73 FR 137 pgs. 40876-40877 - Proposed Data Collections Submitted for Public Comment and Recommendations
Type: NOTICEVolume: 73Number: 137Pages: 40876 - 40877
Docket number: [60Day-08-08BH]
FR document: [FR Doc. E8-16174 Filed 7-15-08; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
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 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.
| Respondents | No. of respondents | No. of responses per respondent | Average burden per response (in hours) | Total burden (in hours) |
|---|---|---|---|---|
| Former active duty marines and navy personnel-Camp Lejeune | 136,500 | 1 | 45/60 | 102,375 |
| 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-Camp Pendleton (comparison group) | 32,500 | 1 | 45/60 | 24,375 |
| Former civilian workers-Camp Pendleton (comparison group) | 6,500 | 1 | 45/60 | 4,875 |
| Total | 146,250 |
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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