Findings of Research Misconduct, 72892-72893 [2013-28887]
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Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices
overall sample along a number of
relevant dimensions (e.g., assessment of
risk of needing long-term care). The
analysis will also characterize the
sample by key indicator variables, to
analyze the role of long-term care
planning within the context of overall
retirement planning, and to understand
long-term care use and payment and
policy preferences. Multivariate
analyses will also be conducted,
primarily of planning activity for longterm care and preferences for public
policies for long-term care financing.
The second set of analyses will
address the DCEs that respondents
conducted to evaluate various features
of long-term care insurance policies.
DCEs are a form of conjoint analysis, an
econometric method used to estimate
the relative importance that respondents
place on the different features of an
individual product (e.g., for long-term
care insurance, such features as length
of coverage, benefit period, benefit
amount, whether there is medical
underwriting, and sponsorship). These
data will be analyzed using standard
discrete choice econometric techniques
in which the parameter estimates in the
choice models indicate the relative
importance to respondents of different
features of long-term care insurance.
Thus, the ratio of two parameters
indicates the marginal rate of
substitution between them (i.e., the rate
at which respondents changed their
selections when attribute levels were
varied).
Likely Respondents: Survey
invitations will be sent by the data
collection partner, GfK, to a random
sample of U.S. adults aged 40–70
participating in its standing Internet
panel, KnowledgePanel. Adults who
read the survey invitation and desire to
participate will be redirected to a
secure, password-protected Web site
hosted by GfK which contains the next
two forms. GfK will send 23,077
invitations to participate to members of
the sample, yielding an estimated
15,000 completed questionnaires based
on an estimated overall response rate of
65 percent.
Burden Statement: The response
burden estimates for this data collection
are shown in Exhibit A.12–1. An IRBapproved consent form must be
acknowledged by respondents before
they are allowed to begin the survey.
Respondents will be asked to read basic
information about the research study,
the study purpose, procedures, duration
of the survey, possible risks or
discomforts from the survey, benefits of
participating, incentive for
participation, privacy protections,
individuals’ rights, and whom to contact
with questions. Respondents will then
be required to click a box indicating that
they have read the information, confirm
that they are between the ages of 40 and
70, and that they voluntarily consent to
participate in the study or decline to
participate. Only those who consent and
certify that they meet the age
qualifications will continue to the full
survey instrument. Estimates for the
time needed to complete the survey are
based on cognitive testing of the
questionnaire conducted during Fall
2012 in Durham, North Carolina, and
Washington, DC. As part of the
cognitive testing, the length of time to
complete the questionnaire was
measured. The cognitive testing suggests
that the questionnaire requires
approximately 45 minutes to complete.
The initial series of questions take
approximately 25 minutes to complete
and the DCE section takes
approximately 15–20 minutes to
complete. Each respondent will answer
the questionnaire only once and there
are no planned follow-up surveys.
Respondents will have the ability to
pause the survey and restart it at a later
time at their convenience.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Task
Number of
respondents
Burden per
response
(hours)
Estimated total
hours of burden
Self-administered, Web-based questionnaire ..................................................................
15,000
0.75
11,250
Source: RTI International estimates.
Darius Taylor,
Deputy, Information Collection Clearance
Officer.
Parkway, Suite 750, Rockville, MD
20852, (240) 453–8800.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–28991 Filed 12–3–13; 8:45 am]
BILLING CODE 4151–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY:
EMCDONALD on DSK67QTVN1PROD with NOTICES
ACTION:
Office of the Secretary, HHS.
Notice.
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case: Timothy Sheehy, B.A., BSc., SAICFrederick, Inc.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
David E. Wright, Ph.D., Director, Office
of Research Integrity, 1101 Wootton
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Timothy Sheehy, B.A., BSc., SAICFrederick, Inc.: Based on the report of an
investigation conducted by SAICFrederick, Inc., and additional analysis
conducted by ORI in its oversight
review, ORI found that Mr. Timothy
Sheehy, former Manager, DNA
Extraction and Staging Laboratory
(DESL), SAIC-Frederick, Inc., the
Operations and Technical Services
(OTC) Contractor for the Frederick
National Laboratory for Cancer Research
(FNLCR), Frederick, MD, engaged in
research misconduct in research
supported by National Cancer Institute
(NCI), National Institutes of Health
(NIH), contract HHSN2612008000001E
awarded by FNLCR/NCI, NIH, to SAICFrederick, Inc., and the intramural
program at the Occupational and
Environmental Epidemiology Branch,
PO 00000
Frm 00034
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Division of Cancer Epidemiology and
Genetics, NCI.
ORI found that the Respondent
engaged in research misconduct by
fabricating and/or falsifying U.S. Public
Health Service (PHS)-supported data in
Table 1 included in Cancer Epidemiol
Biomarkers Prev 19(4):973–977, 2010
(hereafter referred to as the ‘‘CEBP
paper’’).
Specifically, ORI found that
Respondent fabricated the quantitative
and qualitative data for RNA and DNA
purportedly extracted from 900
formalin-fixed, paraffin-embedded
(FFPE) colorectal tissue samples
presented in Table 1 of the CEBP paper
and falsely reported successful
methodology to simultaneously recover
nucleic acids from FFPE tissue
specimens, when neither the extractions
nor analyses of the FFPE samples were
done. Thus, the main conclusions of the
CEBP paper are based on fabricated data
and are false.
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Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices
Mr. Sheehy has entered into a
Voluntary Settlement Agreement and
has voluntarily agreed for a period of
three (3) years, beginning on November
8, 2013:
(1) To have his research supervised;
Respondent agreed that prior to the
submission of an application for U.S.
Public Health Service (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 his duties is
submitted to ORI for approval; the
supervision plan must be designed to
ensure the scientific integrity of
Respondent’s research contribution;
Respondent agreed that he shall not
participate in any PHS-supported
research until such a supervision plan is
submitted to and approved by ORI;
Respondent agreed to maintain
responsibility for compliance with the
agreed-upon supervision plan;
(2) that any institution employing him
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;
(3) to exclude himself 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; and
(4) that a letter will be submitted to
the editors of CEBP requesting that the
journal retract the publication.
David E. Wright,
Director, Office of Research Integrity.
[FR Doc. 2013–28887 Filed 12–3–13; 8:45 am]
EMCDONALD on DSK67QTVN1PROD with NOTICES
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0579]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Biological
Products: Reporting of Biological
Product Deviations and Human Cells,
Tissues, and Cellular and TissueBased Product Deviations in
Manufacturing; Forms FDA 3486 and
3486A
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 3,
2014.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0458. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:
Biological Products: Reporting of
Biological Product Deviations and
Human Cells, Tissues, and Cellular and
Tissue-Based Product Deviations in
Manufacturing; Forms FDA 3486 and
3486A—(OMB Control Number 0910–
0458)—Extension
Under section 351 of the Public
Health Service Act (PHS Act) (42 U.S.C.
262), all biological products, including
human blood and blood components,
offered for sale in interstate commerce
must be licensed and meet standards,
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17:09 Dec 03, 2013
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72893
including those prescribed in the FDA
regulations designed to ensure the
continued safety, purity, and potency of
such products. In addition, under
section 361 of the PHS Act (42 U.S.C.
264), FDA may issue and enforce
regulations necessary to prevent the
introduction, transmission, or spread of
communicable diseases between the
States or possessions or from foreign
countries into the States or possessions.
Further, the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
351) provides that drugs and devices
(including human blood and blood
components) are adulterated if they do
not conform with current good
manufacturing practice (CGMP) assuring
that they meet the requirements of the
FD&C Act. Establishments
manufacturing biological products,
including human blood and blood
components, must comply with the
applicable CGMP regulations (parts 211,
606, and 820 (21 CFR parts 211, 606,
and 820)) and current good tissue
practice (CGTP) regulations (part 1271
(21 CFR part 1271)) as appropriate. FDA
regards biological product deviation
(BPD) reporting and human cells,
tissues and cellular and tissue-based
products (HCT/P) deviation reporting to
be an essential tool in its directive to
protect public health by establishing
and maintaining surveillance programs
that provide timely and useful
information.
Section 600.14 (21 CFR 600.14), in
brief, requires the manufacturer who
holds the biological product license for
other than human blood and blood
components, and who had control over
a distributed product when the
deviation occurred, to report to the
Center for Biologics Evaluation and
Research (CBER) or to the Center for
Drugs Evaluation and Research (CDER)
as soon as possible, but at a date not to
exceed 45 calendar days after acquiring
information reasonably suggesting that a
reportable event has occurred. Section
606.171, in brief, requires licensed
manufacturers of human blood and
blood components, including Source
Plasma, unlicensed registered blood
establishments, and transfusion
services, who had control over a
distributed product when the deviation
occurred, to report to CBER as soon as
possible but at a date not to exceed 45
calendar days after acquiring
information reasonably suggesting that a
reportable event has occurred.
Similarly, § 1271.350(b), in brief,
requires HCT/P establishments that
manufacture non-reproductive HCT/Ps
described in § 1271.10 to investigate and
report to CBER all HCT/P deviations
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]]>Agencies
[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72892-72893]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28887]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
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: Timothy Sheehy,
B.A., BSc., SAIC-Frederick, Inc.
FOR FURTHER INFORMATION CONTACT: David E. Wright, Ph.D., Director,
Office of Research Integrity, 1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453-8800.
SUPPLEMENTARY INFORMATION:
Timothy Sheehy, B.A., BSc., SAIC-Frederick, Inc.: Based on the
report of an investigation conducted by SAIC-Frederick, Inc., and
additional analysis conducted by ORI in its oversight review, ORI found
that Mr. Timothy Sheehy, former Manager, DNA Extraction and Staging
Laboratory (DESL), SAIC-Frederick, Inc., the Operations and Technical
Services (OTC) Contractor for the Frederick National Laboratory for
Cancer Research (FNLCR), Frederick, MD, engaged in research misconduct
in research supported by National Cancer Institute (NCI), National
Institutes of Health (NIH), contract HHSN2612008000001E awarded by
FNLCR/NCI, NIH, to SAIC-Frederick, Inc., and the intramural program at
the Occupational and Environmental Epidemiology Branch, Division of
Cancer Epidemiology and Genetics, NCI.
ORI found that the Respondent engaged in research misconduct by
fabricating and/or falsifying U.S. Public Health Service (PHS)-
supported data in Table 1 included in Cancer Epidemiol Biomarkers Prev
19(4):973-977, 2010 (hereafter referred to as the ``CEBP paper'').
Specifically, ORI found that Respondent fabricated the quantitative
and qualitative data for RNA and DNA purportedly extracted from 900
formalin-fixed, paraffin-embedded (FFPE) colorectal tissue samples
presented in Table 1 of the CEBP paper and falsely reported successful
methodology to simultaneously recover nucleic acids from FFPE tissue
specimens, when neither the extractions nor analyses of the FFPE
samples were done. Thus, the main conclusions of the CEBP paper are
based on fabricated data and are false.
[[Page 72893]]
Mr. Sheehy has entered into a Voluntary Settlement Agreement and
has voluntarily agreed for a period of three (3) years, beginning on
November 8, 2013:
(1) To have his research supervised; Respondent agreed that prior
to the submission of an application for U.S. Public Health Service
(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 his duties is submitted to ORI for approval;
the supervision plan must be designed to ensure the scientific
integrity of
Respondent's research contribution; Respondent agreed that he shall
not participate in any PHS-supported research until such a supervision
plan is submitted to and approved by ORI; Respondent agreed to maintain
responsibility for compliance with the agreed-upon supervision plan;
(2) that any institution employing him 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;
(3) to exclude himself 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; and
(4) that a letter will be submitted to the editors of CEBP
requesting that the journal retract the publication.
David E. Wright,
Director, Office of Research Integrity.
[FR Doc. 2013-28887 Filed 12-3-13; 8:45 am]
BILLING CODE 4150-31-P
