Findings of Scientific Misconduct, 12490-12491 [05-4957]
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Federal Register / Vol. 70, No. 48 / Monday, March 14, 2005 / Notices
meetings and conducting other business
in the interest of the Committee,
including per diem and reimbursement
for travel expenses incurred.
Nominations should be typewritten.
The following information should be
included in the package of material
submitted for each individual being
nominated for consideration: (1) A letter
of nomination that clearly states the
name and affiliation of the nominee, the
basis for the nomination (i.e., specific
attributes which qualify the nominee for
service in this capacity), and a statement
that the nominee is willing to serve as
a member of the Committee; (2) the
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or work address, telephone number, and
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nominee’s curriculum vitae. The names
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nominated for consideration of
appointment to this Committee.
The Department makes every effort to
ensure that the membership of DHHS
Federal advisory committees is fairly
balanced in terms of points of view
represented and the committee’s
function. Every effort is made to ensure
that a broad representation of
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Appointment to this Committee shall be
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basis of age, race, ethnicity, gender,
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status. Nominations must state that the
nominee is willing to serve as a member
of CFSAC and appears to have no
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concerning such matters as financial
holdings, consultancies, and research
grants or contracts to permit evaluation
of possible sources of conflict of
interest.
Dated: March 4, 2005.
Howard A. Zucker,
Executive Secretary, Chronic Fatigue
Syndrome Advisory Committee.
[FR Doc. 05–4949 Filed 3–11–05; 8:45 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Chronic Fatigue
Syndrome Advisory Committee
Department of Health and
Human Services, Office of the Secretary,
Office of Public Health and Science.
AGENCY:
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ACTION:
Notice.
SUMMARY: As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that the
Chronic Fatigue Syndrome Advisory
Committee (CFSAC) will hold a
meeting. The meeting will be open to
the public.
DATES: The meeting will be held on
Monday, April 4, 2005, from 9 a.m. to
5 p.m.
ADDRESSES: Department of Health and
Human Services, Room 800 Hubert H.
Humphrey Building, 200 Independence
Avenue, SW., Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Dr.
Howard Zucker; Executive Secretary,
Chronic Fatigue Syndrome Advisory
Committee; Department of Health and
Human Services, 200 Independence
Avenue, SW., Room 716G, Washington,
DC 20201; (202) 690–7694.
SUPPLEMENTARY INFORMATION: CFSAC
was established on September 5, 2002,
to replace the Chronic Fatigue
Syndrome Coordinating Committee.
CFSAC was established to advise,
consult with, and make
recommendations to the Secretary,
through the Assistant Secretary for
Health, on a broad range of topics
including (1) the current state of
knowledge and research about the
epidemiology and risk factors relating to
chronic fatigue syndrome, and
identifying potential opportunities in
these areas; (2) current and proposed
diagnosis and treatment methods for
chronic fatigue syndrome; and (3)
development and implementation of
programs to inform the public, health
care professionals, and the biomedical,
academic, and research communities
about chronic fatigue syndrome
advances.
The agenda for this meeting is being
developed. The agenda will be posted
on the CFSAC Web site, https://
www.hhs.gov/advcomcfs, when it is
finalized.
Public attendance at the meeting is
limited to space available. Individuals
must provide a photo ID for entry into
the meeting. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the designated contact person.
Members of the public will have the
opportunity to provide comments at the
meeting. Pre-registration is required for
public comment by March 28, 2005.
Any individual who wishes to
participate in the public comment
session should call the telephone
number listed in the contact information
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to register. Public comment will be
limited to five minutes per speaker. Any
members of the public who wish to have
printed material distributed to CFSAC
members should submit materials to the
Executive Secretary, CFSAC, whose
contact information is listed above prior
to close of business March 28, 2005.
Dated: March 4, 2005.
Howard A. Zucker,
Executive Secretary, Chronic Fatigue
Syndrome Advisory Committee.
[FR Doc. 05–4948 Filed 3–11–05; 8:45 am]
BILLING CODE 4150–28–P
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 Acting Assistant Secretary for
Health have taken final action in the
following case:
Gary M. Kammer, M.D., Wake Forest
University: Based on the Wake Forest
University (WFU) Investigation Report,
the respondent’s admission, and
additional analysis conducted by ORI in
its oversight review, the U.S. Public
Health Service (PHS) found that Gary M.
Kammer, M.D., former Professor,
Division of Rheumatology, Department
of Internal Medicine, and Department of
Microbiology and Immunology at the
WFU School of Medicine, engaged in
scientific misconduct by falsification
and fabrication of research in grant
application 2 R01 AR39501–12A1, ‘‘T
Lymphocyte Dysfunction in Lupus
Erythematosus,’’ submitted to the
National Institute of Arthritis and
Musculoskeletal Skin Diseases
(NIAMS), National Institutes of Health
(NIH), and in 1 R01 AI46526–01A2,
‘‘Protein Kinase A–II in the
Pathogenesis of Lupus,’’ submitted to
the National Institute of Allergy and
Infectious Diseases (NIAID), NIH.
Specifically, PHS found that:
• The respondent fabricated Families
2 and 3 in Figure 6 and related text in
application 2 R01 AR39501–12A1 (pp.
29–30), entitled (‘‘T Lymphocyte
Dysfunction in Lupus Erythematosus’’)
by:
a. Making up both of the pedigrees,
b. Fabricating 13 PKA–I and 13 PKA–
II values for these non-existent affected
and unaffected family members, and
c. Composing the false text describing
these two fabricated families.
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Federal Register / Vol. 70, No. 48 / Monday, March 14, 2005 / Notices
• The respondent falsified the text
describing the results in Figure 20
(‘‘Inhibition of c-fos luciferase activity
in S49 T cells transiently transfected
with pIRES2-RIIb-EGFP and treated
with 8-Cl-cAMP’’) in application 1 R01
AI46526–01A2 (p. 27), by falsely
reporting N = 4, P less than 0.002, when
the experiment had been performed
only one time at the time that the
application was submitted.
PHS also concluded that the
respondent further demonstrated a lack
of present responsibility as a Principal
Investigator by submitting NIH grant
proposals with additional unsupported
experimental results:
• The pedigree and data for the
family reported in grant application 2
R01 AR39501–12 and for Family 1 in
grant application 2 R01 AR39501–12A1
are incorrect and the data pertaining to
this family that Dr. Kammer
subsequently provided to WFU after the
inquiry were not the data reported in
the applications. Dr. Kammer stated that
he did not recall who in his laboratory
gave him this pedigree. ORI noted that
the actual PKA data for the ‘‘proof-ofprinciple’’ family, while suggesting that
low PKA values may be hereditary (the
presence of low PKA–I values in three
generations), do not support the claims
of the fabricated and mixed up pedigree
and data that show that low PKA–I
values were associated with Systematic
Lupus Erythematosus (SLE) (application
2R01 AR39501–12).
• In application, R01 AI39501–12A1,
the following unsupported statement
was also included: ‘‘In both normal and
disease controls, all T cells express
CD59+ and there is no significant
difference in its cell surface expression
on CD4+, CD45RA+, CD4+, CD45RO+,
CD8+, CD45RA+, CD8+, CD45RO+
subsets (n=4 each control group; data
not shown).’’ No data could be
produced to support the information in
the grant application about these control
experiments.
Dr. Kammer has entered into a
Voluntary Exclusion Agreement
(Agreement ) in which he has
voluntarily agreed for a period of three
(3) years, beginning on February 15,
2005:
(1) 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,
and
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15:31 Mar 11, 2005
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(2) To exclude himself 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’’ as defined in the
debarment regulations at 45 CFR part
76. This voluntary exclusion precludes
the respondent from receiving Federal
research, research training, or other
research related funds from the Federal
Government for three (3) years, but shall
not apply to the respondent’s
participation in a Federal health care
program as defined in section 1128B(f)
of the Social Security Act and shall not
apply to Federal funds used solely for
purposes of teaching or training medical
students, residents, or fellows in clinical
medical matters.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852; (301) 443–5330.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. 05–4957 Filed 3–11–05; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Proposed Projects:
Title: Evaluation of the Early Head
Start Enhanced Home Visiting Pilot
Project.
OMB No.: New Collection.
Description: The Head Start
Reauthorization Act of 1994 established
a special initiative creating funding for
services for families with infants and
toddlers. In response, the
Administration on Children, Youth and
Families (ACYF) within the
Administration for Children and
Families (ACF) developed the Early
Head Start program. Since its inception,
Early Head Start has expanded to
include more than 700 programs and
70,000 families enrolled nationwide.
The program is designed to produce
outcome sin four domains: (1) Child
development, (2) family development,
(3) staff development and (4)
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12491
community development. The Head
Start Bureau has given programs a
mandate to support the quality of all
settings where children receive care by
providing high-quality services and
supporting parents and child care
providers in caring for their young
children.
In keeping with this mandate, the
Head Start Bureau recently funded 24
Early Head Start programs to participate
in the Enhanced Home Visiting Pilot
Project. The goal of the pilot project is
to develop program models for
supporting relatives and neighbors and
who care for Early Head Start children
in acquiring the knowledge, skills and
resources they need to support
children’s healthy development.
The Enhanced Home Visiting Pilot
Project evaluation will collect and
disseminate information about the
program models and service delivery
strategies developed by the pilot sites,
as well as the characteristics and needs
of participating children, families and
caregivers. The evaluation will collect
and analyze information from three
main sources: (1) Interviews with staff
and focus groups with parents and
caregivers to be conducted during two
rounds of visits to pilot programs (in
spring 2005 and 2006), (2) a program
recordkeeping system for tracking
services to be maintained by the pilot
sites and (3) observational assessments
of the quality of the caregiving
environment and the interactions
between children and caregivers to be
conducted in spring 2006. All datacollection instruments have been
designed to minimize the burden on
respondents by minimizing the time
required to respond. Participation in the
study is voluntary.
The results of the research will be
used by the Head Start Bureau and ACF
to identify and disseminate information
about promising program models and
service delivery strategies and lessons
learned from the experiences of the pilot
programs.
Respondent: Early Head Starts
directors, coordinators, specialists and
home visitors; staff from other
community service providers; parents of
Early Head Start children; and neighbor
and relative caregivers of Early Head
Start children.
Annual Burden Estimates
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]]>Agencies
[Federal Register Volume 70, Number 48 (Monday, March 14, 2005)]
[Notices]
[Pages 12490-12491]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4957]
-----------------------------------------------------------------------
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 Acting Assistant Secretary for Health have taken final
action in the following case:
Gary M. Kammer, M.D., Wake Forest University: Based on the Wake
Forest University (WFU) Investigation Report, the respondent's
admission, and additional analysis conducted by ORI in its oversight
review, the U.S. Public Health Service (PHS) found that Gary M. Kammer,
M.D., former Professor, Division of Rheumatology, Department of
Internal Medicine, and Department of Microbiology and Immunology at the
WFU School of Medicine, engaged in scientific misconduct by
falsification and fabrication of research in grant application 2 R01
AR39501-12A1, ``T Lymphocyte Dysfunction in Lupus Erythematosus,''
submitted to the National Institute of Arthritis and Musculoskeletal
Skin Diseases (NIAMS), National Institutes of Health (NIH), and in 1
R01 AI46526-01A2, ``Protein Kinase A-II in the Pathogenesis of Lupus,''
submitted to the National Institute of Allergy and Infectious Diseases
(NIAID), NIH.
Specifically, PHS found that:
The respondent fabricated Families 2 and 3 in Figure 6 and
related text in application 2 R01 AR39501-12A1 (pp. 29-30), entitled
(``T Lymphocyte Dysfunction in Lupus Erythematosus'') by:
a. Making up both of the pedigrees,
b. Fabricating 13 PKA-I and 13 PKA-II values for these non-existent
affected and unaffected family members, and
c. Composing the false text describing these two fabricated
families.
[[Page 12491]]
The respondent falsified the text describing the results
in Figure 20 (``Inhibition of c-fos luciferase activity in S49 T cells
transiently transfected with pIRES2-RIIb-EGFP and treated with 8-Cl-
cAMP'') in application 1 R01 AI46526-01A2 (p. 27), by falsely reporting
N = 4, P less than 0.002, when the experiment had been performed only
one time at the time that the application was submitted.
PHS also concluded that the respondent further demonstrated a lack
of present responsibility as a Principal Investigator by submitting NIH
grant proposals with additional unsupported experimental results:
The pedigree and data for the family reported in grant
application 2 R01 AR39501-12 and for Family 1 in grant application 2
R01 AR39501-12A1 are incorrect and the data pertaining to this family
that Dr. Kammer subsequently provided to WFU after the inquiry were not
the data reported in the applications. Dr. Kammer stated that he did
not recall who in his laboratory gave him this pedigree. ORI noted that
the actual PKA data for the ``proof-of-principle'' family, while
suggesting that low PKA values may be hereditary (the presence of low
PKA-I values in three generations), do not support the claims of the
fabricated and mixed up pedigree and data that show that low PKA-I
values were associated with Systematic Lupus Erythematosus (SLE)
(application 2R01 AR39501-12).
In application, R01 AI39501-12A1, the following
unsupported statement was also included: ``In both normal and disease
controls, all T cells express CD59+ and there is no significant
difference in its cell surface expression on CD4+, CD45RA+, CD4+,
CD45RO+, CD8+, CD45RA+, CD8+, CD45RO+ subsets (n=4 each control group;
data not shown).'' No data could be produced to support the information
in the grant application about these control experiments.
Dr. Kammer has entered into a Voluntary Exclusion Agreement
(Agreement ) in which he has voluntarily agreed for a period of three
(3) years, beginning on February 15, 2005:
(1) 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, and
(2) To exclude himself 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'' as defined in the debarment
regulations at 45 CFR part 76. This voluntary exclusion precludes the
respondent from receiving Federal research, research training, or other
research related funds from the Federal Government for three (3) years,
but shall not apply to the respondent's participation in a Federal
health care program as defined in section 1128B(f) of the Social
Security Act and shall not apply to Federal funds used solely for
purposes of teaching or training medical students, residents, or
fellows in clinical medical matters.
FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852; (301) 443-5330.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. 05-4957 Filed 3-11-05; 8:45 am]
BILLING CODE 4150-31-P
