Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc., 43572-43573 [2017-19832]

Download as PDF 43572 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 18, 2017. 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 requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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 April 19, 2017, Unither Manufacturing LLC, 331 Clay Road, Rochester, New York 14623 applied to be registered as an importer of methylphenidate (1724), a basic class of controlled substance listed in schedule II. The company plans to import the listed substance solely for updated analytical testing purposes for EU customer requirements. This analysis is required to allow the company to export domestically-manufactured FDF to foreign markets. sradovich on DSKBBY8HB2PROD with NOTICES SUPPLEMENTARY INFORMATION: Dated: September 11, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–19830 Filed 9–15–17; 8:45 am] BILLING CODE 4410–09–P VerDate Sep<11>2014 19:23 Sep 15, 2017 Jkt 241001 DEPARTMENT OF JUSTICE Controlled substance Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Sharp Clinical Services, Inc. ACTION: Notice of application. 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 on or before October 18, 2017. Such persons may also file a written request for a hearing on the application on or before October 18, 2017. DATES: 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 requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. ADDRESSES: 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 August 23, 2017, Sharp Clinical Services, Inc., 300 Kimberton Road, Phoenixville, Pennsylvania 19460 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Marihuana ................................ 3,4-Methylenedioxymethamphetamine. Psilocybin ................................. Drug code Schedule 7360 7405 I I 7437 I The company plans to import the listed controlled substances for analytical research, testing, and clinical trials. No other activity for these drug codes is authorized for this registration. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. Dated: September 11, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–19836 Filed 9–15–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Mylan Pharmaceuticals, Inc. ACTION: Notice of application. 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 1301.34(a) on or before October 18, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 18, 2017. 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 (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. DATES: E:\FR\FM\18SEN1.SGM 18SEN1 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices 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 March 24, 2017, Mylan Pharmaceuticals, Inc., 2898 Manufacturers Road, Greensboro, North Carolina 27406 applied to be registered as an importer of nabilone (7379), a basic class of controlled substance listed in schedule II. The company plans to import the FDA approved drug product in finished dosage form for distribution to its customers. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). SUPPLEMENTARY INFORMATION: Dated: September 11, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–19832 Filed 9–15–17; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Overview of This Information Collection Federal Bureau of Investigation [OMB Number 1110–NEW] Agency Information Collection Activities; Proposed eCollection, eComments Requested; Crime Data Explorer Feedback Survey Federal Bureau of Investigation, Department of Justice. ACTION: 60-Day notice. AGENCY: The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Criminal Justice Information Services Division (CJIS), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. DATES: Comments are encouraged and will be accepted for 60 days until November 17, 2017. sradovich on DSKBBY8HB2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 19:02 Sep 15, 2017 Jkt 241001 All comments, suggestions, or questions regarding additional information, to include obtaining a copy of the proposed information collection instrument with instructions, should be directed to Mrs. Amy C. Blasher, Unit Chief, Federal Bureau of Investigation, Criminal Information Services Division, Module E–3, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306; facsimile (304) 625–3566. SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Federal Bureau of Investigation, including whether the information will have practical utility; —Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. FOR FURTHER INFORMATION CONTACT: 1. Type of Information Collection: New collection. 2. The Title of the Form/Collection: Crime Data Explorer Feedback Survey. 3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: No form number. The applicable component within the Department of Justice is the Criminal Justice Information Services Division, in the Federal Bureau of Investigation. 4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Law enforcement, academia and the general public. Abstract: This survey is needed to collect feedback on the functionality of the CDE in order to make improvements to the application. 5. An estimate of the total number of respondents and the amount of time PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 43573 estimated for an average respondent to respond: UCR Crime Data Explorer Burden Estimation: It is estimated the CDE will generate 200 feedback responses per year with an estimated response time of 2 minutes per response. 6. An estimate of the total public burden (in hours) associated with the collection: There are approximately 7 hours, annual burden, associated with this information collection. If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405A, Washington, DC 20530. Dated: September 13, 2017. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice. [FR Doc. 2017–19814 Filed 9–15–17; 8:45 am] BILLING CODE 4410–02–P DEPARTMENT OF JUSTICE Notice of Lodging of Proposed Consent Decree Under the Clean Water Act, Clean Air Act, Emergency Planning and Community Right-ToKnow Act, and Resource Conservation and Recovery Act On September 12, 2017, the Department of Justice lodged a proposed consent decree with the United States District Court for the Western District of Pennsylvania in the lawsuit entitled United States v. StarKist Co. and Starkist Samoa Co., Civil Action No. 2:17–cv–01190–DSC. The United States filed this lawsuit under the Clean Water Act (CWA), Clean Air Act (CAA), Emergency Planning and Community Right-toKnow Act (EPCRA), and the Resource Conservation and Recovery Act (RCRA). The complaint seeks injunctive relief and civil penalties for violations of these statutes and their implementing regulations at defendants’ seafood processing and canning facility in American Samoa. Specifically, the complaint alleges the following CWA violations: (1) Unpermitted discharges of wastewater through an outfall rupture in 2014; (2) violations of terms and conditions of the facility’s National Pollutant Discharge Elimination System Permit, including effluent limit violations; and (3) violations of the CWA’s Spill Prevention Control and Countermeasures regulations related to the facility’s oil storage tanks. The complaint also alleges violations of the E:\FR\FM\18SEN1.SGM 18SEN1

Agencies

[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43572-43573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19832]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Mylan 
Pharmaceuticals, Inc.

ACTION: Notice of application.

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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 
1301.34(a) on or before October 18, 2017. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before October 18, 2017.

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 (2) Drug Enforcement Administration, 
Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

[[Page 43573]]


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 March 
24, 2017, Mylan Pharmaceuticals, Inc., 2898 Manufacturers Road, 
Greensboro, North Carolina 27406 applied to be registered as an 
importer of nabilone (7379), a basic class of controlled substance 
listed in schedule II.
    The company plans to import the FDA approved drug product in 
finished dosage form for distribution to its customers. Approval of 
permit applications will occur only when the registrant's business 
activity is consistent with what is authorized under 21 U.S.C. 
952(a)(2).

    Dated: September 11, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-19832 Filed 9-15-17; 8:45 am]
 BILLING CODE P