81_FR_15621 81 FR 15565 - Importer of Controlled Substances Application: Pharmacore

81 FR 15565 - Importer of Controlled Substances Application: Pharmacore

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 56 (March 23, 2016)

Page Range15565-15565
FR Document2016-06541

Federal Register, Volume 81 Issue 56 (Wednesday, March 23, 2016)
[Federal Register Volume 81, Number 56 (Wednesday, March 23, 2016)]
[Notices]
[Page 15565]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06541]



[[Page 15565]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Application: Pharmacore

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic class, 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 April 22, 2016. Such persons may also file a 
written request for a hearing on the application pursuant to 21 CFR 
1301.43 on or before April 22, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All request for 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request 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 hearing 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, dispenser, 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 
January 26, 2016, Pharmacore, 4180 Mendenhall Oaks Parkway, High Point, 
North Carolina 27265 applied to be registered as an importer of poppy 
straw concentrate (9670), a basic class of controlled substance listed 
in schedule II.
    The company plans to import the listed controlled substance to bulk 
manufacture into other controlled substances for sale to its customers.

    Dated: March 14, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-06541 Filed 3-22-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                                              Federal Register / Vol. 81, No. 56 / Wednesday, March 23, 2016 / Notices                                                  15565

                                                  DEPARTMENT OF JUSTICE                                   concentrate (9670), a basic class of                    The company plans to manufacture
                                                                                                          controlled substance listed in schedule               the listed controlled substance as an
                                                  Drug Enforcement Administration                         II.                                                   intermediate in the manufacture of an
                                                  [Docket No. DEA–392]                                        The company plans to import the                   active pharmaceutical ingredient to sell
                                                                                                          listed controlled substance to bulk                   to its customers.
                                                  Importer of Controlled Substances                       manufacture into other controlled                       Dated: March 14, 2016.
                                                  Application: Pharmacore                                 substances for sale to its customers.                 Louis J. Milione,
                                                                                                            Dated: March 14, 2016.                              Deputy Assistant Administrator.
                                                  ACTION:   Notice of application.
                                                                                                          Louis J. Milione,                                     [FR Doc. 2016–06534 Filed 3–22–16; 8:45 am]
                                                  DATES:  Registered bulk manufacturers of                Deputy Assistant Administrator.                       BILLING CODE 4410–09–P
                                                  the affected basic class, and applicants                [FR Doc. 2016–06541 Filed 3–22–16; 8:45 am]
                                                  therefore, may file written comments on                 BILLING CODE 4410–09–P
                                                  or objections to the issuance of the                                                                          DEPARTMENT OF JUSTICE
                                                  proposed registration in accordance
                                                                                                          DEPARTMENT OF JUSTICE                                 Drug Enforcement Administration
                                                  with 21 CFR 1301.34(a) on or before
                                                  April 22, 2016. Such persons may also                                                                         [Docket No. DEA–392]
                                                                                                          Drug Enforcement Administration
                                                  file a written request for a hearing on
                                                  the application pursuant to 21 CFR                      [Docket No. DEA–392]                                  Bulk Manufacturer of Controlled
                                                  1301.43 on or before April 22, 2016.                                                                          Substances Application: Siemens
                                                                                                          Manufacturer of Controlled                            Healthcare Diagnostics, Inc.
                                                  ADDRESSES: Written comments should
                                                                                                          Substances Registration: Cody
                                                  be sent to: Drug Enforcement
                                                                                                          Laboratories, Inc.                                    ACTION:   Notice of application.
                                                  Administration, Attention: DEA Federal
                                                  Register Representative/ODW, 8701                       ACTION:   Notice of registration.
                                                  Morrissette Drive, Springfield, Virginia                                                                      DATES:  Registered bulk manufacturers of
                                                  22152. All request for hearing must be                  SUMMARY:    Cody Laboratories, Inc.                   the affected basic class, and applicants
                                                  sent to: Drug Enforcement                               applied to be registered as a                         therefore, may file written comments on
                                                  Administration, Attn: Administrator,                    manufacturer of a certain basic class of              or objections to the issuance of the
                                                  8701 Morrissette Drive, Springfield,                    controlled substance. The Drug                        proposed registration in accordance
                                                  Virginia 22152. All request for hearing                 Enforcement Administration (DEA)                      with 21 CFR 1301.33(a) on or before
                                                  should also be sent to: (1) Drug                        grants Cody Laboratories, Inc.                        May 23, 2016.
                                                  Enforcement Administration, Attn:                       registration as a manufacturer of this                ADDRESSES: Written comments should
                                                  Hearing Clerk/LJ, 8701 Morrissette                      controlled substance.                                 be sent to: Drug Enforcement
                                                  Drive, Springfield, Virginia 22152; and                 SUPPLEMENTARY INFORMATION: By notice
                                                                                                                                                                Administration, Attention: DEA Federal
                                                  (2) Drug Enforcement Administration,                    dated October 13, 2015, and published                 Register Representative/ODW, 8701
                                                  Attn: DEA Federal Register                              in the Federal Register on October 21,                Morrissette Drive, Springfield, Virginia
                                                  Representative/ODW, 8701 Morrissette                    2015, 80 FR 63835, Cody Laboratories,                 22152.
                                                  Drive, Springfield, Virginia 22152.                     Inc., Steven Hartman—Vice President of                SUPPLEMENTARY INFORMATION:      The
                                                  Comments and requests for hearing on                    Compliance, 601 Yellowstone Avenue,                   Attorney General has delegated her
                                                  applications to import narcotic raw                     Cody, Wyoming 82414 applied to be                     authority under the Controlled
                                                  material are not appropriate. 72 FR 3417                registered as a manufacturer of certain               Substances Act to the Administrator of
                                                  (January 25, 2007).                                     basic classes of controlled substances.               the Drug Enforcement Administration
                                                  SUPPLEMENTARY INFORMATION: The                          No comments or objections were                        (DEA), 28 CFR 0.100(b). Authority to
                                                  Attorney General has delegated her                      submitted for this notice.                            exercise all necessary functions with
                                                  authority under the Controlled                              The DEA has considered the factors in             respect to the promulgation and
                                                  Substances Act to the Administrator of                  21 U.S.C. 823(a) and determined that                  implementation of 21 CFR part 1301,
                                                  the Drug Enforcement Administration                     the registration of Cody Laboratories,                incident to the registration of
                                                  (DEA), 28 CFR 0.100(b). Authority to                    Inc. to manufacture the basic classes of              manufacturers, distributors, dispensers,
                                                  exercise all necessary functions with                   controlled substances is consistent with              importers, and exporters of controlled
                                                  respect to the promulgation and                         the public interest and with United                   substances (other than final orders in
                                                  implementation of 21 CFR part 1301,                     States obligations under international                connection with suspension, denial, or
                                                  incident to the registration of                         treaties, conventions, or protocols in                revocation of registration) has been
                                                  manufacturers, distributors, dispenser,                 effect on May 1, 1971. The DEA                        redelegated to the Deputy Assistant
                                                  importers, and exporters of controlled                  investigated the company’s maintenance                Administrator of the DEA Office of
                                                  substances (other than final orders in                  of effective controls against diversion by            Diversion Control (‘‘Deputy Assistant
                                                  connection with suspension, denial, or                  inspecting and testing the company’s                  Administrator’’) pursuant to section 7 of
                                                  revocation of registration) has been                    physical security systems, verifying the              28 CFR part 0, appendix to subpart R.
                                                  redelegated to the Deputy Assistant                     company’s compliance with state and                      In accordance with 21 CFR
                                                  Administrator of the DEA Office of                      local laws, and reviewing the company’s               1301.33(a), this is notice that on
                                                  Diversion Control (‘‘Deputy Assistant                   background and history.                               December 14, 2015, Siemens Healthcare
                                                  Administrator’’) pursuant to section 7 of                   Therefore, pursuant to 21 U.S.C.                  Diagnostics, Inc., 100 GBC Drive,
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  28 CFR part 0, appendix to subpart R.                   823(a), and in accordance with 21 CFR                 Mailstop 514, Newark, Delaware 19702
                                                     In accordance with 21 CFR                            1301.33, the above-named company is                   applied to be registered as a bulk
                                                  1301.34(a), this is notice that on January              granted registration as a bulk                        manufacturer of ecgonine (9180) a basic
                                                  26, 2016, Pharmacore, 4180 Mendenhall                   manufacturer of methadone                             class of controlled substance listed in
                                                  Oaks Parkway, High Point, North                         intermediate (9254), a basic class of                 schedule II.
                                                  Carolina 27265 applied to be registered                 controlled substance listed in schedule                  The company plans to produce the
                                                  as an importer of poppy straw                           II.                                                   listed controlled substance in bulk to be


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Document Created: 2016-03-23 00:03:17
Document Modified: 2016-03-23 00:03:17
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 class, 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 April 22, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before April 22, 2016.
FR Citation81 FR 15565 

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