[Federal Register Volume 63, Number 63 (Thursday, April 2, 1998)] [Notices] [Pages 16262-16264] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-8613] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [INFO-98-15] Proposed Data Collections Submitted for Public Comment and Recommendations 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 Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call the CDC Reports Clearance Officer on (404) 639-7090. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques for other forms of information technology. Send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA 30333. Written comments should be received within 60 days of this notice. Proposed Projects 1. Hemoglobin A1c HEDIS Measure Testing--New--Managed care organizations (MCOs) increasingly use HEDIS measures developed by the Committee on Performance Measurement of the National Committee for Quality Assurance (NCQA) as vehicles to document and track health care quality. NCQA recently formed the Diabetes Quality Improvement Project, whose purposes are to broaden the range and to improve the reliability of diabetes performance measures. Because the Diabetes Control and Complications Trial (DCCT) has established that achieving glycemic control reduces the complications of diabetes, an important focus of the measures will be the association of glycemic control and diabetes-related morbidity. Since complications of diabetes develop over many years, however, use of this data to assess quality of care presents important problems. For example, the measures may reflect problems that developed before enrollment in a health plan rather than the quality of care provided by the health plan. To more accurately assess the quality of diabetes care in a health plan, we need to identify intermediate outcomes measures that are not subject to these problems. Health status is an outcome of medical care that can be obtained readily through member survey and may provide an intermediate measure of quality of care for chronic diseases like diabetes. The purpose of this study is to evaluate perceived health status as a function of glycemic control in diabetic patients. We will investigate associations of changes in member perceptions of their health as a function of changes in their glycemic control. We also will look for variation in the association of health status with glycemic control across subsets of the population. The general plan of analysis is a retrospective, longitudinal design. In January and February of 1997, 931 Kaiser Permanente enrollees with diabetes completed a telephone survey examining knowledge of diabetes and diabetes care, satisfaction with medical care in the health plan, and perceptions of health status. The participants' responses were linked with an existing dataset collected on diabetic members in conjunction with a project conducted by NCQA. The dataset contains enrollment history, outpatient visits, pharmacy dispensings, laboratory tests and results, and inpatient care. The cohort responding to the first survey will be contacted in mid-1998 for a follow-up survey comprised of 51 questions. The second survey will include two instruments used to examine health status. This will increase the data available for measuring health status and will permit a comparison of the two instruments as well. Questions related to blood pressure, foot care, weight, change in weight, and satisfaction with care will also be retained. The general model for analysis will be change in member perceptions of health as a function of changes in HbA1c values. The hypothesis is that improved HbA1c will correlate with improved health status and worsening HbA1c will correlate with worsening health status. By examining this hypothesis, we can assess the utility of perceived health status as a valid intermediate measure of quality of diabetes care. ---------------------------------------------------------------------------------------------------------------- Number of Avg. burden/ Respondents Number of responses/ responses (in Total burden respondents respondent hrs.) (in hrs.) ---------------------------------------------------------------------------------------------------------------- Diabetic patient................................ 600 1 0.5 300 --------------- Total................................... .............. .............. .............. 300 ---------------------------------------------------------------------------------------------------------------- [[Page 16263]] 2. 1999 National Health Interview Survey, Basic Module (0920- 0214)--Revision--The annual National Health Interview Survey (NHIS) is a basic source of general statistics on the health of the U.S. population. Due to the integration of health surveys in the Department of Health and Human Services, the NHIS also has become the sampling frame and first stage of data collection for other major surveys, including the Medical Expenditure Panel Survey, the National Survey of Family Growth, and the National Health and Nutrition Examination Survey. By linking to the NHIS, the analysis potential of these surveys increases. The NHIS has long been used by government, university, and private researchers to evaluate both general health and specific issues, such as cancer, AIDS, and childhood immunizations. Journalists use its data to inform the general public. It will continue to be a leading source of data for the Congressionally-mandated ``Health US'' and related publications, as well as the single most important source of statistics to track progress toward the National Health Promotion and Disease Prevention Objectives, ``Healthy People 2000.'' Because of survey integration and changes in the health and health care of the U.S. population, demands on the NHIS have changed and increased, leading to a major redesign of the annual core questionnaire, or Basic Module, and a redesign of the data collection system from paper questionnaires to computer assisted personal interviews (CAPI). Those redesigned elements were partially implemented in 1996 and fully implemented in 1997. This clearance is for the third full year of data collection using the Basic Module on CAPI, and for implementation of the first ``Periodic Module'', which include additional detail questions on conditions, access to care, and health care utilization. This data collection, planned for January-December 1999, will result in publication of new national estimates of health statistics, release of public use micro data files, and a sampling frame for other integrated surveys. The 1999 Basic Module will include a few new questions on health insurance, and program participation. The Basic Module of the new data system is expected to be in the field at least until 2006. The total cost to respondents is estimated at $692,160 for the whole survey. ---------------------------------------------------------------------------------------------------------------- Number of Avg. burden/ Respondents Number of responses/ responses (in Total burden respondents respondent hrs.) (in hrs.) ---------------------------------------------------------------------------------------------------------------- Family.......................................... 42,000 1 0.5 21,000 Sample adult.................................... 42,000 1 0.80 33,600 Sample child.................................... 18,000 1 0.116 2,088 --------------- Total................................... .............. .............. .............. 56,688 ---------------------------------------------------------------------------------------------------------------- 3. A Longitudinal Study of Lead Poisoning from the Maternal Infant Relationship Through Early Childhood--New--The Agency for Toxic Substances and Disease Registry (ATSDR) is mandated pursuant to the 1980 Comprehensive Environmental Response Compensation and Liability Act (CERCLA), and its 1986 Amendments, The Superfund Amendments and Reauthorization Act (SARA), to prevent or mitigate adverse human health effects and diminished quality of life resulting from exposure to hazardous substances in the environment. Lead exposure has been associated with negative pregnancy outcomes in humans, including low birth weight, spontaneous abortion, congenital malformation, and various neurological effects in newborns and young children. The level of lead considered to be toxic has been lowered over the years by major research groups, organizations, and agencies. While lead has been shown to affect all organs, the brain or nervous system seems to be the most sensitive to lead toxicity, especially in young children. Blood lead levels as low as 10g/dL have been shown to result in delayed cognitive development, reduced IQ scores, and impaired hearing. This study, originally approved by OMB in 1995, examines the long- term effects of low and marginal toxic blood lead levels in neonates and preschool African-American children in the Atlanta area. This study is divided into two components, (i) prevalence of lead exposure in children of preschool age and (ii) longitudinal health effects of low and marginal lead exposure. These studies are conducted concurrently. The primary focus of the prevalence study is the evaluation of the relationship between socio-economic status, elemental blood lead levels within the home environment, and blood lead levels of preschool aged children. The objective of the longitudinal study is the evaluation of the relationship between lead levels found in maternal and cord blood and adverse health effects in the infant, including deficits in behavioral, cognitive and physical development. To correlate cognitive and behavioral development with varying blood lead levels, each newborn is to undergo a series of psychometric testing at birth, then again at 6 months, 1, and 2 years of age. Evaluations of physician development will be conducted by reviewing the medical records of each newborn within the first year after birth. This request is for a 3-year extension of the current OMB approval; however we are requesting a new OMB authority (and number) as the old number (0923-0015) will now apply only to the Substance Specific Applied Research Program (AMHPS) [King/Drew Lead Study in-Person Interview, Lead and Hypertension Screening Questionnaire/Risk Factor Questionnaire]. The requests for OMB approval for the two studies has been separated, with the King/Drew investigation retaining the old OMB number (0923-0015). ---------------------------------------------------------------------------------------------------------------- Number of Avg. burden/ Respondents Number of responses/ response (in Total burden respondents respondent hrs.) (in hrs.) ---------------------------------------------------------------------------------------------------------------- Households..................................... 100 1 0.75 75 Daycare Centers................................ 10 1 0.25 2.5 Pregnant Women................................. 300 3.5 0.167 175.35 [[Page 16264]] Infants........................................ 300 7 0.524 1,100.40 --------------- Total...................................... .............. ............... .............. 1,353.25 ---------------------------------------------------------------------------------------------------------------- 4. Antivirals Usage in Nursing Homes--New--Outbreaks of influenza A in nursing homes (NH) may result in the hospitalization of up to 25% of ill residents and the death of up to 30% of those who are hospitalized. The rapid diagnosis of influenza A and the timely administration of currently available antiviral medications, amantadine and rimantadine, can lessen the impact of these outbreaks. However, it is unknown how often laboratory tests for the rapid diagnosis of influenza A are utilized and how frequently antivirals are used to control nursing home outbreaks of influenza A. The purpose of this survey is to determine how often rapid testing and antivirals are used to control influenza A outbreaks in NH's. A sample of NH's will be selected randomly from one state within each of nine influenza surveillance regions. The survey will be mailed to infection control personnel in the randomly selected NH's. The results will be used to identify where educational efforts should be directed to lessen the impact of influenza A on elderly institutionalized persons. ---------------------------------------------------------------------------------------------------------------- Number of Avg. burden/ Respondents Number of responses/ responses (in Total burden respondents respondent hrs.) (in hrs.) ---------------------------------------------------------------------------------------------------------------- NH infection control............................ 918 1 0.16 147 --------------- Total....................................... .............. .............. .............. 147 ---------------------------------------------------------------------------------------------------------------- Dated: March 27, 1998. Charles Gollmar, Acting Associate Director for Policy, Planning, and Evaluation, Centers for Disease Control and Prevention (CDC). [FR Doc. 98-8613 Filed 4-1-98; 8:45 am] BILLING CODE 4163-18-P