81_FR_64692 81 FR 64510 - Bulk Manufacturer of Controlled Substances Application: Euticals Inc.

81 FR 64510 - Bulk Manufacturer of Controlled Substances Application: Euticals Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 182 (September 20, 2016)

Page Range64510-64510
FR Document2016-22527

Federal Register, Volume 81 Issue 182 (Tuesday, September 20, 2016)
[Federal Register Volume 81, Number 182 (Tuesday, September 20, 2016)]
[Notices]
[Page 64510]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-22527]



[[Page 64510]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Euticals 
Inc.

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 in accordance with 21 CFR 
1301.33(a) on or before November 21, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
authority under the Controlled Substances Act to the Administrator of 
the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, 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 Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant Administrator'') pursuant to section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on July 
4, 2016, Euticals, Inc., 2460 W. Bennett Street, Springfield, Missouri 
65807-1229 applied to be registered as a bulk manufacturer the 
following basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid (2010)...........  I
Amphetamine (1100).........................  II
Lisdexamfetamine (1205)....................  II
Methylphenidate (1724).....................  II
Phenylacetone (8501).......................  II
Methadone (9250)...........................  II
Methadone intermediate (9254)..............  II
Tapentadol (9780)..........................  II
------------------------------------------------------------------------

    The company plans to manufacture the listed controlled substances 
in bulk for distribution and sale to its customers.

    Dated: September 12, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-22527 Filed 9-19-16; 8:45 am]
 BILLING CODE 4410-09-P



                                                64510                        Federal Register / Vol. 81, No. 182 / Tuesday, September 20, 2016 / Notices

                                                DEPARTMENT OF JUSTICE                                       Dated: September 12, 2016.                          other forms of information technology,
                                                                                                          Louis J. Milione,                                     e.g., permitting electronic submission of
                                                Drug Enforcement Administration                           Deputy Assistant Administrator.                       responses.
                                                                                                          [FR Doc. 2016–22527 Filed 9–19–16; 8:45 am]           Overview of This Information
                                                [Docket No. DEA–392]                                      BILLING CODE 4410–09–P                                Collection
                                                Bulk Manufacturer of Controlled                                                                                    (1) Type of Information Collection:
                                                Substances Application: Euticals Inc.                     DEPARTMENT OF JUSTICE                                 Extension of a Currently Approved
                                                                                                                                                                Collection.
                                                ACTION:    Notice of application.                         [OMB Number 1122–0024]                                   (2) Title of the Form/Collection: Semi-
                                                                                                                                                                Annual Progress Report for Grantees
                                                                                                          Agency Information Collection                         from the Tribal Sexual Assault Services
                                                DATES:  Registered bulk manufacturers of                  Activities; Proposed eCollection
                                                the affected basic classes, and                                                                                 Program.
                                                                                                          eComments Requested; Extension of a                      (3) Agency form number, if any, and
                                                applicants therefore, may file written                    Currently Approved Collection                         the applicable component of the
                                                comments on or objections to the
                                                                                                          AGENCY:  Office on Violence Against                   Department of Justice sponsoring the
                                                issuance of the proposed registration in
                                                                                                          Women, Department of Justice.                         collection: Form Number: 1122–0024.
                                                accordance with 21 CFR 1301.33(a) on
                                                                                                                                                                U.S. Department of Justice, Office on
                                                or before November 21, 2016.                              ACTION: 60-Day notice.
                                                                                                                                                                Violence Against Women.
                                                ADDRESSES:   Written comments should                      SUMMARY:   The Department of Justice,                    (4) Affected public who will be asked
                                                be sent to: Drug Enforcement                              Office on Violence Against Women                      or required to respond, as well as a brief
                                                Administration, Attention: DEA Federal                    (OVW) will be submitting the following                abstract: The affected public includes
                                                Register Representative/ODW, 8701                         information collection request to the                 the approximately 15 grantees of the
                                                Morrissette Drive, Springfield, Virginia                  Office of Management and Budget                       Tribal Sexual Assault Services Program.
                                                22152.                                                    (OMB) for review and approval in                      The Sexual Assault Services Program
                                                                                                          accordance with the Paperwork                         (SASP), created by the Violence Against
                                                SUPPLEMENTARY INFORMATION:      The                                                                             Women Act of 2005 (VAWA 2005), is
                                                Attorney General has delegated her                        Reduction Act of 1995.
                                                                                                                                                                the first federal funding stream solely
                                                authority under the Controlled                            DATES: Comments are encouraged and
                                                                                                                                                                dedicated to the provision of direct
                                                Substances Act to the Administrator of                    will be accepted for 60 days until
                                                                                                                                                                intervention and related assistance for
                                                the Drug Enforcement Administration                       November 21, 2016.
                                                                                                                                                                victims of sexual assault. The SASP
                                                (DEA), 28 CFR 0.100(b). Authority to                      FOR FURTHER INFORMATION CONTACT: If                   encompasses four different funding
                                                exercise all necessary functions with                     you have additional comments                          streams for States and Territories,
                                                respect to the promulgation and                           especially on the estimated public                    Tribes, State Sexual Assault Coalitions,
                                                implementation of 21 CFR part 1301,                       burden or associated response time,                   Tribal Coalitions, and culturally specific
                                                incident to the registration of                           suggestions, or need a copy of the                    organizations. Overall, the purpose of
                                                manufacturers, distributors, dispensers,                  proposed information collection                       SASP is to provide intervention,
                                                importers, and exporters of controlled                    instrument with instructions or                       advocacy, accompaniment, support
                                                substances (other than final orders in                    additional information, please contact                services, and related assistance for
                                                connection with suspension, denial, or                    Cathy Poston, Office on Violence                      adult, youth, and child victims of sexual
                                                revocation of registration) has been                      Against Women, at 202–514–5430 or                     assault, family and household members
                                                redelegated to the Deputy Assistant                       Catherine.poston@usdoj.gov.                           of victims, and those collaterally
                                                Administrator of the DEA Office of                        SUPPLEMENTARY INFORMATION:                            affected by the sexual assault.
                                                Diversion Control (‘‘Deputy Assistant                        Written comments and suggestions                      The Tribal SASP supports efforts to
                                                Administrator’’) pursuant to section 7 of                 from the public and affected agencies                 help survivors heal from sexual assault
                                                28 CFR part 0, appendix to subpart R.                     concerning the proposed collection of                 trauma through direct intervention and
                                                  In accordance with 21 CFR                               information are encouraged. Your                      related assistance from social service
                                                1301.33(a), this is notice that on July 4,                comments should address one or more                   organizations such as rape crisis centers
                                                2016, Euticals, Inc., 2460 W. Bennett                     of the following four points:                         through 24-hour sexual assault hotlines,
                                                Street, Springfield, Missouri 65807–                         (1) Evaluate whether the proposed                  crisis intervention, and medical and
                                                1229 applied to be registered as a bulk                   collection of information is necessary                criminal justice accompaniment. The
                                                manufacturer the following basic classes                  for the proper performance of the                     Tribal SASP will support such services
                                                of controlled substances:                                 functions of the agency, including                    through the establishment,
                                                                                                          whether the information will have                     maintenance, and expansion of rape
                                                        Controlled substance                 Schedule     practical utility;                                    crisis centers and other programs and
                                                                                                             (2) Evaluate the accuracy of the                   projects to assist those victimized by
                                                Gamma      Hydroxybutyric          Acid      I
                                                  (2010).
                                                                                                          agency’s estimate of the burden of the                sexual assault.
                                                Amphetamine (1100) ....................      II           proposed collection of information,                      (5) An estimate of the total number of
                                                Lisdexamfetamine (1205) .............        II           including the validity of the                         respondents and the amount of time
                                                Methylphenidate (1724) ................      II           methodology and assumptions used;                     estimated for an average respondent to
                                                Phenylacetone (8501) ..................      II              (3) Enhance the quality, utility, and              respond/reply: It is estimated that it will
                                                                                                                                                                take the approximately 15 respondents
sradovich on DSK3GMQ082PROD with NOTICES




                                                Methadone (9250) ........................    II           clarity of the information to be
                                                Methadone intermediate (9254) ...            II           collected; and                                        (grantees from the Tribal Sexual Assault
                                                Tapentadol (9780) ........................   II              (4) Minimize the burden of the                     Services Program) approximately one
                                                                                                          collection of information on those who                hour to complete a semi-annual progress
                                                  The company plans to manufacture                        are to respond, including through the                 report. The semi-annual progress report
                                                the listed controlled substances in bulk                  use of appropriate automated,                         is divided into sections that pertain to
                                                for distribution and sale to its                          electronic, mechanical, or other                      the different types of activities in which
                                                customers.                                                technological collection techniques or                grantees may engage. A Tribal SASP


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Document Created: 2018-02-09 13:20:32
Document Modified: 2018-02-09 13:20:32
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 in accordance with 21 CFR 1301.33(a) on or before November 21, 2016.
FR Citation81 FR 64510 

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