Findings of Research Misconduct, 63153-63154 [E9-28814]
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Federal Register / Vol. 74, No. 230 / Wednesday, December 2, 2009 / Notices
accompanied, the canceled product. The
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If, as the Agency currently intends, the
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Environmental protection, Pesticides
and pests.
Dated: November 19,2009.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division,
Office of Pesticide Programs.
[FR Doc. E9–28542 Filed 12–1–09; 8:45 am]
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Tuesday, December 1,
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PLACE: 999 E Street, NW., Washington,
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Mary W. Dove,
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[FR Doc. E9–28705 Filed 12–1–09; 8:45 am]
mstockstill on DSKH9S0YB1PROD with NOTICES
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Determination Concerning a Petition
To Add a Class of Employees to the
Special Exposure Cohort
AGENCY: National Institute for
Occupational Safety and Health
VerDate Nov<24>2008
18:28 Dec 01, 2009
Jkt 220001
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
SUMMARY: HHS gives notice of a
determination concerning a petition to
add a class of employees at the BakerPerkins Company, Saginaw, Michigan,
to the Special Exposure Cohort (SEC)
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000 (EEOICPA), 42
U.S.C. 7384q. On November 13, 2009,
the Secretary of HHS determined that
the following class of employees does
not meet the statutory criteria for
addition to the SEC as authorized under
EEOICPA:
All AWE employees who performed
Atomic Energy Commission work at Baker
Perkins Company, in Saginaw, Michigan,
from May 14, 1956 through May 18, 1956.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Interim Director,
Office of Compensation Analysis and
Support, National Institute for
Occupational Safety and Health
(NIOSH), 4676 Columbia Parkway, MS
C–46, Cincinnati, OH 45226, Telephone
513–533–6800 (this is not a toll-free
number). Information requests can also
be submitted by e-mail to
OCAS@CDC.GOV.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. E9–28809 Filed 12–1–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research 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:
Rashanda Robertson, Emory
University: Based on an assessment
conducted by Emory University (EU),
the Respondent’s own admission, and
additional oversight of that admission
conducted by ORI, ORI and EU found
that Ms. Rashanda Robertson, former
Research Coordinator, Department of
General Medicine, EU, engaged in
research misconduct in research
supported by National Heart, Lung, and
Blood Institute (NHLBI), National
Institutes of Health (NIH), grant K23
HL077597. The randomized study for
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63153
which she coordinated was designed to
assess whether patient medication
compliance was improved by a meeting
with a clinical pharmacist to discuss the
patient’s current and newly prescribed
medications prior to the patient’s
discharge from the hospital. The
enrolled subjects randomized to the
intervention group received a card
listing all of their medications and a
‘‘pill box’’ to help them with medication
compliance. The subjects also were
called three days after discharge to
check on their medication compliance.
Specifically, the U.S. Public Health
Service (PHS), EU, and Ms. Robertson,
in a three-way Voluntary Settlement
Agreement, agree that the Respondent
committed the following acts of research
misconduct, which she fully
acknowledged. In an affidavit obtained
by EU, the Respondent admitted that
during the last two weeks of her
employment at EU, she fabricated
enrollment forms to create enrollees
who did not exist and falsified the data
of some enrollees who did not exist to
cover up the data fabrication. To create
the fabricated enrollment forms, the
Respondent:
• Identified patients who were
eligible for the study based on their
charge screens but who were considered
ineligible after a face-to-face screen;
• Obtained patients’ names from the
screening records and used the names to
obtain the personal information (address
and telephone numbers) on these
patients from the site hospital’s
pharmacy online system;
• Created a fabricated enrollment
form for each of the non-existent
enrollees; specifically, Respondent
fabricated a participant’s name by using
the name of a patient who had failed
screening and then fabricated the date of
enrollment by using the date of the
patient’s screening failure; using this
method, Respondent fabricated the
participant names, personal
information, and enrollment dates on
twenty-eight (28) enrollment forms;
• Dispersed the fabricated enrollment
forms among those enrollment forms,
beginning around participant number
136 through 212;
• Falsified the numbering of the
enrollment forms for some individuals
who had actually been enrolled to
disperse the fabricated enrollment forms
among the authentic enrollment forms;
Respondent falsified the status of some
actual participants to include them in
the intervention group, even though
they had not actually received the
intervention; Respondent falsified the
data on both the enrollment form and
the follow-up form for 16 participants
between numbers 137 and 198;
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02DEN1
63154
Federal Register / Vol. 74, No. 230 / Wednesday, December 2, 2009 / Notices
• Respondent falsified data on the
enrollment forms and follow-up forms
for participant numbers 153 and 154 by
changing their enrollment numbers.
ORI acknowledges that the
Respondent was remorseful.
Ms. Robertson has entered into a
Voluntary Settlement Agreement in
which she has voluntarily agreed, for a
period of three (3) years, beginning on
October 14, 2009:
(1) To exclude herself 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;
(2) That any institution that submits
an application for PHS support for a
research project on which the
Respondent’s participation is proposed
or that uses her in any capacity on PHSsupported research, or that submits a
report of PHS-funded research in which
she is involved, must concurrently
submit a plan for supervision of her
duties to the funding agency for
approval; the supervisory plan must be
designed to ensure the scientific
integrity of her research contribution;
respondent agreed that she will not
participate in any PHS-supported
research until such a supervisory plan is
submitted to ORI; and
(3) That any institution employing her
submits, in conjunction with each
application for PHS funds or report,
manuscript, or abstract of PHS-funded
research in which the Respondent is
involved, a certification that the data
provided by the Respondent are based
on actual experiments or are otherwise
legitimately derived and that the data,
procedures, analyses, and methodology
are accurately reported in the
application, report, manuscript, or
abstract. The Respondent must ensure
that the institution sends a copy of the
certification to ORI.
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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. E9–28814 Filed 12–1–09; 8:45 am]
BILLING CODE 4150–31–P
VerDate Nov<24>2008
18:28 Dec 01, 2009
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0554]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Manufactured
Food Regulatory Program Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the Manufactured Food Regulatory
Program Standards.
DATES: Submit written or electronic
comments on the collection of
information by February 1, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
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proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Manufactured Food Regulatory
Program Standards—(OMB Control
Number 0910–0601—Extension)
I. Background
In the Federal Register of July 20,
2006 (71 FR 41221), FDA announced the
availability of a draft document entitled
‘‘Manufactured Food Regulatory
Program Standards.’’ These draft
program standards are the framework
that States should use to design and
manage its manufactured food program.
The implementation of the program
standards will be negotiated as an
option for payment under the State food
contract. States that are awarded this
option will receive up to $25,000 over
a period of 5 years to fully implement
the program standards.
In the first year of implementing the
program standards, the State program
conducts a baseline self-assessment to
determine if they meet the elements of
each standard. The State program
should use the worksheets and forms
contained herein; however it can use
alternate forms that are equivalent. The
State program maintains the documents
and verifying records required for each
standard. The information contained in
the documents must be current and fitfor-use. If the State program fails to meet
all program elements and
documentation requirements of a
standard, it develops a strategic plan to
fully implement the program standards
in 5 years. The strategic plan includes
the following: (1) The individual
element or documentation requirement
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]]>Agencies
[Federal Register Volume 74, Number 230 (Wednesday, December 2, 2009)]
[Notices]
[Pages 63153-63154]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28814]
-----------------------------------------------------------------------
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) and the Assistant Secretary for Health have taken final action in
the following case:
Rashanda Robertson, Emory University: Based on an assessment
conducted by Emory University (EU), the Respondent's own admission, and
additional oversight of that admission conducted by ORI, ORI and EU
found that Ms. Rashanda Robertson, former Research Coordinator,
Department of General Medicine, EU, engaged in research misconduct in
research supported by National Heart, Lung, and Blood Institute
(NHLBI), National Institutes of Health (NIH), grant K23 HL077597. The
randomized study for which she coordinated was designed to assess
whether patient medication compliance was improved by a meeting with a
clinical pharmacist to discuss the patient's current and newly
prescribed medications prior to the patient's discharge from the
hospital. The enrolled subjects randomized to the intervention group
received a card listing all of their medications and a ``pill box'' to
help them with medication compliance. The subjects also were called
three days after discharge to check on their medication compliance.
Specifically, the U.S. Public Health Service (PHS), EU, and Ms.
Robertson, in a three-way Voluntary Settlement Agreement, agree that
the Respondent committed the following acts of research misconduct,
which she fully acknowledged. In an affidavit obtained by EU, the
Respondent admitted that during the last two weeks of her employment at
EU, she fabricated enrollment forms to create enrollees who did not
exist and falsified the data of some enrollees who did not exist to
cover up the data fabrication. To create the fabricated enrollment
forms, the Respondent:
Identified patients who were eligible for the study based
on their charge screens but who were considered ineligible after a
face-to-face screen;
Obtained patients' names from the screening records and
used the names to obtain the personal information (address and
telephone numbers) on these patients from the site hospital's pharmacy
online system;
Created a fabricated enrollment form for each of the non-
existent enrollees; specifically, Respondent fabricated a participant's
name by using the name of a patient who had failed screening and then
fabricated the date of enrollment by using the date of the patient's
screening failure; using this method, Respondent fabricated the
participant names, personal information, and enrollment dates on
twenty-eight (28) enrollment forms;
Dispersed the fabricated enrollment forms among those
enrollment forms, beginning around participant number 136 through 212;
Falsified the numbering of the enrollment forms for some
individuals who had actually been enrolled to disperse the fabricated
enrollment forms among the authentic enrollment forms; Respondent
falsified the status of some actual participants to include them in the
intervention group, even though they had not actually received the
intervention; Respondent falsified the data on both the enrollment form
and the follow-up form for 16 participants between numbers 137 and 198;
[[Page 63154]]
Respondent falsified data on the enrollment forms and
follow-up forms for participant numbers 153 and 154 by changing their
enrollment numbers.
ORI acknowledges that the Respondent was remorseful.
Ms. Robertson has entered into a Voluntary Settlement Agreement in
which she has voluntarily agreed, for a period of three (3) years,
beginning on October 14, 2009:
(1) To exclude herself 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;
(2) That any institution that submits an application for PHS
support for a research project on which the Respondent's participation
is proposed or that uses her in any capacity on PHS-supported research,
or that submits a report of PHS-funded research in which she is
involved, must concurrently submit a plan for supervision of her duties
to the funding agency for approval; the supervisory plan must be
designed to ensure the scientific integrity of her research
contribution; respondent agreed that she will not participate in any
PHS-supported research until such a supervisory plan is submitted to
ORI; and
(3) That any institution employing her submits, in conjunction with
each application for PHS funds or report, manuscript, or abstract of
PHS-funded research in which the Respondent is involved, a
certification that the data provided by the Respondent are based on
actual experiments or are otherwise legitimately derived and that the
data, procedures, analyses, and methodology are accurately reported in
the application, report, manuscript, or abstract. The Respondent must
ensure that the institution sends a copy of the certification to ORI.
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. E9-28814 Filed 12-1-09; 8:45 am]
BILLING CODE 4150-31-P
