58556 Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Notices

this order on a finding that Mr.

Elsharaiha was convicted of a felony

under Federal law for conduct relating

to the regulation of a drug product

under the act. Mr. Elsharaiha failed to

request a hearing and, therefore, has

waived his opportunity for a hearing

concerning this action.

EFFECTIVE DATE: September 29, 2000.

ADDRESSES: Submit applications 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:

Christine F. Rogers, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5640.

SUPPLEMENTARY INFORMATION:

I. Background

On March 4, 1994, the U.S. District

Court for the District of Maryland

entered judgment against Mr. Elsharaiha

for one count of making false

declarations before a grand jury, a

Federal felony offense under 18 U.S.C.

1623.

As a result of this conviction, FDA

published in the Federal Register of

January 19, 1999 (64 FR 2905), a notice

proposing to permanently debar Mr.

Elsharaiha from providing services in

any capacity to a person that has an

approved or pending drug product

application, and offering him an

opportunity for a hearing on the

proposal. The proposal was based on a

finding, under section 306(a)(2)(B) of

the act (21 U.S.C. 355a(a)(2)(B)), that he

was convicted of a felony under Federal

law for conduct relating to the

regulation of a drug product. Mr.

Elsharaiha was provided 30 days to file

objections and request a hearing. Mr.

Elsharaiha did not request a hearing. His

failure to request a hearing constitutes a

waiver of his opportunity for a hearing

and a waiver of any contentions

concerning his debarment.

II. Findings and Order

Therefore, the Director of the Center

for Drug Evaluation and Research, under

section 306(a)(2)(B) of the act, and

under authority delegated to her (21

CFR 5.99), finds that Mr. Rami

Elsharaiha has been convicted of a

felony under Federal law for conduct

relating to the regulation of a drug

product.

As a result of the foregoing finding,

Mr. Rami Elsharaiha 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

September 29, 2000, (21 U.S.C.

335a(c)(1)(B) and (c)(2)(A)(ii) and 21

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

approved or pending drug product

application who knowingly uses the

services of Mr. Elsharaiha, in any

capacity, during his period of

debarment, will be subject to civil

money penalties. If Mr. Elsharaiha,

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. In

addition, FDA will not accept or review

any abbreviated new drug applications

submitted by or with the assistance of

Mr. Elsharaiha during his period of

debarment.

Any application by Mr. Elsharaiha for

termination of debarment under section

306(d)(4) of the act should be identified

with Docket No. 94N–0371 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 between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: September 11, 2000.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 00–25087 Filed 9–28–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–2674]

Jay Marcus; Debarment Order

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

order under the Federal Food, Drug, and

Cosmetic Act (the act) debarring Mr. Jay

Marcus for 5 years 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. Marcus was

convicted of a felony under Federal law

for conspiracy to defraud the United

States. Mr. Marcus failed to request a

hearing and, therefore, has waived his

opportunity for a hearing concerning

this action.

EFFECTIVE DATE: September 29, 2000.

ADDRESSES: Submit applications 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:

Christine F. Rogers, 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 October 21, 1994, the U.S. District

Court for the District of Maryland

accepted Mr. Marcus’ plea of guilty to

one count of conspiracy to defraud the

United States under 18 U.S.C. 371 and

sentenced Mr. Marcus for the crime.

As a result of this conviction, FDA

published in the Federal Register of

October 15, 1999 (64 FR 55944), a

proposal to debar Mr. Marcus for a

period of 5 years from providing

services in any capacity to a person that

has an approved or pending drug

product application. The proposal also

offered Mr. Marcus an opportunity for a

hearing on the proposal. The debarment

proposal was based on a finding, under

section 306(b)(2)(B)(i) of the act (21

U.S.C. 355a(b)(2)(B)(i)), that Mr. Marcus

was convicted of a felony under Federal

law for conspiracy to defraud the United

States. Mr. Marcus was provided 30

days to file objections and request a

hearing. Mr. Marcus did not request a

hearing. His failure to request a hearing

constitutes a waiver of his opportunity

for a hearing and a waiver of any

contentions concerning his debarment.

II. Findings and Order

Therefore, the Director, Center for

Drug Evaluation and Research, under

section 306(b)(2)(B)(i) of the act, and

under authority delegated to her (21

CFR 5.99), finds that Mr. Jay Marcus has

been convicted of a felony under

Federal law for conspiracy to defraud

the United States.

As a result of the foregoing finding,

Mr. Jay Marcus is debarred for a period

of 5 years 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 September 29,

2000 (21 U.S.C. 335a(c)(1)(B) and

(c)(2)(A)(iii) and 21 U.S.C. 321(dd)).

Any person with an approved or

Federal Register / Vol. 65, No. 190 / Friday, September 29, 2000 / Notices 58557

pending drug product application who

knowingly uses the services of Mr.

Marcus in any capacity during his

period of debarment, will be subject to

civil money penalties. If Mr. Marcus,

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. In

addition, FDA will not accept or review

any abbreviated new drug applications

submitted by or with the assistance of

Mr. Marcus during his period of

debarment.

Any application by Mr. Marcus for

termination of debarment under section

306(d)(4) of the act should be identified

with Docket No. 99N–2674 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 between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: September 11, 2000.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 00–25086 Filed 9–28–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 94N–0424]

Mohammad Uddin; Debarment Order

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

order under the Federal Food, Drug, and

Cosmetic Act (the act) permanently

debarring Mr. Mohammad Uddin 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. Uddin

was convicted of a felony under Federal

law for conduct relating to the

regulation of a drug product under the

act. Mr. Uddin failed to request a

hearing and, therefore, has waived his

opportunity for a hearing concerning

this action.

EFFECTIVE DATE: September 29, 2000.

ADDRESSES: Submit applications 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:

Christine F. Rogers, 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 November 19, 1993, the United

States District Court for the District of

Maryland entered judgment against Mr.

Uddin for one count of obstruction of an

agency proceeding, a Federal felony

offense under 18 U.S.C. 1505.

As a result of this conviction, FDA

published in the Federal Register of

January 12, 1999 (64 FR 1809), a notice

proposing to permanently debar Mr.

Uddin from providing services in any

capacity to a person that has an

approved or pending drug product

application and offering him an

opportunity for a hearing on the

proposal. The proposal was based on a

finding, under section 306(a)(2)(B) of

the act (21 U.S.C. 355a(a)(2)(B)), that he

was convicted of a felony under Federal

law for conduct relating to the

regulation of a drug product. Mr. Uddin

was provided 30 days to file objections

and request a hearing. Mr. Uddin did

not request a hearing. His failure to

request a hearing constitutes a waiver of

his opportunity for a hearing and a

waiver of any contentions concerning

his debarment.

II. Findings and Order

Therefore, the Director, Center for

Drug Evaluation and Research, under

section 306(a)(2)(B) of the act, and

under authority delegated to her (21

CFR 5.99), finds that Mr. Mohammad

Uddin has been convicted of a felony

under Federal law for conduct relating

to the regulation of a drug product.

As a result of the foregoing finding,

Mr. Mohammad Uddin 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

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

section 351 of the Public Health Service

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

29, 2000 (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 Mr. Uddin, in any capacity,

during his period of debarment, will be

subject to civil money penalties. If Mr.

Uddin, 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. In

addition, FDA will not accept or review

any abbreviated new drug applications

submitted by or with the assistance of

Mr. Uddin during his period of

debarment.

Any application by Mr. Uddin for

termination of debarment under section

306(d)(4) of the act should be identified

with Docket No. 94N–0424 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 between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: September 11, 2000.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 00–25088 Filed 9–28–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0290]

The Dow Chemical Co.; Withdrawal of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 8B4586) proposing that the food

additive regulations be amended to

provide for the safe use of certain olefin

basic copolymers, derived from ethylene

and alpha monomers with eight or fewer

carbon atoms, as articles or as

components of articles intended for use

in contact with food.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3086.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

May 7, 1998 (63 FR 25212), FDA

announced that a food additive petition

(FAP 8B4586) had been filed by the

Dow Chemical Co., 2030 Dow Center,

Midland, MI 48674. The petition

proposed to amend the food additive