Department of Health and Human Services October 2007 – Federal Register Recent Federal Regulation Documents

This notice announces the tenth meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the 13th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the renewal of the generic information collection project: ``Voluntary Customer Surveys Generic Clearance for the Agency for Healthcare Research and Quality'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on August 3, 2007 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

Pursuant to Public Law 92-463, the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the thirteenth meeting of the Advisory Committee on Organ Transplantation (ACOT), Department of Health and Human Services (HHS). The meeting will be held from approximately 9 a.m. to 5:30 p.m. on November 15, 2007, and from 9 a.m. to 3 p.m. on November 16, 2007, at the Crowne Plaza Hotel Washington, DCSilver Spring, 8777 Georgia Avenue, Silver Spring, MD 20910. The meeting will be open to the public; however, seating is limited and pre-registration is encouraged (see below).

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 (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in: HHS Ref. No. E-321-2007 ``Second Generation Improved Spiral Tube Support for Countercurrent Chromatography'' to CC Biotech LLC, a company incorporated under the laws of the State of Maryland having its headquarters in Rockville, Maryland. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to devices and components for centrifugal or countercurrent chromatographic purification, isolation, or preparation of biomolecules and macromolecules.

The Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB), herein announces the awarding of fifty supplemental awards in the amount of $5,733,115 to Fiscal Year (FY) 2006 Mentoring of Children of Prisoners (MCP) grantees. Section 439 of the Social Security Act, as amended by the Child and Family Services Improvement Act of 2006 (Pub. L. 109-288) authorizes the Secretary of Health and Human Services (HHS) to award grants for the purpose of supporting the establishment or expansion and operation of community-based programs to provide one-on-one mentoring relationships between a child of incarcerated parent(s) and a caring, supportive adult mentor under the Mentoring Children of Prisoners Program (MCP). The program is designed to reach the President's goal of establishing 100,000 mentor/mentee relationships between a caring adult and a young person whose parent(s) is incarcerated in a correctional facility by the end of FY 2008. This funding is requested for those grantees that have demonstrated the capacity to make quality matches and currently making significant process in reaching their match goal. One-third of the grantees have made over 50% of their three-year match goal within their first year. The fifty supplemental awards are important to helping our grantees reach more youth who are in need of a mentor. The following agencies are receiving grant funds for a twelve month project period:

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) announces the approval of a deviation to supplement the National Runaway Switchboard for the purpose of expanding their services. Congress authorized the establishment of a ``national communications system to assist runaway and homeless youth in making contact with their families and service providers'' through the Runaway and Homeless Youth Act (RHYA) of the Juvenile Justice and Delinquency Prevention Act of 1974, as amended. Funding for the system was first authorized in fiscal year 1980. (The system currently is authorized through Part C, section 331, of the ``Runaway, Homeless, and Missing Children Protection Act,'' Pub. L. 108-96.) The Administration on Children, Youth and Families, Family and Youth Services Bureau (FYSB), herein announces an expansion supplement award to the National Runaway Switchboard (NRS) for two initiatives; a comprehensive research project on runaway and at-risk youth and a comprehensive database conversion. The results of the comprehensive research project will enable NRS to better understand how to communicate with youth and develop strategies to connect with them and them with the NRS. The comprehensive database conversion will enhance the Switchboard's capability to download and manage information. This project will provide the NRS with the internal controls necessary to query and analyze data collected in their crisis logs. It is anticipated that the enhanced internal controls will result in a significant improvement in the way needs of runaway, homeless and other youth in at-risk situations are met. This expansion supplement is for a nine month project period for the amount of $162,637.

The Food and Drug Administration (FDA) is announcing the Web location where it will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA is establishing a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.

This document corrects technical errors that appeared in the final rule with comment period entitled ``Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2008 Rates'' that appeared in the August 22, 2007 Federal Register.

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: Jon Sudb[oslash], D.D.S., Norwegian Radium Hospital: Based on the findings of an investigation conducted by the Investigation Commission appointed by Norwegian Radium Hospital (NRH) and the University of Oslo, the respondent's own admission, 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 Jon Sudb[oslash], D.D.S., former doctoral student and faculty member, University of Oslo, and former physician in the Department of Medical Oncology and Radiotherapy, NRH, engaged in scientific misconduct by reporting fabricated and/or falsified research in grant application 1 P01 CA106451-01 submitted to the National Cancer Institute (NCI), National Institutes of Health (NIH), and its first-year progress report. Specifically, PHS found that Dr. Sudb[oslash] engaged in scientific misconduct by falsifying and fabricating research that served as the rationale for Project 1, ``Oral Cancer Prevention with Molecular Targeting Therapy,'' with Dr. Jon Sudb[oslash], as project leader, in the grant application, and by falsifying a progress report for the awarded grant. In particular, in Figure 1 of the Background and Significance section of the grant application, Dr. Sudb[oslash] reported fabricated/falsified results for the effects of lesion ploidy upon survival in patients with oral pre-malignant lesions. In the Preliminary Data section of the grant application, Dr. Sudb[oslash] reported several events intended to demonstrate his experience in the research field that the Investigation Commission stated ``appear as pure fiction.'' Also, in the first yearly progress report for the funded grant, Dr. Sudb[oslash] falsified the number of patients that had been screened for admission to the study. In addition to three publications for which Dr. Sudb[oslash] admitted falsifying and/or fabricating data, the Investigation Commission found at least twelve other publications that warranted retraction because they could not be considered valid. The research reported in these publications was not supported by PHS funds. However, the publications address the same general research area as that addressed in the grant application and demonstrate a pervasive pattern of falsification/fabrication in research reporting on the part of Dr. Sudb[oslash]. The falsified/fabricated data presented in the grant application purport to demonstrate the feasibility of preventing cancer in a high risk population with nontoxic oral agents. Dr. Sudb[oslash] has entered into a Voluntary Exclusion Agreement (Agreement) in which he has voluntarily agreed, beginning on August 31, 2007: (1) To exclude himself permanently 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 delineated in the OMB Guidelines to Agencies on Governmentwide Debarment and Suspension at 2 CFR Part 376, et seq.; Dr. Sudb[oslash] agrees that he will not petition HHS to reverse or reduce the scope of the permanent voluntary exclusion or other administrative actions that are the subject of this Agreement; and (2) To exclude himself permanently 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 or contractor to PHS.

The Office of Population Affairs, OPHS, HHS published a notice in the Federal Register of Monday, June 11, 2007 announcing the anticipated availability of funds for family planning services grants. On July 13, 2007, the Notice was corrected to reflect the availability of Arizona, Navajo Nation for competition. Since that time, an additional State/population/area to be served has become available for competition. This Notice reflects the availability of Illinois, Chicago area for competition.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for an increased level of monensin in four-way combination Type C medicated feeds containing ractopamine, melengestrol, monensin, and tylosin for heifers fed in confinement for slaughter, a revision to bacterial pathogen nomenclature, and an increase in liver tolerance.