Proposed Data Collections Submitted for Public Comment and Recommendations

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Proposed Project: Survey of Chronic Fatigue Syndrome and Chronic Unwellness in Georgia—New—National Center for Infectious Diseases (NCID), Centers for Disease Control and Prevention (CDC).

Congress commissioned CDC to develop research that estimates the magnitude of chronic fatigue syndrome (CFS) in the United States with special consideration of under-served populations (children and racial/ethnic minorities); describe the clinical features of CFS; and identify risk factors and diagnostic markers. CDC is currently planning a study in Georgia to estimate the prevalence of CFS and other fatigue illnesses and to determine whether or not there are differences in occurrence of fatigue illness across metropolitan, urban, rural populations and in racial and ethnic populations.

In 2001, OMB approved the information collection, National Telephone Survey of Chronic Fatigue Syndrome, under OMB Number 0920-0498. In July 2001, CDC conducted a pilot survey to determine feasibility of a national study and to test procedures for this national survey of CFS. The pilot study showed that clinical evaluation to confirm classification of CFS was not practical on a national level, and the planned follow-on national survey was not conducted.

CDC has since modified the concept of the National Survey of CFS by limiting data collection to one southern U.S. state (Georgia). This modified research is better able to serve the objectives of the National Survey of CFS and additional CDC objectives. Reasons supporting this statement are listed below.

• Logistics. A difficulty in the Pilot Test was matching subjects and physicians for clinical evaluations because subjects were scattered across the continent. Focusing on a single state allows operation of regional clinics and greater opportunities for collaboration between and among CDC, Emory University, and consultants.
• Metropolitan, urban, and rural differences. Pilot Test results suggest no regional differences in the occurrence of CFS-like illnesses between and among the Midwest, south, west, and northeast, so concentrating on one state (Georgia) should provide more generalized information. Pilot Test findings suggested that further exploration of urban and rural differences might prove useful. Again, Georgia well-serves such a study with a major metropolitan center (Atlanta), urban areas (Macon and Warner Robins), and rural populations (in counties surrounding Macon) with well-defined regional differences.
• Racial/ethnic differences. The prevalence of CFS in other than the white population has not been definitively measured, although some studies indicate CFS prevalence in minority populations may be higher than generally thought. Georgia has well-characterized urban and rural as well as white, black, and Hispanic populations of varying socioeconomic status living in the regions to be studied. The presence of these populations is ideal for public health surveys. Taken together, the proposed Georgia survey will produce estimates of the prevalence of CFS in metropolitan, urban, and rural populations and will elucidate racial/ethnic differences in CFS in these populations.

The proposed study replicates the Sedgwick County Study and the National Pilot Test using similar methodology and data collection instruments. The study begins with a random-digit-dialing telephone survey to identify fatigued, unwell, and well individuals, followed by detailed telephone interviews to obtain additional data on participant health status. As a result of the telephone interviews, eligible subjects will be asked to participate in clinical evaluations. CDC will estimate the prevalence of CFS and other fatigue illnesses in metropolitan, urban, and rural Georgia and in racial and ethnic populations. CDC will compare prevalence estimates from this proposed study of the Georgia population to estimates obtained for Sedgwick County to ascertain whether or not Sedgwick County findings can be generalized to other populations. The estimated annualized burden is 6,257 hours.