Department of Health and Human Services July 2005 – Federal Register Recent Federal Regulation Documents

This notice is to inform interested parties of a clarification made to Services to Unaccompanied Alien Children funding announcement published on Monday, June 17, 2005. The following clarifications should be noted: Section I, Group I, Chart I on Page 32345:

The Office on Women's Health (OWH) is the focal point for women's and girls' health within the OPHS, DHHS. Under the direction of the Deputy Assistant Secretary for Women's Health, OWH works to improve the health of women across the life cycles and increase awareness and understanding of women's health issues. In addition to its central office, OWH has regional offices located throughout the U.S. staffed by a Regional Women's Health Coordinator (RWHC). Chartered by the U.S. Congress in 1950, Girl Scouts of the USA (GSUSA) is a national nonprofit organization dedicated to helping all girls build character and gain skills for success in the real world in an accepting and nurturing environment. GSUSA operates from its national headquarters in New York City along with its 300 local Girl Scout councils or offices, 236,000 troops/groups, and 986,000 adult volunteers. OWH in collaboration with GSUSA is planning to provide grant support for a Steps to Healthier Girls Program. The purpose is to improve the health of diverse girls ages 11 years to 17 years through educational and experiential activities related to physical activity/ fitness, good nutrition and healthy lifestyles consistent with the Steps to a HealthierUS initiative of the DHHS and the Memorandum of Understanding between DHHS and GSUSA. This project is based on the premise that motivating girls and adolescents to learn about and participate in activities that address these three subject areas can have a significant effect on increasing the quality and years of healthy life and on eliminating health disparities. The Steps to Healthier Girls Program will be a collaborative effort among the Regional Women's Health Coordinators (RWHC), GSUSA, and the selected Girl Scout Councils in each of the eight (8) Regions of the DHHS, OPHS, OWH. The Women's Health Coordinators from two Regions (II and III) will provide overall oversight for the grant, and Region III will be the primary contact, while the RWHC's will provide the technical assistance and local oversight of the project at the regional level. The Federal Government will: a. Conduct an orientation meeting for the grantee within the first month of funding. b. Review and resolve requested project modifications. c. Review the design of the Steps to Healthier Girls programs. d. Make site visits to Steps to Healthier Girls program sites. e. Review and resolve all initial, 3 month after award and final progress reports. f. Participate in meetings with grantee and councils.

This interim final rule with comment period implements provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 that require the implementation of a competitive acquisition program for certain Medicare Part B drugs not paid on a cost or prospective payment system basis. Beginning January 1, 2006, physicians will generally be given a choice between obtaining these drugs from vendors selected through a competitive bidding process or directly purchasing these drugs and being paid under the average sales price system.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Objectives: To provide funds to States to create or expand statewide systems change for Family Support. To allow for the award of competitive grants to conduct training, technical assistance, and other activities designed to address the problems that impede the self-sufficiency of individuals with developmental disabilities and families of children with developmental disabilities. This program announcement will provide funds for the development phase of the Family Support Initiative. This is the last program announcement related to statewide systems change begun in 1999. This is not a funding opportunity related to Family Support 360. Eligible States and territorial entities under this announcement are: Alabama, Iowa, California and Puerto Rico. States and territories not listed above are not eligible to apply. I. Funding Opportunity Description

The purpose of these grants is to support a fourth implementation phase of the Consortium for Longitudinal Studies of Child Abuse and Neglect, which is conducting and coordinating prospective studies of young children who are at risk or who have already experienced maltreatment. These studies are expected to contribute to the knowledge of the etiology and consequences of child maltreatment, and provide new insights into the prevention, identification and treatment of maltreatment.

In accordance with section 431 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Public Law 108- 173, this proposed rule would establish regulatory standards for the new safe harbor under the Federal anti-kickback statute for certain goods, items, services, donations, and loans provided by individuals and entities to certain health centers funded under section 330 of the Public Health Service Act. Under this proposed safe harbor, the goods, items, services, donations, or loans must contribute to the health center's ability to maintain or increase the availability, or enhance the quality, of services available to a medically underserved population.

HIV/AIDS surveillance data have been used for describing the epidemic, planning prevention and treatment activities, developing treatment guidelines, advocating for resources, and allocating and prioritizing available resources within communities. The Health Resources Services Administration (HRSA) uses HIV/AIDS surveillance data from states to estimate severity of need to allocate nearly two billion in funding for HIV-related ambulatory care and support services available annually through the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act. A committee from the Institute of Medicine (IOM) recently reviewed, at the request of Congress, the status of HIV/AIDS surveillance. In the resulting report, three populations of interest were outlined; Persons infected with HIV, who do not have a diagnosis of HIV and are not receiving care. Persons infected with HIV, who have a diagnosis of HIV but are not receiving care. Persons infected with HIV, who have a diagnosis of HIV and are receiving care. Understanding how many and which persons in a community have a diagnosis of HIV but are not receiving care is critically important for estimating the community's resource needs. Of the estimated 850,000- 950,000 HIV-infected persons in the United States, an estimated 75 percent know they are infected. Of these, an estimated 50 percent do not have evidence of having received any medical care for their HIV infection. One of the goals of CDC's Advancing HIV Prevention initiative is to provide HIV testing outside of traditional medical settings, and to increase linkage to HIV care for those whose HIV test results are positive. Because of treatment advances, more people with HIV infection are living longer and healthier lives. Persons who know they are infected can benefit from prophylaxis for opportunistic infections, monitoring of their immune status, and, when recommended, treatment with antiretroviral drugs. Additionally, new HIV therapies may reduce the degree of infectiousness by lowering viral load and thereby reducing HIV transmission. Therefore, to determine the extent of medical services and resources that will be needed for persons who are infected with HIV, but who have not received medical care, it is critically important to quantify and describe the number in this population. In addition, determining factors related to not receiving care will be important in designing effective interventions for linking persons to care. A supplemental surveillance system designed to produce population- based estimates of persons who have a diagnosis of HIV and are receiving care has been developed. Federal awards were made to 26 health departments to collect clinical and behavioral data among persons who have a diagnosis of HIV and are receiving care. Supplemental surveillance systems that collect data about those persons infected with HIV who are and are not receiving care will provide critically needed information on the quality of care and severity of need for care; barriers to receiving care; prevention; and support services at the local level. This information will assist local planning groups (i.e., community planning groups and local planning councils) in determining local allocation of CDC and Ryan White CARE Act funds. Additionally, this type of supplemental surveillance data will provide a means of evaluating new prevention initiatives (e.g., Advancing HIV Prevention) that focus on the provision of prevention services and linkage to care for persons living with HIV (PLWHA) infection. I. Funding Opportunity Description