Office of the Secretary 2005 – Federal Register Recent Federal Regulation Documents

Notice is hereby given that the Office of Research Integrity (ORI) and the Acting Assistant Secretary for Health have taken final action in the following case: Xiaowu Li, MD, PhD, The University of California at San Francisco: On September 16, 2005, the U.S. Public Health Service (PHS) entered into a Voluntary Exclusion Agreement with the University of California at San Francisco (UCSF) and Xiaowu Li, MD, PhD, former postdoctoral fellow at UCSF. Based on the UCSF report and additional analysis conducted by ORI in its oversight review, PHS found that Dr. Li engaged in scientific misconduct in reporting research supported by grants P01 DE13904, ``Adhesion and proliferation in oral cancer progression,'' R01 DE12856, ``Oral melanoma alpha v beta 3 expression and metastasis,'' and R01 DE011930, ``Regulatory function of fyn in oral SCC invasion,'' all funded by the National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH). Specifically, PHS found that Dr. Li falsified three images in Figure 5B of a paper, ``Laminin-5 promotes cell motility by regulating the function of the integrin [alpha]6[beta]1 in pancreatic cancer,'' published online in Carcinogenesis Advance Access, reporting studies on the role of integrin [alpha]6[beta]1 and laminin on the invasiveness of pancreatic cancer cells and their ability to metastasize. In all three images, mouse melanoma cells were falsely represented as being human pancreatic carcinoma cells; the cancer cells were falsely represented as having been plated on medium with laminin-1, whereas they were in fact plated on medium with vitronectin; and for two of the three images, the cancer cells were falsely represented as having been stained with anti-integrin [beta]1, whereas they were actually stained with anti-integrin [beta]3. The misconduct was significant because pancreatic cancer has a poor prognosis for patients, since it tends to invade other tissues and to metastasize early in its course. Knowledge of the factors that facilitate cancer cell invasion and metastasis, which was the focus of the questioned figure and paper, is crucial to attempts to develop better treatments for pancreatic and other cancers. Thus, the falsified figure could have misled other investigators in this important area of medical research. Dr. Li has entered into a Voluntary Exclusion Agreement (Agreement) in which he has voluntarily agreed, for a period of three (3) years, beginning on September 16, 2005: (1) To exclude himself 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 referred to as ``covered transactions'' as defined in the debarment regulations at 45 CFR Part 76; and (2) 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.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.

This final rule revises the Department of Homeland Security's procedures for managing classified national security information. This rule implements procedures required under Executive Order 12958, ``Classified National Security Information,'' as amended by Executive Order 13292, and amends the initial procedures established when the Department was created in January 2003. Further, this rule delegates to the Chief Security Officer of the Department of Homeland Security the responsibility of serving as the ``Senior Agency Official'' pursuant to Executive Order 12958, as amended.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Department of Transportation's (DOT) intention to request an extension of a previously approved information collection.

In compliance with the Paperwork Reduction Act of 1995, the Department of the Interior, Office of the Secretary is announcing its intention to request re-approval for the collection of information for the DI-Form 381, Claim for Relocation Payments-Residential and DI-Form 382, Claim for Relocation PaymentsNonresidential.

The Advisory Committee to the National Center for State and Local Law Enforcement Training will meet at the Embassy Suites, 500 Mall Boulevard, Brunswick, GA, on November 2, 2005, beginning at 8 a.m.

The Department of Transportation is directing all interested persons to show cause why it should not issue an order finding MAXjet Airways, Inc., fit, willing, and able, and awarding it a certificate of public convenience and necessity to engage in interstate scheduled air transportation of persons, property and mail.

As required by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Public Law 108-173, this proposed rule would establish a new safe harbor under the Federal anti-kickback statute for certain arrangements involving the provision of electronic prescribing technology. Specifically, the safe harbor would protect certain arrangements involving hospitals, group practices, and prescription drug plan (PDP) sponsors and Medicare Advantage (MA) organizations that provide to specified recipients certain nonmonetary remuneration in the form of hardware, software, or information technology and training services necessary and used solely to receive and transmit electronic prescription drug information. In addition, using our separate legal authority under section 1128B(b)(3)(E) of the Social Security Act (the ``Act''), we are also proposing separate safe harbor protection for certain electronic health records software and directly related training services. These exceptions are consistent with the President's goal of achieving widespread adoption of interoperable electronic health records for the purpose of improving the quality and efficiency of health care, while maintaining the levels of security and privacy that consumers expect.

The Office of the Secretary of Defense proposes to add a system of records to its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

This proposal would amend Department of Transportation regulations implementing the governmentwide nonprocurement suspension and debarment requirements. Specifically, the DOT proposes to adopt the optional lower tier coverage prohibiting excluded parties from participating in subcontracts at tiers lower than the first tier below a covered nonprocurement transaction.

The Department of the Interior (DOI) is issuing public notice of its intent to create a Privacy Act (PA) system of records in its inventory of records systems subject to the Privacy Act of 1974. This action is necessary to meet the requirements of the Privacy Act to publish in the Federal Register notice of the existence and character of records systems maintained by the agency. The new system of records is captioned, ``Interior/DOI-16,'' and is titled, ``DOI LEARN.'' 5 U.S.C. 552a(e)(11) requires that the public be provided a 30-day period in which to comment on the agency's intended use of the information in the system of records. The Office of Management and Budget, in its Circular A-130, requires an additional 10-day period in which to make comments. Any persons interested in commenting on this proposed amendment may do so by submitting comments in writing to the Departmental Privacy Act Officer, U.S. Department of the Interior, Office of the Chief Information Officer, Mail Stop (MS)-5312-Main Interior Building (MIB), 1849 C Street, NW., Washington, DC 20240, (202) 219-0868 or by e-mail to MarilynLegnini@ios.doi.gov. Comments received within 40 days of publication in the Federal Register will be considered. The system will be effective as proposed at the end of the comment period unless comments are received which would require a contrary determination. The Department will publish a revised notice if changes are made based upon a review of comments received.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated 21 July 1996.

The Office of Hearings and Appeals (OHA) is proposing to amend its existing regulations that implement the Equal Access to Justice Act to bring them up to date with amendments to the statute that have been enacted since OHA adopted the existing regulations in 1983.