82_FR_41221 82 FR 41055 - Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.

82 FR 41055 - Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 166 (August 29, 2017)

Page Range41055-41056
FR Document2017-18315

Federal Register, Volume 82 Issue 166 (Tuesday, August 29, 2017)
[Federal Register Volume 82, Number 166 (Tuesday, August 29, 2017)]
[Notices]
[Pages 41055-41056]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-18315]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer 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 in accordance with 21 CFR 
1301.33(a) on or before October 30, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DRW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

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 July 
6, 2017, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 
19801-4417 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
                                           Drug
          Controlled substance             code          Schedule
------------------------------------------------------------------------
Marihuana..............................     7360  I
Tetrahydrocannabinols..................     7370  I
Codeine-N-oxide........................     9053  I
Dihydromorphine........................     9145  I
Hydromorphinol.........................     9301  I

[[Page 41056]]

 
Morphine-N-oxide.......................     9307  I
Amphetamine............................     1100  II
Methylphenidate........................     1724  II
Nabilone...............................     7379  II
Phenylacetone..........................     8501  II
Codeine................................     9050  II
Dihydrocodeine.........................     9120  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
Opium, granulated......................     9640  II
Oxymorphone............................     9652  II
Noroxymorphone.........................     9668  II
Tapentadol.............................     9780  II
------------------------------------------------------------------------

    The company plans to manufacture the above-listed controlled 
substances in bulk for distribution to its customers. In reference to 
drug code 7360, the company plans to manufacture a synthetic version of 
cannabidiol in bulk for sale to its customers, who are final dosage 
form manufacturers. No other activity for this drug code is authorized 
for this registration.

    Dated: August 21, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-18315 Filed 8-28-17; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                       Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices                                                                                       41055

                                                respect to the promulgation and                                            DEPARTMENT OF JUSTICE                                                      (2) Drug Enforcement Administration,
                                                implementation of 21 CFR part 1301,                                                                                                                   Attn: DEA Federal Register
                                                incident to the registration of                                            Drug Enforcement Administration                                            Representative/DRW, 8701 Morrissette
                                                manufacturers, distributors, dispensers,                                                                                                              Drive, Springfield, Virginia 22152.
                                                                                                                           [Docket No. DEA–392]
                                                importers, and exporters of controlled                                                                                                                Comments and request for hearing on
                                                substances (other than final orders in                                     Importer of Controlled Substances                                          applications to import narcotic raw
                                                connection with suspension, denial, or                                     Application: Cambrex Charles City                                          material are not appropriate. 72 FR 3417
                                                revocation of registration) has been                                                                                                                  (January 25, 2007).
                                                redelegated to the Assistant                                               ACTION:       Notice of application.                                       SUPPLEMENTARY INFORMATION: The
                                                Administrator of the DEA Diversion                                                                                                                    Attorney General has delegated his
                                                Control Division (‘‘Assistant                                              DATES:  Registered bulk manufacturers of                                   authority under the Controlled
                                                Administrator’’) pursuant to section 7 of                                  the affected basic classes, and                                            Substances Act to the Administrator of
                                                                                                                           applicants therefore, may file written                                     the Drug Enforcement Administration
                                                28 CFR part 0, appendix to subpart R.
                                                                                                                           comments on or objections to the                                           (DEA), 28 CFR 0.100(b). Authority to
                                                   In accordance with 21 CFR                                               issuance of the proposed registration in                                   exercise all necessary functions with
                                                1301.34(a), this is notice that on January                                 accordance with 21 CFR 1301.34(a) on                                       respect to the promulgation and
                                                18, 2017, Stepan Company, Natural                                          or before September 28, 2017. Such                                         implementation of 21 CFR part 1301,
                                                Products Dept., 100 W. Hunter Avenue,                                      persons may also file a written request                                    incident to the registration of
                                                Maywood, New Jersey 07607 applied to                                       for a hearing on the application                                           manufacturers, distributors, dispensers,
                                                be registered as an importer of coca                                       pursuant to 21 CFR 1301.43 on or before                                    importers, and exporters of controlled
                                                leaves (9040), a basic class of controlled                                 September 28, 2017.                                                        substances (other than final orders in
                                                substance listed in schedule II.                                           ADDRESSES: Written comments should                                         connection with suspension, denial, or
                                                   The company plans to import the                                         be sent to: Drug Enforcement                                               revocation of registration) has been
                                                listed controlled substance in bulk for                                    Administration, Attention: DEA Federal                                     redelegated to the Assistant
                                                the manufacture of controlled substance                                    Register Representative/DRW, 8701                                          Administrator of the DEA Office of
                                                for distribution to its customers.                                         Morrissette Drive, Springfield, Virginia                                   Diversion Control (‘‘Assistant
                                                                                                                           22152. All requests for hearing must be                                    Administrator’’) pursuant to section 7 of
                                                  Dated: August 21, 2017.                                                  sent to: Drug Enforcement                                                  28 CFR part 0, appendix to subpart R.
                                                Demetra Ashley,                                                            Administration, Attn: Administrator,                                          In accordance with 21 CFR
                                                Acting Assistant Administrator.                                            8701 Morrissette Drive, Springfield,                                       1301.34(a), this is notice that on June
                                                [FR Doc. 2017–18313 Filed 8–28–17; 8:45 am]                                Virginia 22152. All requests for hearing                                   12, 2017, Cambrex Charles City, 1205
                                                BILLING CODE 4410–09–P
                                                                                                                           should also be sent to: (1) Drug                                           11th Street, Charles City, Iowa 50616
                                                                                                                           Enforcement Administration, Attn:                                          applied to be registered as an importer
                                                                                                                           Hearing Clerk/LJ, 8701 Morrissette                                         of the following basic classes of
                                                                                                                           Drive, Springfield, Virginia 22152; and                                    controlled substances:

                                                                                                                        Controlled substance                                                                                        Drug code    Schedule

                                                4-Anilino-N-phenethyl-4-piperidine (ANPP) .....................................................................................................................                           8333   II
                                                Phenylacetone .................................................................................................................................................................           8501   II
                                                Coca Leaves ....................................................................................................................................................................          9040   II
                                                Opium, raw ......................................................................................................................................................................         9600   II
                                                Poppy Straw Concentrate ...............................................................................................................................................                   9670   II



                                                   The company plans to import the                                         applicants therefore, may file written                                     substances (other than final orders in
                                                listed controlled substances for internal                                  comments on or objections to the                                           connection with suspension, denial, or
                                                use, and to manufacture bulk                                               issuance of the proposed registration in                                   revocation of registration) has been
                                                intermediates for sale to its customers.                                   accordance with 21 CFR 1301.33(a) on                                       redelegated to the Assistant
                                                  Dated: August 21, 2017.                                                  or before October 30, 2017.                                                Administrator of the DEA Diversion
                                                Demetra Ashley,                                                            ADDRESSES: Written comments should                                         Control Division (‘‘Assistant
                                                                                                                           be sent to: Drug Enforcement                                               Administrator’’) pursuant to section 7 of
                                                Acting Assistant Administrator.
                                                                                                                           Administration, Attention: DEA Federal                                     28 CFR part 0, appendix to subpart R.
                                                [FR Doc. 2017–18314 Filed 8–28–17; 8:45 am]
                                                                                                                           Register Representative/DRW, 8701                                            In accordance with 21 CFR
                                                BILLING CODE 4410–09–P
                                                                                                                           Morrissette Drive, Springfield, Virginia                                   1301.33(a), this is notice that on July 6,
                                                                                                                           22152.                                                                     2017, Noramco, Inc., 500 Swedes
                                                DEPARTMENT OF JUSTICE                                                      SUPPLEMENTARY INFORMATION: The                                             Landing Road, Wilmington, Delaware
                                                                                                                           Attorney General has delegated his                                         19801–4417 applied to be registered as
                                                Drug Enforcement Administration                                            authority under the Controlled                                             a bulk manufacturer of the following
                                                                                                                           Substances Act to the Administrator of                                     basic classes of controlled substances:
                                                [Docket No. DEA–392]
                                                                                                                           the Drug Enforcement Administration
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                                                                                                                           (DEA), 28 CFR 0.100(b). Authority to                                                  Controlled              Drug
                                                Bulk Manufacturer of Controlled                                                                                                                                                                  Schedule
                                                                                                                                                                                                                 substance               code
                                                Substances Application: Noramco, Inc.                                      exercise all necessary functions with
                                                                                                                           respect to the promulgation and                                             Marihuana .....................    7360   I
                                                ACTION:      Notice of application.                                        implementation of 21 CFR part 1301,                                         Tetrahydrocannabinols              7370   I
                                                                                                                           incident to the registration of                                             Codeine-N-oxide ...........        9053   I
                                                DATES:  Registered bulk manufacturers of                                   manufacturers, distributors, dispensers,                                    Dihydromorphine ..........         9145   I
                                                the affected basic classes, and                                            importers, and exporters of controlled                                      Hydromorphinol ............        9301   I



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                                                41056                              Federal Register / Vol. 82, No. 166 / Tuesday, August 29, 2017 / Notices

                                                         Controlled                 Drug                     DATES:  Comments are encouraged and                   list of persons who have indicated their
                                                                                               Schedule
                                                         substance                  code                     will be accepted for additional days                  availability to represent aliens on a pro
                                                                                                             until September 28, 2017.                             bono basis. Abstract: EOIR seeks to
                                                Morphine-N-oxide .........           9307     I                                                                    replace the current paper version of the
                                                                                                             FOR FURTHER INFORMATION CONTACT: If
                                                Amphetamine ...............          1100     II                                                                   EOIR Forms-56, with an electronic
                                                Methylphenidate ...........          1724     II             you have comments especially on the
                                                Nabilone .......................     7379     II             estimated public burden or associated                 system to make an initial application
                                                Phenylacetone ..............         8501     II             response time, suggestions, or need a                 and apply for continued participation in
                                                Codeine ........................     9050     II             copy of the proposed information                      the List. Form EOIR–56 will be
                                                Dihydrocodeine .............         9120     II             collection instrument with instructions               mandatory, and is intended to elicit, in
                                                Oxycodone ...................        9143     II             or additional information, please                     a uniform manner, all of the required
                                                Hydromorphone ............           9150     II             contact Jean King, General Counsel,                   information for EOIR to determine
                                                Hydrocodone ................         9193     II             USDOJ–EOIR–OGC, Suite 2600, 5107                      whether an applicant meets the
                                                Morphine .......................     9300     II                                                                   eligibility requirements for inclusion on
                                                                                                             Leesburg Pike, Falls Church, Virginia,
                                                Oripavine ......................     9330     II                                                                   the List.
                                                Thebaine .......................     9333     II             20530; telephone: (703) 305–0470.
                                                                                                             Written comments and/or suggestions                      5 An estimate of the total number of
                                                Opium extracts .............         9610     II
                                                Opium fluid extract .......          9620     II             can also be sent to the Office of                     respondents and the amount of time
                                                Opium tincture ..............        9630     II             Management and Budget, Office of                      estimated for an average respondent to
                                                Opium, powdered .........            9639     II             Information and Regulatory Affairs,                   respond: It is estimated that 161
                                                Opium, granulated ........           9640     II             Attention Department of Justice Desk                  respondents will complete each form
                                                Oxymorphone ...............          9652     II             Officer, Washington, DC 20503 or sent                 within approximately 30 minutes.
                                                Noroxymorphone ..........            9668     II             to OIRA_submissions@omb.eop.gov.                         6 An estimate of the total public
                                                Tapentadol ....................      9780     II                                                                   burden (in hours) associated with the
                                                                                                             SUPPLEMENTARY INFORMATION: Written
                                                                                                                                                                   collection: 80.5 annual burden hours.
                                                  The company plans to manufacture                           comments and suggestions from the
                                                                                                             public and affected agencies concerning               If additional information is required
                                                the above-listed controlled substances                                                                             contact: Jake Bishop-Green, Acting
                                                in bulk for distribution to its customers.                   the proposed collection of information
                                                                                                             are encouraged. Your comments should                  Department Clearance Officer, United
                                                In reference to drug code 7360, the                                                                                States Department of Justice, Justice
                                                company plans to manufacture a                               address one or more of the following
                                                                                                             four points:                                          Management Division, Policy and
                                                synthetic version of cannabidiol in bulk                                                                           Planning Staff, Two Constitution
                                                for sale to its customers, who are final                     —Evaluate whether the proposed
                                                                                                                                                                   Square, 145 N Street NE., 3E.405B,
                                                dosage form manufacturers. No other                            collection of information is necessary
                                                                                                                                                                   Washington, DC 20530.
                                                activity for this drug code is authorized                      for the proper performance of the
                                                                                                               functions of the agency, including                    Dated: August 24, 2017.
                                                for this registration.
                                                                                                               whether the information will have                   Jake Bishop-Green,
                                                  Dated: August 21, 2017.
                                                                                                               practical utility;                                  Acting Department Clearance Officer for PRA,
                                                Demetra Ashley,                                              —Evaluate the accuracy of the agency’s                U.S. Department of Justice.
                                                Acting Assistant Administrator.                                estimate of the burden of the                       [FR Doc. 2017–18287 Filed 8–28–17; 8:45 am]
                                                [FR Doc. 2017–18315 Filed 8–28–17; 8:45 am]                    proposed collection of information,                 BILLING CODE 4410–30–P
                                                BILLING CODE 4410–09–P                                         including the validity of the
                                                                                                               methodology and assumptions used;
                                                                                                             —Enhance the quality, utility, and                    DEPARTMENT OF JUSTICE
                                                DEPARTMENT OF JUSTICE                                          clarity of the information to be                    [OMB Number 1121–0220]
                                                [OMB Number 1125–0005]
                                                                                                               collected; and/or
                                                                                                             —Minimize the burden of the collection                Agency Information Collection
                                                Agency Information Collection                                  of information on those who are to                  Activities; Proposed New e-Collection;
                                                Activities; Proposed Collection;                               respond, including through the use of               Bureau of Justice Assistance
                                                Comments Requested; Request To Be                              appropriate automated, electronic,                  Application Form: Public Safety
                                                Included on the List of Pro Bono Legal                         mechanical, or other technological                  Officers’ Benefits (PSOB) Program
                                                Service Providers for Individuals in                           collection techniques or other forms                Applications Package
                                                Immigration Proceedings (Form EOIR–                            of information technology, e.g.,
                                                                                                               permitting electronic submission of                 AGENCY:  Bureau of Justice Assistance,
                                                56)
                                                                                                               responses.                                          Department of Justice.
                                                AGENCY:  Executive Office for                                  Overview of this information                        ACTION: 30-day notice.
                                                Immigration Review, Department of                            collection:
                                                Justice.                                                                                                           SUMMARY: The Department of Justice,
                                                                                                               1 Type of Information Collection:
                                                                                                             Revision of a currently approved                      Office of Justice Programs, Bureau of
                                                ACTION: 30-day Notice.
                                                                                                             collection.                                           Justice Assistance, will be submitting
                                                SUMMARY: The Department of Justice                             2 The Title of the Form/Collection:                 the following information collection
                                                (DOJ), Executive Office for Immigration                      Request to be Included on the List of Pro             request for review and clearance in
                                                Review (EOIR), will be submitting the                        Bono Legal Service Providers for                      accordance with the Paperwork
                                                following information collection request                     Individuals in Immigration Proceedings.               Reduction Act of 1995.
                                                to the Office of Management and Budget                                                                             DATES: Comments are encouraged and
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                               3 The agency form number: EOIR–56
                                                (OMB) for review and approval in                             (OMB #1125–0015).                                     will be accepted for 30 days until
                                                accordance with the Paperwork                                  4 Affected public who will be asked                 September 28, 2017.
                                                Reduction Act of 1995. The proposed                          or required to respond, as well as a brief            FOR FURTHER INFORMATION CONTACT: If
                                                information collection was previously                        abstract:                                             you have additional comments
                                                published in the Federal Register on                           Primary: Legal service providers                    especially on the estimated public
                                                June 26, 2017, allowing for a 60-day                         seeking to be included on the List of Pro             burden or associated response time,
                                                comment period.                                              Bono Legal Service Providers (‘‘List’’), a            suggestions, or need a copy of the


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Document Created: 2017-08-29 01:58:12
Document Modified: 2017-08-29 01:58:12
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 1301.33(a) on or before October 30, 2017.
FR Citation82 FR 41055 

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