Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[INFO-99-38]

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 Agency for Toxic Substances and

Disease Registry (ATSDR) 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

ATSDR 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 Nancy Cheal, Ph.D.,

ATSDR Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA

30333. Written comments should be received within 60 days of this

notice.

Proposed Project

Exposure to Volatile Organic Compounds and Childhood Leukemia

Incidence at MCB Camp Lejeune, North Carolina--Extension--Agency for

Toxic Substances and Disease Registry (ATSDR). There is limited

evidence that in utero exposure to volatile organic compounds (VOCs)

such as trichloroethylene and tetrachloroethylene (PCE) in drinking

water may be strongly associated with childhood leukemia (CL). In 1982,

VOC contamination was identified in certain groundwater supply wells

which supplied drinking water to housing units at U.S. Marine Corps

Base Camp Lejeune in Jacksonville, North Carolina. In a previous health

study of approximately 6,000 infants exposed in utero to this

contaminated water and 6,000 unexposed births, it was shown that

gestational PCE exposure was related to lower birth weights for certain

subgroups. The purpose of the proposed nested case-control study is to

investigate the potential relationship between exposure to VOCs in

drinking water and incidence of CL at Camp Lejeune. A secondary

objective of the proposed study is to investigate the potential

relationship between VOCs in drinking water and birth defects in this

population.

During this phase of the proposed study, an attempt will be made to

locate as many of the children born to base residents between 1968 and

1985 as well as offspring from pregnancies that occurred during this

time period but were not delivered at Camp Lejeune. A brief screening

questionnaire will be interviewer-administered to identify potential

cancer and birth defect cases. Some of the data to be collected by the

questionnaire includes: confirmation of the name(s) of children and

date(s) of birth; dates and location of residence on base during the

pregnancy and/or at the time of delivery; current vital status of each

child; the determination of diagnosis with cancer or birth defects

before age 20. As a result of delays in obtaining data necessary to

trace potential respondents, a renewal for this project has been

requested.

It is necessary to identify each respondent in order to assess

place of residence at Camp Lejeune as a measure of possible VOC

exposure as well as to determine possible case status, i.e. reported

diagnosis of childhood cancer or birth defect. This information will be

used during the next study phase to identify potential cases and

controls for the proposed nested case-control study.

With help from the U. S. Navy and U. S. Marine Corps sources, we

will obtain current address information and attempt to contact

respondents directly. For respondents with unknown current addresses,

tracing efforts will include advertising in the general media as well

as in publications directed toward Marine Corps and Navy personnel.

Once the respondent is located, the questionnaire will be administered

by trained interviewers over the telephone.

Respondents will be one of the following: (1) a parent who gave

birth or was pregnant while residing at MCB Camp Lejeune between 1968

and 1985; (2) a parent who was pregnant while residing at MCB Camp

Lejeune between 1968 and 1985 but gave birth elsewhere; or (3) an

offspring of said parents. The number of births that occurred at MCB

Camp Lejeune during this period is approximately 12,000. It has been

estimated that approximately one-third of women who seek prenatal care

while residing at Camp Lejeune are relocated before delivery.

Therefore, attempts will be made to contact and interview up to an

additional 4,000 respondents. Of the 16,000 total possible respondents,

a conservative estimate of the number that will be located and

subsequently interviewed is 13,000 (about 80%).

The hourly burden has been modified since the first submittal. This

was a result of pretesting of the data collection instrument. It was

found that the average completion time per survey was closer to 15

minutes as opposed to the original estimate of 9 minutes.

[[Page 50818]]

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Number of Avg. burden of

Type of respondents Number of responses/ response (In Total burden

respondents respondent hrs.) (In hrs.)

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Parent/Child born at Camp Lejeune; 1968-1985.... 9,650 1 0.25 2,412.50

Pregnancy at Camp Lejeune, delivery else-where; 3,350 1 0.25 837.50

1968-1985......................................

Total..................................... .............. .............. .............. 3,250.00

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Dated: September 14, 1999.

Nancy Cheal,

Acting Associate Director for Policy, Planning and Evaluation, Centers

for Disease Control and Prevention (CDC).

[FR Doc. 99-24368 Filed 9-17-99; 8:45 am]

BILLING CODE 4163-70-P