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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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FR DATE:04/30/2003

[Federal Register: April 30, 2003 (Volume 68, Number 83)]

[Notices]               
[Page 23138-23139]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap03-62]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0539]

 
Edwin Kokes; 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) permanently 
debarring Edwin Kokes 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. Kokes was convicted of a felony 
under Federal law for conduct relating to the regulation of a drug 
product under the act. Mr. Kokes failed to request a hearing and, 
therefore, has waived his opportunity for a hearing concerning this 
action.

DATES: This order is effective April 30, 2003.

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: Carol Drew, 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 August 19, 1998, the U.S. District Court for the District of 
Nebraska entered judgement against Mr. Kokes for one count of mail 
fraud, a Federal felony offense under 18 U.S.C. 1341. This offense was 
committed as part of a health care fraud scheme involving the sale of 
unapproved drug products to patients.
    As a result of this conviction, FDA served Mr. Kokes by certified 
mail on July 31, 2002, a notice proposing to permanently debar Mr. 
Kokes from providing services in any capacity to a person that has an 
approved or pending drug product application. The proposal also offered 
Mr. Kokes an opportunity for a hearing on the proposal. The debarment 
proposal was based on a finding, under section 306(a)(2)(B) of the act 
(21 U.S.C. 335a(a)(2)(B)), that Mr. Kokes was convicted of a felony 
under Federal law for conduct relating to the

[[Page 23139]]

regulation of a drug product under the act. Mr. Kokes was provided 30 
days to file objections and request a hearing. Mr. Kokes 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 5.34), finds that Mr. Edwin Kokes has been convicted of a 
felony under Federal law for conduct relating to the regulation of a 
drug product under the act.
    As a result of the foregoing finding, Mr. Edwin Kokes 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)(see 
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. Kokes, 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 Mr. Kokes, 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 applications submitted by or with the assistance 
of Mr. Kokes during his period of debarment.
    Any application by Mr. Kokes for termination of debarment under 
section 306(d)(4) of the act should be identified with Docket No. 01N-
0539 and sent to the Dockets Management Branch (see ADDRESSES). 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: March 28, 2003.
Steven K. Galson,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 03-10569 Filed 4-29-03; 8:45 am]

BILLING CODE 4160-01-S