Paul H. Kornak: Debarment Order, 38657-38658 [E9-18619]
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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
forged, with the intent to create a false
impression of a state of facts. Dr.
Hendrick was paid by GlaxoSmithKline
approximately $116,800 in X-ray fees
for his participation in the clinical
research trial. In so doing he caused a
check to be mailed to him through the
Postal Service at the direction of
GlaxoSmithKline as partial payment for
his participation in the clinical trial for
the purpose of executing the scheme to
defraud.
As a result of this conviction, FDA
sent Dr. Hendrick 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
Dr. Hendrick was convicted of a felony
under Federal law for conduct relating
to the development or approval of a
drug product, including the process for
development or approval of a drug
product, and conduct otherwise relating
to the regulation of a drug product
under the act. The proposal also offered
Dr. Hendrick 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. Dr. Hendrick 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 Dr.
Hendrick has been convicted of a felony
under Federal law for conduct relating
to the development or approval of a
drug product, including the process for
development or 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,
Dr. Hendrick 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),
VerDate Nov<24>2008
16:07 Aug 03, 2009
Jkt 217001
and 321(dd)). Any person with an
approved or pending drug product
application who knowingly employs or
retains as a consultant or contractor, or
otherwise uses the services of Dr.
Hendrick, in any capacity, during Dr.
Hendrick’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 Dr. Hendrick, 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 Dr. Hendrick during his
permanent debarment (section
306(c)(1)(B) of the act).
Any application by Dr. Hendrick for
special termination of debarment under
section 306(d)(4) of the act should be
identified with Docket No. FDA–2008–
N–0582 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 15, 2009.
Alyson L. Saben,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. E9–18621 Filed 8–3–09; 8:45 am]
BILLING CODE 4160–01–S
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.
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
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
38657
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
E:\FR\FM\04AUN1.SGM
04AUN1
38658
Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
mstockstill on DSKH9S0YB1PROD with NOTICES
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.
VerDate Nov<24>2008
16:07 Aug 03, 2009
Jkt 217001
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]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0258; FDA–2008–
E–0260; and FDA–2008–E–0261]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; RECOTHROM
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
RECOTHROM and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of three applications to the
Director of Patents and Trademarks,
Department of Commerce, for the
extension of patents which claim that
human biological product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the human
biological product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the human
biological product. Although only a
portion of a regulatory review period
may count toward the actual amount of
extension that the Director of Patents
and Trademarks may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
E:\FR\FM\04AUN1.SGM
04AUN1
Agencies
[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38657-38658]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18619]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4160-01-S