Department of Health and Human Services June 13, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for RESTYLANE 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 Administration for Native Americans (ANA) herein announces a Program Expansion Supplement to the Red Lake Band of Chippewa Indians, Red Lake, Minnesota. This supplement for $136,400 will extend funding for 11 youth volunteers through the second year of the project. In FY 2005, ANA provided an urgent grant award to the Tribe to assist in mitigating the effects of the tragic events of the school shooting in March 2005 that resulted in the death of students, faculty and staff. The shooting marked the highest death toll in U.S. school shootings since the Columbine High School massacre in April 1999. Due to the devastation created by the high school shooting, ANA is providing urgent financial assistance for minor renovations to the local community centers to support positive community development; funding to hire 11 volunteers to assist youth and members of the community in coping with this event; and building support systems, which will aid in preventing future tragedies.

The Food and Drug Administration (FDA) has determined the regulatory review period for LUVERIS 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.

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 Institute of Child Health and Human Development (NICHD), 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.

The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comment on a draft report on policy issues raised by the prospect of the U.S. undertaking a large population cohort project for the study of genes, environment, and disease. A copy of the report, ``Policy Issues Associated with Undertaking a Large U.S. Population Cohort Project on Genes, Environment, and Disease,'' is available electronically at https:// www4.od.nih.gov/oba/ sacghs/publiccomments.htm. A copy may also be obtained from the National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) by e-mailing Ms. Amita Mehrotra at mehrotraa@od.nih.gov or calling 301-496-9838.

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

This notice announces the sixth meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, U.S.C., App.).