Department of Health and Human Services October 5, 2009 – Federal Register Recent Federal Regulation Documents

This notice announces the award of expansion supplement grants to five grantees under the Family and Youth Services Bureau (FYSB)/ Family Violence Prevention and Services Program. Expansion supplement awards are made to four technical assistance (TA) providers to support their capacity to enhance victim services by providing more extensive TA to local domestic violence programs and State domestic violence coalitions under the Open Doors to Safety: Capacity-Building Grant (Capacity-Building) project. The supplemental funds, coupled with the TA providers' expertise, will enable Open Doors Safety Capacity- Building project grantees to receive more training and site-specific consultation, so that they may build program capacity. The awards will also support State-level collaboration between domestic violence organizations and child welfare agencies. These combined efforts will strengthen the ability of domestic violence programs and their partners to better serve survivors who have diverse backgrounds, experiences, and abilities.

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

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act.'' This guidance is intended for manufacturers, retailers, importers, and FDA staff. The Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), states ``A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).'' The guidance discusses certain activities that FDA believes do or do not fall within the scope of the prohibition. The guidance is not intended to be an exhaustive analysis of all activities that may or may not fall within the scope of the prohibition.