April 2011 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Junghee J. Shin, PhD, New York Medical College: Based on the report of an investigation conducted by New York Medical College (NYMC) and additional analysis by the Office of Research Integrity (ORI) in its oversight review, the U.S. Public Health Service (PHS) found that Junghee J. Shin, PhD, former graduate student, NYMC, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants R01 AI048856 and R01 AI043063. PHS found that the Respondent engaged in research misconduct by falsifying data in Figure 4 of a manuscript submitted to the journal Infection and Immunity (Shin, J.J., Godfrey, H.P., & Cabello, F.C. ``Expression and localization of BmpC in Borrelia burgdorferi after growth under various environmental conditions.'' Submitted to Infection and Immunity; hereafter referred to as the ``manuscript'') and Figure 5 of a paper published in Infection and Immunity (Shin, J.J. Bryksin, A.V., Godfrey, H.P., & Cabello, F.C. ``Localization of BmpA on the exposed outer membrane of Borrelia burgdorferi by monospecific anti- recombinant BmpA rabbit antibodies.'' Infection and Immunity 72(4):2280-2287, April 2004; hereafter referred to as the ``paper.'' Retracted in: Infection and Immunity 76(10):4792, October 2008). Specifically, NYMC and ORI found that: Dr. Shin falsified microscopic immunofluorescence blank images in Figure 4 of the manuscript (top row, 1st, 2nd, 4th, and 5th panels, and bottom row, 1st panel) and Figure 5 of the paper (top row, 1st and 5th panels, lower 1st panel) by using one blank image from an unknown experiment to falsely represent the preimmunization control conditions (intact cells and methanol fixation) as well as the negative staining of anti-BmpC and anti-FlaB in Figure 4 and anti-FlaB in Figure 5 on intact cells. Dr. Shin falsified at least one of two images in Figure 4 of the manuscript and Figure 5 of the paper by using different portions of a green-red pair of microscopic immunofluorescence images (1230036.tif and 1230037.tif) because unfixed cells staining positive for BmpA in the top row, 4th panel, of Figure 5 were the same unfixed cells purportedly positive for OspA in the top row, 3rd panel, of Figure 4. Dr. Shin falsified at least one of two images in Figure 4 of the manuscript and Figure 5 of the paper by using different photo cropping from a single microscopic immunofluorescence image (1230039.tif) to represent fixed cells positive for BmpA and labeled with anti-FlaB in the lower row, 5th panel, of Figure 5 and to also represent fixed cells positive for BmpC and stained with anti-FlaB in the lower row, 5th panel, of Figure 4. Dr. Shin has entered into a Voluntary Settlement Agreement in which she has voluntarily agreed, for a period of three (3) years, beginning on April 5, 2011: (1) That any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or that uses her in any capacity on PHS-supported research, or that submits a report of PHS-funded research in which she is involved, must concurrently submit a plan for supervision of her duties to ORI for approval; the supervisory plan must be designed to ensure the scientific integrity of her research contribution; Respondent agrees that she will not participate in any PHS-supported research until such a supervision plan is submitted to ORI; and (2) to exclude herself voluntarily from service 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.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Vipul Bhrigu, PhD, University of Michigan Medical School: Based on the findings of an investigation by the University of Michigan Medical School (UMMS) and additional analysis conducted by the Office of Research Integrity (ORI) during its oversight review, ORI found that Vipul Bhrigu, PhD, former postdoctoral fellow, Department of Internal Medicine, UMMS, engaged in research misconduct in research funded by National Cancer Institute (NCI), National Institutes of Health (NIH), grant R01 CA098730-05. Specifically, ORI found that the Respondent knowingly and intentionally tampered with research materials related to five (5) immunoprecipitation/Western blot experiments and switched the labels on four (4) cell culture dishes for cells used in the same type of experiments to cause false results to be reported in the research record. ORI also found that the Respondent tampered with laboratory research materials by adding ethanol to his colleague's cell culture media, with the deliberate intent to effectuate the death of growing cells, which caused false results to be reported in the research record. ORI has concluded that these acts seriously deviated from those that are commonly accepted within the scientific community for proposing, conducting, and/or reporting research. ORI found that the Respondent's intentional tampering of his colleague's laboratory research constitutes research misconduct as defined by 42 CFR part 93. ORI determined that the Respondent engaged in a pattern of dishonest conduct through the commission of multiple acts of data falsification. ORI also determined that the subterfuge in which he freely engaged for several months constitutes an aggravating factor. The Respondent attempted to mislead the University of Michigan (UM) police by initially denying involvement in the tampering and refusing to accept responsibility for this misconduct. The Respondent eventually made an admission only after the UM police informed him that his actions in the laboratory had been videotaped. This dishonest conduct established the Respondent's lack of present responsibility to be a steward of Federal funds (2 CFR 376 et seq.; 42 CFR 93.408). The following administrative actions have been implemented for a period of three (3) years, beginning on April 7, 2011: (1) Dr. Bhrigu is debarred from eligibility for any contracting or subcontracting with any agency of the United States Government and from eligibility for, or involvement in, nonprocurement programs of the United States Government, referred to as ``covered transactions,'' pursuant to HHS' Implementation of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension (2 CFR 376 et seq.); and (2) Dr. Bhrigu is prohibited from serving in any advisory capacity to the U.S. Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.

This notice announces the availability of the Toxicological Profile for Uranium (Update) for review and comment. These comments can include additional information or reports on studies about the health effects of uranium. Although ATSDR considered key studies for uranium during the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data. ATSDR will evaluate the quality and relevance of such data or studies for possible addition to the profile. ATSDR remains committed to providing a public comment period for this document as a means to best serve public health and our clients. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Sec. 104(i)(3), [42 U.S.C. 9604(i)(3)], directs the ATSDR administrator to prepare toxicological profiles of priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile.

We, the Office of Surface Mining Reclamation and Enforcement (OSM), are announcing receipt of a proposed amendment to the Oklahoma regulatory program under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Oklahoma proposes revisions to its program by adding size limitations for permanent impoundments; adding slope limitations affecting post-mine contours; adding a subsidence allegation reporting requirement; and adding a requirement for bond calculation at renewal. Oklahoma is proposing these additions to its program at its own initiative. This document provides the times and locations that the Oklahoma program and proposed amendment to that program are available for public inspection, the comment period during which you may submit written comments on the amendment, and the procedures that we will follow for the public hearing, if one is requested.

Pursuant to the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)), the National Park Service (NPS) is preparing an Environmental Impact Statement for the Backcountry Management Plan for Grand Canyon National Park. This plan will help guide park decisions on protecting natural and cultural resources while providing for a variety of visitor opportunities to experience the park's backcountry. Over 94% of the park has been proposed as wilderness, and an updated plan is needed to comply with NPS wilderness policy and other policies. A range of reasonable alternatives for managing the park's backcountry will be developed, with public input, through this planning process and will include, at a minimum, a no-action and an agency preferred alternative. Major issues the plan will address include visitor access and use of the park's backcountry, levels of commercial services, levels of administrative and scientific research activities, management of natural and cultural resources, and the protection of wilderness character. The National Park Service will identify additional issues to be addressed through public scoping. A scoping newsletter is being prepared that details the issues identified to date. Copies of that information will be made available on NPS Planning, Environment, and Public Comment (PEPC) at https:// parkplanning.nps.gov/grca.

This final rule amends the Legal Services Corporation's regulation on fee-generating cases to clarify that it applies only to LSC and private non-LSC funds.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of North Carolina (FEMA-1969-DR), dated 04/19/2011. Incident: Severe Storms, Tornadoes and Flooding. Incident Period: 04/16/2011. Effective Date: 04/19/2011. Physical Loan Application Deadline Date: 06/20/2011. Economic Injury (EIDL) Loan Application Deadline Date: 01/19/2012.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). The IRS is soliciting comments concerning information collection requirements related to Sale of Residence From Qualified Personal Residence Trust.

This notice amends the notice of a major disaster declaration for the State of New Mexico (FEMA-1962-DR), dated March 24, 2011, and related determinations.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on March 21, 2011, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Creative Kingdoms, LLC of Wakefield, Rhode Island and New Kingdoms, LLC of Nehalem, Oregon. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain video game systems and wireless controllers and components thereof by reason of infringement of certain claims of U.S. Patent No. 7,500,917 (``the '917 patent''); U.S. Patent No. 6,761,637 (``the '637 patent''); U.S. Patent No. 7,850,527 (``the '527 patent''); and U.S. Patent No. 7,896,742 (``the '742 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainants request that the Commission institute an investigation and, after the investigation, issue an exclusion order and a cease and desist order.

This notice amends the notice of a major disaster declaration for the State of Oregon (FEMA-1964-DR), dated March 25, 2011, and related determinations.

Under the Pre-Disaster Mitigation (PDM) Program and the Hazard Mitigation Grant Program (HMGP), the Federal Emergency Management Agency (FEMA) may provide funding to eligible applicants for eligible, feasible, and cost-effective activities that have the purpose of reducing or eliminating risks to life and property from hazards and their effects. One such activity is the construction and installation of safe rooms to protect populations from extreme wind events (e.g., hurricane, tornado). FEMA has prepared a draft Programmatic Environmental Assessment (PEA) to address the potential impacts to the human environment resulting from the installation and construction of safe rooms. The purpose of the PEA is to facilitate FEMA's compliance with the National Environmental Policy Act (NEPA) by providing a framework to address the potential environmental impacts of this project type.

The FHWA, on behalf of Caltrans, is issuing this notice to announce actions taken by Caltrans that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed highway project, State Route 60 (PM R23.87/R24.48) Westbound On-Ramp at Grand Avenue project in the County of Los Angeles, State of California. Those actions grant licenses, permits, and approvals for the project.

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to revise the definition of multiple-award contract.