Findings of Scientific Misconduct, 32167-32168 [E9-15909]
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Federal Register / Vol. 74, No. 128 / Tuesday, July 7, 2009 / Notices
suggest methods for performing more
economically and share in any resulting
savings or (2) are required to establish
a program to identify and submit to the
Government methods for performing
more economically. These
recommendations are submitted to the
Government as value engineering
change proposals (VECP’s) and they
must include specific information. This
information is needed to enable the
Government to evaluate the VECP and,
if accepted, to arrange for an equitable
sharing plan.
B. Annual Reporting Burden
Respondents: 400.
Responses per Respondent: 4.
Annual Responses: 1,600.
Hours per Response: 30.
Total Burden Hours: 48,000.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (VPR), 1800 F
Street, NW., Room 4041, Washington,
DC 20405, telephone (202) 501–4755.
Please cite OMB Control No. 9000–0027,
Value Engineering Requirements, in all
correspondence.
Dated: June 23, 2009.
Al Matera,
Director, Office of Acquisition Policy.
[FR Doc. E9–15983 Filed 7–6–09; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[OMB Control No. 9000–0095]
Federal Acquisition Regulation;
Information Collection; Commerce
Patent Regulations
AGENCIES: Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice of request for comments
regarding the reinstatement of a
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SUMMARY: Under the provisions of the
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U.S.C. Chapter 35), the Federal
Acquisition Regulation (FAR)
Secretariat will be submitting to the
Office of Management and Budget
(OMB) a request to review and approve
a reinstatement of a previously
approved information collection
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requirement concerning Commerce
Patent Regulations.
Public comments are particularly
invited on: Whether this collection of
information is necessary; whether it will
have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
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who are to respond, through the use of
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techniques or other forms of information
technology.
DATES: Submit comments on or before
September 8, 2009.
ADDRESSES: Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden, to: General Services
Administration (GSA), Regulatory
Secretariat (VPR), 1800 F Street, NW.,
Room 4041, Washington, DC 20405.
Please cite OMB Control No. 9000–0095,
Commerce Patent Regulations, in all
correspondence.
FOR FURTHER INFORMATION CONTACT: Mr.
Ernest Woodson, Procurement Analyst,
Contract Policy Division, GSA, (202)
501–3775.
SUPPLEMENTARY INFORMATION:
A. Purpose
As a result of the Department of
Commerce (Commerce) publishing a
final rule in the Federal Register
implementing Public Law 98–620 (52
FR 8552, March 18, 1987), a revision to
FAR subpart 27.3 to implement the
Commerce regulation was published in
the Federal Register as an interim rule
on June 12, 1989 (54 FR 25060). The
final rule was published without change
on June 21, 1990.
A Government contractor must report
all subject inventions to the contracting
officer, submit a disclosure of the
invention, and identify any publication,
or sale, or public use of the invention
(52.227–11(c), 52.227–12(c), and
52.227–13(e)(2)). Contractors are
required to submit periodic or interim
and final reports listing subject
inventions (27.303(b)(2)(i) and (ii)). In
order to ensure that subject inventions
are reported, the contractor is required
to establish and maintain effective
procedures for identifying and
disclosing subject inventions (52.227–
11, Alternate IV; 52.227–13(e)(1)). In
addition, the contractor must require his
employees, by written agreements, to
disclose subject inventions (52.227–
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32167
11(f)(2); 52.227–12(e)(2); 52.227–
13(e)(4)). The contractor also has an
obligation to utilize the subject
invention, and agree to report, upon
request, the utilization or efforts to
utilize the subject invention (27.302(e);
52.227–11(f); 52.227–12(f)).
B. Annual Reporting Burden
Respondents: 1,200.
Responses per Respondent: 9.75.
Total Responses: 11,700.
Hours per Response: 3.9.
Total Burden Hours: 45,630.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (VPR), 1800 F
Street, NW., Room 4041, Washington,
DC 20405, telephone (202) 501–4755.
Please cite OMB Control No. 9000–0095,
Commerce Patent Regulations, in all
correspondence.
Dated: June 23, 2009.
Al Matera,
Director, Office of Acquisition Policy.
[FR Doc. E9–15979 Filed 7–6–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Scientific Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: Notice is hereby given that
the Office of Research Integrity (ORI)
and the Assistant Secretary for Health
have taken final action in the following
case:
Juan Luis R. Contreras, M.D.,
University of Alabama at Birmingham:
Based on a finding of scientific
misconduct made by the University of
Alabama at Birmingham (UAB) on
January 24, 2008, a report of the UAB
Investigation Committee, dated
November 21, 2007, and analysis
conducted by ORI during its oversight
review, and further discussion between
UAB and ORI to clarify UAB’s
investigative findings and decision with
respect to the requirements of 42 CFR
Parts 50 and 93, the U.S. Public Health
Service (PHS) found that Dr. Juan Luis
R. Contreras, Assistant Professor,
Department of Surgery—
Transplantation, UAB, engaged in
scientific misconduct in research
supported by National Institute of
Allergy and Infectious Diseases (NIAID),
National Institutes of Health (NIH),
grants R01 AI22293, R01 AI39793, and
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32168
Federal Register / Vol. 74, No. 128 / Tuesday, July 7, 2009 / Notices
U19 AI056542, National Institute of
Diabetes and Digestive and Kidney
Diseases (NIDDK), NIH, grant U19
DK57958, and NIH/Novartis
Cooperative Research and Development
Agreement 96–MH–01/NIHITC–0697.
PHS found that Respondent engaged
in scientific misconduct by falsifying in
seven publications reports of research
results in NIH-supported experiments
with non-human primate (NHP) renal
allograft recipients.
Specifically, PHS found that
Respondent engaged in scientific
misconduct by falsely reporting in five
publications 1 that at least 32 specific
non-human primates in a renal allotransplantation study had received
bilateral nephrectomies, while in fact an
intrinsic kidney was left in place in
each animal, and generally, in two
additional publications 2 by reporting
that all long term surviving non-human
primate renal allograft recipients had
1 Hutchings, A., Wu, J., Asiedu, C., Hubbard, W.,
Eckhoff, D., Contreras, J., Thomas, F.T., Neville, D.,
& Thomas, J.M. ‘‘The immune decision toward
allograft tolerance in non-human primates requires
early inhibition of innate immunity and induction
of immune regulation.’’ Transpl Immunol. 11(3–
4):335–344, July–September 2003. (Retraction
required by UAB.)
Thomas, J.M., Eckhoff, D.E., Contreras, J.L.,
Lobashevsky, A.L., Hubbard, W.J., Moore, J.K.,
Cook, W.J., Thomas, F.T., & Neville, D.M. Jr.
‘‘Durable donor-specific T and B cell tolerance in
rhesus macaques induced with peritransplantation
anti-CD3 immunotoxin and deoxyspergualin:
Absence of chronic allograft nephropathy.’’
Transplantation 69(12):2497–2503, June 27, 2000.
(Retracted.)
Thomas, J.M., Contreras, J.L., Jiang, X.L., Eckhoff,
D.E., Wang, P.X., Hubbard, W.J., Lobashevsky, A.L.,
Wang, W., Asiedu, C., Stavrou, S., Cook, W.J.,
Robbin, M.L., Thomas, F.T., & Neville, D.M. Jr.
‘‘Peritransplant tolerance induction in macaques:
Early events reflecting the unique synergy between
immunotoxin and deoxyspergualin.’’
Transplantation 68(11):1660–1673, December 15,
1999. (Retracted.)
Contreras, J.L., Eckhoff, D.E., Cartner, S., Frenette,
L., Thomas, F.T., Robbin, M.L., Neville, D.M. Jr., &
Thomas, J.M. ‘‘Tolerability and side effects of antiCD3-immunotoxin in preclinical testing in kidney
and pancreatic islet transplant recipients.’’
Transplantation 68(2):215–219, July 27, 1999.
(Retracted.)
Contreras, J.L., Wang, P.X., Eckhoff, D.E.,
Lobashevsky, A.L., Asiedu, C., Frenette, L., Robbin,
M.L., Hubbard, W.J., Cartner, S., Nadler, S., Cook,
W.J., Sharff, J., Shiloach, J., Thomas, F.T., Neville,
D.M. Jr., & Thomas, J.M. ‘‘Peritransplant tolerance
induction with anti-CD3-immunotoxin: A matter of
proinflammatory cytokine control.’’
Transplantation 65(9):1159–1169, May 15, 1998.
(Retracted.)
2 Hubbard, W.J., Eckhoff, D., Contreras, J.L.,
Thomas, F.T., Hutchings, A., & Thomas, J.M.
‘‘STEALTH on the preclinical path to tolerance.’’
Graft 5(6):322–330, 2002. (Retraction required by
UAB—Journal has ceased publication.)
Hubbard, W.J., Contreras, J.V., Eckhoff, D.E.,
Thomas, F.T., Neville, D.M., & Thomas, J.M.
‘‘Immunotoxins and tolerance induction in
primates.’’ Current Opinion in Organ
Transplantation 5:29–34, 2000. (Partially retracted.)
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received bilateral nephrectomies of their
native kidneys.
The objective of the research was to
test the effectiveness of different
immunomodulating agents,
administered around the time of renal
transplantation in non-human primates,
in preventing rejection of the
transplanted kidney. To determine
whether or not the transplanted kidney
was functioning (able to sustain life)
after the immunomodulating therapy,
the animals were to have both of their
native kidneys removed at or shortly
after the time of transplant, so that their
survival would depend solely on the
viability of the transplanted kidney.
Failure to remove both native kidneys
rendered it impossible to assess the
effectiveness of the immunomodulating
treatment.
Both Dr. Contreras and PHS are
desirous of concluding this matter
without further expense of time and
other resources, and the parties have
entered into a Voluntary Exclusion
Agreement to settle the matter. Dr.
Contreras accepted responsibility for the
reporting described above, but denied
that he intentionally committed
scientific misconduct. The settlement is
not an admission of liability on the part
of the Respondent.
Dr. Contreras has entered into a
Voluntary Exclusion Agreement in
which he has voluntarily agreed, for a
period of three (3) years, beginning on
June 17, 2009:
(1) To exclude himself voluntarily
from any contracting or subcontracting
with any agency of the United States
Government and from eligibility or
involvement in nonprocurement
programs of the United States
Government referred to as ‘‘covered
transactions’’ and defined by 2 CFR
Parts 180 and 376; and
(2) To exclude himself from serving in
any advisory capacity to PHS, including
but not limited to service on any PHS
advisory committee, board, and/or peer
review committee, or as a consultant.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
John Dahlberg,
Director, Division of Investigative Oversight,
Office of Research Integrity.
[FR Doc. E9–15909 Filed 7–6–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Developmental Disabilities
Program Independent Evaluation
Project.
OMB No.: New Collection.
Description: The Developmental
Disabilities Program Independent
Evaluation (DDPIE) Project is an
independent (non-biased) evaluation to
examine through rigorous and
comprehensive performance-based
research procedures the targeted impact
on the lives of people with
developmental disabilities and their
families of three programs funded under
the Developmental Disabilities
Assistance and Bill of Rights Act of
2000 (DD Act): (1) State Councils on
Developmental Disabilities (SCDDs); (2)
State Protection and Advocacy Systems
for Individuals with developmental
disabilities (P&As); and (3) University
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Disabilities (UCEDDs). The intent of this
evaluation is to understand and report
on the accomplishments of these
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among the DD Network programs. The
results of this evaluation will provide a
report to the Administration on
Developmental Disabilities (ADD) (the
agency that administers these programs)
with information on the effectiveness of
its programs and policies and serve as
a way for ADD to promote
accountability to the public.
The independent evaluation is a
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and Bill of Rights Act of 2000 (DD Act),
the Government Performance and
Results Act (GPRA) of 1993, and the
Program Assessment Rating Tool
(PART), administered by the Office of
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by providing a non-biased method of
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according to indicators (structural,
process, output, and outcome) in key
function areas; and (2) to establish
performance standards for measuring
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[Federal Register Volume 74, Number 128 (Tuesday, July 7, 2009)]
[Notices]
[Pages 32167-32168]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-15909]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Scientific Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that the Office of Research Integrity
(ORI) and the Assistant Secretary for Health have taken final action in
the following case:
Juan Luis R. Contreras, M.D., University of Alabama at Birmingham:
Based on a finding of scientific misconduct made by the University of
Alabama at Birmingham (UAB) on January 24, 2008, a report of the UAB
Investigation Committee, dated November 21, 2007, and analysis
conducted by ORI during its oversight review, and further discussion
between UAB and ORI to clarify UAB's investigative findings and
decision with respect to the requirements of 42 CFR Parts 50 and 93,
the U.S. Public Health Service (PHS) found that Dr. Juan Luis R.
Contreras, Assistant Professor, Department of Surgery--Transplantation,
UAB, engaged in scientific misconduct in research supported by National
Institute of Allergy and Infectious Diseases (NIAID), National
Institutes of Health (NIH), grants R01 AI22293, R01 AI39793, and
[[Page 32168]]
U19 AI056542, National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK), NIH, grant U19 DK57958, and NIH/Novartis Cooperative
Research and Development Agreement 96-MH-01/NIHITC-0697.
PHS found that Respondent engaged in scientific misconduct by
falsifying in seven publications reports of research results in NIH-
supported experiments with non-human primate (NHP) renal allograft
recipients.
Specifically, PHS found that Respondent engaged in scientific
misconduct by falsely reporting in five publications \1\ that at least
32 specific non-human primates in a renal allo-transplantation study
had received bilateral nephrectomies, while in fact an intrinsic kidney
was left in place in each animal, and generally, in two additional
publications \2\ by reporting that all long term surviving non-human
primate renal allograft recipients had received bilateral nephrectomies
of their native kidneys.
---------------------------------------------------------------------------
\1\ Hutchings, A., Wu, J., Asiedu, C., Hubbard, W., Eckhoff, D.,
Contreras, J., Thomas, F.T., Neville, D., & Thomas, J.M. ``The
immune decision toward allograft tolerance in non-human primates
requires early inhibition of innate immunity and induction of immune
regulation.'' Transpl Immunol. 11(3-4):335-344, July-September 2003.
(Retraction required by UAB.)
Thomas, J.M., Eckhoff, D.E., Contreras, J.L., Lobashevsky, A.L.,
Hubbard, W.J., Moore, J.K., Cook, W.J., Thomas, F.T., & Neville,
D.M. Jr. ``Durable donor-specific T and B cell tolerance in rhesus
macaques induced with peritransplantation anti-CD3 immunotoxin and
deoxyspergualin: Absence of chronic allograft nephropathy.''
Transplantation 69(12):2497-2503, June 27, 2000. (Retracted.)
Thomas, J.M., Contreras, J.L., Jiang, X.L., Eckhoff, D.E., Wang,
P.X., Hubbard, W.J., Lobashevsky, A.L., Wang, W., Asiedu, C.,
Stavrou, S., Cook, W.J., Robbin, M.L., Thomas, F.T., & Neville, D.M.
Jr. ``Peritransplant tolerance induction in macaques: Early events
reflecting the unique synergy between immunotoxin and
deoxyspergualin.'' Transplantation 68(11):1660-1673, December 15,
1999. (Retracted.)
Contreras, J.L., Eckhoff, D.E., Cartner, S., Frenette, L.,
Thomas, F.T., Robbin, M.L., Neville, D.M. Jr., & Thomas, J.M.
``Tolerability and side effects of anti-CD3-immunotoxin in
preclinical testing in kidney and pancreatic islet transplant
recipients.'' Transplantation 68(2):215-219, July 27, 1999.
(Retracted.)
Contreras, J.L., Wang, P.X., Eckhoff, D.E., Lobashevsky, A.L.,
Asiedu, C., Frenette, L., Robbin, M.L., Hubbard, W.J., Cartner, S.,
Nadler, S., Cook, W.J., Sharff, J., Shiloach, J., Thomas, F.T.,
Neville, D.M. Jr., & Thomas, J.M. ``Peritransplant tolerance
induction with anti-CD3-immunotoxin: A matter of proinflammatory
cytokine control.'' Transplantation 65(9):1159-1169, May 15, 1998.
(Retracted.)
\2\ Hubbard, W.J., Eckhoff, D., Contreras, J.L., Thomas, F.T.,
Hutchings, A., & Thomas, J.M. ``STEALTH on the preclinical path to
tolerance.'' Graft 5(6):322-330, 2002. (Retraction required by UAB--
Journal has ceased publication.)
Hubbard, W.J., Contreras, J.V., Eckhoff, D.E., Thomas, F.T.,
Neville, D.M., & Thomas, J.M. ``Immunotoxins and tolerance induction
in primates.'' Current Opinion in Organ Transplantation 5:29-34,
2000. (Partially retracted.)
---------------------------------------------------------------------------
The objective of the research was to test the effectiveness of
different immunomodulating agents, administered around the time of
renal transplantation in non-human primates, in preventing rejection of
the transplanted kidney. To determine whether or not the transplanted
kidney was functioning (able to sustain life) after the
immunomodulating therapy, the animals were to have both of their native
kidneys removed at or shortly after the time of transplant, so that
their survival would depend solely on the viability of the transplanted
kidney. Failure to remove both native kidneys rendered it impossible to
assess the effectiveness of the immunomodulating treatment.
Both Dr. Contreras and PHS are desirous of concluding this matter
without further expense of time and other resources, and the parties
have entered into a Voluntary Exclusion Agreement to settle the matter.
Dr. Contreras accepted responsibility for the reporting described
above, but denied that he intentionally committed scientific
misconduct. The settlement is not an admission of liability on the part
of the Respondent.
Dr. Contreras has entered into a Voluntary Exclusion Agreement in
which he has voluntarily agreed, for a period of three (3) years,
beginning on June 17, 2009:
(1) To exclude himself voluntarily from any contracting or
subcontracting with any agency of the United States Government and from
eligibility or involvement in nonprocurement programs of the United
States Government referred to as ``covered transactions'' and defined
by 2 CFR Parts 180 and 376; and
(2) To exclude himself from serving in any advisory capacity to
PHS, including but not limited to service on any PHS advisory
committee, board, and/or peer review committee, or as a consultant.
FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453-8800.
John Dahlberg,
Director, Division of Investigative Oversight, Office of Research
Integrity.
[FR Doc. E9-15909 Filed 7-6-09; 8:45 am]
BILLING CODE 4150-31-P
