Department of Health and Human Services March 27, 2008 – Federal Register Recent Federal Regulation Documents

In accordance with the Privacy Act of 1974, we are proposing to revise the new Privacy Act System of Records (SOR) entitled, ``The National Disaster Medical System (NDMS) Patient Treatment and Tracking Records System,'' System Number 09-90-0040, in response to public comments received. The primary purpose of the NDMS Patient Treatment and Tracking Records System is to collect and store data about individuals who are served by the medical care response capabilities provided by the Department of Health and Human Services (HHS) through the NDMS, and through other HHS medical personnel. The proposed system will cover the collection, storage and sharing of personally identifiable data in accordance with the Privacy Act.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Coronary Drug Eluting StentsNonclinical and Clinical Studies.'' This draft guidance is intended to provide recommendations to sponsors or applicants planning to develop, or to submit to FDA, a marketing application for a coronary drug eluting stent (DES). The draft guidance discusses the clinical studies that should be performed and the data that should be submitted to support such an application. The draft guidance is being issued in two parts. The companion document provides additional and more detailed guidance on some of the recommendations included in this document. The companion document is intended to be used together with this draft guidance.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (0MB) approve the proposed information collection project: ``Health Care Systems for Tracking Colorectal Cancer Screening Tests.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.