82_FR_51652 82 FR 51439 - Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation

82 FR 51439 - Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 213 (November 6, 2017)

Page Range51439-51440
FR Document2017-24090

Federal Register, Volume 82 Issue 213 (Monday, November 6, 2017)
[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Notices]
[Pages 51439-51440]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24090]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: 
Cerilliant Corporation

ACTION: Notice of application.

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

DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration on or before January 5, 2018.

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 May 
23, 2017, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round 
Rock, Texas 78665-2402 applied to be registered as a bulk manufacturer 
of the following basic classes of controlled substances:

------------------------------------------------------------------------
           Controlled substance               Drug code       Schedule
------------------------------------------------------------------------
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-             7010  I
 oxobutan-2-yl)-1-)4-fluorobenzyl)-1-H-
 indazole-3-carboxamide).
MDMB-FUBINACA (Methyl-2-(1-(4-                       7020  I
 fluorobenzyl)-1H-indazole-3-carboxamido)-
 3,3-dimethylbutanoate).
MAB-CHMINACA (N-(1-amino-3,3dimethyl-1-              7032  I
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
 indazole-3-carboxamide).

[[Page 51440]]

 
5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1-1H-           7033  I
 indazole-3-carboxamido)-3-
 methylbutanoate).
5F-ADB;5F-MDMB-PINACA (Methyl 2-(1-(5-               7034  I
 fluoropentyl)-1H-indazole-3-carboxamido)-
 3,3-dimethylbutanoate).
MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1-              7042  I
 (cyclohenxylmethyl)-1H-indole-3-
 carboxamido)-3,3-dimethylbutanoate).
5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-            7049  I
 1-(5-fluoropentyl)-1-1H-indazole-3-
 carboxamide).
U-47700 (3,4-dichloro-N-[2-                          9547  I
 (dimethylamino)cyclohexyl]-N-
 methylbenzamide).
Acryl fentanyl (N-(1-phenethylpiperidin-4-           9811  I
 yl)-N-phenylacrylamide).
4-Fluoroisobutyryl fentanyl (N-(4-                   9824  I
 fluorophenyl)-N-(1-phenethylpiperidin-4-
 yl)isobutyramide).
Furanyl fentanyl (N-(1-phenethylpiperidin-           9834  I
 4-yl)-N-phenylfuran-2-carboxamide).
------------------------------------------------------------------------

    The company plans to manufacture small quantities of the listed 
controlled substances to make reference standards which will be 
distributed to its customers.

    Dated: October 27, 2017.
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-24090 Filed 11-3-17; 8:45 am]
 BILLING CODE 4410-09-P



                                                                           Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices                                                    51439

                                               Registrant, both with respect to the                    he was hospitalized for an overdose on                United States. This Order is applicable
                                               volume of drugs being diverted and by                   multiple occasions), establishes that                 December 6, 2017.
                                               denying that he was engaged in                          there was ‘‘a substantial likelihood of an              Dated: October 31, 2017.
                                               diverting and abusing the controlled                    immediate threat that death, serious                  Robert W. Patterson,
                                               substances. As explained above,                         bodily harm, or abuse of a controlled
                                                                                                                                                             Acting Administrator.
                                               Registrant’s and Chapman’s misconduct                   substance [would] occur in the absence
                                               in diverting drugs, which the latter                                                                          [FR Doc. 2017–24093 Filed 11–3–17; 8:45 am]
                                                                                                       of the immediate suspension of
                                               personally abused, was actionable                       [Registrant’] registration.’’ Id. I therefor          BILLING CODE 4410–09–P

                                               misconduct under both Factor Four                       affirm the issuance of the Immediate
                                               (compliance with applicable laws                        Suspension Order.
                                               related to controlled substances) and                                                                         DEPARTMENT OF JUSTICE
                                                                                                          Pursuant to 21 U.S.C. 824(f), ‘‘[u]pon
                                               Factor Five (other conduct which may                    a revocation order becoming final, all                Drug Enforcement Administration
                                               threaten public health and safety). As                  . . . controlled substances’’ seized
                                               the DI explained, had Chapman been                      pursuant to a suspension order ‘‘shall be
                                               candid during the June 30, 2016                                                                               [Docket No. DEA–392]
                                                                                                       forfeited to the United States’’ and ‘‘[a]ll
                                               interview, he and his colleagues ‘‘would                right, title, and interest in such                    Bulk Manufacturer of Controlled
                                               have pursued immediate criminal action                  controlled substances shall vest in the               Substances Application: Cerilliant
                                               against Chapman’’ as well as                            United States upon a revocation order                 Corporation
                                               administrative action against Registrant.               becoming final.’’ As the Agency has
                                               Indeed, Chapman’s subsequent                            previously held, a registrant cannot                  ACTION:   Notice of application.
                                               admissions during the July 22, 2016                     defeat the effect of this provision by
                                               interview supported both criminal                       allowing its registration to expire.’’                DATES:  Registered bulk manufacturers of
                                               charges against Chapman and the                         S & S Pharmacy, Inc., d/b/a Platinum                  the affected basic classes, and
                                               Immediate Suspension Order.                             Pharmacy & Compounding, 78 FR
                                                 Accordingly, I conclude that the                                                                            applicants therefore, may file written
                                                                                                       57656, 57659 (2013) (citing                           comments on or objections to the
                                               evidence with respect to Factor Five                    Meetinghouse Community Pharmacy,
                                               establishes that Registrant’s principal                                                                       issuance of the proposed registration on
                                                                                                       Inc., 74 FR 10073, 10074 n.5 (2009); RX               or before January 5, 2018.
                                               was abusing controlled substances and                   Direct Pharmacy, Inc., 72 FR 54070,
                                               that he made several materially false                                                                         ADDRESSES: Written comments should
                                                                                                       54072 n.4 (2007)). Registrant had the
                                               statements to DEA investigators. I also                                                                       be sent to: Drug Enforcement
                                                                                                       right to challenge the Immediate
                                               conclude that these acts constitute                                                                           Administration, Attention: DEA Federal
                                                                                                       Suspension Order before the Agency but
                                               actionable misconduct which may                                                                               Register Representative/DRW, 8701
                                                                                                       chose not to. And had Registrant not
                                               threaten public health and safety.                                                                            Morrissette Drive, Springfield, Virginia
                                                                                                       allowed its registration to expire, I
                                                                                                                                                             22152.
                                               Summary of Factors Four and Five and                    would have revoked it.
                                               Imminent Danger                                            Accordingly, I will order that the                 SUPPLEMENTARY INFORMATION:      The
                                                  As found above, the Government’s                     controlled substances seized pursuant to              Attorney General has delegated his
                                               evidence establishes that Registrant                    the Immediate Suspension Order be                     authority under the Controlled
                                               unlawfully distributed controlled                       forfeited to the United States. 21 U.S.C.             Substances Act to the Administrator of
                                               substances to Chapman and failed to                     824(f). I will also declare that ‘‘[a]ll,             the Drug Enforcement Administration
                                               maintain required records. The evidence                 right, title, and interest in’’ the                   (DEA), 28 CFR 0.100(b). Authority to
                                               also establishes that Registrant’s                      controlled substances that were seized                exercise all necessary functions with
                                               principal and pharmacist in charge                      pursuant to the Suspension Order have                 respect to the promulgation and
                                               unlawfully possessed controlled                         vested in the United States. Id.                      implementation of 21 CFR part 1301,
                                               substances, destroyed records that                                                                            incident to the registration of
                                                                                                       Order                                                 manufacturers, distributors, dispensers,
                                               Registrant was required to maintain,
                                               abused controlled substances and made                      Pursuant to the authority vested in me             importers, and exporters of controlled
                                               materially false statements to DEA                      by 21 U.S.C. 824(a) and (d), as well as               substances (other than final orders in
                                               Investigators. I therefore find that                    28 CFR 0.100(b), I order that the Order               connection with suspension, denial, or
                                               Registrant has committed such acts as to                of Immediate Suspension issued to Chip                revocation of registration) has been
                                               render its registration inconsistent with               RX d/b/a City Center Pharmacy be, and                 redelegated to the Assistant
                                               the public interest. 21 U.S.C. 824(a)(4).               it hereby is, affirmed. Pursuant to the               Administrator of the DEA Diversion
                                                  For purposes of the imminent danger                  authority vested in me by 21 U.S.C.                   Control Division (‘‘Assistant
                                               inquiry, these findings also support the                824(f), I order that all controlled                   Administrator’’) pursuant to section 7 of
                                               conclusion that Registrant has ‘‘fail[ed]               substances seized pursuant to the Order               28 CFR part 0, appendix to subpart R.
                                               . . . to maintain effective controls                    of Immediate Suspension be, and they                    In accordance with 21 CFR
                                               against diversion or otherwise comply                   hereby are, forfeited to the United                   1301.33(a), this is notice that on May 23,
                                               with the obligations of a registrant                    States. Pursuant to the authority vested              2017, Cerilliant Corporation, 811
                                               under’’ the CSA. 21 U.S.C. 824(d)(2).                   in me by 21 U.S.C. 824(f), I also declare             Paloma Drive, Suite A, Round Rock,
                                               Also, the evidence that Chapman was                     that all right, title, and interest in all            Texas 78665–2402 applied to be
                                               diverting 200 to 300 milligrams of                      controlled substances seized pursuant to              registered as a bulk manufacturer of the
Pmangrum on DSK3GDR082PROD with NOTICES




                                               narcotics per day, which he then abused                 the Order of Immediate Suspension be,                 following basic classes of controlled
                                               (along with the evidence showing that                   and they hereby are, vested in the                    substances:

                                                                                                     Controlled substance                                                             Drug code    Schedule

                                               ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-)4-fluorobenzyl)-1-H-indazole-3-carboxamide) ............                           7010   I
                                               MDMB-FUBINACA (Methyl-2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) .......................                        7020   I
                                               MAB-CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) .........                              7032   I



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                                               51440                          Federal Register / Vol. 82, No. 213 / Monday, November 6, 2017 / Notices

                                                                                                           Controlled substance                                                                      Drug code    Schedule

                                               5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1-1H-indazole-3-carboxamido)-3-methylbutanoate) ............................................                           7033   I
                                               5F-ADB;5F-MDMB-PINACA (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) .........                                             7034   I
                                               MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1-(cyclohenxylmethyl)-1H-indole-3-carboxamido)-3,3-                                                                    7042   I
                                                 dimethylbutanoate).
                                               5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1-1H-indazole-3-carboxamide) .................................                                  7049   I
                                               U-47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide) ...............................................................                    9547   I
                                               Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) .................................................................................         9811   I
                                               4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) .........................................                       9824   I
                                               Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide) .............................................................                  9834   I



                                                 The company plans to manufacture                              Other important dates:                                         The current competition, Phase 3 (On-
                                               small quantities of the listed controlled                     May 16, 2018 Level 1: Virtual                                  Site Habitat), will focus on the
                                               substances to make reference standards                          Construction Building Information                            technology for autonomous 3D-printing
                                               which will be distributed to its                                Modeling (BIM)—60% Design Results                            and construction of a complete 1:3 sub-
                                               customers.                                                      due to Judges                                                scale habitat (∼10 m2). This competition
                                                 Dated: October 27, 2017.                                    July 11, 2018 Level 2: Foundation Test                         will involve elements from Phase 1
                                               Demetra Ashley,                                                 Results due to Judges                                        design and Phase 2 materials to
                                                                                                             December 5, 2018 Level 3: Hydrostatic                          demonstrate the technology for
                                               Acting Assistant Administrator.
                                                                                                               Test Results due to Judges                                   autonomous construction needed for
                                               [FR Doc. 2017–24090 Filed 11–3–17; 8:45 am]
                                                                                                             January 16, 2019 Level 4: Virtual                              building a habitat on another planet or
                                               BILLING CODE 4410–09–P                                                                                                       even on remote locations on Earth.
                                                                                                               Construction BIM—100% Design
                                                                                                               Results due to Judges                                          A Phase 4 competition (Full-Scale
                                                                                                             April 29—May 4, 2019 Level 5: Subscale                         Habitat), calling for the development of
                                               NATIONAL AERONAUTICS AND                                        Habitat Competition                                          an autonomous 3D-printed construction
                                               SPACE ADMINISTRATION                                                                                                         of a full-scale habitat (∼93 m2), is
                                                                                                             ADDRESSES: The Level 5 On-Site
                                               [Notice: (16–083)]                                            Subscale Habitat Head-to-Head                                  planned to be announced at a later date.
                                                                                                             challenge competition will take place at:                      I. Prize Amounts
                                               Centennial Challenges: 3D-Printed                             Caterpillar Edwards Demonstration and
                                               Habitat Challenge                                             Learning Center, 5801 N. Smith Rd.,                              The 3D Printed Habitat Challenge
                                                                                                             Edwards, IL 61528.                                             Phase 3 On-Site Habitat Competition
                                               AGENCY: National Aeronautics and                                                                                             purse is $2,000,000 (two million dollars)
                                               Space Administration (NASA).                                  FOR FURTHER INFORMATION CONTACT: To
                                                                                                                                                                            to be disbursed as follows:
                                               ACTION: Notice of Centennial Challenges                       register for or get additional information
                                               3D-Printed Habitat Challenge Phase 3:                         regarding the 3D Printed Habitat                               Level 1: Virtual Construction BIM—60%
                                               On-Site Habitat Competition.                                  Challenge, please visit: http://                               Design
                                                                                                             bradley.edu/challenge For general                              $100,000 total prize money to be
                                               SUMMARY:   The 3D-Printed Habitat                             information on the NASA Centennial                               awarded to top 5 qualifiers based on
                                               (3DPH) Challenge Phase 3 On-Site                              Challenges Program please visit: http://                         scoring, as articulated in the
                                               Habitat Competition is open, and teams                        www.nasa.gov/challenges. General                                 competition rules.
                                               that wish to compete may now register.                        questions and comments regarding the
                                               Centennial Challenges is a program of                         program should be addressed to Monsi                           Level 2: Foundation Test
                                               prize competitions to stimulate                               Roman, Centennial Challenges Program,                          $400,000 total prize money to be
                                               innovation in technologies of interest                        NASA Marshall Space Flight Center                                awarded to top 10 qualifiers based on
                                               and value to NASA and the nation. The                         Huntsville, AL 35812. Email address:                             scoring, as articulated in the
                                               3DPH Challenge Phase 3 On-Site Habitat                        hq-stmd-centennialchallenges@                                    competition rules.
                                               Competition is a prize competition with                       mail.nasa.gov.
                                               a $2,000,000 total prize purse to develop                                                                                    Level 3: Hydrostatic Test
                                                                                                             SUPPLEMENTARY INFORMATION:
                                               and demonstrate capabilities to                                                                                              $600,000 total prize money to be
                                               autonomously manufacture through 3D-                          Summary                                                          awarded to top 8 qualifiers based on
                                               printing technologies a habitat on                               The 3DPH Challenge Phase 3                                    scoring, as articulated in the
                                               another planetary body using mission                          Competition (On-Site Habitat) follows                            competition rules.
                                               recycled materials and/or local                               earlier phases of the Challenge as
                                               indigenous materials. The Phase 3                                                                                            Level 4: Virtual Construction BIM—
                                                                                                             described below.
                                               competition consists of 5 levels. This                                                                                       100% Design
                                                                                                                • Design Competition (Phase 1)—
                                               technology demonstration competition                          focused on developing innovative                               $100,000 total prize money to be
                                               has great potential value for terrestrial                     habitat architectural concepts that take                         awarded to top 3 qualifiers based on
                                               applications.                                                 advantage of the unique capabilities that                        scoring, as articulated in the
                                               DATES:  Challenge registration opens                          3D-Printing offers (completed in 2015).                          competition rules.
                                                                                                                • Structural Member Competition
Pmangrum on DSK3GDR082PROD with NOTICES




                                               November 7, 2017, and will remain
                                                                                                                                                                            Level 5: Subscale Habitat Competition
                                               open until February 15, 2018. Early and                       (Phase 2)—focused on the core 3D-
                                               Late registrations are available with                         Printing fabrication technologies and                          $500,000 to first place
                                               discount or late fee respectively.                            materials properties needed to                                 $200,000 to second place
                                               Competitors will be allowed the option                        manufacture structural components                              $100,000 to third place
                                               to participate in the Virtual                                 from indigenous materials combined                               These awards will be made based on
                                               Construction competitions levels 1 & 4                        with recyclables, or indigenous                                scoring, as articulated in the
                                               only with a reduced registration fee.                         materials alone (completed in 2017).                           competition rules.


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Document Created: 2017-11-07 10:30:50
Document Modified: 2017-11-07 10:30:50
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of application.
DatesRegistered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 5, 2018.
FR Citation82 FR 51439 

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