Department of Health and Human Services June 11, 2007 – Federal Register Recent Federal Regulation Documents
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Response to Solicitation of Comments on a Funding Priority for Multiple Counties Under the Fiscal Year 2007 New Access Points in High Poverty Counties Grant Opportunity
A notice was published in the Federal Register (FR) on December 6, 2006, (Vol. 71, No. 234, pp. 70780-70781), describing a funding priority to be included in the fiscal year (FY) 2007 New Access Points in High Poverty Counties grant opportunity. The notice requested public comments on the proposed funding priority to be sent to HRSA no later than January 5, 2007. Comments were received from over 30 organizations and/or individuals in response to the notice of the proposed funding priority. The majority of comments received did not pertain specifically to the proposed funding priority, but rather the President's High Poverty Counties Initiative (``the Initiative'') and grant opportunity; therefore this notice presents a summary of the general comments received with HRSA's corresponding responses including references to the FY 2007 New Access Points in High Poverty Counties (HRSA-07-069) funding opportunity, as well as a summary of the final funding priority.
Healthcare Integrity and Protection Data Bank: Announcement of Proactive Disclosure Service Opening Date and User Fees
The Office of Inspector General (OIG) is announcing the availability of a Proactive Disclosure Service (PDS) Prototype for customers of the Healthcare Integrity and Protection Data Bank (HIPDB). The PDS was developed for the National Practitioner Data Bank (NPDB) in response to customers' interest in real-time monitoring of practitioner credentials. As a result of the technical interoperability of the NPDB and HIPDB, the PDS feature is also being made available to HIPDB customers.
Government-Owned Inventions; Availability for Licensing
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.
Funding Opportunity Title: Announcement of Anticipated Availability of Funds for Family Planning Services Grants
The Office of Population Affairs (OPA), Office of Family Planning (OFP), announces the anticipated availability of funds for Fiscal Year (FY) 2008 family planning services grants under the authority of Title X of the Public Health Service Act. This notice solicits applications for competing grant awards to serve the areas and/or populations listed in Table I. Only applications which propose to serve the areas and/or populations listed in Table I will be accepted for review and possible funding.
Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives on Food Safety Public Advisory Committee and Request for Nominations for Nonvoting Industry Representatives on Food Safety Public Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its Food Advisory Committee for the Center for Food Safety and Applied Nutrition (CFSAN) notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Community Partnerships To Eliminate Health Disparities Demonstration Grant Program
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 Community Partnerships to Eliminate Health Disparities Demonstration Grant Program (hereafter referred to as the Community Partnerships Program). OMH is authorized to conduct this program under 42 U.S.C. 300u-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 Community Partnerships Program is designed to support activities that address, and will subsequently eliminate, racial and ethnic health disparities through community-level activities that promote health, reduce risks, and increase access to and utilization of preventive health care and treatment services. In FY 2007 the Community Partnerships Program will support community-based programs that implement activities through collaborative arrangements among minority serving community-based organizations, health care facilities, and other community entities. This program is intended to ascertain the effectiveness of collaborative community-based interventions, implemented at the grassroots level, on reducing health disparities among racial and ethnic minority populations, and demonstrate the effectiveness of the collaborative partnership approach in: Developing, implementing and conducting demonstration projects in high-risk minority communities which coordinate integrated community-based educational screening and outreach services, and include linkages for access, and treatment to minorities in high-risk, low-income communities; Reducing social cultural and linguistic barriers to health care; and Implementing and/or adapting existing promising practices/ model programs for targeted minority communities. The gap in life expectancy between Black and white Americans has narrowed since 1985, but significant racial and ethnic disparities remain across a wide range of health measures.\1\ The 2005 National Healthcare Disparities Report found that disparities related to race, ethnicity and socioeconomic status continue to pervade the American health care system.\2\ The report also states that since the causes of disparities and their prioritization vary across the country, ``successfully addressing disparities often requires focused community- based projects that are supported by detailed local data.'' Eliminating the disproportionate health care disparities is an HHS priority, and the second goal of Healthy People 2010. The risk of many diseases and health conditions are reduced through preventative actions. A culture of wellness diminishes debilitating and costly health problems. Individual health care is built on a foundation of responsibility for personal wellness, which includes participating in regular physical activity, eating a healthful diet, taking advantage of medical screenings, and making healthy choices to avoid risky behaviors. Background information on health issue areas in which significant racial/ethnic disparities are documented may be found in Section VIII of this announcement.
State Partnership Grant Program to Improve Minority Health
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). OMH is authorized to conduct the State Partnership Grant Program to Improve Minority Health under 42 U.S.C. 300u-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 within the HHS for leadership, policy development and coordination, service demonstrations, information exchange, coalition and partnership building, and related efforts to address the health 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 (www.healthypeople.gov). This funding announcement is also made in support of the OMH National Partnership for Action initiative, an outgrowth of OMH's 2006 National Leadership Summit for Eliminating Racial and Ethnic Disparities in Health. The mission of the National Partnership for Action (NPA) 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 improving coordination and utilization of research and outcome evaluations. OMH conducted a study to assess the minority health infrastructure within selected states and territories, and to examine their capacity to address racial and ethnic health disparities in their jurisdictions. A finding of the Assessment of State Minority Health Infrastructure and Capacity to Address Issues of Health Disparities (final report September 2000) was that, despite many challenges, state and/or territorial offices of minority health are an organized and visible presence at the state policymaking level and provide opportunities for shaping and creating initiatives that could affect the health status of minority populations and serve as pivotal points for federal, state, and local efforts to improve the health status of minority populations. In addition, these offices serve an important information dissemination functionproviding information on minority health issues to policymakers, health professionals, community-based organizations, and the general public. Based, in part, on the results of this study and activities supported under the initial state partnership initiative, the Department announces the availability of FY 2007 funding for the State Partnership Grant Program to Improve Minority Health to continue HHS' efforts to improve the health and well being of racial and ethnic minorities. This program is intended to ascertain the effectiveness of state office of minority health-led interventions, including systems change, in addressing the elimination of health disparities among racial and ethnic minority populations. Although the overall health of the nation has improved, racial and ethnic minority groups continue to experience disparities in health care and are disproportionately affected by chronic disease and health conditions.\1\ Eliminating the disproportionate health care disparities is an HHS priority, and the second goal of Healthy People 2010, a systematic approach to health improvement on a national level.
Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is proposing to amend FDA's regulation on the use of ozone-depleting substances (ODSs) in self-pressurized containers to remove the essential-use designations for oral pressurized metered-dose inhalers (MDIs) containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil. Under the Clean Air Act, FDA, in consultation with the EPA, is required to determine whether an FDA-regulated product that releases an ODS is an essential use of the ODS. Therapeutic alternatives that do not use an ODS are currently marketed and appear to provide all of the important public health benefits of the listed drugs. If the applicable essential-use designations are removed, flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil MDIs containing an ODS could not be marketed after a suitable transition period. We will hold an open public meeting on removing these essential-use designations in the near future.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Wei Jin, Colorado State University: Based on an investigation conducted by Colorado State University (CSU) and additional analysis and information obtained by the Office of Research Integrity during its oversight review, the U.S. Public Health Service (PHS) found that Mr. Wei Jin, former doctoral candidate, Department of Chemistry, CSU, engaged in research misconduct in research funded by National Cancer Institutes (NCI), National Institutes of Health (NIH), grant R01 CA85419. Specifically, Mr. Jin falsified data/results by claiming he had performed a novel total synthesis of renieramycin G, when in fact, he obtained renieramycin G through a relatively simple reaction sequence from renieramycin M, a natural product that was a gift to the laboratory and that had been isolated by others from the Thai sponge. Mr. Jin included the falsified data/results in: His research notebooks and other records of his research; His dissertation, ``Asymmetric total synthesis of (-)- Reineramycin G and studies toward the total synthesis of Ecteinascidin- 743''; A manuscript, Jin, W. & Williams, R., ``Asymmetric total synthesis of (-)-Renieramycin G,'' accepted by the Journal of the American Chemical Society; and Supplemental information relative to the manuscript to be published online. ORI has implemented the following administrative actions for a period of three (3) years, beginning on May 8, 2007: (1) Mr. Jin is debarred from eligibility for any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' as defined in HHS' implementation of OMB Guidelines to Agencies on Government-wide Debarment and Suspension at 2 CFR Part 376, et seq.; and (2) Mr. Jin is prohibited from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
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