Findings of Scientific Misconduct, 6629-6630 [E9-2720]
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Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
unauthorized disclosure, misuse, loss,
alteration, destruction, or other
compromise of such information, and
assess the sufficiency of any safeguards
in place to control these risks;
3. Design and implement reasonable
safeguards to control the risks identified
through risk assessment, and regularly
test or monitor the effectiveness of the
safeguards’ key controls, systems, and
procedures;
4. Develop and use reasonable steps to
retain service providers capable of
appropriately safeguarding personal
information they receive from
respondents and requiring service
providers by contract to implement and
maintain appropriate safeguards; and
5. Evaluate and adjust respondents’
information security program in light of
the results of the testing and monitoring,
any material changes to respondents’
operations or business arrangements, or
any other circumstances that
respondents know or have reason to
know may have a material impact on the
effectiveness of their information
security program.
Part III of the proposed order requires
that respondents, in connection with the
online advertising, marketing,
promotion, offering for sale, or sale of
any product or service to consumers,
obtain within 180 days, and on a
biennial bases thereafter for a period of
ten (10) years, an assessment and report
from a qualified, objective, independent
third-party professional, certifying,
among other things, that respondents
have in place a security program that
provides protections that meet or exceed
the protections required by Part II of the
proposed order; and (2) respondents’
security program is operating with
sufficient effectiveness to provide
reasonable assurance that the security,
confidentiality, and integrity of
consumers’ personal information is
protected.
Parts IV through VIII of the proposed
order are reporting and compliance
provisions. Part IV requires respondents
to retain documents relating to their
compliance with the order. For most
records, the order requires that the
documents be retained for a five-year
period. For the third-party assessments
and supporting documents, respondents
must retain the documents for a period
of three years after the date that each
assessment is prepared. Part V requires
dissemination of the order now and in
the future to persons with
responsibilities relating to the subject
matter of the order. Part VI ensures
notification to the FTC of changes in
corporate status. Part VII mandates that
respondents submit an initial
compliance report to the FTC, and make
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available to the FTC subsequent reports.
Part VIII is a provision ‘‘sunsetting’’ the
order after twenty (20) years, with
certain exceptions.
The purpose of the analysis is to aid
public comment on the proposed order.
It is not intended to constitute an
official interpretation of the proposed
order or to modify its terms in any way.
By direction of the Commission.
Donald S. Clark
Secretary
[FR Doc. E9–2764 Filed 2–9–09: 8:45 am]
BILLING CODE 6750–01–S
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:
Kazuhiro Tanaka, M.D., Ph.D.,
National Institute of Dental and
Craniofacial Research, National
Institutes of Health: Based on the report
of an investigation conducted by the
National Institutes of Health (NIH) and
additional analysis conducted by the
Office of Research Integrity (ORI) in its
oversight review, the U.S. Public Health
Service (PHS) found that Dr. Kazuhiro
Tanaka, former Visiting Postdoctoral
Fellow, Molecular Biology Section,
Craniofacial Developmental and Biology
and Regeneration Branch (CDBRB),
National Institute of Dental and
Craniofacial Research (NIDCR), NIH,
engaged in scientific misconduct in
research supported by PHS funds from
the NIDCR, NIH Intramural Program.
PHS found that Respondent engaged
in scientific misconduct by falsifying
data that were included in three
published papers: Kazuhiro Tanaka,
Yoshihiro Matsumoto, Fumihiko
Nakatani, Yukihide Iwamoto, and
Yoshihiko Yamada, ‘‘A zinc finger
transcription aA-crystallin binding
protein 1, is a negative regulator of the
chondrocyte-specific enhancer of the
a1(II) collagen gene,’’ Molecular and
Cellular Biology (MCB) 20:4428–4435,
2000; Kazuhiro Tanaka, Noriyuki
Tsumaki, Christine A. Kozak, Yoshihiro
Matsumoto, Fumihiko Nakatani,
Yukihide Iwamoto, and Yoshihiko
¨
Yamada, ‘‘A Kruppel-associated boxzinc finger protein, NT2, represses celltype-specific promoter activity of the
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
6629
a2(XI) collagen gene,’’Molecular and
Cellular Biology 22:4256–4267, 2002;
and Ying Liu, Haochuan Li, Kazuhiro
Tanaka, Noriyuki Tsumaki, and
Yoshihiko Yamada, ‘‘Identification of an
enhancer sequence with the first intron
required for cartilage-specific
transcription of the a2(XI) collagen
gene,’’ Journal of Biological Chemistry
(JBC) 275:12712–12718, 2000.
Specifically, PHS found that
Respondent:
• Falsified the results for CRYBP1 or
Sox9 binding to the Col2a1 DNA
sequence in electrophoretic mobility
shift assays in Figure 1D and Figure 7
in MCB 20:4428–4435, 2000. He used
duplicate copies of bands or duplicate
copies of parts of lanes to falsely
represent results from reportedly
different experimental conditions;
• Falsified the results for NT2
binding to the Col11a2 DNA sequence
in electrophoretic mobility shift assays
in Figures 2D and 6B, and falsified the
Western blot for NT2 mutant proteins in
Figure 8B in MCB 22:4256–4267, 2002.
He used duplicate copies of bands, parts
of bands, or duplicate copies of parts of
lanes to falsely represent results from
reportedly different experimental
conditions in Figures 2D and 6B; and
falsely represented results for the Figure
8B Western blot by using duplicate
copies of bands to represent NT2D1
(lane 2) and NT2D4 (lane 5) mutant
proteins;
• Falsified the Western blot for Sox9
protein expression in Figure 4B, JBC
275:12712–12718, 2000, by using
duplicate copies of lanes 1 and 2 to
represent the Sox9 expression in cell
extracts from both Balb 3T3 and
undifferentiated ATDC5 cells; and
• Falsified the Northern blots in
multiple panels of Figure 3, MCB
20:4428–4435, 2000. He used duplicate
copies of bands for CRYBP1, for Type II
collagen, for Type X collagen, and for
GAPDH and 18S EtBr stained control
bands to falsely represent results of
RNA expression from these different
genes in ATDC5 cells. He also used
duplicate copies of bands to falsely
represent the RNA expression in ATDC5
cells grown under different conditions
for either collagen Type II in Figure 3,
MCB 2000 or collagen a1(X) in Figure 5
in MCB 22:4256–4267, 2002. Similarly,
duplicate copies of 18S EtBr stained
control bands were used in both figures
with reportedly different experimental
conditions.
Both Respondent 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 (Agreement). The settlement
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10FEN1
6630
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
is not an admission of liability on the
part of the Respondent. Respondent
neither admits nor denies ORI’s finding
of scientific misconduct. Respondent
acknowledges that original data relating
to the above referenced falsified figures
are missing.
Dr. Tanaka has voluntarily agreed, for
a period of three (3) years, beginning on
January 14, 2009:
(1) 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’’ pursuant to
HHS’ Implementation (2 CFR Part 376 et
seq.) of OMB Guidelines to Agencies on
Government wide Debarment and
Suspension (2 CFR, Part 180); 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.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. E9–2720 Filed 2–9–09; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
erowe on PROD1PC63 with NOTICES
AGENCY: Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
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) approve the proposed
information collection project:
‘‘Evaluation of Phase I Demonstrations
of the Pharmacy Quality Alliance.’’ 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 13, 2009.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
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14:17 Feb 09, 2009
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Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@ahrq.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
e-mail at doris.lefkowitz@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
Evaluation of Phase I Demonstrations of
the Pharmacy Quality Alliance
AHRQ proposes to conduct an
independent evaluation of five Phase I
demonstrations undertaken by the
Pharmacy Quality Alliance (PQA). The
PQA launched the five demonstration
projects to test the feasibility of
implementing a pharmacy provider
report card system, which will be used
to provide feedback to pharmacies on
their performance. The goals of the
demonstrations are to obtain feedback
from pharmacists on the credibility of
the performance reports and their utility
in performance improvement, and to
identify the most efficient and useful
ways to implement a performance-based
quality reporting system. The evaluation
will be conducted for AHRQ by its
contractor, the CNA Corporation and
Thomas Jefferson Medical College.
The purpose of this evaluation is to
identify problems associated with the
implementation of a performance-based
quality reporting system. The evaluation
of the Phase I demonstrations will:
• Test the feasibility and utility of (1)
using 15 PQA claims-based measures on
pharmacy performance and (2) a survey
of consumers about their experience
with pharmacy services, which was
developed by the PQA;
• Determine the resource (time and
cost) requirements for collecting the
data and generating the pharmacy
performance reports; and
• Provide a base of knowledge that
enables the PQA to improve the
implementation process, increase
operational efficiency, reduce
operational costs, and enhance the
utility and validity of the performance
measures.
This project is being conducted
pursuant to AHRQ’s statutory authority
to conduct and support research and
evaluations on health care and on
systems for the delivery of such care,
including activities with respect to (1)
the quality, effectiveness, efficiency,
appropriateness and value of health care
services and (2) quality measurement
and improvement. 42 U.S.C. 299a(a)(1)
and (2).
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Fmt 4703
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Method of Collection
The project will include the following
three data collections: (1) On-site
interviews with key personnel involved
in the demonstration; (2) a pre-interview
questionnaire for the on site interview
participants; and (3) a survey of
pharmacy staff. The data will be
collected to obtain the following types
of information necessary for the
evaluation:
• Organizational background related
to quality measurement, organizational
resources for quality measurement;
• Measurement methodology;
• Opinions on the performance
measures;
• The process for disseminating the
performance measures;
• Incentives and penalties for
participation in pharmacy quality
improvement;
• Usability of the performance
reports;
• Future directions for quality
measurement in the organization; and
• Respondent characteristics.
Onsite Interviews With Key
Demonstration Participants
On-site interviews will be conducted
with up to six persons at each of the five
demonstration sites. The study will try
to interview representatives from the
following job functions: (1) Pharmacy
operations management; (2) clinical
pharmacy staff; (3) qualityimprovement; (4) utilization
management; (5) analytics management
responsible for oversight of performance
report analyses; (6) analytics staff
assigned to complete the performance
reports; (7) information technology (IT)
staff responsible for developing and/or
coordinating Internet components of the
project; and (8) senior management
(executive leadership, i.e., Vice
President level and above).
Pre-Interview Questionnaire
In addition to the on-site interview, a
brief written questionnaire will be used
to collect information from interview
participants prior to the interview.
There will be two different versions of
this questionnaire, one for the
demonstration project leaders and one
for all on-site interview participants.
Survey of Pharmacy Staff
A pharmacy staff survey will be
developed to yield additional
quantitative data about the
demonstration projects. The sample will
consist of practicing pharmacists who
are participating in the demonstration
sites and who received one or more of
the performance reports. It will also
include field managers and supervisors.
E:\FR\FM\10FEN1.SGM
10FEN1
Agencies
[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Notices]
[Pages 6629-6630]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2720]
=======================================================================
-----------------------------------------------------------------------
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:
Kazuhiro Tanaka, M.D., Ph.D., National Institute of Dental and
Craniofacial Research, National Institutes of Health: Based on the
report of an investigation conducted by the National Institutes of
Health (NIH) and additional analysis conducted by the Office of
Research Integrity (ORI) in its oversight review, the U.S. Public
Health Service (PHS) found that Dr. Kazuhiro Tanaka, former Visiting
Postdoctoral Fellow, Molecular Biology Section, Craniofacial
Developmental and Biology and Regeneration Branch (CDBRB), National
Institute of Dental and Craniofacial Research (NIDCR), NIH, engaged in
scientific misconduct in research supported by PHS funds from the
NIDCR, NIH Intramural Program.
PHS found that Respondent engaged in scientific misconduct by
falsifying data that were included in three published papers: Kazuhiro
Tanaka, Yoshihiro Matsumoto, Fumihiko Nakatani, Yukihide Iwamoto, and
Yoshihiko Yamada, ``A zinc finger transcription [alpha]A-crystallin
binding protein 1, is a negative regulator of the chondrocyte-specific
enhancer of the [alpha]1(II) collagen gene,'' Molecular and Cellular
Biology (MCB) 20:4428-4435, 2000; Kazuhiro Tanaka, Noriyuki Tsumaki,
Christine A. Kozak, Yoshihiro Matsumoto, Fumihiko Nakatani, Yukihide
Iwamoto, and Yoshihiko Yamada, ``A Kr[uuml]ppel-associated box-zinc
finger protein, NT2, represses cell-type-specific promoter activity of
the [alpha]2(XI) collagen gene,''Molecular and Cellular Biology
22:4256-4267, 2002; and Ying Liu, Haochuan Li, Kazuhiro Tanaka,
Noriyuki Tsumaki, and Yoshihiko Yamada, ``Identification of an enhancer
sequence with the first intron required for cartilage-specific
transcription of the [alpha]2(XI) collagen gene,'' Journal of
Biological Chemistry (JBC) 275:12712-12718, 2000.
Specifically, PHS found that Respondent:
Falsified the results for CRYBP1 or Sox9 binding to the
Col2a1 DNA sequence in electrophoretic mobility shift assays in Figure
1D and Figure 7 in MCB 20:4428-4435, 2000. He used duplicate copies of
bands or duplicate copies of parts of lanes to falsely represent
results from reportedly different experimental conditions;
Falsified the results for NT2 binding to the Col11a2 DNA
sequence in electrophoretic mobility shift assays in Figures 2D and 6B,
and falsified the Western blot for NT2 mutant proteins in Figure 8B in
MCB 22:4256-4267, 2002. He used duplicate copies of bands, parts of
bands, or duplicate copies of parts of lanes to falsely represent
results from reportedly different experimental conditions in Figures 2D
and 6B; and falsely represented results for the Figure 8B Western blot
by using duplicate copies of bands to represent NT2[Delta]1 (lane 2)
and NT2[Delta]4 (lane 5) mutant proteins;
Falsified the Western blot for Sox9 protein expression in
Figure 4B, JBC 275:12712-12718, 2000, by using duplicate copies of
lanes 1 and 2 to represent the Sox9 expression in cell extracts from
both Balb 3T3 and undifferentiated ATDC5 cells; and
Falsified the Northern blots in multiple panels of Figure
3, MCB 20:4428-4435, 2000. He used duplicate copies of bands for
CRYBP1, for Type II collagen, for Type X collagen, and for GAPDH and
18S EtBr stained control bands to falsely represent results of RNA
expression from these different genes in ATDC5 cells. He also used
duplicate copies of bands to falsely represent the RNA expression in
ATDC5 cells grown under different conditions for either collagen Type
II in Figure 3, MCB 2000 or collagen [alpha]1(X) in Figure 5 in MCB
22:4256-4267, 2002. Similarly, duplicate copies of 18S EtBr stained
control bands were used in both figures with reportedly different
experimental conditions.
Both Respondent 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 (Agreement). The
settlement
[[Page 6630]]
is not an admission of liability on the part of the Respondent.
Respondent neither admits nor denies ORI's finding of scientific
misconduct. Respondent acknowledges that original data relating to the
above referenced falsified figures are missing.
Dr. Tanaka has voluntarily agreed, for a period of three (3) years,
beginning on January 14, 2009:
(1) 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'' pursuant to HHS' Implementation
(2 CFR Part 376 et seq.) of OMB Guidelines to Agencies on Government
wide Debarment and Suspension (2 CFR, Part 180); 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.
Chris B. Pascal,
Director, Office of Research Integrity.
[FR Doc. E9-2720 Filed 2-9-09; 8:45 am]
BILLING CODE 4150-31-P