Department of Health and Human Services June 20, 2007 – Federal Register Recent Federal Regulation Documents
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Findings of Research Misconduct
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: Carlos A. Murillo, M.D., University of Texas Medical Branch at Galveston: Based on the report of an inquiry conducted by the University of Texas Medical Branch at Galveston (UTMB) and additional analysis and information obtained by the Office of Research Integrity during its oversight review, the U.S. Public Health Service (PHS) found that Carlos A. Murillo, M.D., former Surgical Resident, Department of Surgery, UTMB, engaged in research misconduct in research supported by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), grants R01 DK48498 and T32 DK07639. Specifically, Dr. Murillo falsified research on the amelioration by antisense RNA (siRNA) of dextran-induced colonic toxicity in mice. He altered the concentrations of dextran solution fed to mice to induce colonic inflammation, by intentionally including little or no dextran in the drinking water of siRNA treated mice, so that the animals that received siRNA would have few or no colonic lesions. Dr. Murillo has entered into a Voluntary Exclusion Agreement (Agreement) in which he has voluntarily agreed, for a period of three (3) years, beginning on May 30, 2007: (1) That any institution that submits an application for PHS support for a research project on which Dr. Murillo's participation is proposed or that uses him in any capacity on PHS support research, or that submits a report of PHS-funded research in which he is involved, must concurrently submit a plan for supervision of his duties to the funding agency for approval; the supervisory plan must be designed to ensure the scientific integrity of Dr. Murillo's research contribution; Dr. Murillo agrees to ensure that a copy of the supervisory plan is also submitted to ORI by the institution and agrees that he will not participate in any PHS-supported research until such a supervision plan is submitted to ORI; (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 a consultant; and (3) to request retraction of the abstract entitled ``Inhibition of Phosphoinositol 3-kinase Using Anti-p85 siRNA Attenuates Dextran- Sulfate-Induced Inflammatory Bowel Disease'' (Gastroenterology 126:A49, 2004), by signing the letter of retraction prepared by ORI attached as Attachment 2 and made part of the Agreement.
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Prospective Grant of Exclusive License: Anti-Mesothelin Antibodies Useful for Immunological Assays
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/681,104, filed May 12, 2005, entitled ``Anti- Mesothelin Antibodies Useful For Immunological Assays'' [E-015-2005/0- US-01] and PCT Application No. PCT/US2006/018502, filed May 11, 2006, entitled ``Anti-Mesothelin Antibodies Useful For Immunological Assays'' [E-015-2005/0-PCT-02] to Cambridge Antibody Technology, Ltd., which has offices in Cambridge, United Kingdom. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the SSIP immunoconjugate and variants thereof for the treatment of mesothelin expressing cancers.
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Privacy Act of 1974: New System of Records
In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to add a new system of records titled, ``Information Center (IC) Integrated Clearinghouse System (IC/ICS),'' System No. 09-15-0067. The HRSA IC/ICS will facilitate the delivery of publications and requested information by members of the general public. The HRSA IC/ICS will also enable HRSA to deliver information efficiently through physical mailings or broadcast e-mail messages to HRSA Grantee organizations and other interested parties.
Reimbursement Rates for Calendar Year 2007
Notice is given that the Director of Indian Health Service (IHS), under the authority of sections 321(a) and 322(b) of the Public Health Service Act (42 U.S.C. 248 and 249(b)), Public Law 83-568 (42 U.S.C. 2001(a)), and the Indian Health Care Improvement Act (25 U.S.C. 1601 et seq.), has approved the following rates for inpatient and outpatient medical care provided by IHS facilities for Calendar Year 2007 for Medicare and Medicaid beneficiaries and beneficiaries of other Federal programs. The Medicare Part A inpatient rates are excluded from the table below as they are paid based on the prospective payment system. Since the inpatient rates set forth below do not include all physician services and practitioner services, additional payment may be available to the extent that those services meet applicable requirements. Public Law 106-554, section 432, dated December 21, 2000, authorized IHS facilities to file Medicare Part B claims with the carrier for payment for physician and certain other practitioner services provided on or after July 1, 2001.
Establishment of the National Biodefense Science Board
The Office of the Secretary announces establishment of the National Biodefense Science Board. The Board will provide expert advice and guidance to the Secretary on scientific, technical and other matters of special interest to the Department of Health and Human Services regarding activities to prevent, prepare for and respond to adverse health effects of public health emergencies resulting from current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. Resumes or curricula vitae from qualified individuals who wish to be considered for membership on the Board are currently being accepted. To Submit a resume or curriculum vitae, send e-mail to nbsbnominations@hhs.gov.
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