Department of Health and Human Services March 23, 2006 – Federal Register Recent Federal Regulation Documents

The National Centers of Excellence in Women's Health and the National Community Centers of Excellence in Women's Health programs provide funding to academic health centers and community-based organizations to enhance their women's health programs through the integration of these components: (1) Leadership development for women, (2) training for lay, allied health, and professional health care providers, (3) public education and outreach with special emphasis on outreach to minority women, (4) comprehensive health service delivery that includes gender and age-appropriate preventive services and allied health professionals as members of the comprehensive care team, and (5) basic science, clinical and community-based research. In addition, the community centers must replicate their National Community Center of Excellence in Women's Health (CCOE) model in another organization or community.

The Food and Drug Administration (FDA) has determined the regulatory review period for MYCAMINE 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) has determined the regulatory review period for ALAMAST 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.

Briefly provide a statement of the proposed demonstration project indicating that this is a CARE demonstration project and whether it is for a local or statewide project; Type of organization applying (school, state agency, voluntary agency, etc.); Geographic area to be served (urban, rural, suburban); Description of target population to be served; Statement of the program intervention; Brief description of the proposed project. Description of Applicant Organization: Describe the decision-making authority and structure (e.g. relationship to the Board of Directors), its resources, experience, existing program units and/or those to be established if funding is obtained. This description should cover personnel, time and facilities and contain evidence of the organization's capacity to provide the rapid and effective use of resources needed to conduct the project, collect necessary data and evaluate it. Rationale: Describe the rationale for use of the proposed approach based upon previous practice and review of the literature and/ or evaluation findings. Geographic Area: Describe the geographic area to be served. Document the incidence of adolescent pregnancy, and describe economic conditions, income levels, existing services and unmet needs in the proposed service area. Program Outcome Objectives: Provide a clear statement of results or benefits expected that are consistent with the OAPP performance measures. Objectives should be specific, measurable, achievable, realistic, and time-framed. Care Services Demonstration Model: Describe the program, including how services will continue to be provided to clients after the birth of the child to enable parents to acquire good parenting skills and to ensure that their children are developing normally physically, intellectually and emotionally. Describe how the applicant will add care services to supplement existing adolescent health services in a school, hospital or other community setting. Describe how the applicant will provide directly, or by referral, each of the required ten core services and any supplemental services as appropriate. As appropriate, state how the project will be coordinated, integrated and linked to existing services within the service area. Describe case management and follow-up procedures. Describe the population, recruitment methods and selection criteria. Describe how the applicant will as appropriate, involve families, voluntary associations, religious and charitable organizations and other groups in the private sector. Workplan and Timetable: Provide a year long work plan and timetable, which spans at least three years of program implementation. Numbers and Types of Clients: Provide estimates of clients expected to be served during the first year (e.g. adolescent mothers, extended family members, fathers of their children, husbands, and/or male partners with whom they are in a long-term relationship). Documentation of Support: Provide a summary of the views of public agencies, providers of services and the general public in the geographical area to be served. Provide documentation of the support from other community agencies. Continuation Funding: Describe the plan regarding continuation of services at the termination of this Federal funding. Evaluation Plan: The evaluation plan must clearly articulate the program interventions and/or processes to be tested; theory upon which the program intervention is based; proposed questions/hypotheses the evaluation will address; instruments, including information regarding reliability and validity of instruments; sampling plan and data collection schedule; data analysis plan, including statistical tests. Describe how the evaluation is consistent with the program, particularly how data will be used for mid-course corrections and ongoing program improvements. Discuss how the evaluator will ensure confidentiality of the data. Describe the qualitative methodology planned and how it will be integrated with the required quantitative design. Describe how the data will be collected. Appendices: Include articles of incorporation and mission statement for private nonprofit organizations. Resumes of key staff and detailed position descriptions. How the project will obtain parental consent. Letters of commitment and support from other providers. Provide evidence of a working agreements with an evaluator affiliated with a college or university located in the applicant's State. The entities to be involved in the evaluation must be identified, their willingness to participate documented, their role (s) described and their capability documented by an attached curriculum vitae. Provide a copy of the table of contents of the proposed curriculum, plus a list of any other instructional materials that will be an integral part of the proposed project. Applicants must be familiar with Title XX in its entirety to ensure that they have complied with all applicable requirements. A copy of the legislation is included in the application kit. A Dun and Bradstreet Universal Numbering System (DUNS) number is required for all applications for Federal assistance. Organizations should verify that they have a DUNS number or take the steps necessary to obtain one. Instructions for obtaining a DUNS number are included in the application package, and may be downloaded from the OPA Web site.