49506 Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Notices 

1Lortab, which is a combination drug containing 

hydrocodone and acetaminophen, is a schedule III 

controlled substance. 21 CFR 1308.13(e)(iv). 

2Hydrocodone is typically combined with 

acetaminophen. In this formulation, it is a schedule 

III controlled substance. 21 CFR 1308.13(e)(iv). 

3Phenergan with codeine cough syrup consists of 

a combination of promethazine and codeine; it is 

a schedule V controlled substance. 21 CFR 

1308.15(c). 

4 Xanax (alprazolam) is a schedule IV controlled 

substance; 21 CFR 1308.14(c)(1). 

U.S. Department of Justice, Washington, 

DC 20044–7611. When requesting a 

copy by mail, please enclose a check 

payable to the U.S. Treasury in the 

amount of $29.25 (25 cents per page 

reproduction cost). A copy may also be 

obtained by e-mailing or faxing a 

request to Tonia Fleetwood, 

tonia.fleetwood@usdoj.gov, fax number 

(202) 514–0097, phone confirmation 

number (202) 514–1547, and mailing a 

check for the reproduction cost to the 

Consent Decree Library. 

Robert E. Maher, Jr., 

Assistant Section Chief, Environmental 

Enforcement Section, Environment and 

Natural Resources Division. 

[FR Doc. 2011–20321 Filed 8–9–11; 8:45 am] 

BILLING CODE 4410–15–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

Jose Gonzalo Zavaleta, M.D.; Denial of 

Application 

On February 23, 2009, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause (Order) to Jose Gonzalo 

Zavaleta, M.D. (Applicant), of Pineville, 

Louisiana. The Order proposed the 

denial of Applicant’s pending 

application for a DEA Certificate of 

Registration as a practitioner, on the 

ground that his registration would be 

‘‘inconsistent with the public interest.’’ 

Order at 1 (citing 21 U.S.C. 823(f)). 

The Order alleged that Applicant 

voluntarily surrendered his DEA 

Certificate of Registration, BZ5998250, 

on March 26, 2008, after being charged 

with six counts of prescribing controlled 

substances beyond authority and 

accepted medical treatment, in violation 

of La. Rev. Stat. Ann. § 40:971 

(C)(1)(2008) (effective Aug. 15, 2006). Id. 

The Order further alleged that Applicant 

prescribed controlled substances to 

undercover agents with ‘‘cursory or no 

medical examinations, and without a 

legitimate medical purpose in violation 

of 21 U.S.C. 841(a)(1).’’ Id. More 

specifically, the Order alleged that 

Applicant prescribed a total of 75 

dosage units of hydrocodone (including 

Lortab and/or Lorcet), which are 

schedule III narcotics; 20 dosage units of 

Xanax, a schedule IV controlled 

substance; and six ounces of Phenergan 

with codeine, a schedule V narcotic 

cough syrup. Id. Finally, the Order that 

alleged ‘‘[Applicant] facilitated the 

undercover officers’ procurement of 

drugs by fraudulent means’’ when he 

advised them to ‘‘provide false medical 

information’’ to justify ‘‘illegitimate 

prescriptions.’’ Id. at 2. 

On March 2, 2009, the Order, which 

also notified Applicant of his right to 

either request a hearing on the 

allegations or to submit a written 

statement in lieu of a hearing, the 

procedures for doing so, and the 

consequence if he failed to do so, was 

served on Applicant by certified mail 

addressed to him at the address listed 

on his application. Id. at 2 (citing 21 

CFR 1316.47; 21 CFR 1301.43). Since 

service of the Order, more than thirty 

days have now passed and neither 

Applicant, nor anyone purporting to 

represent him, has either requested a 

hearing or submitted a written statement 

in lieu of a hearing. See 21 CFR 

1301.43(b)–(d). Accordingly, I find that 

Applicant has waived his rights to a 

hearing or to submit a written statement. 

Id. 1301.43(d). I therefore issue this 

Decision and Final Order without a 

hearing based on relevant material 

contained in the investigative record 

submitted by the Government. I make 

the following findings. 

Findings 

Applicant was previously the holder 

of DEA Certificate of Registration, 

BZ5998250, which authorized him to 

dispense controlled substances in 

schedules II through V as a practitioner 

at the registered location of 5629 

Jackson Street Ext, Alexandria, 

Louisiana. Affidavit of Diversion 

Investigator (hereinafter, DI Aff.), at 1; 

Applicant Registration Information, at 1. 

However, on March 26, 2008, 

concurrent with Applicant’s arrest on 

state drug charges (the circumstances of 

which are set forth below), he 

voluntarily surrendered his registration. 

DI Aff., at 1. Applicant’s registration 

was then retired by DEA on March 27, 

2008. Applicant Registration 

Information, at 1. On July 28, 2008, 

Applicant applied for a new DEA 

registration as a practitioner in 

schedules IV and V. Id. 

Applicant first came to the attention 

of law enforcement on January 17, 2008, 

when Louisiana State Police received a 

call from a pharmacist that he had 

authorized prescriptions for ‘‘excessive 

amounts of name brand narcotics with 

no generic substitutions allowed.’’ DI 

Aff., at 2. Upon receipt of this 

information, an undercover state trooper 

(UC1) visited Applicant’s clinic with 

audio/video recording equipment on 

January 23, 2008. Id. When Applicant 

asked UC1 ‘‘why he was there,’’ UC1 

responded by requesting 

‘‘[h]ydrocodone pain pills.’’ Id. UC1 

‘‘initially denied that he was in pain 

but, after negotiating with [Applicant], 

he agreed to falsely state that he was 

suffering from a sexually transmitted 

disease,’’ and Applicant recorded this 

false information in UC1’s medical file. 

Id. Then, Applicant, without any 

physical examination to verify the claim 

of illness or symptoms, wrote 

prescriptions for 15 Lortab 1 pills and an 

antibiotic. Id. The undercover agent 

paid $100 for the visit. Id. 

Five days later, on January 28, 2008, 

UC1 returned to Applicant’s clinic 

seeking additional ‘‘pain pills.’’ Id. 

However, Applicant denied his request 

for more pain pills ‘‘because ‘big 

brother’ was watching him.’’ Id. 

Thereafter, on January 30, February 8, 

and February 28, 2008, a second state 

trooper (UC2) visited Applicant’s clinic 

in an undercover capacity, while 

equipped with an audio/video recording 

device. Id. At UC2’s first visit, 

Applicant issued her a prescription for 

hydrocodone,2 notwithstanding UC2’s 

‘‘initially den[ying] she was in pain’’ 

and ‘‘later stat[ing] she was in pain in 

order to obtain a prescription for 

hydrocodone.’’ Id. At her second visit 

on February 8, Applicant provided 

prescriptions for hydrocodone and 

Phenergan with codeine,3 the latter 

being a cough syrup, ‘‘even though she 

had no cough or congestion and 

exhibited no such symptoms.’’ Id. On 

UC2’s third visit, she requested and 

obtained from Applicant, prescriptions 

for hydrocodone and Xanax.4 Id. To 

justify issuing the prescriptions, 

Applicant ‘‘coached’’ UC2 about what to 

say and recorded the coached 

statements in her medical file. Id. At the 

undercover visits, Applicant never 

‘‘require[d] any medical records nor did 

he conduct any physical examinations.’’ 

Id. 

On March 20, 2008, after a state court 

judge issued a warrant for Applicant’s 

arrest, Louisiana State Police alerted 

DEA to the investigation and pending 

arrest. Id. Thereafter, on March 26, 

2008, Applicant was arrested and 

charged with ‘‘six counts of prescribing 

beyond authority and accepted medical 

treatment, a violation of Louisiana 

Revised Statute 40:971C(1).’’ Id. at 3. 

Based on Applicant’s arrest, a DEA 

Diversion Investigator asked for the 

voluntary surrender of his DEA 


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Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Notices 49507 

5Louisiana law defines the term ‘‘prescription’’ to 

mean ‘‘a written request for a drug * * * issued by 

a licensed physician * * * for a legitimate medical 

purpose, for the purpose of correcting a physical, 

mental, or bodily ailment, and acting in good faith 

in the usual course of his professional practice.’’ La. 

Rev. Stat. Ann. § 40.961(33). 

6This statute provides that: 

A prescription, in order to be effective in 

legalizing the possession of legend drugs, shall be 

issued for a legitimate medical purpose by one 

authorized to prescribe the use of such legend 

drugs. An order purporting to be a prescription 

issued to a drug abuser or habitual user of legend 

drugs, not in the course of professional treatment, 

is not a prescription within the meaning and intent 

of this Section. Any person who knows or should 

know that he or she is filling such a prescription 

or order to a drug abuser or habitual user of legend 

drugs, as well as the person issuing the 

prescription, may be charged with a violation of 

this Section. 

La. Rev. Stat. Ann. § 40:1238.2(A). 

registration; Applicant agreed and 

signed a DEA–104, Voluntary Surrender 

of Controlled Substance Privileges. Id. 

Four months later, on July 28, 2008, 

Applicant submitted a DEA application 

for a new registration as a practitioner 

in schedules IV and V. Zavaleta 

Application Information at 1. On his 

application, Applicant stated that ‘‘the 

medical board says there is no merit for 

any disciplinary action,’’ he ‘‘can 

continue working,’’ and his ‘‘license is 

clear.’’ Id. Applicant further stated that 

the State Police had yet to charge him 

and that the charges may be dropped. 

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 in the case of a 

practitioner, 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 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) (citing Morall v. DEA, 412 F.3d 

165, 173–74 (DC Cir. 2005)). 

In this matter, while I have 

considered all of the factors, I conclude 

that it is not necessary to make findings 

with respect to factors one (the 

recommendation of the state licensing 

board), three (applicant’s conviction 

record) and five (such other conduct 

which may threaten public health and 

safety). I find that the Government’s 

evidence with respect to Applicant’s 

experience in dispensing controlled 

substances (factor two) and his 

compliance with applicable Federal and 

State laws related to the distribution 

and dispensing of controlled substances 

(factor four) makes out a prima facie 

case that Applicant has committed acts 

which render his registration 

‘‘inconsistent with the public interest.’’ 

21 U.S.C. 823(f), 824(a)(4). I will 

therefore order that his pending 

application for registration be denied. 

Factors Two and Four—Applicant’s 

Experience in Dispensing Controlled 

Substances and Compliance with 

Applicable Laws Related to Controlled 

Substances 

Under a longstanding DEA regulation, 

a prescription for a controlled substance 

is not ‘‘effective’’ unless it is ‘‘issued for 

a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice.’’ 21 CFR 1306.04(a). This 

regulation further provides that ‘‘an 

order purporting to be a prescription 

issued not in the usual course of 

professional treatment * * * is not a 

prescription within the meaning and 

intent of [21 U.S.C. 829] and * * * the 

person issuing it, shall be subject to the 

penalties provided for violations of the 

provisions of law related to controlled 

substances.’’ Id.; see also La. Rev. Stat. 

Ann. § 40:961(33) (2008) (effective Aug. 

15, 2004); 5 La. Rev. Stat. Ann. 

§ 40:1238.2(A) (2008) (effective Aug. 15, 

2006).6

As the Supreme Court recently 

explained, ‘‘the [CSA’s] prescription 

requirement * * * ensures patients use 

controlled substances under the 

supervision of a doctor so as to prevent 

addiction and recreational abuse. As a 

corollary, [it] also bars doctors from 

peddling to patients who crave the 

drugs for those prohibited uses.’’ 

Gonzales v. Oregon, 546 U.S. 243, 274 

(2006) (citing United States v. Moore, 

423 U.S. 122, 135, 143 (1975)); see also 

La. Rev. Stat. Ann. § 40:1238.2(A) (2008) 

(effective Aug. 15, 2006). 

Under the CSA, it is fundamental that 

a practitioner must establish and 

maintain a bonafide doctor-patient 

relationship in order to act ‘‘in the usual 

course of * * * professional practice’’ 

and to issue a prescription for a 

‘‘legitimate medical purpose.’’ Laurence 

T. McKinney, 73 FR 43260, 43265 n.22 

(2008); see also Moore, 423 U.S. at 142– 

43 (noting that evidence established that 

physician ‘‘exceeded the bounds of 

‘professional practice,’ ’’ when ‘‘he gave 

inadequate physical examinations or 

none at all,’’ ‘‘ignored the results of the 

tests he did make,’’ and ‘‘took no 

precautions against * * * misuse and 

diversion’’). The CSA generally looks to 

state law to determine whether a doctor 

and patient have established a bonafide 

doctor-patient relationship. See Kamir 

Garces-Mejias, 72 FR 54931, 54935 

(2007); United Prescription Services, 

Inc., 72 FR 50397, 50407 (2007); but see 

21 U.S.C. 829(e)(2)(B) (providing 

Federal standard for prescribing over 

the Internet). 

Under the regulation of the Louisiana 

Board of Medical Examiners, in the 

treatment of ‘‘intractable pain * * * a 

physician shall comply’’ with the 

Louisiana Pain Rules, including the 

requirements that a physician perform 

an ‘‘[e]valuation of the [p]atient’’ and 

make a ‘‘[m]edical [d]iagnosis.’’ La. 

Admin. Code tit. 46:XLV.6921(A) 

(2008). ‘‘Evaluation of the patient shall 

initially include relevant medical, pain, 

alcohol and substance abuse histories, 

an assessment of the impact of pain on 

the patient’s physical and psychological 

functions, a review of previous 

diagnostics studies, previously utilized 

therapies, an assessment of coexisting 

illnesses, diseases, or conditions, and an 

appropriate physical examination.’’ Id. 

(emphasis added); see also Armstrong v. 

La. State Bd. of Med. Examiners, 868 So. 

2d 830, 840 (La.App. 4 Cir. Feb. 18, 

2004) (upholding two year suspension 

of physician’s license; noting that when 

prescribing controlled substances for 

relief of non-malignant pain is ’’ 

unaccompanied by appropriate testing, 

diagnosis, oversight and monitoring 

* * * the physician falls below 

generally accepted standards of care’’); 

Pastorek v. La. State Bd. of Med. 

Examiners, 4 So. 3d 833 (La.App. 4 Cir. 

Dec. 17, 2008). The Board’s rules further 

require a ‘‘medical diagnosis * * * be 

established and fully documented in the 

patient’s medical record.’’ La. Admin. 

Code tit. 46:XLV.6921(A)(2) (2008). 

Louisiana law further prohibits a 

physician from ‘‘[a]ssist[ing] a patient or 

any other person in obtaining a 

controlled dangerous substance through 


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49508 Federal Register / Vol. 76, No. 154 / Wednesday, August 10, 2011 / Notices 

misrepresentation, fraud, forgery, 

deception, or subterfuge.’’ La. Rev. Stat. 

Ann. § 40:971.2 (2008) (effective Aug. 

15, 2005). It is also unlawful for a 

physician to ‘‘prescribe * * * legally 

controlled substances beyond his 

respective prescribing authority or for a 

purpose other than accepted medical 

treatment of disease, condition, or 

illness. Id., at § 40:971(C)(1) (2008) 

(effective Sept. 9, 1988). 

As found above, on four occasions, 

Applicant prescribed drugs containing 

hydrocodone (including Lortab and/or 

Lorcet), which are schedule III 

narcotics; Xanax, a schedule IV 

controlled substance; and Phenergan 

with codeine, a schedule V narcotic 

cough syrup, to Louisiana State 

Troopers acting in undercover 

capacities. See DI Aff., at 2. Notably, 

Applicant issued these prescriptions 

without conducting a physical 

examination at any of the visits and the 

undercover agents received these 

prescriptions even though they did not 

demonstrate the conditions or 

symptoms that would justify the 

prescriptions. Id. 

Moreover, both undercover agents 

initially denied they were in pain, but 

Applicant assisted the agents in 

obtaining controlled substances by 

encouraging them to make false 

statements. See id. For example, while 

he denied being in pain, UC1 asked 

Applicant for ‘‘[h]ydrocodone pain 

pills,’’ and then ‘‘negotiate[ed]’’ with 

Applicant to ‘‘falsely state’’ he had a 

sexually transmitted disease. Id. 

Likewise, Applicant also ‘‘coached’’ the 

second undercover agent on what to say 

to ‘‘justify issuing the prescriptions and 

wrote her coached statements in a 

medical file.’’ Id. Therefore, I conclude 

that Applicant failed to establish a 

physician-patient relationship, lacked a 

legitimate medical purpose, and acted 

outside of the usual course of 

professional practice in prescribing 

controlled substances to the undercover 

agents and thus violated Federal law. 

See 21 CFR 1306.04(a); 21 U.S.C. 

841(a)(1); see also Louisiana v. Moody, 

393 So. 2d 1212, 1215 (La. 1981) 

(holding that physician furnished 

prescriptions for ‘‘other than a 

legitimate medical purpose’’ based on 

evidence showing that prescriptions 

were issued in response to specific 

requests of patients and physician did 

not conduct physical examinations or 

take medical histories). 

I therefore hold that granting 

Applicant’s application for a new 

registration ‘‘would be inconsistent with 

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

Accordingly, I will order that 

Applicant’s pending application be 

denied. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 823(f) and 28 CFR 0.100(b), 

I order that the application of Jose 

Gonzalo Zavaleta, M.D., for a DEA 

Certificate of Registration as a 

practitioner be, and it hereby is, denied. 

This order is effective September 9, 

2011. 

Dated: July 27, 2011. 

Michele M. Leonhart, 

Administrator. 

[FR Doc. 2011–20284 Filed 8–9–11; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Office of Disability Employment 

Program 

‘‘Add Us In’’ Initiative 

AGENCY: Office of Disability 

Employment Policy, Department of 

Labor. 

ACTION: Correction to the Funding 

Opportunity Number and Closing Date. 

SUMMARY: The Office of Disability 

Employment Policy, Department of 

Labor is correcting the New Notice of 

Availability of Funds and Solicitation 

for Grant Applications (SGA) for 

Cooperative Agreements published in 

the Federal Register on August 4, 2011 

at 76 FR 150. Specifically, we are 

correcting the Funding Opportunity 

Number to SGA 11–05 and the Closing 

Date for receipt of applications to 

September 2, 2011. The full Solicitation 

for Grant Applications is posted on 

http://www.grants.gov under U.S. 

Department of Labor/ODEP. If you need 

to speak to a person concerning these 

grants, you may telephone Cassandra 

Mitchell at 202–693–4570 (not a tollfree number). 

Signed in Washington, DC, this 4th day of 

August 2011. 

Cassandra R. Mitchell, 

Grant Officer. 

[FR Doc. 2011–20211 Filed 8–9–11; 8:45 am] 

BILLING CODE 4510–FT–P 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

[Notice 11–073] 

NASA Advisory Council; Science 

Committee; Earth Science 

Subcommittee; Meeting 

AGENCY: National Aeronautics and 

Space Administration. 

ACTION: Notice of meeting. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, Public 

Law 92–463, as amended, the National 

Aeronautics and Space Administration 

(NASA) announces a meeting of the 

Earth Science Subcommittee of the 

NASA Advisory Council (NAC). This 

Subcommittee reports to the Science 

Committee of the NAC. The Meeting 

will be held for the purpose of soliciting 

from the scientific community and other 

persons scientific and technical 

information relevant to program 

planning. 

DATES: Wednesday, August 31, 1 p.m. to 

3 p.m. E.D.T. 

ADDRESSES: This meeting will take place 

telephonically. Any interested person 

may call the USA toll free conference 

call number 888–603–9610, pass code 

ESS, to participate in this meeting by 

telephone. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Marian Norris, Science Mission 

Directorate, NASA Headquarters, 

Washington, DC 20546, (202) 358–4452, 

fax (202) 358–4118, or 

mnorris@nasa.gov. 

SUPPLEMENTARY INFORMATION: The 

meeting will be open to the public up 

to the capacity of the room. The agenda 

for the meeting includes the following 

topics: 

—Government Performance and Results 

Act Review 

It is imperative that the meeting be 

held on these dates to accommodate the 

scheduling priorities of the key 

participants. 

August 5, 2011. 

Susan M. Burch, 

Acting Director, Advisory Committee 

Management Division, National Aeronautics 

and Space Administration. 

[FR Doc. 2011–20275 Filed 8–9–11; 8:45 am] 

BILLING CODE 7510–13–P 


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