Findings of Research Misconduct, 966-967 [E7-42]

Download as PDF ycherry on PROD1PC63 with NOTICES 966 Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Notices Interested parties may submit comments on agreements to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in the Federal Register. Copies of agreements are available through the Commission’s Office of Agreements (202–523–5793 or tradeanalysis@fmc.gov). Agreement No.: 010051–038. Title: Mediterranean Space Charter Agreement. Parties: Hapag-Lloyd USA LLC; A.P. Moller-Maersk A/S; Mediterranean Shipping Company, S.A.; Hapag-Lloyd AG; and Zim Integrated Shipping Services, Ltd. Filing Party: Wayne R. Rohde, Esq.; Sher & Blackwell LLP; 1850 M Street, NW.; Suite 900; Washington, DC 20036. Synopsis: The amendment updates CP Ships (USA) LLC’s corporate name to Hapag-Lloyd USA LLC. Agreement No.: 011733–018. Title: Common Ocean Carrier Platform Agreement. Parties: A.P. Moller-Maersk A/S; CMA ¨ CGM; Hamburg-Sud; Hapag-Lloyd AG; Mediterranean Shipping Company S.A.; and United Arab Shipping Company (S.A.G.) as shareholder parties, and Alianca Navegacao e Logistica Ltda.; Kawasaki Kisen Kaisha Ltd.; MISC Berhad; Mitsui O.S.K. lines Ltd.; Nippon Yusen Kaisha; Safmarine Container Lines N.V.; Senator Lines GmbH; and Tasman Orient Line C.V. as non-shareholder parties. Filing Party: Wayne R. Rohde, Esq.; Sher & Blackwell LLP; 1850 M Street, NW.; Suite 900; Washington, DC 20036. Synopsis: The amendment deletes CP Ships Limited; CP Ships (USA) LLC; FESCO Ocean Management Ltd.; and P&O Nedlloyd Limited as parties to the agreement and changes Hapag-Lloyd’s name. Agreement No.: 201174. Title: Port of Kalama/ConAgra Foods, Inc./Kalama Export Company LLC/ Kalama Grain Terminal, Inc. Agreement. Parties: Port of Kalama; ConAgra Foods, Inc.; Kalama Export Company LLC; and Kalama Grain Terminal, Inc. Filing Party: Dennis A. 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[FR Doc. 07–54 Filed 1–5–07; 3:10 pm] BILLING CODE 6760–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: SUMMARY: Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Jong Hyuk Park, Ph.D., University of Pittsburgh: Based on accumulated evidence including the University of Pittsburgh (UP) investigation committee report and additional analysis and information obtained by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Jong Hyuk Park, Ph.D., former postdoctoral fellow, Pittsburgh Development Center of the Magee-Womens Research Institute, UP, engaged in research misconduct in research funded by National Center for Research Resources (NCRR), National Institutes of Health (NIH), grant R24 RR13632 and National Institute of Child Health and Human Development (NICHD), NIH, grant P01 HD047675. Specifically, Dr. Park: (1) Intentionally and knowingly falsified various versions of two figures in a manuscript entitled ‘‘Rhesus Embryonic Stem Cells Established by Nuclear Transfer: Tetraploid ESCs Differ from Fertilized Ones’’ that was being prepared for submission to Nature; E:\FR\FM\09JAN1.SGM 09JAN1 Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Notices (2) Repeatedly misrepresented to the UP investigative panel the accuracy of one of the figures; (3) Presented the false figures as true to members of the laboratory; and (4) Falsified the record of revisions of the figures by deleting all prior versions from the laboratory server. ORI has implemented the following administrative actions for a period of three (3) years, beginning on November 29, 2006: (1) Dr. Park is debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government as defined in the debarment regulations at 45 CFR Part 76; and (2) Dr. Park is prohibited 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, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8800. Chris B. Pascal, Director, Office of Research Integrity. [FR Doc. E7–42 Filed 1–8–07; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0347] In Vitro Diagnostic Multivariate Index Assays; Public Meeting AGENCY: Food and Drug Administration, HHS. ycherry on PROD1PC63 with NOTICES ACTION: Notice of public meeting. SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting on In Vitro Diagnostic Multivariate Index Assays. The meeting is intended to provide a public forum during which FDA will hear presentations and comments from interested stakeholders regarding the draft guidance entitled ‘‘Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.’’ This draft guidance is intended to provide clarification on FDA’s approach to regulation of in vitro diagnostic multivariate index assays. FDA is seeking comments on this draft guidance. VerDate Aug<31>2005 13:55 Jan 08, 2007 Jkt 211001 The public meeting will be held on February 8, 2007, from 8 a.m. to 5 p.m. Online registration is available until 5 p.m. on February 5, 2007; however, if space permits onsite registration will be permitted on February 8, 2007 (see the Registration section of this notice for details). ADDRESSES: The public meeting will be held at the Grand Ballroom of the Hilton Washington DC/Gaithersburg Hotel located at 620 Perry Pkwy., Gaithersburg, MD 20877. Additional information about and directions to the facility are available by calling the hotel at 1–301–977–8900 or on the Internet at: https://www.hilton.com (under Find a Hotel, type in Gaithersburg, MD under city and State). (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) The comment period on this draft guidance closes on March 5, 2007. Submit written comments to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft guidance to https:// www.fda.gov/dockets/ecomments. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Sousan Altaie, Center for Devices and Radiological Health (HFZ–440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240–276– 0450, ext. 106, e-mail: Sousan.Altaie@fda.hhs.gov. SUPPLEMENTARY INFORMATION: DATES: I. Background FDA announced the availability of a draft guidance entitled ‘‘Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays,’’ on September 7, 2006 (71 FR 52800). This draft guidance addresses the definition and regulatory status of a class of in vitro diagnostic devices referred to as In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). The draft guidance also addresses premarket and postmarket requirements with respect to IVDMIAs. An IVDMIA employs clinical data, which may be derived in part from one or more in vitro assays, and an algorithm to integrate the variables, and reports a result that cannot be interpreted by the well-trained health care practitioner using prior knowledge of medicine without information from the test developer regarding its clinical performance and effectiveness. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 967 FDA is seeking comments on this draft guidance and has extended the comment period to March 5, 2007 (71 FR 68822). FDA is announcing in this notice a public meeting on this draft guidance. II. Agenda FDA will start the meeting with a brief presentation on the draft guidance entitled ‘‘Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.’’ The purpose of this meeting is to obtain public input on this guidance. Hence, presentations by the public will make-up the remainder of the agenda. Interested persons who would like to make a presentation during the meeting will be given 10 minutes to do so if they submit their request (electronic or written) and a copy of the material to be presented by February 1, 2007, to the contact person, Sousan Altaie, at the address or the email above and to the docket for this draft guidance. Depending upon the number of presenters submitting requests to present, the allotted time may be expanded or shortened to provide appropriate representation by all interested parties. Presentations and comments are to be identified with the docket number found in brackets in the heading of this document. This public meeting agenda will be available on the Internet on February 7, 2007, at https://www.fda.gov/cdrh/oivd/ meetings/020807agenda.html. III. Registration Those interested in attending may register online at https:// www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfSUD/oivd_meeting.cfm. There is no registration fee to attend the meeting. Please submit registration early in order to reserve a space, as space is limited. You may register online until February 5, 2007; however, onsite registration will be permitted if space remains. If you require special accommodations due to a disability, please contact the Hilton Washington DC/Gaithersburg Hotel directly at 1– 301–977–8900, at least 7 days in advance. Persons without Internet access may call Sousan Altaie at 240–276–0450 ext. 106, by February 5, 2007, to register for onsite meeting attendance. IV. Request for Input and Materials FDA is interested in receiving input from stakeholders on the draft guidance. Send suggestions or recommendations to the Division of Dockets Management (see ADDRESSES). FDA will place an additional copy of any material it E:\FR\FM\09JAN1.SGM 09JAN1

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[Federal Register Volume 72, Number 5 (Tuesday, January 9, 2007)]
[Notices]
[Pages 966-967]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-42]


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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) and the Assistant Secretary for Health have taken final action in 
the following case:
    Jong Hyuk Park, Ph.D., University of Pittsburgh: Based on 
accumulated evidence including the University of Pittsburgh (UP) 
investigation committee report and additional analysis and information 
obtained by the Office of Research Integrity (ORI) during its oversight 
review, the U.S. Public Health Service (PHS) found that Jong Hyuk Park, 
Ph.D., former postdoctoral fellow, Pittsburgh Development Center of the 
Magee-Womens Research Institute, UP, engaged in research misconduct in 
research funded by National Center for Research Resources (NCRR), 
National Institutes of Health (NIH), grant R24 RR13632 and National 
Institute of Child Health and Human Development (NICHD), NIH, grant P01 
HD047675.
    Specifically, Dr. Park:
    (1) Intentionally and knowingly falsified various versions of two 
figures in a manuscript entitled ``Rhesus Embryonic Stem Cells 
Established by Nuclear Transfer: Tetraploid ESCs Differ from Fertilized 
Ones'' that was being prepared for submission to Nature;

[[Page 967]]

    (2) Repeatedly misrepresented to the UP investigative panel the 
accuracy of one of the figures;
    (3) Presented the false figures as true to members of the 
laboratory; and
    (4) Falsified the record of revisions of the figures by deleting 
all prior versions from the laboratory server.
    ORI has implemented the following administrative actions for a 
period of three (3) years, beginning on November 29, 2006:
    (1) Dr. Park is debarred from any contracting or subcontracting 
with any agency of the United States Government and from eligibility or 
involvement in nonprocurement programs of the United States Government 
as defined in the debarment regulations at 45 CFR Part 76; and
    (2) Dr. Park is prohibited 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, Division of Investigative 
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 
750, Rockville, MD 20852, (240) 453-8800.

Chris B. Pascal,
Director, Office of Research Integrity.
 [FR Doc. E7-42 Filed 1-8-07; 8:45 am]
BILLING CODE 4150-31-P
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