83_FR_40725 83 FR 40567 - Bulk Manufacturer of Controlled Substances Application: Rhodes Technologies

83 FR 40567 - Bulk Manufacturer of Controlled Substances Application: Rhodes Technologies

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 158 (August 15, 2018)

Page Range40567-40568
FR Document2018-17605

Federal Register, Volume 83 Issue 158 (Wednesday, August 15, 2018)
[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)]
[Notices]
[Pages 40567-40568]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17605]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Rhodes 
Technologies

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 October 15, 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 delegated 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 June 
28th, 2018, Rhodes Technologies, 498 Washington Street, Coventry, Rhode 
Island 02816 applied to be registered as a bulk manufacturer of the 
following basic classes of controlled substances:

------------------------------------------------------------------------
        Controlled substance             Drug code         Schedule
------------------------------------------------------------------------
Marihuana...........................            7360  I
Tetrahydrocannabinols...............            7370  I
Dihydromorphine.....................            9145  I
Methylphenidate.....................            1724  II
Codeine.............................            9050  II
Dihydrocodeine......................            9120  II
Oxycodone...........................            9143  II
Hydromorphone.......................            9150  II
Hydrocodone.........................            9193  II
Levorphanol.........................            9220  II
Morphine............................            9300  II
Oripavine...........................            9330  II
Thebaine............................            9333  II
Oxymorphone.........................            9652  II
Noroxymorpohone.....................            9668  II
Tapentadol..........................            9780  II
------------------------------------------------------------------------


[[Page 40568]]

    The company plans to manufacture the listed controlled substances 
in bulk for conversion and sale to finished dosage form manufacturers. 
In reference to drug code 7360 and 7370, the company plans to bulk 
manufacture a synthetic CBD and tetrahydrocannabinol. No other activity 
for drug code 7360 and 7370 are authorized for this registration.

    Dated: August 3, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-17605 Filed 8-14-18; 8:45 am]
 BILLING CODE 4410-09-P



                                                                                    Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices                                                                                        40567

                                               60. Courts cannot look beyond the                                           functions vested solely in the executive                                     DATES:  Registered bulk manufacturers of
                                               complaint in making the public interest                                     branch could be undermined by the                                            the affected basic classes, and
                                               determination ‘‘unless the complaint                                        improper use of the APPA as an                                               applicants therefore, may file written
                                               underlying the decree is drafted so                                         antitrust oversight provision.’’) (citation                                  comments on or objections to the
                                               narrowly such that its entry would                                          omitted). A court can make its public                                        issuance of the proposed registration on
                                               appear ‘to make a mockery of judicial                                       interest determination based on the                                          or before October 15, 2018.
                                               power.’’’ Apple, 889 F. Supp. 2d at 631                                     competitive impact statement and
                                               (S.D.N.Y. 2012) (citing SBC Commc’ns,                                       response to public comments alone.                                           ADDRESSES:   Written comments should
                                               489 F. Supp. 2d at 15).                                                     U.S. Airways, 38 F. Supp. 3d at 75.3                                         be sent to: Drug Enforcement
                                                  In its 2004 amendments, Congress                                                                                                                      Administration, Attention: DEA Federal
                                               made clear its intent to preserve the                                       VIII. DETERMINATIVE DOCUMENTS                                                Register Representative/DRW, 8701
                                               practical benefits of utilizing consent                                       There are no determinative materials                                       Morrissette Drive, Springfield, Virginia
                                               decrees in antitrust enforcement, adding                                    or documents within the meaning of the                                       22152.
                                               the unambiguous instruction that                                            APPA that were considered by the
                                               ‘‘[n]othing in this section shall be                                        United States in formulating the                                             SUPPLEMENTARY INFORMATION:
                                               construed to require the court to                                           proposed Final Judgment.                                                        The Attorney General has delegated
                                               conduct an evidentiary hearing or to                                        Dated: August 7, 2018                                                        his authority under the Controlled
                                               require the court to permit anyone to                                                                                                                    Substances Act to the Administrator of
                                                                                                                           Respectfully submitted,
                                               intervene.’’ 15 U.S.C. § 16(e)(2); see also                                                                                                              the Drug Enforcement Administration
                                                                                                                           lllllllllllllllllllll
                                               U.S. Airways, 38 F. Supp. 3d at 75                                                                                                                       (DEA), 28 CFR 0.100(b). Authority to
                                                                                                                           Lowell R. Stern
                                               (indicating that a court is not required                                                                                                                 exercise all necessary functions with
                                               to hold an evidentiary hearing or to                                        United States Department of Justice,
                                                                                                                           Antitrust Division, Media, Entertainment &                                   respect to the promulgation and
                                               permit intervenors as part of its review
                                                                                                                           Professional Services Section, 450 Fifth                                     implementation of 21 CFR part 1301,
                                               under the Tunney Act). The language                                         Street, N.W., Suite 4000, Washington, DC
                                               wrote into the statute what Congress                                                                                                                     incident to the registration of
                                                                                                                           20530, Telephone: (202) 514–3676,                                            manufacturers, distributors, dispensers,
                                               intended when it enacted the Tunney                                         Facsimile: (202) 514–7308, E-mail:
                                               Act in 1974, as Senator Tunney                                              lowell.stern@usdoj.gov
                                                                                                                                                                                                        importers, and exporters of controlled
                                               explained: ‘‘[t]he court is nowhere                                                                                                                      substances (other than final orders in
                                                                                                                           Attorney for Plaintiff United States
                                               compelled to go to trial or to engage in                                                                                                                 connection with suspension, denial, or
                                                                                                                           [FR Doc. 2018–17521 Filed 8–14–18; 8:45 am]
                                               extended proceedings which might have                                                                                                                    revocation of registration) has been
                                                                                                                           BILLING CODE 4410–11–P
                                               the effect of vitiating the benefits of                                                                                                                  delegated to the Assistant Administrator
                                               prompt and less costly settlement                                                                                                                        of the DEA Diversion Control Division
                                               through the consent decree process.’’                                       DEPARTMENT OF JUSTICE                                                        (‘‘Assistant Administrator’’) pursuant to
                                               119 Cong. Rec. 24, 598 (1973) (statement                                                                                                                 section 7 of 28 CFR part 0, appendix to
                                               of Sen. Tunney). Rather, the procedure                                      Drug Enforcement Administration                                              subpart R.
                                               for the public interest determination is                                                                                                                    In accordance with 21 CFR
                                               left to the discretion of the court, with                                   [Docket No. DEA–392]
                                                                                                                                                                                                        1301.33(a), this is notice that on June
                                               the recognition that the court’s ‘‘scope
                                                                                                                           Bulk Manufacturer of Controlled                                              28th, 2018, Rhodes Technologies, 498
                                               of review remains sharply proscribed by
                                               precedent and the nature of Tunney Act                                      Substances Application: Rhodes                                               Washington Street, Coventry, Rhode
                                               proceedings.’’ SBC Commc’ns, 489 F.                                         Technologies                                                                 Island 02816 applied to be registered as
                                               Supp. 2d at 11; see also Apple, 889 F.                                                                                                                   a bulk manufacturer of the following
                                                                                                                           ACTION:       Notice of application.                                         basic classes of controlled substances:
                                               Supp. 2d at 632 (‘‘[P]rosecutorial

                                                                                                                       Controlled substance                                                                                         Drug code     Schedule

                                               Marihuana ......................................................................................................................................................................           7360   I
                                               Tetrahydrocannabinols ..................................................................................................................................................                   7370   I
                                               Dihydromorphine ............................................................................................................................................................               9145   I
                                               Methylphenidate .............................................................................................................................................................              1724   II
                                               Codeine ..........................................................................................................................................................................         9050   II
                                               Dihydrocodeine ..............................................................................................................................................................              9120   II
                                               Oxycodone .....................................................................................................................................................................            9143   II
                                               Hydromorphone .............................................................................................................................................................                9150   II
                                               Hydrocodone ..................................................................................................................................................................             9193   II
                                               Levorphanol ...................................................................................................................................................................            9220   II
                                               Morphine ........................................................................................................................................................................          9300   II
                                               Oripavine ........................................................................................................................................................................         9330   II
                                               Thebaine ........................................................................................................................................................................          9333   II
                                               Oxymorphone ................................................................................................................................................................               9652   II
                                               Noroxymorpohone .........................................................................................................................................................                  9668   II
                                               Tapentadol .....................................................................................................................................................................           9780   II
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                                                 3 See United States v. Enova Corp., 107 F. Supp.                          Cas. (CCH) ¶ 61,508, at 71,980, *22 (W.D. Mo. 1977)                          determine whether those explanations are
                                               2d 10, 17 (D.D.C. 2000) (noting that the ‘‘Tunney                           (‘‘Absent a showing of corrupt failure of the                                reasonable under the circumstances.’’); S. Rep. No.
                                               Act expressly allows the court to make its public                           government to discharge its duty, the Court, in                              93–298, at 6 (1973) (‘‘Where the public interest can
                                               interest determination on the basis of the                                  making its public interest finding, should . . .                             be meaningfully evaluated simply on the basis of
                                               competitive impact statement and response to                                carefully consider the explanations of the
                                                                                                                                                                                                        briefs and oral arguments, that is the approach that
                                               comments alone’’); United States v. Mid-Am.                                 government in the competitive impact statement
                                               Dairymen, Inc., No. 73–CV–681–W–1, 1977–1 Trade                             and its responses to comments in order to                                    should be utilized.’’).




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                                               40568                      Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices

                                                  The company plans to manufacture                     public and affected agencies concerning               Planning Staff, Two Constitution
                                               the listed controlled substances in bulk                the proposed collection of information                Square, 145 N Street NE, 3E.405A,
                                               for conversion and sale to finished                     are encouraged. Your comments should                  Washington, DC 20530.
                                               dosage form manufacturers. In reference                 address one or more of the following                    Dated: August 10, 2018.
                                               to drug code 7360 and 7370, the                         four points:                                          Melody Braswell,
                                               company plans to bulk manufacture a                     —Evaluate whether the proposed
                                                                                                         collection of information is necessary              Department Clearance Officer for PRA, U.S.
                                               synthetic CBD and
                                                                                                                                                             Department of Justice.
                                               tetrahydrocannabinol. No other activity                   for the proper performance of the
                                                                                                                                                             [FR Doc. 2018–17529 Filed 8–14–18; 8:45 am]
                                               for drug code 7360 and 7370 are                           functions of the agency, including
                                                                                                         whether the information will have                   BILLING CODE 4410–02–P
                                               authorized for this registration.
                                                 Dated: August 3, 2018.                                  practical utility;
                                                                                                       —Evaluate the accuracy of the agency’s
                                               John J. Martin,                                                                                               DEPARTMENT OF JUSTICE
                                                                                                         estimate of the burden of the
                                               Assistant Administrator.                                  proposed collection of information,
                                               [FR Doc. 2018–17605 Filed 8–14–18; 8:45 am]                                                                   Office of Justice Programs
                                                                                                         including the validity of the
                                               BILLING CODE 4410–09–P                                    methodology and assumptions used;
                                                                                                       —Evaluate whether and if so how the                   [OJP (NIJ) Docket No. 1750]
                                                                                                         quality, utility, and clarity of the
                                               DEPARTMENT OF JUSTICE                                     information to be collected can be                  Body Armor Manufacturer Workshop
                                               [OMB Number 1110–0067]                                    enhanced; and
                                                                                                       —Minimize the burden of the collection                AGENCY:    National Institute of Justice,
                                                                                                         of information on those who are to                  Justice.
                                               Agency Information Collection
                                               Activities; Proposed eCollection                          respond, including through the use of               ACTION:    Notice.
                                               eComments Requested; Revision of an                       appropriate automated, electronic,
                                               Existing Collection in Use Rap Back                       mechanical, or other technological                  SUMMARY:   The National Institute of
                                               Services Form (1–796)                                     collection techniques or other forms                Justice (NIJ) is hosting a workshop for
                                                                                                         of information technology, e.g.,                    body armor manufacturers to provide an
                                               AGENCY:  Criminal Justice Information                     permitting electronic submission of                 overview of draft NIJ Standard 0101.07,
                                               Services Division, Federal Bureau of                      responses.                                          Ballistic Resistance of Body Armor, and
                                               Investigation, Department of Justice.                                                                         draft NIJ Specification Threat Levels
                                                                                                       Overview of This Information
                                               ACTION: 60-Day notice.                                                                                        and Associated Ammunition to Test
                                                                                                       Collection
                                                                                                                                                             Equipment Intended to Protect U.S. Law
                                               SUMMARY:   The Department of Justice                      (1) Type of Information Collection:                 Enforcement Against Handguns and
                                               (DOJ), Federal Bureau of Investigation                  Revision of an approved collection.                   Rifles. A preliminary outline of how the
                                               (FBI), Criminal Justice Information                       (2) Title of the Form/Collection: Rap               NIJ Compliance Testing Program (CTP),
                                               Services (CJIS) Division, will be                       Back Services Form (1–796).                           which manages conformity assessment
                                               submitting the following information                      (3) Agency form number: The form                    of body armor, will begin to phase out
                                               collection request to the Office of                     number is 1–796. Sponsoring                           use of NIJ Standard 0101.06 and phase
                                               Management and Budget (OMB) for                         component: Department of Justice,                     in the use of NIJ Standard 0101.07 in the
                                               review and approval in accordance with                  Federal Bureau of Investigation,                      administration of the program over
                                               the Paperwork Reduction Act of 1995.                    Criminal Justice Information Services                 approximately the next year will be
                                               DATES: Comments are encouraged and                      Division.                                             presented. The impact of the transition
                                               will be accepted for 60 days until                        (4) Affected public who will be asked
                                                                                                                                                             on the Compliant Products List (CPL)
                                               October 15, 2018.                                       or required to respond, as well as a brief
                                                                                                                                                             and Follow-up Inspection Testing (FIT)
                                               FOR FURTHER INFORMATION CONTACT: If
                                                                                                       abstract: Primary: This form is utilized
                                                                                                                                                             of listed body armor models compliant
                                               you have additional comments                            by authorized agencies to enroll
                                                                                                                                                             with NIJ Standard 0101.06 over a longer
                                               especially on the estimated public                      individuals in the Rap Back Service to
                                                                                                                                                             period of time will also be discussed.
                                               burden or associated response time,                     ensure the submitting agency is notified
                                                                                                       when individuals in positions of trust                   This will be an open forum and there
                                               suggestions, or need a copy of the                                                                            will opportunities for attendees to ask
                                               proposed information collection                         engage in criminal conduct or
                                                                                                       individuals under the supervision of a                questions. Space is limited at this
                                               instrument with instructions or                                                                               workshop, and as a result, only 100
                                               additional information, please contact                  criminal justice agency commit
                                                                                                       subsequent criminal acts.                             participants will be allowed to register.
                                               Gerry Lynn Brovey, Supervisory                                                                                NIJ requests that each manufacturer
                                                                                                         (5) An estimate of the total number of
                                               Information Liaison Specialist, Federal                                                                       limit their representatives to no more
                                                                                                       respondents and the amount of time
                                               Bureau of Investigation, Criminal Justice                                                                     than two per organization. Exceptions to
                                                                                                       estimated for an average respondent to
                                               Information Services Division, 1000                                                                           this limit may occur, should space
                                                                                                       respond: It is estimated that 12
                                               Custer Hollow Road; Clarksburg, WV                                                                            allow. Participants planning to attend
                                                                                                       respondents will complete each form
                                               26306; phone: 304–625–4320 or email                                                                           are responsible for their own travel
                                                                                                       within approximately 5 minutes.
                                               glbrovey@ic.fbi.gov. Written comments                                                                         arrangements. To register for the
                                                                                                         (6) An estimate of the total public
                                               and/or suggestions can also be sent to                                                                        workshop, please send an email to
                                                                                                       burden (in hours) associated with the
                                               the Office of Management and Budget,                                                                          bactp@justnet.org by 5:00 p.m. Eastern
                                                                                                       collection: There are an estimated 60
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                                               Office of Information and Regulatory                                                                          time on September 7, 2018, and provide
                                                                                                       total annual burden hours associated
                                               Affairs, Attention Department of Justice                                                                      the name of your company and the
                                                                                                       with this collection.
                                               Desk Officer, Washington, DC 20503 or                     If additional information is required               names of the representatives who will
                                               sent to OIRA_submissions@                               contact: Melody Braswell, Department                  attend. A preliminary agenda will be
                                               omb.eop.gov.                                            Clearance Officer, United States                      sent to registered attendees
                                               SUPPLEMENTARY INFORMATION:  Written                     Department of Justice, Justice                        approximately one week prior to the
                                               comments and suggestions from the                       Management Division, Policy and                       workshop.


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Document Created: 2018-08-15 01:26:26
Document Modified: 2018-08-15 01:26:26
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 October 15, 2018.
FR Citation83 FR 40567 

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