[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38657-38658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18619]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-N-0501]


Paul H. Kornak: 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 Paul H. Kornak 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 Paul H. Kornak was convicted of 
three felonies under Federal law for conduct relating to the 
development or approval, including the process for development or 
approval, of a drug product, and for conduct otherwise relating to the 
regulation of a drug product under the act. After being given notice of 
the proposed permanent debarment and an opportunity to request a 
hearing within the timeframe prescribed by regulation, Mr. Kornak 
failed to request a hearing. Mr. Kornak's failure to request a hearing 
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is effective August 4, 2009.

ADDRESSES: Submit applications for special termination of debarment to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert L. Hummel, Sr., Division of 
Compliance Policy (HFC-230), Office of Enforcement, Office of 
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 240-632-6845.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(A) of the act (21 U.S.C. 335a(a)(2)(A)) requires 
debarment of an individual if FDA finds that the individual has been 
convicted of a felony under Federal law for conduct relating to the 
development or approval, including the process for development or 
approval, of any drug product. Section 306(a)(2)(B) of the act requires 
debarment of an individual if FDA finds that the individual has been 
convicted of a felony under Federal law for conduct otherwise relating 
to the regulation of any drug product under the act.
    On January 18, 2005, the U.S. District Court for the Northern 
District of New York accepted Mr. Kornak's plea of guilty and entered 
judgment against Mr. Kornak for one count of making and using a 
materially false statement, one count of mail fraud, and one count of 
criminally negligent homicide, federal felony offenses under 18 U.S.C. 
1001(a)(3), 1341 and 1346, and 13, respectively. The actions underlying 
these convictions were committed while Mr. Kornak was employed by the 
Department of Veterans Affairs as the coordinator of several clinical 
studies of drug products. Mr. Kornak participated in a scheme to 
defraud the sponsors of these studies by repeatedly submitting false 
documentation and enrolling and causing to be enrolled persons as study 
subjects who did not qualify under particular study protocols. Mr. 
Kornak admitted to submitting a case report form with regard to a study 
subject knowing the document contained

[[Page 38658]]

materially false laboratory entries and altered information from a 
radiology display report, which were critical factors in determining 
whether the individual was eligible to participate in the clinical 
study. He also admitted to knowingly and willfully misrepresenting the 
results of a blood chemistry analysis related to the participation of a 
study subject who would not otherwise have met the criteria for that 
study. The subject was administered chemotherapeutic drugs in 
connection with the clinical study and died as a result thereof. Mr. 
Kornak's failure to perceive a substantial and unjustifiable risk that 
death would occur when he knowingly and willingly made and used such 
false documents constituted a gross deviation from the standard of care 
that a reasonable person would observe in the situation. Mr. Kornak 
further admitted to knowingly and willfully using interstate mail for 
the purpose of executing the aforesaid scheme and artifice to defraud, 
deprive, and obtain money and property.
    As a result of these convictions, FDA sent Mr. Kornak by certified 
mail on May 4, 2009, a notice proposing to permanently debar him from 
providing services in any capacity to a person that has an approved or 
pending drug product application. The proposal was based on a finding, 
under section 306(a)(2)(A) and (a)(2)(B) of the act, that Mr. Kornak 
was convicted of felonies under Federal law for conduct relating to the 
development or approval of a drug product, and for conduct otherwise 
relating to the regulation of a drug product under the act. The 
proposal also offered Mr. Kornak an opportunity to request a hearing, 
providing him 30 days from the date of receipt of the letter in which 
to file the request, and advised him that failure to request a hearing 
constituted a waiver of the opportunity for a hearing and of any 
contentions concerning this action. Mr. Kornak did not request a 
hearing and has, therefore, waived his opportunity for a hearing and 
any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(a)(2)(A) and (a)(2)(B) of the 
act, and under authority delegated to the Acting Director (Staff Manual 
Guide 1410.35), finds that Mr. Kornak has been convicted of felonies 
under Federal law for conduct relating to the development of approval 
of a drug product and conduct otherwise relating to the regulation of a 
drug product under the act.
    As a result of the foregoing finding, Mr. Kornak 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 (see DATES) 
(see sections 306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) of the act (21 
U.S.C. 335a(c)(1)(B) and (c)(2)(A)(ii), and 321(dd)). Any person with 
an approved or pending drug product application who knowingly employs 
or retains Mr. Kornak as a consultant or contractor, or otherwise uses 
in any capacity the services of Mr. Kornak during Mr. Kornak's 
permanent debarment, will be subject to civil money penalties (section 
307(a)(6) of the act (21 U.S.C. 335b(a)(6))). If Mr. Kornak, 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. Kornak during his period of 
debarment (section 306(c)(1)(B) of the act).
    Any application by Mr. Kornak for special termination of debarment 
under section 306(d)(4) of the act should be identified with Docket No. 
2007-N-0501 and sent to the Division of Dockets Management (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 Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 20, 2009.
Alyson L. Saben,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-18619 Filed 8-3-09; 8:45 am]
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