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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1See 21 CFR 1308.12(c)(9). 

2Applicant’s counsel had represented him during 

an interview with DEA Investigators on November 

7, 2008. 

3Respondent did not challenge whether the 

Government’s mailing of the Show Cause Order to 

the lawyer who previously represented him 

constituted sufficient service. See 21 U.S.C. 824(c) 

(‘‘Before taking action pursuant * * * to a denial of 

registration under section 823 of this title, the 

Attorney General shall serve upon the applicant 

* * * an order to show cause. * * * .’’); see also 

United States v. Ziegler Boat and Parts Co., 111 

F.3d 878, 881 (Fed. Cir. 1997) (‘‘The mere 

relationship between a defendant and his attorney 

does not, in itself, convey authority to accept 

service. * * * Even where an attorney exercises 

broad powers to represent a client in litigation, 

these powers of representation alone do not create 

a specific authority to receive service.’’) (citing 

numerous authorities). However, a challenge to the 

sufficiency of service is deemed waived if it is not 

raised in a party’s first responsive pleading. See 

Hemisphere X Biopharma, Inc., v. Johannesburg 

Consol. Investments, 553 F.3d 1351, 1360 (11th Cir. 

2008). Accordingly, I hold that Respondent has 

waived any challenge to the sufficiency of service. 

application for a DEA registration on 

October 9, 2008. Id. The Order further 

alleged that on ‘‘June 28, 2007, July 19, 

2007, and August 1, 2007,’’ Applicant 

was subjected to random urine drug 

tests and tested positive for fentanyl, a 

Schedule II controlled substance,1

although the drug had never been 

prescribed to him. Id. Relatedly, the 

Order alleged that on November 7, 2008, 

Applicant told DEA Investigators that he 

‘‘obtained the fentanyl from patients 

who returned unused fentanyl to [him], 

because [he] was collecting pain 

medication to give as a donation to the 

Oakpointe Church’s missionary project 

in Zambia, Africa.’’ Id. The Order further 

alleged that DEA Investigators were 

subsequently ‘‘informed by Oakpointe 

Church executives that the church did 

not conduct any Zambian missionary 

projects in 2007, that the Zambian 

missionary projects of previous years 

did not collect donated controlled 

substances, and that [Applicant] did not 

participate in any of the Zambian 

missionary projects.’’ Id. at 1–2. The 

Order then alleged that Applicant’s 

‘‘false statements to DEA investigators 

constituted both conduct which may 

threaten the public health and safety 

pursuant to 21 U.S.C. § 823(f)(5) and 

criminal acts pursuant to 18 U.S.C. 

1001. Id. at 2. 

Next, the Show Cause Order alleged 

that Applicant had previously held a 

DEA Certificate of Registration, 

BK4918528, which he ‘‘surrendered for 

cause on March 7, 2008.’’ Id. The Order 

then alleged that ‘‘[b]etween March 7, 

2008 and November 1, 2008,’’ Applicant 

‘‘issued approximately 435 prescriptions 

for controlled substances despite not 

having a valid DEA Certificate of 

Registration, in violation of 21 U.S.C. 

§ 841(a).’’ Id. Finally, the Order alleged 

that Applicant’s ‘‘violation[s] of Federal 

laws and regulations are inconsistent 

with the public interest.’’ Id. (citing 21 

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

The Show Cause Order also explained 

that Respondent had the right to request 

a hearing on the allegations or to submit 

a written statement in lieu of a hearing, 

the procedures for doing either, and the 

consequences for failing do so. Id. 

(citing 21 CFR 1301.43(c), (d), & (e)). On 

or about September 2, 2009, the 

Government attempted to serve 

Applicant with the Order by certified 

mail addressed to him at the address he 

provided in his application for a new 

registration. However, on or about 

September 11, 2009, the Post Office 

returned the Order as ‘‘not deliverable as 

addressed.’’ 

On or about September 25, 2009, DEA 

made a second attempt to serve 

Applicant with the Order by certified 

mail addressed to him at the address 

given on his application. Again, 

however, the Post Office returned the 

mailing as ‘‘not deliverable as 

addressed.’’ 

On or about September 16, 2009, DEA 

mailed a copy of the Show Cause Order 

to Applicant’s counsel.2 As evidenced 

by a signed return receipt card, 

Applicant’s counsel received the letter 

on September 18, 2009. 

On February 2, 2010, the Office of 

Administrative Law Judges received a 

letter from Applicant (dated Jan. 28, 

2010). Therein, Applicant stated that 

‘‘[a]round mid-October 2009, I received 

a letter from my attorney * * * that was 

supposed to contain a complete copy of 

the letter he received only a few days 

earlier. Due to several different 

miscommunications and difficulty with 

traveling due to expenses, I did not 

appear for the scheduled show cause on 

December 1, 2009. In spite of my 

absence, I am very interested in 

scheduling a show cause.’’ 

Upon receipt of this letter, the ALJ 

ordered that the Government provide 

evidence of the date of service of the 

Show Cause Order upon Applicant by 

February 19, 2010 and to file any 

motion to terminate based on his failure 

to timely request a hearing by the same 

date. Order Granting the Government’s 

Motion to Terminate Proceedings, at 1. 

The Order further directed Applicant to 

file a responsive pleading by February 

26, 2010. Id. 

Thereafter, the Government timely 

filed a Motion to Terminate. Therein, it 

asserted that it ‘‘effected service of the 

OSC on Respondent’s counsel via 

certified mail on or around September 

18, 2009,’’ that the Show Cause Order 

clearly set forth the procedures for 

requesting a hearing and the 

consequences for failing to do so, and 

that he did not request a hearing within 

30 days of receiving the Order as 

required by DEA regulations. Id. at 2. 

Applicant did not file a response to the 

Government’s motion. 

The ALJ granted the Government’s 

motion noting that Applicant did not 

contest the Government’s representation 

that the Show Cause Order had been 

served on his legal counsel/agent on or 

about September 18, 2009, and that, in 

his letter requesting a hearing, 

Applicant had acknowledged that in 

mid-October 2009, he had received a 

document from his attorney ‘‘related to 

this proceeding and ‘did not appear for 

the scheduled show cause hearing on 

December 1, 2009,’’’ which information 

was contained on the front page of the 

Show Cause Order. Id. at 2–3. Because 

Applicant did not request a hearing 

until ‘‘several months after effective 

service of the’’ Order, and did not offer 

good cause for his failure to do so, the 

ALJ concluded that he had waived his 

right to a hearing and terminated the 

proceeding. Id. at 3 (citing 21 CFR 

1301.43). I adopt this finding.3

Thereafter, the investigative record 

was forwarded to me for final agency 

action. Based on relevant evidence 

contained in the record, I conclude that 

granting Respondent’s application 

would be ‘‘inconsistent with the public 

interest.’’ 21 U.S.C. 823(f). Accordingly, 

his application will be denied. I make 

the following findings of fact. 

Findings 

On October 9, 2008, Applicant filed 

an application for a DEA Certificate of 

Registration through DEA’s Web site. 

The application is the subject of this 

proceeding. 

Applicant previously held DEA 

Certificate of Registration BK4918528. 

On March 7, 2008, Respondent 

voluntarily surrendered this registration 

and executed a DEA Form 104, 

Voluntary Surrender of Controlled 

Substances Privileges (which his 

counsel signed as a witness). The form 

clearly stated that it provided ‘‘authority 

for the Administrator * * * to terminate 

and revoke my registration without an 

order to show cause, a hearing, or any 

other proceedings.’’ In addition, the 

form stated: ‘‘I understand that I will not 

be permitted to * * * prescribe, or 

engage in any other controlled 

substance activities whatsoever, until 

such time as I am again properly 

registered.’’ 

According to a report obtained by an 

Agency Investigator from the Michigan 


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4Temporo-mandibular joint dysfunction. 

5Section 16221(a) ‘‘provides the [DS] with the 

authority to take disciplinary action against 

[Applicant] for a violation of general duty, 

consisting of negligence or failure to exercise due 

care . . . or any conduct, practice, or condition 

which impairs or may impair, the ability to safely 

and skillfully practice medicine.’’ Administrative 

Complaint, at 2. 

6Section 16221(b)(i) provides the DS with 

authority to take disciplinary action against a 

licensee for ‘‘incompetence,’’ defined as ‘‘[a] 

departure from, or failure to conform to, minimal 

standards of acceptable and prevailing practice for 

a health profession whether or not actual injury to 

an individual occurs.’’ Administrative Complaint, at 

2. 

7Section 16221(b)(ii) provides the DS with 

authority to take disciplinary action against a 

licensee for ‘‘substance abuse,’’ defined as ‘‘the 

taking of alcohol or other drugs at dosages that 

place an individual’s social, economic, 

psychological, and physical welfare in potential 

hazard or to the extent that an individual loses the 

power of self-control as a result of the use of alcohol 

or drugs, or while habitually under the influence of 

alcohol or drugs, endangers public health, morals, 

safety, or welfare, or a combination thereof.’’ 

Administrative Complaint, at 2. 

8Section 16221(b)(iii) provides the DS with 

authority to take disciplinary action against a 

licensee ‘‘for a mental or physical inability 

reasonably related to and adversely affecting the 

licensee’s ability to practice in a safe and competent 

manner.’’ Administrative Complaint, at 2. 

9Section 16221(c)(iv) provides the DS with 

authority to take disciplinary action against a 

licensee for ‘‘obtaining, possessing, or attempting to 

obtain or possess a controlled substance[] * * * 

without lawful authority; or selling, prescribing, 

giving away, or administering drugs for other than 

lawful diagnostic or therapeutic purposes.’’ 

Administrative Complaint, at 3. 

10On June 4, 2008, a State ALJ dissolved the 

summary suspension of his medical license. Order 

Dissolving Suspension, at 1. 

Automated Prescription System 

(MAPS), within less than three weeks of 

the surrender, Applicant issued 

prescriptions to two patients for 60 and 

90 tablets of OxyContin 80 mg. The 

report further showed that by the end of 

July, Applicant had resumed prescribing 

controlled substances full-bore. 

The investigative record establishes 

that Applicant voluntarily surrendered 

his registration in connection with an 

Administrative Complaint (‘‘Complaint’’) 

filed by the Michigan State Bureau of 

Health Professionals (BHP) on December 

20, 2007. The Complaint alleged two 

counts. Administrative Complaint, In re 

Glenn D. Krieger, M.D., No. 43–07– 

106420. 

First, the Complaint alleged that 

Applicant had self-reported that he was 

abusing fentanyl, a schedule II 

controlled substance, to the Michigan 

Health Professional Recovery Program 

(HPRP) and had undergone a substance 

abuse evaluation and been diagnosed as 

abusing opioids. Id. at 5–6. The 

Complaint alleged that he had tested 

positive for fentanyl during urine drug 

screens conducted on June 28, July 19, 

and August 1, 2007, and that thereafter, 

HPRP advised him that ‘‘he was not safe 

to practice’’ medicine and recommended 

that he admit himself into an inpatient 

rehabilitation program. Id. at 6. The 

Complaint further alleged that he had 

failed to enter an inpatient drug 

rehabilitation program or enter into a 

monitoring agreement with HPRP. The 

BHP charged that his conduct 

‘‘constitute[d] a mental or physical 

inability reasonably related to and 

adversely affecting Respondent’s ability 

to practice in a safe and competent 

manner,’’ ‘‘constitute[d] a conduct that 

impairs or may impair his ability to 

safely and skillfully practice medicine,’’ 

and ‘‘constitute[d] substance abuse,’’ all 

in violation of state law. Id. at 6–7. 

Second, the Complaint alleged that, in 

treating S.S. for chronic back pain, 

TMJ,4 fibromyalgia and depression, 

Applicant’s ‘‘chart for S.S. [was] devoid 

of physical exams or clinical findings to 

support his long term prescribing of 

high doses of opioids, benzodiazepines, 

and stimulants’’ and that he had ‘‘failed 

to recognize that his prescribing of 

escalating doses of opioids was 

detrimental to S.S.’s overall functioning 

and quality of life.’’ Id. at 10. The BHP 

charged that his conduct ‘‘constitute[d] 

negligence,’’ ‘‘incompetence,’’ and the 

‘‘prescribing, giving away or 

administering [of] drugs for other than 

lawful diagnostic or therapeutic 

purposes,’’ all in violation of Michigan 

law. Id. 

The investigative file contains copies 

of the results from the urine drop 

assessments of June 28, July 19, and 

August 1, 2007. These documents 

establish that Applicant tested positive 

for fentanyl on each occasion. 

On December 28, 2007, the BHP’s 

Board of Medicine’s Disciplinary 

Subcommittee (DS) summarily 

suspended Applicant’s state medical 

license effective on service of the order. 

Order of Summary Suspension, at 1. On 

May 30, 2008, Applicant entered into a 

Consent Order with the State. Consent 

Order, at 6. The Consent Order provided 

that the DS found ‘‘that the allegations 

of fact contained in the complaint are 

true’’ and that Applicant had violated 

sections 16221(a),5 (b)(i),6 (b)(ii),7

(b)(iii),8 and (c)(iv)9 of the Michigan 

Public Health Code. Id. at 2. The DS 

thus ordered that Applicant’s license be 

‘‘LIMITED for a minimum period of two 

years’’ such that he ‘‘shall not obtain, 

possess, dispense, administer, or have 

access to any drug designated as a 

controlled substance under the Public 

Health Code or its counterpart in federal 

law unless the controlled substance is 

prescribed or dispensed by a licensed 

physician for [Applicant] as a patient.’’ 

Id. The Consent Order also placed him 

‘‘on PROBATION for a period of two 

years.’’ Id. 

As one of the probationary conditions, 

the State ordered that Applicant ‘‘shall 

comply with the terms of the monitoring 

agreement’’ which he had entered into 

with the HPRP on May 15, 2008. Id. at 

3. The Monitoring Agreement provided, 

inter alia, that he ‘‘will not obtain, 

possess, dispense, or administer 

controlled substances,’’ that he ‘‘will 

practice total abstention from alcohol, 

controlled substances, and other moodaltering substances,’’ and that he ‘‘will 

submit to drug screens as requested by 

HPRP.’’ Monitoring Agreement, at 1–2. 

In the Consent Order, the parties 

stipulated that Applicant ‘‘does not 

contest the allegations of fact and law 

contained in the complaint’’ but that ‘‘by 

pleading no contest * * * does not 

admit the truth of the allegations [and] 

agrees that the Disciplinary 

Subcommittee may treat the allegations 

as true for the resolution of the 

complaint.’’ Consent Order, at 4–5.10

On September 26, 2008, a Diversion 

Investigator (DI) with the DEA Detroit 

Division Office received information 

that Applicant was issuing prescriptions 

using the DEA registration number 

which he had previously surrendered. 

That day he contacted Applicant’s 

attorney and left a phone message 

advising him that Applicant could not 

issue controlled substance prescriptions 

without a valid DEA registration. 

On October 3, 2008, a pharmacist 

phoned the DI and told him that 

Applicant had issued a prescription for 

Vicotussin, a controlled substance. The 

pharmacist further stated that he had 

determined that Applicant did not have 

a valid registration, and therefore, did 

not fill the prescription. The DI again 

left a phone message with Applicant’s 

attorney advising that Applicant could 

not issue controlled substance 

prescriptions without a valid 

registration. The DI also attempted to 

contact Applicant directly; the DI left a 

phone message advising him that he 

was not legally authorized to write 

controlled substance prescriptions 

unless and until he obtained a new 

registration. 

The same day, Applicant’s attorney 

contacted the DI and informed him that 

Applicant’s Michigan medical license 

had been reinstated; the attorney further 

stated that he had advised Applicant 

that all of his licensure had been 

restored upon the reinstatement of his 

medical license such that Applicant had 

issued controlled substance 


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11The record contains copies of various 

controlled substance prescriptions issued by 

Applicant on which he used the DEA registration 

number he had previously surrendered. 

12The attorney also stated that he was unaware 

that Applicant was required to apply for a new 

registration, despite his having witnessed the 

Voluntary Surrender Form previously executed by 

Applicant which had clearly stated that ‘‘I will not 

be permitted to * * * dispense, administer, 

prescribe, or engage in any other controlled 

substance activities * * * until such time as I am 

again properly registered.’’ DEA Form 104. 

13MAPS is part of a mandatory system in 

Michigan through which pharmacies and 

dispensing physicians report their controlled 

substance dispensings twice a month. 

14Two of the prescriptions, dated March 19 and 

April 11, 2008, were issued to patient A.F. and were 

for first 60 tablets and then 90 tablets of OxyContin 

80 mg. The third prescription, issued March 26, 

2008, was for patient D.P. and was for 90 tablets of 

OxyContin 80 mg. 

15On October 4, 2008, Applicant issued two 

prescriptions to patient L.V.: One for hydrocodone/ 

APAP 10 mg./325 mg. (90 tablets) and one for 

OxyContin 40 mg. (180 tablets). On October 8, 2008, 

Applicant wrote five prescriptions for patient K.B.: 

For clonazepam 1 mg. (30 tablets), for Endocet 325 

mg./10 mg. (90 tablets), for Methadone Hcl 10 mg. 

(90 tablets), for Methylin 20 mg. (90 tablets), and 

for OxyContin 80 mg. (75 tablets). On October 9, 

2008, he issued a prescription to patient D.P. for 

alprazolam 1 mg. (75 tablets). 

prescriptions based on the attorney’s 

erroneous advice. The DI informed the 

attorney that Applicant would have to 

apply for a new registration in order to 

prescribe controlled substances. 

On October 5, 2008, the DI received 

a letter from Applicant’s attorney, dated 

October 1, 2008. The letter requested the 

reinstatement of Applicant’s controlled 

substances privileges, based on the 

reinstatement of his medical license. 

The following day, on October 6, 

2008, the DI received a telephone call 

from a second pharmacist regarding a 

controlled substance prescription (for 

120 tablets of Oxycontin 80 mg.) issued 

by Applicant on September 10, 2008. 

The pharmacist had also checked 

Applicant’s registration, found that he 

lacked a valid registration, and did not 

fill the prescription. 

On October 9, 2008, Applicant filed 

an application for a new registration. 

Six days later, the DI received a 

telephone call from a third pharmacist. 

The pharmacist reported that the day 

before, a person had presented to him 

controlled substance prescriptions (for 

OxyContin, Roxicodone, Norco and 

Xanax) issued by Applicant on October 

3, 2008. However, the pharmacy had 

experienced a delay in ordering the 

prescribed medications.11

On October 15, the pharmacist called 

the customer to advise her of the delay. 

Within fifteen minutes, he received a 

phone call from Applicant about the 

delay. Finding this suspicious, the 

pharmacist contacted the DI, who 

advised him that Applicant did not have 

a valid registration. 

On November 7, 2008, the DI and his 

Group Supervisor interviewed 

Applicant in the presence of his 

attorney. During the interview, 

Applicant’s attorney stated that he had 

‘‘fumbled the ball’’ by advising 

Applicant that he could resume his 

customary practice, including 

prescribing controlled substances, upon 

the reinstatement of his medical 

license.12 During the interview, 

Applicant stated that he had stopped 

issuing controlled substance 

prescriptions on October 3, 2008, when 

the DI had notified him that he could 

not do so without first obtaining a new 

registration. He further acknowledged 

that he had previously executed a 

Voluntary Surrender Form. 

The DI also questioned Applicant 

about his abuse of fentanyl. Noting that 

he had obtained a report from the 

Michigan Automated Prescription 

System (MAPS) 13 showing the 

prescriptions Applicant had received as 

a patient and that no fentanyl 

prescriptions were listed, the DI asked 

Applicant how he had obtained the 

fentanyl. Applicant stated that he 

obtained the fentanyl by collecting 

unused pain medication from his 

patients, which he was collecting to give 

as a donation to his church’s missionary 

project in Zambia. He further denied 

that he had issued fentanyl 

prescriptions to patients in order to 

have them fill the prescriptions and 

return the drugs to him for his personal 

use. 

The DI subsequently interviewed 

several individuals associated with the 

church’s missionary project. The 

church’s senior pastor stated that while 

he knew Applicant through the church, 

he was not a member of it, and that 

while the church did conduct 

missionary projects in Zambia, 

Applicant had not participated in any of 

them. Subsequently, the DI interviewed 

a physician, who had run the project in 

2003 and 2008, and a physician 

assistant, who had run the project in 

2004 and 2005. Both individuals stated 

that there had been no missionary 

projects in 2006 and 2007, when 

Respondent tested positive for fentanyl. 

Moreover, the physician had never met 

Applicant and the physician assistant 

had not spoken to him since 2005. 

Finally, according to the church’s 

Executive Pastor, the 2008 project did 

not use controlled substances and any 

drugs that were used had been bought 

and not donated. 

On November 19, 2008, the DI ran 

another MAPS inquiry, this time for 

controlled substance prescriptions 

written by Applicant between March 1 

and November 1, 2008. The report 

shows that between March 7, the date 

on which he surrendered his 

registration, and November 1, Applicant 

issued approximately 438 controlled 

substance prescriptions. The report also 

shows that he issued three controlled 

substance prescriptions prior to June 4, 

the date on which his Michigan medical 

license was reinstated,14 and that he 

issued eight controlled substance 

prescriptions after October 3, 2008,15

the date he received the DI’s phone 

message to stop writing prescriptions 

and the date he claimed that he had 

ceased doing so. 

Discussion 

Section 303(f) of the Controlled 

Substances Act (CSA) provides that the 

Attorney General ‘‘shall register 

practitioners * * * to dispense * * * 

controlled substances in schedule II, III, 

IV, or V, if the applicant is authorized 

to dispense * * * controlled substances 

under the laws of the State in which he 

practices.’’ 21 U.S.C. 823(f). However, 

the statute also provides that the 

Attorney General ‘‘may deny an 

application for such registration if he 

determines that the issuance of such a 

registration is inconsistent with the 

public interest.’’ Id. In determining the 

public interest, Congress directed 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. 

‘‘[T]hese factors are * * * considered 

in the disjunctive.’’ Robert A. Leslie, 68 

FR 15227, 15230 (2003). I may rely on 

any one or a combination of factors and 

may give each factor the weight I deem 

appropriate in determining whether to 

revoke an existing registration or to 

deny an application. Id. Moreover, I am 

‘‘not required to make findings as to all 

of the factors.’’ Hoxie v. DEA, 419 F.3d 

477, 482 (6th Cir. 2005); see also Morall 

v. DEA, 412 F.3d 165, 173–74 (D.C. Cir. 

2005). 

In this matter, I have considered all of 

the factors. While Applicant’s state 

medical license has been re-instated 

(factor one) and there is no evidence 


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20024 Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 

16Putting aside that the State of Michigan has 

made no recommendation as to whether 

Respondent’s application should be granted, this 

Agency has repeatedly held that the possession of 

a valid state license is not dispositive of the public 

interest inquiry. See Patrick W. Stodola, 74 FR 

20727, 20730 n.16 (2009); Robert A. Leslie, 68 FR 

at 15230. As DEA has long recognized, ‘‘the 

Controlled Substances Act requires that the 

Administrator * * * make an independent 

determination as to whether the granting of 

controlled substances privileges would be in the 

public interest.’’ Mortimer Levin, 57 FR 8680, 8681 

(1992). 

Nor is the lack of any criminal convictions related 

to the distribution or dispensing of controlled 

substances dispositive. Edmund Chein, 72 FR 6580, 

6593 n.22 (2007), aff’d, Chein v. DEA, 533 F.3d 828 

(D.C. Cir. 2008). Thus, the facts that Respondent 

holds a Michigan medical license (assuming that he 

is actually authorized to dispense controlled 

substances under the Consent Order) and has not 

been convicted of a relevant criminal offense are 

not dispositive. 

17 Given the terms of the Consent Order, which 

prohibited him from dispensing controlled 

substances, it also appears that his issuance of the 

prescriptions violated that order. However, the 

Government did not allege this in the Show Cause 

Order and thus I do not consider this conduct. 

18The record does not conclusively establish 

whether he told this story to the persons from 

whom he obtained the fentanyl. Were this shown 

to be the case, Respondent would have violated 21 

U.S.C. 843(a)(3), which renders it ‘‘unlawful for any 

person knowingly or intentionally * * * to acquire 

or obtain possession of a controlled substance by 

misrepresentation, fraud, * * * deception, or 

subterfuge[.]’’ 

that he has been convicted of an offense 

related to the distribution or dispensing 

of controlled substances,16 I conclude 

that the evidence relevant to 

Respondent’s experience in dispensing 

controlled substances (factor two) and 

his compliance with applicable laws 

related to controlled substances (factor 

four), conclusively establishes that 

granting his application would be 

‘‘inconsistent with the public interest.’’ 

21 U.S.C. 823(f). 

Factors Two and Four—Respondent’s 

Experience in Dispensing Controlled 

Substance and Compliance With 

Applicable Laws Related to Controlled 

Substances 

Under Federal law, it is unlawful ‘‘for 

any person [to] knowingly or 

intentionally * * * dispense a 

controlled substance’’ ‘‘except as 

authorized by’’ the CSA. 21 U.S.C. 

841(a)(1). It is ‘‘unlawful for any person 

knowingly or intentionally * * * to use 

in the course of the * * * dispensing of 

a controlled substance * * * a 

registration number which is * * * 

revoked.’’ Id. § 843(a)(3). Moreover, 

‘‘[e]very person who dispenses, or 

propose to dispense, any controlled 

substance, shall obtain from the 

Attorney General a registration issued in 

accordance with the rules and 

regulations promulgated by him.’’ Id. 

§ 822(a)(2); see also 21 CFR 1301.11(a) 

(same). Also relevant here is 21 CFR 

1301.13(a), which provides that ‘‘[n]o 

person required to be registered shall 

engage in any activity for which 

registration is required until the 

application for registration is granted 

and a Certificate of Registration is 

issued by the Administrator to such 

person.’’ 

As found above, Applicant issued 

more than 400 controlled substance 

prescriptions even after he had 

surrendered his registration and had no 

authority to lawfully do so. Moreover, 

upon surrendering his registration, 

Respondent acknowledged his 

understanding that his registration was 

being revoked and that he could not 

engage in any controlled substance 

activities including the dispensing of 

drugs ‘‘until such time as I am again 

properly registered.’’ Yet within three 

weeks of surrendering his registration, 

Applicant issued two prescriptions for 

OxyContin 80 mg. Moreover, in late 

July, he escalated his prescribing 

activities. 

During the November 7, 2008 

interview, Applicant’s lawyer stated 

that he had erroneously advised 

Applicant that upon the restoration of 

his state medical license, he could 

resume prescribing controlled 

substances. However, both the 

Voluntary Surrender Form and Federal 

law clearly stated that he could not 

issue controlled substances 

prescriptions until he obtained a new 

DEA registration. Moreover, the 

evidence shows that Applicant issued 

controlled substance prescriptions two 

months before his medical license was 

reinstated 17 and that he issued 

controlled substances prescriptions 

even after he was told to stop doing so 

by the DI. Thus, it is clear that 

Applicant knowingly and intentionally 

issued prescriptions in violation of 

Federal law. See 21 U.S.C. 822(a)(2), 

841(a)(1), 843(a)(3). These violations 

were extensive and provide reason 

alone to deny his application. 

In addition, on at least three occasions 

during the summer of 2007, Respondent 

tested positive for fentanyl, a schedule 

II controlled substance. See 21 CFR 

13087.12(c). According to a MAPS 

report obtained by the DI which listed 

the prescriptions Applicant had 

obtained between September 20, 2004 

and November 20, 2007, Respondent 

was never prescribed fentanyl by any 

physician. Moreover, as found above, 

Respondent told the DI that he obtained 

unused fentanyl from his patients to 

donate to his church’s missionary 

project. 

At a minimum, the evidence 

establishes a violation of 21 U.S.C. 

844(a), which makes it ‘‘unlawful for 

any person knowingly or intentionally 

to possess a controlled substance unless 

such substance was obtained directly, or 

pursuant to a valid prescription or 

order, from a practitioner acting in the 

usual course of his professional 

practice, or except as otherwise 

authorized by’’ the CSA or the 

Controlled Substances Import and 

Export Act. Moreover, while Applicant 

still held a practitioner’s registration 

during the period in which he tested 

positive for fentanyl, such a registration 

authorizes its holder only to dispense, 

i.e., ‘‘to deliver a controlled substance to 

an ultimate user.’’ 21 U.S.C. 802(10). A 

practitioner’s obtaining of a controlled 

substance from a patient is not 

dispensing and thus is not an 

authorized activity under a 

practitioner’s registration. See 21 CFR 

1301.13(e). Thus, even if Applicant had 

not engaged in the self-abuse of 

fentanyl, he was not lawfully authorized 

to obtain possession of the drug in this 

manner.18 This conduct further 

supports the conclusion that granting 

Respondent’s application would be 

‘‘inconsistent with the public interest.’’ 

21 U.S.C. 823(f). 

Factor Five—Such Other Conduct As 

May Threaten Public Health and Safety 

The Government further alleged that 

Applicant made a false statement to an 

Agency Investigator when he stated that 

he had obtained the fentanyl he selfabused because he collected the drugs 

‘‘to give as a donation to the Oakpointe 

Church’s missionary project in Zambia.’’ 

Show Cause Order at 1 (para.2) (citing 

18 U.S.C. 1001). The evidence clearly 

shows that Applicant’s statement to the 

DI was false in that he did not 

participate in the missionary project, let 

alone collect drugs for it. 

That his statement was false does not, 

however, establish a violation by 18 

U.S.C. 1001, because this provision 

requires that the statement be material 

to the matter being investigated by the 

Government. See 18 U.S.C. 1001(a) 

(‘‘whoever, in any matter within the 

jurisdiction of the executive * * * 

branch of the Government of the United 

States, knowingly and willfully * * * 

(2) makes any materially false, fictitious, 

or fraudulent statement or 

representation * * * shall be fined 

under this title, imprisoned not more 

than five years * * * or both’’). The 

Supreme Court has held that for a 

statement to be ‘‘material’’ for purposes 

of section 1001, it ‘‘must have a ‘natural 

tendency to influence, or [be] capable of 


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Federal Register / Vol. 76, No. 69 / Monday, April 11, 2011 / Notices 20025 

19 During the interview, Applicant also denied 

that he had ever issued prescriptions to patients to 

have them obtain drugs for himself. There is, 

however, no evidence that this statement was false. 

influencing, the decisionmaking body to 

which it is addressed.’ ’’ United States v. 

Gaudin, 515 U.S. 506, 509 (1995) 

(quoting Kungys v. United States, 485 

U.S. 759, 770 (1988)). The Court has 

further explained: 

Deciding whether a statement is ‘‘material’’ 

requires the determination of at least two 

subsidiary questions: (a) ‘‘What statement 

was made?’’ and (b) ‘‘what decision was the 

agency trying to make?’’ The ultimate 

question: (c) ‘‘Whether the statement was 

material to the decision,’’ requires applying 

the legal standard of materiality (quoted 

above) to these historical facts. 

Gaudin, 515 U.S. at 512. The ‘‘evidence 

must be clear, unequivocal, and 

convincing.’’ Kungys, 485 U.S. at 772. 

While the DI’s affidavit establishes the 

falsity of Applicant’s statements, the 

Government does not explain what 

decision the statement had ‘‘the natural 

tendency’’ to influence or ‘‘was capable 

of influencing.’’ Gaudin, 515 U.S. at 509 

(quoting Kungys, 485 U.S. at 770). 

Among the possibilities are whether to 

grant or deny his application for 

registration, to pursue criminal charges 

against him, or to conduct further 

investigation to determine whether he 

had committed additional crimes or 

whether individuals (other than naı ̈ve 

patients 19) were involved in supplying 

him with fentanyl. However, because 

the DI’s affidavit does not offer any 

explanation as to why the false 

statement was ‘‘capable of influencing’’ 

any of the possible agency decisions, let 

alone identify which decision(s) the 

false statement was capable of 

influencing, I decline to address 

whether the statement was material. 

In any event, given the extensive 

evidence under factors two and four 

establishing that Respondent knowingly 

wrote hundreds of controlled substance 

prescriptions even though he had 

surrendered his registration, that he 

wrote prescriptions within weeks of 

having surrendered his registration, that 

he wrote prescriptions even after being 

told to stop and that he could not do so 

until he obtained a new registration, as 

well as the evidence that he abused 

fentanyl, it is clear that issuing him a 

new registration would ‘‘be inconsistent 

with the public interest.’’ 21 U.S.C. 

823(f). Accordingly, Respondent’s 

application will be denied. 

Order 

Pursuant to the authority vested in me 

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

0.100(b) & 0.104, I order that the 

application of Glenn D. Krieger for a 

DEA Certificate of Registration as a 

practitioner be, and it hereby is, denied. 

This Order is effective immediately. 

Dated: April 1, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–8546 Filed 4–8–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 09–2] 

Alan H. Olefsky, M.D.; Denial of 

Application 

On August 22, 2008, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to Alan H. Olefsky, M.D. 

(Respondent), of Chicago, Illinois. The 

Show Cause Order proposed the denial 

of Respondent’s application for a DEA 

Certificate of Registration as a 

practitioner, ‘‘for reason that 

[Respondent’s] registration would be 

inconsistent with the public interest, as 

that term is used in 21 U.S.C. 823(f).’’ 

ALJ Ex. 1, at 1 (citing 21 U.S.C. 823(f) 

& 824(a)(4)). 

The Show Cause Order specifically 

alleged that in 1989, Respondent issued 

‘‘two false prescriptions for [the] 

controlled substances [Percocet and 

Halcion (triazolam), schedule II and 

schedule IV drugs, respectively] in the 

names of others and attempted to have 

them filled at a pharmacy in Florida.’’ 

Id. The Show Cause Order alleged that 

on January 9, 1992, and after a hearing, 

the Administrator revoked Respondent’s 

then-existing DEA registration having 

found the allegations proved and that 

Respondent had lied during the hearing 

regarding ‘‘the circumstances 

surrounding [his] misconduct.’’ Id. 

Next, the Show Cause Order alleged 

that ‘‘[f]rom at least December 2002, 

through October 2004,’’ Respondent 

‘‘again issued false prescriptions for 

various controlled substances in the 

names of [M.G., V.G., and T.C.]’’ and 

that ‘‘[t]hese prescriptions were for 

[Respondent’s] personal use.’’ Id. The 

Show Cause Order then alleged that on 

May 25, 2005, ‘‘DEA issued an Order 

proposing to revoke [Respondent’s] DEA 

registration * * * based upon [his] 

issuing false prescriptions,’’ and that on 

July 20, 2007, the Deputy Administrator 

issued a final order denying 

Respondent’s application (his 

registration having expired), having 

found that he ‘‘had issued the 

prescriptions for [his] personal use and 

that such conduct violated federal law.’’ 

Id. at 1–2 (citing 21 U.S.C. 843(a)(3)). 

Finally, the Order alleged that 

Respondent has ‘‘also exhibited a 

pattern of abusing alcohol’’ that includes 

a June 2004 arrest for driving under the 

influence and a January 2007 

hospitalization ‘‘with a blood alcohol 

level of .327,’’ and that his ‘‘history of 

abusing controlled substances and 

alcohol shows that granting [his] 

application for a DEA registration would 

be inconsistent with the public interest.’’ 

Id. at 2. 

By letter of October 6, 2008, counsel 

for Respondent requested a hearing on 

the allegations, ALJ Ex. 2, and the 

matter was placed on the docket of the 

Agency’s Administrative Law Judges 

(ALJs). Following prehearing 

procedures, an ALJ conducted a hearing 

on June 2–3, 2009, in Chicago, Illinois. 

Both parties called witnesses to testify 

and introduced documentary evidence. 

After the hearing, both parties filed 

proposed findings of fact, conclusions of 

law, and argument. 

On February 22, 2010, the ALJ issued 

her Opinion and Recommended Ruling, 

Findings of Fact, Conclusions of Law 

and Decision (also ALJ or 

Recommended Decision). Therein, the 

ALJ considered the evidence pertinent 

to the five public interest factors and 

concluded that granting Respondent’s 

application ‘‘would be inconsistent with 

the public interest.’’ ALJ at 43. 

As to the first factor—the 

recommendation of the appropriate 

State licensing board—the ALJ noted 

that Respondent’s State licenses as a 

physician and as a handler of controlled 

substances ‘‘remain on indefinite 

probation and are subject to the 

restrictions stated in the May 22, 2007, 

consent order.’’ ALJ at 35. Noting that 

Respondent is ‘‘currently authorized to 

handle controlled substances in 

Illinois,’’ the ALJ concluded that ‘‘this 

factor weighs in favor of a finding that 

Respondent’s registration would not be 

inconsistent with the public interest.’’ 

Id. at 35–36. However, because ‘‘state 

licensure is a necessary but not 

sufficient condition for DEA 

registration,’’ the ALJ concluded that 

‘‘this factor is not dispositive.’’ Id. at 36. 

As to the second and fourth factors— 

Respondent’s experience in handling 

controlled substances and his 

compliance with applicable Federal, 

State or local laws—the ALJ first noted 

that Respondent testified ‘‘in the instant 

proceeding that the explanation he 

offered in the 1991 hearing’’ about the 

Halcion and Percocet prescriptions ‘‘was 

true.’’ Id. The ALJ did not, however, find 

his ‘‘explanation credible.’’ Id. 


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