80 FR 34695 - Importer of Controlled Substances Registration: Mylan Technologies, Inc.
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 116 (June 17, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 116 (June 17, 2015)
| Page Range | 34695-34696 | |
| FR Document | 2015-14911 |
[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)] [Notices] [Pages 34695-34696] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-14911] ----------------------------------------------------------------------- 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 February 11, 2015, and published in the Federal Register on February 19, 2015, 80 FR 8902, 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 [[Page 34696]] 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 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: June 11, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015-14911 Filed 6-16-15; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices 34695
Dated: June 11, 2015. Background On March 20, 2015, the DEA
Chuck Rosenberg, published a notice titled, ‘‘Controlled
Section 306 of the Controlled Substances: 2015 Proposed Aggregate
Acting Administrator.
Substances Act (CSA) (21 U.S.C. 826) Production Quotas for Three
[FR Doc. 2015–14910 Filed 6–16–15; 8:45 am]
requires the Attorney General to Temporarily Controlled Synthetic
BILLING CODE 4410–09–P establish aggregate production quotas Cannabinoids’’ in the Federal Register
for each basic class of controlled (80 FR 15034). That notice proposed the
substance listed in schedules I and II 2015 aggregate production quotas for
DEPARTMENT OF JUSTICE and for ephedrine, pseudoephedrine, AB-CHMINACA, AB-PINACA, and THJ-
Drug Enforcement Administration and phenylpropanolamine. The 2201. Interested persons were invited to
Attorney General has delegated this comment on or object to the proposed
[Docket No. DEA–410F]
authority to the Administrator of the aggregate production quotas for AB-
DEA. 28 CFR 0.100(b). CHMINACA, AB-PINACA, and THJ-
Controlled Substances: 2015 On January 30, 2015, the DEA 2201 on or before April 20, 2015. No
Established Aggregate Production published in the Federal Register a final comments were received.
Quotas for Three Temporarily order to temporarily place three
Controlled Synthetic Cannabinoids synthetic cannabinoids, N-(1-amino-3- Analysis for 2015 Established Aggregate
methyl-1-oxobutan-2-yl)-1- Production Quotas
AGENCY: Drug Enforcement (cyclohexylmethyl)-1H-indazole-3- In determining the 2015 aggregate
Administration, Department of Justice. carboxamide (AB-CHMINACA), N-(1- production quotas for N-(1-amino-3-
ACTION: Final order. amino-3-methyl-1-oxobutan-2-yl)-1- methyl-1-oxobutan-2-yl)-1-
pentyl-1H-indazole-3-carboxamide (AB- (cyclohexylmethyl)-1H-indazole-3-
SUMMARY: This final order establishes PINACA), and [1-(5-fluoropentyl)-1H-
the initial 2015 aggregate production carboxamide (AB-CHMINACA), N-(1-
indazol-3-yl](naphthalen-1- amino-3-methyl-1-oxobutan-2-yl)-1-
quotas for three temporarily controlled yl)methanone (THJ-2201), into schedule
synthetic cannabinoids: N-(1-amino-3- pentyl-1H-indazole-3-carboxamide (AB-
I of the CSA (80 FR 5042), making all PINACA), and [1-(5-fluoropentyl)-1H-
methyl-1-oxobutan-2-yl)-1- regulatory controls pertaining to
(cyclohexylmethyl)-1H-indazole-3- indazol-3-yl](naphthalen-1-
schedule I controlled substances yl)methanone (THJ-2201), the DEA has
carboxamide (AB-CHMINACA), N-(1- applicable to AB-CHMINACA, AB-
amino-3-methyl-1-oxobutan-2-yl)-1- taken into consideration the factors set
PINACA, and THJ-2201, including the forth at 21 CFR 1303.11, pursuant to 21
pentyl-1H-indazole-3-carboxamide (AB- requirement to obtain a manufacturing
PINACA), and [1-(5-fluoropentyl)-1H- U.S.C. 826(a), and other relevant factors,
quota pursuant to 21 CFR part 1303. including 2015 export requirements,
indazol-3-yl](naphthalen-1-
yl)methanone (THJ-2201). The 2015 aggregate production quotas industrial use, applications for quotas,
for AB-CHMINACA, AB-PINACA, and as well as information on research and
DATES: Effective June 17, 2015.
THJ-2201 represent those quantities that product development requirements.
FOR FURTHER INFORMATION CONTACT: John may be manufactured in the United Pursuant to 21 U.S.C. 826 and in
R. Scherbenske, Office of Diversion States in 2015 to provide for the accordance with 21 CFR 1303.11, the
Control, Drug Enforcement estimated scientific, research, and Acting Administrator hereby establishes
Administration; Mailing Address: 8701 industrial needs of the United States, the 2015 aggregate production quotas for
Morrissette Drive, Springfield, Virginia lawful export requirements, and the AB-CHMINACA, AB-PINACA, and THJ-
22152; Telephone: (202) 598–6812. establishment and maintenance of 2201, expressed in grams of anhydrous
SUPPLEMENTARY INFORMATION: reserve stocks. acid or base, as follows:
Established
Basic class—schedule I 2015 quota
(g)
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA) ................................. 15
N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) .......................................................... 15
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) .................................................................................. 15
In accordance with 21 CFR 1303.13, DEPARTMENT OF JUSTICE SUPPLEMENTARY INFORMATION: By notice
upon consideration of the relevant dated February 11, 2015, and published
factors, the Acting Administrator may Drug Enforcement Administration in the Federal Register on February 19,
adjust the 2015 aggregate production 2015, 80 FR 8902, Mylan Technologies,
[Docket No. DEA–392] Inc., 110 Lake Street, Saint Albans,
quotas for AB-CHMINACA, AB-
PINACA, and THJ-2201 as needed. Vermont 05478 applied to be registered
Importer of Controlled Substances
as an importer of certain basic classes of
Dated: June 11, 2015. Registration: Mylan Technologies, Inc.
controlled substances. No comments or
Chuck Rosenberg, objections were submitted for this
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ACTION: Notice of registration.
Acting Administrator. notice.
[FR Doc. 2015–14909 Filed 6–16–15; 8:45 am] SUMMARY: Mylan Technologies, Inc. The DEA has considered the factors in
BILLING CODE 4410–09–P applied to be registered as an importer 21 U.S.C. 823, 952(a) and 958(a) and
of certain basic classes of controlled determined that the registration of
substances. The Drug Enforcement Mylan Technologies, Inc. to import the
Administration (DEA) grants Mylan basic classes of controlled substances is
Technologies, Inc. registration as an consistent with the public interest and
importer of those controlled substances. with United States obligations under
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![34696 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices
international treaties, conventions, or comments on the proposed extension of involve settlement agreements. These
protocols in effect on May 1, 1971. The the information collection requests two exemptions are described below:
DEA investigated the company’s (ICRs) contained in the documents PTE 94–71. Granted on September 30,
maintenance of effective controls described below. A copy of the ICRs 1994, PTE 94–71 exempts from certain
against diversion by inspecting and may be obtained by contacting the office restrictions of ERISA and certain taxes
testing the company’s physical security listed in the ADDRESSES section of this imposed by the Code, a transaction or
systems, verifying the company’s notice. ICRs also are available at activity that is authorized, prior to the
compliance with state and local laws, reginfo.gov (http://www.reginfo.gov/ execution of the transaction or activity,
and reviewing the company’s public/do/PRAMain). by a settlement agreement resulting
background and history. DATES: Written comments must be from an investigation of an employee
Therefore, pursuant to 21 U.S.C. submitted to the office shown in the benefit plan conducted by the
952(a) and 958(a), and in accordance Addresses section on or before August Department.
with 21 CFR 1301.34, the above-named 17, 2015. PTE 2003–39. Granted on December
company is granted registration as an 31, 2005, PTE 03–39 exempts from
ADDRESSES: G. Christopher Cosby,
importer of the basic classes of certain restrictions of ERISA and certain
Department of Labor, Employee Benefits
controlled substances: taxes imposed by the Code, transactions
Security Administration, 200
Constitution Avenue NW., Room N– arising out of the settlement of litigation
Controlled substance Schedule that involve the release of claims against
5718, Washington, DC 20210,
cosby.chris@dol.gov, (202) 693–8410, parties in interest in exchange for
Methylphenidate (1724) ................ II
FAX (202) 693–4745 (these are not toll- payment by or on behalf of the party in
Fentanyl (9801) ............................ II
free numbers). interest, provided that certain
The company plans to import the conditions are met.
SUPPLEMENTARY INFORMATION: This Because both exemptions involve
listed controlled substances in finished notice requests public comment on the
dosage form (FDF) from foreign sources settlement agreements, the Department
Department’s request for extension of has combined their information
for analytical testing and clinical trials the Office of Management and Budget’s
in which the foreign FDF will be collection provisions into one ICR and
(OMB) approval of ICRs contained in has obtained OMB approval for their
compared to the company’s own the rules and prohibited transactions
domestically-manufactured FDF. This paperwork burden. The Department
described below. The Department is not believes that the public and the Federal
analysis is required to allow the proposing any changes to the existing
company to export domestically- government are both best served by
ICRs at this time. An agency may not allowing the public to review and
manufactured FDF to foreign markets. conduct or sponsor, and a person is not comment on similar exemption
Dated: June 11, 2015. required to respond to, an information provisions in combination. The ICR is
Joseph T. Rannazzisi, collection unless it displays a valid scheduled to expire on August 31, 2015.
Deputy Assistant Administrator. OMB control number. A summary of the
Agency: Employee Benefits Security
[FR Doc. 2015–14911 Filed 6–16–15; 8:45 am] ICRs and the current burden estimates
Administration, Department of Labor.
follows:
BILLING CODE 4410–09–P Title: Voluntary Fiduciary Correction
Agency: Employee Benefits Security Program.
Administration, Department of Labor. Type of Review: Extension of a
DEPARTMENT OF LABOR Title: Settlement Agreements between currently approved information
a Plan and Party in Interest. collection.
Employee Benefits Security Type of Review: Extension of a OMB Number: 1210–0118.
Administration currently approved collection of Affected Public: Businesses or other
information. for-profits.
Proposed Extension of Information OMB Number: 1210–0091. Respondents: 5,760.
Collection Requests Submitted for Affected Public: Businesses or other Responses: 119,761.
Public Comment for-profits. Estimated Total Burden Hours:
AGENCY: Employee Benefits Security Respondents: 4. 25,920.
Administration, Department of Labor. Responses: 1,080. Estimated Total Burden Cost
ACTION: Notice. Estimated Total Burden Hours: 30. (Operating and Maintenance):
Estimated Total Burden Cost $1,174,000.
SUMMARY: The Department of Labor (the (Operating and Maintenance): $335. Description: This information
Department), in accordance with the Description: Section 408(a) of ERISA collection arises from two related
Paperwork Reduction Act of 1995 (PRA and section 4975(c)(2) of the Internal actions: the Voluntary Fiduciary
95) (44 U.S.C. 3506(c)(2)(A)), provides Revenue Code of 1986 (the Code) give Correction Program (the VFC Program or
the general public and Federal agencies the Secretary of Labor the authority to the Program) and Prohibited
with an opportunity to comment on grant an exemption to a class or order Transaction Class Exemption (PTE)
proposed and continuing collections of of fiduciaries, disqualified persons, or 2002–51 (the Exemption). The
information. This helps the Department transactions from all or part of the Department adopted the Program and
assess the impact of its information restrictions imposed by sections 406 the Exemption in order to encourage
asabaliauskas on DSK5VPTVN1PROD with NOTICES
collection requirements and minimize and 407(a) of ERISA and from the taxes members of the public to voluntarily
the public’s reporting burden. It also imposed by sections 4975(a) and (b) of correct transactions that violate (or are
helps the public understand the the Code, by reason of section 4975(c)(1) suspected of violating) the fiduciary or
Department’s information collection of the Code. This information collection prohibited transaction provisions of the
requirements and provide the requested request (ICR) relates to two prohibited ERISA. Both the Program and the
data in the desired format. The transaction class exemptions (PTEs) that Exemption incorporate information
Employee Benefits Security the Department of Labor (the collection requirements in order to
Administration (EBSA) is soliciting Department) has granted, both of which protect participants and beneficiaries
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Document Created: 2015-12-15 14:23:23
Document Modified: 2015-12-15 14:23:23
| 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 | 80 FR 34695 |
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