Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[INFO-96-18]

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 at (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 Wilma Johnson, CDC

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. Survey of State-Based Diabetes Control Cooperative Agreement

Programs--New--Diabetes mellitus and related complications are the

seventh leading cause of death in the United States, and accounts for

$105 billion in direct medical costs and lost productivity each year.

Approximately 14 million Americans have been diagnosed with diabetes, a

leading cause of new blindness and end-stage renal failure in the

United States and a major co-morbid factor in lower extremity

amputation, cardiovascular disease and related death, and neonatal

morbidity and mortality.

Through the support of the Centers for Disease Control and

Prevention's (CDC) ``State-Based Program to Reduce the Burden of

Diabetes: A Health Systems Approach,'' public health departments in 42

states and four U.S. territorial affiliated jurisdictions have been

charged with providing leadership in reducing the gap between what

should be and what is the current standard of diabetes care.

CDC will collect information from diabetes State Program

Coordinators regarding the four key areas of program implementation.

They are (1) capacity building and infrastructure development, (2)

surveillance and data collection, (3) health systems change, and (4)

working with local programs.

The survey has three main objectives:

1. Document the progress made by Diabetes Control Programs in the

four main areas of program implementation.

2. Assess the relationship between the level of infrastructure

development, and a program's efforts to carry out surveillance

activities, health systems change activities, and work with local

programs. Information will help improve technical assistance (TA) and

guidance offered to states by CDC.

[[Page 34842]]

3. Lay the groundwork for an evaluation instrument that can be used

to collect data from Diabetes Control Programs at the end of the

funding cycle in order to assess whether progress in program

implementation and development is linked to reduced diabetes morbidity

and mortality.

The data will result from self-administered mailed surveys sent to

the Program Coordinator in each state. Most questions will be in the

form of checklists although each of the four sections contain a number

of open-ended questions for explanation of unique features of programs.

It is expected that the burden in time to each respondent will be about

two (2) hours per Program Coordinator or Designee, resulting in a total

burden of 92 hours. Results will also be made available to participants

upon request. The total cost to respondents is estimated at $1,840.

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No. of Avg. burden Total

Respondents No. of responses/ response burden (in

Respondents respondent (in hrs.) hrs.)

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

Diabetes program coordinators............................... 46 1 2 92

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Total................................................... 92

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2. List of Ingredients Added to Tobacco in the Manufacture of

Cigarette Products--(0920-0210)--Extension without change - Cigarette

smoking is the leading preventable cause of premature death and

disability in our nation. Each year more than 400,000 premature deaths

occur as the result of cigarette smoking related diseases. The Centers

for Disease Control and Prevention (CDC), Office on Smoking and Health

has primary responsibility for the Department of Health and Human

Services' (HHS) smoking and health program. HHS's overall goal is to

reduce death and disability resulting from cigarette smoking and other

forms of tobacco use through programs of information, education and

research.

The Comprehensive Smoking Education Act of 1984 (15 USC 1336 Pub.L.

98-474) requires each person who manufactures, packages, or imports

cigarettes to provide the Secretary of HHS with a list of ingredients

added to tobacco in the manufacture of cigarettes. This legislation

also authorizes HHS to undertake research, and to report to the

Congress (as deemed appropriate), on the health effects of the

ingredients.

In 1993, OMB reinstated approval for collection of ingredients

information (0920-0210) after the expiration of the previous approval;

this current approval expires on December 31, 1996. The total cost to

the respondent is estimated at $189,000.

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Average

No. of No. of burden/ Total

Respondents respondents responses/ response burden (in

respondent (in hrs.) hrs.)

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

Tobacco manufacturers....................................... 14 1 190 2,660

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3. The Fourth National Health and Nutrition Examination Survey

(NHANES IV) Pretests--New--The National Health and Nutrition

Examination Survey (NHANES) has been conducted periodically since 1970

by the National Center for Health Statistics, CDC. NHANES IV is planned

for 1998-2004 and two pretests are proposed to include 400 sample

persons in each. They will receive an interview and a physical

examination. The first pretest is needed to test the sampling process,

data collection procedures, computer-assisted personal interviews

(including translations into Spanish), examination protocols, and

automated computer systems. The second pretest will test the revised

survey questionnaires and examination procedures, quality control

procedures and response rates. Participation in the pretests and the

full survey will be completely voluntary and confidential.

NHANES programs produce descriptive statistics which measure the

health and nutrition status of the general population. Through the use

of questionnaires, physical examinations, and laboratory tests, NHANES

studies the relationship between diet, nutrition and health in a

representative sample of the United States. NHANES monitors the

prevalence of chronic conditions and risk factors related to health

such as coronary heart disease, arthritis, osteoporosis, pulmonary and

infectious diseases, diabetes, high blood pressure, high cholesterol,

obesity, smoking, drug and alcohol use, environmental exposures, and

diet. NHANES data are used to establish the norms for the general

population against which health care providers can compare such patient

characteristics as height, weight, and nutrient levels in the blood.

Data from future NHANES can be compared to those from previous NHANES

to monitor changes in the health of the U.S. population. NHANES IV will

also establish a national probability sample of genetic material for

future genetic testing for susceptibility to disease.

Users of NHANES data include Congress; the World Health

Organization; Federal agencies such as NIH, EPA, and USDA; private

groups such as the American Heart Association; schools of public

health; private businesses; individual practitioners; and

administrators. NHANES data are used to establish, monitor, and

evaluate recommended dietary allowances, food fortification policies,

programs to limit environmental exposures, immunization guidelines and

health education and disease prevention programs. The total cost to

respondents for the two pretests is estimated at $54,600.

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Number of Avg. burden/ Total

Respondents Number of responses/ response burden (in

respondents respondent (in hrs.) hrs.)

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

Children.................................................... 80 1 2.75 220

[[Page 34843]]

Adolescents and Adults...................................... 720 1 4.75 3420

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Total................................................... 3640

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4. The Second Longitudinal Study of Aging (LSOA II)--(0920-0219)--

Revision--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. It will replicate portions of the first Longitudinal

Study of Aging (LSOA), particularly the causes and consequences of

changes in functional status. LSOA II is also 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.

Approximately 10,000 persons aged 70 and over were interviewed for

the 1994 National Health Interview Survey's second Supplement on Aging

(SOA II) between October of 1994 and March of 1996. LSOA II will

reinterview the SOA II sample three times: in 1997, 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.

LSOA II will contain modules 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 cost to the

respondents is estimated at $112,500.

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Number of Avg. burden/ Total

Respondents Number of responses/ response burden (in

respondents respondent (in hrs.) hrs.)

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

Sample adult................................................ 10,000 1 .75 7,500

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Total................................................... 7,500

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Dated: June 27, 1996.

Wilma G. Johnson,

Acting Associate Director for Policy Planning and Evaluation, Centers

for Disease Control and Prevention (CDC).

[FR Doc. 96-16947 Filed 7-2-96; 8:45 am]

BILLING CODE 4163-18-P