[Federal Register Volume 75, Number 89 (Monday, May 10, 2010)]
[Notices]
[Pages 25859-25860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11037]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-10-08BH]


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 (404) 639-5960 or send an email to 
<a href="/cdn-cgi/l/email-protection#056a6867456661662b626a73"><span class="__cf_email__" data-cfemail="d8b7b5ba98bbbcbbf6bfb7ae">[email protected]</span></a>. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-5806. 
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

[[Page 25860]]

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


    Dated: May 4, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-11037 Filed 5-7-10; 8:45 am]
BILLING CODE 4163-18-P


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