Department of Health and Human Services September 25, 2006 – Federal Register Recent Federal Regulation Documents

The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of instruments or items that measure perceptions of patients and their informal caregivers regarding the quality of home health care these patients received from home health providers, health plans, other health care providers, stakeholders, vendors, researchers who include home health care as part of their research, and other interested parties. This initiative is in response to the need to develop a new CAHPs[reg] home health care survey. The Centers for Medicare & Medicaid Services is interested in incorporating this survey as part of its Home Health Quality Initiative which is intended to empower consumers with quality of care information to make more informed decisions about their health care while also encouraging Medicare certified home health agencies to improve the quality of care they deliver to all patients regardless of payer source. The survey is likely to assess the quality of care and services provided by nurses, therapists, home heath aides, medical social workers, and home health agency administrative staff. Based on the agency's prior consumer assessment of health care work, there are several functional areas that this instrument could assess such as: Communication; courtesy and respect; information provided and shared decision making; coordination/integration of care; time related issues (e.g., arrived and departed according to schedule, amount of time spent, visit frequency); competence: influence/control over care giver activities; unmet need issues, and customer service.

The Food and Drug Administration (FDA or we) is proposing to amend certain classification regulations to reflect the termination of certain device exemptions and the requirement to submit validation data for specific reprocessed single-use devices (SUDs), as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). This proposed rule is a companion document to a direct final rule published elsewhere in this issue of the Federal Register. This proposed rule will provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This proposed rule would codify actions taken in previous Federal Register notices in accordance with MDUFMA.

The Food and Drug Administration (FDA) has determined the regulatory review period for CLOLAR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.