Department of Health and Human Services June 2007 – Federal Register Recent Federal Regulation Documents

The Substance Abuse and Mental Health Services Administration (SAMHSA) is committed to preventing the onset and reducing the progression of mental illness, substance abuse, and substance-related problems among all individuals, including youth. As part of this effort, SAMHSA has expanded and refined the agency's National Registry of Evidence-based Programs and Practices (NREPP). Two previous notices announcing these changes have been published in the Federal Register (70 FR 50381, Aug. 26, 2005; 71 FR 13133, Mar. 14, 2006). A third notice announced the first open submission period, October 1, 2006, through February 1, 2007 (71 FR 37590, June 30, 2006). This notice explains how SAMHSA and its three Centers will prioritize interventions submitted for NREPP reviews during fiscal year 2008 and provides guidance on the submission process. This information can be helpful to individuals and organizations seeking to have an intervention reviewed and described on the NREPP Web site.

The Agency for Healthcare Research and Quality (AHRQ) is soliciting the submission of survey instruments and items that could be used to measure the quality of Medicaid home and community-based service (HCBS) programs. Specifically, AHRQ is interested in metrics related to assessing the performance of such programs, client functional outcomes and client experience of, and satisfaction with, Medicaid HCBS services and supports. This initiative is in response to the mandate within the Deficit Reduction Act (DRA) of 2005, Public Law 109-171, Section 6086(b) that AHRQ develop such measures, in consultation with relevant stakeholders. In preparation for this task, AHRQ is conducting an environmental scan of existing tools that could be adapted or used for assessing the quality of Medicaid HCBS services and supports. Based on the agency's initial methodological work, there are several quality domains the resulting measure set could assess, including: timeliness of determining need and providing services and supports, person-centeredness, safety, equity, efficiency and, effectiveness of services and supports, qualifications of providers, client health and welfare, program administrative oversight, access, unmet need among current program participants, and coordination of long-term care services with other service providers. For example, relevant measures might include items from a consumer survey that ask about receipt of services or experience with select providers, or metrics that use program administrative data to determine if providers meet program qualifications or if assessments are done on a timely basis.

The Food and Drug Administration (FDA) has determined the regulatory review period for GEM 21S GROWTH-FACTOR ENHANCED MATRIX 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 medical device.

The Food and Drug Administration (FDA) has determined the regulatory review period for PHAKIC INTRAOCULAR LENSES 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 medical device.

The Food and Drug Administration is announcing that a collection of information entitled ``Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines,'' dated May 2007. The guidance document provides to sponsors of pandemic influenza vaccines guidance on clinical development approaches to facilitate and expedite the licensure of influenza vaccines for the prevention of disease caused by pandemic influenza viruses. The guidance provides recommendations concerning clinical data to support traditional license approval of a biologics license application (BLA), or a BLA using the accelerated approval pathway. The guidance announced in this notice finalizes the draft guidance of the same title dated March 2006.

The U.S. Department of Health and Human Services (HHS) announces the first in a series of three federal advisory committee meetings on the Physical Activity Guidelines for Americans, to be held in Washington, DC. These meeting will be open to the public. The Physical Activity Guidelines Advisory Committee will review existing scientific literature to identify where there is sufficient evidence to develop a comprehensive set of specific physical activity recommendations. The Committee will prepare a report to the Secretary of HHS that documents the scientific background and rationale for the issuance of Physical Activity Guidelines for Americans. The report will also identify areas where further scientific research is needed. HHS will use the Final Report of the Committee to develop Physical Activity Guidelines. The intent is to issue physical activity recommendations for all Americans that will be tailored as necessary for specific subgroups of the population.