Department of Health and Human Services July 23, 2007 – Federal Register Recent Federal Regulation Documents

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: James David Lieber, University of California at Los Angeles: Based on the findings of an inquiry report by the University of California at Los Angeles (UCLA) 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 James David Lieber, Staff Research Associate, Semel Institute for Neuroscience and Human Behavior, Integrated Substance Abuse Programs, UCLA, engaged in research misconduct in research funded by National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), grant R01 DA15390. Mr. Lieber knowingly and intentionally falsified and fabricated multiple follow-up interviews, urine samples, and urine sample records of human subject study participants and entered such false and fabricated data into the study's data base. A total of 914 follow-up interviews of opiate users were planned to be completed as part of a study of gender differences in a follow up of opiate users in California. Mr. Lieber was assigned to interview 53 of the 132 subjects located for the follow-up study. Over a six-month period, Mr. Lieber falsely claimed to have conducted face-to-face interviews for the study while subsequent contacts with the subjects revealed that they had not been interviewed for the study. A review by the institution determined that the respondent fabricated interviews for 20 of the 53 interviews assigned to him. In addition, he falsified the urine specimens for those 20 subjects and caused the entry of false information into the study tracking and locating data base for 11 subjects. Aggravating factors included the theft of $5180 for incentive payments to subjects and travel expenses. ORI has implemented the following administrative actions for a period of three (3) years, beginning on July 2, 2007: (1) Mr. Lieber is debarred from eligibility for 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 referred to as ``covered transactions'' as defined in HHS' implementation of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension at 2 CFR part 376, et seq.; and (2) Mr. Lieber 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.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed collection of information concerning cooperative manufacturing arrangements for licensed biologics.