Department of Health and Human Services August 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). This final rule provides that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting. The meeting is 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. Cooperative Research and Development Agreement (CRADA) opportunities are also available.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) 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: California Health Interview Survey Cancer Control Module (CHIS-CCM) 2009. Type of Information Collection Request: New. Need and Use of Information Collection: The NCI has sponsored four Cancer Control Modules in the California Health Interview Survey (CHIS), and will be sponsoring a fifth to be administered in 2009. CHIS is a telephone survey that collects population-based, standardized health-related data to assess California's progress in meeting Healthy People 2010 objectives for the nation and the state. The CHIS sample is designed to provide statistically reliable estimates statewide, for California counties, and for California's ethnically and racially diverse population. Initiated by the UCLA Center for Health Policy Research, the California Department of Health Services, and the California Public Health Institute, the survey is funded by a number of public and private sources. It was first administered in 2001 to 55,428 adults and subsequently in 2003 to 42,043 adults, in 2005 to 43,020 adults, and in 2007 to 48,150 adults. These adults are a representative sample of California's non-institutionalized population living in households. CHIS 2009, the fifth bi-annual survey, is planned for administration to 55,000 adult Californians. This study will allow NCI to examine patterns and trends in cancer screening and follow-up, as well as to study other cancer-related topics such as tobacco control, diet, physical activity, and obesity. Additionally, CHIS is designed to be comparable to the National Health Interview Survey (NHIS) data in order to conduct comparative analyses. CHIS provides enhanced estimates for cancer risk factors and screening among racial/ethnic minority populations. Frequency of Response: Once. Affected public: Individuals or households. Types of Respondents: U.S. adults and adolescents (persons 12 years of age and older). The total annual burden hours requested are 3,276.94 (see Table A). The annualized cost to respondents is estimated at: $55,071.88. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

This rule proposes to adopt updated versions of the standards for electronic transactions originally adopted in the regulations entitled, ``Health Insurance Reform: Standards for Electronic Transactions,'' published in the Federal Register on August 17, 2000, which implemented some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These standards were modified in our rule entitled, ``Health Insurance Reform: Modifications to Electronic Data Transaction Standards and Code Sets,'' published in the Federal Register on February 20, 2003. This rule also proposes the adoption of a transaction standard for Medicaid Pharmacy Subrogation. In addition, this rule proposes to adopt two standards for billing retail pharmacy supplies and professional services, and to clarify who the ``senders'' and ``receivers'' are in the descriptions of certain transactions.

This notice announces three hospitals' requests for a waiver from entering into an agreement with their designated Organ Procurement Organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waivers.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``AHRQ Healthcare Innovations Exchange Innovator Interview and AHRQ Healthcare Innovations Exchange Innovator E-mail Submission Guidelines.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on May 23, 2008 entitled ``Provider Reimbursement Determinations and Appeals.''

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on June 10, 2008 (Vol. 73, No. 112, p. 32717) and allowed 60-days for public comment. There were no public comments received during this time. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: NIH-American Association for Retired Persons (AARP) Comprehensive Lifestyle Interview by Computer (CLIC) Study. Type of Information Collection Request: New. Need and Use of Information Collection: The Nutritional Epidemiology Branch of the Division of Cancer Epidemiology and Genetics of the National Cancer Institute has planned this study to evaluate the feasibility of using these three new computerized questionnaires as well as the Diet and Health Questionnaire (DHQ), a well-established food frequency questionnaire in a population of early-to-late-middle-aged men and women. Participants will be asked to complete one of four different series (pathways) of computerized questionnaires over a 90 day period, with some questionnaires in a series being completed twice. This evaluation study comprises the necessary performance and feasibility tests for the new computerized questionnaires, which will provide an opportunity to assess the possibility of administering computerized questionnaires in future large prospective cohort studies. The computerized questionnaires will support the ongoing examination between cancer and other health outcomes with nutritional, physical activity, and lifestyle exposures. The computerized questionnaires adhere to The Public Health Service Act, Section 412 (42 U.S.C. 285a-1) and Section 413 (42 U.S.C. 285a-2), which authorizes the Division of Cancer Epidemiology and Genetics of the National Cancer Institute (NCI) to establish and support programs for the detection, diagnosis, prevention and treatment of cancer; and to collect, identify, analyze and disseminate information on cancer research, diagnosis, prevention and treatment. Frequency of Response: Either 2 or 4 times, depending on the pathway. Affected Public: Individuals. Type of Respondents: U.S. adults (aged 50 and over). The annual reporting burden is displayed in the table below. The estimated total annual burden hours being requested is 2616. The annualized cost to respondents is estimated at: $46,242. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

The Center for Drug Evaluation and Research (CDER) is seeking sponsors interested in participating in a pilot project to test the submission and processing of clinical study data provided electronically in a standardized format. This pilot will test the data extract, validation, and load procedures developed to populate ``Janus,'' the study data repository component of a common, standards- based infrastructure that is being developed jointly by the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) to support the exchange of clinical research data. The pilot also will test a new XML (extensible markup language)-based submission format for standardized clinical study data. We anticipate that a successful pilot will enable CDER to routinely receive, process, and store all standardized clinical study data in a data warehouse environment that will enhance the center's capability to manage and review standardized study data.

In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection project was previously published in the Federal Register (73 FR 23254) on April 29, 2008 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-NEW, ``Behavioral Health Preventative Care Assessment Focus Group.'' Type of Information Collection Request: Three year approval for this new information collection, 0917-NEW, ``Behavioral Health Preventive Care Assessment Focus Group Guide.'' Form Number(s): None. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission, IHS uses the Government Performance Act (GPRA) to assess quality of care among its Federal, urban, and Tribal health programs. The IHS has been largely successful in meeting GPRA targets for selected clinical performance measures at the national level. However, there is significant variability in performance among IHS and Tribal service units. Until this time, IHS has not undertaken any comprehensive studies to evaluate the reasons for that variability or the factors that contribute to high quality care at the local level. The IHS has three GPRA measures relating to behavioral health, a high priority for the Agency and one of the IHS Director's Initiatives. This study will focus on these three GPRA behavioral health measures: Depression Screening in adults age 18 and over, Domestic/Intimate Partner Violence screening in women ages 15-40 and Alcohol Screening (to prevent Fetal Alcohol Syndrome) in women ages 15-44. Tribal programs voluntarily report their GPRA results quarterly and annually for national reporting. GPRA data collected for these three behavioral health measures includes: The number of patients eligible for a screening (denominator), number of eligible patients who receive a screening (numerator), and the resulting screening rate (percentage). IHS has developed methodology to identify superior and poor performers on these measures in both Tribal and Federal sites using fiscal year 2005, 2006, and 2007 GPRA performance results. IHS will convene focus groups with employees at 17 of these programs (7 IHS and 10 Tribal) in order to identify the factors contributing to (and when appropriate, the barriers preventing) the provision of high quality behavioral health care at the local level. These focus groups will allow employees to provide detailed data regarding program practices, screening and documentation procedures, initiatives, resources, and other factors relating to the provision of behavioral health preventive care at their health program. A total of two to three focus groups, organized by occupational specialty, will be convened at each program. Using the Chronic Care Model and Institute of Medicine recommendations, IHS will analyze the information collected during these site visits, along with background information that is publicly available (e.g., information found on clinic Web pages) on other qualitative and quantitative features of individual programs, such as staffing and funding levels, community demographics, and organizational structure, to develop a behavioral health preventive care model relevant to the unique system of IHS delivery. Affected Public: Individuals. Type of Respondents: Tribal employees at Tribal health programs. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Number of total annual responses, Average burden hour per response, and Total annual burden hour(s).

The U.S. Department of Health and Human Services (HHS) announces the fifth in a series of federal advisory committee meetings regarding the national health promotion and disease prevention objectives for 2020 to be held in Washington, DC. This meeting will be open to the public. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 will review the nation's health promotion and disease prevention objectives and efforts to develop goals and objectives to improve the health status and reduce health risks for Americans by the year 2020. The Committee will provide to the Secretary of Health and Human Services advice and consultation for developing and implementing the next iteration of national health promotion and disease prevention goals and objectives and provide recommendations for initiatives to occur during the initial implementation phase of the goals and objectives. HHS will use the recommendations to inform the development of the national health promotion and disease prevention objectives for 2020 and the process for implementing the objectives. The intent is to develop and launch objectives designed to improve the health status and reduce health risks for Americans by the year 2020.