Department of Health and Human Services April 14, 2009 – Federal Register Recent Federal Regulation Documents

The Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) (a) provide notice of the third meeting of the Dietary Guidelines Advisory Committee, and (b) solicit written comments pertinent to a review of the Dietary Guidelines for Americans.

For many decades, the pediatric medical community, the public health community, and government agencies have recognized a range of questions regarding the use of therapeutics in children, including the shortage of clinical studies of drugs in children resulting in inadequate labeling for pediatric use. The lack of appropriate labeling results in off-label use of prescription drugs in many children and for many conditions. Contributing factors to this frequent off-label use of drugs in pediatrics include the rarity of some conditions in children with limited patient availability, the ethical concerns regarding the conduct of clinical trials in children, the lack of accurate information about which drugs are used by children, and the lack of long-term data on the medications that are frequently used.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of Federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Health Resources and Services Administration (HRSA) is issuing a temporary non-competitive replacement award to the National Jewish Hospital and Research Center to avoid disruption and continue outreach, medical screening and referral services to former uranium mine workers and individuals in the states of Colorado, Wyoming and portions of Southeastern Utah exposed to radioactive fallout during prior testing of nuclear weapons.