[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]
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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
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