Importer of Controlled Substances Registration: Mylan Technologies, Inc., 34695-34696 [2015-14911]

Download as PDF 34695 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices Dated: June 11, 2015. Chuck Rosenberg, Acting Administrator. Background [FR Doc. 2015–14910 Filed 6–16–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–410F] Controlled Substances: 2015 Established Aggregate Production Quotas for Three Temporarily Controlled Synthetic Cannabinoids Drug Enforcement Administration, Department of Justice. ACTION: Final order. AGENCY: This final order establishes the initial 2015 aggregate production quotas for three temporarily controlled synthetic cannabinoids: N-(1-amino-3methyl-1-oxobutan-2-yl)-1(cyclohexylmethyl)-1H-indazole-3carboxamide (AB-CHMINACA), N-(1amino-3-methyl-1-oxobutan-2-yl)-1pentyl-1H-indazole-3-carboxamide (ABPINACA), and [1-(5-fluoropentyl)-1Hindazol-3-yl](naphthalen-1yl)methanone (THJ-2201). DATES: Effective June 17, 2015. FOR FURTHER INFORMATION CONTACT: John R. Scherbenske, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598–6812. SUPPLEMENTARY INFORMATION: SUMMARY: Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this authority to the Administrator of the DEA. 28 CFR 0.100(b). On January 30, 2015, the DEA published in the Federal Register a final order to temporarily place three synthetic cannabinoids, N-(1-amino-3methyl-1-oxobutan-2-yl)-1(cyclohexylmethyl)-1H-indazole-3carboxamide (AB-CHMINACA), N-(1amino-3-methyl-1-oxobutan-2-yl)-1pentyl-1H-indazole-3-carboxamide (ABPINACA), and [1-(5-fluoropentyl)-1Hindazol-3-yl](naphthalen-1yl)methanone (THJ-2201), into schedule I of the CSA (80 FR 5042), making all regulatory controls pertaining to schedule I controlled substances applicable to AB-CHMINACA, ABPINACA, and THJ-2201, including the requirement to obtain a manufacturing quota pursuant to 21 CFR part 1303. The 2015 aggregate production quotas for AB-CHMINACA, AB-PINACA, and THJ-2201 represent those quantities that may be manufactured in the United States in 2015 to provide for the estimated scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks. On March 20, 2015, the DEA published a notice titled, ‘‘Controlled Substances: 2015 Proposed Aggregate Production Quotas for Three Temporarily Controlled Synthetic Cannabinoids’’ in the Federal Register (80 FR 15034). That notice proposed the 2015 aggregate production quotas for AB-CHMINACA, AB-PINACA, and THJ2201. Interested persons were invited to comment on or object to the proposed aggregate production quotas for ABCHMINACA, AB-PINACA, and THJ2201 on or before April 20, 2015. No comments were received. Analysis for 2015 Established Aggregate Production Quotas In determining the 2015 aggregate production quotas for N-(1-amino-3methyl-1-oxobutan-2-yl)-1(cyclohexylmethyl)-1H-indazole-3carboxamide (AB-CHMINACA), N-(1amino-3-methyl-1-oxobutan-2-yl)-1pentyl-1H-indazole-3-carboxamide (ABPINACA), and [1-(5-fluoropentyl)-1Hindazol-3-yl](naphthalen-1yl)methanone (THJ-2201), the DEA has taken into consideration the factors set forth at 21 CFR 1303.11, pursuant to 21 U.S.C. 826(a), and other relevant factors, including 2015 export requirements, industrial use, applications for quotas, as well as information on research and product development requirements. Pursuant to 21 U.S.C. 826 and in accordance with 21 CFR 1303.11, the Acting Administrator hereby establishes the 2015 aggregate production quotas for AB-CHMINACA, AB-PINACA, and THJ2201, expressed in grams of anhydrous acid or base, as follows: Established 2015 quota (g) Basic class—schedule I N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA) ................................. N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA) .......................................................... [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) .................................................................................. asabaliauskas on DSK5VPTVN1PROD with NOTICES In accordance with 21 CFR 1303.13, upon consideration of the relevant factors, the Acting Administrator may adjust the 2015 aggregate production quotas for AB-CHMINACA, ABPINACA, and THJ-2201 as needed. Dated: June 11, 2015. Chuck Rosenberg, Acting Administrator. [FR Doc. 2015–14909 Filed 6–16–15; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 18:47 Jun 16, 2015 Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: Mylan Technologies, Inc. ACTION: Jkt 235001 Notice of registration. 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. SUMMARY: PO 00000 Frm 00090 Fmt 4703 Sfmt 4703 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 SUPPLEMENTARY INFORMATION: DEPARTMENT OF JUSTICE 15 15 15 E:\FR\FM\17JNN1.SGM 17JNN1 34696 Federal Register / Vol. 80, No. 116 / Wednesday, June 17, 2015 / Notices 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) ................ Fentanyl (9801) ............................ II 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 domesticallymanufactured 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 DEPARTMENT OF LABOR Employee Benefits Security Administration Proposed Extension of Information Collection Requests Submitted for Public Comment Employee Benefits Security Administration, Department of Labor. ACTION: Notice. AGENCY: The Department of Labor (the Department), in accordance with the Paperwork Reduction Act of 1995 (PRA 95) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public’s reporting burden. It also helps the public understand the Department’s information collection requirements and provide the requested data in the desired format. The Employee Benefits Security Administration (EBSA) is soliciting asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:47 Jun 16, 2015 Jkt 235001 comments on the proposed extension of the information collection requests (ICRs) contained in the documents described below. A copy of the ICRs may be obtained by contacting the office listed in the ADDRESSES section of this notice. ICRs also are available at reginfo.gov (https://www.reginfo.gov/ public/do/PRAMain). DATES: Written comments must be submitted to the office shown in the Addresses section on or before August 17, 2015. ADDRESSES: G. Christopher Cosby, Department of Labor, Employee Benefits Security Administration, 200 Constitution Avenue NW., Room N– 5718, Washington, DC 20210, cosby.chris@dol.gov, (202) 693–8410, FAX (202) 693–4745 (these are not tollfree numbers). SUPPLEMENTARY INFORMATION: This notice requests public comment on the Department’s request for extension of the Office of Management and Budget’s (OMB) approval of ICRs contained in the rules and prohibited transactions described below. The Department is not proposing any changes to the existing ICRs at this time. An agency may not conduct or sponsor, and a person is not required to respond to, an information collection unless it displays a valid OMB control number. A summary of the ICRs and the current burden estimates follows: Agency: Employee Benefits Security Administration, Department of Labor. Title: Settlement Agreements between a Plan and Party in Interest. Type of Review: Extension of a currently approved collection of information. OMB Number: 1210–0091. Affected Public: Businesses or other for-profits. Respondents: 4. Responses: 1,080. Estimated Total Burden Hours: 30. Estimated Total Burden Cost (Operating and Maintenance): $335. Description: Section 408(a) of ERISA and section 4975(c)(2) of the Internal Revenue Code of 1986 (the Code) give the Secretary of Labor the authority to grant an exemption to a class or order of fiduciaries, disqualified persons, or transactions from all or part of the restrictions imposed by sections 406 and 407(a) of ERISA and from the taxes imposed by sections 4975(a) and (b) of the Code, by reason of section 4975(c)(1) of the Code. This information collection request (ICR) relates to two prohibited transaction class exemptions (PTEs) that the Department of Labor (the Department) has granted, both of which PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 involve settlement agreements. These two exemptions are described below: PTE 94–71. Granted on September 30, 1994, PTE 94–71 exempts from certain restrictions of ERISA and certain taxes imposed by the Code, a transaction or activity that is authorized, prior to the execution of the transaction or activity, by a settlement agreement resulting from an investigation of an employee benefit plan conducted by the Department. PTE 2003–39. Granted on December 31, 2005, PTE 03–39 exempts from certain restrictions of ERISA and certain taxes imposed by the Code, transactions arising out of the settlement of litigation that involve the release of claims against parties in interest in exchange for payment by or on behalf of the party in interest, provided that certain conditions are met. Because both exemptions involve settlement agreements, the Department has combined their information collection provisions into one ICR and has obtained OMB approval for their paperwork burden. The Department believes that the public and the Federal government are both best served by allowing the public to review and comment on similar exemption provisions in combination. The ICR is scheduled to expire on August 31, 2015. Agency: Employee Benefits Security Administration, Department of Labor. Title: Voluntary Fiduciary Correction Program. Type of Review: Extension of a currently approved information collection. OMB Number: 1210–0118. Affected Public: Businesses or other for-profits. Respondents: 5,760. Responses: 119,761. Estimated Total Burden Hours: 25,920. Estimated Total Burden Cost (Operating and Maintenance): $1,174,000. Description: This information collection arises from two related actions: the Voluntary Fiduciary Correction Program (the VFC Program or the Program) and Prohibited Transaction Class Exemption (PTE) 2002–51 (the Exemption). The Department adopted the Program and the Exemption in order to encourage members of the public to voluntarily correct transactions that violate (or are suspected of violating) the fiduciary or prohibited transaction provisions of the ERISA. Both the Program and the Exemption incorporate information collection requirements in order to protect participants and beneficiaries E:\FR\FM\17JNN1.SGM 17JNN1

Agencies

[Federal Register Volume 80, Number 116 (Wednesday, June 17, 2015)]
[Notices]
[Pages 34695-34696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14911]


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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

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