Department of Health and Human Services March 15, 2006 – Federal Register Recent Federal Regulation Documents

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following: Availability of opportunity for the public to enter into a Cooperative Research and Development Agreement (CRADA) to reduce noise emissions from powered hand tools. Notice: This notice invites manufacturers of electric and pneumatic-powered hand tools to enter into a cooperative research and development agreement (CRADA) with NIOSH and some of the leading technical experts on noise control engineering in the United States to reduce noise emissions from powered hand tools. By reducing the noise emissions of electric and pneumatic powered hand tools, the risk of noise-induced hearing loss among construction workers may be lowered. Additional efficiency in tool performance may also be realized as tool designs are optimized to reduce vibration and noise emissions. This effort will identify sources of noise emissions in powered hand tools and will investigate ways to reduce the noise emissions through engineering noise control. NIOSH has successfully worked with university partners to analyze several classes of tools (e.g. table saws, pneumatic nail guns, and air compressors) and demonstrated that significant reductions in noise levels can be achieved through application of noise control engineering. Furthermore, NIOSH expects to partner with academic programs that have advanced technical expertise, acoustic test facilities and specialized equipment, software and data analysis necessary for such an effort. NIOSH is seeking an industrial partner in a CRADA so that particular problems of interest can be targeted for investigation. The industry partners will provide power tools for investigation of noise source identification, product life cycle testing of new designs, and nominal funding of $50,000 to defray expenses in the effort. NIOSH expects to provide up to $50,000 per year over a three-year CRADA agreement. The CRADA defines the role of the various partners regarding intellectual rights, publications, and the material and financial resources that are exchanged during the period of the agreement. At this time, this announcement seeks to identify potential partners in the effort. Detailed development of the CRADA will occur over the next eight months, with the partnership beginning in October 2006. This announcement does not obligate NIOSH to enter into an agreement with any respondent. NIOSH reserves the right to establish a partnership based on engineering analysis and capabilities found by way of this announcement or other searches, if determined to be in the best interest of the government.

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

Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2) notice is hereby given that the President's Committee for People with Intellectual Disabilities will hold its first quarterly meeting of 2006 by telephone conference call. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, assistive listening devices, or materials in alternative format, should inform Ericka Alston, Executive Assistant, PCPID, Telephone202-619-0634, Fax202-205-9519, E-mail: ealston@acf.hhs.gov, no later than March 10, 2006. Efforts will be made to meet special requests received after that date, but availability of special needs accommodations to respond to these requests cannot be guaranteed.

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