83 FR 26065 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary

Federal Register Volume 83, Issue 108 (June 5, 2018)

Page Range		26065-26066
FR Document		2018-12047

Findings of research misconduct have been made on the part of Shiladitya Sen, former graduate student, Department of Chemistry and Biochemistry, The Ohio State University (OSU). Mr. Sen engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM083114. The administrative actions, including debarment for a period of three (3) years, were implemented beginning on May 16, 2018, and are detailed below.

Federal Register, Volume 83 Issue 108 (Tuesday, June 5, 2018)

[Federal Register Volume 83, Number 108 (Tuesday, June 5, 2018)]
[Notices]
[Pages 26065-26066]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-12047]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

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SUMMARY: Findings of research misconduct have been made on the part of 
Shiladitya Sen, former graduate student, Department of Chemistry and 
Biochemistry, The Ohio State University (OSU). Mr. Sen engaged in 
research misconduct in research supported by National Institute of 
General Medical Sciences (NIGMS), National Institutes of Health (NIH), 
grant R01 GM083114. The administrative actions, including debarment for 
a period of three (3) years, were implemented beginning on May 16, 
2018, and are detailed below.

FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Interim 
Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 
750, Rockville, MD 20852, (240) 453-8200.

[[Page 26066]]


SUPPLEMENTARY INFORMATION: Notice is hereby given that the Office of 
Research Integrity (ORI) has taken final action in the following case:
    Shiladitya Sen, The Ohio State University: Based on the report of 
an investigation conducted by OSU and analysis conducted by ORI in its 
oversight review, ORI found that Mr. Shiladitya Sen, former graduate 
student, OSU, engaged in research misconduct in research supported by 
NIGMS, NIH, grant R01 GM083114.
    ORI found that Respondent engaged in research misconduct by 
knowingly and intentionally falsifying and/or fabricating data reported 
in the following published paper, his Ph.D. thesis, a poster 
presentation, and his mentor's grant applications submitted to NIGMS, 
NIH:

 PNAS 110(11):4261-4266, 2013 (hereafter referred to as ``PNAS 
2013''); retracted in: PNAS 114(37):E7855, 2017 Sep
 Sen, S. ``Engineering Proteins for Enhanced Stability using 
High-Throughput and Combinatorial Methods.'' OSU Doctoral Dissertation, 
2013 (hereafter referred to as ``thesis'')
 poster presented at the Annual Symposium of the Protein 
Society in 2012 (hereafter referred to as ``Poster 2012'')
 R01 GM083114 and R01 GM083114-A1

    ORI found that Respondent knowingly and intentionally falsified 
and/or fabricated gene sequencing and high throughput thermal scanning 
(HTTS) data for sequence-stability relationship of Rop protein variants 
in nineteen (19) figures, ten (10) tables, and related text included in 
a poster presentation, his Ph.D. thesis, and two (2) NIH grant 
applications.
    Specifically, Respondent knowingly and intentionally falsified and/
or fabricated:

 Unique sequences and stability data for 1017 active Rop 
variants in Table 3.1 and provided additional analyses purportedly from 
those active Rop variants in Table 3.2 and Figures 3.3, 3.4, 3.5, 3.6, 
3.7, 3.8, and 3.9 in his thesis and in Figures 6, 7, 17, and 20 in two 
(2) grant applications
 unique sequences and stability data for active Rop loop 
variants from four separate mutant libraries, X4, 
LX4, X4-I, LX4-I in Tables 5.2, 5.3, 
5.4, and 5.5, respectively, and presented additional analyses 
purportedly from those active Rop loop variants in Figures 5.3, 5.4, 
5.5, 5.6, and 5.9 and Table 5.1 in his thesis and in Figure 6 in two 
(2) grant applications
 figures entitled ``analysis of more than 1000 active (folded) 
core variants,'' ``Loop Library: How does loop affect stability?'' and 
``Detailed characterization of loop variants'' in Poster 2012
 list of oligonucleotides included in Tables 9.2, 9.3, and 9.4 
in his thesis

    ORI also found that Respondent knowingly and intentionally 
falsified and/or fabricated HTTS data for thermodynamic effects of 
somatic mutation in antibodies 93F3 and OKT3 in ten (10) figures, two 
(2) tables, and related text included in PNAS 2013 and his thesis.
    Specifically, Respondent knowingly and intentionally falsified and/
or fabricated HTTS data:

 In Figures 6.2A, 6.2C, 6.3, and 6.6 and Tables 6.2 and 6.3 in 
his thesis
 also included as Figures 2A, 2C, S2, and S5 and Tables S3 and 
S4 in PNAS 2013
    Mr. Sen entered into a Voluntary Exclusion Agreement and 
voluntarily agreed for a period of three (3) years, beginning on May 
16, 2018:
    (1) To exclude himself voluntarily from any contracting or 
subcontracting with any agency of the United States Government and from 
eligibility for or involvement in nonprocurement programs of the United 
States Government referred to as ``covered transactions'' pursuant to 
HHS' Implementation (2 CFR part 376) of OMB Guidelines to Agencies on 
Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively 
the ``Debarment Regulations'');
    (2) 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.

Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2018-12047 Filed 6-4-18; 8:45 am]
 BILLING CODE 4150-31-P

Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Notices 26065

Average bur-
Number of
Number of Total den per Total burden
Form name responses per
respondents responses response hours
respondent (in hours)

INITIAL Survey of the Secretary’s Discretionary Advisory
Committee on Heritable Disorders in Newborns and
Children’s Public Health System Assessment 1 ............... 59 1 59 10 590
FOLLOW–UP Survey of the Secretary’s Discretionary Ad-
visory Committee on Heritable Disorders in Newborns
and Children’s Public Health System Assessment .......... 2 30 1 30 2 60

Total .............................................................................. 89 ........................ 89 ........................ 650
1 The respondents to the survey will be State and territorial newborn screening programs.
2 Up to 30 States and/or Territories will be asked to complete a follow-up survey.

HRSA specifically requests comments posted prior to the meeting at: https:// Advisory Committee Act, 5 U.S.C. App.,
on (1) the necessity and utility of the www.hhs.gov/ash/advisory-committees/ as amended, to provide expertise and
proposed information collection for the tickbornedisease/index.html. review all HHS, DoD and VA efforts
proper performance of the agency’s FOR FURTHER INFORMATION CONTACT: related to tick-borne diseases to help
functions, (2) the accuracy of the James Berger, Office of HIV/AIDS and ensure interagency coordination and
estimated burden, (3) ways to enhance Infectious Disease Policy, Office of the minimize overlap, examine research
the quality, utility, and clarity of the Assistant Secretary for Health, priorities, and identify and address
information to be collected, and (4) the Department of Health and Human unmet needs. In addition, the Working
use of automated collection techniques Services; via email at tickbornedisease@ Group is required to submit a report to
or other forms of information hhs.gov or by phone at 202–795–7697. the Secretary and Congress on their
technology to minimize the information SUPPLEMENTARY INFORMATION: The findings and any recommendations for
collection burden. Working Group invites public comment improving the federal response to tick-
Amy P. McNulty, on issues related to the Working Group’s borne disease prevention, treatment and
charge. Comments may be provided research, and addressing gaps in those
Acting Director, Division of the Executive
Secretariat. over the phone during the meeting or in areas.
[FR Doc. 2018–12019 Filed 6–4–18; 8:45 am] writing. Persons who wish to provide Dated: May 31, 2018.
BILLING CODE 4165–15–P
comments by phone should review James Berger,
directions at https://www.hhs.gov/ash/ Office of HIV/AIDS and Infectious Disease
advisory-committees/tickbornedisease/ Policy, Designated Federal Officer, Tick-
DEPARTMENT OF HEALTH AND meetings/index.html before submitting a Borne Disease Working Group.
HUMAN SERVICES request via email at tickbornedisease@ [FR Doc. 2018–12045 Filed 6–4–18; 8:45 am]
hhs.gov on or before June 18, 2018. BILLING CODE 4150–28–P
Meeting of the Tick-Borne Disease Phone comments will be limited to
Working Group three minutes each to accommodate as
many speakers as possible. A total of 30 DEPARTMENT OF HEALTH AND
AGENCY: Office of the Secretary, Office minutes will be allocated to public
of the Assistant Secretary for Health, HUMAN SERVICES
comments. If more requests are received
Office of HIV/AIDS and Infectious than can be accommodated, speakers Office of the Secretary
Disease Policy, Department of Health will be randomly selected. The nature of
and Human Services. the comments will not be considered in Findings of Research Misconduct
ACTION: Notice. making this selection. Public comments
may also be provided in writing. AGENCY: Office of the Secretary, HHS.
SUMMARY: The Department of Health and ACTION: Notice.
Human Services (HHS) announces the Individuals who would like to provide
sixth meeting of the Tick-Borne Disease written comment should review
SUMMARY: Findings of research
directions at https://www.hhs.gov/ash/
Working Group (Working Group) on misconduct have been made on the part
advisory-committees/tickbornedisease/
June 21, 2018, from 9:30 a.m. to 6:00 of Shiladitya Sen, former graduate
meetings/index.html before sending
p.m., Eastern Time. The sixth meeting student, Department of Chemistry and
their comments to tickbornedisease@
will be an on-line meeting held via Biochemistry, The Ohio State University
hhs.gov on or before June 18, 2018.
webcast. The Working Group will focus During the meeting, the Working (OSU). Mr. Sen engaged in research
on subcommittee findings and will Group will review and discuss the misconduct in research supported by
review and provide input on the content content of the five draft chapters that National Institute of General Medical
of the five chapters that will be will be part of the Report to Congress. Sciences (NIGMS), National Institutes of
submitted into the Working Group Persons who wish to receive the draft Health (NIH), grant R01 GM083114. The
Congressional Report. document should email the administrative actions, including
DATES: The on-line meeting will be held tickbornedisease@hhs.gov and request a debarment for a period of three (3)
amozie on DSK3GDR082PROD with NOTICES1

on June 21, 2018, from 9:30 a.m. to 6:00 copy. The document will be available years, were implemented beginning on
p.m. Eastern Time. prior to the meeting. May 16, 2018, and are detailed below.
ADDRESSES: This will be an on-line Background and Authority: The Tick- FOR FURTHER INFORMATION CONTACT:
meeting that is held via webcast. Borne Disease Working Group was Wanda K. Jones, Dr.P.H., Interim
Members of the public may attend the established on August 10, 2017, in Director, Office of Research Integrity,
meeting via webcast. Instructions for accordance with section 2062 of the 21st 1101 Wootton Parkway, Suite 750,
attending this virtual meeting will be Century Cures Act, and the Federal Rockville, MD 20852, (240) 453–8200.

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26066 Federal Register / Vol. 83, No. 108 / Tuesday, June 5, 2018 / Notices

SUPPLEMENTARY INFORMATION: Notice is ‘‘Loop Library: How does loop affect the discussions could disclose
hereby given that the Office of Research stability?’’ and ‘‘Detailed confidential trade secrets or commercial
Integrity (ORI) has taken final action in characterization of loop variants’’ in property such as patentable material,
the following case: Poster 2012 and personal information concerning
Shiladitya Sen, The Ohio State • list of oligonucleotides included in individuals associated with the grant
University: Based on the report of an Tables 9.2, 9.3, and 9.4 in his thesis applications, the disclosure of which
investigation conducted by OSU and ORI also found that Respondent would constitute a clearly unwarranted
analysis conducted by ORI in its knowingly and intentionally falsified invasion of personal privacy.
oversight review, ORI found that Mr. and/or fabricated HTTS data for Name of Committee: Center for Scientific
Shiladitya Sen, former graduate student, thermodynamic effects of somatic Review Special Emphasis Panel;
OSU, engaged in research misconduct in mutation in antibodies 93F3 and OKT3 Psychosocial Risk and Disease Prevention.
research supported by NIGMS, NIH, in ten (10) figures, two (2) tables, and Date: June 12, 2018.
grant R01 GM083114. related text included in PNAS 2013 and Time: 8:00 a.m. to 11:00 a.m.
ORI found that Respondent engaged his thesis. Agenda: To review and evaluate grant
in research misconduct by knowingly applications.
Specifically, Respondent knowingly Place: Mayflower Park Hotel, 405 Olive
and intentionally falsifying and/or
and intentionally falsified and/or Way, Seattle, WA 98101.
fabricating data reported in the
fabricated HTTS data: Contact Person: Weijia Ni, Ph.D., Chief/
following published paper, his Ph.D.
thesis, a poster presentation, and his • In Figures 6.2A, 6.2C, 6.3, and 6.6 and Scientific Review Officer, Center for
Tables 6.2 and 6.3 in his thesis Scientific Review, National Institutes of
mentor’s grant applications submitted to Health, 6701 Rockledge Drive, Room 3100,
NIGMS, NIH: • also included as Figures 2A, 2C, S2,
MSC 7808, Bethesda, MD 20892, (301) 594–
• PNAS 110(11):4261–4266, 2013 and S5 and Tables S3 and S4 in PNAS 3292, niw@csr.nih.gov.
(hereafter referred to as ‘‘PNAS 2013
Name of Committee: Center for Scientific
2013’’); retracted in: PNAS Mr. Sen entered into a Voluntary Review Special Emphasis Panel; Risk
114(37):E7855, 2017 Sep Exclusion Agreement and voluntarily Prevention and Health Behavior AREA
• Sen, S. ‘‘Engineering Proteins for agreed for a period of three (3) years, Review.
Enhanced Stability using High- beginning on May 16, 2018: Date: June 19, 2018.
Throughput and Combinatorial (1) To exclude himself voluntarily Time: 12:00 p.m. to 5:00 p.m.
from any contracting or subcontracting Agenda: To review and evaluate grant
Methods.’’ OSU Doctoral Dissertation, applications.
2013 (hereafter referred to as ‘‘thesis’’) with any agency of the United States
Place: National Institutes of Health, 6701
• poster presented at the Annual Government and from eligibility for or
Rockledge Drive, Bethesda, MD 20892
Symposium of the Protein Society in involvement in nonprocurement (Virtual Meeting).
2012 (hereafter referred to as ‘‘Poster programs of the United States Contact Person: John H Newman, Ph.D.,
2012’’) Government referred to as ‘‘covered Scientific Review Officer, Center for
• R01 GM083114 and R01 GM083114– transactions’’ pursuant to HHS’ Scientific Review, National Institutes of
A1 Implementation (2 CFR part 376) of Health, 6701 Rockledge Drive, Room 3222,
ORI found that Respondent OMB Guidelines to Agencies on MSC 7808, Bethesda, MD 20892, (301) 435–
Governmentwide Debarment and 0628, newmanjh@csr.nih.gov.
knowingly and intentionally falsified
and/or fabricated gene sequencing and Suspension, 2 CFR part 180 (collectively Name of Committee: Center for Scientific
the ‘‘Debarment Regulations’’); Review Special Emphasis Panel;
high throughput thermal scanning Atherosclerosis, Inflammation, Molecular
(HTTS) data for sequence-stability (2) to exclude himself voluntarily
and Cellular Hematology.
relationship of Rop protein variants in from serving in any advisory capacity to Date: June 25, 2018.
nineteen (19) figures, ten (10) tables, PHS including, but not limited to, Time: 1:00 p.m. to 3:00 p.m.
and related text included in a poster service on any PHS advisory committee, Agenda: To review and evaluate grant
presentation, his Ph.D. thesis, and two board, and/or peer review committee, or applications.
(2) NIH grant applications. as a consultant. Place: National Institutes of Health, 6701
Specifically, Respondent knowingly Rockledge Drive, Bethesda, MD 20892
Wanda K. Jones, (Telephone Conference Call).
and intentionally falsified and/or
fabricated: Interim Director, Office of Research Integrity. Contact Person: Katherine M Malinda,
[FR Doc. 2018–12047 Filed 6–4–18; 8:45 am] Ph.D., Scientific Review Officer, Center for
• Unique sequences and stability data Scientific Review, National Institutes of
for 1017 active Rop variants in Table BILLING CODE 4150–31–P
Health, 6701 Rockledge Drive, Room 4140,
3.1 and provided additional analyses MSC 7814, Bethesda, MD 20892, 301–435–
purportedly from those active Rop 0912, Katherine_Malinda@csr.nih.gov.
variants in Table 3.2 and Figures 3.3, DEPARTMENT OF HEALTH AND
Name of Committee: Center for Scientific
3.4, 3.5, 3.6, 3.7, 3.8, and 3.9 in his HUMAN SERVICES
Review Special Emphasis Panel; Member
thesis and in Figures 6, 7, 17, and 20 National Institutes of Health Conflict: Integrative Neuroscience.
in two (2) grant applications Date: June 25, 2018.
• unique sequences and stability data Center For Scientific Review; Notice of Time: 12:30 p.m. to 6:00 p.m.
for active Rop loop variants from four Agenda: To review and evaluate grant
Closed Meetings applications.
separate mutant libraries, X4, LX4, X4-
Pursuant to section 10(d) of the Place: National Institutes of Health, 6701
I, LX4-I in Tables 5.2, 5.3, 5.4, and 5.5,
Rockledge Drive, Bethesda, MD 20892
respectively, and presented additional Federal Advisory Committee Act, as
amozie on DSK3GDR082PROD with NOTICES1

(Virtual Meeting).
analyses purportedly from those amended, notice is hereby given of the Contact Person: Ying-Yee Kong, Ph.D.,
active Rop loop variants in Figures following meetings. Scientific Review Officer, Center for
5.3, 5.4, 5.5, 5.6, and 5.9 and Table 5.1 The meetings will be closed to the Scientific Review, National Institutes of
in his thesis and in Figure 6 in two public in accordance with the Health, 6701 Rockledge Drive, Room 5185,
(2) grant applications provisions set forth in sections Bethesda, MD 20892, ying-yee.kong@nih.gov.
• figures entitled ‘‘analysis of more than 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Name of Committee: Center for Scientific
1000 active (folded) core variants,’’ as amended. The grant applications and Review Special Emphasis Panel; PAR Panel:

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Document Created: 2018-11-02 11:46:49
Document Modified: 2018-11-02 11:46:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Contact		Wanda K. Jones, Dr.P.H., Interim Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200.
FR Citation		83 FR 26065

83 FR 26065 - Findings of Research Misconduct

DEPARTMENT OF HEALTH AND HUMAN SERVICESOffice of the Secretary

Federal Register Volume 83, Issue 108 (June 5, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary