34652 Federal Register / Vol. 63, No. 122 /Thursday, June 25, 1998 / Notices

many cancer studies of industrial

cohorts have excluded women. This

study will provide information

concerning: (1) the incidence of breast

cancer in a cohort of women exposed to

ethylene oxide (ETO), and (2) the

incidence of breast cancer in a cohort of

women exposed to polychlorinated

biphenyls (PCBs). Both compounds are

suspected breast carcinogens. These two

cohorts have been previously assembled

by NIOSH, and each represents the

largest and best defined female study

cohort in the U.S. for the respective

exposure.

All women in the existing NIOSH

ethylene oxide cohort (n=9,929) and

PCB cohort (13,736) will be enrolled in

the study. For both cohorts, data from

personnel records has been coded into

a computer file containing demographic,

and work history information. This

information will be used to estimate

workplace exposures. Vital status has

been determined through automated

data sources. Questionnaires are

currently being mailed to each living

cohort member to obtain information on

breast cancer incidence and risk factors

for breast cancer. For deceased cohort

members, next-of-kin will be asked to

provide this information. Other record

sources such as death certificates and

population-based cancer incidence

registries will also be used to identify

cancer cases. The diagnosis will be

confirmed by medical records. Each

questionnaire will take approximately

30 minutes to complete. Total annual

burden hours are 12,500.

Respondents Number of

respondents

Number of

responses/

respondent

Avg. burden/response

(in hours)

Total burden

(in hours)

Workers ............................................................................................................................ 23,000 1 .50 11,500

Medical providers ............................................................................................................. 2,000 1 .50 1,000

2. Tests and Requirements for

Certification and Approval of

Respiratory Protective Devices—42 CFR

84—Regulation—(0920–0109)—

Extension—The regulatory authority for

the National Institute for Occupational

Safety and Health (NIOSH) certification

program for respiratory protective

devices is found in the Mine Safety and

Health Amendments Act of 1977 (30

U.S.C. 577a, 651 et seq., and 657(g)) and

the Occupational Safety and Health Act

of 1970 (30 U.S.C. 3, 5, 7, 811, 842(h),

844). These regulations have, as their

basis, the performance tests and criteria

for approval of respirators used by

millions of American construction

workers, miners, painters, asbestos

removal workers, fabric mill workers,

and fire fighters. In addition to

benefitting industrial workers, the

improved testing requirements also

benefit health care workers

implementing the current CDC

Guidelines for Preventing the

Transmission of Tuberculosis.

Regulations of the Environmental

Protection Agency (EPA) and the

Nuclear Regulatory Commission (NRC)

also require the use of NIOSH-approved

respirators.

NIOSH, in accordance with

implementing regulations 42 CFR 84: (1)

Issues certificates of approval for

respirators which have met improved

construction, performance, and

protection requirements; (2) establishes

procedures and requirements to be met

in filing applications for approval; (3)

specifies minimum requirements and

methods to be employed by NIOSH and

by applicants in conducting inspections,

examinations, and tests to determine

effectiveness of respirators; (4)

establishes a schedule of fees to be

charged applicants for testing and

certification, and (5) establishes

approval labeling requirements. Total

annual burden hours are 177,968.

Respondents (section/data type) Number of

respondents

Number of

responses/

respondent

Average

burden/response

(in hours)

Total burden

(in hours)

84.11/Applications ............................................................................................................ 56 14.0 63.56 49,831

84.33/Labeling .................................................................................................................. 56 14.0 1.54 1,207

84.35/Modifications ........................................................................................................... 56 14.0 79.45 62,289

84.41/Reporting ................................................................................................................ 56 14.0 22.70 17,797

84.43/Record keeping ...................................................................................................... 56 14.0 56.75 44,492

84.257/Labeling ................................................................................................................ 56 14.0 1.50 1,176

84.1103/Labeling .............................................................................................................. 56 14.0 1.50 1,176

Dated: June 18, 1998.

Charles W. Gollmar,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 98–16752 Filed 6–24–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 92N–0429]

Constantine I. Kostas; Denial of

Hearing; Final Debarment Order

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) denies a request

for a hearing and issues a final order

under the Federal Food, Drug, and

Cosmetic Act (the act) permanently

debarring Constantine I. Kostas, Nine

Cedar Mill Rd., Lynnfield, MA 01940,

from providing services in any capacity

to a person that has an approved or

pending drug product application. FDA

bases this order on its finding that Dr.

Kostas was convicted of felonies under

Federal law for conduct relating to the

development or approval, including the

process for development or approval, of

a drug product, and conduct relating to
Federal Register / Vol. 63, No. 122 /Thursday, June 25, 1998 / Notices 34653

the regulation of a drug product under

the act.

EFFECTIVE DATE: June 25, 1998.

ADDRESSES: Application for termination

of debarment to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Leanne Cusumano, 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

Constantine I. Kostas, a former

clinical investigator retained by a

pharmaceutical drug manufacturer to

conduct two investigational drug

studies, pled guilty and was sentenced

on October 13, 1988, to one count of

mail fraud and one count of making

false statements to a governmental

agency. These are Federal felony

offenses under 18 U.S.C. 1341 and 1001,

respectively. These convictions were

based upon Dr. Kostas’ submission of

fabricated patient case report forms to

the sponsor of investigational drug

studies from whom Dr. Kostas received,

via the U.S. Postal Service, payments for

conducting the clinical studies.

On December 14, 1992, Dr. Kostas

received a certified letter from FDA

offering Dr. Kostas an opportunity for a

hearing on the agency’s proposal to

issue an order under the Generic Drug

Enforcement Act (GDEA), section

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

335a(a)(2)). Under section 306(a)(2) of

the act, an individual who has been

convicted of a felony under Federal law

for conduct relating to the development

or approval, including the process for

development or approval, of a drug

product, or conduct relating to the

regulation of a drug product, shall be

debarred from providing services in any

capacity to a person that has an

approved or pending drug product

application. FDA found that Dr. Kostas

was subject to debarment under section

306(a)(2) of the act because he had been

convicted of Federal felony offenses for

conduct related to drug product

development, approval, and regulation.

The certified letter informed Dr.

Kostas 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 certified letter further

notified Dr. Kostas that if it conclusively

appeared from the face of the

information and factual analysis 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 accordance with procedures

set forth at part 12 (21 CFR part 12).

Dr. Kostas requested a hearing in a

letter dated February 12, 1993, based

upon three grounds. His request, in its

entirety, states:

Dr. Kostas, by his attorney, requests a

hearing on the following grounds:

(1) The law, as applied to Dr. Kostas,

violates the expost facto clause of the

Constitution of the United States. Art. I, Sec.

9, cl. 3 of the Constitution. Debarment is, in

effect, a criminal forfeiture and an increased

punishment which could not have been

imposed at the time of Dr. Kostas’ conviction.

In addition, Dr. Kostas’ offer of plea of

guilty to the criminal charges was tendered

and accepted with no mention of P.L. 102–

282 [GDEA]; and

(2) The pleas of guilty which prompted

your letter of December 9, 1992, were based

upon conduct last occurring in 1985. The

conduct was not discovered by the

government, but was reported voluntarily by

Dr. Kostas. In addition, Dr. Kostas

immediately, that is in 1985, returned all

funds to [the pharmaceutical company]. The

pleas of guilty did not result in any

incarceration and Dr. Kostas did not lose his

license to practice. Since in excess of seven

years has passed, application of 21 U.S.C.

§ 335a would be violative of both the ex post

facto and due process clauses of the

Constitution.

(3) Dr. Kostas hereby incorporates all of the

reasons in the preceding paragraph and states

additionally that precepts of constitutional

law require statutes such as 21 U.S.C. § 335a

to be applied prospectively and with the rule

of lenity.

For all of the foregoing reasons, pursuant

to 21 C.F.R. § 12.22, Dr. Kostas requests a

hearing on the above issues. Undersigned

contemplates that briefing of issues and

argument may be necessary, insofar as the

facts are not in dispute.

Although Dr. Kostas concedes that he

was convicted of felonies under Federal

law and that no facts are in dispute, he

argues that FDA’s proposal to debar him

is unconstitutional. The Deputy

Commissioner for Operations has

considered Dr. Kostas’ claims and, for

the reasons discussed below, concludes

that they are unpersuasive and fail to

raise a genuine and substantial issue of

fact requiring a hearing.

II. Dr. Kostas’ Claims in Support of His

Hearing Request

A. The Ex Post Facto Argument

In his hearing request, Dr. Kostas

argues that the ex post facto clause of

the U.S. Constitution prohibits FDA

from retrospectively applying section

306(a)(2) of the act to him. He states that

‘‘debarment is, in effect, a criminal

forfeiture and an increased punishment

which could not have been imposed at

the time of Dr. Kostas’ conviction.’’

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, 377, 18 L. Ed. 366 (1866); Collins

v. Youngblood, 497 U.S. 37 (1990).)

Dr. Kostas’ argument that application

of the mandatory debarment provisions

of the act is prohibited by the ex post

facto clause is unpersuasive, because

the intent of debarment is remedial, not

punitive. Congress created the GDEA in

response to findings of fraud and

corruption in the generic drug industry.

Both the language of the GDEA 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 abbreviated

new drug application approval process

and to protect the public health.’’ (See

section 1, Pub. L. 102–282, GDEA of

1992.) In a suit challenging a debarment

order issued by FDA (58 FR 69368,

December 30, 1993), the

constitutionality of the debarment

provision was upheld against a

challenge under the ex post facto clause.

The reviewing court affirmed the

remedial character of debarment:

Without question, the GDEA serves

compelling governmental interests unrelated

to punishment. 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 v. Shalala, 44 F.3d 489, 493 (7th

Cir. 1995); see also DiCola v. Food and

Drug Administration, 77 F.3d 504 (D.C.

Cir. 1996).) Because the intent of the

GDEA is remedial rather than punitive,

Dr. Kostas’ argument that the GDEA

violates the ex post facto clause must

fail. (See Bae v. Shalala, 44 F.3d at 496–

497.)

Dr. Kostas also states that his ‘‘offer of

plea of guilty to the criminal charges

was tendered and accepted with no

mention or contemplation of

[debarment].’’ It is not the function of

the plea agreement to provide notice of

any subsequent civil or administrative

actions. Nor do the terms of the plea

agreement preclude subsequent civil or

administrative actions against Dr.

Kostas. Therefore, Dr. Kostas’ claim that

the plea agreement does not mention

debarment fails to raise a genuine and

substantial issue of fact.

B. The Due Process Argument

Dr. Kostas argues that, because his

debarment is based upon conduct
34654 Federal Register / Vol. 63, No. 122 /Thursday, June 25, 1998 / Notices

occurring over 7 years before the agency

proposed to debar him, and because of

other mitigating factors, his debarment

also violates the due process clause

(presumably the fifth amendment) of the

U.S. Constitution. Under the fifth

amendment, no person shall be

deprived of life, liberty, or property

without due process of law. Dr. Kostas’

due process claim appears grounded

upon an alleged retroactive deprivation

of future employment.

The Supreme Court has said that

retroactive legislation must be

supported by ‘‘a legitimate legislative

purpose furthered by rational means.’’

(Pension Benefit Guar. Corp. v. R. A.

Gray & Co., 467 U.S. 717, 729 (1984).)

The ‘‘judgments about the wisdom of

such legislation remain within the

exclusive province of the legislative and

executive branches.’’ Id. As discussed

above, Congress intended the GDEA to

be remedial. The GDEA prohibits

certain individuals from providing

services to a person who has an

approved or pending drug 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. In addition, the remedial

nature of the GDEA is not diminished

simply because the GDEA deters

debarred individuals 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).)

Dr. Kostas argues that because he was

not incarcerated and did not lose his

‘‘license to practice,’’ and because he

voluntarily reported his conduct and

provided restitution to the

pharmaceutical company, debarment

under the GDEA would violate the due

process clauses of the Constitution. This

list of mitigating circumstances suggests

a ‘‘takings’’ argument based upon an

expectation of future employment.

However, the expectation of

employment is not recognized as a

protected property interest under the

fifth amendment. (Hoopa Valley Tribe v.

Christie, 812 F.2d 1097, 1102 (9th Cir.

1986); Chang v. United States, 859 F.2d

893, 896–897 (Fed. Cir. 1988).) One who

voluntarily enters a pervasively

regulated industry, such as the

pharmaceutical industry, and then

violates its regulations, cannot

successfully claim that he has a

protected property interest when he is

no longer entitled to the benefits of that

industry. (Erikson v. United States, 67

F.3d 858 (9th Cir. 1995).) Thus,

debarment for a 1985 felony conviction

does not violate the ex post facto or due

process clauses of the Constitution. In

addition, Dr. Kostas’ list of mitigating

circumstances does not raise a genuine

or substantial issue of disputed fact.

C. Prospective Application and the Rule

of Lenity Arguments

Finally, Dr. Kostas argues that

constitutional law requires that the

GDEA be applied ‘‘prospectively’’ and

with ‘‘the rule of lenity.’’ Again Dr.

Kostas’ arguments are unpersuasive.

The GDEA, as remedial legislation, was

intended by Congress to be applied, in

part, to conduct that occurred before

enactment of the legislation. The

express language of section 306(a)(1) of

the act requires that mandatory

debarment apply only prospectively to a

person ‘‘other than an individual’’ who

has been convicted of a Federal felony

offense ‘‘after the date of enactment of

this section [section 306(a)(1)].’’ By

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

which applies only to individuals, omits

the limiting language regarding

prospective application, indicating a

legislative intent to apply this provision

retrospectively. When one of two

closely related subsections within the

same act contains particular language

that is omitted from the other

subsection, ‘‘it is generally presumed

that Congress acted intentionally and

purposely in the disparate inclusion or

exclusion.’’ (Russello v. U.S., 464 U.S.

16, 24 (1983) (citations omitted); USA v.

Olin Corp., 107 F.3d 1506, 1513 (11th

Cir. 1997).) Such retrospective remedial

legislation is not unlawful so long as the

‘‘retroactive application of the

legislation is itself justified by a rational

legislative purpose.’’ (Pension Benefit

Guar. Corp. v. R. A. Gray & Co., 467 U.S.

at 730.) As discussed previously,

debarment under the GDEA meets the

legitimate regulatory purpose of

restoring the integrity of the drug review

process and protecting the public

health.

Dr. Kostas also states that

constitutional law requires that the

‘‘rule of lenity’’ apply to his case. The

rule of lenity applies in criminal cases

and requires a sentencing court to

impose the lesser of two penalties where

there is an actual ambiguity over which

penalty should apply. (U.S. v. Canales,

91 F.3d 363 (2nd Cir. 1996).) The rule

of lenity is not applicable here because

debarment under the GDEA is neither a

criminal law nor a penalty. It is a civil,

remedial law intended to protect the

drug review process and the public

health. Moreover, section 306(a)(2) of

the act requires debarment in this case

and does not provide the agency with

discretion to implement a different

remedy.

None of Dr. Kostas’ arguments raises

a genuine and substantial issue of fact

regarding his conviction. Instead, Dr.

Kostas concedes that there are no facts

in dispute. Moreover, Dr. Kostas’

constitutional arguments are without

merit. Accordingly, the Deputy

Commissioner for Operations denies Dr.

Kostas’ request for a hearing under 21

CFR 12.28.

III. Findings and Order

Therefore, the Deputy Commissioner

for Operations, under section 306(a) of

the act and under authority delegated to

him (21 CFR 5.20), finds that Dr.

Constantine I. Kostas has been

convicted of felonies 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

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

As a result of the foregoing findings,

Dr. Kostas is permanently debarred from

providing services in any capacity to a

person with an approved or pending

drug product application under sections

505, 507, 512, or 802 of the act (21

U.S.C. 355, 357, 360b, or 382), or under

section 351 of the Public Health Service

Act (42 U.S.C. 262), effective June 25,

1998 (sections 306(c)(1)(B) and

(c)(2)(A)(ii) 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 Dr. Kostas 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 Dr. Kostas, during his

period of 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 abbreviated new drug

application or abbreviated antibiotic

drug application submitted by Dr.

Kostas or with his assistance during his

period of debarment (section

306(c)(1)(B) of the act).

Dr. Kostas may file an application to

attempt to terminate his debarment

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

Any such application, if filed, will be

reviewed under the criteria and

processes set forth in section

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

application should be identified with

Docket No. 92N–0429 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
Federal Register / Vol. 63, No. 122 /Thursday, June 25, 1998 / Notices 34655

may be seen in the Dockets Management

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

Monday through Friday.

Dated: June 18, 1998.

Michael A. Friedman,

Acting Commissioner of Food and Drugs.

[FR Doc. 98–16850 Filed 6–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Anti-Infective Drugs Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Anti-Infective

Drugs Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 29, 30, and 31, 1998, 8 a.m.

to 5 p.m.

Location: Gaithersburg Hilton, Grand

Ballroom, 620 Perry Pkwy.,

Gaithersburg, MD.

Contact Person: Ermona B.

McGoodwin, Center for Drug Evaluation

and Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7001, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12530. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will discuss

documents on ‘‘Guidance to Industry’’

being developed by the Office of Drug

Evaluation IV’s Division of AntiInfective Drug Products and the

Division of Special Pathogens and

Immunologic Drug Products. Copies of

these draft guidance documents can be

obtained from the Center for Drug

Evaluation and Research (HFD–210),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–4573, or requested by FAX at

301–827–4577. Electronic versions of

these guidance documents will be

available via Internet using the World

Wide Web (www). To access the

documents on the www, connect to

CDER Home Page at http://

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

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 22, 1998. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 1:30 p.m. on July 29, 30, and

31, 1998. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 22, 1998, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 18, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–16934 Filed 6–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Arthritis Advisory Committee; Notice

of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Arthritis

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on August 7, 1998, 8 a.m. to 5 p.m.

Location: Bethesda Holiday Inn,

Versailles Ballrooms I and II, 8120

Wisconsin Ave., Bethesda, MD.

Contact Person: Kathleen R. Reedy or

LaNise S. Giles, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12532.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will discuss

the safety and efficacy of new drug

application 20–905 Arava (leflunomide,

Hoechst Marion Roussel, Inc., Germany)

for the treatment of rheumatoid arthritis.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 30, 1998. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 12 m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 30, 1998, and submit

a brief statement of the general nature of

the evidence or arguments they wish to

present, the names and addresses of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 15, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–16837 Filed 6–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Ophthalmic Drugs Subcommittee of

the Dermatologic and Ophthalmic

Drugs Advisory Committee; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Ophthalmic

Drugs Subcommittee of the

Dermatologic and Ophthalmic Drugs

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 22, 1998, 8 a.m. to 5 p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.