[Federal Register Volume 65, Number 190 (Friday, September 29, 2000)]
[Notices]
[Pages 58556-58557]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25086]


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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.

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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