80 FR 43784 - Findings of Research Misconduct
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary Federal Register Volume 80, Issue 141 (July 23, 2015)
Office of the Secretary
Federal Register Volume 80, Issue 141 (July 23, 2015)
| Page Range | 43784-43784 | |
| FR Document | 2015-18088 |
[Federal Register Volume 80, Number 141 (Thursday, July 23, 2015)] [Notices] [Page 43784] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-18088] ----------------------------------------------------------------------- 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and/or fabricating data that were included in one (1) publication, two (2) unfunded grant applications, and one (1) unpublished manuscript: Journal of Virology 87:3549-3560, 2013 (hereafter referred to as ``JVI 2013'').R01 AI114367-01A1 R01 AI120787-01 ``A single amino acid in the CD4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 Unpublished manuscript Specifically, ORI found that: 1.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and 8C in R01 AI114367-01A1 Figures 1, 2B, and 3B in R01 AI120787-01 Figures 1A-D, 2D, 3D, 5A-C, 5I, 6C, and S3D in the unpublished manuscript 2.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
![43784 Federal Register / Vol. 80, No. 141 / Thursday, July 23, 2015 / Notices
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
No. of Average
No. of Total annual
Activity disclosures per burden per Total hours
respondents disclosures
respondent disclosure
Format labeling in accordance with § 201.66(c) and (d) 20 3 60 12 ................. 720
for new sunscreen SKUs.
Request for Drug Facts exemption or deferral 1 0.125 0.125 24 ................. 3
§ 201.66(e).
Total ........................................................................... ........................ ............................ ........................ ...................... 723
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated:‘ July 17, 2015. titers on reporter cells, for multiple (2) that if within three (3) years from
Leslie Kux, strains of SIV based chimeric viruses the effective date of the Agreement,
Associate Commissioner for Policy. such that the results were not accurately Respondent receives or applies for PHS
[FR Doc. 2015–18026 Filed 7–22–15; 8:45 am] represented in: support, Respondent agreed that any
BILLING CODE 4164–01–P • Figure 7 in JVI 2013 institution employing her shall submit
• Figures 6B and 8C in R01 AI114367– in conjunction with each application for
01A1 PHS funds, or report, manuscript, or
DEPARTMENT OF HEALTH AND • Figures 1, 2B, and 3B in R01 abstract involving PHS-supported
HUMAN SERVICES AI120787–01 research in which Respondent is
• Figures 1A–D, 2D, 3D, 5A–C, 5I, 6C, involved, a certification to ORI that the
Office of the Secretary and S3D in the unpublished data provided by Respondent are based
manuscript on actual experiments or are otherwise
Findings of Research Misconduct legitimately derived, and that the data,
2. Respondent falsified and/or
AGENCY: Office of the Secretary, HHS. procedures, and methodology are
fabricated in vitro binding data of SIV
ACTION: Notice.
accurately reported in the application,
based chimeric viruses to human or
report, manuscript, or abstract; and
macaque CD4 such that the results were
SUMMARY: Notice is hereby given that (3) to exclude herself voluntarily from
not accurately represented in:
the Office of Research Integrity (ORI) serving in any advisory capacity to PHS
has taken final action in the following • Figure 6 in R01 AI120787–01 including, but not limited to, service on
case: • Figures 5D–F in the unpublished any PHS advisory committee, board,
Julia Bitzegeio, Ph.D., Aaron Diamond manuscript and/or peer review committee, or as a
AIDS Research Center: Based on the ADARC has submitted a request for consultant for a period of three (3) years,
Respondent’s admission, an assessment correction of JVI 2013. beginning on June 23, 2015.
conducted by the Aaron Diamond AIDS Dr. Bitzegeio has entered into a FOR FURTHER INFORMATION CONTACT:
Research Center (ADARC), and analysis Voluntary Settlement Agreement and Acting Director, Office of Research
conducted by ORI in its oversight has voluntarily agreed: Integrity, 1101 Wootton Parkway, Suite
review, ORI found that Dr. Julia (1) That if within three (3) years from 750, Rockville, MD 20852, (240) 453–
Bitzegeio, former Postdoctoral Fellow, the effective date of the Agreement, 8200.
ADARC, engaged in research Respondent receives or applies for U.S
misconduct in research supported by Public Health Service (PHS) support, Donald Wright,
National Institute of Allergy and Respondent agreed to have her research Acting Director, Office of Research Integrity.
Infectious Diseases (NIAID), National supervised for a period of three (3) years [FR Doc. 2015–18088 Filed 7–22–15; 8:45 am]
Institutes of Health (NIH), grants R01 beginning on the date of her BILLING CODE 4150–28–P
AI078788, R21 AI093255, and R37 employment in a position in which she
AI064003. receives or applies for PHS support and
ORI found that Respondent engaged to notify her employer(s)/institution(s) DEPARTMENT OF HEALTH AND
in research misconduct by falsifying of the terms of this supervision; HUMAN SERVICES
and/or fabricating data that were Respondent agreed that prior to the
included in one (1) publication, two (2) submission of an application for PHS National Institutes of Health
unfunded grant applications, and one support for a research project on which Center for Scientific Review; Notice of
(1) unpublished manuscript: her participation is proposed and prior Closed Meeting
Journal of Virology 87:3549–3560, to her participation in any capacity on
2013 (hereafter referred to as ‘‘JVI PHS-supported research, Respondent Pursuant to section 10(d) of the
2013’’). shall ensure that a plan for supervision Federal Advisory Committee Act, as
• R01 AI114367–01A1 of her duties is submitted to ORI for amended (5 U.S.C. App.), notice is
• R01 AI120787–01 approval; the supervision plan must be hereby given of the following meeting.
• ‘‘A single amino acid in the CD4 designed to ensure the scientific The meeting will be closed to the
binding site of HIV–1 Env is a key
mstockstill on DSK4VPTVN1PROD with NOTICES
integrity of her research contribution; public in accordance with the
determinant of species tropism.’’ Respondent agreed that she shall not provisions set forth in sections
Unpublished manuscript participate in any PHS-supported 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Specifically, ORI found that: research until such a supervision plan is as amended. The grant applications and
1. Respondent falsified and/or submitted to and approved by ORI; the discussions could disclose
fabricated in vitro rates of viral Respondent agreed to maintain confidential trade secrets or commercial
replication or infection in human and responsibility for compliance with the property such as patentable material,
macaque lymphocytes and infectious agreed upon supervision plan; and personal information concerning
VerDate Sep<11>2014 18:39 Jul 22, 2015 Jkt 235001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\23JYN1.SGM 23JYN1](https://thefederalregister.org/doc/80_FR_43925/page/1.svg)
Document Created: 2015-12-15 12:53:15
Document Modified: 2015-12-15 12:53:15
| 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 | Acting Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453-8200. | |
| FR Citation | 80 FR 43784 |
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