Importer of Controlled Substances Application: AMRI Rensselaer, Inc., 54603-54604 [2016-19436]

Download as PDF Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016. Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. clinical trials, research and analytical purposes. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–19438 Filed 8–15–16; 8:45 am] BILLING CODE 4410–09–P ADDRESSES: The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy 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 June 2, 2016, Actavis Laboratories FL., Inc., 4955 Orange Drive, Davie, Florida 33314 applied to be registered as an importer of the following basic classes of controlled substances: SUPPLEMENTARY INFORMATION: asabaliauskas on DSK3SPTVN1PROD with NOTICES Controlled substance Schedule Amphetamine (1100) ............ Methylphenidate (1724) ........ Oxycodone (9143) ................ Hydromorphone (9150) ........ Hydrocodone (9193) ............. Fentanyl (9801) .................... II II II II II II The company plans to import the above-listed controlled substances for VerDate Sep<11>2014 18:36 Aug 15, 2016 Jkt 238001 54603 In accordance with 21 CFR 1301.34(a), this is notice that on April 18, 2016, Bellwyck Clinical Services, 8946 Global Way, West Chester, Ohio 45069 applied to be registered as an importer of the following basic classes of controlled substances: Controlled substance Schedule DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: Bellwyck Clinical Services 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 September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. SUMMARY: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 Methylphenidate (1724) ........ Oxycodone (9143) ................ 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. Authorization will not extend to the import of FDA approved or nonapproved finished dosage forms for commercial sale. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–19437 Filed 8–15–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Application: AMRI Rensselaer, 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 September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 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, SUMMARY: E:\FR\FM\16AUN1.SGM 16AUN1 54604 Federal Register / Vol. 81, No. 158 / Tuesday, August 16, 2016 / Notices Attn: DEA Federal Register Representative/ODW, 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 her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy 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 June 27, 2016, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New York 12144 applied to be registered as an importer of poppy straw concentrate (9670), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance to manufacture bulk controlled substance for distribution to its customers. Louis J. Milione, Deputy Assistant Administrator. [FR Doc. 2016–19436 Filed 8–15–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC 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 1301.33(a) on or before October 17, 2016. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 asabaliauskas on DSK3SPTVN1PROD with NOTICES DATES: VerDate Sep<11>2014 18:36 Aug 15, 2016 Jkt 238001 Morrissette Drive, Springfield, Virginia 22152. customers for use as reference standards. The Attorney General has delegated her 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 Deputy Assistant Administrator of the DEA Office of Diversion Control (‘‘Deputy Assistant Administrator’’) pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.33(a), this is notice that on May 5, 2016, Chemtos, LLC, 14101 W. Highway 290, Building 2000B, Austin, Texas 78737–9331 applied to be registered as a bulk manufacturer for the following basic classes of controlled substances: Louis J. Milione, Deputy Assistant Administrator. SUPPLEMENTARY INFORMATION: Controlled Substance Marihuana (7360) ......................... Amphetamine (1100) .................... Methamphetamine (1105) ............ Lisdexamfetamine (1205) ............. Methylphenidate (1724) ................ Nabilone (7379) ............................ Phenylacetone (8501) .................. Cocaine (9041) ............................. Codeine (9050) ............................. Etorphine HCI (9059) ................... Dihydrocodeine (9120) ................. Oxycodone (9143) ........................ Hydromorphone (9150) ................ Ecgonine (9180) ........................... Ethylmorphine (9190) ................... Hydrocodone (9193) ..................... Levomethorphan (9210) ............... Levorphanol (9220) ...................... Isomethadone (9226) ................... Meperidine (9230) ........................ Meperidine intermediate-A (9232) Meperidine intermediate-B (9233) Meperidine intermediate-C (9234) Methadone (9250) ........................ Methadone intermediate (9254) ... Morphine (9300) ........................... Thebaine (9333) ........................... Dihydroetorphine (9334) ............... Levo-alphacetylmethadol (9648) .. Oxymorphone (9652) ................... Racemethorphan (9732) .............. Racemorphan (9733) ................... Schedule I II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II II The company plans to manufacture small quantities of the listed controlled substances in bulk for distribution to its PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 [FR Doc. 2016–19449 Filed 8–15–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE [OMB Number 1105–0086] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension and Revision of a Currently Approved Collection; Attorney Student Loan Repayment Program Electronic Forms Office of Attorney Recruitment and Management, Department of Justice ACTION: 60-Day notice. AGENCY: The Department of Justice (DOJ), Justice Management Division, Office of Attorney Recruitment and Management (OARM), 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 October 17, 2016. FOR FURTHER INFORMATION CONTACT: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the U.S. Department of Justice, Office of Attorney Recruitment and Management, 450 5th Street NW., Suite 10200, Attn: Deana Willis, Washington, DC 20530. 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: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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 SUMMARY: E:\FR\FM\16AUN1.SGM 16AUN1

Agencies

[Federal Register Volume 81, Number 158 (Tuesday, August 16, 2016)]
[Notices]
[Pages 54603-54604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19436]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: AMRI Rensselaer, 
Inc.

ACTION: Notice of application.

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SUMMARY: 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 September 15, 2016. Such persons may also file 
a written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before September 15, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
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,

[[Page 54604]]

Attn: DEA Federal Register Representative/ODW, 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 her 
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 Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy 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 June 
27, 2016, AMRI Rensselaer, Inc., 33 Riverside Avenue, Rensselaer, New 
York 12144 applied to be registered as an importer of poppy straw 
concentrate (9670), a basic class of controlled substance listed in 
schedule II.
    The company plans to import the listed controlled substance to 
manufacture bulk controlled substance for distribution to its 
customers.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-19436 Filed 8-15-16; 8:45 am]
 BILLING CODE 4410-09-P