Findings of Research Misconduct, 52034-52035 [2012-21236]
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Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Notices
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
for public comment. Interested persons
are invited to send comments regarding
this burden estimate or any other aspect
of this collection of information,
including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, email your request,
including your address, phone number
and the document identifier OS–0955–
0002, to Information.Collection
Clearance@hhs.gov or call the
Information Collection Clearance Office
on (202) 690–6162. Comments and
recommendations for the proposed
information collection must be received
within 60 days of the issuance of this
notice.
Proposed Project: Facts for Consumers
about Health IT Service Providers
(Revision)—OMB No. 0955–0002–OS/
Office of the National Coordinator for
Health Information Technology
Abstract: ONC is proposing to revise
current OMB approved Facts for
Consumers about Health IT Service
Providers. The current OMB approval is
applicable through September 30, 2012.
It includes iterative rounds of in-depth
consumer testing to assess and analyze
consumer understanding and input
about a model privacy notice for
personal health records (PHRs). ONC
intends to revise the project to use the
same focus group and cognitive
usability interview testing process for
the development of a model notice of
privacy practices (NPP). 45 CFR 164.520
requires covered entities to make
available a NPP for protected health
information to their patients or health
plan members. The notice must, among
other things, outline the purposes for
which the covered entity is permitted to
use and disclose health information, the
rights of individuals with respect to
their health information, the entities’
duties to protect that information, and
the process for filing a complaint
concerning possible violations of the
HIPAA Privacy Rule, such as an
improper use or disclosure of
information. 45 CFR 164.520 requires
that the notice be written in plain
language, but studies have shown that
these notices are often difficult for
patients to understand due to their
length and complexity.
The Federal Health IT Strategic Plan
identifies the Fair Information Practice
Principles (FIPPS) an important
guidepost in the development of privacy
policies and programs. Openness and
Transparency is a key principle of fair
information practices. The NPP is an
important component of fulfilling this
principle. If patients cannot adequately
understand the notice because of its
length or complexity, then the use and
disclosure of their health information is
not open and transparent.
In addition, each participant will have
been recruited through a 15-minute
screening interview. The participants
will be recruited according to U.S.
census statistics for race/ethnicity, age,
marital status, gender, and income.
ESTIMATED ANNUALIZED BURDEN TABLE
Forms
(if necessary)
Type of
respondent
Number of
responses per
respondent
Number of
respondents
Average burden
hours per
response
Total burden
hours
Cognitive Testing Screening ............................
Cognitive Testing .............................................
General Public
General Public
84
42
1
1
15/60
90/60
21
63
Total ..........................................................
............................
126
............................
............................
84
Keith A. Tucker,
Information Collection Clearance Officer,
Department of Health and Human Services.
[FR Doc. 2012–21103 Filed 8–27–12; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Shane Mayack, Ph.D., Joslin Diabetes
Center: Based on the report of an
investigation conducted by the Joslin
Diabetes Center (Joslin) and additional
analysis conducted by ORI in its
oversight review, ORI found that Dr.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
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16:39 Aug 27, 2012
Jkt 226001
Shane Mayack, former postdoctoral
fellow, Department of Developmental
and Stem Cell Biology, Joslin, engaged
in research misconduct in research
supported by National Institute of
Diabetes and Digestive and Kidney
Diseases (NIDDK), National Institutes of
Health (NIH), grants T32 DK07260–29
and P30 DK036836 and the 2008 NIH
Director’s New Innovator Award
Program grant DP2 OD004345–01.
ORI found that Respondent engaged
in research misconduct involving two
(2) published papers:
• Mayack, S.R., Shadrach, J.L., Kim,
F.S., & Wagers, A.J. ‘‘Systemic
signals regulate ageing and
rejuventation of blood stem cell
niches.’’ Nature 463:495–500, 2010.
• Mayack, S.R., & Wagers, A.J.
‘‘Osteolineage niche cells initiate
hemotopoietic stem cell
mobilization.’’ Blood 112:519–531,
2008.
PO 00000
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Fmt 4703
Sfmt 4703
As a result of Joslin’s investigation,
both Nature 463:495–500, 2010
(hereafter referred to as the ‘‘Nature
paper’’) and Blood 112:519–531, 2008
(hereafter referred to as the ‘‘Blood
paper’’) have been retracted by the
corresponding author.
Specifically, ORI found that:
• Respondent falsely represented von
Kossa-stained bone nodule images in
two (2) published papers:
a. Figure 2B in the Blood paper was
copied from an unrelated published
experiment in Figure 3, J Orth Surg Res
1:7, 2006, and was used to falsely
represent Respondent’s own experiment
for bone nodules formed in cultured
osteoblastic niche cells.
b. Figure S2c in the Nature paper was
copied from an online image for an
unrelated experiment (at https://
skeletalbiology.uchc.edu/
30_ResearchProgram/304_gap/
3042_Lineage%20in%20Vitro/
3042_01_aCellCult.htm#mCOB) and was
E:\FR\FM\28AUN1.SGM
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srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 167 / Tuesday, August 28, 2012 / Notices
used to falsely represent Respondent’s
own experiment for bone nodules
formed in osteoblastic niche cells from
young and aged mice.
• Respondent falsely represented
eight (8) flow cytometry contour plots as
different experimental results by using
identical plots but with different labels
and different numerical percentages.
Specifically, the following contour plots
in the Blood paper, the Nature paper, an
earlier version of the Nature paper
submitted to Science (hereafter referred
to as the ‘‘Science manuscript’’), and a
July 2008 PowerPoint presentation were
identical but were labeled differently:
a. Panels 4 and 2 in Figure 6C, Blood
paper, and panels 1 and 2,
respectively, in supplementary Figure
3b, Nature paper
b. Panel 3 in Figure 6C, Blood paper,
and panel 1 in Figure 2, July 2008
PowerPoint presentation
c. Panels 1 and 2, Figure 2b, Science
manuscript, and panels 2 and 3,
respectively, in Figure 2, July 2008
PowerPoint presentation
d. Panels 2, 3, and 4, supplemental
Figure 4A, Blood paper, and panels 3,
1, and 2, respectively, in Figure 4B,
Science manuscript
Both the Respondent and HHS want
to conclude this matter without further
expenditure of time or other resources
and have entered into a Voluntary
Settlement Agreement to resolve this
matter. Respondent neither admits nor
denies ORI’s finding of research
misconduct. This settlement does not
constitute an admission of liability on
the part of the Respondent. Dr. Mayack
has voluntarily agreed:
(1) If within three (3) years from the
effective date of the Agreement,
Respondent does receive or apply for
U.S. Public Health Service (PHS)
support, Respondent agrees to have her
research supervised for a period of three
(3) years beginning on the date of her
employment in a research position in
which she receives or applies for PHS
support and to notify her employer(s)/
institution(s) of the terms of this
supervision; Respondent agrees that
prior to the submission of an
application for PHS support for a
research project on which the
Respondent’s participation is proposed
and prior to Respondent’s participation
in any capacity on PHS-supported
research, Respondent shall ensure that a
plan for supervision of Respondent’s
duties is submitted to ORI for approval;
the supervision plan must be designed
to ensure the scientific integrity of
Respondent’s research contribution;
Respondent agrees that she shall not
participate in any PHS-supported
VerDate Mar<15>2010
16:39 Aug 27, 2012
Jkt 226001
research until such a supervision plan is
submitted to and approved by ORI;
Respondent agrees to maintain
responsibility for compliance with the
agreed upon supervision plan;
(2) If within three (3) years from the
effective date of the Agreement,
Respondent does receive or apply for
PHS support, Respondent agrees that
any institution employing her shall
submit, in conjunction with each
application for PHS funds, or report,
manuscript, or abstract involving PHSsupported research in which
Respondent is involved, a certification
to ORI that the data provided by
Respondent are based on actual
experiments or are otherwise
legitimately derived and that the data,
procedures, and methodology are
accurately reported in the application,
report, manuscript, or abstract; and
(3) To exclude herself voluntarily
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 a period of three (3)
years, beginning on July 27, 2012.
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. 2012–21236 Filed 8–27–12; 8:45 am]
BILLING CODE 4150–31–P
52035
I. Background
In the FR Doc. 2012–16514 of July 6,
2012 (77 FR 40064), we published a
Paperwork Reduction Act notice
requesting a 60-day public comment
period for the document entitled
‘‘Notice of Denial of Medical Coverage
(or Payment).’’
In the July 6, 2012 notice, we listed
the incorrect contact information.
Therefore, we are correcting that error in
this notice.
II. Correction of Error
In FR Doc. 2012–16514 of July 6, 2012
(77 FR 40064), make the following
correction:
On page 40068, first column, fourth
full paragraph, on the fifteenth line in
the paragraph beginning with ‘‘(For
policy questions regarding, ’’ and
ending with, ‘‘410–786–0273),’’ is
corrected to read as follows.
‘‘(For policy questions regarding this
collection contact Kathryn McCann
Smith at 410–786–7623.)’’
Dated: August 22, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–21076 Filed 8–23–12; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–E–0102]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TORISEL
Centers for Medicare & Medicaid
Services
AGENCY:
[Document Identifier: CMS–10003]
ACTION:
Public Information Collection
Requirements Submitted to the Office
of Management and Budget (OMB);
Correction
SUMMARY:
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Correction of notice.
AGENCY:
This document corrects a
technical error in the notice [Document
Identifier: CMS–10003] entitled ‘‘Notice
of Denial of Medical Coverage (or
Payment)’’ that was published in the
July 6, 2012 (77 FR 40064) Federal
Register.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
William Parham, (410) 786–4669.
SUPPLEMENTARY INFORMATION:
PO 00000
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Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
TORISEL and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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]]>Agencies
[Federal Register Volume 77, Number 167 (Tuesday, August 28, 2012)]
[Notices]
[Pages 52034-52035]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21236]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Findings of Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Notice is hereby given that the Office of Research Integrity
(ORI) has taken final action in the following case:
Shane Mayack, Ph.D., Joslin Diabetes Center: Based on the report of
an investigation conducted by the Joslin Diabetes Center (Joslin) and
additional analysis conducted by ORI in its oversight review, ORI found
that Dr. Shane Mayack, former postdoctoral fellow, Department of
Developmental and Stem Cell Biology, Joslin, engaged in research
misconduct in research supported by National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK), National Institutes of Health
(NIH), grants T32 DK07260-29 and P30 DK036836 and the 2008 NIH
Director's New Innovator Award Program grant DP2 OD004345-01.
ORI found that Respondent engaged in research misconduct involving
two (2) published papers:
Mayack, S.R., Shadrach, J.L., Kim, F.S., & Wagers, A.J.
``Systemic signals regulate ageing and rejuventation of blood stem cell
niches.'' Nature 463:495-500, 2010.
Mayack, S.R., & Wagers, A.J. ``Osteolineage niche cells
initiate hemotopoietic stem cell mobilization.'' Blood 112:519-531,
2008.
As a result of Joslin's investigation, both Nature 463:495-500,
2010 (hereafter referred to as the ``Nature paper'') and Blood 112:519-
531, 2008 (hereafter referred to as the ``Blood paper'') have been
retracted by the corresponding author.
Specifically, ORI found that:
Respondent falsely represented von Kossa-stained bone
nodule images in two (2) published papers:
a. Figure 2B in the Blood paper was copied from an unrelated
published experiment in Figure 3, J Orth Surg Res 1:7, 2006, and was
used to falsely represent Respondent's own experiment for bone nodules
formed in cultured osteoblastic niche cells.
b. Figure S2c in the Nature paper was copied from an online image
for an unrelated experiment (at https://skeletalbiology.uchc.edu/30_ResearchProgram/304_gap/3042_Lineage%20in%20Vitro/3042_01_aCellCult.htm#mCOB) and was
[[Page 52035]]
used to falsely represent Respondent's own experiment for bone nodules
formed in osteoblastic niche cells from young and aged mice.
Respondent falsely represented eight (8) flow cytometry
contour plots as different experimental results by using identical
plots but with different labels and different numerical percentages.
Specifically, the following contour plots in the Blood paper, the
Nature paper, an earlier version of the Nature paper submitted to
Science (hereafter referred to as the ``Science manuscript''), and a
July 2008 PowerPoint presentation were identical but were labeled
differently:
a. Panels 4 and 2 in Figure 6C, Blood paper, and panels 1 and 2,
respectively, in supplementary Figure 3b, Nature paper
b. Panel 3 in Figure 6C, Blood paper, and panel 1 in Figure 2, July
2008 PowerPoint presentation
c. Panels 1 and 2, Figure 2b, Science manuscript, and panels 2 and 3,
respectively, in Figure 2, July 2008 PowerPoint presentation
d. Panels 2, 3, and 4, supplemental Figure 4A, Blood paper, and panels
3, 1, and 2, respectively, in Figure 4B, Science manuscript
Both the Respondent and HHS want to conclude this matter without
further expenditure of time or other resources and have entered into a
Voluntary Settlement Agreement to resolve this matter. Respondent
neither admits nor denies ORI's finding of research misconduct. This
settlement does not constitute an admission of liability on the part of
the Respondent. Dr. Mayack has voluntarily agreed:
(1) If within three (3) years from the effective date of the
Agreement, Respondent does receive or apply for U.S. Public Health
Service (PHS) support, Respondent agrees to have her research
supervised for a period of three (3) years beginning on the date of her
employment in a research position in which she receives or applies for
PHS support and to notify her employer(s)/institution(s) of the terms
of this supervision; Respondent agrees that prior to the submission of
an application for PHS support for a research project on which the
Respondent's participation is proposed and prior to Respondent's
participation in any capacity on PHS-supported research, Respondent
shall ensure that a plan for supervision of Respondent's duties is
submitted to ORI for approval; the supervision plan must be designed to
ensure the scientific integrity of Respondent's research contribution;
Respondent agrees that she shall not participate in any PHS-supported
research until such a supervision plan is submitted to and approved by
ORI; Respondent agrees to maintain responsibility for compliance with
the agreed upon supervision plan;
(2) If within three (3) years from the effective date of the
Agreement, Respondent does receive or apply for PHS support, Respondent
agrees that any institution employing her shall submit, in conjunction
with each application for PHS funds, or report, manuscript, or abstract
involving PHS-supported research in which Respondent is involved, a
certification to ORI that the data provided by Respondent are based on
actual experiments or are otherwise legitimately derived and that the
data, procedures, and methodology are accurately reported in the
application, report, manuscript, or abstract; and
(3) To exclude herself voluntarily 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 a period of three (3) years, beginning on July 27, 2012.
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. 2012-21236 Filed 8-27-12; 8:45 am]
BILLING CODE 4150-31-P
