Department of Health and Human Services July 9, 2010 – 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: Gerardo L. Paez, PhD, University of Pennsylvania: Based on the reports of an inquiry and an investigation conducted by the University of Pennsylvania (UP) and analysis conducted by the ORI Division of Investigative Oversight (DIO), ORI found that Gerardo L. Paez, PhD, former postdoctoral fellow, Section of Medical Genetics, UP School of Veterinary Medicine, engaged in research misconduct in research supported by National Eye Institute (NEI), National Institutes of Health (NIH), awards R01 EY06855 and R01 EY13132. ORI found that the Respondent engaged in research misconduct by falsifying and fabricating retinal gene profile data that he purportedly obtained from three-week old normal dogs and dogs with X- linked progressive retinal atrophy. Specifically, ORI found that: 1. Respondent committed research misconduct by falsifying/ fabricating data for gene expression profiles in retinal tissue from three-week old normal dogs and dogs with X-linked progressive retinal atrophy in abstracts and poster presentations for the 2006 \1\ and 2007 \2\ Association for Research in Vision and Ophthalmology (ARVO) meetings and in an unsubmitted manuscript draft.\3\

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the continuation of a pilot project to evaluate the electronic collection of the 3500A Form for adverse events related to the use of medical products to obtain data from user facilities participating in the Medical Product Safety Network (MedSun). Additionally, the electronic form will include hospital profile information and several other questions related to the use of medical products. It will no longer contain the page called Device-Safety Exchange (DS-X) (formerly called M-Den), which was a moderated site where MedSun members shared information with each other. This will be replaced by a page where questions about possible emerging signals will be asked of the MedSun sites.

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 (the PRA).

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.

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.

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.