83_FR_53310 83 FR 53107 - Importer of Controlled Substances Application: Noramco Inc.

83 FR 53107 - Importer of Controlled Substances Application: Noramco Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 203 (October 19, 2018)

Page Range53107-53108
FR Document2018-22832

Federal Register, Volume 83 Issue 203 (Friday, October 19, 2018)
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Notices]
[Pages 53107-53108]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22832]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Noramco Inc.

ACTION: Notice of application.

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

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 on or before November 19, 2018. 
Such persons may also file a written request for a hearing on the 
application on or before November 19, 2018.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
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 hearings 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/DPW, 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 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 July 
4, 2018, Noramco Inc., 1550 Olympic Drive, Athens, Georgia 30601 
applied to be registered as an importer of the following basic classes 
of controlled substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Marihuana Extract..................            7350  I

[[Page 53108]]

 
Marihuana..........................            7360  I
Tetrahydrocannabinols..............            7370  I
Nabilone...........................            7379  II
Phenylacetone......................            8501  II
Thebaine...........................            9333  II
Poppy Straw Concentrate............            9670  II
Tapentadol.........................            9780  II
------------------------------------------------------------------------

    The company plans to import phenylacetone (8501), and poppy straw 
concentrate (9670) to bulk manufacture other controlled substances for 
distribution to its customers. The company plans to import an 
intermediate form of tapentadol (9780) to bulk manufacture tapentadol 
(9780) for distribution to its customers.
    The company plans to import impunities of buprenorphine that have 
been determined by DEA to be captured under drug code (9333) thebaine.
    In reference to drug codes 7360 and 7370, the company plans to 
import a synthetic cannabidiol and a synthetic tetrahydrocannabinol. No 
other activity for these drug codes is authorized for this 
registration. Placement of these drug codes onto the company's 
registration does not translate into automatic approval of subsequent 
permit applications to import controlled substances. 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 non-
approved finished dosage forms for commercial sale.

    Dated: October 10, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-22832 Filed 10-18-18; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                       Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Notices                                                                                       53107

                                                 The DEA has considered the factors in                                   registration as a bulk manufacturer to                                     SUMMARY:   Registrants listed below have
                                              21 U.S.C. 823(a) and determined that                                       the above listed company.                                                  applied for and been granted
                                              the registration of this registrant to                                       Dated: October 10, 2018.                                                 registration by the Drug Enforcement
                                              manufacture the applicable basic classes                                   John J. Martin,                                                            Administration (DEA) as importers of
                                              of controlled substances is consistent                                                                                                                various classes of schedule I or II
                                                                                                                         Assistant Administrator.
                                              with the public interest and with United                                                                                                              controlled substances.
                                                                                                                         [FR Doc. 2018–22829 Filed 10–18–18; 8:45 am]
                                              States obligations under international
                                              treaties, conventions, or protocols in                                     BILLING CODE 4410–09–P                                                     SUPPLEMENTARY INFORMATION:      The
                                              effect on May 1, 1971. The DEA                                                                                                                        companies listed below applied to be
                                              investigated the company’s maintenance                                                                                                                registered as importers of various basic
                                              of effective controls against diversion by                                 DEPARTMENT OF JUSTICE                                                      classes of controlled substances.
                                              inspecting and testing the company’s                                       Drug Enforcement Administration                                            Information on previously published
                                              physical security systems, verifying the                                                                                                              notices are listed in the table below. No
                                              company’s compliance with state and                                        [Docket No. DEA–392]                                                       comments or objections were submitted
                                              local laws, and reviewing the company’s                                                                                                               and no requests for hearings were
                                              background and history.                                                    Importer of Controlled Substances
                                                                                                                                                                                                    submitted for these notices.
                                                 Therefore, pursuant to 21 U.S.C.                                        Registration
                                              823(a), and in accordance with 21 CFR
                                                                                                                         ACTION:       Notice of registration.
                                              1301.33, the DEA has granted a

                                                                                                                           Company                                                                                          FR Docket         Published

                                              Chattem Chemicals, Inc ..........................................................................................................................................           83 FR 39129 ..    August 8,
                                                                                                                                                                                                                                              2018.
                                              Myoderm .................................................................................................................................................................   83 FR 39130 ..    August 8,
                                                                                                                                                                                                                                              2018.
                                              Mylan Pharmaceuticals, Inc ....................................................................................................................................             83 FR 22517 ..    May 15, 2018.
                                              Anderson Brecon, Inc .............................................................................................................................................          83 FR 39128 ..    August 8,
                                                                                                                                                                                                                                              2018.



                                                 The DEA has considered the factors in                                   DEPARTMENT OF JUSTICE                                                      Attn: DEA Federal Register
                                              21 U.S.C. 823, 952(a) and 958(a) and                                                                                                                  Representative/DPW, 8701 Morrissette
                                              determined that the registration of the                                    Drug Enforcement Administration                                            Drive, Springfield, Virginia 22152.
                                              listed registrants to import the                                                                                                                      Comments and requests for hearings on
                                                                                                                         [Docket No. DEA–392]
                                              applicable basic classes of schedule I or                                                                                                             applications to import narcotic raw
                                              II controlled substances is consistent                                     Importer of Controlled Substances                                          material are not appropriate. 72 FR
                                              with the public interest and with United                                   Application: Noramco Inc.                                                  3417, (January 25, 2007).
                                              States obligations under international                                                                                                                SUPPLEMENTARY INFORMATION: The
                                              treaties, conventions, or protocols in                                     ACTION:       Notice of application.                                       Attorney General has delegated his
                                              effect on May 1, 1971. The DEA                                                                                                                        authority under the Controlled
                                              investigated each company’s                                                DATES:  Registered bulk manufacturers of                                   Substances Act to the Administrator of
                                              maintenance of effective controls                                          the affected basic classes, and                                            the Drug Enforcement Administration
                                                                                                                         applicants therefore, may file written                                     (DEA), 28 CFR 0.100(b). Authority to
                                              against diversion by inspecting and
                                                                                                                         comments on or objections to the                                           exercise all necessary functions with
                                              testing each company’s physical
                                                                                                                         issuance of the proposed registration on                                   respect to the promulgation and
                                              security systems, verifying each                                           or before November 19, 2018. Such
                                              company’s compliance with state and                                                                                                                   implementation of 21 CFR part 1301,
                                                                                                                         persons may also file a written request                                    incident to the registration of
                                              local laws, and reviewing each                                             for a hearing on the application on or                                     manufacturers, distributors, dispensers,
                                              company’s background and history.                                          before November 19, 2018.                                                  importers, and exporters of controlled
                                                 Therefore, pursuant to 21 U.S.C.                                        ADDRESSES: Written comments should                                         substances (other than final orders in
                                              952(a) and 958(a), and in accordance                                       be sent to: Drug Enforcement                                               connection with suspension, denial, or
                                              with 21 CFR 1301.34, the DEA has                                           Administration, Attention: DEA Federal                                     revocation of registration) has been
                                              granted a registration as an importer for                                  Register Representative/DPW, 8701                                          redelegated to the Assistant
                                              schedule I or II controlled substances to                                  Morrissette Drive, Springfield, Virginia                                   Administrator of the DEA Diversion
                                              the above listed companies.                                                22152. All requests for hearing must be                                    Control Division (‘‘Assistant
                                                Dated: October 10, 2018.                                                 sent to: Drug Enforcement                                                  Administrator’’) pursuant to section 7 of
                                                                                                                         Administration, Attn: Administrator,                                       28 CFR part 0, appendix to subpart R.
                                              John J. Martin,
                                                                                                                         8701 Morrissette Drive, Springfield,                                         In accordance with 21 CFR
                                              Assistant Administrator.                                                   Virginia 22152. All requests for hearings                                  1301.34(a), this is notice that on July 4,
                                              [FR Doc. 2018–22830 Filed 10–18–18; 8:45 am]                               should also be sent to: (1) Drug                                           2018, Noramco Inc., 1550 Olympic
                                              BILLING CODE 4410–09–P                                                     Enforcement Administration, Attn:                                          Drive, Athens, Georgia 30601 applied to
amozie on DSK3GDR082PROD with NOTICES1




                                                                                                                         Hearing Clerk/LJ, 8701 Morrissette                                         be registered as an importer of the
                                                                                                                         Drive, Springfield, Virginia 22152; and                                    following basic classes of controlled
                                                                                                                         (2) Drug Enforcement Administration,                                       substances:

                                                                                                                      Controlled substance                                                                                      Drug code         Schedule

                                              Marihuana Extract ...........................................................................................................................................................                7350   I



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                                              53108                                    Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Notices

                                                                                                                       Controlled substance                                                                                          Drug code    Schedule

                                              Marihuana ........................................................................................................................................................................           7360   I
                                              Tetrahydrocannabinols ....................................................................................................................................................                   7370   I
                                              Nabilone ...........................................................................................................................................................................         7379   II
                                              Phenylacetone .................................................................................................................................................................              8501   II
                                              Thebaine ..........................................................................................................................................................................          9333   II
                                              Poppy Straw Concentrate ...............................................................................................................................................                      9670   II
                                              Tapentadol .......................................................................................................................................................................           9780   II



                                                 The company plans to import                                              DEPARTMENT OF JUSTICE                                                        Representative/DPW, 8701 Morrissette
                                              phenylacetone (8501), and poppy straw                                                                                                                    Drive, Springfield, Virginia 22152.
                                              concentrate (9670) to bulk manufacture                                      Drug Enforcement Administration
                                              other controlled substances for                                                                                                                          SUPPLEMENTARY INFORMATION:      The
                                                                                                                          [Docket No. DEA–392]                                                         Attorney General has delegated his
                                              distribution to its customers. The
                                              company plans to import an                                                                                                                               authority under the Controlled
                                                                                                                          Importer of Controlled Substances                                            Substances Act to the Administrator of
                                              intermediate form of tapentadol (9780)                                      Application: Fisher Clinical Services,
                                              to bulk manufacture tapentadol (9780)                                                                                                                    the Drug Enforcement Administration
                                                                                                                          Inc.
                                              for distribution to its customers.                                                                                                                       (DEA), 28 CFR 0.100(b). Authority to
                                                 The company plans to import                                              ACTION:        Notice of application.                                        exercise all necessary functions with
                                              impunities of buprenorphine that have                                                                                                                    respect to the promulgation and
                                              been determined by DEA to be captured                                       DATES:  Registered bulk manufacturers of                                     implementation of 21 CFR part 1301,
                                              under drug code (9333) thebaine.                                            the affected basic classes, and                                              incident to the registration of
                                                 In reference to drug codes 7360 and                                      applicants therefore, may file written                                       manufacturers, distributors, dispensers,
                                              7370, the company plans to import a                                         comments on or objections to the                                             importers, and exporters of controlled
                                              synthetic cannabidiol and a synthetic                                       issuance of the proposed registration on                                     substances (other than final orders in
                                              tetrahydrocannabinol. No other activity                                     or before November 19, 2018. Such                                            connection with suspension, denial, or
                                              for these drug codes is authorized for                                      persons may also file a written request                                      revocation of registration) has been
                                              this registration. Placement of these                                       for a hearing on the application on or                                       redelegated to the Assistant
                                              drug codes onto the company’s                                               before November 19, 2018.                                                    Administrator of the DEA Diversion
                                              registration does not translate into
                                                                                                                          ADDRESSES: Written comments should                                           Control Division (‘‘Assistant
                                              automatic approval of subsequent
                                              permit applications to import controlled                                    be sent to: Drug Enforcement                                                 Administrator’’) pursuant to section 7 of
                                              substances. Approval of permit                                              Administration, Attention: DEA Federal                                       28 CFR part 0, appendix to subpart R.
                                              applications will occur only when the                                       Register Representative/DPW, 8701                                              In accordance with 21 CFR
                                              registrant’s business activity is                                           Morrissette Drive, Springfield, Virginia
                                                                                                                                                                                                       1301.34(a), this is notice that on June 4,
                                              consistent with what is authorized                                          22152. All requests for hearing must be
                                                                                                                                                                                                       2018, Fisher Clinical Services, Inc.,
                                              under 21 U.S.C. 952(a)(2). Authorization                                    sent to: Drug Enforcement
                                                                                                                                                                                                       7554 Schantz Road, Allentown,
                                              will not extend to the import of FDA                                        Administration, Attn: Administrator,
                                                                                                                          8701 Morrissette Drive, Springfield,                                         Pennsylvania 18106 applied to be
                                              approved or non-approved finished                                                                                                                        registered as an importer of the
                                              dosage forms for commercial sale.                                           Virginia 22152. All requests for hearing
                                                                                                                          should also be sent to: (1) Drug                                             following basic class of controlled
                                                Dated: October 10, 2018.                                                  Enforcement Administration, Attn:                                            substance:
                                              John J. Martin,                                                             Hearing Clerk/OALJ, 8701 Morrissette
                                              Assistant Administrator.                                                    Drive, Springfield, Virginia 22152; and
                                              [FR Doc. 2018–22832 Filed 10–18–18; 8:45 am]                                (2) Drug Enforcement Administration,
                                              BILLING CODE 4410–09–P                                                      Attn: DEA Federal Register

                                                                                                                       Controlled substance                                                                                          Drug code    Schedule

                                              Psilocybin .........................................................................................................................................................................         7437   I



                                                 The company plans to import the                                          DEPARTMENT OF JUSTICE                                                        SUMMARY:   The Department of Justice
                                              listed controlled substance for clinical                                                                                                                 (DOJ), Office of Justice Programs,
                                                                                                                          [OMB Number 1121–0184]
                                              trials.                                                                                                                                                  Bureau of Justice Statistics, will be
                                                                                                                          Agency Information Collection                                                submitting the following information
                                                Dated: October 10, 2018.
                                                                                                                          Activities; Proposed eCollection                                             collection request to the Office of
                                              John J. Martin,                                                                                                                                          Management and Budget (OMB) for
                                                                                                                          eComments Requested; Revision of a
                                              Assistant Administrator.                                                                                                                                 review and approval in accordance with
                                                                                                                          Currently Approved Collection;
                                              [FR Doc. 2018–22828 Filed 10–18–18; 8:45 am]
                                                                                                                          Comments Requested: 2019 School                                              the Paperwork Reduction Act of 1995.
amozie on DSK3GDR082PROD with NOTICES1




                                              BILLING CODE 4410–09–P                                                      Crime Supplement (SCS) to the                                                DATES: Comments are encouraged and
                                                                                                                          National Crime Victimization Survey                                          will be accepted for 30 days until
                                                                                                                          (NCVS)                                                                       November 19, 2018.
                                                                                                                          AGENCY:  Bureau of Justice Statistics,                                       FOR FURTHER INFORMATION CONTACT: If
                                                                                                                          Department of Justice.                                                       you have additional comments
                                                                                                                                                                                                       especially on the estimated public
                                                                                                                          ACTION: 30-Day notice.
                                                                                                                                                                                                       burden or associated response time,


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Document Created: 2018-10-19 01:25:27
Document Modified: 2018-10-19 01:25:27
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 on or before November 19, 2018. Such persons may also file a written request for a hearing on the application on or before November 19, 2018.
FR Citation83 FR 53107 

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