June 2007 – Federal Register Recent Federal Regulation Documents

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 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.

The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Allergenic Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nomination will be accepted for current vacancies effective with this notice.

Notice is hereby given that the U.S. International Trade Commission has determined to reverse the presiding administrative law judge's finding of violation of section 337 of the Tariff Act, as amended, and has terminated the investigation with a finding of no violation of section 337.

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.

Periodically, the Department of Energy (``Department'' or ``DOE'') publishes a list of facilities covered under the Energy Employees Occupational Illness Compensation Program Act of 2000 (``Act''), Title 36 of Public Law 106-398 (66 FR 4003; 66 FR 31218). This Notice revises the previous lists because it has been found that some designated atomic weapons employers (AWE) should not have been so designated. Previous lists were published on November 30, 2005, August 23, 2004, July 21, 2003, December 27, 2002, June 11, 2001, and January 17, 2001.

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 that a collection of information entitled ``General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

In accordance with the Federal Advisory Committee Act, the Bureau of Indian Education is announcing that the Advisory Board for Exceptional Children will hold its next meeting in Denver, CO. The purpose of the meeting is to meet the mandates of the Individuals with Disabilities Education Improvement Act of 2004 (IDEIA) on Indian children with disabilities.

The FAA proposes to adopt a new airworthiness directive (AD) for GE CF6-80C2A5F turbofan engines installed on Airbus A300 series airplanes. This proposed AD would require removing previous software versions from the engine electronic control unit (ECU). Engines with new version software will have increased margin to flameout. This proposed AD results from reports of engine flameout events during flight, including reports of events where all engines simultaneously experienced a flameout or other adverse operation. Although the root cause investigation is not yet complete, we believe that exposure to ice crystals during flight is associated with these flameout events. We are proposing this AD to minimize the potential of an all-engine flameout event caused by ice accretion and shedding during flight.

This notice amends the notice of a major disaster declaration for the State of South Dakota (FEMA-1702-DR), dated May 22, 2007, and related determinations.