36758 Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Notices 

1Respondent also invoked the ‘‘mend the hold 

doctrine,’’ an obscure common law rule which 

prohibits a party to a contract from changing its 

position on the contract’s meaning during the 

course of litigation over it. Id. at 3 (citing Utica Mut. 

Ins. Co. v. Vigo Coal Co., Inc., 393 F.3d 707, 716 

(7th Cir. 2004)). Specifically, Respondent 

contended that the Government’s reliance on the 

expiration of Respondent’s lack of a state controlled 

substance license was ‘‘analogous to an attempt to 

mend the hold,’’ presumably because the Show 

Cause Order had cited the consent agreement rather 

than the expiration. Id. at 3 (citation omitted). 

Respondent did not renew this argument in his 

exceptions, and in any event, the analogy is 

misplaced. 

the following: (1) The date that a controlled 

substance was administered, or dispensed 

(whether by prescription or actual delivery of 

the drug); (2) the name of the patient to 

whom a controlled substance was 

administered or dispensed (whether by 

prescription or actual delivery); (3) the 

patient’s dental complaint; (4) the name, 

dosage, and quantity of the substance 

prescribed, dispensed or administered; and 

(5) the date that the medication was 

previously prescribed, dispensed or 

administered to that patient if the medication 

was prescribed, dispensed or administered in 

the last year, as well as the amount last 

provided to that patient. If no controlled 

substances are prescribed, administered, or 

dispensed during a given quarter, 

Respondent shall submit a letter to the DEA 

office indicating that there was no activity to 

report during the quarter. 

(B) Within 15 days of the event, 

Respondent shall inform the local DEA office 

of any proceeding initiated against him by a 

State licensing board, whether the board 

regulates his professional practice or his 

authority to prescribe controlled substances. 

In addition, within 15 days of the event, 

Respondent shall inform the local DEA office 

of any interim or final order of a State 

licensing board which imposes a sanction, 

whether the sanction be a reprimand, a fine, 

a civil penalty, a probationary period, a 

rejection of a petition for termination of 

probation, an imposition of a condition, a 

suspension, or a revocation of any State 

professional license or authority to prescribe 

a controlled substance. 

(C) In the event that Respondent changes 

employment during this three-year period, he 

shall immediately notify the local DEA office 

that is monitoring his drug activity logs. 

To ensure that there is no confusion 

as to the duration of these conditions, 

all three conditions shall remain in 

effect for a period of three years from 

the date of this Order’s publication in 

the Federal Register. 

Moreover, because Respondent has 

not previously appreciated the 

seriousness of these proceedings and his 

obligation to comply with the CSA, the 

Agency’s rules, and the conditions 

imposed pursuant to the 2002 Order, I 

further conclude that a period of 

outright suspension of his registration is 

warranted. Accordingly, while I grant 

Respondent a new registration, said 

registration will be suspended outright 

for a period of three months. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823 and 824, as well as 28 

CFR 0.100(b) and 0.104, I hereby order 

that the application of Gregory D. 

Owens, D.D.S., to renew his DEA 

Certificate of Registration, be, and it 

hereby is, granted subject to the 

conditions set forth above. I further 

order that the DEA Certificate of 

Registration issued to Gregory D. 

Owens, be, and it hereby is, suspended 

for a period of three months from the 

effective date of this Order. This Order 

is effective August 24, 2009. 

Dated: July 16, 2009. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E9–17681 Filed 7–23–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 08–59] 

Roy E. Berkowitz, M.D.; Revocation of 

Registration 

On August 26, 2008, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Roy E. Berkowitz, M.D. 

(Respondent), of Slidell, Louisiana. The 

Show Cause Order proposed the 

revocation of Respondent’s DEA 

Certificate of Registration, BB0492912, 

as a practitioner, and the denial of any 

pending applications to renew or 

modify his registration, on the grounds 

that Respondent does ‘‘not have 

authority to prescribe controlled 

substances in the State of Louisiana,’’ 

and that his ‘‘continued registration is 

inconsistent with the public interest.’’ 

Show Cause Order at 1. 

More specifically, the Show Cause 

Order alleged that as a result of 

prescriptions for controlled substances 

which Respondent issued in 2006 and 

2007 that were inconsistent with State 

rules and regulations, Respondent 

entered into a Consent Order with the 

Louisiana State Board of Medical 

Examiners, which ‘‘strips [Respondent] 

of authority to handle controlled 

substances in the State of Louisiana, the 

state in which [he is] registered with 

DEA.’’ Id. 

Respondent requested a hearing on 

the allegations, and the matter was 

assigned to an Administrative Law 

Judge (ALJ), who commenced prehearing procedures. Thereafter, the 

Government moved for summary 

disposition on the ground that 

Respondent ‘‘currently lacks authority 

to handle controlled substances in the 

State of Louisiana—his state of 

registration.’’ Gov. Mot. at 1. 

In support of its motion, the 

Government attached a declaration of a 

DEA Diversion Investigator (DI). 

Therein, the DI stated that on October 

15, 2008, she had queried the Louisiana 

State Board of Pharmacy’s Web site to 

determine Respondent’s license status, 

and found that ‘‘the Controlled 

Dangerous Substance license #33853 of 

Roy E. Berkowitz, M.D. was delinquent, 

having expired on September 25, 2008.’’ 

Id. at Appendix I. 

The ALJ allowed the Respondent to 

file a response to the motion through 

October 30, 2008. Moreover, on October 

29, 2008, the ALJ granted Respondent 

an extension of the due date until 

November 6, 2008, on which date 

Respondent filed his response. 

Therein, Respondent noted that while 

the Show Cause Order had relied on the 

State Board’s Consent Order, the motion 

for summary disposition relied on a 

‘‘declaration * * * asserting that a 

license issued by the Louisiana Board of 

Pharmacy to [Respondent] expired on 

September 25, 2008.’’ Resp. at 1. 

Respondent maintained that the 

Government was improperly changing 

its theory of the case, and argued that 

‘‘[t]he DEA without leave to amend the 

Order to Show Cause has sought to 

change the underlying basis of the 

case.’’ 1 Id. at 2–3. 

Next, Respondent argued that the 

Agency lacks authority to revoke his 

registration because in his view, 21 

U.S.C. 824(a)(3) requires both a 

suspension, denial or revocation of the 

state license or registration, and that the 

practitioner no longer be authorized by 

state law to handle controlled 

substances. Id. at 3–4. In support of his 

contention, Respondent attached his 

declaration in which he stated that he 

submitted his application for renewal of 

his Louisiana Controlled Dangerous 

Substance License in July 2008, and that 

he was ‘‘advised by the Louisiana Board 

of Pharmacy that this agency was unable 

to process’’ his application. Id., Ex. A at 

1. The declaration further asserted that 

the Louisiana Board of Pharmacy ‘‘did 

not enter an order’’ denying, suspending 

or revoking Respondent’s application. 

Id. at 1–2. Thus, Respondent argued that 

the Government’s motion should be 

denied ‘‘[b]ased upon a failure to 

establish the elements required under 

21 U.S.C. 824(a)(3) and 21 U.S.C. 

824(a)(4).’’ Resp. at 5. 

On January 27, 2009, the ALJ issued 

her Opinion and Recommended 


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Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Notices 36759 

Decision. Therein, the ALJ granted the 

Government’s motion for summary 

disposition and recommended that I 

revoke Respondent’s registration and 

deny any pending applications. The ALJ 

rejected Respondent’s argument that his 

due process rights were violated by the 

Government’s reliance on the expiration 

of his state’s dangerous substances 

license, as Respondent was ‘‘advised 

* * * of the grounds on which the 

Government relied in seeking to revoke 

his registration and * * * addressed 

those grounds in his response.’’ ALJ at 

4. 

The ALJ also rejected Respondent’s 

argument that the Government had 

failed to show that his continued 

registration was inconsistent with the 

public interest, reasoning that the 

‘‘subsections of 21 U.S.C. 824(a) are to 

be considered in the disjunctive.’’ Id. 

Framing the issue as ‘‘whether 

Respondent is currently authorized to 

handle controlled substances in 

Louisiana,’’ the ALJ noted Respondent’s 

contention that he had applied for a 

new state controlled substance 

registration, but that the State Board of 

Pharmacy had advised him that it could 

not act on his application. Id. at 5. The 

ALJ then rejected Respondent’s 

argument, reasoning that Respondent 

did not dispute that his state registration 

‘‘is expired, and although he asserts that 

there should be a hearing on whether 

his filing of a renewal application 

extends his authority to handle 

controlled substances in Louisiana, he 

makes no showing that he has applied 

for and been granted the requisite 

authority.’’ Id. 

The ALJ thus concluded that there 

was no dispute over the material fact 

‘‘that Respondent is currently not 

authorized to handle controlled 

substances in Louisiana, the State in 

which he is registered with the DEA.’’ 

Id. Applying the Agency’s settled rule 

that ‘‘[b]ecause Respondent lacks this 

state authority * * * he is not currently 

entitled to a DEA registration in 

Louisiana,’’ the ALJ granted the 

Government’s motion and 

recommended that Respondent’s 

registration be revoked and that any 

pending application be denied. Id. 

Thereafter, on February 13, 2008, 

Respondent submitted his Exceptions to 

the ALJ’s decision, and on March 9, 

2009, the ALJ forwarded the record to 

me for final agency action. Having 

considered the entire record including 

Respondent’s exceptions, I adopt the 

ALJ’s finding that Respondent currently 

lacks authority to handle controlled 

substances in Louisiana, and therefore, 

is not entitled to maintain his DEA 

registration. I also adopt the ALJ’s 

recommendation that Respondent’s 

registration be revoked and that any 

pending application be denied. 

I find that Respondent currently holds 

DEA Certificate of Registration, 

BB0492912, which authorizes him to 

dispense controlled substances in 

Schedules II through V, as a 

practitioner, at the registered location of 

1632 Marina Drive, Slidell, Louisiana. 

Respondent’s Registration does not 

expire until July 31, 2009. I further find 

that Respondent Louisiana Controlled 

Dangerous Substance (CDS) License 

expired on September 25, 2008. 

I also find that while Respondent has 

applied for a new State CDS license, he 

has provided no evidence that Board of 

Pharmacy has issued one to him. 

Moreover, Respondent cites to no 

authority establishing that under 

Louisiana law, his filing of the 

application extended his CDS license 

past its expiration date. Cf. 5 U.S.C. 

§ 558(c). I thus adopt the ALJ’s 

conclusion that Respondent does not 

possess authority to dispense controlled 

substances under Louisiana law, and 

therefore does not meet an essential 

prerequisite for holding a registration 

under Federal law. ALJ at 5. 

Respondent nonetheless excepts to 

the ALJ’s decision on various grounds. 

First, Respondent contends that the ALJ 

erred in granting the Government’s 

motion for summary disposition 

because it relied on an issue (the 

expiration of his State CDS license) 

which was not raised in the Show Cause 

Order. In Respondent’s view, a motion 

for summary disposition in an 

administrative proceeding should be 

treated analogously to a motion for 

summary judgment, and that the 

‘‘[p]leadings may not be disregarded in 

ruling on a motion for summary 

judgment in Federal court.’’ Exc. at 2. 

According to Respondent, ‘‘if the 

pleadings, depositions, answers to 

interrogatories, and admissions on file, 

together with the affidavits, if any, show 

that there is no genuine issue as to any 

material fact and that the moving party 

is entitled to judgment as a matter of 

law,’’ then the motion should be 

granted. Exc. at 2–3 (emphasis in 

original). By emphasizing, ‘‘pleadings,’’ 

Respondent apparently wished to 

emphasize his position that the Show 

Cause Order should have contained all 

the grounds on which the revocation 

was ultimately based. 

This Agency’s proceedings are not, 

however, governed by the Federal Rules 

of Civil Procedure. And while those 

rules (and the judicial decisions 

interpreting them) may be a useful 

guide, they are not binding on the 

Agency. Instead, what is binding on the 

Agency is the Due Process Clause, the 

Administrative Procedure Act, and the 

Agency’s regulations. 

Contrary to Respondent’s 

understanding, to decide this matter on 

the grounds asserted in the 

Government’s motion does not violate 

his right to due process. As the Federal 

Courts have recognized, ‘‘‘[p]leadings in 

administrative proceedings are not 

judged by the standards applied to an 

indictment at common law.’’’ Citizens 

State Bank of Marshfield v. FDIC, 751 

F.2d 209, 213 (8th Cir. 1984) (quoting 

Aloha Airlines, Inc., v. CAB, 598 F.2d 

250, 262 (DC Cir. 1979)). An agency is 

not required ‘‘to give every 

[Respondent] a complete bill of 

particulars as to every allegation that 

[he] will confront.’’ Boston Carrier, Inc. 

v. ICC, 746 F.2d 1555, 1560 (DC Cir. 

1984); see also Paul H. Volkman, 73 FR 

30630, 30641 n.35 (2008). Indeed, the 

Federal Courts routinely uphold agency 

adjudications which are based on 

matters which were not initially raised 

in a charging document but which were 

nonetheless litigated in a proceeding. 

See, e.g., Pergament United Sales, Inc., 

v. NLRB, 920 F.2d 130, 137 (2d 

Cir.1990) (no due process violation 

where NLRB did not cite in complaint 

specific provision of NLRA which Board 

ultimately relied on in its order because 

the employer ‘‘was not kept in the dark 

[and] was aware of and actively 

litigated’’ the relevant issue); Facet 

Enters., Inc., v. NLRB, 907 F.2d 963, 972 

(10th Cir. 1990) (‘‘A material issue 

which has been fairly tried by the 

parties * * * may be decided by the 

Board regardless of whether it has been 

specifically pleaded.’’); Citizens State 

Bank, 751 F.2d at 213; Kuhn v. CAB, 

183 F.2d 839, 842 (DC Cir. 1950)((‘‘If it 

is clear that the parties understand 

exactly what the issues are when the 

proceedings are had, they cannot 

thereafter claim surprise or lack of due 

process because of alleged deficiencies 

in the language of the particular 

pleadings.’’). 

Notably, in the Show Cause Order, the 

Agency notified Respondent that it was 

seeking the revocation because he 

‘‘do[es] not have authority to prescribe 

controlled substances in the State of 

Louisiana,’’ and that as a consequence, 

‘‘DEA must revoke your DEA 

registration based upon your lack of 

authority to handle controlled 

substances in the State of Louisiana.’’ 

Show Cause Order at 1. The 

Government thus provided Respondent 

with notice as to the legal basis for the 

proceeding. 

Moreover, even though the 

Government relied on the expiration of 

Respondent’s State CDS license rather 


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36760 Federal Register / Vol. 74, No. 141 / Friday, July 24, 2009 / Notices 

2Likewise, the Administrative Procedure Act 

requires only that ‘‘[p]ersons entitled to notice of an 

agency hearing shall be timely informed of * * * 

the matters of fact and law asserted.’’ 5 U.S.C. 

554(b). He was. 

3Because of the importance of the legal issues 

raised by Respondent, I conclude that the public 

interest necessitates that this Order be made 

effective immediately. 

than the Consent Order to support its 

motion, Respondent had an ample and 

meaningful opportunity to present 

evidence refuting the Government’s 

evidence and creating a triable issue 

and/or to make argument (were there 

any viable ones to be made), regarding 

the legal effect of his filing of the State 

renewal application. While Respondent 

further argues that if the Agency ‘‘was 

going to place in issue allegations that 

were not named in the Order to Show 

Cause, the proper course of action 

would have been to move to amend the 

Order to Show Cause,’’ he does not 

identify how he has been prejudiced by 

the Government’s failure to amend the 

Order. Exc. at 4; cf. Facet Enterprises, 

907 F.2d at 972 (‘‘In determining 

whether a respondent can be held liable 

for an unfair labor practice not charged 

in the complaint, the central inquiry is 

fairness: considering the circumstances 

of the case, did the respondent know 

what conduct was being alleged and 

have ‘a fair opportunity to present [its] 

defense?’’’) (quoting Soule Glass & 

Glazing Co. v. NLRB, 652 F.2d 1055, 

1074 (1st Cir. 1985)).2

The rules governing DEA hearings do 

not require the formality of amending a 

show cause order to comply with the 

evidence. The Government’s failure to 

file an amended Show Cause Order 

alleging that Respondent’s state CDS 

license had expired does not render the 

proceeding fundamentally unfair. 

Respondent also argues that the ALJ’s 

ruling on the summary disposition 

motion ‘‘should have been stayed 

pending disclosure of evidence.’’ Exc. at 

5. Respondent analogizes the prehearing 

statements to civil discovery and argues 

that ‘‘the usual prehearing procedures 

for exchanging information was [sic] not 

completed.’’ Id. There is, however, no 

general right to discovery under either 

the APA or DEA regulations, but rather 

only a limited right to receive in 

advance of the hearing the documentary 

evidence and summaries of the 

testimony which the Government 

intends to rely upon. Nicholas A. 

Sychak, d/b/a Medicap Pharmacy, 65 

FR 75959, 75961 (2000) (citing 

McClelland v. Andrus, 606 F.2d 1278, 

1285 (DC Cir. 1979)); see also 21 CFR 

1316.54(e) & 1316.57. Nor, given the 

narrowness of the issue upon which the 

motion for summary disposition was 

based—whether Respondent has 

authority under state law to dispense a 

controlled substance—has Respondent 

shown what material evidence he might 

have obtained from the Government 

which he could not have obtained from 

another source such as the State itself. 

The contention is therefore without 

merit. 

Respondent also argues that the ALJ 

unlawfully shifted the burden of proof 

to him. According to Respondent, 

‘‘[t]here is an issue of disputed fact as 

to whether there has been [a] 

suspension[,] revocation[,] or denial of 

[his] state authority to prescribe 

controlled substances or merely [a] 

delay in processing his renewal 

application.’’ Exc. at 6. Respondent 

further claims that the ALJ did not 

require the DEA to show that the license 

was ‘‘pending,’’ and placed on him the 

burden of ‘‘show[ing] that he had been 

granted the requisite authority.’’ Id. at 7. 

Relatedly, Respondent maintains that 

the Government cannot revoke his 

registration under 21 U.S.C. 824(a)(3) 

because it has not shown that his 

registration has been suspended, 

revoked, or denied by competent 

authority. Id. 

Respondent ignores, however, that 

Congress has made the possession of 

state authority a prerequisite for 

obtaining a DEA registration. See id. 

Section 823(f) (‘‘The Attorney General 

shall register practitioners * * * to 

dispense * * * controlled substances 

* * * if the applicant is authorized to 

dispense * * * controlled substances 

under the laws of the State in which he 

practices.’’). In addition, the CSA 

defines the term ‘‘practitioner’’ to 

‘‘mean[] a physician * * * or other 

person licensed, registered, or otherwise 

permitted, by * * * the jurisdiction in 

which he practices * * * to dispense 

[or] administer * * * a controlled 

substance in the course of professional 

practice.’’ 21 U.S.C. 802(21). A 

physician who no longer holds 

authority under State law to dispense a 

controlled substance is therefore not a 

practitioner within the meaning of the 

CSA and cannot lawfully dispense. 

DEA has therefore consistently held 

that a practitioner may not maintain his 

registration if he lacks state authority to 

dispense controlled substances. This 

rule has been applied to revoke the 

registration of a practitioner even when 

the practitioner’s loss of state authority 

was based on the expiration of a state 

license rather than a formal disciplinary 

action of a state board. See William D. 

Levitt, 64 FR 49822, 49823 (1999); see 

also id. at 49822 (collecting cases). As 

the Agency explained in Levitt, because 

state authorization was clearly intended to be 

a prerequisite to DEA registration, Congress 

could not have intended for DEA to maintain 

a registration if a registrant is no longer 

authorized by the state in which he practices 

to handle controlled substances due to the 

expiration of his state license. Therefore, it is 

reasonable for DEA to interpret that 21 U.S.C. 

§ 824(a)(3) would allow for the revocation of 

a DEA * * * Registration where, as here, a 

registrant’s state authorization has expired. 

Id. at 49823. See also Chevron, Inc., v. 

NRDC, Inc., 467 U.S. 837, 843 (1984) 

(where Congress is silent on a question, 

courts defer to an agency’s reasonable 

interpretation of the statute it 

administers). 

Accordingly, in relying on the 

undisputed fact that Respondent’s State 

CDS license had expired, the ALJ did 

not erroneously shift the burden of 

proof from the Government to him. 

Rather, she correctly applied the 

Agency’s settled precedent that because 

Respondent clearly lacks authority to 

dispense controlled substances in the 

State in which he holds his DEA 

registration and practices medicine, he 

is not entitled to maintain his 

registration. Respondent’s registration 

will therefore be revoked. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823(f) & 824(a), as well as 

by 28 CFR 0.100(b) & 0.104, I hereby 

order that DEA Certificate of 

Registration, BB0492912, issued to Roy 

E. Berkowitz, M.D., be, and it hereby is, 

revoked. I further order that any 

pending application of Roy E. 

Berkowitz, M.D., for renewal or 

modification of his registration be, and 

it hereby is, denied. This order is 

effective immediately.3

Dated: July 17, 2009. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E9–17714 Filed 7–23–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Office of the Secretary 

Submission for OMB Review: 

Comment Request 

July 20, 2009. 

The Department of Labor (DOL) 

hereby announces the submission of the 

following public information collection 

request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval in accordance with 

the Paperwork Reduction Act of 1995 

(Pub. L. 104–13, 44 U.S.C. chapter 35). 

A copy of this ICR, with applicable 


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