Meeting of the Secretary's Advisory Committee on Human Research Protections, 42086-42087 [2023-13833]
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Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
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A 60-day notice published in the
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88, No. 45; pp. 14377, received no
public comments.
Need and Proposed Use of the
Information: PDs of coverage
applications are provided in compliance
with 42 CFR 6.6 and must address
certain specified criteria for coverage
determinations to be issued. The
application provides the Bureau of
Primary Health Care with the
information that is essential for
evaluation of compliance with legal
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determination of coverage under 42 CFR
6.6.
Likely Respondents: Respondents
include recipients of Health Center
Program funds with deemed PHS
employee status under section 224(g)–
(n) of the PHS Act (42 U.S.C. 233(g)–
(n)).
Burden Statement: Burden in this
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persons to generate, maintain, retain,
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develop, acquire, install, and utilize
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a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Application for Federally Supported Health Center Assistance Act (FSHCAA)/Federal Tort Claims Act (FTCA)
Particularized Determination ............................................
12
1
12
2
24
Total ..............................................................................
12
1
12
24
24
HRSA specifically requests comments
on (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.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–13822 Filed 6–28–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Secretary’s Advisory
Committee on Human Research
Protections
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
Pursuant to the Federal
Advisory Committee Act, notice is
hereby given that the Secretary’s
Advisory Committee on Human
Research Protections (SACHRP) will
hold a meeting that will be open to the
public. Information about SACHRP, the
full meeting agenda, and instructions for
linking to public access will be posted
SUMMARY:
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Number of
responses per
respondent
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on the SACHRP website at https://
www.dhhs.gov/ohrp/sachrp-committee/
meetings/.
DATES: The meeting will be held on
Wednesday, July 19, 2023 from 11:00
a.m. until 5:00 p.m., and Thursday, July
20, 2023, from 11:00 a.m. until 5:00 p.m.
(times are tentative and subject to
change). The confirmed times and
agenda will be posted on the SACHRP
website as this information becomes
available.
ADDRESSES: This meeting will be held
via webcast. Members of the public may
also attend the meeting via webcast.
Instructions for attending via webcast
will be posted at least one week prior
to the meeting at https://www.hhs.gov/
ohrp/sachrp-committee/meetings/
index.html.
FOR FURTHER INFORMATION CONTACT: Julia
Gorey, J.D., Executive Director,
SACHRP; U.S. Department of Health
and Human Services, 1101 Wootton
Parkway, Suite 200, Rockville,
Maryland 20852; telephone: 240–453–
8141; fax: 240–453–6909; email address:
SACHRP@hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, section 222
of the Public Health Service Act, as
amended, SACHRP was established to
provide expert advice and
recommendations to the Secretary of
Health and Human Services, through
the Assistant Secretary for Health, on
issues and topics pertaining to or
associated with the protection of human
research subjects.
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The Subpart A Subcommittee (SAS)
was established by SACHRP in October
2006 and is charged with developing
recommendations for consideration by
SACHRP regarding the application of
subpart A of 45 CFR part 46 in the
current research environment.
The Subcommittee on Harmonization
(SOH) was established by SACHRP at its
July 2009 meeting and charged with
identifying and prioritizing areas in
which regulations and/or guidelines for
human subjects research adopted by
various agencies or offices within HHS
would benefit from harmonization,
consistency, clarity, simplification and/
or coordination.
The SACHRP meeting will open to the
public at 11:00 a.m., on Wednesday,
July 19, 2023, followed by opening
remarks from Julie Kaneshiro, Acting
Director of OHRP and Dr. Douglas
Diekema, SACHRP Chair. The meeting
will begin with a discussion of IRB
effectiveness, topic #4 of the recently
published GAO report #GAO–23–
104721, Institutional Review Boards:
Actions Needed to Improve Federal
Oversight and Examine Effectiveness.
This will be followed by commentary on
the FDA draft guidance, Decentralized
Clinical Trials for Drugs, Biological
Products, and Devices, in addition to
discussion of recommendations that
address the ethical conduct of
decentralized clinical trials in human
subjects research more broadly.
Discussion of both topics will
continue on July 20, in addition to
commentary on the recently released
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Federal Register / Vol. 88, No. 124 / Thursday, June 29, 2023 / Notices
draft HHS guidance, Frequently Asked
Questions: Limited Institutional Review
Board Review and Related Exemptions.
Other topics may be added; for the full
and updated meeting agenda, see https://
www.dhhs.gov/ohrp/sachrp-committee/
meetings/. The meeting will
adjourn by 5:00 p.m. July 20, 2023.
Time will be allotted for public
comment on both days of the meeting.
The public may submit written public
comment in advance to SACHRP@
hhs.gov no later than midnight July 12,
2023, ET. Written comments will be
shared with SACHRP members and may
be read aloud during the meeting.
Public comment must be relevant to
topics being addressed by the SACHRP.
Dated: June 12, 2023.
Julia G. Gorey,
Executive Director, SACHRP, Office for
Human Research Protections.
[FR Doc. 2023–13833 Filed 6–28–23; 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:
Findings of research
misconduct have been made against
Yiorgos (Georgios) I. Laliotis, M.D.
(Respondent), who was a Postdoctoral
Fellow, Department of Cancer Biology
and Genetics, College of Medicine, The
Ohio State University (OSU), and
Postdoctoral Fellow, Department of
Oncology, Johns Hopkins University
(JHU). Respondent engaged in research
misconduct in research supported by
U.S. Public Health Service (PHS) funds,
specifically National Cancer Institute
(NCI), National Institutes of Health
(NIH), grants R01 CA186729, R01
CA198117, P30 CA016058, K22
CA245487, and R21 CA252530 and
included in grant applications
submitted for PHS funds, specifically
R01 CA186729–07 and R01 CA198117–
05 submitted to NCI, NIH. The
administrative actions, including
supervision for a period of three (3)
years, were implemented beginning on
June 12, 2023, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Sheila Garrity, JD, MPH, MBA, 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
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Integrity (ORI) has taken final action in
the following case:
Yiorgos (Georgios) I. Laliotis, M.D.,
The Ohio State University and Johns
Hopkins University: Based on the
reports of inquiries conducted by OSU
and JHU, admissions by Respondent,
and analysis conducted by ORI in its
oversight review, ORI found that
Yiorgos (Georgios) I. Laliotis, M.D.,
former Postdoctoral Fellow, Department
of Cancer Biology and Genetics, College
of Medicine, OSU, and former
Postdoctoral Fellow, Department of
Oncology, JHU, engaged in research
misconduct in research supported by
U.S. Public Health Service (PHS) funds,
specifically NCI, NIH, grants R01
CA186729, R01 CA198117, P30
CA016058, K22 CA245487, and R21
CA252530 and included in grant
applications submitted for PHS funds,
specifically R01 CA186729–07 and R01
CA198117–05 submitted to NCI, NIH.
ORI found that Respondent engaged
in research misconduct by intentionally
and knowingly falsifying and/or
fabricating data, methods, results, and
conclusions by representing a fabricated
Exon 2 splice variant of U2AF2, which
would translate as a Serine-ArginineRich deficient U2AF65 isoform, leading
to the repression of lung
adenocarcinomas and by enhancing the
role of splicing in mutant PIK3CA breast
cancer cell lines in the following three
(3) published papers, two (2) NIH grant
applications, and two (2) unpublished
manuscripts:
• AKT3-mediated IWS1
phosphorylation promotes the
proliferation of EGFR-mutant lung
adenocarcinomas through cell cycleregulated U2AF2 RNA splicing. Nat.
Commun. 2021 Jul 30; 12(1):4624. doi:
10.1038/s41467–021–24795–1 (hereafter
referred to as ‘‘Nat. Commun. 2021’’).
Retraction in: Nat. Commun. 2022 Jun
28;13(1):3711. doi: 10.1038/s41467–
022–31445–7.
• Phosphor-IWS1-dependent U2AF2
splicing regulates trafficking of CAR–Epositive intronless gene mRNAs and
sensitivity to viral infection. Commun.
Biol. 2021 Oct 11; 4(1):1179. doi:
10.1038/s42003–021–02668-z (hereafter
referred to as ‘‘Commun. Biol. 2021’’).
Retraction in: Commun. Biol. 2021 Dec
15;4(1):1419. doi: 10.1038/s42003–021–
02941–1.
• Overexpression of the SETD2 WW
domain inhibits the phosphor-IWS1/
SETD2 interaction and the oncogenic
AKT/IWS1 RNA splicing program.
bioRxiv 2021.08.12.454141.
doi: 10.1101/2021.08.12.454141
(hereafter referred to as ‘‘bioRxiv 2021’’).
Withdrawn. The manuscript also was
submitted to Commun. Biol. in 2021 but
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was withdrawn prior to completion of
peer review.
• R01 CA186729–07, ‘‘The role of
IWS1-dependent alternative RNA
splicing in lung cancer,’’ submitted to
NCI, NIH, on November 5, 2020.
• R01 CA198117–05, ‘‘The role of
IWS1 in development and
tumorigenesis,’’ submitted to NCI, NIH,
on June 3, 2019.
• The transcriptomic landscape of
oncogenic P13K reveals key functions in
splicing and gene expression regulation.
Manuscript submitted to Cancer Res.
(hereafter referred to as the ‘‘Cancer Res.
manuscript’’).
• Interpretable deep learning for
chromatin-informed inference of
transcriptional programs driven by
somatic alterations across cancers.
Manuscript in preparation (hereafter
referred to as ‘‘Manuscript 2021’’).
Specifically, ORI finds that
Respondent knowingly and
intentionally:
• falsified the sequencing data in Figure
1g of Nat. Commun. 2021 by splicing
two sequencing chromatograms
together to falsely represent a novel
identification of a previously
undescribed U2AF2 RNA transcript
lacking Exon 2
• falsified conclusions about the
fabricated U2AF2 splice variant in
RT–PCR results in Figures 1f, 2a, 2b,
2c, 3d, 4a, 4b, 4c, 4e, 5h, 6f, 6i, and
7c of Nat. Commun. 2021
• falsified conclusions about the
fabricated U2AF2 splice variant as the
source of two endogenous protein
isoforms in immunoblot panels in
Figures 5c and 5g of Nat. Commun.
2021 and Figure 2 of R01 CA186729–
07
• falsified the experimental conditions
of p-ERK1/2 (Y202/T204), p-CDK1
(Y15), CDK1, and Cyclin B1
immunoblot panels in Figure 5g of
Nat. Commun. 2021 and Figure 2 of
R01 CA186729–07 by using shControl
or shIWS1 instead of the samples as
reported in the figure labels to falsely
represent the immunoblots as the
result of U2AF2 containing spliced
Exon 2
• falsified the experimental conditions
of the a-actinin immunoblot panel in
Figure 1e of Commun. Biol. 2021 by
using shIWS1 instead of shISWS1/
U2AF65b-V5 as reported in the figure
label
• in Commun. Biol. 2021, bioRxiv 2021,
R01 CA186729–07, and R01
CA198117–05, reported falsified
conclusions highlighting the role of
the fabricated U2AF2 RNA transcript
lacking Exon 2 from Nat. Commun.
2021
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Agencies
[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42086-42087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13833]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Secretary's Advisory Committee on Human Research
Protections
AGENCY: Office of the Assistant Secretary for Health, Office of the
Secretary, Department of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: Pursuant to the Federal Advisory Committee Act, notice is
hereby given that the Secretary's Advisory Committee on Human Research
Protections (SACHRP) will hold a meeting that will be open to the
public. Information about SACHRP, the full meeting agenda, and
instructions for linking to public access will be posted on the SACHRP
website at https://www.dhhs.gov/ohrp/sachrp-committee/meetings/.
DATES: The meeting will be held on Wednesday, July 19, 2023 from 11:00
a.m. until 5:00 p.m., and Thursday, July 20, 2023, from 11:00 a.m.
until 5:00 p.m. (times are tentative and subject to change). The
confirmed times and agenda will be posted on the SACHRP website as this
information becomes available.
ADDRESSES: This meeting will be held via webcast. Members of the public
may also attend the meeting via webcast. Instructions for attending via
webcast will be posted at least one week prior to the meeting at
https://www.hhs.gov/ohrp/sachrp-committee/meetings/.
FOR FURTHER INFORMATION CONTACT: Julia Gorey, J.D., Executive
Director, SACHRP; U.S. Department of Health and Human Services, 1101
Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: 240-
453-8141; fax: 240-453-6909; email address: [email protected].
SUPPLEMENTARY INFORMATION: Under the authority of 42 U.S.C. 217a,
section 222 of the Public Health Service Act, as amended, SACHRP was
established to provide expert advice and recommendations to the
Secretary of Health and Human Services, through the Assistant Secretary
for Health, on issues and topics pertaining to or associated with the
protection of human research subjects.
The Subpart A Subcommittee (SAS) was established by SACHRP in
October 2006 and is charged with developing recommendations for
consideration by SACHRP regarding the application of subpart A of 45
CFR part 46 in the current research environment.
The Subcommittee on Harmonization (SOH) was established by SACHRP
at its July 2009 meeting and charged with identifying and prioritizing
areas in which regulations and/or guidelines for human subjects
research adopted by various agencies or offices within HHS would
benefit from harmonization, consistency, clarity, simplification and/or
coordination.
The SACHRP meeting will open to the public at 11:00 a.m., on
Wednesday, July 19, 2023, followed by opening remarks from Julie
Kaneshiro, Acting Director of OHRP and Dr. Douglas Diekema, SACHRP
Chair. The meeting will begin with a discussion of IRB effectiveness,
topic #4 of the recently published GAO report #GAO-23-104721,
Institutional Review Boards: Actions Needed to Improve Federal
Oversight and Examine Effectiveness. This will be followed by
commentary on the FDA draft guidance, Decentralized Clinical Trials for
Drugs, Biological Products, and Devices, in addition to discussion of
recommendations that address the ethical conduct of decentralized
clinical trials in human subjects research more broadly.
Discussion of both topics will continue on July 20, in addition to
commentary on the recently released
[[Page 42087]]
draft HHS guidance, Frequently Asked Questions: Limited Institutional
Review Board Review and Related Exemptions. Other topics may be added;
for the full and updated meeting agenda, see https://www.dhhs.gov/ohrp/sachrp-committee/meetings/. The meeting will adjourn by 5:00
p.m. July 20, 2023.
Time will be allotted for public comment on both days of the
meeting. The public may submit written public comment in advance to
[email protected] no later than midnight July 12, 2023, ET. Written
comments will be shared with SACHRP members and may be read aloud
during the meeting. Public comment must be relevant to topics being
addressed by the SACHRP.
Dated: June 12, 2023.
Julia G. Gorey,
Executive Director, SACHRP, Office for Human Research Protections.
[FR Doc. 2023-13833 Filed 6-28-23; 8:45 am]
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