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

The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for cranial orthosis type devices. These devices are used to improve cranial symmetry in neonates. FDA is publishing this notice in order to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Request for Samples and Protocols'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP BSC is composed of scientists from the public and private sectors and provides primary scientific oversight to the Director for the NTP and evaluates the scientific merit of the NTP's intramural and collaborative programs.

The Translational Research Working Group (TRWG), a broad panel including advocates, researchers from academia, industry representatives, and government officials, was established in early 2005 to evaluate the status of the National Cancer Institute's (NCI) intramural and extramural investment in translational research in order to develop recommendations on ways to coordinate and optimally integrate activities. The TRWG is also charged with developing implementation strategies that will enable the scientific community and NCI leadership to appropriately prioritize its translational research opportunities. Recommendations will be made to the National Cancer Advisory Board in early 2007. To assist in its future planning efforts, the TRWG is asking interested parties for feedback on the seventeen draft initiatives they are proposing. The TRWG compiled these draft initiatives from the comments received during the previous public comment period in early 2006. These draft initiatives address the obstacles to a successful translational research enterprise identified by the TRWG. By listening to interested parties and stakeholders from the wider community, the TRWG hopes to enhance this exciting and important activitycharting the future course of translational progress against cancer.

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Sandia National Laboratories Livermore in Livermore, California, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Sandia National LaboratoriesLivermore in Livermore, California. Locations: Building 913 Room 113, Building 913 Room 128, and Building 941 Room 128. Job Titles and/or Job Duties: All x-ray technologists and materials scientists who worked in the X-ray Diffraction and Fluorescence Laboratory. Period of Employment: December 1967-December 1990.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments,'' dated October 2006. The guidance provides blood and plasma establishments, including licensed blood establishments, unlicensed registered blood establishments, and transfusion services, with the FDA's current thinking related to the biological product deviation reporting requirements. The guidance document will assist blood and plasma establishments in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report. The guidance finalizes the draft guidance document under the same title dated August 2001.

This notice announces an administrative hearing to be held on November 22, 2006, at 26 Federal Plaza, Room 38-110a, New York, NY, 10278, to reconsider CMS' decision to disapprove New York State plan amendment 05-49.