Findings of Research Misconduct, 69034-69035 [2022-25031]
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69034
Federal Register / Vol. 87, No. 221 / Thursday, November 17, 2022 / Notices
Court ordered FDA to complete the
analysis and reconsider its ‘‘no effect’’
determination under the ESA together
with a revised NEPA evaluation. See
Inst. for Fisheries Res. v. U.S. Food and
Drug Admin, 499 F. Supp. 3d 657, 660.
However, the Court did not vacate the
approval; the approval is still in effect.
To address the November 5, 2020,
Court opinion, we have prepared a draft
amended EA, entitled ‘‘Draft Amended
Environmental Assessment for
Production of AquAdvantage Salmon at
the Bay Fortune and Rollo Bay Facilities
on Prince Edward Island, Canada.’’ We
request that the public review the draft
amended EA and submit comments to
the docket.
In this draft amended EA, we have
expanded our assessment beyond that in
the 2015 EA to include an exhaustive
analysis of the likelihood and severity of
harms that could occur if AAS and
AquAdvantage broodstock (collectively
referred to in the amended EA as
AquaBounty Technology (ABT) Salmon)
are assumed to be present in the U.S.
aquatic environment. We outline the
pathways necessary for ABT Salmon to
escape confinement from the PEI
facilities and migrate to and establish a
persistent population in the United
States. We also evaluate the potential
pathways for disease (including
pathogen and parasite) transmission
from ABT Salmon and from the
production of ABT Salmon at facilities
on PEI to wild fish populations. In
addition, we identify and evaluate the
potential harms (consequences) to the
U.S. environment and the endangered
Atlantic salmon of the Gulf of Maine
Distinct Population Segment if these
highly unlikely scenarios were to occur.
Finally, we revisit whether there is a
potential for significant impacts on the
U.S. environment under NEPA, and
whether the action could result in
effects on threatened and endangered
Atlantic salmon and their critical
habitat in the United States under the
ESA. Ultimately, this analysis will aid
the Agency in the decision of whether
to prepare a FONSI or an environmental
impact statement.
We note that the information and
analyses in the draft amended EA reflect
comments and input received from the
National Marine Fisheries Service and
the Fish and Wildlife Service during a
recent ESA technical assistance review
initiated in June 2022 with initial
discussions beginning in March 2021.
FDA intends to initiate an informal
consultation with the services after the
close of the public comment period if
the current conclusions with respect to
the ESA are not altered.
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17:26 Nov 16, 2022
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Elsewhere in this issue of the Federal
Register, we are providing notice of a
virtual public meeting on December 15,
2022. Further information, including the
time the meeting will start, the agenda,
and how to register to attend the
meeting, can be found at https://
www.fda.gov/animal-veterinary/
workshops-conferences-meetings/
virtual-public-meeting-aquadvantagesalmon-draft-amended-environmentalassessment-12152022.
II. Topics for Comment Regarding the
Draft Amended EA
The Agency is placing the draft
amended EA on public display at the
Dockets Management Staff (see DATES
and ADDRESSES) and at https://
www.fda.gov/animal-veterinary/
workshops-conferences-meetings/
virtual-public-meeting-aquadvantagesalmon-draft-amended-environmentalassessment-12152022 for public review
and comment for 60 days.
Comments should be limited to the
draft amended EA only, as described
below. We will not review comments
outside of the scope of the draft
amended EA such as AquAdvantage
Salmon generally or the approved
application. Given that FDA must
comply with a court order and that the
public can comment both by submitting
comments to the docket and by
participating in the public meeting, FDA
believes that a 60-day comment period
is appropriate and does not intend to
grant requests for extension of the
comment period.
We are particularly interested in
receiving comments from the public on
the following:
1. Is the expanded conceptual model
for risk assessment (Figure 4–1) in the
draft amended EA complete?
2. Are the risk-related questions
(Section 4.4) appropriate given the new
expanded conceptual model?
3. Are there any exposure pathways to
the U.S. environment that were not
identified or evaluated in the draft
amended EA?
4. Are there any potential harms
(adverse consequences, effects, or
impacts) to the U.S. environment from
ABT Salmon that were not identified or
evaluated in the draft amended EA?
5. Are there any potential
environmental impacts on endangered
Atlantic salmon or their critical habitat
in the United States that were not
identified or evaluated in the draft
amended EA?
PO 00000
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Dated: November 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–25001 Filed 11–16–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Findings of research
misconduct have been made against
Romina Mizrahi, M.D., Ph.D.
(Respondent), who was a Clinician
Scientist, Positron Emission
Tomography Centre, Centre for
Addiction and Mental Health (CAMH),
and an Associate Professor, Department
of Psychology, University of Toronto
(UT). Respondent engaged in research
misconduct in research reported in a
grant application submitted for U.S.
Public Health Service (PHS) funds,
specifically National Institute of Mental
Health (NIMH), National Institutes of
Health (NIH), grant application R01
MH118495–01. The administrative
actions, including supervision for a
period of one (1) year, were
implemented beginning on November 3,
2022, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr.P.H., Acting
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 240,
Rockville, MD 20852, (240) 453–8200.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Romina Mizrahi, M.D., Ph.D., Centre
for Addiction and Mental Health and
University of Toronto: Based on the
report of an investigation conducted by
CAMH and analysis conducted by ORI
in its oversight review, ORI found that
Dr. Romina Mizrahi, former Clinician
Scientist, Positron Emission
Tomography Centre, CAMH, and an
Associate Professor, Department of
Psychology, UT, engaged in research
misconduct in research reported in a
grant application submitted for PHS
funds, specifically NIMH, NIH, grant
application R01 MH118495–01.
ORI found that Respondent engaged
in research misconduct by intentionally,
knowingly, or recklessly falsifying data
in the following grant application:
• R01 MH118495–01, ‘‘Imaging
nociceptin receptors in clinical high risk
SUMMARY:
E:\FR\FM\17NON1.SGM
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lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 221 / Thursday, November 17, 2022 / Notices
and first episode psychosis,’’ submitted
to NIMH, NIH, on February 2, 2018.
Specifically, ORI finds that
Respondent knowingly, intentionally, or
recklessly falsified the Positron
Emission Tomography (PET) data of the
binding of radiopharmaceutical
[11C]NOP–1A (NOP) in brain regions
between the patient group and healthy
volunteer (HV) group. Respondent
selectively included one (1) and
excluded three (3) participants with
their PET data in the HV group and
selectively excluded four (4)
participants with their PET data in the
patient group, to falsely state that the
NOP binding in the patient group was
statistically higher than that in the HV
group in Figure 3, right panel, and the
corresponding text in grant application
R01 MH118495–01.
Dr. Mizrahi entered into a Voluntary
Settlement Agreement (Agreement) and
voluntarily agreed to the following:
(1) Respondent will have her research
supervised for a period of one (1) year
beginning on November 3, 2022 (the
‘‘Supervision Period’’). Prior to the
submission of an application for PHS
support for a research project on which
Respondent’s participation is proposed
and prior to Respondent’s participation
in any capacity in PHS-supported
research, Respondent will submit a plan
for supervision of Respondent’s duties
to ORI for approval. The supervision
plan must be designed to ensure the
integrity of Respondent’s research.
Respondent will not participate in any
PHS-supported research until such a
supervision plan is approved by ORI.
Respondent will comply with the
agreed-upon supervision plan.
(2) The requirements for Respondent’s
supervision plan are as follows:
i. A committee of 2–3 senior faculty
members at the institution who are
familiar with Respondent’s field of
research, but not including
Respondent’s supervisor or
collaborators, will provide oversight and
guidance for a period of one (1) year
from the effective date of the
Agreement. The committee will review
primary data from Respondent’s
laboratory on a quarterly basis and
submit a report to ORI at six (6) month
intervals setting forth the committee
meeting dates and Respondent’s
compliance with appropriate research
standards and confirming the integrity
of Respondent’s research.
ii. The committee will conduct an
advance review of each application for
PHS funds, or report, manuscript, or
abstract involving PHS-supported
research in which Respondent is
involved. The review will include a
discussion with Respondent of the
VerDate Sep<11>2014
17:26 Nov 16, 2022
Jkt 259001
primary data represented in those
documents and will include a
certification to ORI that the data
presented in the proposed application,
report, manuscript, or abstract are
supported by the research record.
(3) During the Supervision Period,
Respondent will ensure that any
institution employing her submits, 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 and not plagiarized
in the application, report, manuscript,
or abstract.
(4) If no supervision plan is provided
to ORI, Respondent will provide
certification to ORI at the conclusion of
the Supervision Period that her
participation was not proposed on a
research project for which an
application for PHS support was
submitted and that she has not
participated in any capacity in PHSsupported research.
(5) During the Supervision Period,
Respondent will exclude herself
voluntarily from serving in any advisory
or consultant capacity to PHS including,
but not limited to, service on any PHS
advisory committee, board, and/or peer
review committee.
Dated: November 14, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity,
Office of the Assistant Secretary for Health.
[FR Doc. 2022–25031 Filed 11–16–22; 8:45 am]
BILLING CODE 4150–31–P
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National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
Frm 00040
Fmt 4703
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; PAR22–171: NIDDK
Central Repository Non-Renewable Sample
Access (X01) Review.
Date: December 15, 2022.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute of Diabetes and Digestive
and Kidney Diseases, 2 Democracy, 6707
Democracy Blvd., Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Najma S. Begum, Ph.D.,
Scientific Review Officer Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7349, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
Information is also available on the
Institute’s/Center’s home page:
www.niddk.nih.gov/, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: November 14, 2022.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–25023 Filed 11–16–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
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]]>Agencies
[Federal Register Volume 87, Number 221 (Thursday, November 17, 2022)]
[Notices]
[Pages 69034-69035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25031]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Findings of research misconduct have been made against Romina
Mizrahi, M.D., Ph.D. (Respondent), who was a Clinician Scientist,
Positron Emission Tomography Centre, Centre for Addiction and Mental
Health (CAMH), and an Associate Professor, Department of Psychology,
University of Toronto (UT). Respondent engaged in research misconduct
in research reported in a grant application submitted for U.S. Public
Health Service (PHS) funds, specifically National Institute of Mental
Health (NIMH), National Institutes of Health (NIH), grant application
R01 MH118495-01. The administrative actions, including supervision for
a period of one (1) year, were implemented beginning on November 3,
2022, and are detailed below.
FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Acting
Director, Office of Research Integrity, 1101 Wootton Parkway, Suite
240, Rockville, MD 20852, (240) 453-8200.
SUPPLEMENTARY INFORMATION: Notice is hereby given that the Office of
Research Integrity (ORI) has taken final action in the following case:
Romina Mizrahi, M.D., Ph.D., Centre for Addiction and Mental Health
and University of Toronto: Based on the report of an investigation
conducted by CAMH and analysis conducted by ORI in its oversight
review, ORI found that Dr. Romina Mizrahi, former Clinician Scientist,
Positron Emission Tomography Centre, CAMH, and an Associate Professor,
Department of Psychology, UT, engaged in research misconduct in
research reported in a grant application submitted for PHS funds,
specifically NIMH, NIH, grant application R01 MH118495-01.
ORI found that Respondent engaged in research misconduct by
intentionally, knowingly, or recklessly falsifying data in the
following grant application:
R01 MH118495-01, ``Imaging nociceptin receptors in
clinical high risk
[[Page 69035]]
and first episode psychosis,'' submitted to NIMH, NIH, on February 2,
2018.
Specifically, ORI finds that Respondent knowingly, intentionally,
or recklessly falsified the Positron Emission Tomography (PET) data of
the binding of radiopharmaceutical [\11\C]NOP-1A (NOP) in brain regions
between the patient group and healthy volunteer (HV) group. Respondent
selectively included one (1) and excluded three (3) participants with
their PET data in the HV group and selectively excluded four (4)
participants with their PET data in the patient group, to falsely state
that the NOP binding in the patient group was statistically higher than
that in the HV group in Figure 3, right panel, and the corresponding
text in grant application R01 MH118495-01.
Dr. Mizrahi entered into a Voluntary Settlement Agreement
(Agreement) and voluntarily agreed to the following:
(1) Respondent will have her research supervised for a period of
one (1) year beginning on November 3, 2022 (the ``Supervision
Period''). Prior to the submission of an application for PHS support
for a research project on which Respondent's participation is proposed
and prior to Respondent's participation in any capacity in PHS-
supported research, Respondent will submit a plan for supervision of
Respondent's duties to ORI for approval. The supervision plan must be
designed to ensure the integrity of Respondent's research. Respondent
will not participate in any PHS-supported research until such a
supervision plan is approved by ORI. Respondent will comply with the
agreed-upon supervision plan.
(2) The requirements for Respondent's supervision plan are as
follows:
i. A committee of 2-3 senior faculty members at the institution who
are familiar with Respondent's field of research, but not including
Respondent's supervisor or collaborators, will provide oversight and
guidance for a period of one (1) year from the effective date of the
Agreement. The committee will review primary data from Respondent's
laboratory on a quarterly basis and submit a report to ORI at six (6)
month intervals setting forth the committee meeting dates and
Respondent's compliance with appropriate research standards and
confirming the integrity of Respondent's research.
ii. The committee will conduct an advance review of each
application for PHS funds, or report, manuscript, or abstract involving
PHS-supported research in which Respondent is involved. The review will
include a discussion with Respondent of the primary data represented in
those documents and will include a certification to ORI that the data
presented in the proposed application, report, manuscript, or abstract
are supported by the research record.
(3) During the Supervision Period, Respondent will ensure that any
institution employing her submits, 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 and not plagiarized
in the application, report, manuscript, or abstract.
(4) If no supervision plan is provided to ORI, Respondent will
provide certification to ORI at the conclusion of the Supervision
Period that her participation was not proposed on a research project
for which an application for PHS support was submitted and that she has
not participated in any capacity in PHS-supported research.
(5) During the Supervision Period, Respondent will exclude herself
voluntarily from serving in any advisory or consultant capacity to PHS
including, but not limited to, service on any PHS advisory committee,
board, and/or peer review committee.
Dated: November 14, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity, Office of the Assistant
Secretary for Health.
[FR Doc. 2022-25031 Filed 11-16-22; 8:45 am]
BILLING CODE 4150-31-P
