Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 20011 

issuing controlled substance prescriptions ‘‘on 

forms which falsely identified his address.’’ Id. at 

21 & 24. 

authority to dispense controlled 

substances in Utah, the State in which 

he holds his DEA registration. 

The Controlled Substances Act 

defines the ‘‘[t]he term ‘practitioner’ [to] 

mean[] a physician * * * licensed, 

registered, or otherwise permitted, by 

the United States or the jurisdiction in 

which he practice * * * to distribute, 

dispense, [or] administer * * * a 

controlled substance in the course of 

professional practice or research.’’ 21 

U.S.C. 802(21). Moreover, under 21 

U.S.C. 823(f), ‘‘[t]he 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.’’ DEA has therefore repeatedly 

held that holding state authority is an 

essential requirement for obtaining a 

registration and maintaining an existing 

one. See David W. Wang, 72 FR 54297, 

54298 (2007); Sheran Arden Yeates, 71 

FR 39130, 39131 (2006); Dominick A. 

Ricci, 58 FR 51104, 51105 (1993); Bobby 

Watts, 53 FR 11919, 11920 (1988); see 

also 21 U.S.C. 824(a)(3) (authorizing 

revocation ‘‘upon a finding that the 

registrant * * * has had his State 

license or registration suspended, 

revoked, or denied by competent State 

authority and is no longer authorized by 

State law to engage in the * * * 

dispensing of controlled substances’’). 

As the Final Order of the Utah DOPL 

makes clear, Respondent does not 

possess authority under Utah law to 

dispense controlled substances. Because 

he does not meet this requirement, his 

application will be denied. See 21 

U.S.C. 823(f). 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823(f), as well as 28 CFR 

0.100(b) & 0.104, I order that the 

application of Layfe Robert Anthony, 

M.D., for a DEA Certificate of 

Registration as a practitioner be, and it 

hereby is, denied. This Order is effective 

May 11, 2011. 

Dated: April 1, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–8535 Filed 4–8–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 07–20] 

Mark De La Lama, P.A.; Denial of 

Application 

On January 16, 2007, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Mark De La Lama 

(Respondent), of Phoenix, Arizona. The 

Show Cause Order proposed the denial 

of Respondent’s application for a DEA 

Certificate of Registration as a mid-level 

practitioner (i.e., physician assistant) on 

various grounds. 

Specifically, the Show Cause Order 

made four major allegations against 

Respondent. First, the Order alleged that 

Respondent’s former DEA registration 

had expired on June 30, 2003, but that 

Respondent had continued writing 

prescriptions for controlled substances 

after that date. ALJ Ex. 1, at 1 & 3. Next, 

noting that as a condition of his initial 

registration Respondent had entered 

into a Memorandum of Agreement 

(MOA) with the Agency, the Order 

alleged that Respondent had violated 

the MOA in two ways: First, by failing 

to produce the log of his controlled 

substance prescriptions which he was 

required to maintain when DEA 

Diversion Investigators (DIs) visited his 

practice premises on April 13, 2005, 

and; second, by failing to report two 

changes of his practice location. Id. at 1, 

2–3. Finally, the Order alleged that on 

November 21, 2004, Respondent 

submitted a new application for a 

registration which he falsified by failing 

to disclose his April 1992 and October 

1994 felony convictions for offenses 

related to controlled substances, as well 

as the existence of the MOA. Id. at 3. 

Respondent, through his counsel, 

requested a hearing. The matter was 

assigned to a DEA Administrative Law 

Judge (ALJ), who conducted a hearing 

on January 16, 2008, in Phoenix, 

Arizona. ALJ at 2. Both parties called 

witnesses to testify and introduced 

documentary evidence into the record. 

Following the hearing, both parties filed 

briefs containing their proposed 

findings of fact, conclusions of law and 

argument. Id. 

On April 2, 2009, the ALJ issued her 

Recommended Decision. Therein, the 

ALJ concluded that Respondent 

‘‘knowingly issued prescriptions for 

controlled substances using an expired 

DEA registration number over a span of 

nearly two years’’ but that the ‘‘lack of 

evidence that Respondent issued 

prescriptions for other than a legitimate 

purpose * * * weigh[s] in favor of a 

finding that Respondent’s registration 

would not be inconsistent with the 

public interest.’’ Id. at 26. 

The ALJ also found that Respondent’s 

conviction record for two felonies under 

Arizona law involving controlled 

substances weighed ‘‘in favor of a 

finding that Respondent’s registration 

would be inconsistent with the public 

interest.’’ Id. at 27. Based on his failure 

to disclose these two felonies on his 

November 21, 2004 application, the ALJ 

further found that Respondent 

materially falsified his application but 

concluded that his conduct was only 

negligent because an office manager had 

completed the form for him. Id. at 28– 

29. The ALJ credited ‘‘Respondent’s 

testimony and * * * his expressions of 

regret and recognition of his 

wrongdoing on this specific point, and 

* * * therefore conclude[d] that his 

material falsification in the 2004 

application [did] not warrant denying 

his application.’’ Id. at 30. 

Next, the ALJ found ‘‘that Respondent 

failed to adhere to certain requirements 

contained’’ in a Memorandum of 

Agreement (MOA) which he was 

required to enter into with the Agency 

as a condition of obtaining a 

registration. Id. More specifically, 

Respondent ‘‘failed to maintain a log of 

all controlled substances that he 

prescribed as of the date of the April 

2005 site visit’’ and he failed to notify 

the Agency of his changes in the 

location of his practice address. Id. 30– 

31. The ALJ also found, however, that 

Respondent ‘‘equally accepts 

responsibility for what went wrong[ ] 

and has demonstrated a commitment to 

cooperate with DEA in the future.’’ Id. 

at 32. Moreover, while the ALJ noted 

that Respondent had been convicted (in 

1985) in Thailand of possession and 

attempted smuggling of marijuana, as 

well as a more recent conviction for 

driving under the influence, the ALJ 

also noted that Respondent was then 

practicing ‘‘at a clinic that serves a 

primarily underserved and 

underinsured population’’ and that this 

is ‘‘an appropriate consideration in 

determining whether [his] application 

* * * should be granted.’’ Id. at 33. 

Based on his multiple convictions for 

controlled substances offenses and his 

‘‘considerable difficulty [in] adhering to 

some of the requirements of the’’ MOA, 

the ALJ concluded that the Agency had 

‘‘made out a prima facie case for denying 

[Respondent’s] application.’’ Id. The ALJ 

reasoned, however, that ‘‘[d]espite his 

criminal convictions involving 

controlled substances in the 1990s, 

Respondent appears to have put that 

period of his life behind him.’’ Id. at 34. 


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1To make clear, I remanded the case because 

there was no prior Agency decision addressing the 

admissibility of data compilations prepared by 

private entities. 

2Under the express terms of the MOA, 

Respondent agreed to surrender his registration 

without issuance of an Order to Show Cause in the 

event that he failed to comply with the MOA. GX 

3, at 3. Also, a violation of the MOA’s terms would 

‘‘result in the initiation of proceedings to revoke’’ 

Respondent’s registration. Id. 

3The ALJ overruled the objection after 

determining that the Exhibit had been provided to 

Respondent in advance of the hearing even though 

Respondent’s counsel had objected on grounds of 

lack of foundation and that ‘‘we have no way of 

determining the accuracy of the information as set 

forth herein.’’ Tr. 66. While under the Agency’s 

regulation, ‘‘[t]he authenticity of all documents 

submitted in advance [is] deemed admitted unless 

written objection thereto is filed with the presiding 

officer,’’ 21 CFR 1316.59(c), there is no such rule 

applicable to objections based on a lack of 

foundation. The ALJ apparently confused these two 

independent grounds for objecting to the admission 

of evidence. 

4Notably, the Government did not introduce into 

evidence either copies of any prescriptions 

Respondent wrote during this period, or pharmacy 

dispensing logs, even though such evidence should 

have been readily obtainable (as a pharmacy is 

required to keep such records for two years, see 21 

CFR1304.04(a) and 1304.22(c)), and is what the 

Government customarily uses in these proceedings 

to establish that a practitioner wrote unlawful 

prescriptions. 

In the ALJ’s view, Respondent’s ‘‘most 

recent conviction involving controlled 

substances occurred more than fifteen 

years ago [and] [s]ince that time, he has 

neither been implicated in nor been 

convicted of any other crime involving 

controlled substances [and] [t]he 

Government presented no evidence that 

the future would hold any differently.’’ 

Id. Based on his ‘‘expression of remorse 

and his expressed willingness to comply 

with restrictions on his registration,’’ the 

ALJ ‘‘conclude[d] that the public interest 

would best be served by granting 

Respondent a restricted registration’’ 

subject to four conditions. Id. These 

were that: (1) Respondent must comply 

with all Federal, State and local laws 

and regulations relating to controlled 

substances; (2) Respondent may not 

personally use controlled substances in 

any form or for any reason without a 

prescription issued by a duly licensed 

physician who possesses a valid DEA 

Certificate of Registration; (3) 

Respondent must permit DEA personnel 

to enter his practice location at any time 

during normal business hours, without 

prior notice, to verify compliance with 

all applicable laws and regulations 

relating to controlled substances, as well 

as with any or all restrictions imposed 

on Respondent as a condition of his 

registration with the DEA; and (4) 

Respondent must notify the DEA 

Phoenix Division, in writing, of any 

change of business address or employer. 

Id. at 34–35. 

Neither party filed exceptions to the 

ALJ’s decision. On May 7, 2009, the ALJ 

forwarded the record to me for a final 

agency action. 

During the initial review of the 

record, it was noted that the 

Government had introduced into 

evidence—over Respondent’s 

objection—a printout of a data 

compilation prepared by SearchPoint, a 

private entity, which purportedly listed 

the prescriptions Respondent issued 

between October 8, 2003 and May 23, 

2005. The Government introduced this 

document, which is not a record 

required to be maintained under either 

federal or state law, to prove the 

allegations that Respondent had issued 

controlled substance prescriptions even 

after he knew his registration had 

expired and had done so even after 

being told to stop by DEA Investigators. 

Because Respondent’s objection went to 

the foundation for admitting the 

compilation and the reliability of the 

information it contains, and the 

Government did not establish that the 

methods used to compile the data were 

sufficiently trustworthy, I remanded the 

case to the ALJ for further proceedings 

and specifically instructed the 

Government to address various 

questions as set forth in the remand 

order.1 Following additional 

proceedings, the ALJ forwarded the 

record back to me for final agency 

action. 

Having considered the entire record, I 

hereby issue this Decision and Final 

Order. I agree with the ALJ’s 

conclusions that: (1) Respondent 

materially falsified his application, (2) 

that he has a significant history of 

convictions relating to controlled 

substances; (3) that he failed to meet the 

MOA’s requirements with respect to 

both his proper keeping of a log and his 

obligation to notify the Agency of any 

changes in his practice location.2 As the 

ALJ recognized, these findings establish 

a prima facie case for the denial of his 

application. 

However, I reject the ALJ’s conclusion 

that Respondent’s employment at a 

clinic that serves an underserved 

population is ‘‘an appropriate 

consideration in determining whether 

[his] application * * * should be 

granted.’’ ALJ at 33; see also Gregory D. 

Owens, 74 FR 36751, 36756–57 (2009) 

(rejecting consideration of 

socioeconomic status of practitioner’s 

patients as appropriate consideration 

under the CSA). Moreover, while I do 

not reject the ALJ’s findings that 

Respondent has accepted responsibility 

for his misconduct, I reject her proposed 

sanction because it clearly rests on a 

fundamental misunderstanding as to the 

scope of permissible sanctions under 

the CSA. Given the circumstances of 

this matter, I conclude that 

Respondent’s application should be 

denied at this time. 

The Reliability of the SearchPoint Data 

Compilation 

Before proceeding to make factual 

findings, it is necessary to resolve the 

issue of whether the ALJ properly 

admitted—over Respondent’s objection 

that the Government had not laid a 

proper foundation—Government Exhibit 

8, which it represents to be a data 

compilation listing the prescriptions 

Respondent issued between October 8, 

2003 and May 23, 2005.3 The 

Government argues that this exhibit 

showed that Respondent had issued 

controlled substance prescriptions not 

only following the expiration of his 

registration, but also after he knew it 

had expired and even after he was told 

by DEA Investigators to stop doing so.4

Gov. Proposed Findings at 7–8, 10–11. 

The ALJ relied on this evidence, in part, 

in her decision. 

Under the Administrative Procedure 

Act (APA), an Order must be ‘‘supported 

by and in accordance with the reliable, 

probative and substantial evidence.’’ 5 

U.S.C. 556(d). While the Agency’s 

decision may be based on hearsay 

evidence, see Richardson v. Perales, 402 

U.S. 389, 410 (1971), such evidence 

must still be reliable. 

The compilation is not, however, a 

record maintained by a government 

agency. Nor is it a record which is 

required to be maintained under either 

federal or state law. Moreover, on 

reviewing the compilation, there 

appeared to be various discrepancies 

which called into question the data’s 

reliability. As I noted in the remand 

order, this Office is unaware of any 

judicial decisions either admitting or 

excluding similar data compilations 

prepared by SearchPoint. 

At the hearing, a DI testified that 

prescription information is entered by a 

pharmacy into a computer which is then 

collected and sent to SearchPoint. Tr. 

43. The DI did not, however, explain the 

basis of his knowledge. Moreover, the 

record did not establish the procedures 

or methods used by the pharmacies in 

entering the information, when the 

information is entered, whether either 

the pharmacies or SearchPoint have any 

procedures to verify the accuracy of the 

information, whether the data is 

properly secured, and whether there are 

procedures to protect the data from 

manipulation. Cf. McCormick on 

Evidence § 314, at 886 (3d ed. 1984). 


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5On June 16, 1999, the Maricopa County Superior 

Court vacated the judgment of guilt and restored 

Respondent’s civil rights. Id. at 2. This is the felony 

that he listed on his application in 2000. 

The record also did not establish 

whether a prescription that was signed 

by both Respondent and a supervising 

physician (which was one of 

Respondent’s defenses to the allegation 

that he continued to prescribe even after 

he realized his registration had expired) 

would be attributed to Respondent or 

the physician. Nor did the record 

establish why, where refills were 

authorized by a single prescription, the 

printout provided the same date for the 

date the prescription was written and 

the date it was dispensed. 

Because the record did not adequately 

establish the procedures or methods 

used to compile this database and that 

the compilation is sufficiently 

trustworthy so as to satisfy the APA’s 

requirement that the evidence be 

reliable, I remanded the case to the ALJ 

with instructions to address these 

various concerns. I also expressly 

ordered that the questions ‘‘must be 

addressed by a witness who has 

personal knowledge of the procedures 

and methods used by Searchpoint.’’ 

Remand Order at 3. 

On remand, the Government 

submitted an affidavit of the same 

Diversion Investigator whose testimony 

I previously found to be inadequate for 

establishing that the SearchPoint data is 

reliable. From his affidavit, it is clear 

that the DI lacks personal knowledge of 

the procedures and methods used by 

SearchPoint. See Affidavit of Miguel 

Rodriguez. 

This, by itself, is reason to conclude 

that the Government has failed to 

comply with the remand order. 

However, even in his affidavit, the DI 

offered no evidence which establishes 

that the SearchPoint data is reliable. To 

the contrary, the DI explained that: 

[t]he accuracy and authenticity of the data 

was only as good as the accuracy of the 

pharmacy reporting. It was stipulated to all 

DEA investigators, that SearchPoint was only 

a pointing tool and the data provided by 

SearchPoint was to be verified against actual 

records that the pharmacy, distributor, [or] 

practitioner was required to maintain by 

current regulations and laws.’’ 

Id. at 4 (emphasis added). 

The DI further acknowledged that he 

‘‘did not verify the information found 

during the query of the SearchPoint 

database prior to meeting with 

[Respondent] on April 13, 2005.’’ Id. at 

4–5. (Indeed, it is apparent that the DIs 

did not verify the information even after 

meeting with Respondent as there are 

no ‘‘actual records’’ in evidence.) The 

DI’s statement that the SearchPoint data 

was only to be used as a ‘‘pointing tool’’ 

begs the question of why the actual 

pharmacy (or Respondent’s patient) 

records were never obtained. 

Based on the DI’s assertion that the 

SearchPoint database was ‘‘a valuable 

tool in DEA’s investigative efforts,’’ id. at 

5, ‘‘the Government respectfully 

request[ed] an additional finding that 

the SearchPoint data proved useful in 

DEA’s investigation of Respondent, and 

helped further the objectives of DEA’s 

investigation.’’ Gov’t Memorandum on 

Remand at 2. Contrary to the 

Government’s understanding, whether 

the SearchPoint data proved useful in 

its investigation is not material to the 

resolution of any issue in this 

proceeding. 

As the Government’s brief makes 

clear, determining the extent of 

Respondent’s issuance of prescriptions 

after his registration expired and 

assessing his culpability in doing so is 

one of the central issues in this matter. 

Given that there was no clear agency 

precedent addressing the admissibility 

of similar data compilations, this 

proceeding was remanded to determine 

whether the SearchPoint data was 

sufficiently reliable to prove that 

Respondent had continued to issue 

controlled substance prescriptions not 

only after he became aware that his 

registration had expired, but also after 

he was told by a DI to stop doing so. 

Notwithstanding that the remand 

order clearly stated what the 

Government was required to show to 

establish that this evidence is reliable, it 

failed to do so. Because the Government 

failed to comply with the remand order 

and offers no valid excuse for its failure 

to do so, I conclude that the SearchPoint 

compilation is not competent evidence 

and should have been excluded. See 21 

CFR 1316.59(a) (‘‘The presiding officer 

shall admit only evidence that is 

competent, relevant, material and not 

unduly repetitious.’’). Accordingly, as 

ultimate factfinder, I do not base any of 

my findings on it. 

Findings 

Respondent is a physician assistant, 

who is licensed by the Arizona 

Regulatory Board of Physicians 

Assistants (The Board). GXs 6 & 7. At 

the time of the hearing, Respondent was 

49 years of age. Tr. 286. 

Respondent obtained a Bachelor of 

Science degree in human biology in 

1997 and a Master’s degree in physician 

assistant studies in October 1999. Id. at 

208. After obtaining his state license, 

Respondent commenced working as a 

physician assistant; his duties involve 

performing physical exams, making 

diagnoses, treating patients, interpreting 

test results, and ordering diagnostic 

tests and studies. Id. 

On October 26, 2000, Respondent 

applied for a DEA registration to handle 

controlled substances in Schedules II 

through V as a mid-level practitioner. 

GX 2. On the application, Respondent 

was required to answer four ‘‘liability 

questions’’; the questions included 

whether the applicant had ever been 

convicted of an offense related to 

controlled substances under either 

federal or state law. Id. at 2. 

Respondent answered in the 

affirmative and provided an explanation 

of the circumstances surrounding a 1992 

marijuana conviction. Id. Respondent 

wrote that in 1989 or 1990, a friend he 

met in karate class was involved in 

‘‘selling dope’’ and that Respondent 

‘‘made the horrible mistake of trying to 

make a ‘fast buck.’ ’’ Id. Respondent also 

stated on the application that ‘‘I entered 

guilty pleas in 1992 and have never 

violated any of the terms of my 

probation.’’ Id. 

Respondent also stated on the 

application that his ‘‘criminal 

convictions were expunged by the 

Maricopa County Superior Court in 

1999,’’ based on the recommendation of 

his probation officer. Id. He also 

‘‘regret[ted] this experience in [his] life’’ 

and that his ‘‘goal was to be the best P.A. 

and father I can be.’’ Id. 

On February 12, 2001, the Agency 

granted Respondent’s application. GX 1. 

However, because of his prior 

conviction, the Agency issued him a 

restricted registration; as a condition of 

his registration, Respondent was 

required to enter into a Memorandum of 

Agreement (MOA), which imposed 

various conditions on his registration. 

Tr. 19; GX 3. 

The MOA further detailed 

Respondent’s drug-related offenses, 

which included two other drug 

convictions, one of which should 

clearly have been disclosed on his 

application, but was not. On May 3, 

1985, Respondent was convicted in 

Bangkok, Thailand for ‘‘Possession and 

Attempted Smuggling’’ of approximately 

145 grams of marijuana. GX 3, at 1. The 

court suspended the 21-month sentence, 

and Respondent paid a fine and 

completed two years of probation. Id. 

On or about April 10, 1992, 

Respondent entered into a plea 

agreement in which he pled guilty to 

‘‘Attempted[] Possession, Use, 

Production, Sale and Transportation’’ of 

approximately eight pounds of 

marijuana, a class 3 felony under 

Arizona law. Id. Respondent paid a fine, 

was jailed for two months, and was 

placed on five years’ probation.5 Id. 


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6The Superior Court also apparently vacated this 

conviction in 1999, when it restored Respondent’s 

civil rights. Tr. 210. 

7Respondent also testified that the year 2001 was 

a difficult year: In May his father fell from a roof 

and was hospitalized for 21 days with a brain 

hemorrhage before he finally died; Respondent took 

in three more dependents into his household as a 

result of his father’s death; later that year, 

Respondent developed pneumonia, and when he 

returned to work his employer noticed he was 

depressed and referred him to counseling; then the 

national crisis of September 11, 2001 happened. Tr. 

220–221. Respondent testified that ‘‘there was a lot 

of stuff that happened in 2001 that I think I was 

a little bit confused, just overwhelm[ed].’’ Id. at 221. 

While this sequence of events may have 

overwhelmed Respondent, and provide some basis 

for excusing his failure to notify the Agency of his 

having changed his location, it is not a credible 

explanation for his failure to renew his registration, 

which did not expire until June 30, 2003. 

8As was much of his testimony regarding the 

dates of various events, Respondent’s testimony as 

to the date when he left 21st Century and 

commenced working at the 51st Avenue clinic was 

vague. 

9Respondent used the address of this clinic on 

his 2004 application. GX 4. 

With respect to this incident, 

Respondent maintained at the hearing 

that he ‘‘was approached by somebody’’ 

and ended up being ‘‘a fall guy.’’ Tr. 284. 

On October 24, 1994, Respondent was 

found guilty of ‘‘Conspiracy to Transfer, 

Sell or Possess’’ a narcotic drug, a class 

2 felony under Arizona law, based on 

his involvement in a conspiracy to 

illegally import cocaine from Panama to 

the United States. GX 3, at 2. 

Respondent was fined and sentenced to 

seven years’ probation, but the 

probation was subsequently 

reduced.6 Id. With respect to this 

conviction, Respondent maintained at 

the hearing that he was not ‘‘directly 

involved’’ in the conspiracy because he 

only ‘‘had phone conversations with the 

particular individual,’’ but he 

nevertheless pled guilty. Id. at 288–90. 

Respondent did not disclose this 

conviction on his initial application. GX 

2, at 2; Tr. 293. When questioned as to 

why, Respondent stated that he 

‘‘suppose[d]’’ that it was because of 

‘‘inadvertence’’ on his part and added 

that ‘‘[i]t was all at the same time,’’ 

apparently referring to the marijuana 

distribution offense. Tr. 293. 

As found above, as a condition of his 

registration, Respondent entered into an 

MOA, under which he agreed to comply 

with various conditions. The MOA was 

to remain in effect for five years from 

the date of signing, January 25, 2001, 

during which time the DEA would be 

able to monitor Respondent’s handling 

of controlled substances. Tr. 115–16; GX 

3, at 2. 

As relevant to the allegations in this 

proceeding, Respondent agreed ‘‘to 

maintain a log for five years, which will 

list all controlled substances that he 

prescribes.’’ GX 3, at 2. The log was 

‘‘subject to inspection by DEA for five 

years from the date’’ the MOA was ‘‘fully 

executed,’’ which was January 30, 2001. 

Id. at 2–3. 

Second, Respondent agreed ‘‘that DEA 

personnel may enter his place of 

practice at any time during regular 

business hours, without prior notice, to 

verify compliance’’ with the MOA. Id. at 

3. Finally, Respondent agreed ‘‘to notify 

the DEA Phoenix Division prior to 

transferring his DEA Certificate of 

Registration to another address within 

the state of Arizona or to another state.’’ 

Id. In the MOA, Respondent indicated 

that he would be registered at the 

location of 3201 West Peoria Avenue, 

Suite A–202, Phoenix, Arizona. Id. at 1. 

In October 2000, Respondent began 

working as a physician assistant under 

the supervision of a Dr. John Curtin, at 

the above address. Tr. 223. Sometime 

thereafter, Respondent contracted 

pneumonia and missed substantial time 

from work; upon his return, his hours 

were reduced. Id. at 224. Consequently, 

in 2001 or 2002, Respondent left this 

position and went to work for William 

Zachow, D.O., who owned 21st Century 

Family Medicine (21st Century), 6707 

North 19th Ave., Suite 201, Phoenix, 

Arizona. Id. at 167–68, 224. Respondent 

did not notify DEA of this change of 

practice address, as required by the 

MOA.7 Tr. 38–39. 

As part of Respondent’s employment 

agreement at 21st Century, the clinic 

was to handle matters related to his 

licensing fees, his malpractice coverage 

and his DEA registration. Id. at 224. 

Specifically, Sonia Zachow, Dr. 

Zachow’s wife, ‘‘would take care of the 

fees and all the licensing and the DEA.’’ 

Id. at 224–25. Respondent testified that 

this was a verbal agreement, as it had 

originally been with his first employer, 

Dr. John Curtin, and that he trusted Dr. 

Zachow to honor the agreement. Id. at 

219. Respondent testified that ‘‘[f]rom 

my understanding, all my mail went to 

[Sonia Zachow] and through her. I 

didn’t receive any.’’ Id. at 225. In 

particular, Respondent testified that he 

never received a notification from DEA 

that his registration would expire after 

June 30, 2003. Id. Given that he had not 

notified the Agency of his new address, 

this is hardly surprising. 

Shirley Reigle, a medical assistant at 

21st Century, testified that she was 

employed at the clinic when 

Respondent was hired and that she 

worked with Respondent for four or five 

years. Id. at 168, 193. Ms. Reigle 

testified that she managed the ‘‘back 

office,’’ coordinating the activities of the 

medical assistants, while Sonia Zachow 

managed the ‘‘front office,’’ or business 

office. Id. at 169–71. Mrs. Zachow’s 

responsibilities included the renewal of 

the licenses and DEA registrations held 

by the clinic’s physicians and physician 

assistants, the renewal of insurance 

coverage and the billing of insurance 

claims. Id. at 171, 174, 176. According 

to Ms. Reigle, Mrs. Zachow’s 

responsibilities further included 

notifying the DEA if a physician or 

physician assistant moved his or her 

location of practice. Id. at 188. However, 

in one instance prior to Respondent’s 

employment at 21st Century, Ms. Reigle 

tried to induce Mrs. Zachow to give 

notice of a move but ended up having 

to provide the information to DEA 

herself. Id. at 204–05. 

Respondent’s DEA registration 

expired June 30, 2003. Id. at 42; GX 1. 

According to Ms. Reigle, sometime in 

late 2003, Mrs. Zachow entered the 

office that Ms. Reigle shared with 

Respondent and threw a bill from the 

DEA onto Respondent’s desk, saying, 

‘‘Why should I pay his DEA license 

when we’re selling the practice.’’ Tr. 

176–77, 181. Ms. Reigle testified that 

she believed that Respondent ‘‘had gone 

for the day’’ and that, when she told 

Respondent about the incident later and 

he went to his desk to look, the bill was 

no longer on his desk. Id. at 177, 199. 

While Ms. Reigle testified that she told 

Respondent about the incident, he 

apparently took no action to determine 

whether he still held a valid 

registration. 

Respondent testified that he did not 

receive notice that his registration 

required renewal and that, had he 

known, he would not have continued to 

practice without it. Id. at 225. 

Respondent admitted, however, that at 

the time he received his registration he 

knew it was subject to renewal in three 

years. Id. at 301. He further asserted that 

he did not keep track of the time or 

display his registration certificate and 

that he expected the office manager to 

handle matters pertaining to his 

licenses, as that was done for all 

incoming health care providers. Id. 

Respondent did, however, acknowledge 

that he was ultimately responsible for 

renewing his registration. Id. at 220. 

Respondent left 21st Century 

sometime between July and October 

2004, when Dr. Zachow sold the 

clinic.8 Id. at 217. Respondent began 

practicing at the 51st Avenue Clinic 

(51st Avenue), which is located at 4700 

North 51st Street, Suite 6, in Phoenix. 

Id.; GX 4, at 1.9

When the clinic did not offer him 

adequate hours, Respondent resumed 


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10 In a letter he faxed to a DI on April 24, 2005, 

Respondent indicated that in October of 2004, he 

‘‘received a letter stating that my P.A. license had 

expired’’ and that after ‘‘doing some investigation, 

it turn[ed] out [that] my fees had not been paid.’’ 

GX 9, at 1. Sometime around the time that he got 

his state license reinstated, he ‘‘got a call from the 

former office manager stating that I had better check 

up on my malpractice fees. It turn[ed] out those had 

not been paid in over a year.’’ Id. Moreover, in the 

same October time period, his new clinic ‘‘was 

getting calls back from the pharmacy saying that my 

DEA license was no longer valid’’ but that he did 

not think too much about it at first as ‘‘I didn’t know 

that the license could expire.’’ Id. at 2. 

11There was no evidence presented that 

Respondent was under the influence of a controlled 

substance at the time of the incident. Tr. 256. 

Moreover, there is no evidence in this record that 

Respondent has recently abused controlled 

substances. I therefore conclude that the incident 

Continued 

working on a part-time base at 21st 

Century and split his time between the 

two clinics. Tr. 217–18. Sometime in 

October 2004, Respondent received a 

letter from the Arizona Physician’s 

Assistants Board notifying him that his 

‘‘license had lapsed [on] October 1, 

2004.’’ GX 9, at 4. 

Respondent testified that during the 

period in which he moved to the new 

practice, pharmacies were not honoring 

the prescriptions he wrote at his new 

employer, and that his ‘‘office was 

getting calls for the prescriptions that 

[he] had been writing, and they were 

talking about a DEA number.’’ Tr. 226– 

27. Notwithstanding the phone calls, 

Respondent maintained that he did not 

know that the registration had ‘‘lapsed’’ 

until three or four months later when, 

in November 2004 or early 2005, he was 

‘‘contacted by DEA.’’ Id. at 226–27. In 

November 2004, Ms. Muniz, the office 

manager at 51st Avenue, told 

Respondent that he needed to reapply 

for a DEA registration.10 Id. at 228. 

According to Respondent, Ms. Muniz 

filled out the application for him and 

showed him only the signature page, 

which he signed without reviewing. Id. 

at 228–29, 262–63, 309–10. As with his 

previous application, the form asked 

Respondent whether he had ‘‘ever been 

convicted of a crime in connection with 

controlled substances under state or 

federal law?’’ GX 4, at 1; ALJ Ex. 3, at 

3. The ‘‘no’’ answer was circled on the 

application. GX 4, at 1. Moreover, 

Respondent left blank the box which the 

form provided for explaining a ‘‘yes’’ 

answer to this question, and which is on 

the same page as the signature block. Id. 

at 2. The application was then 

submitted. 

As to why he did not disclose his 

convictions, Respondent testified: ‘‘I was 

busy. I was probably seeing 50 patients 

a day. I was trying to make an 

impression.’’ Tr. 228. According to 

Respondent, had Ms. Muniz given him 

the entire application, he would have 

given a detailed explanation and an 

answer of ‘‘yes’’ to the liability question, 

just as he had done on his October 2000 

application. Id. at 229. 

The ALJ specifically credited 

Respondent’s testimony that he would 

not have provided a ‘‘no’’ answer ‘‘had 

he personally filled out the form’’ and 

that ‘‘he would have detailed the 

explanation of his past conduct as he 

had done in 2000.’’ ALJ at 29. The ALJ 

further credited Respondent’s 

‘‘expressions of regret and recognition of 

his wrongdoing’’ in submitting the 

application. Id. at 30. The Government 

did not except to these findings. 

It is undisputed that after filing his 

application, Respondent continued to 

write prescriptions for controlled 

substances under his expired 

registration even though he then clearly 

knew that it had expired and did so 

through at least March 2005. See GX 9, 

at 4; see also Resp. Prop. Findings at 6– 

7. Respondent offered two main (and 

somewhat inconsistent) explanations for 

why he continued to write prescriptions 

during this period. 

First, in a written statement he 

provided to an Agency investigator in 

April 2005, Respondent claimed that 

‘‘after reapplying’’ there was ‘‘some 

confusion * * * as to what was going 

on at that time, some months went by 

and [he] was informed by the clinic’s 

office manager that she had taken care 

of everything and it was okay to write 

again.’’ GX 9, at 4. Continuing, 

Respondent explained that Ms. Muniz 

had contacted someone ‘‘at DEA 

headquarters and he had informed her 

that we had filled out the incorrect 

application and our money had been 

posted to the wrong account, he said he 

would fax over the correct application 

to be filled out immediately and faxed 

back.’’ Id. Respondent maintained that 

employees had said that ‘‘the money 

would be posted to the correct account 

and this would make the license active 

at this point.’’ Id. Respondent faxed in 

the new application on February 17, 

2005. Id. 

Respondent further asserted that he 

‘‘wrote very few prescriptions during 

this time [when he] was waiting for a 

copy of the new license.’’ Id. According 

to Respondent, ‘‘[a]fter several weeks of 

not receiving [the] paperwork[,] we 

called again and were informed that 

there was a problem.’’ Id. Respondent 

added that ‘‘[a]t this time I discontinued 

completely and left the controlled 

substances, the few we do write up to 

the responsibility of my supervising 

physicians.’’ Id. at 5. Finally, 

Respondent claimed that while he could 

not ‘‘recall the very last prescription I 

wrote, it probably was over a month or 

two ago and was some cough syrup with 

codeine as I wrote very little in the first 

place.’’ Id. 

Second, in his testimony, Respondent 

further claimed that he ‘‘was getting cosignatures on the prescriptions if I did 

need to write or just having them 

written altogether by a supervising 

physician.’’ Tr. 230. Respondent 

explained that the co-signed 

prescriptions would be ‘‘[o]ne 

prescription, my name and the doctor’s 

name, usually above mine.’’ Id. at 231. 

Respondent also asserted that the 

pharmacy ‘‘might have run it [the 

prescription] as my DEA, but actually 

the doctor, the supervising physician, it 

was under his DEA as well if his 

signature’’ was on the prescription. Id. 

Respondent further asserted that he had 

‘‘some copies’’ available that would 

show that his prescriptions were being 

co-signed. Id. 

Respondent submitted a letter (which 

is unsworn) dated April 22, 2005 

written by Ms. Muniz, Director of 

Operations for the 51st Ave. Family 

Clinic. RX 8. According to the letter, 

Respondent submitted a renewal 

application sometime around December 

3, 2004, when the payment for the 

application fee cleared. Id. However, 

after several months, Respondent had 

still not gotten his registration. Id. 

According to Ms. Muniz, she then called 

DEA Headquarters and was told that 

Respondent had submitted the wrong 

form. Id. The employee at DEA 

Headquarters then faxed over the correct 

form which Respondent then submitted. 

Id. According to Ms. Muniz, the 

employee told her that he would post 

the previous payment to the correct 

account and this would activate 

Respondent’s registration. Id. However, 

according to an affidavit of a DEA 

Diversion Investigator, ‘‘there is no 

record of’’ Respondent’s having 

submitted an application after 

November 21, 2004. Affidavit of Miguel 

Rodriguez, at 6. 

Based on Respondent’s ‘‘no’’ answer 

on his 2004 application to the liability 

question regarding whether he had any 

prior convictions for controlled 

substances offenses, a DI commenced an 

investigation. Tr. 93. The DI reviewed 

the records from the Agency’s prior 

investigation, police reports and the 

MOA. Id. at 93–95. He also learned that, 

in September 2003, Respondent had 

been arrested in Florida for a hit-andrun incident while driving under the 

influence.11 Id. at 103. 


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has little relevance to the issues in this proceeding 

and deem it unnecessary to make further findings. 

12Copies of this document were apparently 

offered as Respondent’s Exhibit 2. However, the 

Government objected to the admission of the 

exhibit on the ground that it was not timely 

exchanged, and the ALJ sustained the objection. 

13At the hearing, Respondent attempted to enter 

copies of this ‘‘log’’ into evidence as Respondent’s 

Exhibit 1, but the Government objected on the 

ground that the documents had not been timely 

provided to the Government. Id. at 242–43, 248. 

The ALJ’s sustained the objection and rejected the 

evidence. Id. at 248. 

Using Respondent’s registration 

number, the DI also conducted a search 

of Respondent’s controlled substance 

prescriptions using the SearchPoint 

database. Id. at 42–44, 76. The data 

indicated that Respondent had written 

controlled substance prescriptions after 

the expiration of his registration (June 

30, 2003). Id. at 42–43. However, the DI 

testified that after reviewing the data, he 

did not have any concerns about 

Respondent’s prescribing other than that 

he lacked a registration. Tr. 152. 

On April 13, 2005, as part of his 

investigation of Respondent’s 

application, the DI and his senior 

partner visited Respondent at the 51st 

Avenue clinic, which was the address 

Respondent had given on his 

application. Tr. 30–31. However, this 

address was different from Respondent’s 

address of record on file with the 

Agency, as Respondent had not notified 

the Agency that he had changed his 

practice location and had therefore 

violated the MOA. Id. at 31. 

According to the DI, Respondent was 

not authorized to handle controlled 

substances at the 51st Avenue clinic. Id. 

at 33. The DI testified that, although 

failing to notify DEA of a change of 

address is not typically the sole basis for 

revoking a DEA registration, 

Respondent’s failure to comply with the 

address-change provision of the MOA 

gave cause for particular concern. Id. at 

109. However, the Government 

produced no evidence that Respondent 

had done anything other than write 

prescriptions at this address. 

During the visit, the DI did not 

observe Respondent working under the 

supervision of a physician, and 

Respondent did not inform him or his 

partner that he was working under 

physician supervision. Id. at 31–32. The 

DIs then asked to inspect the log which 

Respondent was required to maintain 

under the MOA. Id. at 33. Respondent 

left the room and returned with a box 

containing an assortment of papers and 

several folders in no particular order. Id. 

at 33–34. Respondent partially 

attributed the disorganization of his 

‘‘log’’ to the fact that he was in the 

process of moving into a new practice 

while continuing to work part-time at 

the other such that each location had its 

own records. Id. at 327. Yet, at this 

point, he had been at 51st Avenue clinic 

for at least six months. 

According to the DI, his partner 

examined the contents of the box and 

asked whether Respondent had records 

more recent than those for the year 

2003. Id. at 35–36, 124–25, 160–61. 

Respondent answered that he could ‘‘put 

something together,’’ thus indicating 

that he was not currently keeping a log. 

Id. at 36, 125. However, the DIs did not 

take the box to copy the contents and 

‘‘never asked for a copy.’’ Id. at 249, 251. 

Respondent later testified that ‘‘I had it 

together and I’d have produced—I even 

took a ledger and * * * copied them all 

down so I did have a log book of the 

individual entries.’’ 12 Id. at 251. 

In a subsequent conversation, 

Respondent offered the material to the 

DI to which the latter responded: ‘‘ ‘No, 

I’ll give [the letters] you have already 

provided to me to Washington and it 

will go from there.’ ’’ Id. The DI admitted 

that he and his partner did not ask for 

copies of the materials in the box and 

did not offer Respondent the option to 

submit later the materials that he would 

gather together. Id. at 128. 

Respondent testified that he had 

photocopied his notes of ‘‘patient 

encounters,’’ which contained ‘‘the 

patient’s name, date of birth, everything 

that we’re seeing about that patient on 

that day and the reasonable explanation 

of why you would write a controlled 

substance for that patient on that day’’ 

as well as the controlled substance 

prescriptions he had written and then 

placed the copies in a manila folder in 

a box. Id. at 216, 235, 239. Respondent 

testified that he thought this would be 

‘‘even better than a logbook.’’ Id. at 216, 

235. As he explained: 

Now I thought that if there was ever a 

question about my writing abilities and what 

I was doing, that I could pull up the patient 

encounter and show my reasonable action on 

why I would write a prescription on that 

particular day for that particular patient. So 

I thought it was actually better than a 

logbook. 

Id. at 236.13

The parties disputed whether what 

Respondent had presented to the DIs 

constituted a log. According to the DI, 

a log is ‘‘something that we could easily 

obtain and review to check and verify 

[Respondent’s] prescription habits,’’ 

which would normally be a ‘‘bound 

book with notations’’ or a ‘‘binder with 

prescriptions.’’ Tr. 34–35. The DI 

testified that he did not consider the 

records in the box to be ‘‘easily 

reviewable.’’ Id. at 36. However, he later 

conceded that the MOA did not specify 

what format the log was to be 

maintained in and that the information 

he sought could be obtained from the 

copies of the prescriptions. Id. at 36, 

122. 

Respondent testified that he 

‘‘[p]robably’’ did not ‘‘completely’’ 

understand the MOA’s requirement. Id. 

at 215. However, he also testified that 

‘‘[a] log is actually a journal reading; it’s 

a journal.’’ Id. at 321. Respondent then 

testified that he thought ‘‘that a patient 

list was even better [and] was the same 

thing as a log book.’’ Id. He also 

maintained that ‘‘there was nothing in 

the [MOA] that told me how * * * a 

patient log book should look,’’ but then 

acknowledged that he never inquired of 

the Agency what the log should consist 

of ‘‘[b]ecause [he] thought that from 

what [he] had seen with other 

physicians, what they used was a photoa three- or double—you know, the twosided prescriptions where you just get a 

copy of it, that’s what I’d seen.’’ Id. at 

322. 

Respondent further testified that, 

while initially he kept the copies of 

prescriptions and patient encounters in 

a box in the office in chronological 

order, when he moved from 21st 

Century to 51st Avenue in October 

2004, he placed the records from the 

new location in another box. Id. at 217, 

237. Thus, at the meeting on April 13, 

2005, he was only able to produce a 

portion of the prescriptions he had 

written as the remaining records were at 

21st Century. Id. at 235–38. 

The DIs discussed with Respondent 

the MOA’s requirement that he notify 

the DEA before transferring his 

registration to another address. Id. at 37; 

GX 3, at 3. Respondent told them that 

he was not sure whether he had notified 

the Agency of his most recent move, and 

he acknowledged that he had moved to 

51st Avenue approximately six months 

earlier. Tr. 38–39. He also told the DIs 

that he had worked at 21st Century for 

four years prior to the move to 51st 

Avenue and that this address was also 

different from the address at which he 

had originally been registered. Id. at 38– 

39, 154; RXs 6 & 8. Respondent 

provided the DIs with two changes of 

address: 4700 North 51st Avenue, Suite 

6, Phoenix, Arizona, and 1526 West 

Glendale Avenue, Suite 109, Phoenix, 

Arizona. Tr. 38–39. Although he 

testified that it was ultimately his 

responsibility to advise the DEA that he 

had changed his practice address, 

Respondent maintained that it had been 

the responsibility of Mrs. Zachow to do 

so. Id. at 188 & 190. 

The DIs also discussed with 

Respondent the fact that his DEA 


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14The Government does not address whether this 

practice is even permissible under Arizona law. 

registration had expired. Tr. 59. 

Respondent told them that he had 

learned that the registration had expired 

several months before their meeting. Id. 

at 59, 113–14. Respondent further told 

the investigators that the office manager 

(Sonia Zachow) had been responsible 

for renewing the registration and had 

failed to do so. Id. at 112, 114–15. 

During the April 13, 2005 meeting, 

the DI’s senior partner instructed 

Respondent to desist from writing 

prescriptions for controlled substances; 

Respondent agreed that he would not 

write prescriptions for controlled 

substances. Id. at 62–63, 78. 

At the hearing, Respondent testified 

that he had complied with the DI’s 

instruction. Id. at 345. More specifically, 

Respondent testified that ‘‘I’ve been 

compliant from the day when I said— 

when they told me you can’t write 

controlled substances I’ve been—not 

written one.’’ Id. 

A DI testified that sometime after May 

23, 2005, he conducted a second search 

of Respondent’s DEA registration 

number on SearchPoint and found that 

Respondent had written controlled 

substance prescriptions after the April 

13, 2005, meeting. Tr. 77. However, for 

reasons explained above, because the 

Government did not comply with the 

instructions in the remand order for 

establishing that the SearchPoint data is 

reliable, I conclude that the Government 

has not proved that Respondent violated 

the DI’s order to stop writing 

prescriptions. I further find that the 

Government has failed to produce any 

reliable evidence rebutting 

Respondent’s contention that he had his 

prescriptions co-signed by a supervising 

physician after he became aware that his 

registration had expired.14

At the hearing, Respondent testified 

that he was compliant with the MOA; 

that his work as a physicians assistant 

was difficult and stressful; that he had 

no training in office administration; and 

that he had learned how to be a ‘‘better 

professional’’ from this experience with 

his DEA registration expiring. Tr. 257– 

59. 

Respondent testified that, although he 

currently works as a physicians 

assistant without writing controlled 

substance prescriptions, his lack of 

authority to do so significantly 

diminishes his employer clinic’s ability 

to treat patients: he is the only health 

care provider at the current clinic and 

cannot prescribe drugs necessary to treat 

such common ailments as excessive 

weight, Attention Deficit Disorder/ 

Attention Deficit-Hyperactivity 

Disorder, acute pain, acute anxiety 

attacks, and testosterone deficiencies. 

Id. at 267 & 278. If he cannot substitute 

a non-controlled substance, he must 

refer a patient who requires a controlled 

substance to a physician or another 

facility. Id. at 273. 

According to Respondent, in around 

July 2005, his boss at the 51st Avenue 

clinic gave him two weeks to resolve the 

issues surrounding his DEA registration 

and told him he would lose his job if he 

did not do so because insurance 

companies use the DEA registration 

number as a tracking number for 

reimbursement. Id. at 259–60. 

Respondent subsequently lost his job at 

this clinic but subsequently gained 

employment at his current clinic. Id. at 

260. 

Respondent further testified that he 

had ‘‘made a lot of mistakes’’ and that he 

did not ‘‘plan on this happening again.’’ 

Id. at 267. Respondent added that he 

could not ‘‘afford to make any mistakes 

in [his] life anymore,’’ that he had ‘‘made 

plenty’’ and was ‘‘sorry’’ to have ‘‘made 

them’’ and was ‘‘remorseful.’’ Id. at 268. 

He further stated that while ‘‘I made 

countless errors here * * * I’ve learned 

from them and I don’t think I’ll ever see 

a courtroom again.’’ Id. 

Discussion 

Section 303(f) of the Controlled 

Substances Act (CSA) provides that an 

application for a practitioner’s 

registration may be denied upon a 

determination ‘‘that the issuance of such 

registration would be inconsistent with 

the public interest.’’ 21 U.S.C. 823(f). In 

making the public interest 

determination, the CSA requires that the 

following factors be considered: 

(1) The recommendation of the appropriate 

State licensing board or professional 

disciplinary authority. 

(2) The applicant’s experience in 

dispensing * * * controlled substances. 

(3) The applicant’s conviction record under 

Federal or State laws relating to the 

manufacture, distribution, or dispensing of 

controlled substances. 

(4) Compliance with applicable State, 

Federal, or local laws relating to controlled 

substances. 

(5) Such other conduct which may threaten 

the public health and safety. 

Id. 

These factors may be considered in 

the disjunctive, and I ‘‘may rely on any 

one or a combination of factors and may 

give each factor the weight [I] deem[] 

appropriate’’ in determining whether an 

application for registration should be 

denied. Robert A. Leslie, 68 FR 15227, 

15230 (2003). Moreover, I am ‘‘not 

required to make findings as to all the 

factors.’’ Hoxie v. DEA, 419 F.3d 477, 

482 (6th Cir. 2005); see also Morall v. 

DEA, 412 F.3d 165, 173–74 (DC Cir. 

2005). 

Under DEA precedent, the various 

grounds for revocation or suspension of 

an existing registration which Congress 

enumerated in section 304(a), 21 U.S.C. 

824(a), are also properly considered 

when deciding whether to grant or deny 

an application under section 303(f) 

because ‘‘ ‘the law would not require an 

agency to indulge in the useless act of 

granting a license on one day only to 

withdraw it on the next.’ ’’ Anthony D. 

Funches, 64 FR 14267, 14268 (1999) 

(quoting Kuen H. Chen, 58 FR 65401, 

65402 (1993)); see also Alan R. 

Schankman, 63 FR 45260 (1998). These 

include section 304(a)(1), which 

provides for the suspension or 

revocation of a registration in the event 

that the registrant ‘‘has materially 

falsified any application filed pursuant 

to or required by this subchapter.’’ 21 

U.S.C. 824(a)(1). Thus, the allegation 

that Respondent materially falsified his 

application is properly considered in 

this proceeding. 

The Government bears the burden of 

proof in showing that the issuance of a 

registration is inconsistent with the 

public interest. 21 CFR 1301.44(d). 

However, where the Government has 

made out a prima facie case, the burden 

shifts to the applicant to ‘‘present[] 

sufficient mitigating evidence’’ to show 

why he can be entrusted with a new 

registration. Medicine ShoppeJonesborough, 73 FR 364, 387 (2008) 

(quoting Samuel S. Jackson, 72 FR 

23848, 23853 (2007) (quoting Leo R. 

Miller, 53 FR 21931, 21932 (1988))). 

‘‘Moreover, because ‘past performance is 

the best predictor of future 

performance,’ ALRA Labs, Inc. v. DEA, 

54 F.3d 450, 452 (7th Cir.1995), [DEA] 

has repeatedly held that where a 

registrant has committed acts 

inconsistent with the public interest, the 

registrant must accept responsibility for 

[his] actions and demonstrate that [he] 

will not engage in future misconduct.’’ 

Medicine Shoppe, 73 FR at 387; see also 

Jackson, 72 FR at 23853; John H. 

Kennedy, 71 FR 35705, 35709 (2006); 

Cuong Trong Tran, 63 FR 64280, 62483 

(1998); Prince George Daniels, 60 FR 

62884, 62887 (1995). 

Factor One—The Recommendation of 

the State Licensing Board 

The Arizona Regulatory Board of 

Physician Assistants has made no 

recommendation in this matter as to 

whether Respondent’s application 

should be granted. However, it is 

undisputed that Respondent holds a 

current Arizona Physician Assistant’s 

license and possesses authority under 


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15 It is also noted that in 1985, Respondent was 

convicted in Thailand of the offense of Possession 

and Attempted Smuggling’’ of marijuana. While this 

conviction is not encompassed within factor three, 

it is properly considered under factor five. 

16Respondent did not dispute that he prescribed 

after 2003. 

17While the Government established that 

Respondent’s registration expired on June 30, 2003, 

GX 1, it did not introduce into evidence a copy of 

the Certificate of Registration which was issued to 

him. Such certificates typically include the 

expiration date. Nor does the Government argue 

that proof of actual knowledge is not required to 

sustain a violation of 21 U.S.C. 843(a)(2). 

State law to dispense controlled 

substances. While Respondent therefore 

meets an essential prerequisite for 

obtaining a registration under the CSA, 

21 U.S.C. 823(f), DEA has held 

repeatedly that a practitioner’s 

possession of State authority is not 

dispositive of the public interest 

determination. See Mortimer B. Levin, 

55 FR 8209, 8210 (1990). 

Factors Two, Three, and Four— 

Respondent’s Experience in Dispensing 

Controlled Substances, Conviction 

Record Under Federal and State Laws 

for Offenses Related to the 

Manufacture, Distribution, or 

Dispensing of Controlled Substances, 

and Compliance With Applicable Laws 

Related to Controlled Substances 

As found above, on two prior 

occasions, Respondent was convicted of 

offenses under Arizona law related to 

the distribution of both marijuana (in 

1992) and cocaine (in 1994).15

Subsequently, in 1999, both of these 

convictions were vacated upon his 

having successfully completed 

probation. 

Given the obvious concerns raised by 

his prior criminal conduct, see GX 3, at 

2; following Respondent’s obtaining of 

his PA license, the Agency granted his 

application for a registration on the 

condition that he enter into the MOA, 

under which he agreed to comply with 

several conditions beyond those 

imposed by the CSA and DEA 

regulations. Of relevance here, 

Respondent agreed to maintain, for a 

period of five years, a log ‘‘list[ing] all 

controlled substances that he 

prescribes’’ which was also to ‘‘be 

subject to inspection * * * for five 

years.’’ GX 3, at 3. In addition, 

Respondent ‘‘agree[d] to notify the DEA 

Phoenix Division prior to transferring 

his * * * [r]egistration to another 

address within the state of Arizona or to 

another state.’’ Id. 

As the ALJ found, Respondent did not 

comply with either condition. ALJ at 

30–32. When asked to present his log, 

he provided a box which contained an 

assortment of papers and folders in no 

particular order, with some papers 

hanging out from the sides of the box. 

Moreover, the most recent records were 

for the year 2003. 

While the meaning of the MOA 

provision seems clear, and Respondent 

eventually acknowledged that a log is ‘‘a 

journal,’’ Tr. 321, even accepting 

Respondent’s explanation that he was in 

compliance by compiling his notes of 

patient encounters and the controlled 

substance prescriptions, it undisputed 

that he did not have a complete record 

of his prescribing activities as he lacked 

records after the year 2003.16 I therefore 

hold that he violated the MOA’s logkeeping provision. 

Moreover, while the MOA clearly 

stated that Respondent was required to 

notify the local DEA office prior to 

transferring his registration to another 

address, Respondent twice changed his 

practice location without notifying the 

Agency. Here again, Respondent 

violated the terms of the MOA. 

However, standing alone, Respondent’s 

violations of the MOA would not 

warrant the denial of his application 

given his expression of remorse. 

Alleged Violations of 21 U.S.C. 

843(a)(2) 

Under the CSA, it is ‘‘unlawful for any 

person knowingly or intentionally 

* * * to use in the * * * dispensing of 

a controlled substance * * * a 

registration number which is fictitious, 

revoked, suspended, expired, or issued 

to another person[.]’’ 21 U.S.C. 843(a)(2) 

(emphasis added). Doing so is a felony 

offense which is punishable by ‘‘a term 

of imprisonment of not more than 4 

years, a fine under Title 18, or both.’’ Id. 

at § 843(d)(1). 

The ALJ found that that ‘‘is 

undisputed that Respondent issued 

prescriptions for controlled substances 

after his DEA registration expired in 

June 2003, and that he continued to do 

so even after submitting an application 

for a new registration.’’ ALJ at 24. While 

apparently crediting Respondent’s 

testimony that he was not aware that his 

registration expired ‘‘until late 2004,’’ 

the ALJ concluded that ‘‘there is no 

doubt that he was aware of its 

expiration after that time, and that he 

therefore knowingly used an expired 

registration in violation of the statute 

when he continued to write 

prescriptions after late 2004.’’ Id. (citing 

21 U.S.C. 843(a)(2)). However, the ALJ 

rejected the Government’s contention 

that Respondent issued prescriptions 

even after the April 2005 meeting 

during which a DI told him to stop. Id. 

The Government apparently accepts 

Respondent’s contention that he did not 

know that his registration had expired 

until sometime in the fall of 2004 when 

he applied for a new registration. See 

Gov. Br. 6 (Proposed Finding 11) 

(‘‘Respondent testified that he was 

unaware that his DEA registration had 

expired and wasn’t notified in writing 

or otherwise of the expiration.’’).17 The 

Government’s contention that 

Respondent violated 21 U.S.C. 843(a)(2) 

is therefore based on his having issued 

prescriptions even after he submitted 

his application and clearly knew that 

his registration had expired. Id. at 10. 

The Government further argues that 

‘‘exacerbat[ing] his unlawful conduct, 

Respondent continued issuing 

prescriptions under his expired * * * 

registration after DEA investigators 

advised him against doing so during the 

* * * April 2005 inspection.’’ Id. at 10– 

11. 

To prove these allegations, the 

Government relied on a data 

compilation of his purported 

prescriptions, the reliability of which it 

failed to establish. As the DI candidly 

explained, this data ‘‘was only a 

pointing tool’’ and ‘‘was to be verified 

against the actual records that’’ a 

pharmacy or practitioner is ‘‘required to 

maintain’’ under the CSA and DEA’s 

regulations. Inexplicably, the 

Government did not produce any 

reliable evidence showing the 

controlled substances prescriptions he 

authorized such as patient medical 

records, copies of the actual 

prescriptions, or pharmacy dispensing 

logs. In sum, the Government did not 

produce reliable evidence establishing 

the extent to which Respondent 

continued to prescribe controlled 

substances following the expiration of 

his registration. 

It acknowledged that in a letter to one 

of the DIs, Respondent stated that he 

had resumed prescribing at some point 

following the submission of his 

application. Moreover, there is a degree 

of inconsistency between Respondent’s 

contentions that: (1) His office manager 

had contacted someone at DEA 

Headquarters and been told that he 

could write again; and (2) that he had 

a supervising physician co-sign the 

prescriptions. Nonetheless, because 

there is no reliable proof establishing 

the specific prescriptions which 

Respondent wrote following his 

becoming aware that his registration had 

expired, and the Government does not 

dispute either the factual basis of his 

contention that he had his prescriptions 

co-signed or the legality of this practice, 

there is insufficient evidence to show 

that Respondent violated 21 U.S.C. 

843(a)(2). I therefore reject the 


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Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 20019 

18She also considered Respondent’s violations of 

the MOA under this factor. I conclude, however 

that these violations are properly considered in 

assessing his experience in dispensing controlled 

substances. Moreover, as noted above, Respondent’s 

1985 conviction in the Thai courts for possession 

and attempting to smuggle marijuana is properly 

considered under this factor. However, it is noted 

that this conviction is now twenty-five years old. 

Government’s contention (and the ALJ’s 

conclusion) that Respondent violated 21 

U.S.C. 843(a)(2). 

Factor Five—Such Other Conduct 

Which May Threaten Public Health and 

Safety 

Under this factor, the ALJ considered 

the allegations that Respondent 

materially falsified his 2004 application 

and that he had been convicted of 

driving under the influence. ALJ at 27– 

33. She also deemed it appropriate to 

consider Respondent’s ‘‘employment at 

a clinic that serves a primarily 

underserved and underinsured 

population.’’ Id. at 33.18

The Material Falsification Allegation 

As found above, on his 2004 

application, Respondent answered ‘‘no’’ 

to the question: ‘‘Has the applicant ever 

been convicted of a crime in connection 

with controlled substances under state 

or federal law?’’ GX 4, at 1. Moreover, 

Respondent left blank the box which the 

application provided for explaining a 

‘‘yes’’ answer. Id. at 2. By signing the 

application, Respondent ‘‘certif[ied] that 

the forgoing information furnished on 

[the] application [wa]s true and correct.’’ 

Id. 

Respondent does not dispute that he 

should have disclosed the two Arizona 

convictions on his application. Resp. Br. 

at 13 (‘‘It seems obvious that the 2004 

application should have included the 

same information regarding felony 

convictions that [the] 2000 application 

had.’’). Indeed, it cannot be disputed 

that his answer was false and materially 

so given that under the public interest 

standard, the Agency is required to 

consider, inter alia, both an ‘‘applicant’s 

conviction record under Federal or State 

laws relating to the manufacture, 

distribution, or dispensing of controlled 

substances,’’ 21 U.S.C. 823(f)(3), and his 

‘‘[c]ompliance with applicable State, 

Federal, or local laws relating to 

controlled substances.’’ Id. § 823(f)(4). 

Given the statutory factors, it is clear 

that Respondent’s false answer was 

‘‘capable of influencing’’ the decision as 

to whether his application should be 

granted. See Jackson, 72 FR at 23852 

(‘‘ ‘The most common formulation’ of the 

concept of materiality is that ‘a 

concealment or misrepresentation is 

material if it ‘‘has a natural tendency to 

influence, or was capable of influencing, 

the decision of’’ the decisionmaking 

body to which it was addressed.’ ’’ 

(quoting Kungys v. United States, 485 

U.S. 759, 770 (1988) (quoting Weinstock 

v. United States, 231 F.2d 699, 701 (DC 

Cir. 1956))). 

That the Agency did not rely on 

Respondent’s false statement and grant 

his application does not make the 

statement immaterial. The Lawsons, 

Inc., 72 FR 74334, 74339 (2007) (quoting 

United States v. Alemany Rivera, 781 

F.2d 229, 234 (1st Cir. 1985) (‘‘It makes 

no difference that a specific falsification 

did not exert influence so long as it had 

the capacity to do so.’’); United States v. 

Norris, 749 F.2d 1116, 1121 (4th Cir. 

1984) (‘‘There is no requirement that the 

false statement influence or effect the 

decision making process of a 

department of the United States 

Government.’’). Nor does it matter that 

some employees of the Agency were 

previously aware of Respondent’s 

criminal history. See The Lawsons, 72 

FR at 74339 n.7. 

Respondent nonetheless contends that 

he did not intentionally falsify the 

application, Resp. Br. at 13–14, and the 

ALJ credited his testimony that the 

office manager at the clinic, where he 

was then working, filled out the 

application for him and that he signed 

it in haste without carefully reviewing 

it. ALJ at 8. The ALJ also credited his 

testimony that if he had ‘‘personally 

filled out the form * * * he would have 

detailed the explanation of his past 

conduct as he had done in 2000.’’ Id. at 

29. 

While I accept the ALJ’s credibility 

findings, I reject her conclusion that 

Respondent was merely ‘‘negligent.’’ Id. 

Notably, between the form’s blocks for 

signing and printing one’s name, the 

form stated: ‘‘I hereby certify that the 

forgoing information furnished on this 

application is true and correct.’’ GX 4, at 

2. Given the certification’s location on 

the application, Respondent cannot 

credibly claim that he did not read it. 

Respondent’s testimony simply begs the 

question of what information he thought 

he was certifying as being ‘‘true.’’ 

Likewise, the form’s block for 

explaining his answers to the liability 

questions was on the same side as the 

signature and certification blocks. In 

addition, Respondent had previously 

completed an application in which he 

disclosed his criminal convictions; he 

likewise knew, based on the detailed 

recitation of his various drug-related 

offenses in the MOA (although he 

apparently rarely, if ever, reviewed the 

MOA), that these offenses were of 

particular concern to DEA. Respondent 

clearly had reason to know that he was 

required to disclose his criminal 

convictions to the Agency. 

Finally, the ALJ gave insufficient 

consideration to the circumstances 

surrounding the 2004 renewal. Notably, 

this was not a routine renewal. Rather, 

at the time it was submitted, 

Respondent clearly knew that his 

registration had long since expired. 

And, notwithstanding his claim that he 

was a harried practitioner who was 

trying to make an impression with his 

employer by seeing numerous patients, 

reviewing the form for completeness 

would have taken no more than a few 

minutes. 

I therefore conclude that Respondent 

deliberately failed to read the front of 

the form. As several courts have noted, 

deliberate avoidance is generally not a 

defense to an allegation of material 

misrepresentation. United States v. 

Puente, 982 F.2d 156, 159 (5th Cir. 

1993) (‘‘[A] defendant who deliberately 

avoids reading the form he is signing 

cannot avoid criminal sanctions for any 

false statements contained therein.’’); 

Hanna v. Gonzales, 128 Fed. Appx. 478, 

480 (6th Cir. 2005) (rejecting alien’s 

claim that he did not willfully 

misrepresent material fact because 

friend filled out application for him; 

having signed the application under 

oath, his ‘‘failure to apprise himself of 

the contents of this important document 

constituted deliberate avoidance—an act 

the law generally does not recognize as 

a defense to misrepresentation’’). 

The ALJ failed to acknowledge this 

line of authority. Instead, she relied on 

several Agency decisions and reasoned 

that the ‘‘lack of intent to deceive is a 

relevant consideration in determining 

whether a registrant or applicant should 

possess a DEA registration.’’ ALJ at 30 

(quoting Rosalind A. Cropper, 66 FR 

41040, 41048 (2001)). However, the 

cases cited by the ALJ are readily 

distinguishable. See id. (citing Samuel 

Arnold, 63 FR 8687 (1998); Martha 

Hernandez, 62 FR 61145 (1997)). 

For instance, in Cropper, the 

physician was completely unaware of 

the underlying agency action which she 

had failed to disclose on her 

application. 66 FR at 41048. That is a far 

cry from this case as Respondent clearly 

knew that he had been previously 

convicted of two felony drug offenses in 

the Arizona courts. 

In Samuel Arnold, a physician failed 

to disclose on his application a prior 

suspension of his state medical license 

based on misconduct which was not 

related to controlled substances. 63 FR 

at 8687. However, the Deputy 

Administrator found credible the 

testimony of two witnesses that 

Respondent had called a DEA Office on 


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20020 Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 

19Having reviewed the Agency’s decision in 

Neujahr, I conclude that the case was wrongly 

decided because the respondent there did not fully 

address his misconduct, which included not only 

his failure to disclose his having surrendered his 

authority under Federal law to write prescriptions 

for schedule II controlled substances, but also his 

failure to disclose a State proceeding which placed 

his veterinary license on probation; at his DEA 

hearing, the respondent offered no explanation as 

to this separate act of material falsification. 65 FR 

at 5681. In Neujahr, the ALJ concluded that the 

respondent ‘‘apparently regretted that conduct.’’ Id. 

at 5682. To make clear, the Agency should not have 

to guess as to whether one has accepted 

responsibility for his misconduct. A registrant/ 

applicant’s acceptance of responsibility must be 

clear and manifest. 

20 I place no weight on Respondent’s DUI/Hit and 

Run conviction there being no evidence that he was 

under the influence of a controlled substance at the 

time. See David E. Trawick, 53 FR 5326, 5327 

(1988) (noting that factor five encompasses 

‘‘wrongful acts relating to controlled substances 

committed by a registrant outside of his 

professional practice but which relate to controlled 

substances’’). 

The ALJ also opined that it is appropriate to 

consider Respondent’s employment at a clinic that 

serves an ‘‘underserved and underinsured 

populations.’’ ALJ at 33. However, I have previously 

rejected this reasoning noting that ‘‘[t]he public 

interest standard of 21 U.S.C. 823(f) is not a 

freewheeling inquiry but is guided by the five 

specific factors which Congress directed the 

Attorney General to consider [and that] 

consideration of the socioeconomic status of a 

practitioner’s patient population is not mandated by 

the text of either 21 U.S.C. 823(f) or 824(a)(4), 

which focus primarily on the acts committed by a 

practitioner.’’ Gregory D. Owens, 74 FR 36751, 

36757 (2009). I further noted that such a rule is 

‘‘unworkable,’’ and ‘‘would inject a new level of 

complexity into already complex proceedings and 

take the Agency far afield of the purpose of the 

CSA’s registration provisions, which is to prevent 

diversion.’’ Id. at n.22. I therefore do not consider 

the issue. 

a speaker phone to inquire as to whether 

he was required to disclose the 

suspension and was told by an Agency 

employee that he did not have to 

because his ‘‘license was no longer 

suspended.’’ Id. at 8687–88. Here, 

however, Respondent makes no claim 

that in filling out the application he 

relied on erroneous advice from an 

Agency employee as to what he was 

required to disclose. 

Of the cases cited by the ALJ, only 

Martha Hernandez, 62 FR 61145 (1997), 

and Theodore Neujahr, 65 FR 5680 

(2000), provide any comfort to 

Respondent. In Hernandez, while my 

predecessor concluded that the 

practitioner’s material falsifications in 

failing to disclose the suspension by two 

States of her medical licenses (for failing 

to pay her student loans, which she 

believed was not within the intent of the 

liability question) ‘‘indicate a careless 

disregard for attention to detail,’’ he 

imposed only a reprimand and 

conditions on her registration. Id. at 

61148. While my predecessor agreed 

that ‘‘this lack of connection to 

controlled substances [wa]s not 

dispositive of the matter,’’ he concluded 

that it was ‘‘relevant in determining the 

appropriate remedy.’’ Id. Here, by 

contrast, Respondent’s falsifications 

involve his failure to disclose his 

convictions for controlled substances 

offenses and are clearly relevant in 

determining the appropriate 

sanction.19See 21 U.S.C. 823(f)(3). 

The ALJ also relied on Neujahr, a case 

in which the Agency granted the 

application of practitioner, 

notwithstanding that he had he had 

materially falsified it, because he 

‘‘acknowledged that he falsified his 

applications, he apparently regretted 

that conduct, and [the ALJ] believe[d] 

that he will not repeat it.’’ ALJ at 30 & 

n.86 (quoting 65 FR at 5682). 

Subsequently in her decision, the ALJ 

reasoned that while the Government 

had ‘‘made out a prima face case for 

denying his application, * * * it is 

important to note that the [Agency’s] 

decision whether to grant or deny an 

application for registration is a 

prospective, rather than a retrospective, 

determination.’’ Id. at 34. 

It is true that proceedings under 

section 303 and 304 of the CSA are 

remedial and not punitive. See, e. g., 

Jackson, 72 FR at 23853. However, 

contrary to the ALJ’s understanding, the 

remedial nature of this proceeding does 

not preclude the Agency from 

considering the deterrent value of a 

sanction with respect to both the 

Respondent and others in setting the 

remedy. See Southwood 

Pharmaceuticals, Inc., 72 FR 36487, 

36504 (2007). As Southwood makes 

clear, ‘‘even when a proceeding serves a 

remedial purpose, an administrative 

agency can properly consider the need 

to deter others from engaging in similar 

acts.’’ Id. (citing Butz v. Glover Livestock 

Commission Co., Inc., 411 U.S. 182, 

187–188 (1973) (upholding Agency’s 

authority ‘‘to employ that sanction as in 

[its] judgment best serves to deter 

violations and achieve the objectives of 

[the] statute’’)). The ALJ, however, did 

not even acknowledge Southwood. 

Contrary to the ALJ’s conclusion that 

Respondent will conduct himself 

henceforth in a responsible fashion, see 

ALJ at 34, Respondent made a similar 

promise in the MOA when he agreed to 

‘‘abide by its contents in good faith.’’ GX 

3, at 3. See also ALRA Laboratories, Inc. 

v. DEA, 54 F.3d 450, 452 (7th Cir. 1995) 

(‘‘An agency rationally may conclude 

that past performance is the best 

predictor of future performance.’’). 

Respondent, however, then proceeded 

to ignore his obligations under the 

MOA. 

Under these circumstances, granting 

Respondent’s application subject to the 

restrictions proposed by the ALJ, which 

do no more than replicate the 

conditions imposed by the MOA, 

amounts to no sanction at all. In short, 

adopting the ALJ’s proposed sanction 

would send the wrong message to both 

Respondent, who has demonstrated a 

disturbing lack of attention to the 

requirements of being a registrant, as 

well as other applicants/registrants, 

especially those who would submit an 

application without carefully reviewing 

it for completeness and truthfulness. 

Accordingly, I conclude that 

Respondent’s application should be 

denied. However, given Respondent’s 

expression of remorse, I conclude that 

Respondent can re-apply for a new 

registration six months from the 

effective date of this Order. Provided 

that his application is not materially 

false and that he has committed no 

other acts which would warrant the 

denial of his application, the Agency 

will expeditiously grant his renewal 

application and issue him a new 

registration subject to the conditions of 

the 2001 MOA.20

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823(f), as well as 28 CFR 

0.100(b) and 0.104, I order that the 

application of Mark De La Lama for a 

DEA Certificate of Registration as a midlevel practitioner be, and it hereby is, 

denied. This order is effective May 11, 

2011. 

Dated: April 1, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–8536 Filed 4–8–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Glenn D. Krieger, M.D.; Denial of 

Application 

On August 31, 2009, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Glenn D. Krieger, M.D. 

(‘‘Applicant’’), of West Bloomfield, 

Michigan. The Show Cause Order 

proposed the denial of Applicant’s 

application for a DEA Certificate of 

Registration on the ground that his 

‘‘registration would be inconsistent with 

the public interest as defined by 21 

U.S.C. §§ 823(f) and 824(a)(4).’’ Show 

Cause Order, at 1. 

More specifically, the Show Cause 

Order alleged that Applicant filed an 


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