Department of Health and Human Services June 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for RAXAR (grepafloxacin hydrochloride (HCl)) Tablets held by Otsuka Pharmaceutical Co., Ltd. (Otsuka), c/o Otsuka Pharmaceutical Development & Commercialization, Inc., 2440 Research Blvd., Rockville, MD 20850. Otsuka has voluntarily requested that approval of this application be withdrawn because the product is no longer marketed, thereby waiving its opportunity for a hearing.

The Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) personnel (Corps Personnel, Corps members) for the period July 1, 2007 through June 30, 2008 is posted on the NHSC Web site at https://nhsc.bhpr.hrsa.gov/ resources/fedreg-hpol/. This list specifies which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program, the NHSC Loan Repayment Program, and Corps members who have become Corps members other than pursuant to contractual obligations under the Scholarship or Loan Repayment Programs. Please note that not all vacancies associated with sites on this list will be for Corps members, but could be for individuals serving an obligation to the NHSC through the Private Practice Option.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed continuing collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the continuation of a pilot project to evaluate the electronic collection of the 3500A form for adverse events related to the use of medical products to obtain data from user facilities participating in the Medical Device Safety Network (MedSun). Additionally, the electronic form will include hospital profile information and several other questions related to the use of medical products. A portion of the MedSun software, called Device-Safety Exchange (DS-X) (formerly called M-Den), is a moderated site where MedSun members may share information with each other.

The Food and Drug Administration (FDA) is reclassifying intervertebral body fusion devices that contain bone grafting material, from class III (premarket approval) into class II (special controls), and retain those that contain any therapeutic biologic (e.g., bone morphogenic protein) in class III. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device. This reclassification is based upon on the recommendation of the Orthopaedic and Rehabilitation Devices Panel (the Panel).

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.

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.

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.

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.

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.

The Administration on Aging (AoA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to The Fourth National Survey of Older Americans Act Service Recipients. This information collection, builds on earlier national pilot studies and performance measurement tools developed by grantees in the Performance Outcomes Measures Project (POMP). It will include consumer assessment surveys for congregate and home delivered meal nutrition program, transportation, homecare services and other Title IIIB services, and National Family Caregiver Support Program. Copies of the POMP instruments can be located at https://www.gpra.net. Information collected through this study will be used by AoA to track performance outcome measures, support budget requests; comply with Government Performance and Results Act (GPRA) reporting requirements; provide information for OMB's program assessment (PART) process: Provide national benchmark information for grantees and inform program improvement and management initiatives.

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 public advisory committees for the Center for Drug Evaluation Research (CDER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CDER's public advisory committees. 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.