Proposed Data Collections Submitted for Public Comment and Recommendations

Federal RegisterFeb 4, 1997

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[INFO-97-02]

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 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. Employee Vital Status Letter (0920-0035)--Extension--The

employee vital status letter is an update of a letter originally

approved by OMB in 1977 and last approved in 1994. The vital status

letter is used for a type of study known as ``retrospective

mortality.'' The retrospective mortality study involves the

identification of a study population of present and former workers who

were exposed to a toxic substance in the workplace that is suspected of

causing a long term adverse health effect to the exposed workers. The

adverse health effects may be identified by observing the cause of

specific mortality in the study population and comparing that to the

expected mortality. The study populations are identified through

employment records of past and present workers in given industries

where the suspected toxins are found. In order to identify these

deaths, it is necessary to determine the vital status (i.e., whether

the individual is alive or deceased) of all members of the study

population as of a given cut-off date and then obtain the medical

certification of cause of death on all deceased members. This letter is

sent to study cohort members as a last resort. If the vital status of

an individual cannot be determined from a number of available data

sources (such as the National Death Index and the Social Security

Administration), the letter is sent to determine if the respondent is

deceased or alive--if deceased, the data and place of death is

requested from next of kin. The total cost to respondents for the three

year period is $1,890.

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No. of Avg. burden/ Total

Respondents No. of responses/ response burden (in

respondents respondent (in hrs.) hrs.)

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

Workers..................................................... 756 1 .166 126

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Total................................................. ........... ........... ........... 126

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2. Airways Disease in Miners--(0920-0349)--Extension--A

relationship between coal mining exposure and lung function loss has

been demonstrated. Both smoking and coal mine dust exposure are

associated with clinically important respiratory dysfunction. Their

separate contributions to obstructive airway disease in coal miners

appear to be additive. However, much of the apparent variation in the

health risks of coal mine dust exposure remains unexplained. Miners

exposed to similar levels of coal mine dust demonstrate large

variations in lung function loss. Intrinsic susceptibility to the dust

or some environmental factor not yet identified must be sought to

explain why some individuals suffer severe lung damage and others

experience stable or age related changes in lung function in responses

to inhalation of respirable dust.

The spectrum of respiratory disease in coal miners is certainly

broad. Pneumoconiosis is widely accepted as specific to mine dust

exposure. It has been observed that emphysema is more common and severe

in coal miners than non-miners. Symptoms of chronic bronchitis are

common in miners and the risk of their development has been related to

exposure to the mine environment. Over 50% of non-smoking coal miners

with identifiable airflow obstruction may have asthma. Questions that

remain include: What are the predictable factors which relate

variations in airflow obstruction in miners to measured respirable coal

mine dust exposure? What are the specific processes responsible for

lung function losses in miners?

The goals of this investigation are to: 1) Improve our

understanding of the processes and mechanisms involved in the

development of pulmonary diseases and accelerated lung function losses

in underground coal miners and other dust exposed workers, and to

further define the consequences of inhalation of coal mine and other

dusts; and 2) Identify potential risk factors in the development of

excessive respiratory function loss as a basis for interventions to

reduce morbidity and mortality associated with respirable dust in the

work place.

The data collected in this study will be used to provide a basis

for improving the understanding of pulmonary disease processes in dust

exposed workers, and as a basis for intervention strategies to reduce

morbidity in the coal mining and possibly other industries.

The total cost to respondents is $0.00.

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No. of Avg. burden/ Total

Respondents No of responses/ response (in burden (in

respondents respondent hrs.) hrs.)

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

Physicians................................................. 40 1 0.17 7

Volunteers................................................. 36 1 7.0 252

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Total.................................................. ........... ........... ............ 259

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3. Former Waste-To-Energy Facility, Columbus, Ohio: Dioxin and

Cadmium Exposure Study--New--The Agency for Toxic Substances and

Disease Registry is announcing the request for a three year OMB

approval for a new information collection entitled: ``Former Waste-To-

Energy Facility, Columbus, Ohio: Dioxin and Cadmium Exposure Study.''

The purpose of this proposed study is to determine whether blood serum

dioxin and urine cadmium levels of an adult population residing near

the Waste-To-Energy Facility are elevated compared to an adult

population not residing near the Waste-To-Energy Facility. A

scientifically valid exposure assessment is crucial in determining

whether the health of exposed populations may have been adversely

impacted.

The two study groups, target population and comparison population,

will be selected using environmental data, census data, systematic

sampling method, and eligibility criteria. The statistical analysis

will include the comparison of serum dioxin and urine cadmium average

concentration levels for target and comparison populations while

adjusting for factors that affect the concentration levels. This

study's average concentration will be compared to the levels of other

similar health studies. Other than their time, there will be no cost to

the respondents.

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Average

No. of No. of burden/ Total

Respondents respondents respondents/ response burden (in

respondents (in hrs.) hrs.)

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

Systematic Phone Census Survey............................. 2000 1 .10 200

Verify Participant Eligibility............................. 800 1 .15 120

Medical Questionnaire...................................... 440 1 .15 66

Specimen Collection........................................ 440 1 .25 110

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Total................................................ ........... ............ ........... 496

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