[Federal Register: July 16, 2008 (Volume 73, Number 137)]
[Notices]               
[Page 40876-40877]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jy08-86]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-08-08BH]

 
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 404-639-5960 
and send comments to Maryam I. Daneshvar, CDC Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to omb@cdc.gov.
    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. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Health survey 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), 
Coordinating Center for Environmental Health and Injury Prevention 
(CCEHIP), 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

[[Page 40877]]

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 will include 
questions on non-fatal diseases that can be confirmed by medical 
records and are known or suspected of being associated with solvent 
exposures.
    This project proposes to examine the relationship between medically 
confirmed cancers and trichloroethylene--(TCE) or perchloroethylene--
(PCE) contaminated drinking water 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 TCE- or PCE-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, and scleroderma. In addition, the 
health survey will include questions on miscarriages occurring to women 
who were pregnant while residing or working on base.
    The health survey 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.
    There are no costs to the respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                      No. of      Average burden
                   Respondents                        No. of       responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Former active duty marines and navy personnel--          136,500               1           45/60         102,375
 Camp Lejeune...................................
Former civilian workers--Camp Lejeune...........           5,200               1           45/60           3,900
Former dependents (now all adults)--Camp Lejeune          14,300               1           45/60          10,725
Former active duty marines and navy personnel--           32,500               1           45/60          24,375
 Camp Pendleton (comparison group)..............
Former civilian workers--Camp Pendleton                    6,500               1           45/60           4,875
 (comparison group).............................
                                                                                                 ---------------
    Total.......................................  ..............  ..............  ..............         146,250
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    Dated: July 1, 2008.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E8-16174 Filed 7-15-08; 8:45 am]

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