June 3, 2005 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI), the Acting Assistant Secretary for Health, and another Federal agency have taken final action in the following case: Jason W. Lilly, Ph.D., Boyce Thompson Institute: Based on the report of an investigation conducted by the Boyce Thompson Institute (BTI Report), the investigation report of another Federal agency, and additional analysis conducted by ORI in its oversight review, the U.S. Public Health Service (PHS) found that Jason W. Lilly, Ph.D., former postdoctoral fellow at BTI, engaged in scientific misconduct in research supported by the National Research Service Award, National Institutes of Health (NIH) postdoctoral fellowship, F32 GM64276. This case has been jointly handled by ORI and another Federal agency under the government-wide debarment regulations. Specifically, PHS found that: A. Dr. Lilly falsified Figure 4, presenting a hierarchical cluster analysis of differential mRNA accumulation in cells grown in medium deficient in sulfate or phosphate in ``The Chlamydonomas reinhardtii organellar genomes respond transcriptionally and post-transcriptionally to abiotic stimuli,'' The Plant Cell 14:2681:2706, 2002 (hereafter referred to as the Plant Cell paper) by claiming it was an average of three experiments when only one had been conducted; B. Dr. Lilly further falsified Figure 4 of the Plant Cell paper by falsely coloring two cells in the blown-up portion of the figure that illustrated the induction of high levels of mRNA from the Sac1 gene; C. Dr. Lilly falsified the supplemental gene array experiments published online claimed to be replicate assays by manipulation of both spreadsheet and image data from a single assay to make the altered data sufficiently different to appear to be separate assays; D. Dr. Lilly falsified the text describing Figure 5 of the Plant Cell paper by claiming that the run-on assays had been replicated when they had not been; E. Dr. Lilly falsified the purported replicates of run-on transcription experiments provided in the on-line supplemental material by manipulation of a single assay to make the variant versions appear different; and F. Dr. Lilly falsified Figure 1 of the Plant Cell paper by using the same 16S control bands for RNA blots of two different genes (psbF and PsaG). Dr. Lilly has been debarred by the lead agency for a period of two (2) years, beginning on March 4, 2005, and ending on March 4, 2007, and has entered into a Voluntary Exclusion Agreement (Agreement ) with PHS in which he has voluntarily agreed: (1) To exclude himself 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, for a period of four (4) years, beginning on April 18, 2005; and (2) That he will ensure that any institution employing him submits, in conjunction with each application for PHS funds or report, manuscript, or abstract of PHS funded research in which Dr. Lilly is involved, a certification that the data provided by Dr. Lilly 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 for a period of two (2) years, beginning on April 18, 2007, approximately corresponding to the termination date of the debarment period initiated by the lead agency. Dr. Lilly must ensure that the institution also sends a copy of the certification to ORI.

This document announces receipt by the National Highway Traffic Safety Administration (NHTSA) of a petition for a decision that 2005 Smart Car Passion, Pulse, and Pure (coupe and cabriolet) passenger cars that were not originally manufactured to comply with all applicable Federal motor vehicle safety standards are eligible for importation into the United States because they have safety features that comply with, or are capable of being altered to comply with, all such standards.

The Coast Guard seeks applications for membership on the Great Lakes Pilotage Advisory Committee (GLPAC). GLPAC provides advice and makes recommendations to the Secretary on a wide range of issues related to pilotage on the Great Lakes, including the rules and regulations that govern the registration, operating requirements, and training policies for all U.S. registered pilots. The Committee also advises on matters related to ratemaking to determine the appropriate charge for pilot services on the Great Lakes.

The General Services Administration (GSA) is amending the General Services Administration Acquisition Regulation (GSAR) in order to be consistent with the Federal Acquisition Regulation (FAR), to update GSAR clauses pertaining to subcontracting plans to include veteran-owned and service-disabled veteran-owned small businesses.

This document adopts rules on procedures related to negotiated service agreements. The rules are designed to assist in clarifying the type of requests that qualify as extensions and the type of conditions that constitute modifications. Relative to the proposed rules, the final set of rules reflect several changes based on consideration of comments. These changes include adoption of deadlines for issuance of a recommended decision.

With the publication of this final rule, EPA is designating two open-water dredged material disposal sites, Central Long Island Sound (CLIS) and Western Long Island Sound (WLIS), for the disposal of dredged material from harbors and navigation channels in the Long Island Sound vicinity in the states of Connecticut and New York. This action is necessary to provide long-term, open-water, dredged material disposal sites as an alternative for the possible future disposal of such material. The basis for this action is described in a Final Environmental Impact Statement (FEIS) published by EPA in March 2004. The FEIS identifies designation of the CLIS and WLIS dredged material disposal sites as the preferred alternatives from the range of options considered. On September 12, 2003, EPA published in the Federal Register a proposed rule and a notice of availability of a Draft EIS (DEIS) for this action. These disposal site designations are subject to various restrictions designed to support the goal of terminating or reducing the disposal of dredged material into Long Island Sound, as explained below in subsection E. 3 of the Supplementary Information section. EPA has conducted the disposal site designation process consistent with the requirements of the Marine Protection, Research, and Sanctuaries Act (MPRSA), the Clean Water Act (CWA), the National Environmental Policy Act (NEPA), the Coastal Zone Management Act (CZMA), and other relevant statutes and regulations. Under NEPA, federal agencies prepare a public record of decision (ROD) at the time of their decision on any action for which an FEIS has been prepared. This Federal Register notice for the final rule will also serve as EPA's ROD for the site designations. The site designations are intended to be effective for an indefinite period of time. EPA has agreed, however, that use of the sites pursuant to these designations may be suspended or terminated in accordance with the Restrictions included in the final rule. The designation of these two disposal sites does not by itself authorize the disposal of dredged material from any particular dredging project at either site. The designation of the CLIS and WLIS disposal sites simply makes those sites available for use for the dredged material from a specific project if no environmentally preferable, practicable alternative for managing that dredged material exists, and if analysis of the dredged material indicates that it is suitable for open-water disposal. Thus, each proposed dredging project will be evaluated to determine whether there are practicable, environmentally preferable alternatives to open-water disposal. In addition, the dredged material from each proposed disposal project will be subjected to MPRSA and/or CWA sediment testing requirements to determine its suitability for possible open-water disposal at an approved site. Alternatives to open-water disposal that will be considered include upland disposal and beneficial uses such as beach nourishment. If environmentally preferable, practicable disposal alternatives exist, open-water disposal will not be allowed. In addition, the dredged material will undergo physical, chemical, and biological analysis to determine its suitability for open-water disposal. EPA will not approve dredged material for open- water disposal if it determines that the material has the potential to cause unacceptable adverse effects to the marine environment or human health. The review process for proposed disposal projects is discussed in more detail below and in the FEIS. As dredged material disposal sites designated by EPA under the MPRSA, CLIS and WLIS also will be subject to newly developed, detailed management and monitoring protocols to track site conditions and prevent the occurrence of unacceptable adverse effects. These management and monitoring protocols are described in the CLIS and WLIS Site Management and Monitoring Plans (SMMPs), which are incorporated in the FEIS as Appendix J. EPA is authorized to close or limit the use of these sites to further disposal activity if their use causes unacceptable adverse impacts to the marine environment or human health.