Department of Health and Human Services June 14, 2006 – Federal Register Recent Federal Regulation Documents

This announcement is made by the United States Department of Health and Human Services (HHS or Department), Office of Minority Health (OMH) located within the Office of Public Health and Science (OPHS), and working in a ``One-Department'' approach collaboratively with participating HHS agencies and programs (entities). The mission of the OMH is to improve the health of racial and ethnic minority populations through the development of policies and programs that address disparities and gaps. OMH serves as the focal point in the HHS for leadership, policy development and coordination, service demonstrations, information exchange, coalition and partnership building, and related efforts to address the health needs of racial and ethnic minorities. This announcement supports the Healthy People 2010 overarching goal to eliminate health disparities. As part of a continuing HHS effort to improve the health and well being of racial and ethnic minorities, the Department announces availability of FY 2006 funding for the Mississippi Institute for Improvement of Geographic Minority Health and Health Disparities Program. Despite significant improvements in the overall health status of the nation over the past decades, disparities in health status continue to persist among racial and ethnic minority and disadvantaged populations. Such disparities are clearly illustrated by health status statistics in southern areas of the United States. Mississippi serves as an important pilot location for the development of a geographic and minority health disparities model for the nation. Mississippi has a population of 2.8 million, 37 percent of whom are African American, and 51percent of whom live in rural areas. It is the fourth most rural state in the nation, and is ranked 31st in terms of population size. The significant disease burden of the state is well documented. It ranks first of all states and the District of Columbia in mortality rates due to cardiovascular disease (30 percent higher than the national average). In 1996, the cardiovascular disease-related death rate for African Americans in the state was 37 percent greater than for whites, and 60 percent greater than the overall national rate. Stroke mortality, the third leading cause of death in Mississippi, is 18 percent higher than the rate for the U.S. as a whole. It has the highest prevalence of diabetes and obesity in the nation; approximately 9 percent of the state's adult population are diabetic and 55 percent are obese. Mississippi ranks 5th highest overall in cancer mortality rates among the 50 states and the District of Columbia. African Americans make up more than 75 percent of the state's reported new AIDS cases. Premature death rates are almost 2 times greater for American Indians and 1.5 times greater for African Americans than whites. The infant mortality rate in a number of counties along the Mississippi Delta is three times that of the national average. Mississippi has many challenges affecting access to medical care. Almost one-quarter of the state's population, aged 18 to 64, report having no health insurance; higher than the 15.7 percent of people nationally without health insurance in 2004, according to the U.S. Census. Other reasons for insufficient access include the state's ratio of medical doctors to its general population, which is about half the national average, and the large percentage of rural, sparsely-populated areas within the state. Access to health care and delivery of services to a sizeable population in Mississippi, already inadequate, have been further impacted by the devastation caused by last year's hurricanes. The Gulf Coast of Mississippi suffered massive damage from the impact of Hurricane Katrina on August 29, 2005, leaving 236 people dead, 67 missing, and an estimated $125 billion in damages. Mississippi's healthcare system has been seriously disrupted, resulting in new health problems for people living in affected areas. The grant will provide an opportunity to address these health problems and to aid in restructuring the healthcare system.

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 Food and Drug Administration (FDA) has determined the regulatory review period for DUTASTERIDE 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 that claims that human drug product.

The Food and Drug Administration (FDA) does not intend to further delay the effective date of certain provisions of the final regulation published in the Federal Register of December 3, 1999 (64 FR 67720). The provisions will therefore go into effect on December 1, 2006. In addition, FDA is announcing the availability of a new compliance policy guide (CPG) 160.900 entitled ``Prescription Drug Marketing Act Pedigree Requirements Under 21 CFR Part 203'' for public comment. This CPG describes how the agency intends to prioritize its enforcement efforts during the next year with respect to pedigree requirements set forth in the Federal Food, Drug, and Cosmetic Act (the act) and certain FDA regulations.