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

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Annual Reports for Approved Premarket Approval Applications.'' This draft guidance document outlines the information required by a certain FDA regulation in periodic reports (usually referred to as annual reports) and FDA's recommendations for the level of detail that manufacturers should provide. This draft guidance is not final nor is it in effect at this time.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Please be advised that the Hydroxyurea Expert Panel Roster as published in the Federal Register (Vol. 71, No. 199, pp. 60746-60748) on October 16, 2006 should include Francesco Marchetti, Ph.D., Lawrence Berkeley National Laboratory, Berkeley, CA. Marvin Meistrich, Ph.D. was listed as a panel member, but is not a member of the panel.

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

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and FDA Staff: Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems.'' This draft guidance provides FDA's recommendations concerning portable invasive blood glucose monitoring systems (BGMSs).

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.