2010-11037. 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 [phone] or send an email to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Morbidity Study of Former Marines, Dependents, and Employees Potentially Exposed to Contaminated Drinking Water at USMC Camp Lejeune—New—Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

On January 28, 2008, President Bush signed H.R. 4986: National Defense Authorization Act for Fiscal Year 2008 which requires ATSDR to develop a health survey of individuals possibly exposed to contaminated drinking water at Camp Lejeune. The survey will collect personal health information that may provide a basis for further reliable scientific studies of potentially adverse health impacts of exposure to contaminated water at Camp Lejeune. The Act requires the survey to be developed within 120 days of enactment and to be conducted within one year of enactment.

Additionally, in 2005, a panel of independent scientists convened by ATSDR to explore opportunities for conducting additional health studies at Camp Lejeune recommended that the agency:

• Identify cohorts of individuals with potential exposure, including adults who lived on base; adults who resided off base, but worked on base; children who lived on base; and those who may have been exposed while in utero; and
• Conduct a feasibility assessment to address the issues involved in planning future studies of mortality, cancer incidence, and other health outcomes of interest at the base.

In response, ATSDR prepared a report on the feasibility of conducting future epidemiological studies at the base. ATSDR determined that available databases could be used to identify adults who lived at the base or civilians who worked at the base during the period when drinking water was contaminated with volatile organic compounds (VOCs).

In addition to questions on cancers, the health survey instrument will include questions on non-fatal diseases that can be confirmed by medical records and are known or suspected of being associated with VOCs.

This project proposes to examine the relationship between medically confirmed cancers and drinking water contaminated with VOCs including trichloroethylene (TCE), perchloroethylene, (PCE), and BTEX (benzene, toluene, ethylbenzene and xylenes) compounds by mathematically modeling the exposure to contaminated drinking water while living or working at Camp Lejeune.

The relationship between the following non-fatal diseases that can be confirmed by medical records and VOC-contaminated drinking water will also be examined: Parkinson's disease, kidney failure and other severe kidney diseases, severe liver diseases, lupus, aplastic anemia, TCE-related skin disorders, scleroderma, multiple sclerosis, motor neuron disease/amyotrophic lateral sclerosis, and infertility. In addition, the health survey instrument will include questions on miscarriages occurring to women who were pregnant while residing or working on base.

The health survey instrument will request information about the type of cancer or non-fatal, non-cancer disease, date of diagnosis, hospital of diagnosis, and doctor who diagnosed the disease to facilitate the acquisition of medical record confirmation. Because medical records are usually unavailable for miscarriages, the survey will not request information to facilitate medical record confirmation of this adverse outcome. For cancers, state of diagnosis will also be obtained to facilitate acquisition of cancer registry data. Self-reported cancers and other diseases will be confirmed by medical records or cancer registrations. To facilitate medical record confirmation, the participant will be asked to provide a copy of the medical record to ATSDR or to sign a medical records release form allowing ATSDR to gain access to the medical record. The survey will also collect information on residential history on base, occupational history, and information on several risk factors (e.g., socio-economic status, demographics, smoking, alcohol consumption, etc.). A space will also be provided so that the respondent can report other disease conditions. The collected information will be used to assign exposure status and to assess potential confounding.

To improve the credibility of the study, it is necessary to include an external, unexposed comparison group, similar in all respects to the Marines and civilian workers at Camp Lejeune except for exposure to VOC-contaminated drinking water. Camp Pendleton is that comparison group.

As required by law, health surveys will also be mailed to those who registered with the United States Marine Corps. Health surveys completed by those who were identified solely because they registered with the USMC will be analyzed separately (“registered” group).

There are no costs to the respondents other than their time. The estimated annualized burden hours are 58,013.

Estimated Annualized Burden Hours

Respondents	Number of respondents	Number of responses per respondent	Average burden per response (in hours)
Former active duty marines and navy personnel stationed at Camp Lejeune during 1975-1985	45,500	1	45/60
Former civilian workers employed at Camp Lejeune during 1972-1985	1,733	1	45/60
Former dependents (now all adults) and former Marines who were stationed at Camp Lejeune prior to 1975—Camp Lejeune	6,284	1	45/60
Former active duty marines and navy personnel stationed at Camp Pendleton during 1975-1985 (comparison group)	10,833	1	45/60
Former civilian workers employed at Camp Pendleton during 1972-1985 (comparison group)	2,167	1	45/60
“Registered” group	10,833	1	45/60

Dated: May 4, 2010.

Maryam I. Daneshvar,

Reports Clearance Officer, Centers for Disease Control and Prevention.