Findings of Misconduct in Science, 24703-24704 [2010-10605]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Notices
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
A. Purpose
To protect the Government’s interest
and to ensure timely delivery of items
of the requisite quality, contracting
officers, prior to award, must make an
affirmative determination that the
prospective contractor is responsible,
i.e., capable of performing the contract.
Before making such a determination, the
contracting officer must have in his
possession or must obtain information
sufficient to satisfy himself that the
prospective contractor (i) Has adequate
financial resources, or the ability to
obtain such resources, (ii) is able to
comply with required delivery
schedule, (iii) has a satisfactory record
of performance, (iv) has a satisfactory
record of integrity, and (v) is otherwise
qualified and eligible to receive an
award under appropriate laws and
regulations. If such information is not in
the contracting officer’s possession, it is
obtained through a preaward survey
conducted by the contract
administration office responsible for the
plant and/or the geographic area in
which the plant is located. The
necessary data is collected by contract
administration personnel from available
data or through plant visits, phone calls,
and correspondence. This data is
entered on Standard Forms 1403, 1404,
1405, 1406, 1407, and 1408 in detail
commensurate with the dollar value and
complexity of the procurement.
B. Annual Reporting Burden
sroberts on DSKD5P82C1PROD with NOTICES
Respondents: 5,800.
Responses per Respondent: 1.
Total Responses: 5,800.
Hours per Response: 21.
Total Burden Hours: 121,800.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (MVCB), 1800 F
Street, NW., Room 4041, Washington,
DC 20405, telephone (202) 501–4755.
Please cite OMB Control Number 9000–
0011, Preaward Survey Forms (Standard
Forms 1403, 1404, 1405, 1406, 1407,
and 1408), in all correspondence.
Dated: April 30, 2010.
Al Matera,
Director, Acquisition Policy Division.
[FR Doc. 2010–10543 Filed 5–4–10; 8:45 am]
BILLING CODE 6820–EP–P
VerDate Mar<15>2010
19:02 May 04, 2010
Jkt 220001
Office of the Secretary
Findings of Misconduct in Science
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: Notice is hereby given that on
March 18, 2010, the Department of
Health and Human Services (HHS)
Debarring Official, on behalf of the
Secretary of HHS, issued a final notice
of debarment based on the misconduct
in science findings of the Office of
Research Integrity (ORI) in the following
case:
Scott J. Brodie, DVM, Ph.D.,
University of Washington: Based on the
findings in an investigation report by
the University of Washington (UW) and
additional analysis conducted by ORI in
its oversight review, ORI found that
Scott J. Brodie, DVM, Ph.D., former
Research Assistant Professor,
Department of Laboratory Medicine, and
Director of the UW Retrovirology
Pathogenesis Laboratory, UW,
committed misconduct in science
(scientific misconduct) in research
supported by or reported in the
following U.S. Public Health Service
(PHS) grant applications:
• 1 P01 HD40540–01 (National
Institute of Child Health and Human
Development [NICHD], National
Institutes of Health [NIH])
• 5 P01 HD40540–02 (NICHD, NIH)
• 1 P01 AI057005–01 (National
Institute of Allergy and Infectious
Diseases [NIAID], NIH)
• 1 R01 DE014149–01 (National
Institute of Dental and Craniofacial
Research [NIDCR], NIH)
• 2 U01 AI41535–05 (NIAID, NIH)
• 1 R01 HL072631–01 (National
Heart, Lung, and Blood Institute
[NHLBI], NIH)
• 1 R01 (U01) AI054334–01 (NIAID,
NIH)
• 1 R01 DE014827–01 (NIDCR, NIH)
• 1 R01 AI051954–01 (NIAID, NIH).
Specifically, ORI made fifteen
findings of misconduct in science based
on evidence that Dr. Brodie knowingly
and intentionally fabricated and
falsified data reported in nine PHS grant
applications and progress reports and
several published papers, manuscripts,
and PowerPoint presentations. The
fifteen findings are as follows:
1. Respondent knowingly and
intentionally falsified a figure that was
presented in manuscripts submitted to
the Journal of Experimental Medicine
and the Journal of Virology and in
several PowerPoint presentations that
PO 00000
Frm 00136
Fmt 4703
Sfmt 4703
24703
purported to represent rectal mucosal
leukocytes in some instances and lymph
nodes in other instances.
2. Respondent knowingly and
intentionally falsified portions of a
three-paneled figure included in several
manuscript submissions, PowerPoint
presentations, and grant applications.
3. Respondent knowingly and
intentionally falsified a figure included
as Figure 1N in American Journal of
Pathology 54:1453–1464, 1999, three
NIH grant applications, and several
PowerPoint presentations.
4. Respondent knowingly and
intentionally falsified a figure that was
published as an insert within Figure 1K
in American Journal of Pathology
54:1453, 1999 and included the figure in
a number of NIH grant applications.
5. Respondent knowingly and
intentionally falsified a figure
representing a panel of four green
fluorescent cells and included it as a
figure in several grant applications
claiming that each cell had been
subjected to different treatments when
three of the cells came from a single
image.
6. Respondent knowingly and
intentionally falsified an image
included as Figure 5A in a paper
published in the Journal of Clinical
Investigations 105:1407, 2000 and
submitted to various journals and
included in different grant applications.
7. Respondent knowingly and
intentionally falsified a figure appearing
as Figure 3.III.A, inset, in a manuscript
submitted to Science entitled ‘‘A
persistent reservoir of HIV–1 in
pulmonary macrophages’’ and as figures
in various grant applications and
PowerPoint presentations.
8. Respondent knowingly and
intentionally falsified multiple versions
of a figure depicting green and red
fluorescent cells used as Figures 3.III.H
and I in a manuscript submitted to
Science, as Figures 6C and 6D of NIDCR,
NIH, grant application 1 R01 DE14827–
01, as Figures C.2.1 1H and C.2.11I of
NHLBI, NIH, grant application 1 R01
HL072631–01, and in PowerPoint
presentations.
9. Respondent knowingly and
intentionally falsified a figure, labeled
as Figure 9E in NIDCR, NIH, grant
application 1 R01 DE014827–01 and in
various other grant applications and
PowerPoint presentations.
10. Respondent knowingly and
intentionally falsified the bottom half of
Figure C.2.5 of NHLBI, NIH, grant
application 1 R01 HL072631–01 by
using the same image twice, labeling it
once as being treated for 2 hours with
lipopolysaccharide (LPS) and the
second as being treated for 12 hours
E:\FR\FM\05MYN1.SGM
05MYN1
sroberts on DSKD5P82C1PROD with NOTICES
24704
Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Notices
with LPS. Respondent also used a
second image twice, labeling it once as
‘‘no LPS’’ and the second time as ‘‘24
hours with LPS.’’
11. Respondent knowingly and
intentionally falsified a figure that
purports to represent viral decay in
rectal mucosa and included the figure as
a slide in two PowerPoint presentations
and three NIH grant applications.
12. Respondent knowingly and
intentionally falsified: (a) A
histopathology figure that was described
in a paper published in the Journal of
Infectious Diseases 83:1466, 2001, as
inguinal lymph nodes from an untreated
AIDS patient using in situ PCR to show
the presence of HIV–1 cells when it was
actually from a tissue expressing the
neomycin marker; (b) the gel images
resembling Figures 2A and C, which
Respondent claimed to be based on
lymph node cells, although he reported
the gel images elsewhere to represent
results from rectal tissue; and (c) various
versions of these blots that Respondent
reported elsewhere and labeled
differently with respect to the copy
numbers detected and as detecting DNA
in some instance and RNA in others.
13. Respondent knowingly and
intentionally falsified Figures 2DI and
2DII included in a paper published in
the Journal of Leukocyte Biology
68:351–359, 2000.
14. Respondent knowingly and
intentionally falsified Figure 4, Panels A
and B, in NIDCR, NIH, grant application
1 R01 DE014827–01 by manipulating
the source images.
15. Respondent knowingly and
intentionally falsified a number of
figures and made false statements in the
text of NIAID, NIH, grant application 1
R01 AI051954–01 submitted jointly
with a colleague by relabeling figures
based on research carried out with HIV–
1 or HIV–2 and identifying the figures
and text as research conducted with
ovine lentivirus (OvLV).
ORI issued a charge letter
enumerating the above findings of
misconduct in science and proposing
HHS administrative actions. Dr. Brodie
subsequently requested a hearing before
an Administrative Law Judge (ALJ) of
the Departmental Appeals Board to
dispute these findings. In January 2009,
the ALJ issued a ruling holding that
there were no triable issues challenging
ORI’s findings that there were materially
false statements, images, and other data
in the relevant publications,
presentations, and grant applications.
However, the ALJ held that Dr. Brodie
raised triable issues about his intent to
commit scientific misconduct and the
reasonableness of the proposed
debarment of seven (7) years.
VerDate Mar<15>2010
19:02 May 04, 2010
Jkt 220001
On January 12, 2010, the ALJ issued
a recommended decision to the HHS
Assistant Secretary for Health (ASH)
granting summary disposition to ORI.
The ALJ also stated that Dr. Brodie
committed scientific misconduct on
multiple occasions and that its extent
amply justified debarment for a period
of seven (7) years. Pursuant to 42 CFR
93.523(c), the ASH forwarded the ALJ’s
recommended decision to the HHS
Debarring Official, which constituted
the findings of fact required under 2
CFR parts 180 and 376.
On February 1, 2010, Dr. Brodie
submitted a letter to the HHS Debarring
Official with attachments to request that
the ALJ’s recommended decision be
rejected as a whole. On February 26,
2010, Dr. Brodie submitted a letter
requesting the opportunity to meet with
the HHS Debarring Official to orally
present the reasons supporting his
request that the ALJ’s recommended
decision be rejected. However, the HHS
Debarring Official determined that Dr.
Brodie had been afforded an
opportunity to contest ORI’s findings of
scientific misconduct in accordance
with 42 CFR part 93, subpart E. Given
the findings of facts in this case, the
HHS Debarring Official determined that
the issues in his presentation in
opposition to the ALJ’s recommended
decision did not raise a genuine dispute
over facts material to the recommended
debarment. Accordingly, the HHS
Debarring Official also denied Dr.
Brodie’s request to make an oral
presentation and issued a notice of
debarment to begin on March 18, 2010,
and end on March 17, 2017.
On March 23, 2010, Dr. Brodie
submitted a letter requesting a
postponement of the effective date of
the debarment. This request was denied
by the Debarring Official on April 6,
2010.
Thus, the misconduct in science
findings set forth above became
effective, and the following
administrative actions have been
implemented for a period of seven (7)
years, beginning on March 18, 2010:
(1) Dr. Brodie has been debarred 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’’ pursuant to the
Department of Health and Human
Service’s Implementation (2 CFR part
376 et seq.) of OMB Guidelines to
Agencies on Governmentwide
Debarment and Suspension, 2 CFR part
180; and
PO 00000
Frm 00137
Fmt 4703
Sfmt 4703
(2) Dr. Brodie is prohibited 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
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. 2010–10605 Filed 5–4–10; 8:45 am]
BILLING CODE 4160–17–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–10–0733]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call Maryam I. Daneshvar, the
CDC Reports Clearance Officer, at (404)
639–5960 or send an e-mail to
omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Early Hearing Detection and
Intervention Hearing Screening and
Follow-up Survey (OMB No. 0920–0733
exp. 10/31/2009)—Reinstatement With
Change—National Center on Birth
Defects and Developmental Disabilities
(NCBDDD), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The National Center on Birth Defects
and Developmental Disabilities at CDC
promotes the health of babies, children,
and adults with disabilities. As part of
these efforts the Center is actively
involved in addressing hearing loss (HL)
among newborns and infants. HL is a
common birth defect that affects
approximately 12,000 infants each year
and, when left undetected, can result in
developmental delays. As awareness
about infant HL increases, so does the
E:\FR\FM\05MYN1.SGM
05MYN1
]]>Agencies
[Federal Register Volume 75, Number 86 (Wednesday, May 5, 2010)]
[Notices]
[Pages 24703-24704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-10605]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Misconduct in Science
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that on March 18, 2010, the Department
of Health and Human Services (HHS) Debarring Official, on behalf of the
Secretary of HHS, issued a final notice of debarment based on the
misconduct in science findings of the Office of Research Integrity
(ORI) in the following case:
Scott J. Brodie, DVM, Ph.D., University of Washington: Based on the
findings in an investigation report by the University of Washington
(UW) and additional analysis conducted by ORI in its oversight review,
ORI found that Scott J. Brodie, DVM, Ph.D., former Research Assistant
Professor, Department of Laboratory Medicine, and Director of the UW
Retrovirology Pathogenesis Laboratory, UW, committed misconduct in
science (scientific misconduct) in research supported by or reported in
the following U.S. Public Health Service (PHS) grant applications:
1 P01 HD40540-01 (National Institute of Child Health and
Human Development [NICHD], National Institutes of Health [NIH])
5 P01 HD40540-02 (NICHD, NIH)
1 P01 AI057005-01 (National Institute of Allergy and
Infectious Diseases [NIAID], NIH)
1 R01 DE014149-01 (National Institute of Dental and
Craniofacial Research [NIDCR], NIH)
2 U01 AI41535-05 (NIAID, NIH)
1 R01 HL072631-01 (National Heart, Lung, and Blood
Institute [NHLBI], NIH)
1 R01 (U01) AI054334-01 (NIAID, NIH)
1 R01 DE014827-01 (NIDCR, NIH)
1 R01 AI051954-01 (NIAID, NIH).
Specifically, ORI made fifteen findings of misconduct in science
based on evidence that Dr. Brodie knowingly and intentionally
fabricated and falsified data reported in nine PHS grant applications
and progress reports and several published papers, manuscripts, and
PowerPoint presentations. The fifteen findings are as follows:
1. Respondent knowingly and intentionally falsified a figure that
was presented in manuscripts submitted to the Journal of Experimental
Medicine and the Journal of Virology and in several PowerPoint
presentations that purported to represent rectal mucosal leukocytes in
some instances and lymph nodes in other instances.
2. Respondent knowingly and intentionally falsified portions of a
three-paneled figure included in several manuscript submissions,
PowerPoint presentations, and grant applications.
3. Respondent knowingly and intentionally falsified a figure
included as Figure 1N in American Journal of Pathology 54:1453-1464,
1999, three NIH grant applications, and several PowerPoint
presentations.
4. Respondent knowingly and intentionally falsified a figure that
was published as an insert within Figure 1K in American Journal of
Pathology 54:1453, 1999 and included the figure in a number of NIH
grant applications.
5. Respondent knowingly and intentionally falsified a figure
representing a panel of four green fluorescent cells and included it as
a figure in several grant applications claiming that each cell had been
subjected to different treatments when three of the cells came from a
single image.
6. Respondent knowingly and intentionally falsified an image
included as Figure 5A in a paper published in the Journal of Clinical
Investigations 105:1407, 2000 and submitted to various journals and
included in different grant applications.
7. Respondent knowingly and intentionally falsified a figure
appearing as Figure 3.III.A, inset, in a manuscript submitted to
Science entitled ``A persistent reservoir of HIV-1 in pulmonary
macrophages'' and as figures in various grant applications and
PowerPoint presentations.
8. Respondent knowingly and intentionally falsified multiple
versions of a figure depicting green and red fluorescent cells used as
Figures 3.III.H and I in a manuscript submitted to Science, as Figures
6C and 6D of NIDCR, NIH, grant application 1 R01 DE14827-01, as Figures
C.2.1 1H and C.2.11I of NHLBI, NIH, grant application 1 R01 HL072631-
01, and in PowerPoint presentations.
9. Respondent knowingly and intentionally falsified a figure,
labeled as Figure 9E in NIDCR, NIH, grant application 1 R01 DE014827-01
and in various other grant applications and PowerPoint presentations.
10. Respondent knowingly and intentionally falsified the bottom
half of Figure C.2.5 of NHLBI, NIH, grant application 1 R01 HL072631-01
by using the same image twice, labeling it once as being treated for 2
hours with lipopolysaccharide (LPS) and the second as being treated for
12 hours
[[Page 24704]]
with LPS. Respondent also used a second image twice, labeling it once
as ``no LPS'' and the second time as ``24 hours with LPS.''
11. Respondent knowingly and intentionally falsified a figure that
purports to represent viral decay in rectal mucosa and included the
figure as a slide in two PowerPoint presentations and three NIH grant
applications.
12. Respondent knowingly and intentionally falsified: (a) A
histopathology figure that was described in a paper published in the
Journal of Infectious Diseases 83:1466, 2001, as inguinal lymph nodes
from an untreated AIDS patient using in situ PCR to show the presence
of HIV-1 cells when it was actually from a tissue expressing the
neomycin marker; (b) the gel images resembling Figures 2A and C, which
Respondent claimed to be based on lymph node cells, although he
reported the gel images elsewhere to represent results from rectal
tissue; and (c) various versions of these blots that Respondent
reported elsewhere and labeled differently with respect to the copy
numbers detected and as detecting DNA in some instance and RNA in
others.
13. Respondent knowingly and intentionally falsified Figures 2DI
and 2DII included in a paper published in the Journal of Leukocyte
Biology 68:351-359, 2000.
14. Respondent knowingly and intentionally falsified Figure 4,
Panels A and B, in NIDCR, NIH, grant application 1 R01 DE014827-01 by
manipulating the source images.
15. Respondent knowingly and intentionally falsified a number of
figures and made false statements in the text of NIAID, NIH, grant
application 1 R01 AI051954-01 submitted jointly with a colleague by
relabeling figures based on research carried out with HIV-1 or HIV-2
and identifying the figures and text as research conducted with ovine
lentivirus (OvLV).
ORI issued a charge letter enumerating the above findings of
misconduct in science and proposing HHS administrative actions. Dr.
Brodie subsequently requested a hearing before an Administrative Law
Judge (ALJ) of the Departmental Appeals Board to dispute these
findings. In January 2009, the ALJ issued a ruling holding that there
were no triable issues challenging ORI's findings that there were
materially false statements, images, and other data in the relevant
publications, presentations, and grant applications. However, the ALJ
held that Dr. Brodie raised triable issues about his intent to commit
scientific misconduct and the reasonableness of the proposed debarment
of seven (7) years.
On January 12, 2010, the ALJ issued a recommended decision to the
HHS Assistant Secretary for Health (ASH) granting summary disposition
to ORI. The ALJ also stated that Dr. Brodie committed scientific
misconduct on multiple occasions and that its extent amply justified
debarment for a period of seven (7) years. Pursuant to 42 CFR
93.523(c), the ASH forwarded the ALJ's recommended decision to the HHS
Debarring Official, which constituted the findings of fact required
under 2 CFR parts 180 and 376.
On February 1, 2010, Dr. Brodie submitted a letter to the HHS
Debarring Official with attachments to request that the ALJ's
recommended decision be rejected as a whole. On February 26, 2010, Dr.
Brodie submitted a letter requesting the opportunity to meet with the
HHS Debarring Official to orally present the reasons supporting his
request that the ALJ's recommended decision be rejected. However, the
HHS Debarring Official determined that Dr. Brodie had been afforded an
opportunity to contest ORI's findings of scientific misconduct in
accordance with 42 CFR part 93, subpart E. Given the findings of facts
in this case, the HHS Debarring Official determined that the issues in
his presentation in opposition to the ALJ's recommended decision did
not raise a genuine dispute over facts material to the recommended
debarment. Accordingly, the HHS Debarring Official also denied Dr.
Brodie's request to make an oral presentation and issued a notice of
debarment to begin on March 18, 2010, and end on March 17, 2017.
On March 23, 2010, Dr. Brodie submitted a letter requesting a
postponement of the effective date of the debarment. This request was
denied by the Debarring Official on April 6, 2010.
Thus, the misconduct in science findings set forth above became
effective, and the following administrative actions have been
implemented for a period of seven (7) years, beginning on March 18,
2010:
(1) Dr. Brodie has been debarred 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'' pursuant to
the Department of Health and Human Service's Implementation (2 CFR part
376 et seq.) of OMB Guidelines to Agencies on Governmentwide Debarment
and Suspension, 2 CFR part 180; and
(2) Dr. Brodie is prohibited 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 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. 2010-10605 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-17-P
