Department of Health and Human Services January 9, 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: Jong Hyuk Park, Ph.D., University of Pittsburgh: Based on accumulated evidence including the University of Pittsburgh (UP) investigation committee report 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 Jong Hyuk Park, Ph.D., former postdoctoral fellow, Pittsburgh Development Center of the Magee-Womens Research Institute, UP, engaged in research misconduct in research funded by National Center for Research Resources (NCRR), National Institutes of Health (NIH), grant R24 RR13632 and National Institute of Child Health and Human Development (NICHD), NIH, grant P01 HD047675. Specifically, Dr. Park: (1) Intentionally and knowingly falsified various versions of two figures in a manuscript entitled ``Rhesus Embryonic Stem Cells Established by Nuclear Transfer: Tetraploid ESCs Differ from Fertilized Ones'' that was being prepared for submission to Nature; (2) Repeatedly misrepresented to the UP investigative panel the accuracy of one of the figures; (3) Presented the false figures as true to members of the laboratory; and (4) Falsified the record of revisions of the figures by deleting all prior versions from the laboratory server. ORI has implemented the following administrative actions for a period of three (3) years, beginning on November 29, 2006: (1) Dr. Park is debarred from 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 as defined in the debarment regulations at 45 CFR Part 76; and (2) Dr. Park 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), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in cosponsorship with the FDA Medical Device Industry Coalition (FMDIC) and the Risk Management Small Business Development Center (RMSBDC), is announcing a public workshop entitled ``Medical Devices 101: An Educational Forum.'' This public workshop is intended to provide an overview on FDA's medical device requirements to entrepreneurs, startup companies, and small businesses. Date and Time: The public workshop will be held on February 9, 2007, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Hoblitzelle Auditorium at the Bill Priest Campus of El Centro College, 1402 Corinth St. in Dallas, TX. Contact Person: David Arvelo, Food and Drug Administration, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952, FAX: 214-253-4970, e-mail: oraswrsbr@fda.hhs.gov. Registration: Registration by January 26, 2007, is strongly encouraged. The RMSBDC has a $75 early registration fee to cover the cost of facilities, materials, and refreshments. Please submit your registration as soon as possible. Registration at the site may be possible on a space available basis on the day of the public workshop beginning at 8 a.m. The cost of registration after January 26, 2007, is $99 payable to RMSBDC. If you need special accommodations due to a disability, please contact David Arvelo (see Contact Person) at least 7 days in advance. Registration Form Instructions: To register, please complete the RMSBDC registration form and submit along with payment to RMSBDC, Attn: Saira Roberts, 1402 Corinth St., Dallas, TX 75215. You may fax the completed registration form to RMSBDC at 214-860-5867. To obtain a copy of the registration form, please call RMSBDC at 214-860-5887 or 214- 860-5849. The registration form is also available online at https:// www.ntsbdc.org/. Transcripts: Transcripts of the public workshop will not be available due to the format of this workshop. Course handouts may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 15 working days after the public workshop at a cost of 10 cents per page.