80_FR_50201 80 FR 50042 - Drug Enforcement Administration

80 FR 50042 - Drug Enforcement Administration

DEPARTMENT OF JUSTICE

Federal Register Volume 80, Issue 159 (August 18, 2015)

Page Range50042-50043
FR Document2015-20344

Federal Register, Volume 80 Issue 159 (Tuesday, August 18, 2015)
[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50042-50043]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20344]


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

 DEPARTMENT OF JUSTICE

[Docket No. 13-29]


Drug Enforcement Administration

Matthew Valentine/Liar Catchers; Order

    On April 5, 2013, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Matthew Valentine (hereinafter, Applicant), of Lexington, 
Kentucky. The Show Cause Order proposed the denial of Applicant's 
pending application for a DEA Certificate of Registration as a 
Researcher, which would authorize Applicant to possess and use 
controlled substances as a canine handler, on the ground that his 
registration would be inconsistent with the public interest. GX 1, at 1 
(citing 21 U.S.C. 823(f)).
    On April 29, 2013, Applicant, acting pro se, filed a request for a 
hearing with the DEA Office of Administrative Law Judges. GX 2. After 
the matter was assigned to an Administrative Law Judge (ALJ), Applicant 
submitted a letter in which he requested to withdraw his application. 
GX 3. Therein, Applicant stated that he was ``not in a position to 
fight this legal battle at this time.'' Id. A few weeks later, 
Applicant requested a stay until May 31, 2013, see GX 4, which was 
granted by the ALJ. See GX 5.
    Upon presentation of Applicant's withdrawal request to the Office 
of Diversion Control (OD), the latter advised Government Counsel that 
it would accept the request only if Applicant agreed not to reapply for 
three years. Request for Final Agency Action, at 3. Applicant rejected 
OD's offer. Id. Thereafter, OD made a subsequent offer that would have 
allowed Applicant to withdraw if he agreed not to reapply for two 
years. Id. Applicant also rejected this offer. Id.
    According to Government Counsel, on May 22, 2012, OD, ``without 
providing a basis for its decision,'' notified the former that it had 
rejected Applicant's withdrawal request and ``instructed Chief Counsel 
to take the matter to hearing.'' Id. The next day, Government Counsel 
notified the ALJ of OD's decision. The ALJ then vacated the stay and 
set the matter for hearing. GX 7, at 1-2.
    On May 29, 2013, Applicant submitted a request to waive his right 
to a hearing and submitted various documents in support of his 
application. GX 8. The ALJ then ordered that the proceeding be 
terminated. GX 9. Thereafter, on October 29, 2013, the Government 
submitted a Request for Final Agency Action. Req. for Final Agency 
Action, at 15. Therein, the Government sought the denial of Applicant's 
application. Id. at 1.
    Upon review, the then-Administrator denied the Government's 
request. Order of the Administrator, at 3 (May 2, 2015) (hereinafter, 
Order). The then-Administrator specifically explained that under a DEA 
regulation, ```[a]n application may be amended or withdrawn with 
permission of the Administrator at any time where good cause is shown 
by the applicant or where the amendment or withdrawal is in the public 
interest.''' Id. at 2 (quoting 21 CFR 1301.16(a)). The then-
Administrator also relied on section 555(e) of the Administrative 
Procedure Act, which provides that:

    Prompt notice shall be given of the denial in whole or in part 
of a written application, petition, or other request of an 
interested person made in connection with any agency proceedings. 
Except in affirming a prior denial or when the denial is self-
explanatory, the notice shall be accompanied by a brief statement of 
the grounds for denial.

5 U.S.C. 555(e) (quoted in Order, at 2).

    Based on the plain language of section 555(e), the then-
Administrator held that Applicant's withdrawal request clearly was a 
``request of an interested person made in connection with [an] agency 
proceeding.'' Order, at 2. She further noted that the grounds for 
denying Applicant's withdrawal request were not ``self-explanatory,'' 
and were, in fact, ``totally unknown.'' Id. Accordingly, the then-
Administrator held that the Office of Diversion Control was required to 
provide Applicant with a `` `notice,' '' which was `` `accompanied by a 
brief statement of the grounds for

[[Page 50043]]

denial' '' of his withdrawal request. Id. at 3 (quoting 5 U.S.C. 
555(e)).
    Because the Office of Diversion Control had not complied with 
section 555(e), the then-Administrator denied the Government's Request 
for Final Agency Action. Id. The then-Administrator returned the record 
to the Government's Counsel, with the instruction that its Request 
should not be re-submitted until such time as the Office of Diversion 
Control complied with 5 U.S.C. 555(e) and explained why Applicant has 
not demonstrated good cause to withdraw his application, as well as why 
the withdrawal is not in the public interest. Id.
    On August 7, 2015, Government Counsel filed a Request for Dismissal 
of Order to Show Cause. Therein, Government Counsel represents that on 
July 30, 3015, the Office of Diversion Control had decided to allow 
Respondent to withdraw his application. The Government therefore 
requests an Order dismissing the Show Cause Order.
    Because the Office of Diversion Control has granted Respondent's 
withdrawal request, there is no longer an application to act upon and 
the case is now moot. See Thomas E. Mitchell, 76 FR 20032, 20033 
(2011). Accordingly, I grant the Government's Request and dismiss the 
Order to Show Cause.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well 
as 28 CFR 0.100(b), I order that the Order to Show Cause issued to 
Matthew Valentine/Liar Catchers be, and it hereby is, dismissed. This 
Order is effective immediately.

    Dated: August 10, 2015.
Chuck Rosenberg,
Acting-Administrator.
[FR Doc. 2015-20344 Filed 8-17-15; 8:45 am]
 BILLING CODE 4410-09-P



                                                    50042                                   Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices

                                                                                                                                          Controlled substance                                                                                                      Schedule

                                                    Psilocyn (7438) ............................................................................................................................................................................................    I
                                                    5-Methoxy-N,N-diisopropyltryptamine (7439) ..............................................................................................................................................                       I
                                                    N-Ethyl-1-phenylcyclohexylamine (7455) ....................................................................................................................................................                     I
                                                    1-(1-Phenylcyclohexyl)pyrrolidine (7458) ....................................................................................................................................................                   I
                                                    1-[1-(2-Thienyl)cyclohexyl]piperidine (7470) ...............................................................................................................................................                    I
                                                    2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C–E) (7509) .....................................................................................................................                                  I
                                                    2-(2,5-Dimethoxyphenyl) ethanamine (2C–H) (7517) .................................................................................................................................                              I
                                                    2-(4-lodo-2,5-dimethoxyphenyl) ethanamine (2C–I) (7518) ........................................................................................................................                                I
                                                    2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine (2C–T–4) (7532) ....................................................................................................                                        I
                                                    Dihydromorphine (9145) ..............................................................................................................................................................................           I
                                                    Heroin (9200) ...............................................................................................................................................................................................   I
                                                    Normorphine (9313) ....................................................................................................................................................................................         I
                                                    Methamphetamine (1105) ...........................................................................................................................................................................              II
                                                    1-Phenylcyclohexylamine (7460) .................................................................................................................................................................                II
                                                    Phencyclidine (7471) ...................................................................................................................................................................................        II
                                                    Phenylacetone (8501) .................................................................................................................................................................................          II
                                                    1-Piperidinocyclohexanecarbonitrile (8603) ................................................................................................................................................                     II
                                                    Cocaine (9041) ............................................................................................................................................................................................     II
                                                    Codeine (9050) ............................................................................................................................................................................................     II
                                                    Dihydrocodeine (9120) ................................................................................................................................................................................          II
                                                    Ecgonine (9180) ..........................................................................................................................................................................................      II
                                                    Meperidine intermediate-B (9233) ...............................................................................................................................................................                II
                                                    Morphine (9300) ..........................................................................................................................................................................................      II
                                                    Noroxymorphone (9668) ..............................................................................................................................................................................            II



                                                      The company plans to manufacture                                         letter in which he requested to                                              Government sought the denial of
                                                    high purity drug standards used for                                        withdraw his application. GX 3.                                              Applicant’s application. Id. at 1.
                                                    analytical applications only in clinical,                                  Therein, Applicant stated that he was                                          Upon review, the then-Administrator
                                                    toxicological, and forensic laboratories                                   ‘‘not in a position to fight this legal                                      denied the Government’s request. Order
                                                    and for distribution to its customers.                                     battle at this time.’’ Id. A few weeks                                       of the Administrator, at 3 (May 2, 2015)
                                                      Dated: August 10, 2015.                                                  later, Applicant requested a stay until                                      (hereinafter, Order). The then-
                                                    Joseph T. Rannazzisi,                                                      May 31, 2013, see GX 4, which was                                            Administrator specifically explained
                                                    Deputy Assistant Administrator.
                                                                                                                               granted by the ALJ. See GX 5.                                                that under a DEA regulation, ‘‘‘[a]n
                                                                                                                                  Upon presentation of Applicant’s                                          application may be amended or
                                                    [FR Doc. 2015–20283 Filed 8–17–15; 8:45 am]
                                                                                                                               withdrawal request to the Office of                                          withdrawn with permission of the
                                                    BILLING CODE 4410–09–P
                                                                                                                               Diversion Control (OD), the latter                                           Administrator at any time where good
                                                                                                                               advised Government Counsel that it                                           cause is shown by the applicant or
                                                    DEPARTMENT OF JUSTICE                                                      would accept the request only if                                             where the amendment or withdrawal is
                                                                                                                               Applicant agreed not to reapply for                                          in the public interest.’’’ Id. at 2 (quoting
                                                    [Docket No. 13–29]                                                         three years. Request for Final Agency                                        21 CFR 1301.16(a)). The then-
                                                                                                                               Action, at 3. Applicant rejected OD’s                                        Administrator also relied on section
                                                    Drug Enforcement Administration                                            offer. Id. Thereafter, OD made a                                             555(e) of the Administrative Procedure
                                                                                                                               subsequent offer that would have                                             Act, which provides that:
                                                    Matthew Valentine/Liar Catchers;
                                                                                                                               allowed Applicant to withdraw if he                                            Prompt notice shall be given of the denial
                                                    Order
                                                                                                                               agreed not to reapply for two years. Id.                                     in whole or in part of a written application,
                                                       On April 5, 2013, the Deputy                                            Applicant also rejected this offer. Id.                                      petition, or other request of an interested
                                                    Assistant Administrator, Office of                                            According to Government Counsel, on                                       person made in connection with any agency
                                                    Diversion Control, Drug Enforcement                                        May 22, 2012, OD, ‘‘without providing                                        proceedings. Except in affirming a prior
                                                                                                                               a basis for its decision,’’ notified the                                     denial or when the denial is self-explanatory,
                                                    Administration, issued an Order to                                                                                                                      the notice shall be accompanied by a brief
                                                    Show Cause to Matthew Valentine                                            former that it had rejected Applicant’s
                                                                                                                                                                                                            statement of the grounds for denial.
                                                    (hereinafter, Applicant), of Lexington,                                    withdrawal request and ‘‘instructed
                                                                                                                               Chief Counsel to take the matter to                                          5 U.S.C. 555(e) (quoted in Order, at 2).
                                                    Kentucky. The Show Cause Order
                                                    proposed the denial of Applicant’s                                         hearing.’’ Id. The next day, Government                                         Based on the plain language of section
                                                    pending application for a DEA                                              Counsel notified the ALJ of OD’s                                             555(e), the then-Administrator held that
                                                    Certificate of Registration as a                                           decision. The ALJ then vacated the stay                                      Applicant’s withdrawal request clearly
                                                    Researcher, which would authorize                                          and set the matter for hearing. GX 7, at                                     was a ‘‘request of an interested person
                                                    Applicant to possess and use controlled                                    1–2.                                                                         made in connection with [an] agency
                                                    substances as a canine handler, on the                                        On May 29, 2013, Applicant                                                proceeding.’’ Order, at 2. She further
                                                    ground that his registration would be                                      submitted a request to waive his right to                                    noted that the grounds for denying
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    inconsistent with the public interest. GX                                  a hearing and submitted various                                              Applicant’s withdrawal request were
                                                    1, at 1 (citing 21 U.S.C. 823(f)).                                         documents in support of his                                                  not ‘‘self-explanatory,’’ and were, in
                                                       On April 29, 2013, Applicant, acting                                    application. GX 8. The ALJ then ordered                                      fact, ‘‘totally unknown.’’ Id.
                                                    pro se, filed a request for a hearing with                                 that the proceeding be terminated. GX 9.                                     Accordingly, the then-Administrator
                                                    the DEA Office of Administrative Law                                       Thereafter, on October 29, 2013, the                                         held that the Office of Diversion Control
                                                    Judges. GX 2. After the matter was                                         Government submitted a Request for                                           was required to provide Applicant with
                                                    assigned to an Administrative Law                                          Final Agency Action. Req. for Final                                          a ‘‘ ‘notice,’ ’’ which was ‘‘ ‘accompanied
                                                    Judge (ALJ), Applicant submitted a                                         Agency Action, at 15. Therein, the                                           by a brief statement of the grounds for


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                                                                                 Federal Register / Vol. 80, No. 159 / Tuesday, August 18, 2015 / Notices                                              50043

                                                    denial’ ’’ of his withdrawal request. Id.               ADDRESSES:   Written comments should                      ACTION:   30-Day notice.
                                                    at 3 (quoting 5 U.S.C. 555(e)).                         be sent to: Drug Enforcement
                                                       Because the Office of Diversion                      Administration, Attention: DEA Federal                    SUMMARY:   The Department of Justice,
                                                    Control had not complied with section                   Register Representative/ODXL, 8701                        Office of Justice Programs, Bureau of
                                                    555(e), the then-Administrator denied                   Morrissette Drive, Springfield, Virginia                  Justice Assistance, will submit the
                                                    the Government’s Request for Final                      22152. Request for hearings should be                     following information collection request
                                                    Agency Action. Id. The then-                            sent to: Drug Enforcement                                 for review and clearance in accordance
                                                    Administrator returned the record to the                Administration, Attention: Hearing                        with the Paperwork Reduction Act of
                                                    Government’s Counsel, with the                          Clerk/LJ, 8701 Morrissette Drive,                         1995. The proposed information
                                                    instruction that its Request should not                 Springfield, Virginia 22152.                              collection was previously published in
                                                    be re-submitted until such time as the                  SUPPLEMENTARY INFORMATION: The                            80 FR 32180, on June 5, 2015, allowing
                                                    Office of Diversion Control complied                    Attorney General has delegated his                        for a 60-day comment period.
                                                    with 5 U.S.C. 555(e) and explained why                  authority under the Controlled
                                                    Applicant has not demonstrated good                                                                               DATES:  Comments are encouraged and
                                                                                                            Substances Act to the Administrator of                    will be accepted for an additional 30
                                                    cause to withdraw his application, as                   the Drug Enforcement Administration
                                                    well as why the withdrawal is not in the                                                                          days until September 17, 2015.
                                                                                                            (DEA), 28 CFR 0.100(b). Authority to
                                                    public interest. Id.                                    exercise all necessary functions with                     FOR FURTHER INFORMATION CONTACT:      If
                                                       On August 7, 2015, Government                        respect to the promulgation and                           you have additional comments,
                                                    Counsel filed a Request for Dismissal of                implementation of 21 CFR part 1301,                       suggestions, or need a copy of the
                                                    Order to Show Cause. Therein,                           incident to the registration of                           proposed information collection
                                                    Government Counsel represents that on                   manufacturers, distributors, dispensers,                  instrument with instructions or
                                                    July 30, 3015, the Office of Diversion                  importers, and exporters of controlled                    additional information, please contact
                                                    Control had decided to allow                            substances (other than final orders in                    C. Casto at 1–202–353–7193, Bureau of
                                                    Respondent to withdraw his                              connection with suspension, denial, or                    Justice Assistance, Office of Justice
                                                    application. The Government therefore                   revocation of registration) has been                      Programs, U. S. Department of Justice,
                                                    requests an Order dismissing the Show                   redelegated to the Deputy Assistant                       810 7th Street NW., Washington, DC,
                                                    Cause Order.                                            Administrator of the DEA Office of                        20531 or by email at Chris.Casto@
                                                       Because the Office of Diversion                      Diversion Control (‘‘Deputy Assistant                     usdoj.gov. You may also contact the
                                                    Control has granted Respondent’s                        Administrator’’) pursuant to section 7 of                 Office of Management and Budget,
                                                    withdrawal request, there is no longer                  28 CFR part 0, appendix to subpart R.                     Office of Information and Regulatory
                                                    an application to act upon and the case                   In accordance with 21 CFR                               Affairs, Attention Department of Justice
                                                    is now moot. See Thomas E. Mitchell,                    1301.33(a), this is notice that on April                  Desk Officer, Washington, DC 20503.
                                                    76 FR 20032, 20033 (2011).                              23, 2015, Austin Pharma LLC, 811                          Additionally, comments may be
                                                    Accordingly, I grant the Government’s                   Paloma Drive, Suite C, Round Rock,                        submitted via email to OIRA_
                                                    Request and dismiss the Order to Show                   Texas 78665–2402 applied to be                            submissions@omb.eop.gov.
                                                    Cause.                                                  registered as a bulk manufacturer of the
                                                                                                                                                                      SUPPLEMENTARY INFORMATION:    Written
                                                    Order                                                   following basic classes of controlled
                                                                                                                                                                      comments and suggestions from the
                                                                                                            substances:
                                                      Pursuant to the authority vested in me                                                                          public and affected agencies concerning
                                                    by 21 U.S.C. 823(f), as well as 28 CFR                          Controlled substance                  Schedule    the proposed collection of information
                                                    0.100(b), I order that the Order to Show                                                                          are encouraged. Your comments should
                                                    Cause issued to Matthew Valentine/Liar                  Marihuana (7360) .........................    I           address one or more of the following
                                                    Catchers be, and it hereby is, dismissed.               Tetrahydrocannabinols (7370) .....            I           four points:
                                                    This Order is effective immediately.                                                                              —Evaluate whether the proposed
                                                                                                              The company plans to manufacture
                                                      Dated: August 10, 2015.                                                                                          collection of information is necessary
                                                                                                            bulk synthetic active pharmaceutical
                                                    Chuck Rosenberg,
                                                                                                            ingredients (APIs) for product                             for the proper performance of the
                                                    Acting-Administrator.                                   development and distribution to its                        functions of the National Motor
                                                    [FR Doc. 2015–20344 Filed 8–17–15; 8:45 am]             customers. No other activity for this                      Vehicle Title Information System
                                                    BILLING CODE 4410–09–P                                  drug code is authorized for this                           (NMVTIS), including whether the
                                                                                                            registration.                                              information will have practical utility;
                                                                                                                                                                      —Evaluate the accuracy of the agency’s
                                                    DEPARTMENT OF JUSTICE                                     Dated: August 10, 2015.
                                                                                                                                                                       estimate of the burden of the
                                                                                                            Joseph T. Rannazzisi,
                                                                                                                                                                       proposed collection of information,
                                                    Drug Enforcement Administration                         Deputy Assistant Administrator.                            including the validity of the
                                                    [Docket No. DEA–392]                                    [FR Doc. 2015–20284 Filed 8–17–15; 8:45 am]                methodology and assumptions used;
                                                                                                            BILLING CODE 4410–09–P
                                                                                                                                                                      —Evaluate whether and if so how the
                                                    Bulk Manufacturer of Controlled                                                                                    quality, utility, and clarity of the
                                                    Substances Application: Austin                                                                                     information to be collected can be
                                                    Pharma LLC                                              DEPARTMENT OF JUSTICE
                                                                                                                                                                       enhanced; and
                                                                                                            [OMB Number 1121–0335]                                    —Minimize the burden of the collection
asabaliauskas on DSK5VPTVN1PROD with NOTICES




                                                    ACTION:   Notice of application.
                                                                                                            Agency Information Collection                              of information on those who are to
                                                    DATES:  Registered bulk manufacturers of                Activities; Proposed eCollection                           respond, including through the use of
                                                    the affected basic classes, and                         eComments Requested; National                              appropriate automated, electronic,
                                                    applicants therefore, may file written                  Motor Vehicle Title Information System                     mechanical, or other technological
                                                    comments on or objections to the                        (NMVTIS)                                                   collection techniques or other forms
                                                    issuance of the proposed registration in                                                                           of information technology, e.g.,
                                                    accordance with 21 CFR 1301.33(a) on                    AGENCY:Bureau of Justice Assistance,                       permitting electronic submission of
                                                    or before October 19, 2015.                             Department of Justice.                                     responses.


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Document Created: 2015-12-15 12:05:04
Document Modified: 2015-12-15 12:05:04
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
FR Citation80 FR 50042 

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