Department of Health and Human Services May 2006 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC) invites individuals and organizations to nominate public health topic areas or related population-oriented interventions (i.e., interventions delivered to groups of people in communities or healthcare systems) for the Task Force on Community Preventive Services (Task Force) to consider for review. Topics that have been recently reviewed by the Task Force or are currently under review are listed below in the SUPPLEMENTARY INFORMATION section. The Task Force is an independent panel of experts that makes evidence-based recommendations regarding use of population-based interventions, which are selected from broad topic areas. Recommendations are based on the evidence gathered in rigorous and systematic scientific reviews of published studies conducted by Guide to Community Preventive Services (Community Guide) scientific teams. The findings from reviews are published in peer-reviewed journals and made available through the Community Guide Web site (https:// thecommunityguide.org). Community Guide topics coordinate with Healthy People 2010 objectives; address topics related to the large preventable burden of disease; provide guidance on ways to reduce disease, injury, and impairment; and address social challenges. Topics can be nominated by individuals or organizations. The Task Force will consider nominations and prioritize topics for review using the following criteria: Public health importance (burden of disease, injury, impairment, or exposure); preventability (amount of burden that could realistically be reduced given adequate resources); relationship to other public health initiatives; and usefulness of the package of topics selected and level of current research and intervention activity in the public and private sectors. The Task Force will also prioritize topics for which there are gaps in the evidence and the potential to significantly improve public health decisionmaking. Nominations can be for new topics or topics previously reviewed by the Task Force. Basic Topic Nomination Requirements: Nominations must be no more than 250 words long and must include the following information. (A separate appendix, not included in the word count, can contain references and supporting documents.) 1. Name of topic or intervention. 2. Rationale for consideration by the Task Force, to include as appropriate: a. Justification that topic area addresses risk behaviors related to the largest burden of disease; provides guidance on ways to reduce disease, injury, and impairment; or addresses environmental and social challenges. b. Description of public health importance (burden of disease, injury, impairment, or exposure). Citations and supporting documents are recommended. c. Public health relevance (amount of burden that could realistically be reduced given adequate resources). d. Summary of new evidence, if any, that has potential to affect the Task Force's recommendation on a previously reviewed topic. Please refer to https://thecommunityguide.org for current Task Force recommendations. Citations and supporting documents are recommended. e. In topic areas that have already been addressed or identified as high priority by the Task Force, important interventions that have not yet been addressed or where additional new information may lead to updated conclusions can be identified. Please refer to https:// thecommunityguide.org for existing Task Force recommendations. Citations and supporting documents are recommended.

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 Schering-Plough Animal Health Corp. The supplemental NADA provides for revised food safety labeling for trimethoprim and sulfadiazine injectable suspension, administered to horses as a systemic antibacterial.

For more than a quarter century, the NTP testing program has provided extensive and useful scientific information for predicting human health hazards and protecting public health. The NTP periodically conducts reviews of models used in its testing program to critically analyze their predictive power and determine whether study protocols should be altered. As part of this effort, the NTP is convening a workshop titled ``Biomarkers for Toxicology Studies.'' The meeting will be held on September 20-21, 2006, at the NIEHS in Research Triangle Park, NC. The workshop will include plenary sessions and three simultaneous breakout group sessions for in-depth discussion. The workshop's overall goal is to identify biomarkers for carbohydrate/lipid metabolism and lung and cardiac function and then evaluate their utility for inclusion in rodent toxicology studies to better characterize endpoints of environmentally induced diseases or biological processes related to disease etiology. This meeting is open to the public with time set aside for public comments during the plenary session on the first day. The public is invited to attend the breakout groups as observers. A copy of the agenda and any additional information about the workshop, including background materials, public comments, and invited participants, will be posted on the NTP Web site when available (see NTP Web site https://ntp.niehs.nih.gov select ``Calendar of Upcoming Events'').

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.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on Investigational Device Exemptions Reports and Records.

We are proposing to set forth changes to the fee schedule for payment of ambulance services by adopting revised geographic designations for urban and rural areas as set forth in Office of Management and Budget's (OMB) Core-Based Statistical Areas (CBSAs) standard. We propose to remove the definition of Goldsmith modification and reference the most recent version of Goldsmith modification in the definition of rural area. In addition, we propose to add the definition of urban area as defined by OMB and revise our definitions of emergency response, rural area, and specialty care transport (SCT). We also propose to discontinue the annual review of the conversion factor (CF) and of air ambulance rates. We would continue to monitor payment and billing data on an ongoing basis and make adjustments to the CF and to air ambulance rates as appropriate to reflect any significant changes in these data.

This rule adopts as final the provisions in the interim final regulation that published June 1, 2000, which explain the terms and conditions that apply to State grants for counseling and assistance to Medicare beneficiaries, and makes several minor technical clarifications.