Department of Health and Human Services April 18, 2007 – Federal Register Recent Federal Regulation Documents
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Advancing System Improvements to Support Targets for Healthy People 2010 (ASIST2010)
The DHHS Office on Women's Health (OWH) was established in 1991 to improve the health and well being of all women and girls in the United States (US). To achieve this long-term goal, the OWH focuses on reducing the health differences (disparities) between women and men, between girls and boys, and among populations of women by supporting programs such as the 48 Multidisciplinary Health Models for Women sites throughout the U.S. Each site has implemented its own paradigm and blend of services to fit the needs of its community. The National Centers of Excellence in Women's Health (CoEs), National Community Centers of Excellence in Women's Health (CCOEs), and the CoE- and CCOE- Ambassadors for Change (AFCs), in particular, have served as leaders and change agents in the area of women's health. Their pioneering efforts have led to changes in the way women's health services are delivered, changes in women's health curricula, acceptance of community health workers and allied health professionals as key members of the care delivery team, development of leadership and empowerment programs for women, and much more. These programs have also demonstrated that, on a local level, the formation of collaborative partnerships across schools, clinics, and disciplines within the academic community, and among community-based organizations with similar missions, leads to broader outreach, the delivery of more counseling and preventive services, improved access to more comprehensive services, and greater patient satisfaction. More information about these programs can be found at https://www.womenshealth.gov/owh/multidisciplinary/. A recent literature review commissioned by the OWH (Literature Review on Effective Sex- and Gender-Based Systems/Models of Care, 2007, also available at (https://www.womenshealth.gov/owh/multidisciplinary/ reports/GenderBasedMedicine/) to help guide the development of this RFA, reports that the comprehensive, integrated, multidisciplinary models of women's health care, first implemented by OWH about a decade ago, have helped to raise awareness of women's health issues and have helped to establish women's health as a discipline. A recommendation made was that it is time for OWH to move to a broader sex- and gender- based approach to health care, building on the success of its comprehensive, integrated, multidisciplinary models programs. The literature review addressed several broad questions and contains interesting and useful information on a variety of topics relevant to this RFA. The information on sex and gender \1\ differences in the current healthcare system, the effectiveness of sex- and gender-based healthcare practices, the effectiveness of a sex- and gender-based focus on clinical care, and the effectiveness of patient advocates/ navigators in getting men into the healthcare system and to needed care may be useful background information for applicants.
Meeting of the Advisory Committee on Blood Safety and Availability
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public on both Thursday, May 10 and Friday, May 11, 2007.
Memorandum of Understanding Between the National Cancer Institute and the Food and Drug Administration
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the National Cancer Institute (NCI), part of the National Institutes of Health (NIH) of the Department of Health and Human Services (DHHS). The purpose of this MOU is to establish a formal collaboration between FDA and NCI regarding the creation of a common standards-based data repository to facilitate the electronic exchange and analysis of data from research studies on investigational drugs in a fully secure manner.
Medical Device User Fee and Modernization Act; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting to discuss our proposed recommendations for the reauthorization of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA I) for fiscal years (FY) 2008 through 2012, as well as other proposals to improve the review of medical devices and the third party inspection program. These proposed recommendations were developed after discussions with the regulated industry. Section 105 of MDUFMA I directs FDA to publish these proposed recommendations in the Federal Register, hold a meeting at which the public may present its views on the recommendations, and provide for a period of 30 days for the public to provide written comments on the recommendations. The public meeting and comment period will provide an opportunity for public input on the proposed recommendations from all interested parties, including the regulated industry, scientific and academic experts, healthcare professionals, and representatives of patient and consumer advocacy groups.
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