81_FR_47094 81 FR 46956 - Importer of Controlled Substances Application: Rhodes Technologies

81 FR 46956 - Importer of Controlled Substances Application: Rhodes Technologies

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 138 (July 19, 2016)

Page Range46956-46957
FR Document2016-17062

Federal Register, Volume 81 Issue 138 (Tuesday, July 19, 2016)
[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Notices]
[Pages 46956-46957]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-17062]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Rhodes 
Technologies

ACTION: Notice of application.

-----------------------------------------------------------------------

DATES: Registered bulk manufacturers of the affected basic classes, and

[[Page 46957]]

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 August 18, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before August 18, 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. 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 March 
25, 2016, Rhodes Technologies, 498 Washington Street, Coventry, Rhode 
Island 02816 applied to be registered as an importer of the following 
basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Tetrahydrocannabinols (7370)...............  I
Methylphenidate (1724).....................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Hydrocodone (9193).........................  II
Morphine (9300)............................  II
Oxymorphone (9652).........................  II
Opium, raw (9600)..........................  II
Poppy Straw Concentrate (9670).............  II
------------------------------------------------------------------------

    The company plans to import opium, raw (9600) and poppy straw 
concentrate (9670) in order to bulk manufacture controlled substances 
in Active Pharmaceutical Ingredient (API) form. The company distributes 
the manufactured APIs in bulk to its customers. The company plans to 
import the other listed controlled substances for internal reference 
standards use only. The comparisons of foreign reference standards to 
the company's domestically manufacture API will allow the company to 
export domestically manufacture API to foreign markets.

Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-17062 Filed 7-18-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                  46956                           Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices

                                                  INTERNATIONAL TRADE                                      Delmex de Juarez S. de R.L. de C.V. of                the Drug Enforcement Administration
                                                  COMMISSION                                               Parque Industrial Intermex, Cd. Juarez,               (DEA), 28 CFR 0.100(b). Authority to
                                                                                                           Chihuahua, Mexico. Id. The Office of                  exercise all necessary functions with
                                                  [Investigation No. 337–TA–964]
                                                                                                           Unfair Import Investigations is not                   respect to the promulgation and
                                                  Certain Windscreen Wipers and                            participating in the investigation.                   implementation of 21 CFR part 1301,
                                                  Components Thereof; Notice of a                             On May 27, 2016, complainant and                   incident to the registration of
                                                  Commission Determination Not To                          respondents filed a joint motion to                   manufacturers, distributors, dispensers,
                                                  Review an Initial Determination                          terminate this investigation in its                   importers, and exporters of controlled
                                                  Granting a Joint Motion To Terminate                     entirety based on a settlement                        substances (other than final orders in
                                                  the Investigation Based on a                             agreement.                                            connection with suspension, denial, or
                                                  Settlement Agreement                                        On June 20, 2016, the ALJ issued an                revocation of registration) has been
                                                                                                           ID (Order No. 29), granting the motion                redelegated to the Deputy Assistant
                                                  AGENCY: U.S. International Trade                         for termination. The ALJ found that the               Administrator of the DEA Office of
                                                  Commission.                                              joint motion complies with the                        Diversion Control (‘‘Deputy Assistant
                                                  ACTION: Notice.                                          Commission Rules and that termination                 Administrator’’) pursuant to section 7 of
                                                                                                           of the investigation will not adversely               28 CFR part 0, appendix to subpart R.
                                                  SUMMARY:   Notice is hereby given that                   affect the public interest. No party                    In accordance with 21 CFR
                                                  the U.S. International Trade                             petitioned for review of the subject ID.              1301.33(a), this is notice that on May 5,
                                                  Commission has determined not to                         The Commission has determined not to                  2016, Cambrex Charles City, 1205 11th
                                                  review an initial determination (‘‘ID’’)                 review the ID.                                        Street, Charles City, Iowa 50616 applied
                                                  (Order No. 29) issued by the presiding                      The authority for the Commission’s                 to be registered as a bulk manufacturer
                                                  administrative law judge (‘‘ALJ’’)                       determination is contained in section                 the following basic classes of controlled
                                                  granting a joint motion to terminate the                 337 of the Tariff Act of 1930, as                     substances:
                                                  investigation based on a settlement                      amended (19 U.S.C. 1337), and in Part
                                                  agreement.                                               210 of the Commission’s Rules of                              Controlled Substance                   Schedule
                                                  FOR FURTHER INFORMATION CONTACT:                         Practice and Procedure (19 CFR part
                                                                                                                                                                 Amphetamine (1100) ....................               II
                                                  Michael Liberman, Esq., Office of the                    210).                                                 Lisdexamfetamine (1205) .............                 II
                                                  General Counsel, U.S. International                        By Order of the Commission.                         Methylphenidate (1724) ................               II
                                                  Trade Commission, 500 E Street SW.,                        Issued: July 13, 2016.                              4-Anilino-N-phenethyl-4-piperidine
                                                  Washington, DC 20436, telephone (202)                                                                            (ANPP) (8333) ..........................            II
                                                                                                           William R. Bishop,
                                                  205–3115. Copies of non-confidential                                                                           Phenylacetone (8501) ..................               II
                                                                                                           Supervisory Hearings and Information                  Cocaine (9041) .............................          II
                                                  documents filed in connection with this
                                                                                                           Officer.                                              Codeine (9050) .............................          II
                                                  investigation are or will be available for
                                                                                                           [FR Doc. 2016–17011 Filed 7–18–16; 8:45 am]           Oxycodone (9143) ........................             II
                                                  inspection during official business                                                                            Hydromorphone (9150) ................                 II
                                                                                                           BILLING CODE 7020–02–P
                                                  hours (8:45 a.m. to 5:15 p.m.) in the                                                                          Hydrocodone (9193) .....................              II
                                                  Office of the Secretary, U.S.                                                                                  Morphine (9300) ...........................           II
                                                  International Trade Commission, 500 E                                                                          Oripavine (9330) ...........................          II
                                                  Street SW., Washington, DC 20436,                        DEPARTMENT OF JUSTICE                                 Thebaine (9333) ...........................           II
                                                  telephone (202) 205–2000. General                                                                              Opium extracts (9610) ..................              II
                                                  information concerning the Commission                    Drug Enforcement Administration                       Opium fluid extract (9620) ............               II
                                                                                                                                                                 Opium tincture (9630) ...................             II
                                                  may also be obtained by accessing its                    [Docket No. DEA–392]                                  Opium, powdered (9639) ..............                 II
                                                  Internet server at http://www.usitc.gov.                                                                       Oxymorphone (9652) ....................               II
                                                  The public record for this investigation                 Bulk Manufacturer of Controlled                       Noroxymorphone (9668) ...............                 II
                                                  may be viewed on the Commission’s                        Substances Application: Cambrex                       Fentanyl (9801) ............................          II
                                                  electronic docket (EDIS) at http://                      Charles City
                                                  edis.usitc.gov. Hearing-impaired                                                                                 The company plans to manufacture
                                                  persons are advised that information on                  ACTION:   Notice of application.                      the listed controlled substances in bulk
                                                  this matter can be obtained by                                                                                 for sale to its customers, for dosage form
                                                  contacting the Commission’s TDD                          DATES:  Registered bulk manufacturers of              development, for clinical trials, and for
                                                  terminal on (202) 205–1810.                              the affected basic classes, and                       use in stability qualification studies.
                                                  SUPPLEMENTARY INFORMATION: The
                                                                                                           applicants therefore, may file written
                                                                                                           comments on or objections to the                      Louis J. Milione,
                                                  Commission instituted this investigation                                                                       Deputy Assistant Administrator.
                                                  under section 337 of the Tariff Act of                   issuance of the proposed registration in
                                                  1930, 19 U.S.C. 1337, on August 24,                      accordance with 21 CFR 1301.33(a) on                  [FR Doc. 2016–17061 Filed 7–18–16; 8:45 am]

                                                  2015, based on a complaint, as                           or before September 19, 2016.                         BILLING CODE 4410–09–P

                                                  supplemented, filed by Trico Products                    ADDRESSES: Written comments should
                                                  Corporation of Rochester Hills,                          be sent to: Drug Enforcement
                                                                                                           Administration, Attention: DEA Federal                DEPARTMENT OF JUSTICE
                                                  Michigan, alleging a violation of section
                                                  337 based upon the importation into the                  Register Representative/ODW, 8701                     Drug Enforcement Administration
                                                  United States, the sale for importation,                 Morrissette Drive, Springfield, Virginia
                                                  and the sale within the United States                    22152. Comments and requests for                      [Docket No. DEA–392]
mstockstill on DSK3G9T082PROD with NOTICES




                                                  after importation of certain windscreen                  hearings on applications to import raw
                                                                                                           material are not appropriate. 72 FR 3417              Importer of Controlled Substances
                                                  wipers and components thereof by                                                                               Application: Rhodes Technologies
                                                  reason of infringement of certain claims                 (January 25, 2007).
                                                  of U.S. Patent Nos. 6,836,925 and                        SUPPLEMENTARY INFORMATION:                            ACTION:    Notice of application.
                                                  6,799,348. 80 FR 51309 (Aug. 24, 2015).                     The Attorney General has delegated
                                                  The respondents are Valeo North                          her authority under the Controlled                    DATES:  Registered bulk manufacturers of
                                                  America, Inc. of Troy, Michigan, and                     Substances Act to the Administrator of                the affected basic classes, and


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                                                                                     Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices                                                46957

                                                  applicants therefore, may file written                            Controlled substance               Schedule    per day). (Please note: There were 365
                                                  comments on or objections to the                                                                                 days in FY 2015.) The average annual
                                                  issuance of the proposed registration in                   Poppy Straw Concentrate (9670)            II          cost to confine an inmate in a
                                                  accordance with 21 CFR 1301.34(a) on                                                                             Residential Re-entry Center for Fiscal
                                                  or before August 18, 2016. Such persons                      The company plans to import opium,                  Year 2015 was $26,082.90 ($71.46 per
                                                  may also file a written request for a                      raw (9600) and poppy straw concentrate                day).
                                                  hearing on the application pursuant to                     (9670) in order to bulk manufacture
                                                                                                             controlled substances in Active                       Kathleen M. Kenney,
                                                  21 CFR 1301.43 on or before August 18,
                                                  2016.                                                      Pharmaceutical Ingredient (API) form.                 Assistant Director/General Counsel, Federal
                                                                                                             The company distributes the                           Bureau of Prisons.
                                                  ADDRESSES: Written comments should
                                                  be sent to: Drug Enforcement                               manufactured APIs in bulk to its                      [FR Doc. 2016–17040 Filed 7–18–16; 8:45 am]
                                                  Administration, Attention: DEA Federal                     customers. The company plans to                       BILLING CODE 4410–05–P
                                                  Register Representative/ODW, 8701                          import the other listed controlled
                                                  Morrissette Drive, Springfield, Virginia                   substances for internal reference
                                                  22152. All requests for hearing must be                    standards use only. The comparisons of
                                                  sent to: Drug Enforcement                                  foreign reference standards to the                    NATIONAL ARCHIVES AND RECORDS
                                                  Administration, Attn: Administrator,                       company’s domestically manufacture                    ADMINISTRATION
                                                  8701 Morrissette Drive, Springfield,                       API will allow the company to export
                                                  Virginia 22152. All requests for hearing                   domestically manufacture API to foreign               [NARA–2016–041]
                                                  should also be sent to: (1) Drug                           markets.
                                                  Enforcement Administration, Attn:                          Louis J. Milione,                                     Privacy Act of 1974, as Amended;
                                                  Hearing Clerk/LJ, 8701 Morrissette                         Deputy Assistant Administrator.                       System of Records Notice
                                                  Drive, Springfield, Virginia 22152; and                    [FR Doc. 2016–17062 Filed 7–18–16; 8:45 am]
                                                  (2) Drug Enforcement Administration,                                                                             AGENCY:National Archives and Records
                                                                                                             BILLING CODE 4410–09–P
                                                  Attn: DEA Federal Register                                                                                       Administration (NARA).
                                                  Representative/ODW, 8701 Morrissette                                                                             ACTION: Privacy Act system of records
                                                  Drive, Springfield, Virginia 22152.                        DEPARTMENT OF JUSTICE                                 notice (SORN) of a new system, NARA
                                                  Comments and requests for hearings on                                                                            45; Withdrawal.
                                                  applications to import narcotic raw                        Bureau of Prisons
                                                  material are not appropriate. 72 FR
                                                                                                                                                                   SUMMARY:    The National Archives and
                                                  3417, (January 25, 2007).                                  Annual Determination of Average Cost
                                                                                                                                                                   Records Administration (NARA)
                                                  SUPPLEMENTARY INFORMATION: The                             of Incarceration
                                                                                                                                                                   published notice in the Federal Register
                                                  Attorney General has delegated her                         AGENCY:   Bureau of Prisons, Justice.                 on June 8, 2016 (81 FR 36959) of a
                                                  authority under the Controlled                             ACTION:   Notice.                                     proposed new system of records subject
                                                  Substances Act to the Administrator of                                                                           to the Privacy Act of 1974, as amended
                                                  the Drug Enforcement Administration                        SUMMARY:   The fee to cover the average               (5 U.S.C. 552(a)) (‘‘Privacy Act’’). The
                                                  (DEA), 28 CFR 0.100(b). Authority to                       cost of incarceration for Federal inmates             new system was NARA 45, Insider
                                                  exercise all necessary functions with                      in Fiscal Year 2015 was $31,977.65                    Threat Program records. In addition,
                                                  respect to the promulgation and                            ($87.61 per day). (Please note: There                 NARA updated Appendix B to add the
                                                  implementation of 21 CFR part 1301,                        were 365 days in FY 2015.) The average                SORN’s system manager to the list of
                                                  incident to the registration of                            annual cost to confine an inmate in a                 system managers and their addresses.
                                                  manufacturers, distributors, dispensers,                   Residential Re-entry Center for Fiscal                The system of records notice (SORN)
                                                  importers, and exporters of controlled                     Year 2015 was $26,082.90 ($71.46 per                  included a comment period ending on
                                                  substances (other than final orders in                     day).                                                 July 8, 2016, and an automatic effective
                                                  connection with suspension, denial, or                                                                           date of July 18, 2016. However, NARA
                                                                                                             DATES: Effective Date: July 19, 2016.
                                                  revocation of registration) has been                                                                             is now withdrawing this SORN due to
                                                                                                             ADDRESSES: Office of General Counsel,
                                                  redelegated to the Deputy Assistant                                                                              changes in the scope of the system and
                                                  Administrator of the DEA Office of                         Federal Bureau of Prisons, 320 First St.
                                                                                                             NW., Washington, DC 20534.                            it will no longer be effective. We will
                                                  Diversion Control (‘‘Deputy Assistant                                                                            reissue the SORN once we have revised
                                                  Administrator’’) pursuant to section 7 of                  FOR FURTHER INFORMATION CONTACT:
                                                                                                             Sarah Qureshi, (202) 307–2105.                        it.
                                                  28 CFR part 0, appendix to subpart R.
                                                     In accordance with 21 CFR                               SUPPLEMENTARY INFORMATION: 28 CFR                     DATES:  This withdrawal notice is
                                                  1301.34(a), this is notice that on March                   part 505 allows for assessment and                    effective July 18, 2016.
                                                  25, 2016, Rhodes Technologies, 498                         collection of a fee to cover the average
                                                                                                                                                                   ADDRESSES: National Archives and
                                                  Washington Street, Coventry, Rhode                         cost of incarceration for Federal
                                                                                                                                                                   Records Administration; Regulations
                                                  Island 02816 applied to be registered as                   inmates. We calculate this fee by
                                                                                                                                                                   Comment Desk, Suite 4100; 8601
                                                  an importer of the following basic                         dividing the number representing
                                                                                                                                                                   Adelphi Road; College Park, MD 20740.
                                                  classes of controlled substances:                          Bureau of Prisons facilities’ monetary
                                                                                                             obligation (excluding activation costs)               FOR FURTHER INFORMATION CONTACT:
                                                          Controlled substance                  Schedule     by the number of inmate-days incurred                 Kimberly Keravuori, External Policy
                                                                                                             for the preceding fiscal year, and then               Program Manager, by email at
mstockstill on DSK3G9T082PROD with NOTICES




                                                  Tetrahydrocannabinols (7370) .....            I            by multiplying the quotient by 365.                   regulation_comments@nara.gov, or by
                                                  Methylphenidate (1724) ................       II           Under § 505.2, the Director of the                    telephone at 301–837–3151.
                                                  Oxycodone (9143) ........................     II
                                                  Hydromorphone (9150) ................         II
                                                                                                             Bureau of Prisons determined that,
                                                                                                                                                                   Kimberly Keravuori,
                                                  Hydrocodone (9193) .....................      II           based upon fiscal year 2015 data, the fee
                                                                                                             to cover the average cost of                          External Policy Program Manager.
                                                  Morphine (9300) ...........................   II
                                                  Oxymorphone (9652) ...................        II           incarceration for Federal inmates in                  [FR Doc. 2016–17146 Filed 7–18–16; 8:45 am]
                                                  Opium, raw (9600) .......................     II           Fiscal Year 2015 was $31,977.65 ($87.61               BILLING CODE 7515–01–P




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Document Created: 2016-07-19 01:10:52
Document Modified: 2016-07-19 01:10:52
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 21 CFR 1301.34(a) on or before August 18, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before August 18, 2016.
FR Citation81 FR 46956 

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