Findings of Research Misconduct, 22973-22975 [2014-09434]

Download as PDF 22973 Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices First National Bank of Elk City ............................................................................. Bank of the Panhandle ......................................................................................... First National Bank in Marlow .............................................................................. BancFirst .............................................................................................................. First American Bank ............................................................................................. The Farmers State Bank ...................................................................................... First National Bank & Trust Company ................................................................. Valley National Bank ............................................................................................ The First National Bank of Vinita ......................................................................... Elk City .................................................. Guymon ................................................ Marlow .................................................. Oklahoma City ...................................... Purcell ................................................... Quinton ................................................. Shawnee ............................................... Tulsa ..................................................... Vinita ..................................................... Oklahoma. Oklahoma. Oklahoma. Oklahoma. Oklahoma. Oklahoma. Oklahoma. Oklahoma. Oklahoma. Federal Home Loan Bank of San Francisco—District 11 Bank 1440 ............................................................................................................ Bay Federal Credit Union ..................................................................................... Xceed Financial Federal Credit Union ................................................................. Fremont Bank ....................................................................................................... American First Credit Union ................................................................................. Silvergate Bank .................................................................................................... Preferred Bank ..................................................................................................... Broadway Federal Bank, F.S.B. ........................................................................... Monterey County Bank ......................................................................................... Oak Valley Community Bank ............................................................................... Malaga Bank, F.S.B. ............................................................................................ El Dorado Savings Bank, F.S.B. .......................................................................... Bank of Southern California, National Association .............................................. Bank of San Francisco ......................................................................................... CSAA Insurance Exchange .................................................................................. AltaPacific Bank ................................................................................................... Bank of America California, N.A. ......................................................................... Phoenix ................................................. Capitola ................................................. El Segundo ........................................... Fremont ................................................. La Habra ............................................... La Jolla ................................................. Los Angeles .......................................... Los Angeles .......................................... Monterey ............................................... Oakdale ................................................. Palos Verdes Estates ........................... Placerville .............................................. Ramona ................................................ San Francisco ....................................... San Francisco ....................................... Santa Rosa ........................................... Walnut Creek ........................................ Arizona. California. California. California. California. California. California. California. California. California. California. California. California. California. California. California. California. Federal Home Loan Bank of Seattle—District 12 Mt. McKinley Bank ............................................................................................... BankPacific ........................................................................................................... Ireland Bank ......................................................................................................... First Federal Savings Bank of Twin Falls ............................................................ United Bank .......................................................................................................... Pioneer Federal Savings & Loan Association ..................................................... American Federal Savings Bank .......................................................................... Glacier Bank ......................................................................................................... First Security Bank of Malta ................................................................................. Bank of American Fork ........................................................................................ TransWest Credit Union ....................................................................................... Bank of Fairfield ................................................................................................... Kitsap Bank .......................................................................................................... Washington Federal ............................................................................................. Sterling Savings Bank .......................................................................................... mstockstill on DSK4VPTVN1PROD with NOTICES II. Public Comments To encourage the submission of public comments on the community support performance of Bank members, on or before May 8, 2014, each Bank will notify its Advisory Council and nonprofit housing developers, community groups, and other interested parties in its district of the members selected for community support review in the 2014–2015 Review Cycle—2nd Round. 12 CFR 1290.2(b)(2)(ii). In reviewing a member for community support compliance, FHFA will consider any public comments it has received concerning the member. 12 CFR 1290.2(d). To ensure consideration by FHFA, comments concerning the community support performance of members selected for the 2014–2015 Review Cycle—2nd Round must be delivered to FHFA, either by hard-copy mail at the Federal Housing Finance VerDate Mar<15>2010 16:57 Apr 24, 2014 Jkt 232001 Fairbanks .............................................. Hagatna ................................................ Malad .................................................... Twin Falls .............................................. Absarokee ............................................. Dillon ..................................................... Helena ................................................... Kalispell ................................................. Malta ..................................................... American Fork ...................................... Salt Lake City ....................................... Fairfield ................................................. Port Orchard ......................................... Seattle ................................................... Spokane ................................................ Agency, Ninth Floor, Housing Mission and Goals (DHMG), 400 Seventh Street SW., Washington, DC 20024, or by electronic mail to hmgcommunitysupportprogram@ fhfa.gov on or before the June 9, 2014 deadline for submission of Community Support Statements. Dated: April 17, 2014. Melvin L. Watt, Director, Federal Housing Finance Agency. [FR Doc. 2014–09336 Filed 4–24–14; 8:45 am] BILLING CODE 8070–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct AGENCY: PO 00000 Office of the Secretary, HHS. Frm 00031 Fmt 4703 Sfmt 4703 ACTION: Alaska. Guam. Idaho. Idaho. Montana. Montana. Montana. Montana. Montana. Utah. Utah. Washington. Washington. Washington. Washington. Notice. Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Li Chen, Ph.D., Mount Sinai School of Medicine: Based on evidence and findings of an investigation report by Mount Sinai School of Medicine (MSSM) transmitted to the United States Department of Health and Human Services (HHS), Office of Research Integrity (ORI), in April 2010 and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Li Chen, former Postdoctoral Fellow, Department of Gene and Cell Medicine, MSSM, engaged in research misconduct in research that was supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grant R01 DK062972 and National SUMMARY: E:\FR\FM\25APN1.SGM 25APN1 mstockstill on DSK4VPTVN1PROD with NOTICES 22974 Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices Institute of General Medical Sciences (NIGMS), NIH, grant P20 GM075019 and was submitted in grant applications R01 DK074695 and R01 DK083286 to NIDDK, NIH, P20 GM075019 to NIGMS, NIH, and R01 NS062054 to the National Institute of Neurological Disorders and Stroke (NINDS), NIH. ORI found that the Respondent intentionally, knowingly, and recklessly fabricated and falsified data reported in four (4) publications, one (1) submitted manuscript, and four (4) grant applications: • Chen, L., & Woo, S.L.C. ‘‘Complete and persistent phenotypic correction of phenylketonuria in mice by site-specific genome integration of murine phenylalanine hydroxylase cDNA.’’ Proc. Natl. Acad. Sci. U.S.A. 102(43):15581–15586, October 2005 (hereafter referred to as ‘‘PNAS 2005’’). • Chen, L., Thung, S.N., & Woo, S.L.C. ‘‘Metabolic Basis of Sexual Dimorphism in PKU Mice After Genome-targeted PAH Gene Therapy.’’ Mol. Ther. 15:1079–1085, June 2007; Retracted in December 2010 (hereafter referred to as ‘‘Mol. Ther. June 2007’’). • Chen, L., & Woo, S.L.C. ‘‘Correction in Female PKU Mice by Repeated Administration of mPAH cDNA Using phiBT1 Integration System.’’ Mol. Ther. 15:1789–1795, October 2007; Retracted in December 2010 (hereafter referred to as ‘‘Mol. Ther. Oct. 2007’’). • Chen, L., & Woo, S.L.C. ‘‘SiteSpecific Transgene Integration in the ¨ Human Genome Catalyzed by OBT1 Phage Integrase.’’ Hum. Gene Ther. 19:143–151, February 2008; Retracted in August 2010 (hereafter referred to as ‘‘HGT 2008’’). • Chen, L., Roy, I., Prasad, P.N., & Woo, S.L.C. ‘‘Nanoparticle-Based Gene Therapy for Metabolic Disorders: Hepatic Delivery of Minicircle DNA for Complete Correction of Phenylketonuria.’’ Submitted for publication in Proc. Natl. Acad. Sci. U.S.A. (hereafter referred to as the ‘‘PNAS 2008 manuscript’’). • R01 DK074695, ‘‘Genome-targeted PAH Gene Integration in PKU Mice and Sexual Dimorphism,’’ Savio L.C. Wood, Ph.D., Principal Investigator (P.I.) (hereafter referred to as ‘‘R01 DK074695’’). • P20 GM075019, ‘‘Growth, Differentiation & Genetic Alteration of Human ES Cells,’’ Gordon M. Keller, Ph.D., P.I. (hereafter referred to as ‘‘P20 GM075019’’). • R01 NS062054, ‘‘Nanoparticlemedicated Gene Therapy for PKU,’’ Savio L. Woo, Ph.D., P.I. (hereafter referred to as ‘‘R01 NS062054’’). • R01 DK083285, ‘‘NanoparticleMediated Gene Therapy PKU,’’ Savio L. VerDate Mar<15>2010 16:57 Apr 24, 2014 Jkt 232001 Woo, Ph.D., P.I. (hereafter referred to as ‘‘R01 DK083285’’). The Respondent fabricated figures reporting the chromosomal locations of integration sites, fabricated data reporting the use of polymerase chain reaction (PCR) to determine integration frequencies, falsified data representing the detection of chromosomal translocations in human cells, and fabricated figures by falsely reporting the results of High-Performance Liquid Chromatography (HPLC) assays. The Respondent also falsified experimental data for LacZ stained liver sections and for hematoxylin and eosin (H&E) stained liver sections. Specifically, ORI finds by a preponderance of the evidence that the Respondent engaged in misconduct in science and research misconduct by intentionally, knowingly, and recklessly: 1. fabricating and/or falsifying nineteen (19) figures by falsely reporting that phenylketonuria (PKU) gene therapy experiments were successfully completed, when the available evidence shows the experiments were not performed; specifically the Respondent: (a) fabricated figures where DNA sequencing was purportedly used to identify the chromosomal locations of integration sites for the PAH gene in mouse and human cells, reported in seven (7) figures: • PNAS 2005, Figure 2A • HGT 2008, Figures 3b and 3c • R01 NS062054, Figures 3 and 20 • R01 DK074695, Figure 6 • R01 DK083286, Figure 17 • P20 GM075019, Figure 4 (b) fabricated data purportedly representing the use of PCR to determine integration frequencies for the phenylalanine hydroxylase (PAH) gene and the secreted embryonic alkaline phosphatase (SEAP) reporter gene, in mouse and human cells, reported in eleven (11) figures: • PNAS 2005, Figures 2C and 3B • Mol. Ther. June 2007, Figures 2a and 5a • Mol. Ther. Oct. 2007, Figures 2d and 5a • HGT 2008, Figure 4 • R01 NS062054, Figures 4b and 10a • R01 DK074695, Figure 7b • R01 DK083286, Figure 2b (c) falsified figures representing the detection of chromosomal tranlocations in human cells, purportedly determined by PCR in two (2) figures: • HGT 2008, Figure 5a • R01 NS062054, Figure 21a 2. fabricating the results of HPLC assays to show generally lowered blood levels of phenylalanine after PKU gene therapy and to show liver levels of BH4 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 when the Respondent did not have the HPLC data needed to support those claims; specifically the Respondent: (a) fabricated serum phenylalanine graphs in: • PNAS 2005, Figure 4B; this false data also is presented in R01 DK074695, Figure 10b • Mol. Ther. June 2007, Figure 1a; this false data also is presented in R01 DK074695, Figure 11 • R01 DK083286, Figure 3; this false data also is presented in Mol. Ther. June 2007, Figure 3, and R01 NS062054, Figure 7 • Mol. Ther. Oct. 2007, Figure 4a; this false data also is presented in R01 NS062054, Figure 9a • PNAS 2008 manuscript, Figure 4 (b) fabricated graphs for BH4 levels in: • Mol. Ther. June 2007, Figure 5c; this false data also is presented in R01 NS062054, Figure 8c 3. falsely reporting the results of LacZ stained liver sections by reusing and relabeling an image and claiming that it represents different experiments; specifically, the same image was used to represent mice treated with a nanoplex gene delivery system in R01 NS062054, Figure 14b (right panel), and also to represent a wholly different experiment for mice treated with 10 injections of the phiBT1 integrase system alone in R01 NS062054, Figure 4c (right panel), and Mol. Ther. Oct. 2007, Figure 2b (D panel) 4. falsely reporting the results of H&E stained liver sections in R01 NS062054, Figure 6, by using the identical image to represent four (4) different experimental treatments of H&E stained liver sections; specifically the Respondent reused and relabeled one image to represent liver sections from mice that received either 1 or 10 injections, with or without the phiBT1 integrase plasmid. The Respondent failed to take responsibility for the fabrication and falsification described in ORI’s findings. The following administrative actions have been implemented for a period of three (3) years, beginning on April 11, 2014: (1) Respondent is debarred 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 et seq.) of Office of Management and Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and Suspension, 2 CFR part 180 (collectively the ‘‘Debarment Regulations’’); and (2) Respondent is prohibited from serving in any advisory capacity to PHS, E:\FR\FM\25APN1.SGM 25APN1 Federal Register / Vol. 79, No. 80 / Friday, April 25, 2014 / Notices 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: DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Acting Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453– 8800. [Document Identifiers CMS–10517] Donald Wright, Acting Director, Office of Research Integrity. AGENCY: [FR Doc. 2014–09434 Filed 4–24–14; 8:45 am] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, HHS. ACTION: Notice. BILLING CODE 4150–31–P The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (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. DATES: Comments must be received by June 24, 2014. ADDRESSES: When commenting, please reference the document identifier or OMB control number (OCN). To be assured consideration, comments and recommendations must be submitted in any one of the following ways: 1. Electronically. You may send your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) that are accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development Attention: Document Identifier/OMB Control Number ___, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review mstockstill on DSK4VPTVN1PROD with NOTICES The meeting announced below concerns Reducing Youth Exposure to Alcohol Marketing, Special Interest Projects (SIP)14–009, Panel A, initial review. In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the aforementioned meeting: Time and Date: 10:00 a.m.–5:00 p.m., May 19, 2014 (Closed). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters for Discussion: The meeting will include the initial review, discussion, and evaluation of applications received in response to ‘‘Reducing Youth Exposure to Alcohol Marketing, SIP14–009, Panel A, initial review.’’ Contact Person for More Information: M. Chris Langub, Ph.D., Scientific Review Officer, CDC, 4770 Buford Highway, NE., Mailstop F–80, Atlanta, Georgia 30341, Telephone: (770) 488–3585, EEO6@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2014–09373 Filed 4–24–14; 8:45 am] BILLING CODE 4163–18–P VerDate Mar<15>2010 16:57 Apr 24, 2014 Jkt 232001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 22975 To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following: 1. Access CMS’ Web site address at https://www.cms.hhs.gov/Paperwork ReductionActof1995. 2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov. 3. Call the Reports Clearance Office at (410) 786–1326. FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786– 1326. SUPPLEMENTARY INFORMATION: Contents This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection’s supporting statement and associated materials (see ADDRESSES). CMS–10517 The Predictive Learning Analytics Tracking Outcome (PLATOTM) Under the PRA (44 U.S.C. 3501– 3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term ‘‘collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice. Information Collection 1. Type of Information Collection Request: New collection (Request for a new control number); Title of Information Collection: The Predictive Learning Analytics Tracking Outcome (PLATOTM); Use: The Predictive Learning Analytics Tracking Outcome (PLATOTM) is a web-based application tool that will serve as the centerpiece of the advanced analytics initiative with the Centers for Medicare & Medicaid Services (CMS) and Health Integrity, LLC, the National Benefit Integrity E:\FR\FM\25APN1.SGM 25APN1

Agencies

[Federal Register Volume 79, Number 80 (Friday, April 25, 2014)]
[Notices]
[Pages 22973-22975]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09434]


=======================================================================
-----------------------------------------------------------------------

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:
    Li Chen, Ph.D., Mount Sinai School of Medicine: Based on evidence 
and findings of an investigation report by Mount Sinai School of 
Medicine (MSSM) transmitted to the United States Department of Health 
and Human Services (HHS), Office of Research Integrity (ORI), in April 
2010 and additional analysis conducted by ORI in its oversight review, 
ORI found that Dr. Li Chen, former Postdoctoral Fellow, Department of 
Gene and Cell Medicine, MSSM, engaged in research misconduct in 
research that was supported by National Institute of Diabetes and 
Digestive and Kidney Diseases (NIDDK), National Institutes of Health 
(NIH), grant R01 DK062972 and National

[[Page 22974]]

Institute of General Medical Sciences (NIGMS), NIH, grant P20 GM075019 
and was submitted in grant applications R01 DK074695 and R01 DK083286 
to NIDDK, NIH, P20 GM075019 to NIGMS, NIH, and R01 NS062054 to the 
National Institute of Neurological Disorders and Stroke (NINDS), NIH.
    ORI found that the Respondent intentionally, knowingly, and 
recklessly fabricated and falsified data reported in four (4) 
publications, one (1) submitted manuscript, and four (4) grant 
applications:
     Chen, L., & Woo, S.L.C. ``Complete and persistent 
phenotypic correction of phenylketonuria in mice by site-specific 
genome integration of murine phenylalanine hydroxylase cDNA.'' Proc. 
Natl. Acad. Sci. U.S.A. 102(43):15581-15586, October 2005 (hereafter 
referred to as ``PNAS 2005'').
     Chen, L., Thung, S.N., & Woo, S.L.C. ``Metabolic Basis of 
Sexual Dimorphism in PKU Mice After Genome-targeted PAH Gene Therapy.'' 
Mol. Ther. 15:1079-1085, June 2007; Retracted in December 2010 
(hereafter referred to as ``Mol. Ther. June 2007'').
     Chen, L., & Woo, S.L.C. ``Correction in Female PKU Mice by 
Repeated Administration of mPAH cDNA Using phiBT1 Integration System.'' 
Mol. Ther. 15:1789-1795, October 2007; Retracted in December 2010 
(hereafter referred to as ``Mol. Ther. Oct. 2007'').
     Chen, L., & Woo, S.L.C. ``Site-Specific Transgene 
Integration in the Human Genome Catalyzed by [Ouml]BT1 Phage 
Integrase.'' Hum. Gene Ther. 19:143-151, February 2008; Retracted in 
August 2010 (hereafter referred to as ``HGT 2008'').
     Chen, L., Roy, I., Prasad, P.N., & Woo, S.L.C. 
``Nanoparticle-Based Gene Therapy for Metabolic Disorders: Hepatic 
Delivery of Minicircle DNA for Complete Correction of 
Phenylketonuria.'' Submitted for publication in Proc. Natl. Acad. Sci. 
U.S.A. (hereafter referred to as the ``PNAS 2008 manuscript'').
     R01 DK074695, ``Genome-targeted PAH Gene Integration in 
PKU Mice and Sexual Dimorphism,'' Savio L.C. Wood, Ph.D., Principal 
Investigator (P.I.) (hereafter referred to as ``R01 DK074695'').
     P20 GM075019, ``Growth, Differentiation & Genetic 
Alteration of Human ES Cells,'' Gordon M. Keller, Ph.D., P.I. 
(hereafter referred to as ``P20 GM075019'').
     R01 NS062054, ``Nanoparticle-medicated Gene Therapy for 
PKU,'' Savio L. Woo, Ph.D., P.I. (hereafter referred to as ``R01 
NS062054'').
     R01 DK083285, ``Nanoparticle-Mediated Gene Therapy PKU,'' 
Savio L. Woo, Ph.D., P.I. (hereafter referred to as ``R01 DK083285'').
    The Respondent fabricated figures reporting the chromosomal 
locations of integration sites, fabricated data reporting the use of 
polymerase chain reaction (PCR) to determine integration frequencies, 
falsified data representing the detection of chromosomal translocations 
in human cells, and fabricated figures by falsely reporting the results 
of High-Performance Liquid Chromatography (HPLC) assays. The Respondent 
also falsified experimental data for LacZ stained liver sections and 
for hematoxylin and eosin (H&E) stained liver sections.
    Specifically, ORI finds by a preponderance of the evidence that the 
Respondent engaged in misconduct in science and research misconduct by 
intentionally, knowingly, and recklessly:
    1. fabricating and/or falsifying nineteen (19) figures by falsely 
reporting that phenylketonuria (PKU) gene therapy experiments were 
successfully completed, when the available evidence shows the 
experiments were not performed; specifically the Respondent:
    (a) fabricated figures where DNA sequencing was purportedly used to 
identify the chromosomal locations of integration sites for the PAH 
gene in mouse and human cells, reported in seven (7) figures:
     PNAS 2005, Figure 2A
     HGT 2008, Figures 3b and 3c
     R01 NS062054, Figures 3 and 20
     R01 DK074695, Figure 6
     R01 DK083286, Figure 17
     P20 GM075019, Figure 4
    (b) fabricated data purportedly representing the use of PCR to 
determine integration frequencies for the phenylalanine hydroxylase 
(PAH) gene and the secreted embryonic alkaline phosphatase (SEAP) 
reporter gene, in mouse and human cells, reported in eleven (11) 
figures:
     PNAS 2005, Figures 2C and 3B
     Mol. Ther. June 2007, Figures 2a and 5a
     Mol. Ther. Oct. 2007, Figures 2d and 5a
     HGT 2008, Figure 4
     R01 NS062054, Figures 4b and 10a
     R01 DK074695, Figure 7b
     R01 DK083286, Figure 2b
    (c) falsified figures representing the detection of chromosomal 
tranlocations in human cells, purportedly determined by PCR in two (2) 
figures:
     HGT 2008, Figure 5a
     R01 NS062054, Figure 21a
    2. fabricating the results of HPLC assays to show generally lowered 
blood levels of phenylalanine after PKU gene therapy and to show liver 
levels of BH4 when the Respondent did not have the HPLC data 
needed to support those claims; specifically the Respondent:
    (a) fabricated serum phenylalanine graphs in:
     PNAS 2005, Figure 4B; this false data also is presented in 
R01 DK074695, Figure 10b
     Mol. Ther. June 2007, Figure 1a; this false data also is 
presented in R01 DK074695, Figure 11
     R01 DK083286, Figure 3; this false data also is presented 
in Mol. Ther. June 2007, Figure 3, and R01 NS062054, Figure 7
     Mol. Ther. Oct. 2007, Figure 4a; this false data also is 
presented in R01 NS062054, Figure 9a
     PNAS 2008 manuscript, Figure 4
    (b) fabricated graphs for BH4 levels in:
     Mol. Ther. June 2007, Figure 5c; this false data also is 
presented in R01 NS062054, Figure 8c
    3. falsely reporting the results of LacZ stained liver sections by 
reusing and relabeling an image and claiming that it represents 
different experiments; specifically, the same image was used to 
represent mice treated with a nanoplex gene delivery system in R01 
NS062054, Figure 14b (right panel), and also to represent a wholly 
different experiment for mice treated with 10 injections of the phiBT1 
integrase system alone in R01 NS062054, Figure 4c (right panel), and 
Mol. Ther. Oct. 2007, Figure 2b (D panel)
    4. falsely reporting the results of H&E stained liver sections in 
R01 NS062054, Figure 6, by using the identical image to represent four 
(4) different experimental treatments of H&E stained liver sections; 
specifically the Respondent reused and relabeled one image to represent 
liver sections from mice that received either 1 or 10 injections, with 
or without the phiBT1 integrase plasmid.
    The Respondent failed to take responsibility for the fabrication 
and falsification described in ORI's findings.
    The following administrative actions have been implemented for a 
period of three (3) years, beginning on April 11, 2014:
    (1) Respondent is debarred 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 et seq.) of Office of Management and 
Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and 
Suspension, 2 CFR part 180 (collectively the ``Debarment 
Regulations''); and
    (2) Respondent is prohibited from serving in any advisory capacity 
to PHS,

[[Page 22975]]

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: Acting Director, Office of Research 
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 
453-8800.

Donald Wright,
Acting Director, Office of Research Integrity.
[FR Doc. 2014-09434 Filed 4-24-14; 8:45 am]
BILLING CODE 4150-31-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.