Findings of Research Misconduct, 79460-79461 [2013-31160]

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FOR FURTHER INFORMATION CONTACT: Mr. Harold Hendrick, Strategic Planning and Performance Management Division, Office of the Chief Financial Officer at perform@gsa.gov or telephone 202–208– 1752. SUMMARY: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 The GPRA Modernization Act holds federal agencies accountable for using resources wisely and achieving program results. Specifically, the GPRA Modernization Act requires agencies to develop: Strategic Plans, which include a mission statement, set out long-term goals, objectives, and strategic measures, and describe strategies to achieve them over a four-year time horizon; Annual Performance Plans, which provide annual performance measures and activities toward the long-term Strategic Plan; and Annual Performance Reports, which evaluate an agency’s success in achieving the annual performance measures. 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AGENCY: ACTION: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Baoyan Xu, M.D., Ph.D., National Heart, Lung, and Blood Institute, National Institutes of Health: Based on allegations made by readers of a published paper,1 additional review by the National Institutes of Health (NIH) and ORI, and a limited admission by the Respondent that ‘‘some better looking strips were repeatedly used as representatives for several times [sic],’’ ORI found that Dr. Baoyan Xu, formerly a Postdoctoral Fellow, Hematology Branch, Systems Biology Center, SUMMARY: 1 Xu, B., Zhi, N., Hu, G., Wan, Z., Zheng, X., Liu, X., Wong, S., Kajigaya, S., Zhao, K., Mao, Q., & Young, N.S. ‘‘Hybrid DNA virus in Chinese patients with seronegative hepatitis discovered by deep sequencing.’’ Proc. Natl. Acad. Sci. (US) 110(25):10264–10269; hereafter referred to as the ‘‘PNAS paper.’’ E:\FR\FM\30DEN1.SGM 30DEN1 Federal Register / Vol. 78, No. 250 / Monday, December 30, 2013 / Notices National Heart, Lung, and Blood Institute (NHLBI), NIH, and currently at the Institute of Infectious Diseases, Southwest Hospital, Third Military Medical University, Chonqing, China, engaged in research misconduct in research supported by intramural research at NHLBI, NIH. The questioned research involves a Western blot analysis of IgM and IgG antibodies from Chinese subjects in patients with non-A–E hepatitis and control subjects to test reactivity towards a newly discovered virus. Analysis of Figure 6 of the published paper and Figure S4 of the online supplemental information identified thirteen pairs of Western blot bands which had a common origin yet were labeled as from different subjects and usually as detecting a different class of immunoglobulin. Specifically the following pairs were shown to match using forensically useful tools in Photoshop. Each represent a falsification in one or both of the figures as indicated in the table: Located in: A1 IgM/F1 IgG ........... B6 IgM/E1 IgM .......... D7 IgM/A11 IgG ........ G3 IgM/H4 IgG .......... H9 IgM/F4 IgG ........... A4 IgM/E2 IgG ........... A5 IgM/B9 IgM .......... C9 IgG/C6 IgM .......... D11 IgM/H11 IgG ...... D5 IgM/A1 IgG .......... A10 1gM/F7 IgG ........ C11 1gM/E9 IgG ....... F3 IgG/E9 IgM ........... maindgalligan on DSK5TPTVN1PROD with NOTICES Identity of strips Fig. 6 & Fig. S4. Fig. 6 & Fig. S4. Fig. 6 & Fig. S4. Fig. S4. Fig. S4. Fig. S4. Fig. S4. Fig. S4. Fig. S4. Fig. S4. Fig. S4. Fig. 6. F3 in S4/E9 in Fig. 6. The Respondent agreed to correction of Figures 6 and S4 of the PNAS paper. Dr. Xu has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of three (3) years, beginning on December 6, 2013: (1) That prior to the submission of an application for U.S. Public Health Service (PHS) support (including NIH support) for a research project on which the Respondent’s participation is proposed, and prior to Respondent’s participation in any capacity on PHSsupported 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 Respondent’s research contribution; Respondent agrees that she shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain VerDate Mar<15>2010 17:15 Dec 27, 2013 Jkt 232001 responsibility for compliance with the agreed-upon supervision plan; (2) That any institution employing her shall submit, in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHSsupported 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, that the data procedures, and methodology are accurately reported in the application, report, manuscript, or abstract, and that the text in such submission is her own or properly cites the source of copied language and ideas; 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 FURTHER INFORMATION CONTACT: Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8800. David E. Wright, Director, Office of Research Integrity. [FR Doc. 2013–31160 Filed 12–27–13; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1155] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Regulations AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 29, 2014. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All SUMMARY: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 79461 comments should be identified with the OMB control number 0910–0381. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Food Labeling Regulations—21 CFR Parts 101, 102, 104, and 105 (OMB Control Number 0910–0381)—Revision to Include Collections Previously Approved By OMB, But Currently in Use Without Approval Our food labeling regulations require food producers to disclose to consumers and others specific information about themselves or their products on the label or labeling of their products. Related regulations require that food producers retain records establishing the basis for the information contained in the label or labeling of their products and provide those records to regulatory officials. Finally, certain regulations provide for the submission of food labeling petitions to us. We issued our food labeling regulations under parts 101, 102, 104, and 105 (21 CFR parts 101, 102, 104, and 105) under the authority of sections 4, 5, and 6 of the Fair Packaging and Labeling Act (FPLA) (15 U.S.C. 1453, 1454, and 1455) and sections 201, 301, 402, 403, 409, 411, 701, and 721 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e). Most of these regulations derive from section 403 of the FD&C Act, which provides that a food product shall be deemed to be misbranded if, among other things, its label or labeling fails to bear certain required information concerning the food product, is false or misleading in any particular, or bears certain types of unauthorized claims. The disclosure requirements and other collections of information in the regulations in parts 101, 102, 104, and 105 are necessary to ensure that food products produced or sold in the United States are in compliance with the labeling provisions of the FD&C Act and FPLA. Upon review of the information collection requests supporting these food labeling regulations, FDA found that the third-party disclosure burdens associated with the requirements found in §§ 101.9(c)(2)(ii) and 101.36(b)(2) to E:\FR\FM\30DEN1.SGM 30DEN1

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[Federal Register Volume 78, Number 250 (Monday, December 30, 2013)]
[Notices]
[Pages 79460-79461]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-31160]


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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:
    Baoyan Xu, M.D., Ph.D., National Heart, Lung, and Blood Institute, 
National Institutes of Health: Based on allegations made by readers of 
a published paper,\1\ additional review by the National Institutes of 
Health (NIH) and ORI, and a limited admission by the Respondent that 
``some better looking strips were repeatedly used as representatives 
for several times [sic],'' ORI found that Dr. Baoyan Xu, formerly a 
Postdoctoral Fellow, Hematology Branch, Systems Biology Center,

[[Page 79461]]

National Heart, Lung, and Blood Institute (NHLBI), NIH, and currently 
at the Institute of Infectious Diseases, Southwest Hospital, Third 
Military Medical University, Chonqing, China, engaged in research 
misconduct in research supported by intramural research at NHLBI, NIH.
---------------------------------------------------------------------------

    \1\ Xu, B., Zhi, N., Hu, G., Wan, Z., Zheng, X., Liu, X., Wong, 
S., Kajigaya, S., Zhao, K., Mao, Q., & Young, N.S. ``Hybrid DNA 
virus in Chinese patients with seronegative hepatitis discovered by 
deep sequencing.'' Proc. Natl. Acad. Sci. (US) 110(25):10264-10269; 
hereafter referred to as the ``PNAS paper.''
---------------------------------------------------------------------------

    The questioned research involves a Western blot analysis of IgM and 
IgG antibodies from Chinese subjects in patients with non-A-E hepatitis 
and control subjects to test reactivity towards a newly discovered 
virus. Analysis of Figure 6 of the published paper and Figure S4 of the 
online supplemental information identified thirteen pairs of Western 
blot bands which had a common origin yet were labeled as from different 
subjects and usually as detecting a different class of immunoglobulin. 
Specifically the following pairs were shown to match using forensically 
useful tools in Photoshop. Each represent a falsification in one or 
both of the figures as indicated in the table:

------------------------------------------------------------------------
            Identity of strips                       Located in:
------------------------------------------------------------------------
A1 IgM/F1 IgG.............................  Fig. 6 & Fig. S4.
B6 IgM/E1 IgM.............................  Fig. 6 & Fig. S4.
D7 IgM/A11 IgG............................  Fig. 6 & Fig. S4.
G3 IgM/H4 IgG.............................  Fig. S4.
H9 IgM/F4 IgG.............................  Fig. S4.
A4 IgM/E2 IgG.............................  Fig. S4.
A5 IgM/B9 IgM.............................  Fig. S4.
C9 IgG/C6 IgM.............................  Fig. S4.
D11 IgM/H11 IgG...........................  Fig. S4.
D5 IgM/A1 IgG.............................  Fig. S4.
A10 1gM/F7 IgG............................  Fig. S4.
C11 1gM/E9 IgG............................  Fig. 6.
F3 IgG/E9 IgM.............................  F3 in S4/E9 in Fig. 6.
------------------------------------------------------------------------

    The Respondent agreed to correction of Figures 6 and S4 of the PNAS 
paper.
    Dr. Xu has entered into a Voluntary Settlement Agreement and has 
voluntarily agreed for a period of three (3) years, beginning on 
December 6, 2013:
    (1) That prior to the submission of an application for U.S. Public 
Health Service (PHS) support (including NIH support) for a research 
project on which the Respondent's participation is proposed, and prior 
to Respondent's 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 Respondent's research 
contribution; Respondent agrees that she shall not participate in any 
PHS-supported research until such a supervision plan is submitted to 
and approved by ORI; Respondent agrees to maintain responsibility for 
compliance with the agreed-upon supervision plan;
    (2) 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, that the data 
procedures, and methodology are accurately reported in the application, 
report, manuscript, or abstract, and that the text in such submission 
is her own or properly cites the source of copied language and ideas; 
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 FURTHER INFORMATION CONTACT: Director, Office of Research 
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 
453-8800.

David E. Wright,
Director, Office of Research Integrity.
[FR Doc. 2013-31160 Filed 12-27-13; 8:45 am]
BILLING CODE 4150-31-P

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