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.