3454 Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

requests, call the CDC Reports Clearance

Officer at (404) 639–7090. Send written

comments to CDC, Desk Officer; Human

Resources and Housing Branch, New

Executive Office Building, Room 10235;

Washington, DC 20503. Written

comments should be received within 30

days of this notice.

Proposed Project

1. A Pilot Study to Evaluate CDC’s

1998 Guidelines for the Treatment of

Sexually Transmitted Diseases Among

Clinicians in Two Managed Care

Organizations—The National Center for

HIV, STD, and TB Prevention (NCHSTP)

is proposing a pilot survey of 1,000

practitioners in two managed care plans

to evaluate how CDC’s most recent

edition (1998) of the Sexually

Transmitted Disease (STD) Treatment

Guidelines influence practice. The pilot

survey will be conducted in two large,

mixed model managed care plans which

are located in two different geographic

regions of the U.S. The survey is

expected to last from 3–6 months. The

CDC periodically publishes national

guidelines on the diagnosis and

treatment of sexually transmitted

diseases; however, little is known about

the impact of the guidelines on clinical

practice and treatment choices, the

practical use of the guidelines, or utility

to providers. Data gathered from this

study will provide preliminary

information about the extent to which

providers are aware of the guidelines,

their access to the guidelines, their use

of the guidelines, and factors that enable

or preclude use of the guidelines. The

information will assist CDC in

determining ways to improve

practitioners’ understanding and

promote utilization of the guidelines;

determine ways to make them more

available for medical practitioners; and

increase the use of the guidelines in

appropriate medical practices. The total

annual burden hours are 334.

Respondents

No. of

respondents

No. of

responses/

respondent

Avg.

burden/response

(in

hours)

Managed care

physicians or

advance

practice

Nurses .......... 1,000 1 .334

Dated: January 14, 2000.

Nancy Cheal, Ph.D.,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 00–1452 Filed 1–20–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 94N–0162]

Premchand Girdhari; Denial of

Hearing; Final Debarment Order

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is denying the

request of Premchand Girdhari, 643

Rassbach St., Eau Claire, WI 54701, for

a hearing, and is issuing a final order

under the Federal Food, Drug, and

Cosmetic Act (the act) permanently

debarring Mr. Girdhari 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. Girdhari was

convicted of two felonies under Federal

law relating to the regulation of a drug

product under the act. Mr. Girdhari has

failed to file with the agency

information and analyses sufficient to

create a basis for a hearing concerning

this action.

EFFECTIVE DATE: January 21, 2000.

ADDRESSES: Application for termination

of debarment to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Richard L. Arkin, Center for Veterinary

Medicine (HFV–6), Food and Drug

Administration, 7500 Standish Pl.

Rockville, MD 20855, 301–827–0141,

FAX 301–827–5510, e-mail

‘‘rarkin@bangate.fda.gov’’.

SUPPLEMENTARY INFORMATION:

I. Background

On May 8, 1991, United States District

Court for the Western District of

Wisconsin accepted a plea of guilty

from Premchand Girdhari, former

President of Radix Laboratories, Inc., to

a two count information, for making

false statements and distributing

adulterated drugs with the intent to

defraud and mislead in violation of the

act, Federal felony offenses under 18

U.S.C. 1001 and sections 301(a) and

303(b) of the act (21 U.S.C. 331(a) and

333(b)). On July 8, 1991, judgment

against Mr. Girdhari was entered and

the court advised him of his sentence.

The court amended its judgment to

correct a clerical error but otherwise

affirmed its earlier judgment and

sentence on October 7, 1991.

Mr. Girdhari was the president of

Radix Laboratories, Inc., a Wisconsin

corporation that manufactured a variety

of animal drugs. In that capacity, he

caused to be introduced into commerce

adulterated drugs. Specifically, Mr.

Girdhari marketed the drug

‘‘Antihistamine (2%),’’ which drug is

adulterated within the meaning of

(section 501(a)(5) and (a)(2)(B) of the act

(21 U.S.C. 351(a)(5) and (a)(2)(B)),

because the drug was not the subject of

the necessary FDA approvals nor was it

manufactured in conformity with good

manufacturing practice. He also

knowingly and willfully made a false

statement in a matter, within the

jurisdiction of FDA, related to FDA’s

regulation of the injectable animal drug,

‘‘Cal–Plex.’’

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

335a(a)(2)) mandates debarment of an

individual if FDA finds that the

individual has been convicted of a

felony under Federal law for conduct

relating to the regulation of any drug

product under the act. Under section

306(l)(2) of the act, mandatory

debarment applies when an individual

is convicted within 5 years preceding

the initiation of the agency’s action to

debar. Section 306(c)(2)(A)(ii) of the act

requires that such debarment be

permanent.

FDA has made a finding that Mr.

Girdhari was convicted of two felonies

under Federal law for conduct relating

to the regulation of Radix drug products.

Mr. Girdhari’s first felony conviction

under 18 U.S.C. 1001 was for making a

false statement to FDA about the

manufacture and distribution of the

unapproved injectable animal drug,

‘‘Cal–Plex.’’ The information he falsified

concerns matters that affect FDA’s

regulatory decisions about drug

products. His second felony conviction

under section 301(a) of the act was for

violations of provisions of the act that

prohibit introduction and delivery for

introduction into interstate commerce of

any drug that is adulterated, a felony

conviction under Federal law for

conduct relating to the regulation of a

drug product under the act.

In a certified letter received by Mr.

Girdhari on October 17, 1994, the

Interim Deputy Commissioner for

Operations of FDA proposed to issue an

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

permanently debarring Mr. Girdhari

Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices 3455

from providing services in any capacity

to a person that has an approved or

pending drug product application. The

letter offered Mr. Girdhari an

opportunity for a hearing on the

agency’s proposal to issue such an

order. FDA based the proposal to debar

Mr. Girdhari on its finding that he had

been convicted of two felonies under

Federal law for conduct relating to the

regulation of Radix’s drug products.

The certified letter also informed Mr.

Girdhari 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 notified Mr.

Girdhari 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 November 10, 1994,

Mr. Girdhari requested a hearing on the

proposal and indicated that further

information would be submitted. On

December 14, 1994, Mr. Girdhari

submitted arguments and information in

support of his hearing request.

In his request for a hearing, Mr.

Girdhari acknowledges that he pleaded

guilty to offenses charged under 18

U.S.C. 1001 and sections 301(a) and

303(b) of the act and that convictions

and sentencing for these offenses were

entered pursuant to the guilty pleas on

July 8, 1991. However, Mr. Girdhari

argues that FDA’s findings based on the

conviction are incorrect and that the

agency’s proposal to debar him is

unconstitutional.

The Commissioner of Food and Drugs

(the Commissioner) has considered Mr.

Girdhari’s arguments and concludes that

they are unpersuasive and fail to raise

a genuine and substantial issue of fact

requiring a hearing. Moreover, the legal

arguments that Mr. Girdhari offers do

not create a basis for a hearing. (See 21

CFR 12.24(b)(1).) Mr. Girdhari’s

arguments are discussed below.

II. Mr. Girdhari’s Arguments in

Support of a Hearing

A. Retroactive Application of Statute Is

Improper

Mr. Girdhari contends that

‘‘retroactive application’’ of the Generic

Drug Enforcement Act (GDEA) of 1992

(Pub. L. 102–282), is improper and

argues that Congress did not intend that

the debarment provisions of the GDEA

be applied retroactively.

Mr. Girdhari states that the GDEA was

not enacted until May 13, 1992, which

was subsequent to the date of his

conviction on July 8, 1991. He contends

that he could not have anticipated the

collateral legal consequences of the

GDEA in plea negotiations, and had he

known of the potential for possible

future debarment, he either might not

have agreed to plead guilty to violations

that could be used as the foundation for

debarment, or he might have pleaded

innocent and sought a trial by jury.

Thus, he contends that debarment

would mean that he would suffer an

unforeseen and substantial additional

penalty of permanent prohibition from

providing services in any capacity to a

person with an approved or pending

drug application.

Mr. Girdhari argues that under the

Supreme Court’s holding in Landgraf v.

USI Film Products, et al., 114 S.Ct. 1483

(1994), legislative enactments will not

be presumed to apply retroactively

unless Congress has expressed clear

intent to the contrary. Mr. Girdhari

further argues that neither the GDEA’s

provisions nor its legislative history

constitute a clear expression of

retroactive intent.

The Supreme Court in Landgraf v.

USI Film Products, 114 S.Ct. 1483

(1994), clarified the standard to be

applied in determining whether or not

a statute operates retroactively. Under

the analysis established in Landgraf, a

statute applies retroactively if ‘‘Congress

has expressly prescribed’’ such

application. (Landgraf, 114 S.Ct. 1505.)

If the statute contains ‘‘no such express

command,’’ then the statute can only be

applied retroactively if the statute

would not have a ‘‘retroactive effect,’’

which ‘‘would impair a party’s rights

which he possessed when acting,

increase a party’s liability for past

conduct, or impose new duties with

respect to transactions already

completed.’’ (Id.)

Mr. Girdhari’s argument that the

GDEA cannot be applied retroactively

under the standard set forth in Landgraf

is unpersuasive. Mr. Girdhari’s

debarment is permissible because his

debarment does not have a ‘‘retroactive

effect’’ as that term is defined in

Landgraf. Moreover, even if Mr.

Girdhari’s debarment were viewed as

retroactive, the plain language of the

GDEA evinces a clear congressional

intent to debar specified individual

felons from future participation in the

pharmaceutical industry, irrespective of

whether their violations predate the

enactment of the GDEA. Finally, the

remedial goals of the GDEA demonstrate

Congress’s intent to apply debarment

under the GDEA to individuals

convicted before the statute’s

amendment.

1. Debarment Is Not Retroactive Under

Landgraf

Contrary to Mr. Girdhari’s argument,

Landgraf does not bar the future

application of a statute premised upon

events predating its enactment unless

the new statute has true ‘‘retroactive

effect.’’ (Landgraf, 114 S.Ct. 1505.)

Statutes authorizing injunctive or

other prospective relief do not have

retroactive effect, even if they are

predicated upon events antecedent to

the enactment of the statute. (Landgraf,

114 S.Ct. 1501.) Although the issuance

of an injunction is invariably

precipitated by past legal violations or

other misconduct, ‘‘the purpose of

prospective relief is to affect the future

rather than remedy the past,’’ id. at 1525

(Scalia, J., concurring), and the

injunction itself operates solely ‘‘in

futuro,’’ affecting only conduct that

occurs after it has been issued. (Id.

(quoting American Steel Foundries v.

Tri–City Central Trades Council, 257

U.S. 184, 201 (1921)).) Thus, ‘‘(w)hen

(an) intervening statute authorizes or

affects the propriety of prospective

relief, application of the new provision

is not retroactive.’’ (Landgraf, 114 S.Ct.

at 1501; see also American Steel

Foundries, 257 U.S. at 201 (because

relief by injunction operates only in

futuro, right to such relief must be

determined by law in effect at time

injunction is entered).)

Statutes that operate in futuro are not

retroactive within the meaning of

Landgraf, even if their application is

triggered by events antecedent to the

enactment of the statute. (See Bell

Atlantic Telephone Companies v. FCC,

79 F.3d 1195, 1207 (D.C. Cir. 1996) (FCC

‘‘add-back order’’ was not ‘‘retroactive’’

within the meaning of Landgraf and was

purely prospective, because even

though the order required the

assessment of past earnings, such an

order determined how much a carrier

could charge for future services);

Scheidemann v. INS, 83 F.3d 1517,

1523 (3rd Cir. 1995) (an amendment to

immigration law, ‘‘[l]ike statutes altering

the standards for injunctive relief,’’ had

only a ‘‘prospective’’ impact and, thus,

was not retroactive under Landgraf).)

Debarment under the GDEA, like an

injunction, plainly does not have

retroactive effect within the meaning of

Landgraf. Unlike the compensatory

damages at issue in Landgraf, which

were ‘‘quintessentially backwardlooking,’’ Landgraf, 114 S.Ct. at 1506,

the purpose of debarment is to restrict

future conduct, notwithstanding the fact

that its application is triggered by past

3456 Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices

events. For purposes of retroactivity

analysis, debarment orders are

indistinguishable from injunctions and

other forms of prospective relief. Mr.

Girdhari’s debarment is, in practical

effect, simply a statutorily-mandated

administrative injunction prohibiting

him from engaging in certain conduct in

the future.

As the Courts of Appeals for the

District of Columbia and the Seventh

Circuits have recognized, debarment

under the GDEA is a forward-looking

remedial action; it does not impose

additional punishment for past conduct

but, rather, reflects a congressional

judgment ‘‘that the integrity of the drug

industry, and with it public confidence

in that industry, will suffer if those who

manufacture drugs use the services of

someone who has committed a felony

subversive of FDA regulation.’’ (DiCola

v. FDA, 77 F.3d 504, 507 (D.C. Cir.

1996); see also Bae v. Shalala, 44 F.3d

489, 493, 496 (7th Cir. 1995) (debarment

under GDEA is solely remedial).)

2. The Plain Language of the GDEA

Demonstrates That Congress Intended

That FDA Debar Individuals Whose

Criminal Activity Predates the

Enactment of the GDEA

Even if debarment were viewed as

having ‘‘retroactive effect,’’ Mr.

Girdhari’s debarment is still permissible

under Landgraf because the plain

language of the GDEA evinces a clear

congressional intent that the statute be

applied to events that occurred prior to

its enactment.

First, section 306(l)(2) of the act,

which sets forth the effective dates for

various provisions of the act,

demonstrates that Congress intended

that section 306(a)(2) be applied

retroactively. Section 306(l)(2) of the act

states that section 306(a) shall not apply

to a conviction which occurred more

than 5 years before the initiation of an

agency action. This language indicates

that an applicable conviction may be

used as the basis for debarment, so long

as it occurred no more than 5 years prior

to the initiation of debarment

proceedings. At the time of the passage

of the statute on May 13, 1992, at which

point the agency could initiate a

debarment action under section

306(a)(2) of the act, any applicable

conviction up to 5 years before such

date could serve as the basis for the

debarment. Thus, the statute addresses

retroactivity, and sets forth the

boundaries of its application.

Second, the use of limiting language

in section 306(a)(1) of the act with

regard to mandatory debarment of

corporations and the omission of such

language in section 306(a)(2) with

regard to mandatory debarment of

individuals also demonstrates that

Congress intended that the latter section

be applied retroactively. Section

306(a)(1) of the act provides that

mandatory debarment of corporations

applies only to convictions ‘‘after the

date of enactment of this section.’’

However, section 306(a)(2) of the act,

which pertains to mandatory debarment

of individuals, does not contain this

limiting language. A commonly used

rule of statutory construction states that

where Congress includes particular

language in one section of a statute but

omits such language in another section

of the same act, it is generally presumed

that Congress acts intentionally and

purposefully in the disparate inclusion

or exclusion. (I.N.S. v. Cardoza–

Fonseca, 107 S.Ct. 1207, 1213 (1987)

(citing Russelo v. United States, 104

S.Ct. 296, 300 (1983)).) Accordingly,

here Congress intended that section

306(a)(2) of the act have retroactive

effect because it did not specify in

section 306(a)(2) that it applied only to

convictions ‘‘after the date of enactment

of this section’’ as specified in section

306(a)(1) of the act.

The negative inference drawn from

the omission in section 306(a)(2) of the

act of the language in section 306(a)(1),

which limits the latter section’s effect to

convictions after the date of enactment,

arises directly from the disparate

treatment of two provisions within a

subsection which are much more

closely related than the diverse sections

of the Civil Rights Act of 1991 cited by

appellant in Landgraf. The debarment

provisions at issue involve two types of

mandatory debarment, individual and

corporate, while the provisions of the

Civil Rights Act at issue in Landgraf

involved the foreign application of Title

VII, punitive and compensatory

damages, and the right to a jury trial.

Thus, the related debarment provisions

make a clear showing of retroactive

intent.

Moreover, even under Landgraf,

‘‘negative inference’’ may provide

evidence of congressional intent

regarding retroactive application of a

statute. Courts applying the (Landgraf)

analysis have found a sufficient

showing of congressional intent based

on negative inference drawn from the

statutory language to justify retroactive

application of the statute. (See

Scheidemann v. INS, 83 F.3d 1517,

1524 (3rd Cir. 1996); Nevada v. United

States, 925 F. Supp. 691, 693 (D. Nev.

1996) (the ‘‘(Landgraf) Court did not

preclude all future use of a negative

inference analysis in support of

retroactive intent’’).) Similarly, the

negative inference in the debarment

provisions of the GDEA demonstrates

the clear congressional intent for

retroactive application of the statute.

3. The Remedial Goals of the GDEA

Demonstrate That Congress Intended the

GDEA To Be Applied Retroactively

The circumstances giving rise to the

passage of the GDEA demonstrate that

Congress intended the statute to be

applied retroactively. Congress enacted

the GDEA in order to restore the

integrity of the drug approval process

and to protect the public health. (See

Generic Drug Enforcement Act of 1992,

Pub. L. 102–282, Section 102, 106 Stat.

149, 149 (1992).) In order to restore

consumer confidence in the drug

industry, Congress intended that

individuals convicted of felonies

relating to the development or approval,

or otherwise relating to the regulation,

of drug products be prohibited from

continuing to work in that industry.

(See section 306(a)(2) of the act.)

Construing the GDEA to permit the

debarment of individuals whose

felonious conduct occurred prior to the

GDEA’s enactment serves these

remedial goals of the statute.

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.)

Likewise, in DiCola v. FDA, 77 F.3d

504 (D.C. Cir. 1996), the Court of

Appeals for the District of Columbia

Circuit upheld the debarment of another

former generic drug company executive,

rejecting ex post facto, double jeopardy,

and vagueness challenges to his

debarment. The D.C. Circuit, like the

Seventh Circuit, found that the GDEA

legitimately achieved its remedial

purposes by barring convicted felons

from future contact with the industry.

(DiCola, 77 F.3d at 507.)

The GDEA is not punitive, but

accomplishes remedial goals by

removing convicted felons from the

industry they have exploited. The

Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices 3457

remedial goals would not be achieved,

however, if individuals convicted of

felonies prior to the GDEA’s enactment

continued to work in the drug industry.

Retroactive application of the GDEA is

not only permissible, but necessary,

because Congress’ aim of restoring

consumer confidence in the drug

industry is only served by applying the

statute to permit the debarment of

individuals, like Mr. Girdhari, whose

violations predate, and, in some cases,

precipitated, the statute’s enactment.

(See United States v. The Schooner

Peggy, 5 U.S. (1 Cranch) 103 (1801)

(courts to adopt interpretation that

serves overall purposes of the statute);

see also Scheidemann v. INS, 83 F.3d

1517, 1521 (3rd Cir. 1996) (Congress’s

intent to be deduced from statutory

scheme as a whole).) Thus, the remedial

goals of the GDEA demonstrate that

Congress intended the statute to be

applied retroactively.

B. Retroactive Application of the Statute

Violates the Ex Post Facto Clause

Mr. Girdhari argues that retroactive

application of the debarment provisions

of the GDEA to him violates the Ex Post

Facto Clause of the U.S. Constitution

because the debarment provisions,

which were not in effect at the time of

his criminal conduct, are punitive in

nature.

An ex post facto law is one that

reaches back to punish acts that

occurred before the enactment of a law

or that adds a new punishment to one

that was already in effect when the

crime was committed. (Ex Parte

Garland, 4 Wall. 333, 337, 18 L.Ed. 366

(1866); Collins v. Youngblood, 110 S.Ct.

2715 (1990).) Mr. Girdhari claims that

the debarment provisions are punitive

in nature for several reasons.

First, Mr. Girdhari argues that the

debarment provisions are punitive in

nature because the GDEA punishes

individuals for past behavior and deters

future misconduct both by the

individual who is debarred and by other

individuals in the drug industry.

Second, he argues that the debarment

provisions’ permanent prohibition on

providing services ‘‘in any capacity’’ to

a drug company constitutes an overly

broad restriction which is punitive in

nature. Third, he argues that such an

overly broad restriction distinguishes

his case from DeVeau v. Braisted, 80

S.Ct. 1146, 1155 (1960), in which the

Supreme Court found the retroactive

application of a law which prohibited

convicted felons from union office was

remedial in nature because the

restriction was ‘‘a relevant incident to a

regulation of a present situation.’’

Finally, he argues that application of the

debarment provisions to individuals

convicted of Federal felonies related to

the regulation of animal drugs would

not serve any remedial purpose, because

the statute’s remedial purpose is limited

to ensuring the integrity of the human

generic drug industry, safeguarding

human health, and restoring human

consumer confidence.

Mr. Girdhari’s arguments that

application of the debarment provisions

of the act to him is prohibited by the Ex

Post Facto Clause are unpersuasive. In

determining whether a statute violates

the Ex Post Facto Clause, the critical

consideration is whether the provision

is remedial or punitive in nature.

Because the intent underlying

debarment under section 306(a)(2) is

remedial rather than punitive,

application of the section to him does

not violate the Ex Post Facto Clause. Mr.

Girdhari’s arguments are addressed in

turn below.

1. Remedial Nature of the GDEA

Mr. Girdhari contends that the GDEA

is punitive because it punishes past

behavior and deters future misconduct.

It is clear, however, that the statute is

remedial in nature. Congress created the

GDEA in response to findings of fraud

and corruption in the generic drug

industry. Congress made explicit

findings regarding the necessity of the

GDEA that were incorporated into

section 1 of the statute and also were

made part of the legislative history. (See

H.R. Rep. No. 272, 102d Cong., 1st Sess.

10–11 (1991), reprinted in 1992

U.S.C.C.A.N. 103, 104–105.) Congress

found that ‘‘(1) there is substantial

evidence that significant corruption

occurred in FDA’s process of approving

drugs under abbreviated drug

applications, (2) there is a need to

establish procedures designed to restore

and to ensure the integrity of the

abbreviated drug application process

and to protect the public health, and (3)

there is a need to establish procedures

to bar individuals who have been

convicted of crimes pertaining to the

regulation of drug products from

working for companies that manufacture

or distribute such products.’’ (Generic

Drug Enforcement Act of 1992, Pub. L.

102–282, Section 102, 106 Stat. 149, 149

(1992).)

Moreover, the Courts of Appeals for

the District of Columbia Circuit and

Seventh Circuits have held that the

debarment provisions do not violate the

Ex Post Facto Clause, because the

provisions are remedial in nature, rather

than punitive. (DiCola v. F.D.A., 77 F.3d

504, 507 (D.C. Cir. 1996); Bae v. Shalala,

44 F.3d 489, 493 (7th Cir. 1995).) The

court in Bae concluded, ‘‘The clear and

unambiguous intent of Congress in

passing the GDEA was to purge the

generic drug industry of corruption and

to restore consumer confidence in

generic drug products. The GDEA’s civil

debarment penalty is solely remedial

* * *’’ (Bae at 493.) The court in DiCola

agreed with this conclusion. (DiCola at

507.)

Furthermore, the Supreme Court has

long held that statutes that deny future

privileges to convicted offenders

because of their previous criminal

activities in order to ensure against

corruption in specified areas do not

punish those offenders for past conduct

and, therefore, do not violate the ex post

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

New York, 18 S.Ct. 573 (1898)

(physician barred from practicing

medicine for a prior felony conviction);

DeVeau v. Braisted, 80 S.Ct. 1146 (1960)

(convicted felon’s exclusion from

employment as officer of waterfront

union is not a violation of the Ex Post

Facto Clause).)

Contrary to Mr. Girdhari’s

contentions, the remedial nature of the

GDEA is not diminished simply because

the GDEA deters debarred individuals

and others from future misconduct. The

Supreme Court in U.S. v. Halper, 109

S.Ct. 1892, 1901, n.7 (1989), noted that

‘‘for the defendant even remedial

sanctions carry the sting of

punishment.’’ The Court found that

such deterrent effects would not

diminish the remedial nature of a civil

sanction. (Halper at 1902.) Furthermore,

the Supreme Court in Hudson v. United

States, 118 S.Ct. 488, 494 (1997), stated,

‘‘We have since [the Halper ruling]

recognized that all civil penalties have

some deterrent effect’’ (emphasis

added). (See Department of Revenue of

Mont. v. Kurth Ranch, 114 S.Ct. 1937,

1945, n.14 (1994); United States v.

Ursery, 116 S.Ct. 2135, 2145, n. 2

(1996).) The Court continued, ‘‘(b)ut the

mere presence of this purpose

(deterrence) is insufficient to render a

sanction criminal * * *’’ (Hudson at

496.) As the court in Bae stated, ‘‘The

punitive effects of the GDEA are merely

incidental to its overriding purpose to

safeguard the integrity of the generic

drug industry while protecting public

health.’’ (Bae at 493; see also Mannochio

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

Cir. 1992).) Thus, Mr. Girdhari’s

argument that any incidental deterrent

effects cause the statute to be punitive

is without merit.

2. Permanent Prohibition on Services in

Any Capacity

Mr. Girdhari argues that the GDEA’s

permanent prohibition on providing

services ‘‘in any capacity’’ to a company

3458 Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices

with an approved or pending drug

application is an overly broad

restriction which is punitive in nature.

a. Prohibition on services in any

capacity. Mr. Girdhari contends that the

prohibition on providing services ‘‘in

any capacity’’ would include services

that have ‘‘no rational connection’’ to

the drug approval process. Mr. Girdhari

argues that such a prohibition would

not serve any remedial purpose of the

statute and would constitute

punishment for the debarred individual.

Mr. Girdhari’s arguments are

unpersuasive for the reasons given

below.

Congress enacted the GDEA in order

to restore the integrity of the drug

approval process and to protect the

public health. All facets of the drug

industry were implicated in the

scandals that led to the enactment of the

GDEA, including generic drug company

executives, scientists at both generic

and innovator firms, consultants,

research laboratories, and FDA

employees. (See H.R. Rep. No. 102–272,

102d Cong., 1st Sess., at 14 (1991).) In

light of this background, Congress

rationally concluded that in order to

ensure the integrity of the drug approval

process and to protect the public health,

it was necessary, among other things, to

unequivocally exclude from the drug

industry those individuals, like Mr.

Girdhari, who had previously engaged

in fraudulent or corrupt acts with

respect to the regulation of drugs. The

D.C. Circuit in DiCola held that the

debarment provisions’ prohibition on

services ‘‘in any capacity’’ serves the

statute’s remedial purpose. (DiCola at

507.) As the Seventh Circuit noted in

Bae, ‘‘the duration or severity of any

employment restriction will not mark it

as punishment where it is intended to

further a legitimate governmental

purpose.’’ (Bae at 495.)

The breadth of the debarment

imposed under the GDEA furthers the

statute’s remedial goals by promoting

efficient administration of the

debarment provisions, ensuring uniform

treatment of offenders, and restoring

public confidence in the pharmaceutical

industry. Congress prohibited all

services in the GDEA in order to avoid

the serious administrative difficulties

involved in distinguishing between

those positions clearly related to drug

regulation and those not so related.

(DiCola at 507.) These difficulties would

include the problem of ascertaining the

exact nature of an employee’s or

contractor’s relationship with an

employer or the person entering the

contract, as well as defining what

constitutes a sufficient nexus with the

regulatory scheme under all

circumstances. (DiCola at 507; see also

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

Cir. 1988).)

Additionally, the GDEA’s prohibition

on services ‘‘in any capacity’’ ensures

that the purposes underlying the

debarment sanction are not

circumvented or undermined. Any

attempt to list or define particular areas

of employment that are prohibited to

debarred individuals would be subject

to creative exploitation by those

determined to reenter a familiar field.

The D.C. Circuit in DiCola concluded

that the agency would be especially

concerned about ‘‘any employment that

might create an opportunity for regular

and frequent contact’’ between a

debarred individual and the

management of a drug company,

because ‘‘[t]he agency would find it very

difficult, if not impossible, to assure

itself and the public that [the

individual] is not, through that contact,

actually selling advice or other services

related to the circumvention of Federal

regulation.’’ (DiCola at 507; see also

Farlee and Calfee, Inc. v. USDA, 941

F.2d 964, 968 (9th Cir. 1991).)

Furthermore, courts have upheld

many other types of debarment

provisions that involved employment

restrictions that were as broad, or

broader than, the GDEA’s prohibition on

services ‘‘in any capacity.’’ For instance,

the United States Supreme Court in

Hudson v. United States, 118 S.Ct. 488

(1997), upheld a broad sanction that

debarred participation in any banking

activities. Furthermore, the Seventh

Circuit Court of Appeals in United

States v. Furlett, 974 F.2d 839, 844 (7th

Cir. 1992), upheld a debarment order

that prohibited a commodities trader

from trading on any contract market,

even as a retail customer of another

broker. (See also Manocchio v.

Kusserow, 961 F.2d 1539, 1541–42

(upholding exclusion from participation

in any Medicare program); United States

v. Bizzell, 921 F.2d at 267 (upholding

exclusion from participation in any

Housing and Urban Development

program).)

Finally, Mr. Girdhari cites Kennedy v.

Mendoza-Martinez, 83 S.Ct. 554, 568

(1963), in support of his argument that

the prohibition on services ‘‘in any

capacity’’ is not related to any remedial

purpose of the GDEA. Specifically, Mr.

Girdhari notes that the Supreme Court

held in Kennedy that the excessive

effect of a sanction relative to its

remedial purpose is relevant in

determining whether the sanction is

civil or criminal. (Kennedy at 568.) The

decision in Kennedy, however, does not

support Mr. Girdhari’s argument that

debarment is a punitive sanction.

The Supreme Court in Kennedy listed

the relevant factors, including whether

a sanction’s effect is excessive in

relation to its nonpunitive purpose, to

determine whether a civil penalty

removing an individual’s citizenship

was in effect a criminal penalty

requiring the procedural safeguards of

the Fifth and Sixth Amendments.

(Kennedy at 567–68.) As shown above,

the GDEA’s prohibition on providing

services ‘‘in any capacity’’ to

individuals with pending or approved

drug product applications is necessary

to promote the remedial purpose of the

statute and, thus, is not excessive.

Furthermore, the Supreme Court in

Hudson v. United States, 118 S.Ct. 488

(1997), held that a debarment order was

not a criminal punishment based, in

part, on the factors set forth in Kennedy.

As noted above, the debarment order at

issue in Hudson was as broad as the

GDEA’s prohibition on providing

services ‘‘in any capacity’’. Therefore,

by the reasoning in Kennedy, the

GDEA’s prohibition on providing

services ‘‘in any capacity’’ is not

punitive.

b. Permanence of the prohibition. As

for the prohibition’s duration, both the

District of Columbia and the Seventh

Circuits have held that the permanence

of the debarment is rationally related to

the remedial goals of the statute. (DiCola

at 507; Bae at 495.) The District of

Columbia Circuit in DiCola stated, ‘‘The

permanence of the debarment can be

understood, without reference to

punitive intent, as reflecting a

congressional judgment that the

integrity of the drug industry, and with

it public confidence in that industry,

will suffer if those who manufacture

drugs use the services of someone who

has committed a felony subversive of

FDA regulation.’’ (DiCola at 507.) The

Seventh Circuit in Bae emphasized that

permanent debarment from providing

services in any capacity is ‘‘not

disproportionate to the remedial goals of

the GDEA or to the magnitude of (the

defendant’s) wrongdoing.’’ (Bae at 496.)

Additionally, the Supreme Court has

upheld other statutes which, for

remedial purposes, permanently bar a

class or group of individuals from

certain occupations due to a prior

criminal conviction. (See Hawker v.

New York, 18 S.Ct. 573 (1898); DeVeau

v. Braisted, 80 S.Ct. 1146 (1960).)

Therefore, Mr. Girdhari’s argument that

the permanent nature of the debarment

is punitive must fail.

3. DeVeau

Mr. Girdhari contends that the GDEA

can be distinguished from DeVeau

because the permanent prohibition on

Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices 3459

providing services ‘‘in any capacity’’ to

an individual with an approved or

pending drug application cannot be

justified as ‘‘incident to a regulation of

a present situation’’ and thus reveals

punitive intent. However, the

debarment provisions’ prohibitions are

clearly incident to regulation of a

present situation and, as such, the

Court’s reasoning in DeVeau applies.

In DeVeau, 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

ensure against future corruption in the

waterfront unions. The Court in

DeVeau, 80 S.Ct. at 1155, 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 * * *.

As with DeVeau, the legislative

purpose of the relevant statute here is to

ensure that fraud and corruption are

eliminated from the drug industry and,

therefore, the public’s confidence in that

industry will be restored. The

restrictions placed on individuals

convicted of a felony under Federal law

are not intended as punishment but are

intended to preserve the integrity of the

drug approval process and protect the

public health, purposes which are

clearly ‘‘incident to a regulation of a

present situation’’ and, as such,

consistent with DeVeau. Therefore, this

argument must also fail.

4. Applicability of GDEA to Animal

Drug Convictions

Mr. Girdhari argues that the

debarment provisions of section

306(a)(2) of the act cannot be

retroactively applied to him because the

remedial purposes of the GDEA are

unrelated to the activities upon which

his conviction was based. He contends

that Congress intended the GDEA to

apply to convictions involving human

drugs, not animal drugs. Therefore, he

concludes that retroactive application of

section 306(a)(2) of the act to him would

not serve any remedial purpose.

Mr. Girdhari’s argument that section

306(a)(2) of the act cannot be

retroactively applied to convictions

involving animal drugs is unpersuasive.

Congress clearly intended the GDEA to

apply to convictions involving animal

drugs. The Supreme Court has held

repeatedly that the starting point for

determining the meaning of a statute is

the plain language of the statute.

(Norfolk & Western Railway Company v.

American Train Dispatchers

Association, 111 S.Ct. 1156, 1163

(1991); Mallard v. U.S. District Court

for the Southern District of Iowa, 109

S.Ct. 1814, 1818 (1989).) If the language

of the statute is clear on its face, that

language must ordinarily be regarded as

conclusive. (Negonsott v. Samuels, 113

S.Ct. 1119, 1122 (1993).)

It is clear from the plain language of

the GDEA that it explicitly includes

animal drugs within its scope. Section

306(a)(2) of the act applies to ‘‘an

individual who has been convicted of a

felony under Federal law for conduct

relating to the regulation of any drug

product.’’ (emphasis added.)

Additionally, section 306(a)(2) of the act

debars such individual ‘‘from providing

services in any capacity to a person that

has an approved or pending drug

product application.’’ (emphasis added.)

Section 201(dd) of the act (21 U.S.C.

321(dd)) defines drug product

specifically for the purpose of section

306 of the act as a drug subject to

regulation under section 505, 507, 512,

or 802 of the act (21 U.S.C. 355, 357,

360b, or 382), or section 351 of the

Public Health Service Act. Section 512

of the act regulates both pioneer and

generic animal drugs.

The intent of Congress to apply the

debarment provisions to animal drug

convictions is clearly shown by the

reference to section 512 of the act in the

definition of ‘‘drug product’’ in section

201(dd) of the act. Congress clearly

intended the GDEA to ensure the

integrity of the animal drug approval

process and thereby protect the public

health, because the plain language of the

GDEA applies to convictions related to

animal drugs. Therefore, Mr. Girdhari’s

argument that application of the GDEA

to convictions related to animal drugs

would not serve any remedial purpose

and, as such, retroactive application of

section 306(a)(2) of the act to him would

be punitive, is without merit.

C. Retroactive Application of the Statute

Violates the Due Process Clause

Mr. Girdhari argues that retroactive

application of the GDEA violates the

Due Process Clause of the U.S.

Constitution. First, Mr. Girdhari relies

on Usery v. Turner Elkhorn Mining Co.,

96 S.Ct. 2882, 2893 (1976), to argue that

retroactive application of the GDEA is

not justified under the Due Process

Clause. Second, Mr. Girdhari argues that

the terms of the GDEA as applied to him

are overly vague.

1. Usery

Mr. Girdhari argues that even if the

GDEA’s main purpose is remedial,

justification sufficient to support the

prospective application of a statute

under the Due Process Clause of the

Constitution is not always sufficient to

justify retrospective application of that

statute. Mr. Girdhari cites Usery v.

Turner Elkhorn Mining Co., 96 S.Ct.

2882, 2893 (1976), in support of this

argument. In that case the Court held

that the retroactive application of a

remedial statute designed to compensate

disabled coal miners was not arbitrary

and capricious under the Due Process

Clause, although the Court noted that it

would ‘‘hesitate to approve the

retrospective imposition of liability on

any theory of deterrence * * * or

blameworthiness.’’ (Id. (citations

omitted).)

Mr. Girdhari’s argument is

unpersuasive. Mr. Girdhari fails to

demonstrate that his debarment is

unrelated to any legitimate purpose, or

that the retroactive application of the

GDEA can only be justified on a theory

of deterrence or blameworthiness. As

shown above, debarment guards against

future violations by prohibiting

individuals ‘‘from providing services in

any capacity to a person that has an

approved or pending drug product

application’’ in order to meet the

legitimate regulatory purpose of

restoring the integrity of the drug

approval and regulatory process and

protecting the public health.

Additionally, as shown above, the

remedial nature of the GDEA is not

diminished simply because the GDEA

deters debarred individuals and others

from future misconduct. (U.S. v. Halper,

109 S.Ct. 1892, 1901, n.7 (1989); Bae v.

Shalala, 44 F.3d 489, 493 (7th Cir.

1995).) Thus, the GDEA satisfies the

requirements of the Due Process Clause

for retroactive application.

2. Vagueness

Mr. Girdhari asserts that the statute’s

prohibition on providing services ‘‘in

any capacity’’ is overly vague. The

Supreme Court held in Roberts v.

United States Jaycees, 104 S.Ct. 3244,

3256 (1984) (quoting Connally v.

General Construction Co., 46 S.Ct. 126,

127 (1926)), that ‘‘a statute which either

forbids or requires the doing of some act

in terms so vague that [persons] of

common intelligence must necessarily

guess at its meaning and differ as to its

application, violates the first essential of

due process of law.’’ The Roberts Court

explained that the constitutional

prohibition against such vague statutes

‘‘enables individuals to conform their

conduct to the requirements of the law.’’

(Roberts at 3256.)

The terms of the debarment order,

drawn from the language of the statute,

3460 Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices

are sufficiently clear to allow Mr.

Girdhari to conform his conduct to the

requirements of the law. The court in

DiCola held that the debarment order’s

prohibition on services ‘‘in any

capacity’’ did not render the order

unconstitutionally vague under the Due

Process Clause of the U.S. Constitution.

(DiCola at 509.)

The court explained that ‘‘all direct

employment by a drug company’’ would

be within the remedial scope of the

debarment order. (DiCola at 509.) The

court further explained that for

employment by enterprises that

provided goods or services to a drug

company, a debarred individual would

‘‘usually have a pretty good idea

whether a position with a firm that is

not itself a drug manufacturer runs afoul

of the remedial purpose for which he

has been debarred* * *’’ (DiCola at 509.)

Finally, the court in DiCola noted that

a debarred individual could seek a

prospective ruling about a specific

employment opportunity by filing a

citizen petition with the agency. (DiCola

at 509.) Likewise, if Mr. Girdhari is

uncertain whether a specific type of

employment would be within the scope

of the debarment order, he may file a

citizen petition with the agency

regarding his inquiry.

D. Application of the Statute Violates

the Double Jeopardy Clause

Finally, Mr. Girdhari argues that the

proposal to debar him under section

306(a)(2) of the act 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. Girdhari argues that the proposed

debarment constitutes additional

punishment for activities for which he

has already been punished.

Furthermore, Mr. Girdhari relies on U.S.

v. Halper, 490 U.S. 435 (1989), to argue

that permanent debarment is not

rationally related to any remedial

purpose because such debarment

unnecessarily reaches activities that are

completely unrelated to drug regulation

(e.g., photocopying documents for a

drug company).

Mr. Girdhari’s arguments are

unpersuasive. The Supreme Court in

Hudson v. United States, 118 S.Ct. 488

(1997), in large part disavowed the

method of analysis used in United

States v. Halper, 109 S.Ct. 1892 (1989),

to determine whether a sanction violates

the Double Jeopardy Clause. The Court

in Hudson held that the Double

Jeopardy Clause did not preclude the

criminal prosecution for violation of

Federal banking statutes of a defendant

who had previously been permanently

debarred from participating in any

banking activities for the same conduct.

The Double Jeopardy Clause protects

only against the imposition of multiple

criminal punishments for the same

offense in successive proceedings.

Hudson v. United States, 118 S.Ct. at

493. The Double Jeopardy Clause 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

in Hudson held that whether a

particular punishment is criminal or

civil is first a matter of statutory

construction. (Hudson v. United States,

118 S.Ct. at 493 (quoting Helvering v.

Mitchell, 58 S.Ct. 630, 633 (1938)).) 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.’’ (Hudson v.

United States, 118 S.Ct. at 493 (quoting

United States v. Ward, 100 S.Ct. at

2641).) Second, 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,’’ Hudson v. United States, 118

S.Ct. at 493 (quoting United States v.

Ward, 100 S.Ct. at 2641), as to

‘‘transform what was clearly intended as

a civil remedy into a criminal penalty,’’

Hudson v. United States, 118 S.Ct. at

493 (quoting Rex Trailer Co. v. United

States, 76 S.Ct. 219, 222 (1956)).

The debarment of Mr. Girdhari is not

a criminal penalty under Hudson. First,

the legislature in enacting the GDEA

intended clearly 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.) Here, the GDEA

explicitly provides FDA, through the

Secretary of Health and Human

Services, with the authority to

permanently debar individuals

convicted of certain felonies, such as

Mr. Girdhari, 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,

118 S.Ct. at 495 (quoting United States

v. Ursery, 116 S.Ct. 2135, 2148 (1996)).)

The Court in Hudson applied the

analysis of Kennedy v. Mendoza–

Martinez, 83 S.Ct. 554, 567–68 (1963), to

reaching this holding.

In Hudson, the Court first noted that

debarment proceedings have not

historically been viewed as punishment.

(Hudson at 495–96.) Second, the Court

found that ‘‘[debarment] sanctions do

not involve an ‘affirmative disability or

restraint,’ as that term is normally

understood.’’ (Hudson at 496 (quoting

Kennedy, 83 S.Ct. at 567).) Third, the

Court found that the debarment sanction

in the banking statute at issue in that

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, 83 S.Ct. at 567).)

Likewise, the GDEA does not require a

finding of willfulness as a prerequisite

to imposing debarment. Fourth, 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 company with an approved or

pending drug product application is not

excessive in relation to the statute’s

remedial purpose. As shown above,

both the District of Columbia and the

Seventh Circuits have upheld the

permanence of the debarment

provisions as rationally related to the

remedial goals of the statute, (DiCola at

507; Bae at 495.), and the Supreme

Court has upheld similar statutes which,

for remedial purposes, impose

permanent prohibitions. (See Hudson v.

United States, 118 S.Ct. 488 (1997);

Hawker v. New York, 170 U.S. 189, 190

Federal Register / Vol. 65, No. 14 / Friday, January 21, 2000 / Notices 3461

(1898); DeVeau v. Braisted, 80 S.Ct.

1146 (1960).)

The preclusion of Mr. Girdhari 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. As

stated above, the D.C. Circuit has held

that the GDEA’s prohibition on services

in any capacity serves the statute’s

remedial purpose. (DiCola at 507.)

Congress prescribed all services in order

to avoid the serious administrative

difficulties involved in distinguishing

between those positions clearly related

to drug regulation and those not clearly

related. (DiCola at 507; see also Seigel 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 at 507; see also Farlee and

Calfee, Inc. v. USDA, 941 F.2d 964, 968

(9th Cir. 1991).) Finally, as noted above,

the Supreme Court in Hudson v. United

States, 118 S.Ct. 488 (1997), upheld a

similar statute which, for remedial

purposes, imposes a prohibition on

participation in any banking activity.

Under Hudson, debarment pursuant

to the GDEA is not so punitive either in

purpose or effect as to render the

penalty criminal. Thus, Mr. Girdhari’s

argument that debarment under the

GDEA violates the Double Jeopardy

Clause must fail.

E. Conclusion

Mr. Girdhari acknowledges that he

was convicted as alleged by FDA in its

proposal to debar him and has raised no

genuine and substantial issue of fact

regarding this conviction. In addition,

Mr. Girdhari’s legal arguments do not

create a basis for a hearing and, in any

event, are unpersuasive. Accordingly,

the Commissioner denies Mr. Girdhari’s

request for a hearing.

III. Findings and Order

Therefore, the Commissioner, under

section 306(a) of the act, and under

authority delegated to her (21 CFR 5.10),

finds that Premchand Girdhari has been

convicted of a felony under Federal law

for conduct: (1) Relating to the

development or approval, including the

process for development or approval, of

a drug product (section 306(a)(2)(A) of

the act); and (2) relating to the

regulation of a drug product (section

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

As a result of the foregoing findings,

Premchand Girdhari is permanently

debarred from providing services in any

capacity to a person with an approved

or pending drug product application

under section 505, 512, or 802 of the act,

or under section 351 of the Public

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

effective January 21, 2000, (sections

306(c)(1)(B) and (c)(2)(A)(ii) and 201(ee)

of the act). Any person with an

approved or pending drug product

application who knowingly uses the

services of Mr. Girdhari in any capacity,

during his period of debarment, will be

subject to civil money penalties (section

307(a)(7) of the act (21 U.S.C.

335b(a)(7))). In addition, FDA will not

accept or review any abbreviated drug

application submitted by or with Mr.

Girdhari’s assistance during his period

of debarment (section 306(c)(1) of the

act).

Mr. Girdhari may file an application

to attempt 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. 94N–0162

and sent to the Dockets Management

Branch (address above). 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(j). Publicly

available submissions may be seen in

the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

Dated: January 13, 2000.

Bernard A. Schwetz,

Acting Deputy Commissioner for Food and

Drugs.

[FR Doc. 00–1406 Filed 1–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0120]

Safety of Imported Foods; Public

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

two public meetings on the safety of

imported foods. These meetings are

intended to give an overview of, and

discuss the six specific objectives of, the

proposed plan announced by the

President in his radio address of

December 11, 1999. FDA and the U.S.

Customs Service have developed

proposed new operational procedures to

accomplish these objectives. The public

meetings also are intended to give the

public an opportunity to comment on

the proposed procedures.

DATES: See Table 1 in the

SUPPLEMENTARY INFORMATION section of

this document.

ADDRESSES: See Table 1 in the

SUPPLEMENTARY INFORMATION section of

this document. Submit written

comments to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, Rm.

1061, Rockville, MD 20852. Two copies

of any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT: For

general information regarding this

document: Mary J. Ayling, Center for

Food Safety and Applied Nutrition

(HFS–32), Food and Drug

Administration, 200 C St. SW., Rm.

3823, Washington, DC 20204, 202–260–

5348, FAX 202–260–9653, e-mail:

mayling@bangate.fda.gov. The

comprehensive plan is available at

http://www.foodsafety.gov.

SUPPLEMENTARY INFORMATION: On July 3,

1999, the President announced an

initiative to ensure the safety of

imported food by directing the

Secretaries of the U.S. Department of

Health and Human Services and the

U.S. Department of Treasury to develop

new operational procedures to protect

public health. This initiative is geared to

optimize the statutory authorities and

resources available to FDA and the U.S.

Customs Service to take whatever steps

are feasible to protect consumers from

unsafe imported foods. The President

directed the agencies to target

unscrupulous importers who violate the

rules and work to subvert the system by

moving unsafe foods into U.S. markets.

The agenda for the public meetings

will include the following six specific

objectives emphasized in the President’s

directive: (1) To prevent distribution of

imported unsafe food by means such as

requiring food to be held until reviewed

by FDA; (2) destroy imported food that

poses a serious public health threat; (3)

prohibit the reimportation of food that

has been previously refused admission

and has not been brought into

compliance and require the marking of

shipping containers and/or papers of

imported food that is refused admission

for safety reasons; (4) set standards for

the use of private laboratories for the

collection and analysis of samples of

imported food for the purpose of gaining

entry into the United States; (5) increase

the amount of the bond posted for