70148 Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Notices 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document.

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology.

2005 Food Safety Survey

Under section 903(b)(2) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

393(b)(2)), FDA is authorized to conduct 

research relating to foods and to 

conduct educational and public 

information programs relating to the 

safety of the Nation’s food supply. FDA 

is planning to conduct a consumer 

survey about food safety under this 

authority. The food safety survey will 

provide information about consumers’

food safety awareness, knowledge, 

concerns, and practices. A nationally 

representative sample of 4,000 adults in 

households with telephones will be 

selected at random and interviewed by 

telephone. This survey will include an 

oversample of Hispanics with a 

minimum of 500 Hispanics sampled. 

Additionally, 200 initial 

nonrespondents will be asked to 

participate in a short version of the 

survey to conduct a nonresponse 

analysis. Participation will be voluntary. 

Detailed information will be obtained 

about food safety risk perception, 

perceived sources of food 

contamination, knowledge of particular 

microorganisms, food handling 

practices, consumption of raw foods 

from animals, and perceived foodborne 

illness and food allergy experience.

The majority of the questions to be 

asked are identical to ones asked in the 

2001 Food Safety Survey (the 2001 

survey). Because of recent national 

consumer education campaigns about 

food safety and the large amount of 

media attention to food safety issues in 

the past few years, consumer attitudes, 

knowledge, and practices are likely to 

have changed greatly since the 2001 

survey. FDA needs current information 

to support consumer education 

programs and regulatory development. 

Additionally, this data will be used to 

measure changes in food safety handling 

practices and food allergy reactions as 

part of the Healthy People 2010 food 

safety objectives and allergen goals. 

New areas on the survey include 

awareness of bovine spongiform 

encephalopathy and acrylamide, 

refrigeration practices, and updated 

questions on washing practices for fresh 

fruits and vegetables.

FDA estimates the burden of this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses

Hours per

Response Total Hours 

10,000—Screener 1 10,000 .0167 167

4,000—Survey 1 4,000 .3 1,200

200—Short survey of 

‘‘initial nonresponders’’ 1 200 .10 20

Total 1 14,200 .4167 1,387

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimate is based on 

FDA’s experience with the 2001 survey 

mentioned previously in this document.

Dated: November 26, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26551 Filed 12–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002N–0291]

Baldev Raj Bhutani; Denial of Hearing; 

Final Debarment Order

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is denying Baldev 

Raj Bhutani’s request for a hearing and 

is issuing a final order under the Federal 

Food, Drug, and Cosmetic Act (the act) 

permanently debarring Baldev Raj 

Bhutani from providing services in any 

capacity to a person that has an 

approved or pending drug product 

application. FDA bases this order on a 

finding that Mr. Bhutani was convicted 

of a felony under Federal law for 

conduct related to the regulation of a 

drug product under the act. Mr. Bhutani 

has failed to file with the agency 

information and analyses sufficient to 

create a basis for a hearing concerning 

this action.

DATES: This order is effective December 

2, 2004.

ADDRESSES: Submit applications for 

termination of debarment to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852.

FOR FURTHER INFORMATION CONTACT: S. 

Mitchell Weitzman, Center for Drug 

Evaluation and Research (HFD–7), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

On February 12, 1996, Mr. Bhutani, 

former President and Treasurer of Alra 

Laboratories, Inc. (Alra), was found 

Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Notices 70149

1Mr. Bhutani’s response pre-dated his actual 

receipt of the certified letter. This was because 

service was initially attempted at his home instead 

of at the prison at which he was incarcerated. We 

presume that Mr. Bhutani was informed of this 

attempted service and preemptively submitted his 

request for a hearing. A second attempt at service 

at the prison facility at which he is incarcerated was 

successful. In any event, the delivery dates do not 

alter the nature of Mr. Bhutani’s request for a 

hearing or our application of summary judgment in 

this matter.

guilty of one count of conspiracy, a 

Federal felony offense under 18 U.S.C. 

371, and six other counts, also Federal 

felonies, related to violations under 

sections 301(a), (e), and (k) and 303 of 

the act (21 U.S.C. 331(a), (e), and (k) and 

333(a)(2)). A new trial was ordered by 

the U.S. District Court for the Northern 

District of Illinois-Eastern Division on 

December 17, 1997. On April 28, 1999, 

the U.S. Court of Appeals for the 

Seventh Circuit reversed the District 

Court’s ruling that Mr. Bhutani was 

entitled to a new trial and reinstated his 

convictions. On October 12, 1999, Mr. 

Bhutani pled guilty to one count of wire 

fraud, a Federal felony under 18 U.S.C. 

1343. On February 15, 2000, Mr. 

Bhutani was adjudged guilty of all of 

these offenses and sentenced by the U.S. 

District Court for the Northern District 

of Illinois-Eastern Division. The U.S. 

Court of Appeals for the Seventh Circuit 

affirmed the District Court’s denial of a 

motion for a new trial on September 12, 

2001.

The basis for these convictions were 

Mr. Bhutani’s violations of various 

sections of the act involving the drug 

products LACTULOSE Syrup and K+10 

(potassium chloride extended-release 

tablets). Specifically, Mr. Bhutani, the 

President and Treasurer of Alra, was 

convicted of the following:

• Conspiracy (in violation of 18 

U.S.C. 371) to commit the following 

offenses against the United States: (1) 

Manufacturing and introducing 

adulterated and misbranded generic 

drug products into interstate commerce 

(in violation of 21 U.S.C. 331(a)); (2) 

failing to establish and maintain records 

as required under the act (in violation 

of 21 U.S.C. 331(e)); (3) making false 

statements to FDA (in violation of 18 

U.S.C. 1001); (4) obstructing the 

administration of law in proceedings 

pending before FDA (in violation of 18 

U.S.C. 1505); and (5) obstructing 

proceedings before a Federal grand jury 

(in violation of 18 U.S.C. 1503).

• Adulterating the drug product 

LACTULOSE Syrup, United States 

Pharmacopeia (USP), lot 52–230–P, in 

violation of 21 U.S.C. 331(k), by 

including decomposed LACTULOSE 

raw material in the finished drug 

product, and by deviating from the 

approved manufacturing procedures by 

adding an undocumented substance, 

sodium hydroxide, to this drug product 

in an unapproved manner.

• Failing to establish and maintain 

records as required under the act (in 

violation of 21 U.S.C. 331(e)), 

specifically failing to establish and 

maintain accurate drug manufacturing 

batch production records for the drug 

product LACTULOSE Syrup, USP, lot 

52–230–P, in that he failed to document 

the unauthorized addition of sodium 

hydroxide more than 2 years after the 

original manufacture of this lot.

• Introducing into interstate 

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

331(a), the drug product LACTULOSE 

Syrup, USP, lot 52–230–P, which (1) 

was not manufactured in accordance 

with current good manufacturing 

practice regulations and (2) contained 

an undocumented substance, sodium 

hydroxide.

• Adulterating the drug product 

LACTULOSE Syrup, USP, lot 92–558–P, 

by violating current good manufacturing 

practice regulations and by preparing 

and holding the drug product under 

unsanitary conditions whereby it may 

have been contaminated with filth (21 

U.S.C. 331(k)). Specifically, Mr. Bhutani 

received the drug product’s active raw 

material, LACTULOSE concentrate, in 

punctured drums and then directed Alra 

employees to inject hot glue into the 

punctures to plug the leaks, and to wrap 

self-adhesive duct tape over the 

punctures, and thereafter used this 

contaminated raw material in the 

manufacture of a finished drug product.

• Introducing into interstate 

commerce the drug product 

LACTULOSE, lot 92–558–P, which was 

adulterated in that it was not 

manufactured in accordance with 

current good manufacturing practice 

regulations, and it was prepared and 

held under unsanitary conditions 

whereby it may have been contaminated 

with filth, in violation of 21 U.S.C. 

331(a). Alra then used this 

contaminated raw material in the 

manufacture of a finished drug product 

and shipped it in interstate commerce to 

customers.

• Adulterating the drug product K+10 

by violating current good manufacturing 

practice regulations under 21 U.S.C. 

331(k), by contaminating this drug 

product with metal shavings from a 

stainless steel pipe, and by preparing 

and holding the drug product under 

unsanitary conditions whereby it may 

have been contaminated with filth and 

rendered injurious to health. 

Specifically, Mr. Bhutani directed 

employees to make tablets from the drug 

product when he knew the granulation 

powder contained metal fragments from 

a stainless steel pipe.

As a result of Mr. Bhutani’s 

convictions and because he was 

convicted of felonies that were clearly 

related to the regulation of a drug 

product under the act, FDA served him 

by certified letter on February 6, 2003, 

a proposal to permanently debar him 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application. The 

proposal also offered Mr. Bhutani an 

opportunity for a hearing on the 

proposal. FDA based the debarment 

proposal on a finding that Mr. Bhutani 

was convicted of a felony under Federal 

law for conduct relating to the 

regulation of Alra’s drug products.

The certified letter informed Mr. 

Bhutani that his request for a hearing 

could not rest upon mere allegations or 

denials, but must present specific facts 

showing that there was a genuine and 

substantial issue of fact requiring a 

hearing. The letter also informed Mr. 

Bhutani that the only material issue of 

fact was whether he was convicted as 

alleged in the letter. Finally, the letter 

informed Mr. Bhutani that if it 

conclusively appeared from the face of 

the information and factual analyses in 

his request for a hearing that there was 

no genuine and substantial issue of fact 

that precluded the order of debarment, 

FDA would enter summary judgment 

against him and deny his request for a 

hearing.

In a letter dated January 30, 2003, 1

Mr. Bhutani requested a hearing on the 

proposal and attached supporting 

materials. In his request for a hearing, 

Mr. Bhutani acknowledges his 

convictions under Federal law as 

alleged by FDA. However, he disputes 

many of the facts and judicial decisions 

that formed the basis for his 

convictions.

We reviewed these materials, as well 

as supplementary submissions from Mr. 

Bhutani dated February 25, 2003, March 

17, 2003, February 17, 2004, and 

November 12, 2004, and find that they 

do not create a basis for a hearing 

because hearings will be granted only if 

there is a genuine and substantial issue 

of fact. Hearings will be granted neither 

on issues of policy or law or on mere 

allegations, denials, or general 

descriptions of positions and 

contentions, nor on data and 

information insufficient to justify the 

factual determination urged. (See 21 

CFR 12.24(b).)

The Associate Commissioner for 

Regulatory Affairs has considered Mr. 

Bhutani’s arguments and concludes that 

they are unpersuasive and fail to raise 

70150 Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Notices 

a genuine and substantial issue of fact 

requiring a hearing.

II. Legal Arguments Raised by Mr. 

Bhutani

Mr. Bhutani raised a number of legal 

arguments in support of his hearing 

request. These legal arguments are not 

relevant to the decision to grant a 

hearing because Mr. Bhutani has not 

raised a genuine and substantial issue of 

fact. A hearing will not be granted on 

issues of law. See 21 CFR 12.24(b)(1). 

Mr. Bhutani’s legal arguments are 

discussed in the following paragraphs.

A. Materiality as an Element of ‘‘Intent 

to Defraud’’

Mr. Bhutani contends that 

‘‘materiality’’ as an element of ‘‘intent to 

defraud’’ was erroneously not given as 

a jury instruction, citing U.S. v. Neder, 

527 U.S. 1 (1999). Neder held that when 

Congress used the term ‘‘to defraud’’ in 

the mail and wire fraud statutes, 

Congress incorporated the common law 

requirement of materiality as an element 

of the offense.

Mr. Bhutani maintains that the 

violations cited by the proposal to debar 

are not material and that there is no 

evidence that the acts underlying the 

violations affected the quality, strength, 

purity, or potency of the drug products 

under his control.

The act requires FDA to mandatorily 

debar an individual who has been 

convicted of certain Federal felonies. 

Thus, the only relevant factual issue 

here is whether Mr. Bhutani was, in 

fact, convicted of a Federal felony for 

conduct related to the regulation of a 

drug product, and not whether the acts 

underlying the violations are material. 

Accordingly, Mr. Bhutani’s argument is 

without merit.

B. Ex Post Facto

Mr. Bhutani maintains that in 1988, 

section 301(e) of the act did not 

specifically require batch 

documentation, as it does now, and 

therefore ex post facto principles apply. 

An ex post facto law is one that reaches 

back to punish acts that occurred before 

enactment of the law or that adds a new 

punishment to one that was in effect 

when the crime was committed. Ex 

Parte Garland, 4 Wall 333, 337, 18L. Ed 

366 (1866); Collins v. Youngblood, 497 

U.S. 37 (1990).

Mr. Bhutani’s assertion regarding 

section 301(e) relates to the facts and 

findings underlying his conviction. 

These facts and findings are not relevant 

to this debarment proceeding. As stated 

previously in this document, the only 

relevant consideration under section 

306(a)(2) of the act (21 U.S.C. 335a(a)(2)) 

is whether Mr. Bhutani was convicted of 

a felony under Federal law for conduct 

related to the regulation of a drug 

product under the act. Therefore, Mr. 

Bhutani’s argument regarding section 

301(e) and the Ex Post Facto Clause in 

connection with this debarment 

proceeding is without merit.

Mr. Bhutani also suggests that, in 

general, the Ex Post Facto Clause of the 

U.S. Constitution prohibits application 

of section 306(a)(2) of the act (21 U.S.C. 

335a(a)(2)) to him because this section 

was not in effect at the time of Mr. 

Bhutani’s criminal conduct.

With the enactment of the Generic 

Drug Enforcement Act (GDEA) on May 

13, 1992, Congress amended the act to 

include section 306(a)(2) of the act. Mr. 

Bhutani’s implication that application 

of the mandatory debarment provisions 

of the act is prohibited by the Ex Post 

Facto Clause is unpersuasive. Because 

the intent behind debarment under 

section 306(a)(2) of the act is remedial 

rather than punitive, this section does 

not violate the Ex Post Facto Clause. 

The congressional intent with respect to 

actions under section 306(a)(2) of the act 

is clearly remedial. Congress created the 

GDEA in response to findings of fraud 

and corruption in the generic drug 

industry. Both the language of the GDEA 

itself and its legislative history reveal 

that the purpose of the debarment 

provisions set forth in the GDEA is ‘‘to 

restore and ensure the integrity of the 

ANDA [abbreviated new drug 

application] approval process and to 

protect the public health.’’ (See section 

1, Public Law 102–282, the Generic 

Drug Enforcement Act of 1992.) This is 

a remedial rather than punitive goal. In 

Bae v. Shalala, 44 F. 3d 489 (7th Cir. 

1995), the Seventh Circuit upheld FDA’s 

debarment under the GDEA of the 

former president of a generic drug 

manufacturing firm, based on his 

antecedent conviction for providing an 

‘‘unlawful gratuity’’ to an FDA official. 

Although Bae argued that his debarment 

was ‘‘retroactive punishment’’ in 

violation of the Ex Post Facto Clause of 

the U.S. Constitution, the Seventh 

Circuit found that Bae’s debarment was 

remedial, not punitive, and therefore 

did not violate the Ex Post Facto Clause. 

(Bae, 44 F. 3d at 493, 495–96). The 

Seventh Circuit recognized that, to 

achieve its remedial goal of restoring 

consumer confidence in the generic 

drug industry, Congress appropriately 

determined that it could prohibit felons 

such as Bae from future activity in the 

industry. (Id. at 496.) (See also DiCola

v. FDA, 77 F. 3d 504 (D.C. Cir. 1996 

(debarment of a convicted felon did not 

violate Ex Post Facto Clause); 

Manocchio v. Kusserow, 961 F. 2d 1539, 

1542 (11th Cir. 1992) (exclusion of 

physician from participation in 

Medicare programs because of criminal 

conviction is remedial, not punitive and 

therefore did not violate the Ex Post 

Facto Clause).)

The Supreme Court has long held that 

statutes that deny future privileges to 

convicted offenders because of their 

previous criminal activities to insure 

against corruption in specified areas do 

not impose penalties for past conduct 

and, therefore, do not violate the ex post 

facto prohibitions. (See, e.g., Hawker v. 

New York, 170 U.S. 189, 190 (1898) 

(physician barred from practicing 

medicine for a prior felony conviction); 

De Veau v. Braisted, 363 U.S. 144 (1960) 

(convicted felon’s exclusion from 

employment as officer of waterfront 

union is not a violation of the Ex Post 

Facto Clause).) In De Veau, the court 

upheld a law that prohibited a 

convicted felon from employment as an 

officer in a waterfront union. The 

purpose of the law was to remedy the 

past corruption and to insure against 

future corruption in the waterfront 

unions. The court in De Veau, 363 U.S. 

at 160, stated:

The question in each case where 

unpleasant consequences are brought to bear 

upon an individual for prior conduct, is 

whether the legislative aim was to punish 

that individual for past activity, or whether 

the restriction of the individual comes about 

as a relevant incident to a regulation of a 

present situation, such as the proper 

qualifications for a profession * * *.

As in De Veau, the legislative purpose 

of section 306(a)(2) of the act is to 

ensure that fraud and corruption are 

eliminated from the drug industry. The 

restrictions placed on individuals 

convicted of a felony under Federal law 

are not intended as punishment but are 

‘‘incident to a regulation of a present 

situation’’ (De Veau, 363 U.S. at 160) 

and are necessary to remedy the past 

fraud and corruption in the industry. 

Because the intent of the GDEA is 

remedial rather than punitive, Mr. 

Bhutani’s argument that the GDEA 

violates the Ex Post Facto Clause must 

fail.

C. Scope of Debarment Authority

Mr. Bhutani asserts that the proposal 

to debar him and the debarment 

provisions themselves (section 

306(a)(2)(B) of the act) are too broad and 

not specific, so he is entitled to a 

hearing. This argument is without merit.

Neither the proposal to debar nor the 

act’s debarment provisions, on which 

the proposal to debar was based, are 

broad or unspecific. The debarment 

proposal set forth expressly the conduct 

on which the proposal is based, the 

findings of FDA, the agency’s proposed 

Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Notices 70151

action, and the procedure for requesting 

a hearing. Section 306(a)(2)(B) of the act 

clearly mandates the debarment of an 

individual who has been convicted of a 

Federal felony for conduct relating to 

the regulation of any drug product. The 

act defines the conduct and felony 

conviction that lead to debarment. The 

period of debarment is also in section 

306(c)(2) of the act, which states that the 

debarment is permanent.

In fact, the debarment provisions are 

narrowly drawn to accomplish the 

legitimate government purposes of 

ensuring the integrity of the drug 

regulatory process and protecting the 

public health. The debarment 

provisions further the compelling 

governmental interest of ‘‘restor[ing] 

consumer confidence in generic drugs 

by eradicating the widespread 

corruption in the generic drug approval 

process.’’ (Bae v. Shalala, 44 F. 3d 489, 

493 (7th Cir. 1995).)

D. Double Jeopardy

Mr. Bhutani asserts that as he has 

already been convicted and sentenced 

for his actions, further punishment in 

the form of a permanent debarment 

violates the Double Jeopardy Clause of 

the Fifth Amendment to the U.S. 

Constitution. The Double Jeopardy 

Clause states that no person shall ‘‘be 

subject for the same offense to be twice 

put in jeopardy of life or limb.’’ Mr. 

Bhutani relies on U.S. v. Halper, 490 

U.S. 435 (1989), which held that a civil 

sanction can constitute a multiple 

punishment of the sort prohibited by the 

Double Jeopardy Clause, to argue that 

permanent debarment is not rationally 

related to any remedial purpose and is 

disproportionate to damages resulting 

from his violative acts.

Mr. Bhutani’s arguments are 

unpersuasive. First, ‘‘jeopardy’’ cannot 

attach because the effect of section 

306(a)(2) of the act is remedial, not 

punitive. As previously stated, the 

legislative goal of this section of the act 

is to restore and ensure the integrity of 

the drug approval process and to protect 

the public health by eradicating fraud 

and corruption from the drug industry. 

This is plainly a remedial rather than 

punitive goal.

Second, the Supreme Court in 

Hudson v. United States, 522 U.S. 93 

(1997), in large part disavowed the 

method of analysis used in Halper to 

determine whether a sanction violates 

the Double Jeopardy Clause. The Court 

in Hudson stated that the Double 

Jeopardy Clause protects only against 

the imposition of multiple criminal 

punishments for the same offense in 

successive proceedings. (Hudson, 522 

U.S. at 98–99). It does not prohibit the 

imposition of any additional sanction 

that could, ‘‘in common parlance,’’ be 

described as punishment. (Id.) (Internal 

quotation marks and citations omitted).

The Court added that whether a 

particular punishment is considered 

criminal or civil is first a matter of 

statutory construction. (Id.) That is, a 

court first must ask whether the 

legislature, ‘‘in establishing the 

penalizing mechanism, indicated either 

expressly or impliedly a preference for 

one label or the other.’’ (Id. at 99 

(quoting United States v. Ward, 448 U.S. 

242, 248 (1980)).) Moreover, where the 

legislature has indicated an intention to 

establish a civil penalty, a court must 

inquire further whether the statutory 

scheme is ‘‘so punitive either in purpose 

or effect’’ as to ‘‘transform what was 

clearly intended as a civil remedy into 

a criminal penalty.’’ (Id. at 99 (quoting 

Rex Trailer Co. v.United States, 350 U.S. 

148, 154 (1956)).)

The debarment of Mr. Bhutani is not 

a criminal penalty under Hudson. In 

enacting the GDEA, Congress clearly 

intended that debarment serve as a civil 

penalty. In Hudson, the Court found ‘‘it 

significant that the authority to issue 

debarment orders is conferred [by 

statute] upon the ‘appropriate Federal 

banking agencies’,’’ holding ‘‘[t]hat such 

[debarment] authority was conferred 

upon administrative agencies is prima 

facie evidence that Congress intended to 

provide for a civil sanction.’’ (Id. at 103 

(citations omitted).)

The GDEA explicitly provides FDA 

with the authority to permanently debar 

individuals convicted of certain 

felonies, such as Mr. Bhutani, from 

‘‘providing services in any capacity to a 

person that has an approved or pending 

drug product application’’ (section 

306(a)(2) of the act). Thus, under 

Hudson, the terms of the GDEA are 

prima facie evidence that Congress 

intended the debarment provisions to be 

civil in nature.

Under the second prong of Hudson, 

the debarment authorized by the GDEA 

is not so punitive either in purpose or 

effect as to transform this civil remedy 

into a criminal penalty. In Hudson, the 

Court considered whether a permanent 

debarment sanction prohibiting 

participation in any banking activities 

had such a punitive purpose or effect. 

The Court concluded that there was no 

evidence to establish that the debarment 

sanction at issue was ‘‘so punitive in 

form and effect as to render [it] criminal 

despite Congress’ intent to the 

contrary.’’ (Hudson v. United States, 

522 U.S. at 104 (quoting United States

v. Ursery, 518 U.S. 267, 290 (1996)).) 

The Court in Hudson relied on the 

analysis of Kennedy v. MendozaMartinez, 372 U.S. 144, 168–169 (1963), 

in reaching this holding.

The Hudson court further noted that 

debarment proceedings have not 

historically been viewed as punishment. 

(Hudson, 552 U.S. at 104). The Court 

found that ‘‘the [debarment] sanctions 

imposed do not involve an ‘affirmative 

disability or restraint, ’ as that term is 

normally understood.’’ (Id. (quoting 

Flemming v. Nestor, 363 U.S. 603, 617 

(1960)).) The Court also found that the 

debarment sanction in the banking 

statute at issue in the Hudson case does 

not ‘‘come into play ‘only ’ on a finding 

of scienter,’’ because willfulness is not 

a prerequisite to the imposition of the 

debarment sanction. (Id. (quoting 

Kennedy, 372 U.S. at 169).) Likewise, 

the GDEA does not require a finding of 

willfulness as a prerequisite to imposing 

debarment. In addition, the Court 

explained that the fact that the conduct 

for which the debarment is imposed 

may also be criminal is insufficient to 

render the debarment sanctions 

criminally punitive. (Id.) Finally, and 

significantly, the Court explained that 

the general deterrence of the conduct at 

issue resulting from an individual 

debarment is insufficient to render the 

debarment criminal. (Id.) These factors 

apply as much to debarment under the 

GDEA.

Furthermore, the GDEA’s permanent 

prohibition on services in any capacity 

to a person with an approved or 

pending drug product application is not 

excessive in relation to the statute’s 

remedial purpose. The Supreme Court 

has upheld similar statutes which, for 

remedial purposes, impose permanent 

prohibitions. (See Hudson v.United 

States, 522 U.S. 93 (1997); Hawker v. 

New York, 170 U.S. 189, 190 (1898); De 

Veau v. Braisted, 363 U.S. 144 (1960).)

The preclusion of Mr. Bhutani from 

providing any type of service to holders 

of pending or approved drug product 

applications is not excessive in relation 

to the remedial goals of the GDEA. The 

D.C. Circuit has held that the GDEA’s 

prohibition on services in any capacity 

serves the statute’s remedial purpose. 

(FDA v. DiCola, 77 F. 3d 504 (D.C. Cir. 

1996).) Congress prohibited all services 

to avoid the serious administrative 

difficulties involved in distinguishing 

between those positions clearly related 

to drug regulation and those not clearly 

related. (Id. at 507; see also Siegel v. 

Lyng, 851 F. 2d 412, 416 (D.C. Cir. 

1988).) Furthermore, the GDEA’s 

prohibition ensures that the purposes 

underlying the debarment provisions 

are not circumvented or undermined. 

(DiCola, 77 F. 3d at 507; see also Farley 

and Calfee, Inc. v. USDA, 941 F. 2d 964, 

968 (9th Cir. 1991).) Finally, as 

70152 Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Notices 

previously noted, the Supreme Court in 

Hudson upheld a similar statute that, for 

remedial purposes, imposes a 

prohibition on participation in any 

banking activity. (See also DiCola, 77 F. 

3d at 506–507 (debarment of a convicted 

felon does not violate the Double 

Jeopardy Clause); Manocchio v. 

Kusserow, 961 F. 2d 1539, 1542 (11th 

Cir. 1992) (exclusion of a physician 

from the Medicaid program because of 

a criminal conviction does not violate 

the Double Jeopardy Clause).)

Under Hudson, debarment under the 

GDEA is not so punitive either in 

purpose or effect as to render the 

penalty criminal. Thus, Mr. Bhutani’s 

argument that debarment under the 

GDEA violates the Double Jeopardy 

Clause is unpersuasive.

E. Waiver of Further Remedial, Civil, or 

Criminal Actions

Mr. Bhutani maintains that FDA is 

estopped from seeking to debar him 

because the agency waived additional 

remedial, civil, or criminal actions 

against him by entering into 

‘‘agreements’’ with him concerning his 

cooperation in bringing Alra’s 

operations in compliance with FDA 

regulations. Mr. Bhutani also asserts 

that the proposal to debar is punitive 

rather than remedial. These arguments 

are also unpersuasive.

As discussed in section II.D of this 

document, a debarment is a remedial, 

not punitive, action. Furthermore, Mr. 

Bhutani’s argument that FDA is 

estopped from pursuing further 

administrative action by virtue of prior 

‘‘agreements’’ is unpersuasive. Mr. 

Bhutani cites no legal authority, and we 

are unaware of any such authority, that 

would bar FDA from pursuing this 

appropriate remedial action as 

mandated by the GDEA.

F. ‘‘Clean Hands’’ Doctrine

Mr. Bhutani maintains that he and 

Alra entered into two agreements (a 

consent agreement and a voluntary 

agreement) with FDA that he and Alra 

complied with and that FDA was 

satisfied with. He asserts that under 

Congressional pressure, FDA initiated a 

seizure action and a criminal 

proceeding against Alra. Mr. Bhutani 

contends that FDA has acted in bad 

faith and, under the ‘‘clean hands’’

doctrine, should not be allowed to seek 

additional remedies and relief. This 

argument is also without merit.

Under the ‘‘clean hands’’ doctrine, a 

party seeking a judgment is not entitled 

to relief in equity if the person has done 

anything unfair or illegal in relation to 

the subject of the lawsuit. Precision 

Instrument Mfg. Co. v. Automotive 

Maintenance Machinery Co., 324 U.S. 

806, 814 (1945). FDA has not acted in 

bad faith with respect to any agreements 

with Mr. Bhutani or Alra. Furthermore, 

FDA is not seeking any judgment or 

relief in equity against Mr. Bhutani. 

FDA is applying to Mr. Bhutani the 

statutory requirement regarding 

mandatory debarment of individuals 

convicted of a felony under Federal law 

for conduct related to the regulation of 

a drug product under the act. Therefore, 

Mr. Bhutani’s argument regarding the 

‘‘clean hands’’ doctrine is without merit.

G. Estoppel by Laches

Mr. Bhutani maintains that FDA is 

estopped from taking this regulatory 

action due to an ‘‘unreasonable amount 

of time that has elapsed.’’ He cites 

Costello v. U.S., 365 U.S. 265 (1961), in 

support of his contention. Costello

involved an individual whose U.S. 

naturalization was revoked 27 years 

after his application. The Costello case 

is not in any way relevant or analogous 

to the circumstances at issue here, but 

even if it were, the Court’s holding that 

the petitioner’s rights were not violated 

by a 27-year delay in initiating 

citizenship revocation undermines, as 

opposed to supports, Mr. Bhutani’s 

argument. The Court cited, as is the case 

here, the availability of accurate records 

and documents attesting to the 

petitioner’s misdeeds (Id. at 282–283).

FDA initiated administrative action to 

debar Mr. Bhutani in a timely fashion. 

Section 306(l)(2) of the act provides a 5-

year window from the date of 

conviction for the agency to initiate the 

debarment process. Mr. Bhutani’s 

conviction was reinstated on April 29, 

1999. The agency issued a proposal to 

debar on February 6, 2003, within the 5-

year statutory window. Therefore, Mr. 

Bhutani’s assertion is unpersuasive.

H. Other Arguments

Finally, Mr. Bhutani argues that FDA 

must consider a number of factors in 

this debarment proceeding, including 

the nature and seriousness of the 

offense; management participation in 

the offense; voluntary steps taken to 

minimize the impact of the offense on 

the public; changes in ownership, 

management, or operations that have 

corrected the cause of the offense and 

decreased the likelihood of a recurrence; 

evidence that current production of 

drugs subject to abbreviated drug 

applications and all pending 

abbreviated drug applications are free of 

fraud or material false statements; and 

prior convictions. Again, the only 

relevant fact under section 306(a)(2) of 

the act is whether Mr. Bhutani was 

convicted of a felony under Federal law 

for conduct related to the regulation of 

a drug product. Therefore, Mr. Bhutani’s 

argument that FDA must consider other 

factors is without merit.

III. Denial of Hearing

In his requests for a hearing, Mr. 

Bhutani does not present any 

information showing there is a genuine 

and substantial issue of fact requiring a 

hearing. Mr. Bhutani does not dispute 

that he pled guilty to one count of wire 

fraud and that he was found guilty of 

seven other counts, all felonies under 

Federal law. Nor does he dispute that he 

was convicted of felonies that were 

clearly related to the regulation of a 

drug product under the act. The facts 

underlying Mr. Bhutani’s convictions 

have been established by his 

convictions and, therefore, are not at 

issue. Thus, FDA finds that Mr. Bhutani 

has failed to identify any genuine and 

substantial issue of fact requiring a 

hearing. In addition, Mr. Bhutani’s legal 

arguments do not create a basis for a 

hearing and, in any event, are 

unpersuasive. Accordingly, FDA denies 

Mr. Bhutani’s request for a hearing.

IV. Findings and Order

Therefore, the Associate 

Commissioner for Regulatory Affairs, 

under section 306(a) of the act and 

under authority delegated to him, finds 

that Mr. Baldev Bhutani has been 

convicted of a felony under Federal law 

for conduct relating to the regulation of 

a drug product under the act (Section 

306(a)(2)(B)) of the act).

As a result of the foregoing findings, 

Mr. Baldev Raj Bhutani is permanently 

debarred from providing services in any 

capacity to a person with an approved 

or pending drug product application 

under sections 505, 512, or 802 of the 

act (21 U.S.C. 355, 360b, or 382), or 

under section 351 of the Public Health 

Service Act (42 U.S.C. 262), effective 

(see DATES) (sections 306(c)(1)(B) and 

(c)(2)(A)(iii) and 201(dd) of the act (21 

U.S.C. 321(dd))). Any person with an 

approved or pending drug product 

application who knowingly uses the 

services of Mr. Bhutani in any capacity, 

during his period of debarment, will be 

subject to civil money penalties (section 

307(a)(6) of the act (21 U.S.C. 

335b(a)(6)). If Mr. Bhutani, during the 

period of his debarment, provides 

services in any capacity to a person with 

an approved or pending drug product 

application, he will be subject to civil 

money penalties (section 307(a)(7) of the 

act). In addition, FDA will not accept or 

review any ANDAs submitted by or 

with the assistance of Mr. Bhutani 

during the period of his debarment.

Federal Register / Vol. 69, No. 231 / Thursday, December 2, 2004 / Notices 70153

We note that Mr. Bhutani has 

petitioned the U.S. Supreme Court for 

writ of certiorari of the Seventh Circuit’s 

decision in his case. Should the 

outcome of further judicial proceeding 

result in Mr. Bhutani’s conviction being 

reversed, under section 306(d)(3)(B)(i) of 

the act, the order of debarment will be 

withdrawn. Mr. Bhutani may file an 

application to terminate his debarment, 

under section 306(d)(4)(A) of the act. 

Any such application would be 

reviewed under the criteria and 

processes set forth in section 

306(d)(4)(C) and (d)(4)(D) of the act. 

Such an application should be 

identified with Docket No. 2002N–0291 

and sent to the Division of Dockets 

Management (see ADDRESSES). All such 

submissions are to be filed in four 

copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(f). Publicly 

available submissions may be seen in 

the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday.

Dated: November 24, 2004.

John M. Taylor,

Associate Commissioner for Regulatory 

Affairs.

[FR Doc. 04–26532 Filed 12–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0493]

Draft Guidance for Industry on 

Recommended Approaches to 

Integration of Genetic Toxicology 

Study Results; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Recommended 

Approaches to Integration of Genetic 

Toxicology Study Results.’’ This draft 

guidance is intended to inform industry 

on how the Center for Drug Evaluation 

and Research (CDER) views positive 

findings in genetic toxicology assays, 

and to provide recommendations to 

industry on how to proceed in assuring 

safety of healthy subjects or patients 

when results in genotoxicity studies 

suggest a potential cancer or genetic 

hazard.

DATES: Submit written or electronic 

comments on the draft guidance by 

January 31, 2005. General comments on 

agency guidance documents are 

welcome at any time.

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATIONsection 

for electronic access to the draft 

guidance document.

FOR FURTHER INFORMATION CONTACT:

David Jacobson-Kram, Center for Drug 

Evaluation and Research (HFD–024), 

Food and Drug Administration, 5515 

Security Lane, Rockville, MD 20852, 

301–443–5346.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Recommended Approaches to 

Integration of Genetic Toxicology Study 

Results.’’ Risk for carcinogenesis is 

usually determined in rodent assays, in 

either 2–year studies or shorter-term 

studies using alternative models (ICH 

S1B). Regulatory decisions involving 

both single- and repeat-dose clinical 

studies are discussed in this guidance. 

Pharmaceuticals administered through 

oral, intravenous, topical, and other 

routes, as appropriate, are subject to this 

guidance.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on recommended approaches to 

integration of genetic toxicology study 

results. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

paper copies of mailed comments are to 

be submitted, except that individuals 

may submit one paper copy. Comments 

are to be identified with the docket 

number found in brackets in the 

heading of this document. The draft 

guidance and received comments are 

available for public examination in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday.

III. Electronic Access

Persons with access to the Internet 

may obtain the document at either http:/

/www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: November 23, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–26533 Filed 12–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Longitudinal 

Investigation of Fertility and the 

Environment

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Institute of Child Health and Human 

Development, the National Institutes of 

Health has submitted to the Office of 

Management and Budget (OMB) a 

request to review and approve the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register, under the title ‘‘Determinants 

of Male and Female Fecundity and 

Fertility,’’ on January 9, 2004, page 1589 

and allowed 60-days for public 

comment. Two public comments were 

received from the American Society for 

Reproductive Medicine and the 

American Chemistry Council Phthalate 

Esters Panel regarding specific aspects 

of the proposed methodology. Overall, 

comments from the former group 

pertained predominantly to clinical 

issues while the latter group’s 

comments provided their rationale for 

the omission of phthalates from the 

protocol. These comments were useful 

in modifying the proposed study and 

instruments. The purpose of this notice 

is to allow an additional 30 days for 

public comment. 

5 CFR 1320.5 (General Requirements) 

Reporting and Recordkeeping 

Requirements: Final Rule requires 

that the agency inform the potential