[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]


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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.

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                                                                     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
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[[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.

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                                                                     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
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    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 10 g/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).

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                                                                    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
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    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.

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                                                                     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