Debarment, 9555-9556 [E6-2667]
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Federal Register / Vol. 71, No. 37 / Friday, February 24, 2006 / Notices
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Additional information on all bank
holding companies may be obtained
from the National Information Center
website at www.ffiec.gov/nic/.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than March 23,
2006.
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A. Federal Reserve Bank of Chicago
(Patrick M. Wilder, Assistant Vice
President) 230 South LaSalle Street,
Chicago, Illinois 60690-1414:
1. Community State Bank Employee
Stock Ownership Plan and Trust, Union
Grove, Wisconsin; to increase its
ownership to 33.95 percent of the voting
shares of Union Bancorporation, Inc.,
Union Grove, Wisconsin, and thereby
indirectly acquire Community State
Bank, Union Grove, Wisconsin.
2. Gerber Bancshares, Inc., Argenta,
Illinois; to become a bank holding
company by acquiring 100 percent of
the voting shares of Gerber State Bank,
Argenta, Illinois.
B. Federal Reserve Bank of St. Louis
(Glenda Wilson, Community Affairs
Officer) 411 Locust Street, St. Louis,
Missouri 63166-2034:
1. First Banks, Inc., Hazelwood,
Missouri, and its subsidiary bank, The
San Francisco Company, San Francisco,
California; to acquire 80 percent of the
voting shares of First Independent
National Bank, Plano, Texas.
2. First Banks, Inc. , Hazelwood,
Missouri, and its subsidiary bank
holding company, The San Francisco
Company, San Francisco, California; to
acquire 100 percent of Pittsfield
Community Bancorp, Inc., Pittsfield,
Illinois, and thereby indirectly acquire
Community Bank of Pittsfield, Pittsfield,
Illinois.
Board of Governors of the Federal Reserve
System, February 21, 2006.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E6–2640 Filed 2–23–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
beneficiary satisfaction; and program
administration.
Assistant Secretary for Planning and
Evaluation; Medicaid Program;
Meeting of the Medicaid Commission—
March 13–15, 2006
Procedure and Agenda
This meeting is open to the public.
There will be a public comment period
at the meeting. The Commission may
limit the number and duration of oral
presentations to the time available. We
will request that you declare at the
meeting whether or not you have any
financial involvement related to any
services being discussed.
After the presentations and public
comment period, the Commission will
deliberate openly. Interested persons
may observe the deliberations, but the
Commission will not hear further
comments during this time except at the
request of the Chairperson. The
Commission will also allow an open
public session for any attendee to
address issues specific to the topic.
Assistant Secretary for
Planning & Evaluation (ASPE), HHS.
ACTION: Notice of meeting.
AGENCY:
SUMMARY: This notice announces a
public meeting of the Medicaid
Commission. Notice of this meeting is
given under the Federal Advisory
Committee Act (5 U.S.C. App. 2, section
10(a)(1) and (a)(2)). The Medicaid
Commission will advise the Secretary
on ways to modernize the Medicaid
program so that it can provide highquality health care to its beneficiaries in
a financially sustainable way.
DATES: The Meeting: March 13–15, 2006.
The meeting will begin at 6 p.m. on
March 13, 9 a.m. on March 14, and 8:30
a.m. on March 15.
Special Accommodations: Persons
attending the meeting who are hearing
or visually impaired, or have a
condition that requires special
assistance or accommodations, are
asked to notify the Medicaid
Commission by March 3, 2006 (see FOR
FURTHER INFORMATION CONTACT).
ADDRESSES: The Meeting: The meeting
will be held at the following address:
Crowne Plaza-Atlanta-Perimeter N.W.,
6345 Powers Ferry Road, NW., Atlanta,
GA 30339, United States, telephone: 1
(770) 955–1700, fax: 1 (770) 850–0444.
Web site: You may access up-to-date
information on the Medicaid
Commission at https://aspe.hhs.gov/
medicaid/.
FOR FURTHER INFORMATION CONTACT:
Margaret Reiser, (202) 205–8255.
SUPPLEMENTARY INFORMATION: On May
24, 2005, we published a notice (70 FR
29765) announcing the Medicaid
Commission and requesting
nominations for individuals to serve on
the Medicaid Commission. This notice
announces a public meeting of the
Medicaid Commission.
Topics of the Meeting
The Commission will discuss options
for making longer-term
recommendations on the future of the
Medicaid program that ensure long-term
sustainability. Issues to be addressed
may include, but are not limited to:
Eligibility, benefit design, and delivery;
expanding the number of people
covered with quality care while
recognizing budget constraints; long
term care; quality of care, choice, and
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Authority: 5 U.S.C. App. 2, section 10(a)(1)
and (a)(2).
Dated: February 16, 2006.
Mary M. McGeein,
Deputy Assistant Secretary for Planning and
Evaluation, Office of Disability, Aging and
Long-Term Care.
[FR Doc. E6–2608 Filed 2–23–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Debarment
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: Notice is hereby given that
the Deputy Assistant Secretary for the
Office of Acquisition Management and
Policy of the Department of Health and
Human Services (HHS) has taken final
agency action in the following case:
Paul H. Kornak, Stratton VA Medical
Center, Albany, New York: Upon
recommendations from the Office of
Research Integrity (ORI), Acting
Assistant Secretary for Health for the
Department of Health and Human
Services (HHS), the Office of Research
Oversight (ORO), and the Under
Secretary for Health, Department of
Veterans Affairs (VA), that were based
on the criminal convictions of making
and using a materially false statement,
in violation of 18 U.S.C. 1001(a)(3); mail
fraud, in violation of 18 U.S.C. 1341 and
1346; and criminally negligent
homicide, in violation of 18 U.S.C. 13
and New York Penal Law § 125.10, the
HHS debarring official has permanently
debarred Mr. Paul Kornak, former
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9556
Federal Register / Vol. 71, No. 37 / Friday, February 24, 2006 / Notices
research coordinator at the Stratton VA
Medical Center. This action is taken
pursuant to the HHS government-wide
nonprocurement debarment and
suspension regulation at 45 CFR part 76.
As such, Mr. Kornak is excluded for life
from participating in any and all Federal
agency transactions, both procurement
and nonprocurement, as set forth in part
76.
Of the 48 criminal charges contained
in his Indictment, Paul Kornak pled
guilty to the three criminal charges
listed above. See United States of
America v. Paul H. Kornak, Criminal
Action No. 03–CR–436 (FJS), U.S.
District Court (N.D.N.Y.) (January 18,
2005). In addition to the 71-month term
of imprisonment imposed, Mr. Kornak
was directed to pay restitution to two
pharmaceutical companies and the VA
in the amount of approximately
$639,000.
As part of his guilty plea, Mr. Kornak
admitted to the following facts:
• In August 2000, Mr. Kornak applied
for employment to the VA, submitting a
false ‘‘Declaration for Federal
Employment’’ form. Mr. Kornak denied
that he had been convicted or on
probation in the preceding 10 years,
whereas in fact, he had been convicted
of mail fraud in 1992 and placed on
probation for 3 years.
• By October of 2000, Mr. Kornak was
responsible for organizing, coordinating,
implementing, and directing all research
elements in the Stratton VA Medical
Center oncology research program.
Specifically, Mr. Kornak was the site
coordinator at the Stratton VA Medical
Center for the ‘‘Iron (Fe) and
Atherosclerosis Study’’ (FeAST), cancer
studies known as Tax 325 and Tax 327,
and a bladder cancer study. The FeAST
study was a clinical trial that tested a
novel procedure for controlling
atherosclerosis, also known as
hardening of the arteries, by reducing
the iron in the body through blood
drawing. The Tax 325 cancer treatment
study involved the administration of
pharmaceutical products to patients
with metastatic or locally recurrent
gastric cancer previously untreated with
chemotherapy for advanced disease.
The Tax 327 study involved the
administration of pharmaceutical
products to patients with metastatic
hormone refractory prostate cancer. The
purpose of the bladder cancer study,
which was co-sponsored by the National
Cancer Institute, National Institutes of
Health, was to compare the use of
difluoromethylornithine (DFMO) to the
use of a placebo in patients with low
grade superficial bladder cancer
according to time to first recurrence of
the tumor and toxicities.
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• From May 14, 1999, to July 10,
2002, in connection with the above
protocols, Mr. Kornak participated in a
scheme to defraud the sponsors of the
clinical studies in that ‘‘he would and
repeatedly did submit false
documentation regarding patients and
study subjects and enroll and cause to
be enrolled persons as study subjects
who did not qualify under the particular
study protocol.’’
• Mr. Kornak caused the death of a
study subject when he ‘‘failed to
perceive a substantial and unjustifiable
risk that death would occur when he
knowingly and willfully made and used
* * * documents falsely stating and
representing the results of [the study
subject’s] blood chemistry analysis
* * *, which false documents
purported that [the study subject] met
the inclusion and exclusion criteria for
participation in Tax 325 when the
actual results did not meet the inclusion
and exclusion criteria and showed
impaired kidney and liver function, and
[the study subject] thus was
administered the chemotherapeutic
drugs docetaxel, cisplatin, and 5–FU in
connection with Tax 325 on or about
May 31, 2001, and died as a result
thereof on or about June 11, 2001.’’
Based on the criminal conviction and
the facts admitted to above, HHS and
VA believe that a debarment period
longer than the standard length of
debarment is warranted in this case. Mr.
Kornak admitted to a dishonest
handling of the research records and
demonstrated a complete disregard for
the well-being of vulnerable human
subjects under his care. In pleading
guilty to criminally negligent homicide,
Mr. Kornak admitted that a reasonable
person would have perceived a
substantial and unjustifiable risk of
death if an ineligible subject were
enrolled in the cancer study in question
and that his failure to perceive such a
risk in enrolling the ineligible subject
constituted a gross deviation from the
standard of care.
Moreover, a longer debarment period
is warranted in this case because of an
established pattern of misconduct and
criminal behavior on the part of Mr.
Kornak. As stated above, Mr. Kornak has
a prior conviction of mail fraud. In
addition, the Office of Personnel
Management excluded Mr. Kornak from
all Federal nonprocurement transactions
for an indefinite period, effective July
22, 1993. Nonetheless, beginning in
1999, Mr. Kornak actively participated
in federally sponsored research
protocols in violation of the imposed
exclusion.
A lifetime debarment of Mr. Kornak is
necessary to protect the public interest
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overall. Given the scope of his criminal
conviction, his longstanding pattern of
criminal behavior, and his total
disregard for the safety and well-being
of human subjects, Mr. Kornak’s
responsibility to engage in transactions
with the Federal Government cannot be
assured at any time in the future.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight,
Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852.
(240) 453–8800,
or
Peter Poon,
Health Science Specialist,
Office of Research Oversight,
Veteran’s Health Administration, VA,
811 Vermont Ave., NW. (10R), Suite
574,
Washington, DC 20420.
(202) 565–8107.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. E6–2667 Filed 2–23–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) allow the proposed
information collection project: ‘‘Use of
IT and Health IT Among Health Centers
funded under Section 330 of the Public
Health Service Act’’. In accordance with
the Paperwork Reduction Act of 1995,
Public Law 104–13 (44 U.S.C.
3506(c)(2)(A)), AHRQ invites the public
to comment on this proposed
information collection.
DATES: Comments on this notice must be
received by April 25, 2006.
ADDRESSES: Written comments should
be submitted to: Cynthia D. McMichael,
Reports Clearance Officer, AHRQ, 540
Gaither Road, Suite 5022, Rockville, MD
20850. Copies of the proposed
collection plan, data collection
instrument, and specific details on the
estimated burden can be obtained from
AHRQ’s Reports Clearance Officer.
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[Federal Register Volume 71, Number 37 (Friday, February 24, 2006)]
[Notices]
[Pages 9555-9556]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-2667]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Debarment
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that the Deputy Assistant Secretary for
the Office of Acquisition Management and Policy of the Department of
Health and Human Services (HHS) has taken final agency action in the
following case:
Paul H. Kornak, Stratton VA Medical Center, Albany, New York: Upon
recommendations from the Office of Research Integrity (ORI), Acting
Assistant Secretary for Health for the Department of Health and Human
Services (HHS), the Office of Research Oversight (ORO), and the Under
Secretary for Health, Department of Veterans Affairs (VA), that were
based on the criminal convictions of making and using a materially
false statement, in violation of 18 U.S.C. 1001(a)(3); mail fraud, in
violation of 18 U.S.C. 1341 and 1346; and criminally negligent
homicide, in violation of 18 U.S.C. 13 and New York Penal Law Sec.
125.10, the HHS debarring official has permanently debarred Mr. Paul
Kornak, former
[[Page 9556]]
research coordinator at the Stratton VA Medical Center. This action is
taken pursuant to the HHS government-wide nonprocurement debarment and
suspension regulation at 45 CFR part 76. As such, Mr. Kornak is
excluded for life from participating in any and all Federal agency
transactions, both procurement and nonprocurement, as set forth in part
76.
Of the 48 criminal charges contained in his Indictment, Paul Kornak
pled guilty to the three criminal charges listed above. See United
States of America v. Paul H. Kornak, Criminal Action No. 03-CR-436
(FJS), U.S. District Court (N.D.N.Y.) (January 18, 2005). In addition
to the 71-month term of imprisonment imposed, Mr. Kornak was directed
to pay restitution to two pharmaceutical companies and the VA in the
amount of approximately $639,000.
As part of his guilty plea, Mr. Kornak admitted to the following
facts:
In August 2000, Mr. Kornak applied for employment to the
VA, submitting a false ``Declaration for Federal Employment'' form. Mr.
Kornak denied that he had been convicted or on probation in the
preceding 10 years, whereas in fact, he had been convicted of mail
fraud in 1992 and placed on probation for 3 years.
By October of 2000, Mr. Kornak was responsible for
organizing, coordinating, implementing, and directing all research
elements in the Stratton VA Medical Center oncology research program.
Specifically, Mr. Kornak was the site coordinator at the Stratton VA
Medical Center for the ``Iron (Fe) and Atherosclerosis Study'' (FeAST),
cancer studies known as Tax 325 and Tax 327, and a bladder cancer
study. The FeAST study was a clinical trial that tested a novel
procedure for controlling atherosclerosis, also known as hardening of
the arteries, by reducing the iron in the body through blood drawing.
The Tax 325 cancer treatment study involved the administration of
pharmaceutical products to patients with metastatic or locally
recurrent gastric cancer previously untreated with chemotherapy for
advanced disease. The Tax 327 study involved the administration of
pharmaceutical products to patients with metastatic hormone refractory
prostate cancer. The purpose of the bladder cancer study, which was co-
sponsored by the National Cancer Institute, National Institutes of
Health, was to compare the use of difluoromethylornithine (DFMO) to the
use of a placebo in patients with low grade superficial bladder cancer
according to time to first recurrence of the tumor and toxicities.
From May 14, 1999, to July 10, 2002, in connection with
the above protocols, Mr. Kornak participated in a scheme to defraud the
sponsors of the clinical studies in that ``he would and repeatedly did
submit false documentation regarding patients and study subjects and
enroll and cause to be enrolled persons as study subjects who did not
qualify under the particular study protocol.''
Mr. Kornak caused the death of a study subject when he
``failed to perceive a substantial and unjustifiable risk that death
would occur when he knowingly and willfully made and used * * *
documents falsely stating and representing the results of [the study
subject's] blood chemistry analysis * * *, which false documents
purported that [the study subject] met the inclusion and exclusion
criteria for participation in Tax 325 when the actual results did not
meet the inclusion and exclusion criteria and showed impaired kidney
and liver function, and [the study subject] thus was administered the
chemotherapeutic drugs docetaxel, cisplatin, and 5-FU in connection
with Tax 325 on or about May 31, 2001, and died as a result thereof on
or about June 11, 2001.''
Based on the criminal conviction and the facts admitted to above,
HHS and VA believe that a debarment period longer than the standard
length of debarment is warranted in this case. Mr. Kornak admitted to a
dishonest handling of the research records and demonstrated a complete
disregard for the well-being of vulnerable human subjects under his
care. In pleading guilty to criminally negligent homicide, Mr. Kornak
admitted that a reasonable person would have perceived a substantial
and unjustifiable risk of death if an ineligible subject were enrolled
in the cancer study in question and that his failure to perceive such a
risk in enrolling the ineligible subject constituted a gross deviation
from the standard of care.
Moreover, a longer debarment period is warranted in this case
because of an established pattern of misconduct and criminal behavior
on the part of Mr. Kornak. As stated above, Mr. Kornak has a prior
conviction of mail fraud. In addition, the Office of Personnel
Management excluded Mr. Kornak from all Federal nonprocurement
transactions for an indefinite period, effective July 22, 1993.
Nonetheless, beginning in 1999, Mr. Kornak actively participated in
federally sponsored research protocols in violation of the imposed
exclusion.
A lifetime debarment of Mr. Kornak is necessary to protect the
public interest overall. Given the scope of his criminal conviction,
his longstanding pattern of criminal behavior, and his total disregard
for the safety and well-being of human subjects, Mr. Kornak's
responsibility to engage in transactions with the Federal Government
cannot be assured at any time in the future.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative Oversight,
Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852.
(240) 453-8800,
or
Peter Poon,
Health Science Specialist,
Office of Research Oversight,
Veteran's Health Administration, VA,
811 Vermont Ave., NW. (10R), Suite 574,
Washington, DC 20420.
(202) 565-8107.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. E6-2667 Filed 2-23-06; 8:45 am]
BILLING CODE 4160-17-P
