Department of Health and Human Services July 6, 2007 – Federal Register Recent Federal Regulation Documents

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.

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). 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 2007 funding for the American Indian/Alaska Native Health Disparities Program (hereafter referred to as the AI/AN Health Disparities Program). OMH is authorized to conduct this program under 42 U.S.C. 300 u-6, section 1707 of the Public Health Service Act, as amended. 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. OMH activities are implemented in an effort to address Healthy People 2010, a comprehensive set of disease prevention and health promotion objectives for the Nation to achieve over the first decade of the 21st century (https://www.healthypeople.gov). This funding announcement is also made in support of the OMH National Partnership for Action initiative. The mission of the National Partnership for Action is to work with individuals and organizations across the country to create a Nation free of health disparities with quality health outcomes for all by achieving the following five objectives: Increasing awareness of health disparities; strengthening leadership at all levels for addressing health disparities; enhancing patient-provider communication; improving cultural and linguistic competency in delivering health services; and better coordinating and utilizing research and outcome evaluations. The AI/AN Health Disparities Program is intended to strengthen the capacity of Tribal Epidemiology Centers (TECs) to collect and manage data more effectively and to better understand and develop the link between public health problems and behavior, socioeconomic conditions, and geography. The establishment of the TECs was authorized by Congress to provide support to tribes in the areas of health data acquisition, analysis, and interpretation. The TECs were identified for this program because they are uniquely positioned to be effective in disease surveillance and control programs, assessing the effectiveness of public health programs and recognizing the significance and complexities of tribal communities, and understand their distinct operating systems. TECs recognize the challenge of adapting their services to geographically isolated communities, whose access to information, technology, data, and manpower varies considerably by tribe. TECs must possess a breadth of knowledge about a multitude of health topics, housing, social and economic issues, and evidence-based methodologies to better inform decision-making and planning. TECs recognize the importance of providing services in a culturally sensitive manner, and understand and appreciate tribal history and customs. Health disparities continue to plague the American Indian and Alaska Native communities. Tribal leaders have discussed with HHS the numerous health issues that affect their communities and the dearth of American Indian and Alaska Native health professionals. According to the Centers for Disease Control and Prevention: Heart disease and cancer are the leading causes of death among American Indians and Alaska Natives; American Indian and Alaska Native adults are 60% more likely to have a stroke than white adults are; American Indians and Alaska Natives have a 40% higher AIDS rate than their non-Hispanic counterparts do; The age-adjusted prevalence of diabetes for American Indians and Alaska Natives is over twice that for all U.S. adults; The infant mortality rate for the American Indian and Alaska Native populations is 1.7 times higher than the non-Hispanic white population; and The sudden infant death syndrome (SIDS) rate is the highest of any population group, more than double that of whites in 1999. However, unlike other ethnic minority groups, American Indians and Alaska Natives frequently contend with issues such as: geographic isolation, inadequate sewage disposal, and occasional conflicts between western medical practices and traditional spiritual beliefs, which prevent them from receiving quality medical care. The American Indian/Alaska Native Health Disparities Program is designed to address these barriers to healthcare as well as concerns raised by Tribal Leaders regarding the lack of American Indian and Alaska Native healthcare professionals, paraprofessionals, and researchers by funding tribal epidemiology centers (TECs). TEC activities include: Data collection; Evaluating existing delivery systems, data systems, and other systems that impact the improvement of American Indian and Alaska Native health; Assisting tribes and urban American Indian and Alaska Native communities in identifying their highest priority health status objectives and the services needed to achieve such objectives, based on epidemiological data; Making recommendations for the targeting of services needed by tribal, urban, and other American Indian and Alaska Native communities; and Making recommendations to improve healthcare delivery systems for American Indians and Alaska Natives. However, the mission of TECs is not limited to epidemiological research. TECs are also responsible for the development and implementation of disease control and prevention programs in addition to the coordination of activities with other public health authorities in the region. Different from other potential grant applicants, TECs are ideally situated to work locally and be responsive to the needs and sensitivities of tribal communities while cultivating close collaborative relationships with State and Federal agencies and academic departments. Because of this potential to serve as a bridge between the American Indian and Alaska Native communities and institutions of higher learning, TECs are excellent vehicles for: Providing research internships and opportunities to current and future American Indian and Alaska Native health professionals; Increasing awareness within the American Indian and Alaska Native populations of the need for healthcare professionals; Disseminating information about educational opportunities in the healthcare field; and Working cooperatively with tribal providers of health and social services in order to avoid duplication of existing services. In FY 2007 the AI/AN Health Disparities Program will support projects that enhance the TECs' capacity to carry out disease surveillance, including the interpretation and dissemination of surveillance data; address vital statistics needs; conduct epidemiologic analysis; investigate disease outbreaks; develop disease control and prevention strategies and programs; and/or coordinate with other health agencies in the region. In addition, to building their data capacity, TECs may form collaborative partnerships and alliances to improve access to quality health and human services, and/or design programs to increase the number of American Indians and Alaska Natives serving as health professionals, para-professionals, and researchers. OMH recognizes the importance of optimizing the use of Federal resources and makes this announcement with the expectation of coordinating its efforts under this program with other HHS agencies that support the TECs (e.g., AHRQ, CDC, IHS, NIH) to ensure that activities are complementary and not duplicative.

The Food and Drug Administration (FDA) is announcing the increased fees the agency will assess for inspections of mammography facilities starting October 1, 2007. The Mammography Quality Standards Act of 1992 (the MQSA) requires FDA to assess and collect fees from mammography facilities to cover the costs of annual inspections required by the MQSA. Because these costs have increased, FDA is raising the fees to ensure the program is able to meet its objective of ensuring that high quality mammography remains available to women. This document explains which facilities are subject to payment of inspection fees, provides information on the costs included in developing inspection fees, and provides information on the inspection billing and collection processes.