[Federal Register Volume 63, Number 220 (Monday, November 16, 1998)]
[Notices]
[Pages 63735-63738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30459]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[30DAY-02-99]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
the CDC Reports Clearance Officer at (404) 639-7090. Send written 
comments to CDC, Desk Officer; Human Resources and Housing Branch, New 
Executive Office Building, Room 10235; Washington, DC 20503. Written 
comments should be received within 30 days of this notice.

Proposed Projects

    1. The Second Longitudinal Study of Aging (LSOA II)-(0920-0411)--
Revision--National Center for Health Statistics (NCHS). The Second 
Longitudinal Study of Aging is a second-generation, longitudinal survey 
of a nationally representative sample of civilian, non-
institutionalized persons 70 years of age and older. Participation is 
voluntary, and individually identified data are confidential. The LSOA 
II replicates portions of the first Longitudinal Study of Aging (LSOA), 
particularly the causes and consequences of changes in functional 
status. In addition, the LSOA II is designed to monitor the impact of 
changes in Medicare, Medicaid, and managed care on the health status of 
the elderly and their patterns of health care utilization. Both LSOAs 
are joint projects of the National Center for Health Statistics (NCHS) 
and the National Institute on Aging (NIA).
    The Supplement on Aging (SOA), part of the 1984 National Health 
Interview Survey (NHIS), established a baseline on 7,527 persons who 
were then aged 70 and older. The first LSOA reinterviewed them in 1986, 
1988 and 1990. Data from the SOA and LSOA have been widely used for 
research and policy analysis relevant to the older population.
    In 1994, 9,447 persons aged 70 and over were interviewed as part of 
the National Health Interview Survey's Second Supplement on Aging (SOA 
II) between October of 1994 and March of 1996. The first LSOA II re-
interview wave was conducted between May 1997 and March 1998. The LSOA 
II will re-interview the SOA II sample two

[[Page 63736]]

additional times: in 1999 and 2001. As in the first LSOA, these 
reinterviews will be conducted using computer assisted telephone 
interviewing (CATI). Beyond that, LSOA II will use methodological and 
conceptual developments of the past decade.
    The LSOA II contains substantive topics on scientifically important 
and policy-relevant domains, including: (1) Assistance with activities 
of daily living, (2) chronic conditions and impairments, (3) family 
structure, relationships, and living arrangements, (4) health opinions 
and behaviors, (5) use of health, personal care and social services, 
(6) use of assistive devices and technologies, (7) health insurance, 
(8) housing and long-term care, (9) social activity, (10) employment 
history, (11) transportation, and (12) cognition. This new data will 
result in publication of new national health statistics on the elderly 
and the release of public use micro data files. The total annual burden 
hours are 6,854.

------------------------------------------------------------------------
                                                             Avg. burden
                                                 Number of       per
            Respondent              Number of    responses/    response
                                   respondents   respondent      (in
                                                               minutes)
------------------------------------------------------------------------
Practice.........................           50            1         0.75
Telephone Locator Calls..........        8,472            1         0.05
Telephone Interview..............        8,222            1         0.75
Mailout Interview................          250            1         0.90
------------------------------------------------------------------------

    2. 1999 National Health Interview Survey, Basic Module (0920-
0214)--Revision--National Center for Health Statistics. 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 annual burden hours are 48,600.

------------------------------------------------------------------------
                                                 Number of   Avg. burden/
           Respondents              Number of    responses/   responses
                                   respondents   respondent   (in hrs.)
------------------------------------------------------------------------
Family Core (adult family member)       42,000            1         0.35
Adult Core (sample adult)........       42,000            1         0.35
Child Core (adult family member).       18,000            1         0.25
Periodic Module (sample adult)...       42,000            1         0.35
------------------------------------------------------------------------

    3. National Tuberculosis Surveillance Activity Form (CDC 72.9)--
(0920-0026)--Extension--The National Center for HIV, STD and TB 
Prevention (NCHSTP)--Tuberculosis (TB) is transmitted when contagious 
TB patients aerosolize Mycobacterium tuberculosis and susceptible 
persons (i.e., ``contacts'') are exposed. Some contacts are especially 
endangered by TB if they become infected--children younger than 5 years 
old, and anyone with an illness that weakens the immune system (e.g., 
the acquired immunodeficiency syndrome, AIDS). The prompt evaluation of 
all contacts is crucial for finding early TB cases and latent 
infections. For latent TB infections, treatment with isoniazid 
preventive therapy can prevent new TB cases from developing.
    Evaluation, follow-up, and preventive therapy for contacts comprise 
the most efficient approach for finding and treating recent TB 
infections and preventing future cases. Therefore, it is one of the 
highest priorities for the national TB control strategy, second only to 
finding and treating contagious cases. NCHSTP is requesting an 
extension of this package with a few modifications. The Program 
Management Reports, which was a part of this OMB submission has been 
separated from this request as they are undergoing significant 
revision. The new Program Management Reports will be submitted as a new 
package. The total burden hours are 400.

[[Page 63737]]



------------------------------------------------------------------------
                                                Number of
                                  Number of    responses/   Avg. burden/
            Report               respondents   respondent     response
                                                (in hrs.)     (in hrs.)
------------------------------------------------------------------------
Report of Verified Case of
 Tuberculosis.................         1600             1          0.25
------------------------------------------------------------------------

    4. Lead Exposure and Blood Pressure During Pregnancy Study (Charles 
Drew Medical)--(0923-0015)--EXTENSION--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 the exposure to 
hazardous substances into the environment. Disadvantaged minorities in 
large urban areas have higher than national blood lead levels.
    Some of these groups also suffer from disproportionately high rates 
of hypertension. Previous data shows a relationship between higher 
blood lead levels and higher blood pressure, even at the lowest lead 
exposure. To facilitate this effort, this study examines the 
relationship between lead exposure history in inner city minorities and 
blood pressure, using a group at special risk for elevated blood 
pressure, pregnant women. Elevated blood lead and elevated blood 
pressure are two problems that disproportionately affect minority 
groups. Establishing a link between blood pressure and lead exposure, 
especially utilizing two new biomarkers of lead exposure, bone lead and 
serum lead, can provide a new tool for dealing with elevated blood 
pressure nationwide.
    This request is for a 3-year extension. Two previously approved 
questionnaires will continue to be used to collect socioeconomic data, 
and data pertaining to risk factors for elevated blood pressure and 
lead exposure. A new questionnaire assessing social stress (Scale of 
Chronic Social Role Stressors) and a 16 item, four response choice 
scale will be added to better control for social stress factors 
affecting blood pressure. The total annual burden hours are 838.

------------------------------------------------------------------------
                                   Number of    Number of    Avg. burden
       Type of respondent         respondents   responses/  per Response
                                    per Year    respondent     (in hrs)
------------------------------------------------------------------------
Screening Questionnaire.........          583            1         0.5
Perceived Stress Scale..........          583            1         0.08
Risk Questionnaire..............          330            2         0.75
St. Francis Medical Center
 Participants...................          292            1         0.008
------------------------------------------------------------------------

    5. Substance--Specific Applied Research Program Epidemiologic 
Studies on Lead (Morehouse School of Medicine)--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 ``/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). The total annual burden hours are 882.*

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                                                                                        Number of   Avg. burden/
                   Study                             Respondents           Number of    responses/     response
                                                                          respondents   respondent    (in hrs.)
----------------------------------------------------------------------------------------------------------------
Prevalence................................  Child Questionnaire.........          400            1         0.333

[[Page 63738]]

                                            Family Questionnaire........          400            1         0.083
                                            Household Questionnaire.....          400            1         0.333
                                            Environmental Survey........          400            1         0.25
                                            Day Care Center                        20            1         0.25
                                             Participation.
Longitudinal..............................  Hospital/Clinic Participants            1            1         0.083
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                                     Childhood Lead Poisoning Questionnaire
----------------------------------------------------------------------------------------------------------------
                                            Family Questionnaire........          600            1         0.083
                                            Household Questionnaire.....           12            1         0.333
                                            Environmental Survey........           12            1         0.166
                                            Home Visits.................          600            9         0.25
----------------------------------------------------------------------------------------------------------------
                              Neurobehavioral and Developmental Testing in Children
----------------------------------------------------------------------------------------------------------------
                                            Brazelton Assessment........          600            2         0.583
                                            Denver Screening............          600            1         0.5
                                            Bayley Scales...............          600            2         1
                                            Fagan Battery...............          600            1         0.666
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* Estimate of annualized burden was determined by taking the total burden and dividing it by 5 years.


    Dated: November 4, 1998.
Charles W. Gollmar,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 98-30459 Filed 11-13-98; 8:45 am]
BILLING CODE 4163-18-P