81 FR 3158 - Irwin August, D.O.; Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 12 (January 20, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 12 (January 20, 2016)
| Page Range | 3158-3159 | |
| FR Document | 2016-00895 |
[Federal Register Volume 81, Number 12 (Wednesday, January 20, 2016)] [Notices] [Pages 3158-3159] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00895] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 16-4] Irwin August, D.O.; Decision and Order On November 6, 2015, Administrative Law Judge Charles Wm. Dorman (ALJ) issued the attached Recommended Decision (R.D.).\1\ Therein, the ALJ found that it is undisputed that Respondent's Connecticut Controlled Substance Registration is suspended, thus rendering him without authority to dispense controlled substances in Connecticut, the State in which he holds DEA Registration FA3033002. R.D. at 4. The ALJ also found that, by virtue of the Voluntary Agreement Not to Practice Medicine which Respondent entered into with the Massachusetts Board of Registration in Medicine, he is also currently without authority to dispense controlled substances in that State, where he holds DEA Registration BA4089721. Id. The ALJ thus granted the Government's Motion for Summary Disposition and recommended that I revoke both of Respondent's registrations and deny any pending applications. --------------------------------------------------------------------------- \1\ All citations to the Recommended Decision are to the slip opinion issued by the ALJ. --------------------------------------------------------------------------- Neither party filed exceptions to the Recommended Decision. Having reviewed the record, I adopt the ALJ's factual findings that Respondent's Connecticut Controlled Substance Registration has been suspended and that he has entered into the Voluntary Agreement with the Massachusetts Board. I also adopt the ALJ's legal conclusions that Respondent currently lacks authority to dispense controlled substances in each State.\2\ Accordingly, I will also adopt the ALJ's recommendation that I revoke both registrations and deny any pending applications to renew or modify each registration. --------------------------------------------------------------------------- \2\ Respondent does not dispute the allegations that his DEA registration for his Massachusetts office does not expire until June 30, 2018 and that his DEA registration for his Connecticut office does not expire until June 30, 2017. Resp.'s Affirmation in Opp., at 1. Accordingly, I find that there is a live controversy with respect to both registrations. --------------------------------------------------------------------------- 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 Certificates of Registration BA4089721 and FA3033002 issued to Irwin August, D.O., be, and they hereby are, revoked. I further order that any pending application of Irwin August, D.O., to renew or modify either of the above registrations, be, and it hereby is, denied. This Order is effective February 19, 2016. Dated: January 8, 2016. Chuck Rosenberg, Acting Administrator. W. Brian Bayly, Esq., for the Government. John J. Tierney, Esq., for the Respondent. Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision Charles Wm. Dorman, Administrative Law Judge. The Deputy Assistant Administrator, Drug Enforcement Administration (``DEA'' or ``Government''), issued an Order to Show Cause (``OSC''), seeking to revoke the DEA Certificates of Registration (``CORs'') of Irwin August, D.O. (``Respondent''), pursuant to 21 U.S.C. 824(a)(3), and deny any pending applications for renewal or modification of the CORs, pursuant to 21 U.S.C. 823(f). The Government alleged that the Respondent lacks state authority to handle controlled substances in Massachusetts and Connecticut, where DEA CORs Numbers BA4089721 and FA3033002, respectively, are registered. OSC at 2. The Respondent filed a timely Request for Hearing. Therein, the Respondent did not discuss the voluntary suspension of his Massachusetts license. However, he did allege that his Connecticut license may be restored because the Connecticut Commissioner of Consumer Affairs currently is reviewing the suspension of his license. Req. for Hr'g at 1. [[Page 3159]] On October 27, 2015, the Government filed a Motion for Summary Disposition Based on Respondent's Lack of State Authorization to Handle Controlled Substances and Submission of Evidence in Support of Such Motion (``Motion for Summary Disposition''). Therein, the Government argued that the Respondent currently lacks state authority in Massachusetts and Connecticut to handle controlled substances. Mot. for Summ. Disp. at 3. First, the Government argued that the Respondent voluntarily agreed with the Massachusetts Board of Registration in Medicine (``Massachusetts Board'') to refrain from practicing medicine. Mot. for Summ. Disp. at 2. Attached to the Government's Motion is a copy of the Voluntary Agreement Not to Practice Medicine, entered into by the Respondent and the Massachusetts Board. Mot. for Summ. Disp. Ex. C, at 3-4. Second, the Government argued that the Respondent's Connecticut controlled substance registration was suspended because the Respondent made false statements in his renewal application. Mot. for Summ. Disp. at 2. Attached to the Government's Motion is the Connecticut Department of Consumer Protection's (``CDCP'') Order of Immediate Suspension of Controlled Substance Registration No. 22241. Mot. for Summ. Disp. Ex. D, at 1-2. On November 4, 2015, the Respondent's counsel filed an Affirmation in Opposition (``Respondent's Reply''). In his Reply, the Respondent's counsel asserted that, although the Respondent's Connecticut controlled substance registration currently is suspended, the CDCP conducted a hearing on September 17, 2015, regarding the suspension. Resp't Reply at 1-2. The Respondent's counsel asserted that the CDCP's final decision may change his registration status. Resp't Reply at 1-2, 7-8. The Respondent's counsel also asserted that, although the Respondent signed an agreement not to practice in Massachusetts, that agreement was predicated on the suspension of the Respondent's Rhode Island license, and that his Rhode Island license may be restored.\3\ Resp't Reply at 4-5, 7. --------------------------------------------------------------------------- \3\ The Respondent asserts that he entered a voluntary agreement suspending his Massachusetts license because his Rhode Island license was suspended. Resp't Reply at 4-6. The Respondent also asserts that he requested a hearing on the suspension of his Rhode Island license, but has not challenged his Massachusetts license's suspension. Req. for Hr'g at 1; Resp't Reply at 7. This case, however, do not address any DEA registration to dispense controlled substances in Rhode Island. Thus, the status of the Respondent's Rhode Island license is not considered here. See Brian Earl Cressman, M.D., 78 FR 12091, 12092 n.2 (2013) (noting that ``a registrant's controlled substance privileges in a state outside the state of his DEA registration [are] irrelevant'') (citing Shahid Musud Siddiqui, M.D., 61 FR 14818 (1996)). --------------------------------------------------------------------------- In revocation cases, the Government has the burden of proving that the requirements for revocation are satisfied. 21 CFR 1301.44(e) (2015). The Government also bears the initial burden of production. If the Government makes a prima facie case for revocation, the burden of production shifts to the registrant to show that revocation is inappropriate. Morall v. DEA, 412 F.3d 165, 174 (D.C. Cir. 2005). To maintain a DEA registration, a practitioner must be currently authorized to handle controlled substances in the jurisdiction where he practices. See 21 U.S.C. 802(21), 823(f) (2012). A registrant must possess state authority to dispense controlled substances in order to obtain and maintain DEA registration. E.g., Serenity Caf[eacute], 77 FR 35027, 35028 (2012). Accordingly, the Controlled Substances Act ``requires the revocation of a registration issued to a practitioner whose State license has been suspended or revoked.'' Scott Sandarg, D.M.D., 74 FR 17528, 17529 (2009). The Respondent argues that his COR should not be revoked because the CDCP may restore his Connecticut registration. However, ``it does not matter whether the suspension . . . [is] pending the outcome of a state proceeding. Rather, what matters--as DEA has repeatedly held--is whether Respondent is without authority under [state] law to dispense a controlled substance.'' Bourne Pharmacy, Inc., 72 FR 18273, 18274 (2007); see also Grider Drug #1 & Grider Drug #2, 77 FR 44069, 44104 n.97 (2012). The Respondent requested a stay of these proceedings until the CDCP reaches a final decision regarding his Connecticut registration. Req. for Hr'g at 2; Resp't Reply at 8. This Agency routinely denies ``requests to stay the issuance of a final order of revocation . . . [because] a practitioner must be currently authorized to handle controlled substances . . . to maintain [his] DEA registration.'' Gregory F. Saric, M.D., 76 FR 16821 (2011) (emphasis added) (internal quotations and citations omitted). Because evaluating ``whether Respondent's state license will be re-instated is entirely speculative,'' id., ``[i]t is not DEA's policy to stay proceedings . . . while registrants litigate in other forums.'' Newcare Home Health Servs., 72 FR 42126, 42127 n.2 (2007) (citing Bourne Pharmacy, 72 FR at 18273; Oakland Med. Pharmacy, 71 FR 50100 (2006); Kennard Kobrin, M.D., 70 FR 33199 (2005)). Therefore, the Respondent's request to stay the proceedings pending the CDCP's final decision is denied. The disposition of the Government's Motion depends on whether the Respondent possesses state authority to handle controlled substances. The administrative record establishes that he does not. The CDCP's Order of Immediate Suspension of Controlled Substance Registration No. 22241 establishes that his Connecticut controlled substances registration currently is suspended. Accordingly, the Respondent lacks authorization to handle controlled substances in Connecticut, where DEA COR Number FA3033002 is registered. Additionally, the Massachusetts Voluntary Agreement Not to Practice Medicine establishes that the Respondent currently lacks authorization to handle controlled substances in Massachusetts, where DEA COR Number BA4089721 is registered. Where there is no genuine question of fact, or there is agreement upon the material facts, a plenary, adversarial hearing is not required. See, e.g., Jesus R. Juarez, M.D., 62 FR 14945 (1997). Thus, summary disposition is warranted here because ``there is no factual dispute of substance.'' See Veg-Mix, Inc., 832 F.2d 601, 607 (D.C. Cir. 1987). As of the date of this Recommended Decision, the Respondent currently lacks state authority to handle controlled substances in both Connecticut and Massachusetts; therefore, he cannot maintain his DEA registrations. The Government's Motion for Summary Disposition is granted, and it is recommended that the Respondent's DEA registrations be revoked and any pending applications for renewal be denied. Dated: November 6, 2015 Charles Wm. Dorman, Administrative Law Judge. [FR Doc. 2016-00895 Filed 1-19-16; 8:45 am] BILLING CODE 4410-09-P
![3158 Federal Register / Vol. 81, No. 12 / Wednesday, January 20, 2016 / Notices
representative consumer organizations Procedures, 76 FR 62092 (Oct. 6, 2011), Agreement with the Massachusetts
have the right to appear as parties in available on the Commission’s Web site Board. I also adopt the ALJ’s legal
Commission antidumping duty and at http://edis.usitc.gov. conclusions that Respondent currently
countervailing duty investigations. The In accordance with sections 201.16(c) lacks authority to dispense controlled
Secretary will prepare a public service and 207.3 of the rules, each document substances in each State.2 Accordingly,
list containing the names and addresses filed by a party to the investigations I will also adopt the ALJ’s
of all persons, or their representatives, must be served on all other parties to recommendation that I revoke both
who are parties to these investigations the investigations (as identified by registrations and deny any pending
upon the expiration of the period for either the public or BPI service list), and applications to renew or modify each
filing entries of appearance. a certificate of service must be timely registration.
Limited disclosure of business filed. The Secretary will not accept a
proprietary information (BPI) under an Order
document for filing without a certificate
administrative protective order (APO) of service. Pursuant to the authority vested in me
and BPI service list.—Pursuant to by 21 U.S.C. 823(f) and 824(a), as well
Authority: These investigations are being
section 207.7(a) of the Commission’s conducted under authority of title VII of the as 28 CFR 0.100(b), I order that DEA
rules, the Secretary will make BPI Tariff Act of 1930; this notice is published Certificates of Registration BA4089721
gathered in these investigations pursuant to section 207.12 of the and FA3033002 issued to Irwin August,
available to authorized applicants Commission’s rules. D.O., be, and they hereby are, revoked.
representing interested parties (as I further order that any pending
By order of the Commission.
defined in 19 U.S.C. 1677(9)) who are application of Irwin August, D.O., to
Issued: January 13, 2016.
parties to the investigations under the renew or modify either of the above
APO issued in the investigations, Lisa R. Barton,
registrations, be, and it hereby is,
provided that the application is made Secretary to the Commission. denied. This Order is effective February
not later than seven days after the [FR Doc. 2016–00931 Filed 1–19–16; 8:45 am] 19, 2016.
publication of this notice in the Federal BILLING CODE 7020–02–P
Dated: January 8, 2016.
Register. A separate service list will be
Chuck Rosenberg,
maintained by the Secretary for those
parties authorized to receive BPI under Acting Administrator.
DEPARTMENT OF JUSTICE
the APO. W. Brian Bayly, Esq., for the Government.
Conference.—The Commission’s Drug Enforcement Administration John J. Tierney, Esq., for the Respondent.
Director of Investigations has scheduled
[Docket No. 16–4] Recommended Rulings, Findings of
a conference in connection with these
investigations for 9:30 a.m. on February Fact, Conclusions of Law, and Decision
Irwin August, D.O.; Decision and Order
3, 2016, at the U.S. International Trade Charles Wm. Dorman, Administrative
Commission Building, 500 E Street SW., On November 6, 2015, Administrative Law Judge. The Deputy Assistant
Washington, DC. Requests to appear at Law Judge Charles Wm. Dorman (ALJ) Administrator, Drug Enforcement
the conference should be emailed to issued the attached Recommended Administration (‘‘DEA’’ or
William.bishop@usitc.gov and Decision (R.D.).1 Therein, the ALJ found ‘‘Government’’), issued an Order to
Sharon.bellamy@usitc.gov (DO NOT that it is undisputed that Respondent’s Show Cause (‘‘OSC’’), seeking to revoke
FILE ON EDIS) on or before February 1, Connecticut Controlled Substance the DEA Certificates of Registration
2016. Parties in support of the Registration is suspended, thus (‘‘CORs’’) of Irwin August, D.O.
imposition of countervailing and rendering him without authority to (‘‘Respondent’’), pursuant to 21 U.S.C.
antidumping duties in these dispense controlled substances in 824(a)(3), and deny any pending
investigations and parties in opposition Connecticut, the State in which he applications for renewal or modification
to the imposition of such duties will holds DEA Registration FA3033002. of the CORs, pursuant to 21 U.S.C.
each be collectively allocated one hour R.D. at 4. The ALJ also found that, by 823(f). The Government alleged that the
within which to make an oral virtue of the Voluntary Agreement Not Respondent lacks state authority to
presentation at the conference. A to Practice Medicine which Respondent handle controlled substances in
nonparty who has testimony that may entered into with the Massachusetts Massachusetts and Connecticut, where
aid the Commission’s deliberations may Board of Registration in Medicine, he is DEA CORs Numbers BA4089721 and
request permission to present a short also currently without authority to FA3033002, respectively, are registered.
statement at the conference. dispense controlled substances in that OSC at 2.
Written submissions.—As provided in State, where he holds DEA Registration The Respondent filed a timely
sections 201.8 and 207.15 of the BA4089721. Id. The ALJ thus granted Request for Hearing. Therein, the
Commission’s rules, any person may the Government’s Motion for Summary Respondent did not discuss the
submit to the Commission on or before Disposition and recommended that I voluntary suspension of his
February 8, 2016, a written brief revoke both of Respondent’s Massachusetts license. However, he did
containing information and arguments registrations and deny any pending allege that his Connecticut license may
pertinent to the subject matter of the applications. be restored because the Connecticut
investigations. Parties may file written Neither party filed exceptions to the Commissioner of Consumer Affairs
testimony in connection with their Recommended Decision. Having currently is reviewing the suspension of
presentation at the conference. If briefs reviewed the record, I adopt the ALJ’s his license. Req. for Hr’g at 1.
tkelley on DSK4VPTVN1PROD with NOTICES
or written testimony contain BPI, they factual findings that Respondent’s
must conform with the requirements of Connecticut Controlled Substance 2 Respondent does not dispute the allegations that
sections 201.6, 207.3, and 207.7 of the Registration has been suspended and his DEA registration for his Massachusetts office
Commission’s rules. Please consult the does not expire until June 30, 2018 and that his
that he has entered into the Voluntary DEA registration for his Connecticut office does not
Commission’s rules, as amended, 76 FR expire until June 30, 2017. Resp.’s Affirmation in
61937 (Oct. 6, 2011) and the 1 All citations to the Recommended Decision are Opp., at 1. Accordingly, I find that there is a live
Commission’s Handbook on Filing to the slip opinion issued by the ALJ. controversy with respect to both registrations.
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![Federal Register / Vol. 81, No. 12 / Wednesday, January 20, 2016 / Notices 3159
On October 27, 2015, the Government In revocation cases, the Government Kennard Kobrin, M.D., 70 FR 33199
filed a Motion for Summary Disposition has the burden of proving that the (2005)). Therefore, the Respondent’s
Based on Respondent’s Lack of State requirements for revocation are request to stay the proceedings pending
Authorization to Handle Controlled satisfied. 21 CFR 1301.44(e) (2015). The the CDCP’s final decision is denied.
Substances and Submission of Evidence Government also bears the initial The disposition of the Government’s
in Support of Such Motion (‘‘Motion for burden of production. If the Motion depends on whether the
Summary Disposition’’). Therein, the Government makes a prima facie case Respondent possesses state authority to
Government argued that the Respondent for revocation, the burden of production handle controlled substances. The
currently lacks state authority in shifts to the registrant to show that administrative record establishes that he
Massachusetts and Connecticut to revocation is inappropriate. Morall v. does not. The CDCP’s Order of
handle controlled substances. Mot. for DEA, 412 F.3d 165, 174 (D.C. Cir. 2005). Immediate Suspension of Controlled
Summ. Disp. at 3. First, the Government To maintain a DEA registration, a Substance Registration No. 22241
argued that the Respondent voluntarily practitioner must be currently establishes that his Connecticut
agreed with the Massachusetts Board of authorized to handle controlled controlled substances registration
Registration in Medicine substances in the jurisdiction where he currently is suspended. Accordingly,
(‘‘Massachusetts Board’’) to refrain from practices. See 21 U.S.C. 802(21), 823(f) the Respondent lacks authorization to
practicing medicine. Mot. for Summ. (2012). A registrant must possess state handle controlled substances in
Disp. at 2. Attached to the Government’s authority to dispense controlled Connecticut, where DEA COR Number
Motion is a copy of the Voluntary substances in order to obtain and FA3033002 is registered. Additionally,
Agreement Not to Practice Medicine, maintain DEA registration. E.g., Serenity the Massachusetts Voluntary Agreement
entered into by the Respondent and the Café, 77 FR 35027, 35028 (2012). Not to Practice Medicine establishes
Massachusetts Board. Mot. for Summ. Accordingly, the Controlled Substances that the Respondent currently lacks
Disp. Ex. C, at 3–4. Second, the Act ‘‘requires the revocation of a authorization to handle controlled
Government argued that the registration issued to a practitioner substances in Massachusetts, where
Respondent’s Connecticut controlled whose State license has been suspended DEA COR Number BA4089721 is
substance registration was suspended or revoked.’’ Scott Sandarg, D.M.D., 74 registered.
because the Respondent made false FR 17528, 17529 (2009). Where there is no genuine question of
statements in his renewal application. The Respondent argues that his COR fact, or there is agreement upon the
Mot. for Summ. Disp. at 2. Attached to should not be revoked because the material facts, a plenary, adversarial
the Government’s Motion is the CDCP may restore his Connecticut hearing is not required. See, e.g., Jesus
Connecticut Department of Consumer registration. However, ‘‘it does not R. Juarez, M.D., 62 FR 14945 (1997).
Protection’s (‘‘CDCP’’) Order of matter whether the suspension . . . [is] Thus, summary disposition is warranted
Immediate Suspension of Controlled pending the outcome of a state here because ‘‘there is no factual dispute
Substance Registration No. 22241. Mot. proceeding. Rather, what matters—as of substance.’’ See Veg-Mix, Inc., 832
for Summ. Disp. Ex. D, at 1–2. DEA has repeatedly held—is whether F.2d 601, 607 (D.C. Cir. 1987). As of the
On November 4, 2015, the Respondent is without authority under date of this Recommended Decision, the
Respondent’s counsel filed an [state] law to dispense a controlled Respondent currently lacks state
Affirmation in Opposition substance.’’ Bourne Pharmacy, Inc., 72 authority to handle controlled
(‘‘Respondent’s Reply’’). In his Reply, FR 18273, 18274 (2007); see also Grider substances in both Connecticut and
the Respondent’s counsel asserted that, Drug #1 & Grider Drug #2, 77 FR 44069, Massachusetts; therefore, he cannot
although the Respondent’s Connecticut 44104 n.97 (2012). maintain his DEA registrations. The
controlled substance registration The Respondent requested a stay of Government’s Motion for Summary
currently is suspended, the CDCP these proceedings until the CDCP Disposition is granted, and it is
conducted a hearing on September 17, reaches a final decision regarding his recommended that the Respondent’s
2015, regarding the suspension. Resp’t Connecticut registration. Req. for Hr’g at DEA registrations be revoked and any
Reply at 1–2. The Respondent’s counsel 2; Resp’t Reply at 8. This Agency pending applications for renewal be
asserted that the CDCP’s final decision routinely denies ‘‘requests to stay the denied.
may change his registration status. issuance of a final order of revocation
Resp’t Reply at 1–2, 7–8. The Dated: November 6, 2015
. . . [because] a practitioner must be
Respondent’s counsel also asserted that, Charles Wm. Dorman,
currently authorized to handle
although the Respondent signed an controlled substances . . . to maintain Administrative Law Judge.
agreement not to practice in [his] DEA registration.’’ Gregory F. [FR Doc. 2016–00895 Filed 1–19–16; 8:45 am]
Massachusetts, that agreement was Saric, M.D., 76 FR 16821 (2011) BILLING CODE 4410–09–P
predicated on the suspension of the (emphasis added) (internal quotations
Respondent’s Rhode Island license, and and citations omitted). Because
that his Rhode Island license may be evaluating ‘‘whether Respondent’s state DEPARTMENT OF JUSTICE
restored.3 Resp’t Reply at 4–5, 7. license will be re-instated is entirely [OMB Number 1110–0011]
speculative,’’ id., ‘‘[i]t is not DEA’s
3 The Respondent asserts that he entered a
policy to stay proceedings . . . while Agency Information Collection
voluntary agreement suspending his Massachusetts
license because his Rhode Island license was registrants litigate in other forums.’’ Activities; Proposed eCollection
suspended. Resp’t Reply at 4–6. The Respondent Newcare Home Health Servs., 72 FR eComments Requested; Revision of a
also asserts that he requested a hearing on the 42126, 42127 n.2 (2007) (citing Bourne Previously Approved Collection
tkelley on DSK4VPTVN1PROD with NOTICES
suspension of his Rhode Island license, but has not Pharmacy, 72 FR at 18273; Oakland
challenged his Massachusetts license’s suspension.
Med. Pharmacy, 71 FR 50100 (2006); AGENCY: Federal Bureau of
Req. for Hr’g at 1; Resp’t Reply at 7. This case, Investigation, Department of Justice
however, do not address any DEA registration to
dispense controlled substances in Rhode Island. (noting that ‘‘a registrant’s controlled substance Violent Criminal Apprehension Program
Thus, the status of the Respondent’s Rhode Island privileges in a state outside the state of his DEA (ViCAP).
license is not considered here. See Brian Earl registration [are] irrelevant’’) (citing Shahid Musud ACTION: 60-day notice.
Cressman, M.D., 78 FR 12091, 12092 n.2 (2013) Siddiqui, M.D., 61 FR 14818 (1996)).
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Document Created: 2016-01-19 23:44:02
Document Modified: 2016-01-19 23:44:02
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