Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices 42595

1995, based upon a finding of medical

incompetency and a finding of

continuing or recurring medical practice

which fails to satisfy the prevailing and

usually accepted standards of medical

practice in the State of Louisiana. The

Acting Deputy Administrator finds that

in light of the fact that Dr. Golden is not

currently licensed to practice medicine

in the State of Louisiana, it is reasonable

to infer that he is not currently

authorized to handle controlled

substances in that state.

The DEA does not have statutory

authority under the Controlled

Substances Act to issue or maintain a

registration if the applicant or registrant

is without state authority to handle

controlled substances in the state in

which he conducts his business. 21

U.S.C. 802(21), 823(f) and 824(a)(3).

This prerequisite has been consistently

upheld. See Romeo J. Perez, M.D., 62 FR

16193 (1997); Demetris A. Green, M.D.,

61 FR 60728 (1996); Dominick A. Ricci,

M.D., 58 FR 51104 (1993).

Dr. Golden did not dispute that he is

not authorized to handle controlled

substances in Louisiana. Therefore, in

light of his lack of authorization in

Louisiana, Dr. Golden is not entitled to

a DEA registration in that state.

However, the Acting Deputy

Administrator finds that revocation of

Dr. Golden’s registrations is not

appropriate. The suspension of Dr.

Golden’s state privileges expires on

September 1, 1997, and presumably at

that time he will be authorized to

handle controlled substances in the

State of Louisiana. Given that his state

suspension was not based upon his

handling of controlled substances and

that his privileges will be reinstated in

approximately one month, the Acting

Deputy Administrator concludes that

Dr. Golden’s DEA registrations should

be suspended until such time as his

state privileges are reinstated.

Accordingly, the Acting Deputy

Administrator of the Drug Enforcement

Administration, pursuant to the

authority vested in him by 21 U.S.C. 823

and 824 and 28 CFR 0.100(b) and 0.104,

hereby orders that DEA Certificates of

Registration, BG3086306 and

BG3039218, previously issued to David

Golden, M.D., be, and they hereby are,

suspended until his state license to

practice medicine in Louisiana is

reinstated and he is thereby authorized

to handle controlled substances in that

state. The suspension shall remain in

effect until the DEA office in New

Orleans receives notification from Dr.

Golden that his state privileges have

been reinstated. Regarding any pending

applications for registration submitted

by David Golden, M.D., the Acting

Deputy Administrator orders that these

applications shall be granted upon

DEA’s receipt of notification from Dr.

Golden that his state privileges have

been reinstated and that he still desires

to be registered at the address listed on

the application. This order is effective

August 7, 1997.

Dated: August 1, 1997.

James S. Milford,

Acting Deputy Administrator.

[FR Doc. 97–20786 Filed 8–6–97; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 96–45]

Rick’s Pharmacy, Inc., Continuation of

Registration With Restrictions

On August 29, 1996, the Deputy

Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration (DEA), issued an Order

to Show Cause to Rick’s Pharmacy, Inc.,

(Respondent) of Clayton, New Mexico,

notifying it of an opportunity to show

cause as to why DEA should not revoke

its DEA Certificate of Registration,

BR0924440, under 21 U.S.C. 824 (a)(2)

and (a)(4), and deny any pending

applications for registration as a retail

pharmacy under 21 U.S.C. 823(f), for

reason that its owner/pharmacist has

been convicted of a controlled substance

related felony offense and that its

continued registration would be

inconsistent with the public interest.

By letter dated September 5, 1996,

Respondent, through counsel, filed a

timely request for a hearing. In the

midst of prehearing proceedings,

Respondent’s counsel filed a motion to

withdraw as counsel, which was

granted. Thereafter, Respondent was

represented by Rick Balzano, the

principal shareholder and pharmacist of

Respondent. A hearing was held in

Santa Fe, New Mexico on February 5,

1997, before Administrative Law Judge

Gail A. Randall. At the hearing, both

parties called witnesses and introduced

documentary evidence. After the

hearing, Government counsel submitted

proposed findings of fact, conclusions of

law and argument, and Respondent

submitted a letter setting forth its

position. On May 16, 1997, Judge

Randall issued her Opinion and

Recommended Ruling, recommending

that Respondent’s registration be

continued subject to certain conditions.

On June 6, 1997, Government counsel

filed exceptions to the Opinion and

Recommended Ruling of the

Administrative Law Judge, and on June

18, 1997, Judge Randall transmitted the

record of these proceedings, including

the Government’s exceptions to the

Acting Deputy Administrator.

The Acting Deputy Administrator has

considered the record in its entirety,

and pursuant to 21 CFR 1316.67, hereby

issues his final order based upon

findings of fact and conclusions of law

as hereinafter set forth. the Acting

Deputy Administrator adopts, except as

specifically noted below, the Opinion

and Recommended Ruling of the

Administrative Law Judge. His adoption

is in no manner diminished by any

recitation of facts, issues and

conclusions herein, or of any failure to

mention a matter of fact or law.

The Acting Deputy Administrator

finds that Rick Balzano purchased

Respondent pharmacy with his parents

in 1987. Mr. Balzano is the president

and pharmacist-in-charge of

Respondent, his father is the vice

president and his mother is the

secretary and treasurer. In addition to

Respondent pharmacy, there is only one

other retail pharmacy and one hospital

pharmacy in Clayton, New Mexico, with

the next closest pharmacy

approximately 82 miles from Clayton.

Mr. Balzano is one of only two

pharmacists practicing in Clayton.

On October 6 and 7, 1992, New

Mexico Board of Pharmacy inspectors

went to Respondent pharmacy to

conduct a routine inspection and audit

of controlled substances. According to

Mr. Balzano, by the time the inspectors

arrived at the pharmacy at 4:00 p.m. on

the first day, he had already consumed

approximately 50 controlled substance

pills.

The audit covered the period from

January 6, 1991 to October 6, 1992, and

revealed overages and shortages for all

of the audited substances. Significantly,

Respondent could not account for

19,394 dosage units of Lortab 7.5 mg.;

8,201 dosage units of phentermine 30

mg.; 2,100 dosage units of ‘‘Darvon

Compound-65 generic’’; 1,430 dosage

units of Halcion 0.25 mg.; 1,121 dosage

units of temazepam 30 mg.; 1,546

dosage units of clorazepate 7.5 mg.;

1,244 dosage units of diazepam 10 mg.;

2,800 dosage units of Roxicet; and 1,397

dosage units of Tylox. Significant

overages, where Respondent could

account for more of a drug than it was

accountable for include, 1,521 dosage

units of Darvon-N-100; 1,606 Wygesic

generic; and 1,994 Tranxene 3.75 mg.

On October 28, 1992, the inspectors

went to Respondent pharmacy to return

the records used in conducting the audit

and to discuss the audit with Mr.

Balzano. At that time, Mr. Balzano
42596 Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices

1 In her opinion and Recommended Ruling, the

Administrative Law Judge indicated that

Respondent pharmacy remained closed for three

months, however, Mr. Balzano testified that the

pharmacy was closed for three weeks.

admitted that he had a drug abuse

problem. Mr. Balzano testified at the

hearing in this matter that his tolerance

to the drugs built up to the point that

he could ingest more than 50 pills per

day. He admitted to personally taking a

number of the missing controlled

substances, including lorazepam,

Ativan, Dalmane, flurazepam, Fastin,

phentermine, Halcion, Restoril,

temazepam, Valium, diazepam, Xanax,

Lorcet, Lortab, Vicodin, Dexedrine,

Percodan, Roxiprin, Percocet, Roxicet,

and Tylox. However, Mr. Balzano

denied taking the remaining substances

that were unaccounted for during the

audit period. He suggested at the

hearing that had he been given an

opportunity to explain the audit

discrepancies, the overages and

shortages may have balanced each other

out based upon the dispensing of a

generic substance when a brand name

substance had been prescribed or based

upon the potential labeling or

mislabeling of the substances.

During the investigation, the New

Mexico Board of Pharmacy inspectors

discovered several prescriptions

apparently issued by a local dentist for

Mr. Balzano and other patients. The

dentist denied writing any of the

prescriptions for Mr. Balzano, and Mr.

Balzano ultimately admitted that he had

forged several of the dentist’s

prescriptions. Mr. Balzano also admitted

filling prescriptions that had been

issued by the dentist for individuals for

the stimulant drugs, phentermine and

Fastin. In addition, the inspectors

discovered 16 prescriptions for Fastin

for an individual that were allegedly

written by a local physician. The

physician denied writing these

prescriptions, and Mr. Balzano admitted

at the hearing in this matter to

improperly dispensing the drugs.

Finally, the investigation revealed

several prescriptions for family

members allegedly authorized by Mr.

Balzano’s brother who is a dentist. Dr.

Balzano indicated to the inspectors that

he had not authorized some of these

prescriptions, and Mr. Balzano testified

that he now understands that he should

not have dispensed these controlled

substances.

Mr. Balzano testified that after the

inspectors were at Respondent

pharmacy in early October 1992, he

began his recovery efforts from drug

addiction, and has not improperly taken

any controlled substances since October

28, 1992. Which he began his recovery

efforts on his own, in March 1993, he

entered a local treatment center where

he stayed for three weeks, during which

time he closed Respondent pharmacy

and informed the community of his

drug abuse problem.1 Following his inpatient treatment, Mr. Balzano signed a

two-year voluntary contract with the

Pharmacists’ Recovery Network

Committee of New Mexico (PRN) which

required at least 12 random urine

screens a year, attendance at 3 to 4

Alcoholics Anonymous or Narcotics

Anonymous meetings per week, and

attendance at monthly PRN meetings in

Albuquerque, New Mexico. During the

term, of the contract, Mr. Balzano

underwent 22 random urine screens,

and all were negative. According the

PRN, Mr. Balzano complied with all the

requirements of the contract. Following

the expiration of the contract in March

1995, Mr. Balzano remained an active

member of the PRN.

As a result of the investigation,

information was filed in the United

States District Court for the District of

New Mexico, charging that Mr. Balzano

knowingly and intentionally acquired

60 Lortab 7.5 mg. tablets, a Schedule III

controlled substance, by forging the

local dentist’s name to a prescription in

violation of 21 U.S.C. 843(a)(3).

Thereafter, in March 1994, following

Mr. Balzano’s entering a plea of guilty,

he was convicted of the felony offense

of acquiring or obtaining a controlled

substance by forgery, deception or

subterfuge in violation of 21 U.S.C.

843(a)(3). Mr. Balzano was sentenced to

two years probation, and on August 31,

1995, he was granted early termination

of probation due to satisfactory

behavior.

In August 1996, New Mexico Board of

Pharmacy inspectors conducted another

inspection at Respondent pharmacy.

The inspector who testified at the

hearing in this matter indicated that the

following violations were revealed: (1)

A required reference book, and the New

Mexico Pharmacy Laws and Regulations

were not on the premises; (2) a required

‘‘Purchaser’s Statement’’ was missing

from the exempt narcotic book; (3) the

time of day was not properly recorded

on the 1996 inventory; and (4) the

practitioner’s DEA registration number

was not recorded on several

prescription forms. The inspectors did

not conduct an audit of controlled

substances during this inspection.

According to the inspector, the noted

violations were corrected and

Respondent pharmacy has been in

compliance with these requirements

since the August 1996 inspection.

Following a formal hearing on January

28, 1997, the New Mexico Board of

Pharmacy (Board) issued a decision on

February 24, 1997, regarding Mr.

Balzano’s pharmacist license. The Board

found inter alia, that Mr. Balzano was

the pharmacist-in-charge of Respondent;

that the 1992 inspection revealed

shortages of Schedule II, III and IV

controlled substances; that Mr. Balzano

was convicted in March 9, 1994 in the

United States District Court of the

District of New Mexico of one count of

acquiring or obtaining a controlled

substance by forgery, deception or

subterfuge, and was sentenced to two

years probation with conditions; that

Mr. Balzano completed his probation

and program with the PRN; and that Mr.

Balzano admitted that he had a

substance abuse problem and had the

drugs for his own use. As a result, the

Board placed Mr. Balzano on probation

for two years, and his pharmacist’s

license was suspended for two years

with all but 28 days held in abeyance

pending successful completion of the

probationary period. In addition, the

Board ordered Mr. Balzano to sign a

new five year contract with the PRN; to

not dispense any controlled substances

to himself or to his immediate family

members; an to notify the Board of any

personal controlled substance

prescription ‘‘with a copy of the

prescription attached and a note from

the prescribing authority that the

prescription is medically indicated.’’

Finally, the Board noted that, ‘‘[i]f it

comes to the attention of the Board that

[Mr. Balzano] was violated the terms

and conditions of probation, [Mr.

Balzano’s] license to practice will be

immediately suspended pending a

hearing before the Board.’’

Respondent entered into evidence

affidavits from the administrator of the

local hospital, the president of a local

bank, the chairman of the PRN, the

assistant director of the PRN, several

physicans, including the local dentist

whose name Mr. Balzano had forged on

the prescription for Lortab, and others.

These individuals attested to Mr.

Balzano’s professional integrity and to

the community’s need for the continued

operation of Respondent pharmacy.

The Deputy Administrator may

revoke or suspend a DEA Certificate of

Registration under 21 U.S.C. § 824(a),

upon a finding that the registrant:

* * * * *

(2) Has been convicted of a felony under

this subchapter or subchapter II of this

chapter or any other law of the United States,

or of any State relating to any substance

defined in this subchapter as a controlled

substance;

* * * * *

(4) Has committed such acts as would

render his registration under section 823 of
Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices 42597

2The Government asserts that the inspection also

revealed that Respondent failed to have controlled

substance invoices readily retrievable. However, the

testimony of the inspector at the hearing in this

matter did not specifically address Respondent’s

failure to comply with this requirement of the state

regulations.

this title inconsistent with the public interest

as determined under such section;

* * * * *

It is undisputed that Mr. Balzano was

convicted on March 9, 1994, of a felony

violation of 21 U.S.C. 843(a)(3). It is

well settled that a pharmacy operates

under the control of owners,

stockholders, pharmacists or other

employees, and if any such person is

convicted of a felony offense related to

controlled substances, grounds exist to

revoke the pharmacy’s registration

under 21 U.S.C. 824(a)(2). See Maxicare

Pharmacy, 61 FR 27,368 (1996); Big-T

Pharmacy, Inc., 47 FR 51,830 (1982).

Therefore, the Acting Deputy

Administrator concurs with Judge

Randall’s conclusion that the

Government has proven by a

preponderance of the evidence that

grounds exist to revoke Respondent’s

registration under 21 U.S.C. 824(a)(2),

based upon the controlled substance

related felony conviction of its owner/

pharmacist, Mr. Balzano.

Pursuant to 21 U.S.C. §§ 823(f) and

824(a)(4), the Deputy Administrator may

also revoke a DEA Certificate of

Registration and deny any pending

applications, if he determines that the

continued registration would be

inconsistent with the public interest.

Section 823(f) 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, or conducting research with

respect to 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 or safety.

These factors are to be considered in the

disjunctive; the Deputy Administrator

may rely on any one or a combination

of factors and may give each factor the

weight he deems appropriate in

determining whether a registration

should be revoked or an application for

registration be denied. See Henry J.

Schwarz, Jr., M.D., Docket No. 88–42, 54

FR 16,422 (1989). In this case, all five

factors are relevant.

As to factor one, it is undisputed that

on February 24, 1997, the New Mexico

Board of Pharmacy issued a decision

placing Mr. Balzano on probation for

two years and suspending his

pharmacist license for two years with all

but 28 days held in abeyance pending

successful completion of the

probationary period. As terms of his

probation, the Board ordered Mr.

Balzano to sign a five year contract with

the PRN, prohibiting him from

dispensing controlled substances to

himself or to immediate family

members, and required him to notify the

Board if he obtained any personal

controlled substance prescriptions.

Factors two and four, respondent’s

experience in dispensing controlled

substances and compliance with state,

Federal or local laws relating to

controlled substances, are relevant in

determining the public interest. The

1992 audit results which revealed

significant overages and shortages of

Schedule II–IV controlled substances

indicated at the very least a failure to

maintain complete and accurate records

as required by 21 U.S.C. 827. However,

Mr. Balzano admitted to diverting many

of the missing drugs for his personal use

in violation of under 21 U.S.C. 843(a)(3).

Although Mr. Balzano admitted to

having a drug abuse problem, he denied

taking a significant number of the

unaccounted for controlled substances.

The Acting Deputy Administrator

concurs with Judge Randall’s finding

that Mr. Balzano ‘‘failed to provide a

persuasive explanation for these

shortages.’’

Mr. Balzano admitted to other

instances of improper dispensing of

controlled substances. He admitted to

forging several prescriptions for his

personal use with the name of the local

dentist in violation of 21 U.S.C. 829 and

843(a)(3). He admitted to filling

prescriptions for Fastin/phentermine

issued by a dentist not in the usual

course of professional practice in

violation of 21 U.S.C. 829 and 21 CFR

1306.04. Finally, he admitted to

dispensing controlled substances to

family members and to another

individual without the appropriate

authorization from a practitioner in

violation of 21 U.S.C. 829 and 841.

The subsequent state audit conducted

in 1996 revealed the following state

regulatory violations: a required

reference book and the New Mexico

Pharmacy Laws and Regulations were

not on the premises; a statement was

missing in the exempt narcotic book; the

time of day was not recorded on the

1996 inventory, and the practitioner’s

DEA registration number was not on

several prescription forms.2 Failure to

record the time of the day on the

inventory was also a violation of 21 CFR

1304.11, and failure to place the

practitioner’s DEA registration on

prescriptions was also a violation of 21

CFR 1306.05. The Acting Deputy

Administrator disagrees with Judge

Randall’s finding that ‘‘although the

1996 Board inspection found

administrative discrepancies, none of

these errors involved the handling of

controlled substances.’’ Failure to note

the time on a controlled substance

inventory and failure to place a

practitioner’s DEA registration on

prescriptions clearly are violations that

relate to the handling of controlled

substances. However, the Acting Deputy

Administrator notes that since the 1996

inspection, Respondent has been in

compliance with these requirements.

As to factor three, it is undisputed

that Mr. Balzano, Respondent’s owner/

pharmacist was convicted in March

1994 of one count of acquiring or

obtaining controlled substances by

misrepresentation, fraud, forgery,

deception, or subterfuge in violation of

21 U.S.C. 843(a)(3), as a result of his

forging a local dentist’s name to a

prescription for Lortab in order to obtain

controlled substances for his own use.

As discussed previously, a pharmacy’s

registration may be revoked on the basis

of the owner/pharmacist’s felony

conviction relating to controlled

substances.

Regarding factor five, Mr. Balzano

admitted that he had a substance abuse

problem for a number of years. Further,

he admitted that he diverted a

significant amount of controlled

substances from the pharmacy for his

own use. A number of the missing drugs

however, remain unaccounted for

following the 1992 audit. The Acting

Deputy Administrator agrees with Judge

Randall and the Government, ‘‘that the

public health and safety was placed at

risk by Mr. Balzano’s lack of judgment

and concern for the precision needed by

a pharmacist to properly fill

prescriptions for patients relying on his

professionalism.’’

The Government has proven by a

preponderance of the evidence that

grounds exist to revoke Respondent

pharmacy’s DEA registration under 21

U.S.C. 824(a)(4). However, like Judge

Randall, the Acting Deputy

Administrator finds that while

‘‘Respondent’s evidence in mitigation

does not justify or excuses the

misconduct of Mr. Balzano, [it is]

significant and credible that he admitted

to the extensive scope of his previous

drug addiction and to his misconduct

that flowed from his illness, to include

the forging of prescriptions.’’ Mr.

Balzano last improperly used controlled
42598 Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices

substances in October 1992. He has

undergone extensive rehabilitation

treatment which will now continue

until the year 2002 in light of the

Board’s recent decision requiring him to

enter into a five year contract with the

PRN.

It is significant that beyond diverting

drugs from the pharmacy for his own

use, Mr. Balzano forged prescriptions,

and improperly dispensed controlled

substances to his family members and

others. In addition, the other shortages

and overages revealed by the 1992 audit

have yet to be explained. However, Mr.

Balzano testified at the hearing in this

matter that, ‘‘I did some things when I

was on drugs that I just cannot believe

that I did them. You’re a different

person when you’re on these drugs. I

can’t explain some of the things I did or

why I did them.’’

As noted above, Mr. Balzano has been

free from drugs since October 1992, and

Respondent has continued in operation

since 1992 with no allegations of

improper handling of controlled

substances other than the several

violations found during the August 1996

inspection which have since been

corrected. Previously, DEA has held that

while a lapse in time since the

wrongdoing is not dispositive, it is a

factor to be considered. See Norman

Alpert, M.D., 58 FR 67,420 (1993). In

this case, it is significant that since the

1992 inspection, Mr. Balzano has

undergone extensive treatment for his

drug addiction, has remained drug-free,

has accepted responsibility for his past

misconduct, and has essentially

remained in compliance with the laws

and regulations relating to controlled

substances. In addition, as Judge

Randall noted that should Respondent’s

DEA registration be revoked, ‘‘the

residents of Clayton, New Mexico will

be left with only one retail pharmacy

* * * [and] will either have to use this

pharmacy or travel 82 miles to the next

closest pharmacy.’’

Judge Randall concluded ‘‘that the

public interest will best be served by

allowing the Respondent to continue

with its Certificate of Registration with

certain conditions’’ beyond those

required by the Board’s decision. Judge

Randall recommended that Respondent

shall comply with the following terms

for three years from the effective date of

the final order:

(1) submit to the local DEA office a

copy of the Respondent’s state-required

annual inventory;

(2) submit to the local DEA office the

results of any audit or inspection

conducted upon the Respondent by the

Board; and

(3) notify the local DEA office within

5 work days in the event the New

Mexico Pharmacy Board reinstates the

suspension of Mr. Balzano’s license.

Judge Randall further recommended

that ‘‘[i]n the event Mr. Balzano ceases

to work as the Respondent’s pharmacist,

the Respondent may apply to DEA to

have these conditions removed from its

Certificate of Registration.’’

The Government filed exceptions to

the Administrative Law Judge’s Opinion

and Recommended Ruling, arguing that

the Administrative Law Judge failed to

‘‘make a finding with respect to

unexplained controlled substance

shortages which were not alleged to

have been consumed by Respondent’s

pharmacist,’’ The Government argued

that ‘‘at a minimum, Respondent and

pharmacist Balzano failed to keep

complete and accurate records. * * *’’

The Government further contended that

the ‘‘evidence of Mr. Balzano’s activity

with regard to unlawful distribution of

controlled substances by falsified

prescriptions * * * could support an

inference that other missing controlled

substances were also diverted.’’ The

Acting Deputy Administrator finds that

the Administrative Law Judge, in

considering factors two, four and five,

did in fact find that Mr. Balzano did not

provide a persuasive explanation for the

missing drugs other than those he

admitted to consuming. The Acting

Deputy Administrator agrees with the

Government’s contention, that at a

minimum, these shortages represent

faulty recordkeeping. However, the

Acting Deputy Administrator rejects the

Government’s argument that the

evidence presented supports an

inference that the missing drugs were

diverted. While Mr. Balzano admitted

that several forged prescriptions were

filled and that controlled substances

were improperly dispensed on several

occasions, there was no evidence

presented at the hearing which would

warrant a finding that the unexplained

shortages were the result of diversion.

The Government also argued in its

exceptions that Judge Randall’s

‘‘recommended action in this matter is

a departure from prior agency practice

and policy.’’ In support of its argument,

the Government cited to several cases

where a pharmacy’s DEA registration

was revoked based upon the improper

dispensing of controlled substances and

the conviction of the pharmacist for a

felony offense relating to controlled

substances. See Farmacia Ortiz, 61 FR

726 (1996); Dellmar Pharmacy #4, 59 FR

46,066 (1994); and Nasir Gore, T/A All

Drugs Pharmacy, Inc., 59 FR 60,661

(1994). The Acting Deputy

Administrator recognizes that the DEA

registrations of these pharmacies were

in fact revoked, however these cases can

be distinguished from the instant

proceeding. In this case, Respondent’s

owner/pharmacist admitted to a serious

drug abuse problem which caused his

misconduct. Mr. Balzano has accepted

responsibility for his past behavior and

has undergone extensive rehabilitation.

He has been drug-free since October

1992, and will continue to be monitored

by the PRN for a number of years. In

addition, Respondent pharmacy has

continued in operation since 1992 with

no evidence of violations of a similar

nature to those revealed by the 1992

inspection. Therefore, the Acting

Deputy Administrator does not find that

the Administrative Law Judge’s

recommendation to continue

Respondent’s registration subject to

certain restrictions is a departure from

prior agency practice. The Acting

Deputy Administrator concludes that it

is in the public interest to continue

Respondent’s registration in light of the

foregoing, as well as the need for

Respondent pharmacy in the

community.

Nevertheless, the Acting Deputy

Administrator does concur with the

Government’s contention that if

Respondent’s registration is to be

continued, the restrictions imposed on

its registration should more directly

address the nature of Respondent’s

misconduct, than those restrictions

recommended by Judge Randall. Mr.

Balzano suffered from a serious drug

abuse problem causing him to divert

controlled substances from the

pharmacy for his own use, to

improperly dispense controlled

substances to others, and at the very

least, to fail to maintain complete and

accurate records of controlled

substances. Consequently, the Acting

Deputy Administrator concludes that

Respondent’s registration shall be

subject to the following conditions:

(1) If Mr. Balzano’s contract with the

PRN is terminated before the expiration

of the five year term, Mr. Balzano shall

continue to undergo random urinalysis

at his own expense no less than one

time per month for the original term of

the contract. Results of these urine

screens shall be submitted to the DEA

office in Albuquerque, New Mexico.

(2) If Mr. Balzano’s contract with the

PRN is terminated before the expiration

of the five year term, Mr. Balzano shall

be prohibited from dispensing

controlled substances to himself or

members of his immediate family for the

original term of the contract.

(3) For three years from the effective

date of this final order, Respondent

shall undergo an annual audit of
Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices 42599

controlled substances conducted by an

independent auditor hired by

Respondent. Results of these audits

shall be forwarded to the DEA office in

Albuquerque, New Mexico.

(4) Respondent shall notify the local

DEA office in Albuquerque, New

Mexico within 5 work days in the event

the New Mexico Pharmacy Board

reinstates the suspension of Mr.

Balzano’s pharmacist license.

Accordingly, the Acting Deputy

Administrator of the Drug Enforcement

Administration, pursuant to the

authority vested in him by 21 U.S.C. 823

and 824, and 28 CFR 0.100(b) and 0.104,

hereby orders that DEA Certificate of

Registration, BR0924440, issued to

Rick’s Pharmacy, Inc., be continued,

and any pending applications for

renewal be granted, subject to the above

described restrictions. This order is

effective September 8, 1997.

Dated: July 31, 1997.

James S. Milford,

Acting Deputy Administrator.

[FR Doc. 97–20787 Filed 8–6–97; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Immigration and Naturalization Service

Agency Information Collection

Activities: Existing Collection;

Comment Request

ACTION: Extension of an existing

collection: Application for action on an

approved application or petition.

The Department of Justice,

Immigration and Naturalization Service

has submitted the following information

collection request to the Office of

Management and Budget (OMB) for

review and clearance in accordance

with the Paperwork Reduction Act of

1995. The information collection is

published to obtain comments from the

public and affected agencies. Comments

are encouraged and will be accepted

until October 6, 1997.

Written comments and suggestions

from the public and affected agencies

concerning the collection of information

should address one or more of the

following four points.

(1) Evaluate whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information will have

practical utility;

(2) Evaluate the accuracy of the

agencies estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used;

(3) Enhance the quality, utility, and

clarity of the information to be

collected; and

(4) Minimize the burden of the

collection of information on those who

are to respond, including through the

use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology,

e.g., permitting electronic submission of

responses.

Overview of This Information

Collection

(1) Type of Information Collection:

Extension of currently approved

information collection.

(2) Title of the Form/Collection:

Application for Action on an Approved

Application or Petition.

(3) Agency form number, if any, and

the applicable component of the

Department of Justice sponsoring the

collection: Form I–824. Adjudications

Division, Immigration and

Naturalization Service.

(4) Affected public who will be asked

or required to respond, as well as a brief

abstract: Primary: Individuals or

Households. This form is used to

request a duplicate approval notice, to

notify the U.S. Consulate that a person

has been adjusted to permanent resident

status so family member can apply for

derivative immigrant visa and to request

another U.S. Consulate be notified that

a petition has been approved.

(5) An estimate of the total number of

respondents and the amount of time

estimated for an average respondent to

respond: 43,772 respondents at 25

minutes (.416) hours per response.

(6) An estimate of the total public

burden (in hours) associated with the

collection: 18,209 annual burden hours.

If you have additional comments,

suggestions, or need a copy of the

proposed information collection

instrument with instructions, or

additional information, please contact

Mr. Richard A. Sloan, 202–616–7600,

Director, Policy Directives and

Instructions Branch, Immigration and

Naturalization Service, U.S. Department

of Justice, Room 5307, 425 I Street, NW.,

Washington, DC 20536.

If additional information is required

contact: Mr. Robert B. Briggs, Clearance

Officer, United States Department of

Justice, Information Management and

Security Staff, Justice Management

Division, Suite 850, Washington Center,

1001 G Street, NW., Washington, DC

20530.

Dated: August 24, 1997.

Robert B. Briggs,

Department Clearance Officer, United States

Department of Justice.

[FR Doc. 97–20880 Filed 8–6–97; 8:45 am]

BILLING CODE 4410–18–M

DEPARTMENT OF JUSTICE

Immigration and Naturalization Service

Agency Information Collection

Activities: Existing Collection;

Comment Request

ACTION: Extension of an existing

collection. Application for Replacement

Naturalization/Citizenship Document.

The Department of Justice

Immigration and Naturalization Service

has submitted the following information

collection request to the Office of

Management and Budget (OMB) for

review and clearance in accordance

with the Paperwork Reduction Act of

1995. The information collection is

published to obtain comments from the

public and affected agencies. Comments

are encouraged and will be accepted

until October 6, 1997. Written

comments and suggestions from the

public and affected agencies concerning

the proposed collection of information

should address one or more of the

following four points.

(1) Evaluate whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information will have

practical utility;

(2) Evaluate the accuracy of the

agencies estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used;

(3) Enhance the quality, utility, and

clarity of the information to be

collected; and

(4) Minimize the burden of the

collection of information on those who

are to respond, including through the

use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology,

e.g., permitting electronic submission of

responses.

Overview of This Information

Collection

(1) Type of Information Collection:

Extension of currently approved

information collection.

(2) Title of the Form/Collection:

Application for Replacement

Naturalization/Citizenship Document.