80_FR_46475 80 FR 46326 - Manufacturer of Controlled Substances Registration: National Center for Natural Products Research (NIDA MPROJECT), Inc.

80 FR 46326 - Manufacturer of Controlled Substances Registration: National Center for Natural Products Research (NIDA MPROJECT), Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 80, Issue 149 (August 4, 2015)

Page Range46326-46327
FR Document2015-19172

National Center for Natural Products Research (NIDA MPROJECT), Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants National Center for Natural Products Research (NIDA MPROJECT), Inc. registration as a manufacturer of those controlled substances.

Federal Register, Volume 80 Issue 149 (Tuesday, August 4, 2015)
[Federal Register Volume 80, Number 149 (Tuesday, August 4, 2015)]
[Notices]
[Pages 46326-46327]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19172]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: National 
Center for Natural Products Research (NIDA MPROJECT), Inc.

ACTION: Notice of registration.

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

SUMMARY: National Center for Natural Products Research (NIDA MPROJECT), 
Inc. applied to be registered as a manufacturer of certain basic 
classes of controlled substances. The Drug Enforcement Administration 
(DEA) grants National Center for Natural Products Research (NIDA 
MPROJECT), Inc. registration as a manufacturer of those controlled 
substances.

SUPPLEMENTARY INFORMATION: By notice dated April 14, 2015, and 
published in the Federal Register on April 22, 2015, 80 FR 22559, 
National Center for Natural Products Research (NIDA MPROJECT), Inc., 
University of Mississippi, 135 Coy Waller Complex, University, 
Mississippi 38677-1848 applied to be registered as a manufacturer of 
certain basic classes of controlled substances. No comments or 
objections were submitted for this notice.
    The DEA has considered the factors in 21 U.S.C. 823(a) and 
determined that the registration of National Center for Natural 
Products Research (NIDA MPROJECT), Inc. to manufacture the basic 
classes of controlled substances is consistent with the public interest 
and with United States obligations under international treaties, 
conventions, or protocols in effect on May 1, 1971. The DEA 
investigated the company's maintenance of effective controls against 
diversion by inspecting and testing the company's physical security 
systems, verifying the company's compliance with state and local laws, 
and reviewing the company's background and history.
    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 
CFR 1301.33, the above-named company is granted registration as a bulk 
manufacturer of the basic classes of controlled substances:

[[Page 46327]]



------------------------------------------------------------------------
               Controlled substance                       Schedule
------------------------------------------------------------------------
Marihuana (7360).................................  I
Tetrahydrocannabinols (7370).....................  I
------------------------------------------------------------------------

    The company plans to cultivate marihuana in support of the National 
Institute on Drug Abuse for research approved by the Department of 
Health and Human Services.

    Dated: July 29, 2015.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2015-19172 Filed 8-3-15; 8:45 am]
BILLING CODE P



                                              46326                         Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices

                                              with a hearing to challenge the State’s                 registration. Simply put, there is no                  DEPARTMENT OF JUSTICE
                                              action at which he may ultimately                       contested factual matter adducible at a
                                              prevail.’’ Kamal Tiwari, M.D., 76 FR                    hearing that would provide DEA with                    Drug Enforcement Administration
                                              71604, 71606, (2011); see also Bourne                   the authority to allow the Respondent to
                                              Pharmacy, Inc., 72 FR 18273, 18274                      continue to hold his COR.                              [Docket No. DEA–392]
                                              (2007); Anne Lazar Thorn, 62 FR 12847                     Accordingly, I hereby
                                              (1997). Additionally, Agency precedent                    GRANT the Government’s Motion for                    Manufacturer of Controlled
                                              has established that the existence of                   Summary Disposition; and further                       Substances Registration: National
                                              other proceedings in which the                            DENY the Respondent’s Request for                    Center for Natural Products Research
                                              Respondent is involved is not a basis                   Stay; and further                                      (NIDA MPROJECT), Inc.
                                              upon which to justify a stay of DEA                       RECOMMEND that the Respondent’s
                                              administrative enforcement                              DEA registration be REVOKED forthwith                  ACTION:   Notice of registration.
                                              proceedings. Grider Drug #1 & Grider                    and any pending applications for
                                              Drug #2, 77 FR 44069, 44104 n.97                        renewal be DENIED.                                     SUMMARY:    National Center for Natural
                                              (2012).                                                   Dated: March 20, 2015.                               Products Research (NIDA MPROJECT),
                                                 Congress does not intend for                         JOHN J. MULROONEY, II,
                                                                                                                                                             Inc. applied to be registered as a
                                              administrative agencies to perform                      Chief Administrative Law Judge.                        manufacturer of certain basic classes of
                                              meaningless tasks. See Philip E. Kirk,                                                                         controlled substances. The Drug
                                                                                                      [FR Doc. 2015–19119 Filed 8–3–15; 8:45 am]
                                              M.D., 48 FR 32887 (1983), aff’d sub                                                                            Enforcement Administration (DEA)
                                                                                                      BILLING CODE 4410–09–P
                                              nom. Kirk v. Mullen, 749 F.2d 297 (6th                                                                         grants National Center for Natural
                                              Cir. 1984); see also Puerto Rico                                                                               Products Research (NIDA MPROJECT),
                                              Aqueduct & Sewer Auth. v. EPA, 35                       DEPARTMENT OF JUSTICE                                  Inc. registration as a manufacturer of
                                              F.3d 600, 605 (1st Cir. 1994); NLRB v.                                                                         those controlled substances.
                                              Int’l Assoc. of Bridge, Structural &                    Drug Enforcement Administration                        SUPPLEMENTARY INFORMATION: By notice
                                              Ornamental Ironworkers, AFL–CIO, 549                    [Docket No. 12–49]                                     dated April 14, 2015, and published in
                                              F.2d 634 (9th Cir. 1977); United States                                                                        the Federal Register on April 22, 2015,
                                              v. Consol. Mines & Smelting Co., 455                    AIM Pharmacy & Surgical S. Corp.                       80 FR 22559, National Center for
                                              F.2d 432, 453 (9th Cir. 1971). Thus, it                 Order                                                  Natural Products Research (NIDA
                                              is well-settled that, where no genuine                                                                         MPROJECT), Inc., University of
                                              question of fact is involved, or when the                 On May 8, 2015, the Administrator of                 Mississippi, 135 Coy Waller Complex,
                                              material facts are agreed upon, a                       the Drug Enforcement Administration,                   University, Mississippi 38677–1848
                                              plenary, adversarial administrative                     noting that the expiration date of                     applied to be registered as a
                                              proceeding is not required. See Jesus R.                Respondent’s registration was June 30,                 manufacturer of certain basic classes of
                                              Juarez, M.D., 62 FR 14945 (1997);                       2014, ordered the parties to address                   controlled substances. No comments or
                                              Dominick A. Ricci, M.D., 58 FR 51104                    whether the case is now moot. The                      objections were submitted for this
                                              (1993). Here, the supplied IDFPR Order                  Administrator’s Order was served on                    notice.
                                              establishes, and the Respondent does                    Respondent’s counsel at his address of                   The DEA has considered the factors in
                                              not contest, that the Respondent is                     record.                                                21 U.S.C. 823(a) and determined that
                                                                                                        The Government filed a timely                        the registration of National Center for
                                              currently without authorization to
                                                                                                      response and served a copy of its                      Natural Products Research (NIDA
                                              handle controlled substances in Illinois,
                                                                                                      response on Respondent’s counsel at his                MPROJECT), Inc. to manufacture the
                                              the jurisdiction where the Respondent
                                                                                                      address of record. Govt. Response to                   basic classes of controlled substances is
                                              holds the DEA COR that is the subject
                                                                                                      Administrator’s May 8, 2015 Order, at 1.               consistent with the public interest and
                                              of this litigation.
                                                                                                      Respondent has not filed a response.1                  with United States obligations under
                                                 Summary disposition of an                              In its Response, the Government
                                              administrative case is warranted where,                                                                        international treaties, conventions, or
                                                                                                      advises that Respondent neither
                                              as here, ‘‘there is no factual dispute of                                                                      protocols in effect on May 1, 1971. The
                                                                                                      submitted a renewal application prior to
                                              substance.’’ See Veg-Mix, Inc., 832 F.2d                                                                       DEA investigated the company’s
                                                                                                      the expiration of its registration nor an
                                              601, 607 (D.C. Cir. 1987) (‘‘an agency                                                                         maintenance of effective controls
                                                                                                      application for a new registration. Id.
                                              may ordinarily dispense with a hearing                                                                         against diversion by inspecting and
                                                                                                      The Government therefore
                                              when no genuine dispute exists’’).4 At                                                                         testing the company’s physical security
                                                                                                      acknowledges that this case is now
                                              this juncture, no genuine dispute exists                                                                       systems, verifying the company’s
                                                                                                      moot. Id.; see Ronald J. Riegel, 63 FR
                                              over the fact that the Respondent lacks                                                                        compliance with state and local laws,
                                                                                                      67132, 67133 (1998). Accordingly, I
                                              state authority to handle controlled                                                                           and reviewing the company’s
                                                                                                      dismiss the Order to Show Cause.
                                              substances in the state of Illinois.                      It is so ordered.                                    background and history.
                                              Because the Respondent lacks such state                                                                          Therefore, pursuant to 21 U.S.C.
                                              authority, both the plain language of                     Date: July 27, 2015.                                 823(a), and in accordance with 21 CFR
                                              applicable federal statutory provisions                 Chuck Rosenberg,                                       1301.33, the above-named company is
                                              and Agency interpretive precedent                       Acting Administrator.                                  granted registration as a bulk
                                              dictate that the Respondent is not                      [FR Doc. 2015–19116 Filed 8–3–15; 8:45 am]             manufacturer of the basic classes of
                                              entitled to maintain his DEA                            BILLING CODE 4410–09–P                                 controlled substances:
tkelley on DSK3SPTVN1PROD with NOTICES




                                                4 Even assuming, arguendo, the possibility that       pending in the state courts. Michael G. Dolin, M.D.,   different address than that listed in the record.
                                              the Respondent’s state controlled substances            65 FR 5661, 5662 (2000).                               Notice of Recent Order and Government’s Response
                                              privileges could be reinstated, summary disposition       1 After both the Administrator’s Order and the       II, at 1–2. The Government represents that on June
                                              would still be warranted because ‘‘revocation is also                                                          30, 2015, it served both the Administrator’s Order
                                                                                                      Government’s Response were returned to the
                                              appropriate when a state license has been
                                                                                                      Agency as undelivered following efforts to serve       and its Response on each of Respondent’s attorneys
                                              suspended, but with the possibility of future
                                              reinstatement,’’ Rodriguez, 70 FR at 33207 (citations   both of Respondent’s counsels, the Government          by mailing them to the addresses of Respondent’s
                                              omitted), and even where there is a judicial            determined through the New York State Unified          attorneys as listed in the New York Unified Court
                                              challenge to the state medical board action actively    Court System’s database that each attorney had a       System’s database. Id. at 2.



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                                                                                       Federal Register / Vol. 80, No. 149 / Tuesday, August 4, 2015 / Notices                                                                                                     46327

                                                                                                                                    Controlled substance                                                                                                      Schedule

                                              Marihuana (7360) ........................................................................................................................................................................................       I
                                              Tetrahydrocannabinols (7370) .....................................................................................................................................................................              I



                                                The company plans to cultivate                                           SUMMARY:   Sigma-Aldrich International                                         The DEA has considered the factors in
                                              marihuana in support of the National                                       GMBH, Sigma Aldrich Co., LLC applied                                         21 U.S.C. 823, 952(a) and 958(a) and
                                              Institute on Drug Abuse for research                                       to be registered as an importer of certain                                   determined that the registration of
                                              approved by the Department of Health                                       basic classes of controlled substances.                                      Sigma-Aldrich International GMBH,
                                              and Human Services.                                                        The Drug Enforcement Administration                                          Sigma Aldrich Co., LLC to import the
                                                Dated: July 29, 2015.                                                    (DEA) grants Sigma-Aldrich                                                   basic classes of controlled substances is
                                              Joseph T. Rannazzisi,
                                                                                                                         International GMBH, Sigma Aldrich Co.,                                       consistent with the public interest and
                                                                                                                         LLC registration as an importer of those                                     with United States obligations under
                                              Deputy Assistant Administrator.
                                                                                                                         controlled substances.                                                       international treaties, conventions, or
                                              [FR Doc. 2015–19172 Filed 8–3–15; 8:45 am]
                                                                                                                         SUPPLEMENTARY INFORMATION: By notice                                         protocols in effect on May 1, 1971. The
                                              BILLING CODE P                                                                                                                                          DEA investigated the company’s
                                                                                                                         dated April 14, 2015, and published in
                                                                                                                         the Federal Register on April 22, 2015,                                      maintenance of effective controls
                                                                                                                         80 FR 22552, Sigma-Aldrich                                                   against diversion by inspecting and
                                              DEPARTMENT OF JUSTICE
                                                                                                                         International GMBH, Sigma Aldrich Co.,                                       testing the company’s physical security
                                              Drug Enforcement Administration                                            LLC, 3500 Dekalb Street, St. Louis,                                          systems, verifying the company’s
                                                                                                                         Missouri 63118 applied to be registered                                      compliance with state and local laws,
                                              [Docket No. DEA–392]                                                       as an importer of certain basic classes of                                   and reviewing the company’s
                                                                                                                         controlled substances. No comments or                                        background and history.
                                              Importer of Controlled Substances                                          objections were submitted for this                                             Therefore, pursuant to 21 U.S.C.
                                              Registration: Sigma-Aldrich                                                notice. Comments and requests for                                            952(a) and 958(a), and in accordance
                                              International GMBH, Sigma Aldrich                                          hearings on applications to import                                           with 21 CFR 1301.34, the above-named
                                              Co., LLC                                                                   narcotic raw material are not                                                company is granted registration as an
                                                                                                                         appropriate. 72 FR 3417, (January 25,                                        importer of the basic classes controlled
                                              ACTION:       Notice of registration.
                                                                                                                         2007).                                                                       substances:

                                                                                                                                    Controlled substance                                                                                                      Schedule

                                              Cathinone (1235) .........................................................................................................................................................................................      I
                                              Methcathinone (1237) ..................................................................................................................................................................................         I
                                              Mephedrone (4-Methyl-N-methylcathinone (1248) ......................................................................................................................................                            I
                                              N-Ethylamphetamine (1475) ........................................................................................................................................................................              I
                                              Aminorex (1585) ..........................................................................................................................................................................................      I
                                              Gamma Hydroxybutyric Acid (2010) ...........................................................................................................................................................                    I
                                              Methaqualone (2565) ..................................................................................................................................................................................          I
                                              Alpha-ethyltryptamine (7249) ......................................................................................................................................................................             I
                                              Ibogaine (7260) ...........................................................................................................................................................................................     I
                                              Lysergic acid diethylamide (7315) ...............................................................................................................................................................               I
                                              Marihuana (7360) ........................................................................................................................................................................................       I
                                              Tetrahydrocannabinols (7370) .....................................................................................................................................................................              I
                                              Mescaline (7381) .........................................................................................................................................................................................      I
                                              4-Bromo-2,5-dimethoxyamphetamine (7391) ..............................................................................................................................................                          I
                                              4-Bromo-2,5-dimethoxyphenethylamine (7392) ..........................................................................................................................................                           I
                                              4-Methyl-2,5-dimethoxyamphetamine (7395) ..............................................................................................................................................                         I
                                              2,5-Dimethoxyamphetamine (7396) ............................................................................................................................................................                    I
                                              3,4-Methylenedioxyamphetamine (7400) ....................................................................................................................................................                       I
                                              N-Hydroxy-3,4-methylenedioxyamphetamine (7402) ..................................................................................................................................                               I
                                              3,4-Methylenedioxy-N-ethylamphetamine (7404) ........................................................................................................................................                           I
                                              3,4-Methylenedioxymethamphetamine (7405) ............................................................................................................................................                           I
                                              4-Methoxyamphetamine (7411) ...................................................................................................................................................................                 I
                                              Bufotenine (7433) ........................................................................................................................................................................................      I
                                              Diethyltryptamine (7434) .............................................................................................................................................................................          I
                                              Dimethyltryptamine (7435) ..........................................................................................................................................................................            I
                                              Psilocybin (7437) .........................................................................................................................................................................................     I
                                              Psilocyn (7438) ............................................................................................................................................................................................    I
                                              1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ...............................................................................................................................................                    I
                                              N-Benzylpiperazine (7493) ..........................................................................................................................................................................            I
                                              MDPV (3,4-Methylenedioxypyrovalerone) (7535) .......................................................................................................................................                            I
                                              Heroin (9200) ...............................................................................................................................................................................................   I
                                              Normorphine (9313) ....................................................................................................................................................................................         I
tkelley on DSK3SPTVN1PROD with NOTICES




                                              Etonitazene (9624) ......................................................................................................................................................................................       I
                                              Amphetamine (1100) ...................................................................................................................................................................................          II
                                              Methamphetamine (1105) ...........................................................................................................................................................................              II
                                              Methylphenidate (1724) ...............................................................................................................................................................................          II
                                              Amobarbital (2125) ......................................................................................................................................................................................       II
                                              Pentobarbital (2270) ....................................................................................................................................................................................       II
                                              Secobarbital (2315) .....................................................................................................................................................................................       II



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Document Created: 2015-12-18 14:51:55
Document Modified: 2015-12-18 14:51:55
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 registration.
FR Citation80 FR 46326 

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