Department of Health and Human Services October 25, 2010 – Federal Register Recent Federal Regulation Documents

This notice announces that the Administration for Children and Families (ACF), Administration on Developmental Disabilities (ADD) has awarded three single-source expansion supplements for data collection, analyses, and reporting. The following projects will be funded: The University of Colorado Health Sciences Center, Aurora, CO. This cooperative agreement will allow for data collection, analysis and reporting on spending and services for individuals with intellectual and developmental disabilities, including disaggregation of data related to specific demographic groups. The project will analyze and report on trends in utilization of and spending for institutional services and home and community-based services. Project staff will also participate in collaborative efforts with ADD and other data collection projects to review and report on unmet needs in data collection, analyses, and reporting activities that would promote the self- determination, independence, productivity, and integration and inclusion of people with intellectual and developmental disabilities in all facets of community life. The University of Massachusetts (Institute for Community Inclusion), Boston, MA. This cooperative agreement will provide for data collection and analyses related to the effectiveness of State agencies in promoting community integrated employment for individuals with intellectual and developmental disabilities. The project will collect data, analyze, and report on the employment and economic status of individuals with intellectual and developmental disabilities including disaggregation of data related to specific demographic groups. The project will also make recommendations related to the standardization of data and reporting of employment outcomes. Project staff will also participate in collaborative efforts with ADD and other data collection projects to review and report on unmet needs in data collection, analyses, and reporting activities that would promote the self-determination, independence, productivity, and integration and inclusion of people with intellectual and developmental disabilities in all facets of community life. The University of Minnesota (The Research and Training Center), Minneapolis, MN. This cooperative agreement will provide for data collection, analyses, and reporting of national and State statistics on public and private residential services for individuals with intellectual and developmental disabilities, including disaggregation of data related to specific demographic groups. The project will conduct analyses that describe the movement of individuals with intellectual and developmental disabilities from institutional to community settings. Project staff will also participate in collaborative efforts with ADD and other data collection projects to review and report on unmet needs in data collection, analyses, and reporting activities that would promote the self-determination, independence, productivity, and integration and inclusion of people with intellectual and developmental disabilities in all facets of community life. Contact for Further Information: Ophelia McLain, Supervisory Program Specialist, Administration on Developmental Disabilities, 370 L'Enfant Promenade, SW., Mail Stop: HHH-405D, Washington, DC 20447. Telephone: 202-690-7025 E-mail: ophelia.mclain@acf.hhs.gov.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Qualification Process for Drug Development Tools.'' This draft guidance describes the qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple drug development programs. The draft guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and DDT sponsors to support work towards qualification of an identified DDT and creates a mechanism for formal review of data by CDER to qualify the DDT and ensure that the evaluation is comprehensive and reliable.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on an information request regarding the use of dissolvable tobacco products.