Findings of Research Misconduct, 43784 [2015-18088]

Download as PDF 43784 Federal Register / Vol. 80, No. 141 / Thursday, July 23, 2015 / Notices TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Format labeling in accordance with § 201.66(c) and (d) for new sunscreen SKUs. Request for Drug Facts exemption or deferral § 201.66(e). Total ........................................................................... 1 There Total annual disclosures Average burden per disclosure Total hours 20 3 60 12 ................. 720 1 0.125 0.125 24 ................. 3 ........................ ............................ ........................ ...................... 723 are no capital costs or operating and maintenance costs associated with this collection of information. Dated:‘ July 17, 2015. Leslie Kux, Associate Commissioner for Policy. titers on reporter cells, for multiple strains of SIV based chimeric viruses such that the results were not accurately represented in: • Figure 7 in JVI 2013 • Figures 6B and 8C in R01 AI114367– 01A1 • Figures 1, 2B, and 3B in R01 AI120787–01 • Figures 1A–D, 2D, 3D, 5A–C, 5I, 6C, and S3D in the unpublished manuscript [FR Doc. 2015–18026 Filed 7–22–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of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. ACTION: Notice. AGENCY: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Julia Bitzegeio, Ph.D., Aaron Diamond AIDS Research Center: Based on the Respondent’s admission, an assessment conducted by the Aaron Diamond AIDS Research Center (ADARC), and analysis conducted by ORI in its oversight review, ORI found that Dr. Julia Bitzegeio, former Postdoctoral Fellow, ADARC, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants R01 AI078788, R21 AI093255, and R37 AI064003. ORI found that Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in one (1) publication, two (2) unfunded grant applications, and one (1) unpublished manuscript: Journal of Virology 87:3549–3560, 2013 (hereafter referred to as ‘‘JVI 2013’’). • R01 AI114367–01A1 • R01 AI120787–01 • ‘‘A single amino acid in the CD4 binding site of HIV–1 Env is a key determinant of species tropism.’’ Unpublished manuscript Specifically, ORI found that: 1. Respondent falsified and/or fabricated in vitro rates of viral replication or infection in human and macaque lymphocytes and infectious SUMMARY: mstockstill on DSK4VPTVN1PROD with NOTICES No. of disclosures per respondent No. of respondents Activity VerDate Sep<11>2014 18:39 Jul 22, 2015 Jkt 235001 2. Respondent falsified and/or fabricated in vitro binding data of SIV based chimeric viruses to human or macaque CD4 such that the results were not accurately represented in: • Figure 6 in R01 AI120787–01 • Figures 5D–F in the unpublished manuscript ADARC has submitted a request for correction of JVI 2013. Dr. Bitzegeio has entered into a Voluntary Settlement Agreement and has voluntarily agreed: (1) That if within three (3) years from the effective date of the Agreement, Respondent receives or applies for U.S Public Health Service (PHS) support, Respondent agreed to have her research supervised for a period of three (3) years beginning on the date of her employment in a position in which she receives or applies for PHS support and to notify her employer(s)/institution(s) of the terms of this supervision; Respondent agreed that prior to the submission of an application for PHS support for a research project on which her participation is proposed and prior to her participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of her duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of her research contribution; Respondent agreed that she 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; PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 (2) that if within three (3) years from the effective date of the Agreement, Respondent receives or applies for PHS support, Respondent agreed that any institution employing her 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; and (3) to exclude herself 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 for a period of three (3) years, beginning on June 23, 2015. FOR FURTHER INFORMATION CONTACT: Acting Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453– 8200. Donald Wright, Acting Director, Office of Research Integrity. [FR Doc. 2015–18088 Filed 7–22–15; 8:45 am] BILLING CODE 4150–28–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), 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 E:\FR\FM\23JYN1.SGM 23JYN1

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[Federal Register Volume 80, Number 141 (Thursday, July 23, 2015)]
[Notices]
[Page 43784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18088]


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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.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that the Office of Research Integrity 
(ORI) has taken final action in the following case:
    Julia Bitzegeio, Ph.D., Aaron Diamond AIDS Research Center: Based 
on the Respondent's admission, an assessment conducted by the Aaron 
Diamond AIDS Research Center (ADARC), and analysis conducted by ORI in 
its oversight review, ORI found that Dr. Julia Bitzegeio, former 
Postdoctoral Fellow, ADARC, engaged in research misconduct in research 
supported by National Institute of Allergy and Infectious Diseases 
(NIAID), National Institutes of Health (NIH), grants R01 AI078788, R21 
AI093255, and R37 AI064003.
    ORI found that Respondent engaged in research misconduct by 
falsifying and/or fabricating data that were included in one (1) 
publication, two (2) unfunded grant applications, and one (1) 
unpublished manuscript:
    Journal of Virology 87:3549-3560, 2013 (hereafter referred to as 
``JVI 2013'').

 R01 AI114367-01A1
 R01 AI120787-01
 ``A single amino acid in the CD4 binding site of HIV-1 Env is 
a key determinant of species tropism.'' Unpublished manuscript

    Specifically, ORI found that:
    1. Respondent falsified and/or fabricated in vitro rates of viral 
replication or infection in human and macaque lymphocytes and 
infectious titers on reporter cells, for multiple strains of SIV based 
chimeric viruses such that the results were not accurately represented 
in:

 Figure 7 in JVI 2013
 Figures 6B and 8C in R01 AI114367-01A1
 Figures 1, 2B, and 3B in R01 AI120787-01
 Figures 1A-D, 2D, 3D, 5A-C, 5I, 6C, and S3D in the unpublished 
manuscript

    2. Respondent falsified and/or fabricated in vitro binding data of 
SIV based chimeric viruses to human or macaque CD4 such that the 
results were not accurately represented in:

 Figure 6 in R01 AI120787-01
 Figures 5D-F in the unpublished manuscript

    ADARC has submitted a request for correction of JVI 2013.
    Dr. Bitzegeio has entered into a Voluntary Settlement Agreement and 
has voluntarily agreed:
    (1) That if within three (3) years from the effective date of the 
Agreement, Respondent receives or applies for U.S Public Health Service 
(PHS) support, Respondent agreed to have her research supervised for a 
period of three (3) years beginning on the date of her employment in a 
position in which she receives or applies for PHS support and to notify 
her employer(s)/institution(s) of the terms of this supervision; 
Respondent agreed that prior to the submission of an application for 
PHS support for a research project on which her participation is 
proposed and prior to her participation in any capacity on PHS-
supported research, Respondent shall ensure that a plan for supervision 
of her duties is submitted to ORI for approval; the supervision plan 
must be designed to ensure the scientific integrity of her research 
contribution; Respondent agreed that she 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 if within three (3) years from the effective date of the 
Agreement, Respondent receives or applies for PHS support, Respondent 
agreed that any institution employing her 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; and
    (3) to exclude herself 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 for a period of three (3) years, beginning on June 23, 2015.

FOR FURTHER INFORMATION CONTACT: Acting Director, Office of Research 
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 
453-8200.

Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2015-18088 Filed 7-22-15; 8:45 am]
 BILLING CODE 4150-28-P
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