controlled Substances BILLING CODE 4410–09–P
functions of the agency, including
Registration: Mylan Technologies, Inc. whether the information will have
ACTION: Notice of registration. practical utility;
—Evaluate the accuracy of the agency’s
SUMMARY: Mylan Technologies, Inc. estimate of the burden of the
applied to be registered as an importer proposed collection of information,
of certain basic classes of controlled including the validity of the
substances. The Drug Enforcement methodology and assumptions used;
VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1](https://thefederalregister.org/doc/81_FR_22387/page/1.svg)
Document Created: 2016-04-15 00:55:32
Document Modified: 2016-04-15 00:55:32
| 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 registration. | |
| FR Citation | 81 FR 22314 |
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