83 FR 15630 - Witold Marek Zajewski, M.D.; Decision and Order

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 83, Issue 70 (April 11, 2018)

Page Range		15630-15633
FR Document		2018-07454
Federal Register, Volume 83 Issue 70 (Wednesday, April 11, 2018)
[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15630-15633]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07454]


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 DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 17-46]


Witold Marek Zajewski, M.D.; Decision and Order

    On July 27, 2017, the Acting Assistant Administrator, Diversion 
Control Division, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Witold Marek Zajewski, M.D. (Respondent), of 
Mount Prospect, Illinois. The Show Cause Order proposed the revocation 
of Respondent's DEA Certificate of Registration No. BZ5641419 on the 
ground that he has ``no state authority to handle controlled 
substances.'' Order to Show Cause, at 1 (citing 21 U.S.C. 824(a)(3)). 
For the same reason, the Order also proposed the denial of any of 
Respondent's ``applications for renewal or modification of such 
registration and any applications for any other DEA registrations. Id.
    With respect to the Agency's jurisdiction, the Show Cause Order

[[Page 15631]]

alleged that Respondent is the holder of Certificate of Registration 
No. BZ5641419, pursuant to which he is authorized to dispense 
controlled substances as a practitioner in schedules II through V, at 
the registered address of 609 N. Main Street, Suite 102, Mount 
Prospect, Illinois. Id. The Order also alleged that this registration 
does not expire until May 31, 2018. Id.
    Regarding the substantive grounds for the proceeding, the Show 
Cause Order alleged that on June 29, 2017, the Illinois Department of 
Financial and Professional Regulation, Division of Professional 
Regulation (IDFPR), ``issued an Order suspending [his] Illinois 
Physician and Surgeon License No. 036.096849 and suspending [his] 
Illinois Controlled Substance License No. 336.063325,'' and he is 
therefore ``without authority to practice medicine or handle controlled 
substances in the State of Illinois, the [S]tate in which [he is] 
registered with the DEA.'' Id. at 1-2. Based on his ``lack of authority 
to [dispense] controlled substances in . . . Illinois,'' the Order 
asserted that ``DEA must revoke'' his registration. Id. at 2 (citing 21 
U.S.C. 824(a)(3)); 21 CFR 1301.37(b)).
    The Show Cause Order notified Respondent of (1) his right to 
request a hearing on the allegations or to submit a written statement 
in lieu of a hearing, (2) the procedure for electing either option, and 
(3) the consequence for failing to elect either option. Id. (citing 21 
CFR 1301.43). The Show Cause Order also notified Respondent of his 
right to submit a corrective action plan. Id. at 2-3 (citing 21 U.S.C. 
824(c)(2)(C)).
    On August 21, 2017, Respondent, through counsel, filed a letter 
requesting a hearing on the allegations. Letter from Respondent's 
Counsel to Hearing Clerk (dated Aug. 18, 2017) (hereinafter, Hearing 
Request). In this letter, Respondent ``objects to the statement that 
his licenses have been suspended'' because the IDFPR ``entered only a 
temporary order of suspension of his license'' until ``an informal 
hearing'' scheduled in December 2017.'' Id. at 1. Respondent also 
requested to ``continue this matter to in or after January 2018.'' Id. 
at 1 (emphasis omitted).
    The matter was placed on the docket of the Office of Administrative 
Law Judges and assigned to Administrative Law Judge Mark M. Dowd 
(hereinafter, ALJ). On August 25, 2017, the ALJ ordered the Government 
to ``file evidence to support the allegation that the Respondent lacks 
state authority to handle controlled substances,'' ``respond to the 
Respondent's request for continuance,'' and file ``any motion for 
summary disposition'' no later than September 6, 2017. Order Directing 
the Filing of Government Evidence of Lack of State Authority and 
Briefing Schedule, at 1. The ALJ also directed Respondent to file his 
response to any summary disposition motion no later than September 15, 
2017. Id. at 2.
    On September 1, 2017, the Government filed its Motion for Summary 
Disposition. In its Request, the Government argued that it is 
undisputed that Respondent lacks authority to handle controlled 
substances in Illinois because the IDFPR suspended Respondent's medical 
license and his controlled substance license. Government's Motion for 
Summary Disposition (hereinafter Government's Motion or Govt. Mot.) at 
2. The Government also noted that, in his Hearing Request, Respondent 
did not dispute that the IDFPR had suspended these licenses. Id. at 3 
n.1. The Government further argued that, ``[a]bsent authority by the 
State of Illinois to dispense controlled substances, Respondent is not 
authorized to possess a DEA registration in that state.'' Id. at 3. 
Lastly, the Government argued that under Agency precedent, revocation 
is warranted even where a State has temporarily suspended a 
practitioner's state authority and has yet to provide the practitioner 
with a hearing where he may prevail. Govt. Mot., at 3-4 (citations 
omitted). As support for its summary disposition request, the 
Government attached, inter alia, a copy of the IDFPR's June 29, 2017 
Order directing that (1) Respondent's medical and controlled substance 
licenses ``be SUSPENDED, pending proceedings before an Administrative 
Law Judge at'' IDFPR and (2) Respondent to ``immediately surrender all 
indicia of licensure(s) to'' IDFPR. Government Exhibit (GX) 2 to Govt. 
Mot., at 1.
    In his responsive pleading, Respondent did not dispute that the 
IDFPR ``temporarily suspended'' his medical and controlled substance 
licenses. Respondent's Sept. 15, 2017 Motion for Extension of Time to 
Respond to Government's Motion for Summary Disposition (hereinafter, 
Resp. Reply), at 1. Instead, he argued that the suspensions were 
``pending proceedings'' before a state administrative law judge and 
that he ``believe[s] this matter may be resolved'' at an ``informal 
hearing'' in December 2017. Id. Respondent also argued that the ALJ 
should grant him an extension of time to respond to the Government's 
Motion in ``the interest of administrative/judicial economy'' until 
then. Id. at 1-2 (quoting Robert Clark Maiocco, M.D., 82 FR 19383, 
19384 (2017)).
    The ALJ denied ``Respondent's request for an extension of time--in 
essence to stay these proceedings,'' noting that ``revocation of a 
practitioner's registration is warranted whenever his (or its) state 
authority to dispense controlled substances has been suspended or 
revoked.'' Order Denying the Respondent's Request for an Extension of 
Time, Granting the Government's Motion for Summary Disposition, and 
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge (R.D.), at 2 (internal quotations and 
citations omitted), 3. While he was ``not unmindful of the Respondent's 
argument that granting an extension of time has been used in the past'' 
in Maiocco, the ALJ nevertheless ``disagree[d]'' that the same 
``interest of administrative/judicial economy'' that was present in 
Maiocco was present in this case. Id. at 2-3, 3 n.3. Specifically, the 
ALJ in Maiocco granted that respondent's three-week extension of time 
request because the Colorado Board of Medicine was scheduled to 
consider Respondent's proposed ``Stipulation and Final Agency Order'' 
``two weeks after the Respondent submitted his Motion for Extension of 
Time to the ALJ.'' Id. at 3 n.3 (citing Maiocco, 82 FR at 19384). Here, 
the ALJ reasoned, Respondent lacked the same ``interest of 
administrative/judicial economy'' because ``Respondent has submitted 
no[ ] proposed stipulation, Respondent only `anticipates' an informal 
hearing to take place.'' Id. (citing Resp. Reply at 1). Finally, the 
ALJ concluded that the DEA has previously held ``that a stay in 
administrative enforcement proceedings is `unlikely to ever be 
justified' due to ancillary proceedings involving the Respondent.'' Id. 
at 3 (quoting Grider Drug #1 & Grider Drug #2, 77 FR 44070, 44104 n.97 
(2012)).\1\
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    \1\ I agree with this statement of the Agency's precedents. 
However, the ALJ also cited Odette L. Campbell, 80 FR 41062 (2015), 
as contrary authority. See id. The ALJ characterized Campbell as 
``holding revocation proceedings in abeyance at the post-hearing 
adjudication level for a lengthy period pending the resolution of 
both criminal fraud charges and concurrent state administrative 
proceedings against the respondent,'' id. Notably, Campbell involved 
an application for registration, not a revocation of an existing 
registration, at the time the proceeding was held in abeyance. This 
is significant, as an applicant, like Campbell, does not have the 
current authority to handle controlled substances during any stay of 
the proceedings, while a registrant does.
    Moreover, one week before the evidentiary hearing, the 
respondent was indicted on 30 counts of Health Care Fraud, as well 
as five counts of altering records during a federal investigation. 
80 FR at 41063. Had the respondent been convicted of Health Care 
Fraud, she would have been subject to mandatory exclusion from 
federal healthcare programs under 42 U.S.C. 1320a-7(a) and her 
application would have been subject to denial on that basis as well. 
Id. at 41064 (citing 21 U.S.C. 824(a)(5)). Furthermore, even after 
the respondent successfully completed pre-trial diversion and the 
charges were dismissed, the state medical board brought a proceeding 
against her license, and had the board suspended or revoked her 
medical license, denial of her application would have been required 
under the CSA. Id. (citing 21 U.S.C. 802(21) & 823(f)). Given the 
pending proceedings, Campbell was the rare case where withholding 
the issuance of a final decision was warranted. For these reasons, 
and those set forth in other final orders, I hold that Campbell does 
not support the issuance of stay of proceedings involving the 
suspension or revocation of DEA registrations. See, e.g., Judson H. 
Somerville, 82 FR 21408, 21409 n.3 (2017).

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[[Page 15632]]

    The ALJ then found that there was no dispute over the fact that 
``Respondent currently lacks state authority to handle controlled 
substances in Illinois due to [the IDFPR's] Order dated July 29, 2017, 
which suspended his state licenses to practice medicine and distribute 
controlled substances.'' Id. at 5. Reasoning that ``[b]ecause the 
Respondent lacks state authority at the present time . . . he is not 
entitled to maintain his DEA registration,'' the ALJ granted the 
Government's motion and recommended that his registration be revoked 
and that any pending renewal applications be denied. Id. at 5-6.
    Neither party filed exceptions to the ALJ's Recommended Decision. 
Thereafter, the record was forwarded to my Office for Final Agency 
Action. Having reviewed the record, I adopt the ALJ's finding that by 
virtue of the IDFPR's Order, Respondent is currently without authority 
to handle controlled substances in Illinois, the State in which he 
holds his registration with the Agency, and is thus not entitled to 
maintain his registration. I further adopt the ALJ's recommendation 
that I revoke his registration and deny any pending renewal 
application. I make the following factual findings.

Findings of Fact

    Respondent is the holder of DEA Certificate of Registration No. 
BZ5641419, pursuant to which he is authorized to dispense controlled 
substances in schedules II through V as a practitioner. GX 1. Although 
not alleged in the Show Cause Order, I also find that Respondent is the 
holder of DATA-Waiver Identification Number XZ5641419, see id., which 
authorizes Respondent to dispense or prescribe schedule III-V narcotic 
controlled substances which ``have been approved by the Food and Drug 
Administration . . . specifically for use in maintenance or 
detoxification treatment'' for up to 100 patients. 21 CFR 1301.28(a) & 
(b)(1)(iii). Respondent's registered address is 609 N. Main Street, 
Suite 102, Mount Prospect, Illinois. GX 1. Respondent's registration 
and DATA-Waiver authority do not expire until May 31, 2018. Id.
    On June 29, 2017, the IDFPR issued an Order suspending Respondent's 
Illinois Physician and Surgeon License No. 036.096849 and his Illinois 
Controlled Substance License No. 336.063325 ``pending proceedings 
before an Administrative Law Judge at the'' IDFPR. GX 2, at 2. The 
Order also directed Respondent to ``immediately surrender all indicia 
of licensure(s) to the'' IDFPR. Id.
    In January 2018, the IDFPR announced another enforcement action 
regarding Respondent's state licenses, stating that his ``physician and 
surgeon license [is] restored to indefinite probation for a minimum of 
three years and [his] controlled substance license, 336063325, [is] 
indefinitely suspended, 12 months minimum, effective retroactive to 
June 29, 2017 for inappropriately prescribing controlled substances to 
patients of his practice.'' \2\ I take official notice of the IDFPR's 
January 2018 enforcement action \3\ and find that Respondent currently 
does not possess a controlled substance license in the State of 
Illinois, and thus does not possess authority to dispense controlled 
substances in the State in which he is registered with the DEA. See 77 
Ill. Adm. Code Sec.  3100.370(a) (``A prescription for a controlled 
substance may be issued only by an individual practitioner who: (1) 
Holds an active professional license in Illinois as an individual 
practitioner; and (2) Holds an active controlled substances license 
under the Act or is exempted from licensure pursuant to Section 
3100.80'').
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    \2\ See www.idfpr.com/Forms/DISCPLN/2018_01enf.pdf.
    \3\ 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, Respondent 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 Respondent the opportunity to refute the 
facts of which I take official notice, Respondent 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.
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Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized 
to suspend or revoke a registration issued under section 823 of the 
CSA, ``upon a finding that the registrant . . . has had his State 
license . . . suspended [or] revoked . . . by competent State authority 
and is no longer authorized by State law to engage in the . . . 
dispensing of controlled substances.'' Also, DEA has long held that the 
possession of authority to dispense controlled substances under the 
laws of the State in which a practitioner engages in professional 
practice is a fundamental condition for obtaining and maintaining a 
practitioner's registration. See, e.g., James L. Hooper, 76 FR 71371 
(2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); see 
also Frederick Marsh Blanton, 43 FR 27616 (1978) (``State authorization 
to dispense or otherwise handle controlled substances is a prerequisite 
to the issuance and maintenance of a Federal controlled substances 
registration.'').
    This rule derives from the text of two provisions of the CSA. 
First, Congress defined ``the term `practitioner' [to] mean[ ] a . . . 
physician . . . or other person licensed, registered or otherwise 
permitted, by . . . the jurisdiction in which he practices . . . to 
distribute, dispense, [or] administer . . . a controlled substance in 
the course of professional practice.'' 21 U.S.C. 802(21). Second, in 
setting the requirements for obtaining a practitioner's registration, 
Congress directed that ``[t]he Attorney General shall register 
practitioners . . . if the applicant is authorized to dispense . . . 
controlled substances under the laws of the State in which he 
practices.'' 21 U.S.C. 823(f).
    Thus, ``the controlling question'' in a proceeding brought under 21 
U.S.C. 824(a)(3) is whether the holder of a DEA registration ``is 
currently authorized to handle controlled substances in the [S]tate'' 
in which the practitioner is registered. Hooper, 76 FR at 71371 
(quoting Anne Lazar Thorn, 62 FR 12847, 12848 (1997)). Here, there is 
no dispute over the material fact that Respondent is no longer 
currently authorized to dispense controlled substances in Illinois, the 
State in which he is registered. See 77 Ill. Adm. Code Sec.  
3100.370(a). Accordingly, he is not entitled to maintain his 
registration.
    I will therefore adopt the ALJ's recommendation that I revoke 
Respondent's registration and deny any pending applications to renew 
his registration. R.D. at 6. I will also deny any pending application 
to modify his registration, or any pending application for any other 
registration in Illinois, as requested in the Show Cause Order. Order 
to Show Cause, at 1. Finally, because Respondent's DATA-Waiver

[[Page 15633]]

authority is contingent on Respondent being a practitioner with a valid 
DEA registration, see 21 U.S.C. 823(g)(2)(A); 21 CFR 1301.28(a), I will 
revoke his DATA-Waiver authority as well.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration No. BZ5641419 and DATA-Waiver Identification Number 
XZ5641419, issued to Witold Marek Zajewski, M.D., be, and they hereby 
are, revoked. I further order that any pending application of Witold 
Marek Zajewski to renew or modify the above registration, or any 
pending application of Witold Marek Zajewski for any other registration 
in the State of Illinois, be, and it hereby is, denied. This Order is 
effective immediately.\4\
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    \4\ For the same reasons which led the IDFPR to revoke 
Respondent's controlled substance license, I conclude that the 
public interest necessitates that this Order be effective 
immediately. 21 CFR 1316.67.

    Dated: April 4, 2018.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2018-07454 Filed 4-10-18; 8:45 am]
 BILLING CODE 4410-09-P
15630 Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices

Controlled substance Drug code Schedule

Phenmetrazine ........................................................................................................................................................ 1631 II.
Methylphenidate ...................................................................................................................................................... 1724 II.
Amobarbital ............................................................................................................................................................. 2125 II.
Pentobarbital ........................................................................................................................................................... 2270 II.
Secobarbital ............................................................................................................................................................. 2315 II.
Glutethimide ............................................................................................................................................................ 2550 II.
Nabilone .................................................................................................................................................................. 7379 II.
1-Phenylcyclohexylamine ........................................................................................................................................ 7460 II.
Phencyclidine .......................................................................................................................................................... 7471 II.
4-Anilino-N-phenethyl-4-piperidine (ANPP) ............................................................................................................. 8333 II.
Phenylacetone ......................................................................................................................................................... 8501 II.
1-Piperidinocyclohexanecarbonitrile ........................................................................................................................ 8603 II.
Alphaprodine ........................................................................................................................................................... 9010 II.
Anileridine ................................................................................................................................................................ 9020 II.
Cocaine ................................................................................................................................................................... 9041 II.
Codeine ................................................................................................................................................................... 9050 II.
Etorphine HCl .......................................................................................................................................................... 9059 II.
Dihydrocodeine ........................................................................................................................................................ 9120 II.
Oxycodone .............................................................................................................................................................. 9143 II.
Hydromorphone ....................................................................................................................................................... 9150 II.
Diphenoxylate .......................................................................................................................................................... 9170 II.
Ecgonine .................................................................................................................................................................. 9180 II.
Ethylmorphine .......................................................................................................................................................... 9190 II.
Hydrocodone ........................................................................................................................................................... 9193 II.
Levomethorphan ...................................................................................................................................................... 9210 II.
Levorphanol ............................................................................................................................................................. 9220 II.
Isomethadone .......................................................................................................................................................... 9226 II.
Meperidine ............................................................................................................................................................... 9230 II.
Meperidine intermediate-B ...................................................................................................................................... 9233 II.
Metazocine .............................................................................................................................................................. 9240 II.
Methadone ............................................................................................................................................................... 9250 II.
Methadone intermediate .......................................................................................................................................... 9254 II.
Metopon ................................................................................................................................................................... 9260 II.
Dextropropoxyphene, bulk (non-dosage forms) ...................................................................................................... 9273 II.
Morphine .................................................................................................................................................................. 9300 II.
Thebaine .................................................................................................................................................................. 9333 II.
Dihydroetorphine ..................................................................................................................................................... 9334 II.
Levo-alphacetylmethadol ......................................................................................................................................... 9648 II.
Oxymorphone .......................................................................................................................................................... 9652 II.
Noroxymorphone ..................................................................................................................................................... 9668 II.
Phenazocine ............................................................................................................................................................ 9715 II.
Piminodine ............................................................................................................................................................... 9730 II.
Racemethorphan ..................................................................................................................................................... 9732 II.
Racemorphan .......................................................................................................................................................... 9733 II.
Alfentanil .................................................................................................................................................................. 9737 II.
Remifentanil ............................................................................................................................................................. 9739 II.
Sufentanil ................................................................................................................................................................. 9740 II.
Carfentanil ............................................................................................................................................................... 9743 II.
Tapentadol ............................................................................................................................................................... 9780 II.
Bezitramide .............................................................................................................................................................. 9800 II.
Fentanyl ................................................................................................................................................................... 9801 II.

The company plans to import Dated: April 4, 2018. Administration (DEA), issued an Order
analytical reference standards for Susan A. Gibson, to Show Cause to Witold Marek
distribution to its customers for research Deputy Assistant Administrator. Zajewski, M.D. (Respondent), of Mount
and analytical purposes. Placement of [FR Doc. 2018–07442 Filed 4–10–18; 8:45 am] Prospect, Illinois. The Show Cause
these drug codes onto the company’s BILLING CODE 4410–09–P
Order proposed the revocation of
registration does not translate into Respondent’s DEA Certificate of
automatic approval of subsequent Registration No. BZ5641419 on the
permit applications to import controlled DEPARTMENT OF JUSTICE ground that he has ‘‘no state authority
substances. Approval of permit to handle controlled substances.’’ Order
applications will occur only when the Drug Enforcement Administration to Show Cause, at 1 (citing 21 U.S.C.
registrant’s business activity is 824(a)(3)). For the same reason, the
[Docket No. 17–46]
amozie on DSK30RV082PROD with NOTICES

consistent with what is authorized Order also proposed the denial of any of
Witold Marek Zajewski, M.D.; Decision Respondent’s ‘‘applications for renewal
under 21 U.S.C. 952(a)(2). Authorization
and Order or modification of such registration and
will not extend to the import of FDA
any applications for any other DEA
approved or non-approved finished On July 27, 2017, the Acting Assistant registrations. Id.
dosage forms for commercial sale. Administrator, Diversion Control With respect to the Agency’s
Division, Drug Enforcement jurisdiction, the Show Cause Order

VerDate Sep<11>2014 17:17 Apr 10, 2018 Jkt 244001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\11APN1.SGM 11APN1
Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices 15631

alleged that Respondent is the holder of September 6, 2017. Order Directing the Maiocco, M.D., 82 FR 19383, 19384
Certificate of Registration No. Filing of Government Evidence of Lack (2017)).
BZ5641419, pursuant to which he is of State Authority and Briefing The ALJ denied ‘‘Respondent’s
authorized to dispense controlled Schedule, at 1. The ALJ also directed request for an extension of time—in
substances as a practitioner in schedules Respondent to file his response to any essence to stay these proceedings,’’
II through V, at the registered address of summary disposition motion no later noting that ‘‘revocation of a
609 N. Main Street, Suite 102, Mount than September 15, 2017. Id. at 2. practitioner’s registration is warranted
Prospect, Illinois. Id. The Order also On September 1, 2017, the whenever his (or its) state authority to
alleged that this registration does not Government filed its Motion for dispense controlled substances has been
expire until May 31, 2018. Id. Summary Disposition. In its Request, suspended or revoked.’’ Order Denying
Regarding the substantive grounds for the Government argued that it is the Respondent’s Request for an
the proceeding, the Show Cause Order undisputed that Respondent lacks Extension of Time, Granting the
alleged that on June 29, 2017, the authority to handle controlled Government’s Motion for Summary
Illinois Department of Financial and substances in Illinois because the IDFPR Disposition, and Recommended
Professional Regulation, Division of suspended Respondent’s medical Rulings, Findings of Fact, Conclusions
Professional Regulation (IDFPR), license and his controlled substance of Law, and Decision of the
‘‘issued an Order suspending [his] license. Government’s Motion for Administrative Law Judge (R.D.), at 2
Illinois Physician and Surgeon License Summary Disposition (hereinafter (internal quotations and citations
No. 036.096849 and suspending [his] Government’s Motion or Govt. Mot.) at omitted), 3. While he was ‘‘not
Illinois Controlled Substance License 2. The Government also noted that, in unmindful of the Respondent’s
No. 336.063325,’’ and he is therefore his Hearing Request, Respondent did argument that granting an extension of
‘‘without authority to practice medicine not dispute that the IDFPR had time has been used in the past’’ in
or handle controlled substances in the suspended these licenses. Id. at 3 n.1. Maiocco, the ALJ nevertheless
State of Illinois, the [S]tate in which [he The Government further argued that, ‘‘disagree[d]’’ that the same ‘‘interest of
is] registered with the DEA.’’ Id. at 1– ‘‘[a]bsent authority by the State of administrative/judicial economy’’ that
2. Based on his ‘‘lack of authority to Illinois to dispense controlled was present in Maiocco was present in
[dispense] controlled substances in . . . substances, Respondent is not this case. Id. at 2–3, 3 n.3. Specifically,
Illinois,’’ the Order asserted that ‘‘DEA authorized to possess a DEA registration the ALJ in Maiocco granted that
must revoke’’ his registration. Id. at 2 in that state.’’ Id. at 3. Lastly, the respondent’s three-week extension of
(citing 21 U.S.C. 824(a)(3)); 21 CFR time request because the Colorado
Government argued that under Agency
1301.37(b)). Board of Medicine was scheduled to
precedent, revocation is warranted even
The Show Cause Order notified consider Respondent’s proposed
Respondent of (1) his right to request a where a State has temporarily
suspended a practitioner’s state ‘‘Stipulation and Final Agency Order’’
hearing on the allegations or to submit ‘‘two weeks after the Respondent
a written statement in lieu of a hearing, authority and has yet to provide the
practitioner with a hearing where he submitted his Motion for Extension of
(2) the procedure for electing either Time to the ALJ.’’ Id. at 3 n.3 (citing
option, and (3) the consequence for may prevail. Govt. Mot., at 3–4
(citations omitted). As support for its Maiocco, 82 FR at 19384). Here, the ALJ
failing to elect either option. Id. (citing reasoned, Respondent lacked the same
21 CFR 1301.43). The Show Cause summary disposition request, the
Government attached, inter alia, a copy ‘‘interest of administrative/judicial
Order also notified Respondent of his economy’’ because ‘‘Respondent has
right to submit a corrective action plan. of the IDFPR’s June 29, 2017 Order
directing that (1) Respondent’s medical submitted no[ ] proposed stipulation,
Id. at 2–3 (citing 21 U.S.C. 824(c)(2)(C)). Respondent only ‘anticipates’ an
On August 21, 2017, Respondent, and controlled substance licenses ‘‘be
SUSPENDED, pending proceedings before informal hearing to take place.’’ Id.
through counsel, filed a letter requesting (citing Resp. Reply at 1). Finally, the
a hearing on the allegations. Letter from an Administrative Law Judge at’’ IDFPR
and (2) Respondent to ‘‘immediately ALJ concluded that the DEA has
Respondent’s Counsel to Hearing Clerk
surrender all indicia of licensure(s) to’’ previously held ‘‘that a stay in
(dated Aug. 18, 2017) (hereinafter,
IDFPR. Government Exhibit (GX) 2 to administrative enforcement proceedings
Hearing Request). In this letter,
Govt. Mot., at 1. is ‘unlikely to ever be justified’ due to
Respondent ‘‘objects to the statement
In his responsive pleading, ancillary proceedings involving the
that his licenses have been suspended’’
Respondent did not dispute that the Respondent.’’ Id. at 3 (quoting Grider
because the IDFPR ‘‘entered only a
IDFPR ‘‘temporarily suspended’’ his Drug #1 & Grider Drug #2, 77 FR 44070,
temporary order of suspension of his
medical and controlled substance 44104 n.97 (2012)).1
license’’ until ‘‘an informal hearing’’
scheduled in December 2017.’’ Id. at 1. licenses. Respondent’s Sept. 15, 2017 1 I agree with this statement of the Agency’s
Respondent also requested to ‘‘continue Motion for Extension of Time to precedents. However, the ALJ also cited Odette L.
this matter to in or after January 2018.’’ Respond to Government’s Motion for Campbell, 80 FR 41062 (2015), as contrary
Id. at 1 (emphasis omitted). Summary Disposition (hereinafter, Resp. authority. See id. The ALJ characterized Campbell
The matter was placed on the docket Reply), at 1. Instead, he argued that the as ‘‘holding revocation proceedings in abeyance at
the post-hearing adjudication level for a lengthy
of the Office of Administrative Law suspensions were ‘‘pending period pending the resolution of both criminal
Judges and assigned to Administrative proceedings’’ before a state fraud charges and concurrent state administrative
Law Judge Mark M. Dowd (hereinafter, administrative law judge and that he proceedings against the respondent,’’ id. Notably,
ALJ). On August 25, 2017, the ALJ ‘‘believe[s] this matter may be resolved’’ Campbell involved an application for registration,
not a revocation of an existing registration, at the
amozie on DSK30RV082PROD with NOTICES

ordered the Government to ‘‘file at an ‘‘informal hearing’’ in December time the proceeding was held in abeyance. This is
evidence to support the allegation that 2017. Id. Respondent also argued that significant, as an applicant, like Campbell, does not
the Respondent lacks state authority to the ALJ should grant him an extension have the current authority to handle controlled
handle controlled substances,’’ of time to respond to the Government’s substances during any stay of the proceedings,
while a registrant does.
‘‘respond to the Respondent’s request Motion in ‘‘the interest of Moreover, one week before the evidentiary
for continuance,’’ and file ‘‘any motion administrative/judicial economy’’ until hearing, the respondent was indicted on 30 counts
for summary disposition’’ no later than then. Id. at 1–2 (quoting Robert Clark Continued

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Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices 15633

authority is contingent on Respondent registration in the State of Illinois, be, SUMMARY: Registrants listed below have
being a practitioner with a valid DEA and it hereby is, denied. This Order is applied for and been granted
registration, see 21 U.S.C. 823(g)(2)(A); effective immediately.4 registration by the Drug Enforcement
21 CFR 1301.28(a), I will revoke his Dated: April 4, 2018. Administration (DEA) as importers of
DATA-Waiver authority as well. Robert W. Patterson, various classes of schedule I or II
Order Acting Administrator. controlled substances.
Pursuant to the authority vested in me [FR Doc. 2018–07454 Filed 4–10–18; 8:45 am] SUPPLEMENTARY INFORMATION:
by 21 U.S.C. 823(f) and 824(a), as well BILLING CODE 4410–09–P
The companies listed below applied
as 28 CFR 0.100(b), I order that DEA to be registered as importers of various
Certificate of Registration No. basic classes of controlled substances.
BZ5641419 and DATA-Waiver DEPARTMENT OF JUSTICE
Information on previously published
Identification Number XZ5641419,
Drug Enforcement Administration notices is listed in the table below. No
issued to Witold Marek Zajewski, M.D.,
comments or objections were submitted
be, and they hereby are, revoked. I [Docket No. DEA–392]
further order that any pending and no requests for hearing were
application of Witold Marek Zajewski to Importer of Controlled Substances submitted for these notices.
renew or modify the above registration, Registration
or any pending application of Witold
ACTION: Notice of registration.
Marek Zajewski for any other

Company FR docket Published

Sharp (Bethlehem), LLC ..................................................... 83 FR 539 .......................................................................... January 4, 2018.
Catalent Pharma Solutions, LLC ........................................ 83 FR 2215 ........................................................................ January 16, 2018.
Janssen Pharmaceuticals, Inc ............................................ 83 FR 2214 ........................................................................ January 16, 2018.
Mylan Pharmaceuticals, Inc ............................................... 83 FR 5809 ........................................................................ February 9, 2018.
Meridian Medical Technologies, Inc ................................... 83 FR 5810 ........................................................................ February 9, 2018.
Noramco, Inc ...................................................................... 83 FR 5810 ........................................................................ February 9, 2018.
Johnson Matthey, Inc ......................................................... 83 FR 5811 ........................................................................ February 9, 2018.
Mylan Technologies, Inc ..................................................... 83 FR 5811 ........................................................................ February 9, 2018.
Mylan Pharmaceuticals, Inc ............................................... 83 FR 8107 ........................................................................ February 23, 2018.

The Drug Enforcement with 21 CFR 1301.34, the DEA has SUMMARY: Registrants listed below have
Administration (DEA) has considered granted a registration as an importer for applied for and been granted
the factors in 21 U.S.C. 823, 952(a) and schedule I or II controlled substances to registration by the Drug Enforcement
958(a) and determined that the the above listed companies. Administration (DEA) as bulk
registration of the listed registrants to Dated: April 4, 2018. manufacturers of various classes of
import the applicable basic classes of Susan A. Gibson, schedule I and II controlled substances.
schedule I or II controlled substances is
Deputy Assistant Administrator. SUPPLEMENTARY INFORMATION:
consistent with the public interest and
with United States obligations under [FR Doc. 2018–07444 Filed 4–10–18; 8:45 am]
The companies listed below applied
international treaties, conventions, or BILLING CODE 4410–09–P
to be registered as bulk manufacturers of
protocols in effect on May 1, 1971. The various basic classes of controlled
DEA investigated each company’s substances. Information on previously
maintenance of effective controls DEPARTMENT OF JUSTICE
published notices is listed in the table
against diversion by inspecting and Drug Enforcement Administration below. No comments or objections were
testing each company’s physical submitted for these notices.
security systems, verifying each [Docket No. DEA–392]
company’s compliance with state and
local laws, and reviewing each Bulk Manufacturer of Controlled
company’s background and history. Substances Registration
Therefore, pursuant to 21 U.S.C.
ACTION: Notice of registration.
952(a) and 958(a), and in accordance

Company FR docket Published

Nanosyn, Inc ....................................................................... 82 FR 56993 ...................................................................... December 1, 2017.
Janssen Pharmaceutical, Inc ............................................. 82 FR 58027 ...................................................................... December 8, 2017.
Cambrex High Point, Inc .................................................... 82 FR 61795 ...................................................................... December 29, 2017.
AMPAC Fine Chemicals LLC ............................................. 82 FR 61795 ...................................................................... December 29, 2017.
Organix, Inc ........................................................................ 83 FR 150 .......................................................................... January 2, 2018.
amozie on DSK30RV082PROD with NOTICES

Johnson Matthey Inc .......................................................... 83 FR 2215 ........................................................................ January 16, 2018.
Chemtos, LLC ..................................................................... 83 FR 2671 ........................................................................ January 18, 2018.
Alcami Wisconsin Corporation ........................................... 83 FR 2675 ........................................................................ January 18, 2018.

4 For the same reasons which led the IDFPR to conclude that the public interest necessitates that this Order be effective immediately. 21 CFR
revoke Respondent’s controlled substance license, I 1316.67.

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Document Created: 2018-04-10 23:59:38
Document Modified: 2018-04-10 23:59:38
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		83 FR 15630
83 FR 15630 - Witold Marek Zajewski, M.D.; Decision and Order

DEPARTMENT OF JUSTICEDrug Enforcement Administration

Federal Register Volume 83, Issue 70 (April 11, 2018)

DEPARTMENT OF JUSTICE
Drug Enforcement Administration
