Department of Health and Human Services February 16, 2006 – Federal Register Recent Federal Regulation Documents
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Findings of Research Misconduct
Notice is hereby given that on January 13, 2006, the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the research misconduct findings of the U.S. Public Health Service (PHS) in the following case: April Swe, University of Wisconsin-Madison: Based on the report of an investigation conducted by the University of Wisconsin-Madison (UWM) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, PHS found that Ms. Swe, former graduate student at UWM, engaged in research misconduct by fabricating data on thirty-nine (39) questionnaires of sibling human subjects associated with an autism study. The research was supported by National Institute on Aging, National Institutes of Health (NIH), grant R01 AG08768. In a final decision dated January 13, 2006, the HHS Debarring Official, on behalf of the Secretary of HHS, issued the final debarment notice based on the PHS findings of research misconduct. The following administrative actions have been implemented for a period of three (3) years, beginning on January 13, 2006: (1) Ms. Swe has been debarred from eligibility for or involvement as a principal in nonprocurement transactions (e.g., grants and cooperative agreements) of the Federal Government and from contracting or subcontracting with any Federal Government agency, except as provided in 45 CFR 76.120. This action is being taken pursuant to the debarment regulations at 45 CFR part 76. (2) Ms. Swe has been 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 consultant.
Findings of Scientific Misconduct
Notice is hereby given that the Office of Research Integrity (ORI), the Assistant Secretary for Health, and another Federal agency have taken final action in the following case: Amy Beth Goldring, University of California at Los Angeles: Based on an investigation conducted by the University of California at Los Angeles (UCLA) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, ORI found that Ms. Goldring, former graduate student, Department of Psychology, UCLA, engaged in scientific misconduct by falsifying or fabricating data and statistical results for up to nine pilot studies on the impact of vulnerability on decision-making from Fall 2000 to Winter 2002 as a basis for her doctoral thesis research. The falsified or fabricated data was included in a manuscript submitted to Psychological Science, in National Institutes of Mental Health (NIMH), National Institutes of Health (NIH), grant application 1 R01 MH65238-01A1, and in NIMH, NIH, pre-doctoral training grant T32 MH15750. Ms. Goldring has been debarred by another agency with joint jurisdiction for a period of three (3) years, beginning on May 13, 2005, and ending on May 13, 2008. On December 16, 2005, Ms. Goldring received a detailed explanation of ORI's proposed finding and was given thirty (30) days to contest the finding and the proposed administrative action. The thirty-day period has elapsed and ORI has not received a response. Accordingly, the following administrative action has been implemented for a period of three (3) years, beginning on January 18, 2006: (1) Ms. Goldring 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.
Guidance for Industry on Reports on the Status of Postmarketing Study Commitments-Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Reports on the Status of Postmarketing Study CommitmentsImplementation of Section 130 of the Food and Drug Administration Modernization Act of 1997.'' This guidance provides recommendations on procedures, content, and format for submitting a postmarketing study status report for an approved human drug or licensed biological product; timeframes for FDA's review of postmarketing study commitments; and information about postmarketing study commitments that will be available to the public. The guidance is intended to assist applicants in meeting the requirements of section 130 of the Food and Drug Administration Modernization Act of 1997.
HIPAA Administrative Simplification: Enforcement
The Secretary of Health and Human Services is adopting rules for the imposition of civil money penalties on entities that violate rules adopted by the Secretary to implement the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191 (HIPAA). The final rule amends the existing rules relating to the investigation of noncompliance to make them apply to all of the HIPAA Administrative Simplification rules, rather than exclusively to the privacy standards. It also amends the existing rules relating to the process for imposition of civil money penalties. Among other matters, the final rule clarifies and elaborates upon the investigation process, bases for liability, determination of the penalty amount, grounds for waiver, conduct of the hearing, and the appeal process.
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