[Federal Register Volume 68, Number 138 (Friday, July 18, 2003)]
[Notices]
[Pages 42732-42733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18225]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-03-97]


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) 498-1210.
    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 or other 
forms of information technology. Send comments to Seleda Perryman, CDC 
Assistant 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 in Drinking Water and 
Specific Birth Defects and Childhood Cancers at United States Marine 
Corps Base Camp Lejeune, North Carolina--New--The Agency for Toxic 
Substances and Disease Registry (ATSDR).
    ATSDR is mandated pursuant to the 1980 Comprehensive Environmental 
Response, Compensation, and Liability Act (CERCLA) and its 1986 
Amendments, the Superfund Amendments and Re-authorization Act (SARA), 
to prevent or mitigate adverse human health effects and diminished 
quality of life resulting from exposure to hazardous substances in the 
environment. ATSDR plans activities to address these issues which 
include conducting health studies at sites on the Environmental 
Protection Agency's (EPA) National Priorities List (NPL) to determine 
whether and to what degree exposure to hazardous substances at these 
sites are harmful to human health.
    The United States Marine Corps Base Camp Lejeune, North Carolina, 
is one of the federal facilities on EPA's National Priorities List. In 
1982, periodic sampling of drinking water sources began at Camp Lejeune 
to comply with regulations of the national Safe Drinking Water Act. The 
sample results showed that the drinking water supplied to some of the 
base housing units was contaminated with volatile organic compounds 
(VOCs). The specific chemicals of concern were trichloroethylene (TCE), 
tetrachloroethylene (or perchloroethylene) (PCE), dichloroethylene, and 
methylene chloride. These chemicals are used as solvents to clean 
machinery and weapons and in dry cleaning operations. A 1997 ATSDR 
public health assessment (PHA) of the base recommended that an 
epidemiological study be considered to determine if mothers exposed to 
VOCs in drinking water during their pregnancies were at higher risk of 
giving birth to a child with health problems such as a birth defect or 
a childhood cancer. ATSDR's initial response to the PHA recommendation 
was to conduct a study at Camp Lejeune to evaluate whether mothers who 
were exposed to the contaminated drinking water during pregnancy were 
at higher risk of having a child which was ``small for gestational 
age'' (i.e., an infant weighing less than the 10th percentile based on 
published sex-specific growth curves). This study was completed in 1998 
and found an association between mothers' exposures to the contaminated 
drinking water during pregnancy and small for gestational age infants. 
The association between birth defects and drinking

[[Page 42733]]

water contaminated with TCE or PCE could not be reasonably evaluated in 
the 1998 study because of extreme under-ascertainment of cases using 
data from birth certificates.
    In response to the PHA recommendation, ATSDR began the multi-step 
process of determining the appropriateness of conducting an 
epidemiological study of specific childhood cancers and birth defects 
at Camp Lejeune. Based on the scientific literature, ATSDR decided to 
focus on specific childhood cancers and birth defects: Childhood 
leukemia, childhood non-Hodgkin's lymphoma, spina bifida, anencephaly, 
cleft lip and cleft palate. ATSDR conducted a survey in 1999-2002 (OMB 
No. 0923-0023) to identify all cases of the specific birth defects and 
childhood cancers. About an 80 percent participation rate was achieved 
among the approximately 16,000 to 17,000 births that occurred among 
women who were pregnant while living at Camp Lejeune during the study 
period 1968-1985. These years were chosen because 1968 is the first 
year that birth certificates were computerized in North Carolina, and 
1985 is the last year that VOC contamination was detected at the base. 
All of the participants who took part in the Camp Lejeune Survey in 
1999-2002 gave permission to be contacted for future studies. 
Additionally, many survey participants have telephoned ATSDR to request 
the results of the survey and inquire about future studies.
    The overall objective of the proposed case-control study is to 
examine whether there is an association between maternal exposures 
during pregnancy to TCE and PCE in drinking water at Camp Lejeune 
during the period of 1968-1985 and the risk of specific birth defects 
(spina bifida, anencephaly, cleft lip and cleft palate) and childhood 
cancers (childhood leukemia and Non-Hodgkin's Lymphoma) in offspring.
    ATSDR is in the process of verifying that the child had the birth 
defect or childhood cancer reported by the parents in the survey. The 
parents of the children with possible birth defects or childhood 
cancers of concern were contacted and asked to sign a medical records 
release form so that ATSDR could gain access to the medical records for 
their children. If the child had reached 18 years of age, he or she was 
contacted and asked to sign a medical records release form.
    Once the review of medical records is complete, the final step is 
to conduct an epidemiological study that includes all the cases of 
birth defects and childhood cancers of concern. The study will also 
include a control sample of children who did not have a birth defect or 
a childhood cancer and whose mothers lived at Camp Lejeune during their 
pregnancy over the period 1968-1985. The study plans to enroll 100 
cases and 500 controls over the course of one year. The epidemiological 
study will require the computer modeling of the drinking water system 
at Camp Lejeune over the period 1968-1985 in order to determine as 
accurately as possible which mothers were exposed to the VOCs in the 
drinking water during their pregnancy and which mothers were not 
exposed during their pregnancy.
    To reduce the amount of time required by the respondents, Computer 
Assisted Telephone Interviews (CATI) will be conducted. Following 
completion of all respondent interviews, the data will be tabulated and 
analyzed (the case group will be compared with the control group). 
Because only a very small number of studies have looked at the risk of 
birth defects and childhood cancers among children born to mothers 
exposed during pregnancy to VOCs in drinking water, the proposed study 
will aid in developing or contributing to generalizable knowledge.
    Other than their time to participate, there is no cost to the 
respondents.

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                                                                Number of      Average burden
               Respondents                    Number of       responses per   per response (in  Total burden (in
                                             respondents       respondent           hrs.)             hrs.)
----------------------------------------------------------------------------------------------------------------
Cases...................................               100                 1             45/60                75
Controls................................               500                 1             45/60               375
                                         -------------------
        Total...........................  ................  ................  ................               450
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    Dated: July 14, 2003.
Thomas A. Bartenfeld,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 03-18225 Filed 7-17-03; 8:45 am]
BILLING CODE 4163-18-P