09/29/2000

[Federal Register: September 29, 2000 (Volume 65, Number 190)]

[Notices]              

[Page 58556-58557]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr29se00-102]                        

 

-----------------------------------------------------------------------

 

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

 

[[Page 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