82_FR_51856 82 FR 51642 - Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City

82 FR 51642 - Bulk Manufacturer of Controlled Substances Application: Cambrex Charles City

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 214 (November 7, 2017)

Page Range51642-51643
FR Document2017-24201

Federal Register, Volume 82 Issue 214 (Tuesday, November 7, 2017) 
[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Notices]
[Pages 51642-51643]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24201]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Cambrex 
Charles City

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 on or before 
January 8, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152. Comments and 
requests for hearings on applications to import raw material are not 
appropriate. 72 FR 3417 (January 25, 2007).

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 1301.33(a), this is notice that on June 
12, 2017, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 
50616 applied to be registered as a bulk manufacturer of the following 
basic classes of controlled substances:

 
------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..........            2010  I
Amphetamine........................            1100  II
Lisdexamfetamine...................            1205  II
Methylphenidate....................            1724  II
4-Anilino-N-phenethyl-4-piperidine             8333  II
 (ANPP).
Phenylacetone......................            8501  II
Cocaine............................            9041  II
Codeine............................            9050  II
Oxycodone..........................            9143  II
Hydromorphone......................            9150  II
Hydrocodone........................            9193  II
Morphine...........................            9300  II
Oripavine..........................            9330  II
Thebaine...........................            9333  II
Opium extracts.....................            9610  II
Opium fluid extract................            9620  II
Opium tincture.....................            9630  II
Opium, powdered....................            9639  II
Oxymorphone........................            9652  II
Noroxymorphone.....................            9668  II
Fentanyl...........................            9801  II
------------------------------------------------------------------------


[[Page 51643]]

    The company plans to manufacture the listed controlled substances 
in bulk for sale to its customers, for dosage form development, for 
clinical trials, and for use in stability qualification studies.

    Dated: October 30, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-24201 Filed 11-6-17; 8:45 am]
BILLING CODE 4410-09-P

51642 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices INTERNATIONAL TRADE containing information concerning the DATES: Registered bulk manufacturers of COMMISSION subject matter of the review will be the affected basic classes, and placed in the nonpublic record on applicants therefore, may file written [Investigation Nos. 701–TA–442 and 731– TA–1095–1096 (Second Review)] January 3, 2018 and made available to comments on or objections to the persons on the Administrative issuance of the proposed registration in Lined Paper School Supplies From Protective Order service list for this accordance with on or before January 8, China and India; Amended Schedule review. Comments pursuant to section 2018. for Expedited Reviews 207.62(d) of the Commission’s rules are ADDRESSES: Written comments should due on or before January 9, 2018. be sent to: Drug Enforcement AGENCY: United States International The Commission has determined that Trade Commission. Administration, Attention: DEA Federal these reviews are extraordinarily Register Representative/DRW, 8701 ACTION: Notice. complicated and therefore has Morrissette Drive, Springfield, Virginia determined to exercise its authority to 22152. Comments and requests for DATES: October 27, 2017. extend the review period by up to 90 FOR FURTHER INFORMATION CONTACT: hearings on applications to import raw days pursuant to 19 U.S.C. material are not appropriate. 72 FR 3417 Calvin Chang (202–205–3062), Office of 1675(c)(5)(B). Investigations, U.S. International Trade (January 25, 2007). For further information concerning Commission, 500 E Street SW., these investigations see the SUPPLEMENTARY INFORMATION: The Washington, DC 20436. Hearing- Commission’s notice cited above. Attorney General has delegated his impaired persons can obtain authority under the Controlled information on this matter by contacting Authority: These investigations are being Substances Act to the Administrator of conducted under authority of title VII of the the Commission’s TDD terminal on 202– the Drug Enforcement Administration Tariff Act of 1930; this notice is published 205–1810. Persons with mobility pursuant to section 207.21 of the (DEA), 28 CFR 0.100(b). Authority to impairments who will need special Commission’s rules. exercise all necessary functions with assistance in gaining access to the respect to the promulgation and By order of the Commission. Commission should contact the Office implementation of 21 CFR part 1301, Issued: November 1, 2017. of the Secretary at 202–205–2000. incident to the registration of Lisa R. Barton, General information concerning the manufacturers, distributors, dispensers, Commission may also be obtained by Secretary to the Commission. importers, and exporters of controlled accessing its internet server (https:// [FR Doc. 2017–24174 Filed 11–6–17; 8:45 am] substances (other than final orders in www.usitc.gov). The public record for BILLING CODE 7020–02–P connection with suspension, denial, or this investigation may be viewed on the revocation of registration) has been Commission’s electronic docket (EDIS) redelegated to the Assistant at https://edis.usitc.gov. DEPARTMENT OF JUSTICE Administrator of the DEA Diversion SUPPLEMENTARY INFORMATION: On Control Division (‘‘Assistant October 6, 2017, the Commission Drug Enforcement Administration Administrator’’) pursuant to section 7 of established a schedule for conducting 28 CFR part 0, appendix to subpart R. expedited reviews on lined paper school [Docket No. DEA–392] In accordance with 21 CFR supplies from China and India. On 1301.33(a), this is notice that on June October 26, 2017, the schedule was Bulk Manufacturer of Controlled 12, 2017, Cambrex Charles City, 1205 published in the Federal Register (82 Substances Application: Cambrex 11th Street, Charles City, Iowa 50616 FR 49659). This notice corrects several Charles City applied to be registered as a bulk dates in the previously-published manufacturer of the following basic ACTION: Notice of application. schedule. In particular, the staff report classes of controlled substances: Controlled substance Drug code Schedule Gamma Hydroxybutyric Acid ........................................................................................................................................... 2010 I Amphetamine ................................................................................................................................................................... 1100 II Lisdexamfetamine ............................................................................................................................................................ 1205 II Methylphenidate .............................................................................................................................................................. 1724 II 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... 8333 II Phenylacetone ................................................................................................................................................................. 8501 II Cocaine ............................................................................................................................................................................ 9041 II Codeine ........................................................................................................................................................................... 9050 II Oxycodone ....................................................................................................................................................................... 9143 II Hydromorphone ............................................................................................................................................................... 9150 II Hydrocodone ................................................................................................................................................................... 9193 II Morphine .......................................................................................................................................................................... 9300 II Oripavine ......................................................................................................................................................................... 9330 II Thebaine .......................................................................................................................................................................... 9333 II ethrower on DSK3G9T082PROD with NOTICES Opium extracts ................................................................................................................................................................ 9610 II Opium fluid extract .......................................................................................................................................................... 9620 II Opium tincture ................................................................................................................................................................. 9630 II Opium, powdered ............................................................................................................................................................ 9639 II Oxymorphone .................................................................................................................................................................. 9652 II Noroxymorphone ............................................................................................................................................................. 9668 II Fentanyl ........................................................................................................................................................................... 9801 II VerDate Sep<11>2014 17:29 Nov 06, 2017 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\07NON1.SGM 07NON1

Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Notices 51643 The company plans to manufacture the proposed collection of information Department of Justice, Justice the listed controlled substances in bulk are encouraged. Your comments should Management Division, Policy and for sale to its customers, for dosage form address one or more of the following Planning Staff, Two Constitution development, for clinical trials, and for four points: Square, 145 N Street NE., 3E.405A, use in stability qualification studies. —Evaluate whether the proposed Washington, DC 20530. Dated: October 30, 2017. collection of information is necessary Dated: November 2, 2017. Demetra Ashley, for the proper performance of the Melody Braswell, Acting Assistant Administrator. functions of the Bureau of Justice Department Clearance Officer for PRA, U.S. [FR Doc. 2017–24201 Filed 11–6–17; 8:45 am] Statistics, including whether the Department of Justice. BILLING CODE 4410–09–P information will have practical utility; [FR Doc. 2017–24208 Filed 11–6–17; 8:45 am] —Evaluate the accuracy of the agency’s BILLING CODE 4410–02–P estimate of the burden of the DEPARTMENT OF JUSTICE proposed collection of information, including the validity of the DEPARTMENT OF JUSTICE [OMB Number 1110–0060] methodology and assumptions used; —Evaluate whether and if so how the Notice of Lodging of Proposed Agency Information Collection quality, utility, and clarity of the Consent Decree Under the Clean Air Activities; Proposed eCollection information to be collected can be Act eComments Requested; Revision of a enhanced; and Currently Approved Collection—CJIS On October 31, 2017, the Department —Minimize the burden of the collection Name Check Form (1–791) of Justice lodged a proposed consent of information on those who are to AGENCY: Criminal Justice Information respond, including through the use of decree with the United States District Services Division, Federal Bureau of appropriate automated, electronic, Court for the Southern District of Texas Investigation, Department of Justice. mechanical, or other technological in the lawsuit entitled United States and ACTION: 60-Day notice. collection techniques or other forms the Louisiana Department of of information technology, e.g., Environmental Quality v. Exxon Mobil SUMMARY: The Department of Justice permitting electronic submission of Corp. and ExxonMobil Oil Corp., Civil (DOJ), Federal Bureau of Investigation responses. Action No. 4:17-cv-03302. (FBI), Criminal Justice Information The United States and Louisiana Services (CJIS) Division, will be Overview of this information collection: Department of Environmental Quality submitting the following information filed this lawsuit under the Clean Air collection request to the Office of (1) Type of Information Collection: Revision of a currently approved Act and Louisiana Environmental Management and Budget (OMB) for Quality Act. The complaint seeks review and approval in accordance with collection in use without an OMB control number. injunctive relief and civil penalties the Paperwork Reduction Act of 1995. based on violations of the Clean Air (2) The Title of the Form/Collection: The proposed information collection is Act’s New Source Review requirements, CJIS Name Check Request. published to obtain comments from the New Source Performance Standards, (3) The agency form number, if any, public and affected agencies. National Emissions Standards for and the applicable component of the DATES: Comments are encouraged and Hazardous Air Pollutants, ‘‘Title V’’ Department sponsoring the collection: will be accepted for 60 days until 1–791. program requirements and operating January 8, 2018. (4) Affected public who will be asked permits, and related Texas and FOR FURTHER INFORMATION CONTACT: If or required to respond, as well as a brief Louisiana state implementation plan you have additional comments abstract: requirements. The alleged violations especially on the estimated public Primary: Agencies authorized to involve flares used at petrochemical burden or associated response time, submit applicant fingerprints into the manufacturing plants owned and suggestions, or need a copy of the Next Generation Identification (NGI) operated by the defendants, Exxon proposed information collection system for noncriminal justice purposes Mobil Corp. and ExxonMobil Oil Corp., instrument with instructions or such as employment, benefits, and in Baytown and Beaumont, Texas, and additional information, please contact licensing. This form is completed to Baton Rouge, Louisiana. The consent Gerry Lynn Brovey, Supervisory obtain a name check for an applicant decree requires the defendants to Information Liaison Specialist, FBI, when the fingerprints have been perform injunctive relief, pay a CJIS, Resources Management Section, rejected twice for quality to ensure $2,500,000 civil penalty, perform a Administrative Unit, Module C–2, 1000 eligible individuals are not denied Supplemental Environmental Project in Custer Hollow Road, Clarksburg, West employment, benefits, or licensing. Baytown, Texas, and two Beneficial Virginia 26306 (facsimile: 304–625– (5) An estimate of the total number of Environmental Projects in Louisiana. 5093) or email glbrovey@ic.fbi.gov. respondents and the amount of time The publication of this notice opens Written comments and/or suggestions estimated for an average respondent to a period for public comment on the can also be sent to the Office of respond: It is estimated that 77,816 proposed consent decree. Comments Management and Budget, Office of respondents will complete each form should be addressed to the Assistant Information and Regulatory Affairs, within approximately 5 minutes. Attorney General, Environment and Attention Department of Justice Desk (6) An estimate of the total public Natural Resources Division, and should ethrower on DSK3G9T082PROD with NOTICES Officer, Washington, DC 20503. burden (in hours) associated with the refer to United States and the Louisiana Additionally, comments may be collection: There are an estimated 6,485 Department of Environmental Quality v. submitted via email to OIRA_ total annual burden hours associated Exxon Mobil Corp. and ExxonMobil Oil submission@omb.eop.gov. with this collection. Corp., D.J. Ref. No. 90–5–2–1–10128. All SUPPLEMENTARY INFORMATION: Written If additional information is required comments must be submitted no later comments and suggestions from the contact: Melody Braswell, Department than thirty (30) days after the public and affected agencies concerning Clearance Officer, United States publication date of this notice. VerDate Sep<11>2014 17:29 Nov 06, 2017 Jkt 244001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\07NON1.SGM 07NON1


Document Created: 2018-10-25 10:26:10
Document Modified: 2018-10-25 10:26:10
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of application.
DatesRegistered 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 on or before January 8, 2018.
FR Citation82 FR 51642 
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