Department of Health and Human Services May 21, 2007 – Federal Register Recent Federal Regulation Documents
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Findings of Research Misconduct
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: Kartik Prabhakaran, University of Pittsburgh: Based on the report of an inquiry conducted by the University of Pittsburgh (UP), extensive oral and written admissions by the Respondent, and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Mr. Kartik Prabhakaran, former graduate student in the joint M.D./Ph.D. program at UP, engaged in research misconduct while supported by National Institutes of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grant F30 NS50905-01 and National Eye Institute (NEI), NIH, grants 5 R01 EY005945, 5 P30 EY008098, and 5 R01 EY015291. Specifically, Mr. Prabhakaran falsified and fabricated data that was included in a PowerPoint presentation and in a paper published in Immunity (Immunity 23:515-525, November 2005). Mr. Prabhakaran's research misconduct occurred while he was a student in the M.D./Ph.D. program for UP's School of Medicine. He is no longer in UP's Ph.D. program but is still enrolled in its M.D. program in the School of Medicine. The Immunity publication has been retracted (Immunity 24:657, May 2006). Mr. Prabhakaran has entered into a Voluntary Exclusion Agreement in which he has voluntarily agreed, for a period of four (4) years, beginning on March 15, 2007: (1) To exclude himself 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; and (2) That any institution that submits an application for PHS support for a research project on which Mr. Prabhakaran's participation is proposed, that uses him in any capacity on PHS supported research, or that submits a report of PHS-funded research in which he is involved must concurrently submit a plan for supervision of his duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of his research contribution. Mr. Prabhakaran agreed to ensure that a copy of the supervisory plan also is submitted to ORI by the institution. Mr. Prabhakaran agreed that he will not participate in any PHS-supported research until such a supervision plan is submitted to ORI.
Determination of Regulatory Review Period for Purposes of Patent Extension; IRESSA
The Food and Drug Administration (FDA) has determined the regulatory review period for IRESSA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; NOXAFIL
The Food and Drug Administration (FDA) has determined the regulatory review period for NOXAFIL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
The Food and Drug Administration (FDA) has determined the regulatory review period for GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 017
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 017'' (Recognition List Number: 017), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Continuous Marketing Applications: Pilot 2-Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act
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.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
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