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

In compliance with the provisions of Section 3506 (c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comments on proposed data collection projects, the National Institutes of Health (NIH), National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Physician Survey of Practices on Diet, Physical Activity, and Weight Control. Type of Information Collection Request: NEW. Need and Use of Information Collection: This study will obtain current, national data on primary care physicians' knowledge, attitudes, and practices related to diet, physical activity, and weight control. Obesity, poor diet, and lack of physical activity are becoming recognized as major public health problems in the United States, and have been linked to increased risk, adverse prognosis, and poor quality of life for cancer and many other chronic diseases. The data collected in this study will support and further NCI work in monitoring and evaluating providers' cancer prevention knowledge, attitudes, and practices and their impact on population health, as well as enable monitoring of progress toward major cancer control goals. Data from the survey will be used to profile existing physician practice, understand barriers to counseling and referral, and to inform methods for improving the utilization of these services for adults and children. Two questionnaires, one sent to physicians and one sent to their practice administrators, will be administered by mail or telephone to a randomly-selected national sample of 2,000 physicians belonging to primary care specialties. Study participants will be 2,000 practicing physicians who are family practitioners, general internists, pediatricians, and obstetrician/gynecologists and 2,000 practice administrators. The annual reporting burden is as follows: Estimated Number of Respondents: 4,000; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .333; and Estimated Total Annual Burden Hours Requested: 1,332. The annualized cost to respondents is estimated at: $65,048. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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 HIV/AIDS Health Promotion and Education Program (hereafter referred to as the HIV/AIDS Program). OMH is authorized to conduct this program under 42 U.S.C. 300 u-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 (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. Minority communities are currently at the center of the HIV/AIDS epidemic in this country. The Centers for Disease Control and Prevention (CDC) estimates that more than 1.1 million Americans were living with HIV/AIDS at the end of 2005.\1\ The CDC also states that young people in the U.S. are at persistent risk for HIV infection. ``This risk is especially notable for youth of minority races and ethnicities.'' \2\ Multifaceted approaches to HIV/AIDS prevention which involve peers, school, faith-based, and community components are necessary to reduce the incidence of HIV/AIDS among young people.\3\ Background information on racial/ethnic disparities in HIV/AIDS can be found in Section VIII of this announcement.

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 program (entities). OMH is authorized to conduct the Bilingual/Bicultural Demonstration Grant Program (hereafter referred to as the Bilingual/Bicultural 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 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 (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 Bilingual/Bicultural Program was developed in response to a congressional mandate to develop the capacity of health care professionals to address the cultural and linguistic barriers to health delivery and increase access to health care for limited English- proficient (LEP) populations, particularly those who are racial ethnic minorities. OMH is committed to working with faith- and community-based organizations to improve and enhance access to quality and comprehensive health services for LEP, particularly racial/ethnic minority, populations. The OMH intends to demonstrate the merit of projects partnering community-based, minority-serving organizations and health care facilities in a collaborative effort to address cultural and linguistic barriers to effective health care service delivery, and to increase access to quality and comprehensive health care for LEP and racial/ethnic minority populations living in the United States. The Bilingual/Bicultural Program seeks to improve the health status of LEP populations, particularly racial and ethnic minorities who face cultural and linguistic barriers to health services by: reducing barriers to care; increasing access to quality care; supporting and increasing national, state and local efforts to expand the pool of health care professionals, paraprofessionals, and students who are from diverse communities to provide linguistically and culturally competent services; conducting and disseminating research to connect cultural competency behaviors to specific health outcomes; and assessing the impact of cultural and linguistic training models. As cited in the National Healthcare Disparities Report, clear communication is an important component of effective health care delivery. It is vital for providers to understand patients' health care needs and for patients to understand providers' diagnoses and treatment recommendations. Communication barriers can relate to language, culture, and health literacy.\1\About 47 million Americans, or 18 percent of the population, spoke a language other than English at home in 2000, up from 32 million in 1990.\2\ Census data convey a sense of the growing portion of the United States population that is likely to experience LEP.\3\ The 2000 Census reported that 4.4 million households are linguistically isolated, meaning that no person in the household speaks English ``very well.'' This is a significant increase from 1990, when 2.9 million households were linguistically isolated.\4\ In responding to the need to ensure that all people entering the health care system receive equitable and effective treatment in a culturally and linguistically appropriate manner, the OMH published the National Standards on Culturally and Linguistically Appropriate Services (CLAS) in Health Care for voluntary adoption by health care organizations.\5\ CLAS consists of 14 standards that are organized by three themesCulturally Competent Care (Standards 1-3), Language Access Services (Standards 4-7), and Organizational Supports for Cultural Competence (Standards 8-14). The standards are intended to be inclusive of all cultures and not limited to any particular population group or sets of groups, to contribute to the elimination of racial and ethnic health disparities, and to improve the health of all Americans.

The Food and Drug Administration (FDA) 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 information collection requirements for premarket approval of medical devices.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Adoption of FDA Food Code by Local, State and Tribal Governments'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) 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 recordkeeping requirements for institutional review boards (IRBs).

The Department of Health and Human Services (``HHS'' or the ``Department'') adopted, by an interim final rule, the Office of Management and Budget (OMB) guidance at 2 CFR part 180 on nonprocurement debarment and suspension including some provisions specific to HHS. Public comment on this action was solicited in a Federal Register notice dated March 1, 2007. No comments were received; therefore, the Department makes no changes to its interim final rule and it remains in effect as of March 1, 2007. Pursuant to the requirements in OMB guidance, HHS makes final the following regulatory actions: Removes its existing regulation on nonprocurement debarment at 45 CFR part 76, establishes a new part 376 in title 2 Code of Federal Regulations (CFR) adopting OMB's guidance and adding provisions specific to HHS, and revises the reference in 45 CFR 74.13 to reflect the new citation to 2 CFR part 376.

This notice announces the 17th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the 10th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the 12th meeting of the American Health Information Community Confidentiality, Privacy, and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the intention of the Agency for Healthcare and Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Development of an Electronic System for Reporting Medication Errors and Adverse Drug Events in Primary Care Practice (MEADERS).'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. An earlier version of this proposed information collection notice was previously published in the Federal Register and a period of 90 days was allowed for public comment. At the request of OMB, AHRQ is publishing this notice to allow an additional 30 days for public comment. The original 30 day notice is available at https://a257.g.akamaitech.net/7/257/2422/ 01jan20071800/edocket.access.gpo.gov/2007/pdf/07-574.pdf .

The Department of Health and Human Services (HHS) published a document in the Federal Register of June 20 2007, concerning the establishment of the National Biodefense Science Board. The document should have provided additional information indicating the timeframe the nomination for membership will remain open.

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.

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its thirteenth meeting. The meeting will be open to the public.

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.

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: Diana Layman, University of Oklahoma Health Sciences Center: Based on the report of an investigation conducted by the University of Oklahoma Health Sciences Center (OUHSC) and additional analysis conducted by the Office of Research Integrity during its oversight review, the U.S. Public Health Service (PHS) found that Ms. Diana Layman, Tribal Efforts Against Lead (TEAL) phlebotomist, OUHSC, engaged in scientific misconduct in research supported by National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), grant R01 ES008755. Specifically, Ms. Layman falsified research in the TEAL study by substituting or conspiring with another phlebotomist to substitute her blood or blood of another phlebotomist for blood samples of 10-15 child participants in the TEAL study. Ms. Layman has entered into a Voluntary Exclusion Agreement (Agreement) in which she has voluntarily agreed, for a period of three (3) years, beginning on May 30, 2007: (1) To exclude herself from 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 as defined in HHS' implementation of OMB Guidelines to Agencies on Governmentwide Debarment and Suspension at 2 CFR part 376, et seq.; and (2) To exclude herself 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.

The Food and Drug Administration (FDA) is issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

This notice announces a public meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC) (Committee). Among other things, the Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting will consider the evidence on the diagnostic criteria for obstructive sleep apnea (OSA) in Medicare beneficiaries who may be candidates for continuous positive airway pressure (CPAP) therapy and alternatives to facility-based polysomnography (PSG) in the diagnosis of OSA, including home sleep testing devices and clinical diagnosis without the use of sleep testing. This meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to publish a Medicare final rule no later than 3 years after the publication date of the proposed rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with section 1871(a)(3)(B) of the Act, which allows us to extend the timeline for publication of final rules under exceptional circumstances.

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.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in U.S. Patent Application No. 60/681,104, filed May 12, 2005, entitled ``Anti- Mesothelin Antibodies Useful For Immunological Assays'' [E-015-2005/0- US-01] and PCT Application No. PCT/US2006/018502, filed May 11, 2006, entitled ``Anti-Mesothelin Antibodies Useful For Immunological Assays'' [E-015-2005/0-PCT-02] to Cambridge Antibody Technology, Ltd., which has offices in Cambridge, United Kingdom. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory may be worldwide, and the field of use may be limited to the use of the SSIP immunoconjugate and variants thereof for the treatment of mesothelin expressing cancers.

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.

In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing notice of a proposal to add a new system of records titled, ``Information Center (IC) Integrated Clearinghouse System (IC/ICS),'' System No. 09-15-0067. The HRSA IC/ICS will facilitate the delivery of publications and requested information by members of the general public. The HRSA IC/ICS will also enable HRSA to deliver information efficiently through physical mailings or broadcast e-mail messages to HRSA Grantee organizations and other interested parties.

The Office of the Secretary announces establishment of the National Biodefense Science Board. The Board will provide expert advice and guidance to the Secretary on scientific, technical and other matters of special interest to the Department of Health and Human Services regarding activities to prevent, prepare for and respond to adverse health effects of public health emergencies resulting from current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. Resumes or curricula vitae from qualified individuals who wish to be considered for membership on the Board are currently being accepted. To Submit a resume or curriculum vitae, send e-mail to nbsbnominations@hhs.gov.

The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Pharmacogenetic Tests and Genetic Tests for Heritable Markers.'' This document is intended to provide guidance on preparing and reviewing premarket approval applications (PMAs) and 510(k) submissions for pharmacogenetic and other genetic tests, whether testing is for single markers or for multiple markers simultaneously (multiplex tests).

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue-based products (HCT[sol]Ps), and related labeling. FDA is taking this action to complete the rulemaking initiated with the interim final rule.

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of June 7, 2007 (72 FR 31587). The document announced an amendment to the notice of meeting of the Science Board to the Food and Drug Administration. The meeting was originally announced in the Federal Register of May 21, 2007 (72 FR 28499). The document was published with an incorrect docket number. This document corrects that error.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Div. of Pfizer, Inc. The supplemental NADA provides for the use of lincomycin in feed of swine weighing greater than 250 pounds and for the addition of a reproductive cautionary statement to labeling.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill three vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 99-660 and as subsequently amended, and advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).

The Food and Drug Administration (FDA) 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 hourly burden necessary to complete FDA Form 3546, ``Animal Drug User Fee Cover Sheet.''

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.