Department of Health and Human Services August 14, 2007 – Federal Register Recent Federal Regulation Documents

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: Juan Carlos Jorge-Rivera, Ph.D., Dartmouth College: Based on the findings of an inquiry conducted by Dartmouth College, an investigation conducted by another Federal agency, and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, the U.S. Public Health Service (PHS) found that Juan Carlos Jorge- Rivera, Ph.D., former postdoctoral fellow, Department of Physiology, Dartmouth College, engaged in misconduct in science in research funded by National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grant R01 NS28668. Specifically, Dr. Jorge-Rivera knowingly and intentionally falsified amplifier gain in at least eleven (11) experiments of his postdoctoral research aimed at measuring the effects of anabolic steroids on GABAnergic current in brain cells and reported the falsified data in Figures 4 and 6 of the following paper: Jorge-Rivera, J.C., McIntyre, K.L., & Henderson, L.P. ``Anabolic steroids induce region- and subunit-specific modulations of GABA receptor mediated currents in the rat forebrain.'' Journal of Neurophysiology 83:3299- 3309, 2000. Dr. Jorge-Rivera has been debarred by the Federal agency with joint jurisdiction for a period of two (2) years, beginning on January 11, 2007, and ending on January 11, 2009. ORI has implemented the following administrative actions: (1) For a period of three (3) years, beginning on June 23, 2007, and ending on June 22, 2010, Dr. Jorge-Rivera 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; and (2) for a period of three (3) years, beginning at the end of his debarment period (January 11, 2009), and ending on January 10, 2012, Dr. Jorge-Rivera must submit, in conjunction with each application for PHS funds, annual reports, manuscripts, or abstracts of PHS-funded research in which he is involved, a certification that the data he provides are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application or report.

The Food and Drug Administration (FDA) seeks additional information on issues related to clinical development programs for human drugs, biological products, and medical devices for the treatment and prevention of osteoarthritis (OA). We will take such information into account as we work to finalize our draft guidance issued in July 1999. Once finalized, the guidance will aid sponsors and other interested parties in developing new products to treat OA. Before the agency can issue such guidance, a critical appraisal of certain fundamentals of the science related to OA is needed. FDA is inviting any interested party, or parties, to conduct and manage the coordination of this critical appraisal. FDA believes that the party, or parties', first step in conducting the critical appraisal would be to hold a public meeting to discuss issues related to OA assessment and trial design. FDA intends to submit to the docket all the information received in response to this notice so that interested parties may be fully informed and to facilitate participation in and coordination of these activities.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``FDA Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996.'' The guidance document addresses issues pertaining to the exportation of human drugs, animal drugs, biologics, devices, food, food additives, color additives and dietary supplements under the FDA Export Reform and Enhancement Act.

The Food and Drug Administration (FDA) is confirming the effective date of July 20, 2007, for the final rule that appeared in the Federal Register of June 19, 2007 (72 FR 33664). The final rule amended the color additive regulations to provide for the safe use of D&C Black No. 3 (bone black, subject to FDA batch certification) as a color additive in the following cosmetics: Eyeliner, eye shadow, mascara, and face powder.

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its thirtieth meeting, at which it will (1) Discuss a projected ``white paper'' on the neurological standard for the determination of death; (2) continue the exploratory phase of a potential inquiry into the ``crisis'' of the healing professions with expert presentations and Council discussions; and (3) continue the exploratory phase of a potential inquiry into ethical issues associated with nanotechnology with expert presentations and Council discussions. Subjects discussed at past Council meetings (although not on the agenda for the September 2007 meeting) include: therapeutic and reproductive cloning, assisted reproduction, reproductive genetics, the ethics of health care, neuroscience, aging retardation, organ transplantation, newborn screening, human dignity, personalized medicine, and lifespan- extension. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnolody and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Cells: A White Paper (May 2005), and Taking Care: Ethical Caregiving in Our Aging Society (September 2005). Reports on the bioethical significance of the concept of human dignity and on organ procurement, transplantation, and allocation are forthcoming.