Agency Forms Undergoing Paperwork Reduction Act Review

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.*

----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------

* 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