83_FR_52181 83 FR 51982 - Phillip O. Rawlings, Jr., M.D.; Decision and Order

83 FR 51982 - Phillip O. Rawlings, Jr., M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 199 (October 15, 2018)

Page Range51982-51983
FR Document2018-22421

Federal Register, Volume 83 Issue 199 (Monday, October 15, 2018)
[Federal Register Volume 83, Number 199 (Monday, October 15, 2018)]
[Notices]
[Pages 51982-51983]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-22421]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Phillip O. Rawlings, Jr., M.D.; Decision and Order

    On March 8, 2018, the Acting Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Phillip O. Rawlings, Jr., M.D. (Registrant), of 
Mobile, Alabama. The Show Cause Order proposed the revocation of 
Registrant's DEA Certificate of Registration No. FR0024997 on the 
ground that he has ``no state authority to handle controlled 
substances.'' Order to Show Cause, Government Exhibit (GX) 8, at 1 
(citing 21 U.S.C. 824(a)(3)). For the same reason, the Order also 
proposed the denial of any of Registrant's ``applications for renewal 
or modification of such registration and any applications for any other 
DEA registrations.'' Id.
    Regarding the Agency's jurisdiction, the Show Cause Order alleged 
that Registrant holds DEA Certificate of Registration No. FR0024997, 
pursuant to which he is authorized to dispense controlled substances as 
a practitioner in schedules II through V at the registered address of 
Providence Family Physicians, 8833 Cottage Hill Road, Mobile, Alabama. 
Id. The Order also alleged that this registration was set to expire by 
its terms on April 30, 2018. Id.
    The substantive ground for the proceeding set forth in the Show 
Cause Order is that Registrant is ``currently without authority to 
practice medicine or handle controlled substances in the State of 
Alabama, the state in which [he is] registered with the DEA'' because 
Registrant's Alabama Medical License and Alabama Controlled Substances 
Certificate have been in ``Inactive-By Request'' status since December 
31, 2016 . Id. As a consequence, the Order alleged that ``DEA must 
revoke your DEA registration.'' Id. at 2.
    The Show Cause Order notified Registrant of his right to request a 
hearing on the allegations or to submit a written statement in lieu of 
a hearing, the procedures for electing each option, and the 
consequences for failing to elect either option. Id. (citing 21 CFR 
1301.43). The Order also notified Registrant of the opportunity to 
submit a corrective action plan. Id. at 2-3 (citing 21 U.S.C. 
824(c)(2)(C)).
    On April 26, 2018, my office received the Government's Second 
Request for Final Agency Action (SRFAA) \1\ describing Diversion 
Investigators' attempts to serve the Show Cause Order and seeking a 
final order revoking Registrant's registration. SRFAA, at 2, 6. The 
Government also submitted a Certification of Registration History, 
which was sworn to on December 28, 2017 by the Associate Chief of the 
Registration and Program Support Section. GX 1. In that Certification, 
she stated that DEA Registration No. FR0024997 ``expires on April 30, 
2018.'' Id. at 1. The Associate Chief further stated that ``Phillip O. 
Rawlings, Jr., M.D., has no other pending or valid DEA registration(s) 
in Alabama.'' Id. According to the Agency's current registration 
records for Registrant, of which I take official notice,\2\ DEA 
Registration No. FR0024997 expired on April 30, 2018, and he has not 
submitted an application to renew his registration or for any other 
registration in the State of Alabama. Thus, I find that Registrant's 
registration expired on April 30, 2018, and that there is no 
application upon which to act.\3\
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    \1\ On January 10, 2018, the Government submitted a Request for 
Final Agency Action seeking to revoke Registrant's same DEA 
registration based on an October 31, 2017 Order to Show Cause. GX 6. 
In that Request, the Government represented that Registrant did not 
request a hearing and ``ha[d] not otherwise corresponded or 
communicated with DEA regarding the Order served on him . . . within 
30 days of receipt of the Order.'' Id. at 1-2. However, on February 
6, 2018, the then-Acting Administrator issued an Order noting that, 
``although the Government is clearly in possession of information 
suggesting that Registrant now lives in California, it has offered 
no explanation for why it did not attempt to obtain Registrant's 
address from the Board of Medical Examiners and serve Registrant at 
that address.'' GX 7, at 1. As a result, the then-Administrator 
denied the Government's Request for Final Agency Action without 
prejudice. Id. at 2. See also SRFAA, at 1-2. By that time, the 
December 26, 2017 hearing date listed in the 2017 Show Cause Order 
had passed. SRFAA, at 2 n.1. As a result, the Agency issued the 
pending Show Cause Order on March 8, 2018, with a new hearing date 
of April 24, 2018. Id.; GX 8, at 1. It is this new Show Cause Order 
for which the Government now seeks final agency action.
    \2\ Under the Administrative Procedure Act (APA), an agency 
``may take official notice of facts at any stage in a proceeding--
even in the final decision.'' U.S. Dept. of Justice, Attorney 
General's Manual on the Administrative Procedure Act 80 (1947) (Wm. 
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and 
DEA's regulations, Registrant is ``entitled on timely request to an 
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21 
CFR 1316.59(e). To allow Registrant the opportunity to refute the 
facts of which I take official notice, Registrant may file a motion 
for reconsideration within 15 calendar days of service of this order 
which shall commence on the date this order is mailed.
    \3\ As already noted, my Office received the Government's Second 
Request for Final Agency Action on April 26, 2018. This filing 
arrived in my office too late for me to issue a final decision and 
order before the registration would expire on April 30, 2018. DEA 
regulation 21 CFR 1316.67 requires that I issue a final order that 
takes effect not less than 30 days from the date of publication in 
the Federal Register unless the public interest necessitates an 
earlier effective date. The record before me fails to include facts 
supporting a finding that ``the public interest in the matter 
necessitates an earlier effective date.'' 21 CFR 1316.67. Thus, even 
if I had submitted a final order in this case to the Federal 
Register on the same day (April 26, 2018) that my office received 
the SRFAA to revoke Registrant's registration, I could not have 
issued an order that would have taken effect by April 30, 2018 
because the Federal Register would not have been able to publish it 
30 days before the registration's April 30, 2018 expiration. And as 
the Agency has previously noted, there is no point in issuing a 
ruling on a Show Cause Order where, as here, that ruling would 
constitute an advisory opinion subject to vacation on judicial 
review. See, e.g., Josip Pasic, M.D., 82 FR 24146, 24147 (2017) 
(``As the requested factual findings and legal conclusions would be 
subject to vacation on judicial review, there is no point in making 
them.'').
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    DEA has long held that `` `if a registrant has not submitted a 
timely renewal application prior to the expiration date, then the 
registration expires and there is nothing to revoke.' '' Donald Brooks 
Reece II, M.D., 77 FR 35054, 35055 (2012) (quoting Ronald J. Riegel, 63 
FR 67312, 67133 (1998)); see also Greg N. Rampey, D.O., 83 FR

[[Page 51983]]

42696, 42697 (2018). ``Moreover, in the absence of an application 
(whether timely filed or not), there is nothing to act upon.'' Reece, 
77 FR at 35055, Rampey, 83 FR at 42697. Accordingly, because Registrant 
has allowed his registration to expire and has not filed an application 
to renew his registration or for any other registration in Alabama, 
this case is now moot and will be dismissed.

Order

    Pursuant to 28 CFR 0.100(b) and the authority thus vested in me by 
21 U.S.C. 824(a), I order that the Order to Show Cause issued to 
Phillip O. Rawlings, Jr., M.D., be, and it hereby is, dismissed. This 
Order is effective immediately.

    Dated: September 26, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-22421 Filed 10-12-18; 8:45 am]
 BILLING CODE 4410-09-P



                                               51982                        Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Notices

                                               (except for exportation), and soliciting                any applications for any other DEA                        The Government also submitted a
                                               U.S. agents or distributors for, non-                   registrations.’’ Id.                                      Certification of Registration History,
                                               volatile memory device and products                        Regarding the Agency’s jurisdiction,                   which was sworn to on December 28,
                                               containing same covered by claim 6 of                   the Show Cause Order alleged that                         2017 by the Associate Chief of the
                                               the ’602 patent.                                        Registrant holds DEA Certificate of                       Registration and Program Support
                                                  The Commission has also determined                   Registration No. FR0024997, pursuant to                   Section. GX 1. In that Certification, she
                                               that the public interest factors                        which he is authorized to dispense                        stated that DEA Registration No.
                                               enumerated in section 337(d) and (f) (19                controlled substances as a practitioner                   FR0024997 ‘‘expires on April 30, 2018.’’
                                               U.S.C. 1337(d) and (f)) do not preclude                 in schedules II through V at the                          Id. at 1. The Associate Chief further
                                               issuance of the limited exclusion order                 registered address of Providence Family                   stated that ‘‘Phillip O. Rawlings, Jr.,
                                               or cease and desist orders. Finally, the                Physicians, 8833 Cottage Hill Road,                       M.D., has no other pending or valid
                                               Commission has determined that a bond                   Mobile, Alabama. Id. The Order also                       DEA registration(s) in Alabama.’’ Id.
                                               in the amount of 100 percent of entered                 alleged that this registration was set to                 According to the Agency’s current
                                               value for Toshiba flash memory devices,                 expire by its terms on April 30, 2018. Id.                registration records for Registrant, of
                                               solid-state drives, USB flash drives, and                  The substantive ground for the                         which I take official notice,2 DEA
                                               microcontroller units; and a bond in the                proceeding set forth in the Show Cause                    Registration No. FR0024997 expired on
                                               amount of six percent of entered value                  Order is that Registrant is ‘‘currently                   April 30, 2018, and he has not
                                               for Toshiba personal computers, multi-                  without authority to practice medicine                    submitted an application to renew his
                                               function printers, and air conditioners is              or handle controlled substances in the                    registration or for any other registration
                                               required to permit temporary                            State of Alabama, the state in which [he                  in the State of Alabama. Thus, I find
                                               importation during the period of                        is] registered with the DEA’’ because                     that Registrant’s registration expired on
                                               Presidential review (19 U.S.C. 1337(j))                 Registrant’s Alabama Medical License                      April 30, 2018, and that there is no
                                               of products that are subject to the                     and Alabama Controlled Substances                         application upon which to act.3
                                               remedial orders. The Commission’s                       Certificate have been in ‘‘Inactive-By                      DEA has long held that ‘‘ ‘if a
                                               orders and opinion were delivered to                    Request’’ status since December 31,                       registrant has not submitted a timely
                                               the President and to the United States                  2016 . Id. As a consequence, the Order                    renewal application prior to the
                                               Trade Representative on the day of their                alleged that ‘‘DEA must revoke your                       expiration date, then the registration
                                               issuance.                                               DEA registration.’’ Id. at 2.                             expires and there is nothing to revoke.’ ’’
                                                                                                          The Show Cause Order notified                          Donald Brooks Reece II, M.D., 77 FR
                                                  The authority for the Commission’s
                                                                                                       Registrant of his right to request a                      35054, 35055 (2012) (quoting Ronald J.
                                               determination is contained in section
                                                                                                       hearing on the allegations or to submit                   Riegel, 63 FR 67312, 67133 (1998)); see
                                               337 of the Tariff Act of 1930, as
                                                                                                       a written statement in lieu of a hearing,                 also Greg N. Rampey, D.O., 83 FR
                                               amended (19 U.S.C. 1337), and in Part
                                                                                                       the procedures for electing each option,
                                               210 of the Commission’s Rules of
                                                                                                       and the consequences for failing to elect                    2 Under the Administrative Procedure Act (APA),
                                               Practice and Procedure (19 CFR part
                                                                                                       either option. Id. (citing 21 CFR                         an agency ‘‘may take official notice of facts at any
                                               210).                                                                                                             stage in a proceeding—even in the final decision.’’
                                                                                                       1301.43). The Order also notified
                                                 By order of the Commission.                                                                                     U.S. Dept. of Justice, Attorney General’s Manual on
                                                                                                       Registrant of the opportunity to submit                   the Administrative Procedure Act 80 (1947) (Wm.
                                                 Issued: October 9, 2018                               a corrective action plan. Id. at 2–3                      W. Gaunt & Sons, Inc., Reprint 1979). In accordance
                                               Katherine Hiner,                                        (citing 21 U.S.C. 824(c)(2)(C)).                          with the APA and DEA’s regulations, Registrant is
                                               Supervisory Attorney.                                      On April 26, 2018, my office received                  ‘‘entitled on timely request to an opportunity to
                                                                                                                                                                 show to the contrary.’’ 5 U.S.C. 556(e); see also 21
                                               [FR Doc. 2018–22325 Filed 10–12–18; 8:45 am]            the Government’s Second Request for                       CFR 1316.59(e). To allow Registrant the opportunity
                                               BILLING CODE 7020–02–P
                                                                                                       Final Agency Action (SRFAA) 1                             to refute the facts of which I take official notice,
                                                                                                       describing Diversion Investigators’                       Registrant may file a motion for reconsideration
                                                                                                       attempts to serve the Show Cause Order                    within 15 calendar days of service of this order
                                                                                                                                                                 which shall commence on the date this order is
                                                                                                       and seeking a final order revoking
                                               DEPARTMENT OF JUSTICE                                   Registrant’s registration. SRFAA, at 2, 6.
                                                                                                                                                                 mailed.
                                                                                                                                                                    3 As already noted, my Office received the

                                               Drug Enforcement Administration                                                                                   Government’s Second Request for Final Agency
                                                                                                          1 On January 10, 2018, the Government submitted        Action on April 26, 2018. This filing arrived in my
                                                                                                       a Request for Final Agency Action seeking to revoke       office too late for me to issue a final decision and
                                               Phillip O. Rawlings, Jr., M.D.; Decision                Registrant’s same DEA registration based on an            order before the registration would expire on April
                                               and Order                                               October 31, 2017 Order to Show Cause. GX 6. In            30, 2018. DEA regulation 21 CFR 1316.67 requires
                                                                                                       that Request, the Government represented that             that I issue a final order that takes effect not less
                                                  On March 8, 2018, the Acting                         Registrant did not request a hearing and ‘‘ha[d] not      than 30 days from the date of publication in the
                                               Assistant Administrator, Diversion                      otherwise corresponded or communicated with               Federal Register unless the public interest
                                               Control Division, Drug Enforcement                      DEA regarding the Order served on him . . . within        necessitates an earlier effective date. The record
                                                                                                       30 days of receipt of the Order.’’ Id. at 1–2.            before me fails to include facts supporting a finding
                                               Administration (DEA), issued an Order                   However, on February 6, 2018, the then-Acting             that ‘‘the public interest in the matter necessitates
                                               to Show Cause to Phillip O. Rawlings,                   Administrator issued an Order noting that,                an earlier effective date.’’ 21 CFR 1316.67. Thus,
                                               Jr., M.D. (Registrant), of Mobile,                      ‘‘although the Government is clearly in possession        even if I had submitted a final order in this case
                                               Alabama. The Show Cause Order                           of information suggesting that Registrant now lives       to the Federal Register on the same day (April 26,
                                                                                                       in California, it has offered no explanation for why      2018) that my office received the SRFAA to revoke
                                               proposed the revocation of Registrant’s                 it did not attempt to obtain Registrant’s address         Registrant’s registration, I could not have issued an
                                               DEA Certificate of Registration No.                     from the Board of Medical Examiners and serve             order that would have taken effect by April 30, 2018
                                               FR0024997 on the ground that he has                     Registrant at that address.’’ GX 7, at 1. As a result,    because the Federal Register would not have been
                                               ‘‘no state authority to handle controlled               the then-Administrator denied the Government’s            able to publish it 30 days before the registration’s
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                                                                                                       Request for Final Agency Action without prejudice.        April 30, 2018 expiration. And as the Agency has
                                               substances.’’ Order to Show Cause,                      Id. at 2. See also SRFAA, at 1–2. By that time, the       previously noted, there is no point in issuing a
                                               Government Exhibit (GX) 8, at 1 (citing                 December 26, 2017 hearing date listed in the 2017         ruling on a Show Cause Order where, as here, that
                                               21 U.S.C. 824(a)(3)). For the same                      Show Cause Order had passed. SRFAA, at 2 n.1. As          ruling would constitute an advisory opinion subject
                                               reason, the Order also proposed the                     a result, the Agency issued the pending Show Cause        to vacation on judicial review. See, e.g., Josip Pasic,
                                                                                                       Order on March 8, 2018, with a new hearing date           M.D., 82 FR 24146, 24147 (2017) (‘‘As the requested
                                               denial of any of Registrant’s                           of April 24, 2018. Id.; GX 8, at 1. It is this new Show   factual findings and legal conclusions would be
                                               ‘‘applications for renewal or                           Cause Order for which the Government now seeks            subject to vacation on judicial review, there is no
                                               modification of such registration and                   final agency action.                                      point in making them.’’).



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                                                                            Federal Register / Vol. 83, No. 199 / Monday, October 15, 2018 / Notices                                                                            51983

                                               42696, 42697 (2018). ‘‘Moreover, in the                   Dated: September 26, 2018.                                        registration by the Drug Enforcement
                                               absence of an application (whether                      Uttam Dhillon,                                                      Administration (DEA) as importers of
                                               timely filed or not), there is nothing to               Acting Administrator.                                               various classes of schedule I or II
                                               act upon.’’ Reece, 77 FR at 35055,                      [FR Doc. 2018–22421 Filed 10–12–18; 8:45 am]                        controlled substances.
                                               Rampey, 83 FR at 42697. Accordingly,                    BILLING CODE 4410–09–P
                                               because Registrant has allowed his                                                                                          SUPPLEMENTARY INFORMATION:       The
                                               registration to expire and has not filed                                                                                    company listed below applied to be
                                               an application to renew his registration                DEPARTMENT OF JUSTICE                                               registered as an importer of various
                                               or for any other registration in Alabama,                                                                                   basic classes of controlled substances.
                                               this case is now moot and will be                       Drug Enforcement Administration                                     Information on previously published
                                               dismissed.                                                                                                                  notices is listed in the table below. No
                                                                                                       [Docket No. DEA–392]
                                                                                                                                                                           comments or objections were submitted
                                               Order
                                                                                                       Importer of Controlled Substances                                   and no requests for hearing were
                                                 Pursuant to 28 CFR 0.100(b) and the                                                                                       submitted for these notices.
                                                                                                       Registration
                                               authority thus vested in me by 21 U.S.C.
                                               824(a), I order that the Order to Show                  ACTION:    Notice of registration.
                                               Cause issued to Phillip O. Rawlings, Jr.,
                                               M.D., be, and it hereby is, dismissed.                  SUMMARY:  Registrant listed below have
                                               This Order is effective immediately.                    applied for and been granted

                                                                            Company                                                                         FR Docket                                                 Published

                                               Galephar Pharmaceutical Research Inc .................................    83 FR 37525 ..........................................................................   August 1, 2018.



                                                 The Drug Enforcement                                  DATES:  Registered bulk manufacturers of                            Administrator of the DEA Diversion
                                               Administration (DEA) has considered                     the affected basic classes, and                                     Control Division (‘‘Assistant
                                               the factors in 21 U.S.C. 823, 952(a) and                applicants therefore, may file written                              Administrator’’) pursuant to section 7 of
                                               958(a) and determined that the                          comments on or objections to the                                    28 CFR part 0, appendix to subpart R.
                                               registration of the listed registrant to                issuance of the proposed registration on                              In accordance with 21 CFR
                                               import the applicable basic classes of                  or before November 14, 2018. Such                                   1301.34(a), this is notice that on July 16,
                                               schedule I or II controlled substances is               persons may also file a written request                             2018, Cambrex High Point Inc., 4180
                                               consistent with the public interest and                 for a hearing on the application on or                              Mendenhall Oaks Parkway, High Point,
                                               with United States obligations under                    before November 14, 2018.                                           North Carolina 27265–8017 applied to
                                               international treaties, conventions, or                 ADDRESSES: Written comments should                                  be registered as an importer of the
                                               protocols in effect on May 1, 1971. The                 be sent to: Drug Enforcement                                        following basic classes of controlled
                                               DEA investigated the company’s                          Administration, Attention: DEA Federal                              substances:
                                               maintenance of effective controls                       Register Representative/DPW, 8701
                                               against diversion by inspecting and                                                                                                     Controlled                   Drug
                                                                                                       Morrissette Drive, Springfield, Virginia                                        substance                    code   Schedule
                                               testing each company’s physical                         22152. All requests for hearing must be
                                               security systems, verifying the                         sent to: Drug Enforcement                                           Amphetamine ...................          1100   II
                                               company’s compliance with state and                     Administration, Attn: Administrator,                                Codeine ............................     9050   II
                                               local laws, and reviewing the company’s                 8701 Morrissette Drive, Springfield,                                Oxymorphone ...................          9652   II
                                               background and history.                                 Virginia 22152. All requests for hearing                            Noroxymorphone ..............            9668   II
                                                 Therefore, pursuant to 21 U.S.C.                      should also be sent to: (1) Drug
                                               952(a) and 958(a), and in accordance                    Enforcement Administration, Attn:                                     The company plans to manufacture
                                               with 21 CFR 1301.34, the DEA has                        Hearing Clerk/LJ, 8701 Morrissette                                  the above listed controlled substances in
                                               granted a registration as an importer for               Drive, Springfield, Virginia 22152; and                             bulk for distribution to its customers.
                                               schedule I or II controlled substance to                (2) Drug Enforcement Administration,                                  Dated: October 1, 2018.
                                               the above listed company.                               Attn: DEA Federal Register                                          John J. Martin,
                                                 Dated: September 24, 2018.                            Representative/DPW, 8701 Morrissette                                Assistant Administrator.
                                                                                                       Drive, Springfield, Virginia 22152.                                 [FR Doc. 2018–22416 Filed 10–12–18; 8:45 am]
                                               John J. Martin,
                                               Assistant Administrator.                                SUPPLEMENTARY INFORMATION: The                                      BILLING CODE 4410–09–P

                                               [FR Doc. 2018–22420 Filed 10–12–18; 8:45 am]
                                                                                                       Attorney General has delegated his
                                                                                                       authority under the Controlled
                                               BILLING CODE 4410–09–P
                                                                                                       Substances Act to the Administrator of                              DEPARTMENT OF JUSTICE
                                                                                                       the Drug Enforcement Administration
                                                                                                       (DEA), 28 CFR 0.100(b). Authority to                                Drug Enforcement Administration
                                               DEPARTMENT OF JUSTICE
                                                                                                       exercise all necessary functions with                               [Docket No. DEA–392]
                                               Drug Enforcement Administration                         respect to the promulgation and
                                                                                                       implementation of 21 CFR part 1301,
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                                                                                                                                                                           Bulk Manufacturer of Controlled
                                                                                                       incident to the registration of                                     Substances Application: Specgx, LLC
                                               [Docket No. DEA–392]
                                                                                                       manufacturers, distributors, dispensers,
                                               Importer of Controlled Substances                       importers, and exporters of controlled                              ACTION:      Notice of application.
                                               Application: Cambrex High Point, Inc.                   substances (other than final orders in
                                                                                                       connection with suspension, denial, or                              DATES:  Registered bulk manufacturers of
                                                                                                       revocation of registration) has been                                the affected basic classes, and
                                               ACTION:   Notice of application.
                                                                                                       redelegated to the Assistant                                        applicants therefore, may file written


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Document Created: 2018-10-13 10:04:12
Document Modified: 2018-10-13 10:04:12
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 Citation83 FR 51982 

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