83_FR_44842 83 FR 44672 - Bulk Manufacturer of Controlled Substances Application: National Center for Natural Products Research NIDA MPROJECT

83 FR 44672 - Bulk Manufacturer of Controlled Substances Application: National Center for Natural Products Research NIDA MPROJECT

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 170 (August 31, 2018)

Page Range44672-44673
FR Document2018-18983

Federal Register, Volume 83 Issue 170 (Friday, August 31, 2018)
[Federal Register Volume 83, Number 170 (Friday, August 31, 2018)]
[Notices]
[Pages 44672-44673]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18983]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: National 
Center for Natural Products Research NIDA MPROJECT

ACTION: Notice of application.

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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 30, 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 
pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on July 
6, 2018, National Center for Natural Products Research NIDA MPROJECT, 
University of Mississippi, 135 Coy Waller Complex, P.O. Box 1848, 
University, Mississippi 38677-1848 applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

------------------------------------------------------------------------
       Controlled substance             Drug code           Schedule
------------------------------------------------------------------------
Marihuana Extract.................  7350.............  I
Marihuana.........................  7360.............  I
Tetrahydrocannabinols.............  7370.............  I
------------------------------------------------------------------------


[[Page 44673]]

    The company plans to bulk manufacture the listed controlled 
substances to make available to the National Institute on Drug Abuse 
(NIDA) a supply of bulk marihuana for distribution to research 
investigators in support of the national research program needs. No 
other activities for these drug codes are authorized for this 
registration.

     Dated: August 22, 2018.
John J. Martin,
Assistant Administrator.
[FR Doc. 2018-18983 Filed 8-30-18; 8:45 am]
 BILLING CODE 4410-09-P



                                               44672                         Federal Register / Vol. 83, No. 170 / Friday, August 31, 2018 / Notices

                                               complaint can be accessed on the                           (ii) identify any public health, safety,             Issued: August 27, 2018.
                                               Commission’s electronic docket (EDIS)                   or welfare concerns in the United States              Katherine Hiner,
                                               at https://edis.usitc.gov, and will be                  relating to the recommended orders;                   Supervisory Attorney.
                                               available for inspection during official                   (iii) identify like or directly                    [FR Doc. 2018–18886 Filed 8–30–18; 8:45 am]
                                               business hours (8:45 a.m. to 5:15 p.m.)                 competitive articles that complainant,                BILLING CODE 7020–02–P
                                               in the Office of the Secretary, U.S.                    its licensees, or third parties make in the
                                               International Trade Commission, 500 E                   United States which could replace the
                                               Street SW, Washington, DC 20436,                        subject articles if they were to be                   DEPARTMENT OF JUSTICE
                                               telephone (202) 205–2000.                               excluded;
                                                  General information concerning the                      (iv) indicate whether complainant,                 Drug Enforcement Administration
                                               Commission may also be obtained by                      complainant’s licensees, and/or third
                                               accessing its internet server (https://                                                                       [Docket No. DEA–392]
                                                                                                       party suppliers have the capacity to
                                               www.usitc.gov). The public record for                   replace the volume of articles                        Bulk Manufacturer of Controlled
                                               this investigation may be viewed on the                 potentially subject to the recommended                Substances Application: National
                                               Commission’s electronic docket (EDIS)                   exclusion order and/or a cease and                    Center for Natural Products Research
                                               at https://edis.usitc.gov. Hearing-                     desist order within a commercially                    NIDA MPROJECT
                                               impaired persons are advised that                       reasonable time; and
                                               information on this matter can be                          (v) explain how the limited exclusion              ACTION:    Notice of application.
                                               obtained by contacting the                              order and cease and desist orders would
                                               Commission’s TDD terminal on (202)                      impact consumers in the United States.                DATES:  Registered bulk manufacturers of
                                               205–1810.                                                                                                     the affected basic classes, and
                                                                                                          Written submissions from the public
                                               SUPPLEMENTARY INFORMATION: Section                                                                            applicants therefore, may file written
                                                                                                       must be filed no later than by close of
                                               337 of the Tariff Act of 1930 provides                                                                        comments on or objections to the
                                                                                                       business on September 13, 2018.
                                               that if the Commission finds a violation                                                                      issuance of the proposed registration on
                                                                                                          Persons filing written submissions                 or before October 30, 2018.
                                               it shall exclude the articles concerned                 must file the original document
                                               from the United States:                                                                                       ADDRESSES: Written comments should
                                                                                                       electronically on or before the deadlines
                                               unless, after considering the effect of such                                                                  be sent to: Drug Enforcement
                                                                                                       stated above and submit 8 true paper
                                               exclusion upon the public health and                                                                          Administration, Attention: DEA Federal
                                                                                                       copies to the Office of the Secretary by
                                               welfare, competitive conditions in the United                                                                 Register Representative/DRW, 8701
                                                                                                       noon the next day pursuant to section
                                               States economy, the production of like or                                                                     Morrissette Drive, Springfield, Virginia
                                                                                                       210.4(f) of the Commission’s Rules of
                                               directly competitive articles in the United                                                                   22152.
                                               States, and United States consumers, it finds           Practice and Procedure (19 CFR
                                                                                                       210.4(f)). Submissions should refer to                SUPPLEMENTARY INFORMATION: The
                                               that such articles should not be excluded
                                               from entry.                                             the investigation number (‘‘Inv. No.                  Attorney General has delegated his
                                                                                                       337–TA–1050’’) in a prominent place on                authority under the Controlled
                                               19 U.S.C. 1337(d)(1). A similar                         the cover page and/or the first page. (See            Substances Act to the Administrator of
                                               provision applies to cease and desist                   Handbook for Electronic Filing                        the Drug Enforcement Administration
                                               orders. 19 U.S.C. 1337(f)(1).                           Procedures, https://www.usitc.gov/                    (DEA), 28 CFR 0.100(b). Authority to
                                                  The Commission is interested in                      secretary/documents/handbook_on_                      exercise all necessary functions with
                                               further development of the record on                    filing_procedures.pdf.) Persons with                  respect to the promulgation and
                                               the public interest in these                            questions regarding filing should                     implementation of 21 CFR part 1301,
                                               investigations. Accordingly, parties are                contact the Secretary (202–205–2000).                 incident to the registration of
                                               to file public interest submissions                                                                           manufacturers, distributors, dispensers,
                                               pursuant to pursuant to 19 CFR                             Any person desiring to submit a
                                                                                                       document to the Commission in                         importers, and exporters of controlled
                                               210.50(a)(4). In addition, members of                                                                         substances (other than final orders in
                                               the public are hereby invited to file                   confidence must request confidential
                                                                                                       treatment. All such requests should be                connection with suspension, denial, or
                                               submissions of no more than five (5)                                                                          revocation of registration) has been
                                               pages, inclusive of attachments,                        directed to the Secretary to the
                                                                                                       Commission and must include a full                    redelegated to the Assistant
                                               concerning the public interest in light of                                                                    Administrator of the DEA Diversion
                                               the administrative law judge’s                          statement of the reasons why the
                                                                                                       Commission should grant such                          Control Division pursuant to section 7
                                               Recommended Determination on                                                                                  of 28 CFR part 0, appendix to subpart
                                               Remedy and Bonding issued in this                       treatment. See 19 CFR 201.6. Documents
                                                                                                       for which confidential treatment by the               R.
                                               investigation on July 23, 2018.                                                                                  In accordance with 21 CFR
                                               Comments should address whether                         Commission is properly sought will be
                                                                                                       treated accordingly. A redacted non-                  1301.33(a), this is notice that on July 6,
                                               issuance of a limited exclusion order                                                                         2018, National Center for Natural
                                               and cease and desist orders in this                     confidential version of the document
                                                                                                       must also be filed simultaneously with                Products Research NIDA MPROJECT,
                                               investigation directed to respondents’                                                                        University of Mississippi, 135 Coy
                                               LiSi Press products would affect the                    any confidential filing. All non-
                                                                                                       confidential written submissions will be              Waller Complex, P.O. Box 1848,
                                               public health and welfare in the United                                                                       University, Mississippi 38677–1848
                                               States, competitive conditions in the                   available for public inspection at the
                                                                                                       Office of the Secretary and on EDIS.                  applied to be registered as a bulk
                                               United States economy, the production                                                                         manufacturer of the following basic
                                               of like or directly competitive articles in                The authority for the Commission’s
                                                                                                                                                             classes of controlled substances:
daltland on DSKBBV9HB2PROD with NOTICES




                                               the United States, or United States                     determination is contained in section
                                               consumers.                                              337 of the Tariff Act of 1930, as                                                    Drug
                                                                                                       amended (19 U.S.C. 1337), and in Part                  Controlled substance                  Schedule
                                                  In particular, the Commission is                                                                                                          code
                                               interested in comments that:                            210 of the Commission’s Rules of
                                                  (i) Explain how the articles                         Practice and Procedure (19 CFR part                   Marihuana Extract ......        7350   I
                                                                                                       210).                                                 Marihuana ..................    7360   I
                                               potentially subject to the recommended                                                                        Tetrahydrocannabinols           7370   I
                                               orders are used in the United States;                     By order of the Commission.



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                                                                             Federal Register / Vol. 83, No. 170 / Friday, August 31, 2018 / Notices                                           44673

                                                 The company plans to bulk                             may be examined electronically at                     continue to experience delays in
                                               manufacture the listed controlled                       http://www.justice.gov/enrd/Consent_                  receiving mail in the Washington, DC
                                               substances to make available to the                     Decrees.html.                                         area, commenters are strongly
                                               National Institute on Drug Abuse                                                                              encouraged to transmit their comments
                                                                                                       Cherie L. Rogers,
                                               (NIDA) a supply of bulk marihuana for                                                                         electronically via email or to submit
                                               distribution to research investigators in               Assistant Section Chief, Environmental                them by mail early. Comments,
                                                                                                       Defense Section, Environment and Natural
                                               support of the national research                                                                              including any personal information
                                                                                                       Resources Division.
                                               program needs. No other activities for                                                                        provided, become a matter of public
                                                                                                       [FR Doc. 2018–18871 Filed 8–30–18; 8:45 am]
                                               these drug codes are authorized for this                                                                      record. They will also be summarized
                                                                                                       BILLING CODE 4410–15–P
                                               registration.                                                                                                 and/or included in the request for Office
                                                 Dated: August 22, 2018.                                                                                     of Management and Budget (OMB)
                                               John J. Martin,                                                                                               approval of the information collection
                                                                                                       DEPARTMENT OF LABOR                                   request.
                                               Assistant Administrator.
                                               [FR Doc. 2018–18983 Filed 8–30–18; 8:45 am]             Wage and Hour Division                                FOR FURTHER INFORMATION CONTACT:
                                               BILLING CODE 4410–09–P
                                                                                                                                                             Robert Waterman, Compliance
                                                                                                       Agency Information Collection                         Specialist, Division of Regulations,
                                                                                                       Activities; Comment Request;                          Legislation, and Interpretation, Wage
                                               DEPARTMENT OF JUSTICE                                   Information Collections: Work Study                   and Hour Division, U.S. Department of
                                                                                                       Program of the Child Labor                            Labor, Room S–3502, 200 Constitution
                                               Corrected Notice of Lodging Proposed                    Regulations                                           Avenue NW, Washington, DC 20210;
                                               Consent Decree                                                                                                telephone: (202) 693–0406 (this is not a
                                                                                                       AGENCY: Wage and Hour Division,                       toll-free number). Copies of this notice
                                                  In accordance with Departmental                      Department of Labor,                                  may be obtained in alternative formats
                                               Policy, 28 CFR 50.7, notice is hereby                   ACTION: Notice.                                       (Large Print, Braille, Audio Tape, or
                                               given that a proposed Consent Decree in
                                               United States v. Richard M. Osborne,                                                                          Disc), upon request, by calling (202)
                                                                                                       SUMMARY:   The Department of Labor                    693–0023 (not a toll-free number). TTY/
                                               Sr., et al., Case No. 1:11–cv–2039–CAB,                 (DOL) is soliciting comments
                                               was lodged with the United States                                                                             TTD callers may dial toll-free (877) 889–
                                                                                                       concerning a proposed extension to the                5627 to obtain information or request
                                               District Court for the Northern District                information collection request (ICR)
                                               of Ohio on August 10, 2018.                                                                                   materials in alternative formats.
                                                                                                       titled, ‘‘Work-Study Program of the
                                                  This proposed Consent Decree                                                                               SUPPLEMENTARY INFORMATION:
                                                                                                       Child Labor Regulations.’’ This                          I. Background: The Wage and Hour
                                               concerns a complaint filed by the                       comment request is part of continuing
                                               United States against Defendants                                                                              Division (WHD) of the Department of
                                                                                                       Departmental efforts to reduce                        Labor administers the Fair Labor
                                               Richard M. Osborne, Sr., Great Plains                   paperwork and respondent burden in
                                               Exploration, LLC, Center Street                                                                               Standards Act (FLSA). Section 3(l) of
                                                                                                       accordance with the Paperwork                         the Act establishes a minimum age of 16
                                               Investments, Inc., Callendar Real Estate                Reduction Act of 1995 (PRA), 44 U.S.C.
                                               Development Company, LLC, and Osair,                                                                          years for most nonagricultural
                                                                                                       3501 et seq.                                          employment, but allows the
                                               Inc., pursuant to Sections 301(a), 309(b),                 This program helps to ensure that
                                               and 309(d) of the Clean Water Act, 33                                                                         employment of 14- and 15-year olds in
                                                                                                       requested data can be provided in the                 occupations other than manufacturing
                                               U.S.C. 1311(a), 1319(b), and 1319(d), to                desired format, reporting burden (time
                                               obtain injunctive relief from and impose                                                                      and mining if the Secretary of Labor
                                                                                                       and financial resources) is minimized,                determines such employment is
                                               civil penalties against the Defendants                  collection instruments are clearly
                                               for violating the Clean Water Act by                                                                          confined to: (1) Periods that will not
                                                                                                       understood, and the impact of collection              interfere with the minor’s schooling;
                                               discharging pollutants without a permit                 requirements on respondents can be
                                               into waters of the United States. The                                                                         and (2) conditions that will not interfere
                                                                                                       properly assessed. A copy of the                      with the minor’s health and well-being.
                                               proposed Consent Decree resolves these                  proposed information request can be
                                               allegations by requiring the Defendants                                                                       FLSA section 11(c) requires all covered
                                                                                                       obtained by contacting the office listed              employers to make, keep, and preserve
                                               to mitigate for the harms caused by the                 below in the FOR FURTHER INFORMATION
                                               impacted areas.                                                                                               records of their employees’ wages,
                                                                                                       CONTACT section of this Notice.
                                                  The Department of Justice will accept                                                                      hours, and other conditions and
                                               written comments relating to this                       DATES: Written comments must be                       practices of employment. Section 11(c)
                                               proposed Consent Decree for thirty (30)                 submitted to the office listed in the                 authorizes the Secretary of Labor to
                                               days from the date of publication of this               ADDRESSES section below on or before                  prescribe the recordkeeping and
                                               Corrected Notice. Please address                        October 30, 2018.                                     reporting requirements for these
                                               comments to Phillip R. Dupré, United                   ADDRESSES: You may submit comments                    records. The regulations set forth
                                               State Department of Justice,                            identified by Control Number 1235–                    reporting requirements that include a
                                               Environment and Natural Resources                       0024, by either one of the following                  Work Study Program application and
                                               Division, Post Office Box 7611,                         methods: Email: WHDPRAComments@                       written participation agreement. In
                                               Washington, DC 20044–7611 and refer                     dol.gov; Mail, Hand Delivery, Courier:                order to utilize the child labor work
                                               to United States v. Richard M. Osborne,                 Division of Regulations, Legislation, and             study provisions, § 570.35(b) requires a
                                               Sr., et al., Case No. 1:11–cv–2039–CAB,                 Interpretation, Wage and Hour, U.S.                   local public or private school system to
                                               DJ #90–5–1–1–18628.                                     Department of Labor, Room S–3502, 200                 file with the Wage and Hour Division
daltland on DSKBBV9HB2PROD with NOTICES




                                                  The proposed Consent Decree may be                   Constitution Avenue NW, Washington,                   Administrator an application for
                                               examined at the Clerk’s Office, United                  DC 20210. Instructions: Please submit                 approval of a Work Study Program as
                                               States District Court for the Northern                  one copy of your comments by only one                 one that does not interfere with the
                                               District of Ohio, Carl B. Stokes United                 method. All submissions received must                 schooling or health and well-being of
                                               States Courthouse, 801 West Superior                    include the agency name and Control                   the minors involved. The regulations
                                               Avenue, Cleveland, OH 44113. In                         Number identified above for this                      also require preparation of a written
                                               addition, the proposed Consent Decree                   information collection. Because we                    participation agreement for each student


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Document Created: 2018-08-31 00:53:54
Document Modified: 2018-08-31 00:53:54
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 30, 2018.
FR Citation83 FR 44672 

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