E7-24933. 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 e-mail 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

Conduct a Chronic Fatigue Syndrome Registry Pilot Test (Bibb County, Georgia)—New—National Center for Zoonotic, Vector-borne, and Enteric Diseases (NCZVED), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC is tasked with establishing a registry of chronic fatigue syndrome (CFS) and other fatiguing illnesses. The objective of the registry is to identify persons with unexplained fatiguing illnesses, including CFS, who access the healthcare system because of their symptoms. Patients will be between the ages of 12 and 59, inclusive.

Specific aims of the registry are: (1) Identify and enroll patients with CFS and other unexplained fatiguing illnesses who are receiving medical and ancillary medical care and describe their epidemiologic and clinical characteristics; (2) follow CFS patients and patients with other fatiguing illnesses over time to characterize the natural history of CFS and other unexplained fatiguing illnesses; (3) assess and monitor health care providers' knowledge, attitudes, and beliefs concerning CFS; (4) and to identify well-characterized CFS patients for clinical studies and intervention trials. These specific aims require inclusion of subjects in early stages of CFS (i.e., ill less than one year duration) who can be followed longitudinally to assess changes in their CFS symptoms. Data on persons with CFS in the general population has been collected in a separate study and is not an objective of this Registry.

In order to determine the most effective and cost-efficient design for achieving the objective and specific aims, CDC will conduct a pilot test of the Registry of CFS and other fatiguing illnesses in Bibb County, Georgia. The CFS Registry Pilot Test will assess two Registry designs for efficacy and efficiency in identifying adult and adolescent subjects with CFS who are receiving medical and ancillary medical care. Specifically, the CFS Registry Pilot Test will evaluate surveillance of patients with CFS identified through physician practices and a surveillance of CFS patients identified by physicians and other health care providers.

The proposed study will begin when a provider refers a patient to the registry. Patients who consent to be contacted for the registry will be asked to complete a detailed telephone interview that screens for medical and psychiatric eligibility. Eligible subjects will be invited to have a clinical evaluation that comprises a physical examination; collection of blood, urine, and saliva specimens; a mental health interview; and self-administered questionnaires.

There is no cost to respondents other than their time. Patients who are clinically evaluated will be reimbursed for their time and effort. The total estimated annualized burden hours are 2,077.

Estimated Annualized Burden Hours

Form	Number of respondents	Number of responses per respondent	Average hours per response
Health Care Provider Verification Form	583	1	17/60
Health Care Provider Knowledge, Attitudes and Beliefs Questionnaire (Pre-intervention)	466	1	8/60
Health Care Provider Knowledge, Attitudes and Beliefs Questionnaire (Post Intervention)	373	1	8/60
Health Care Provider Knowledge Attitudes and Beliefs Questionnaire (at CDC presentations)	100	1	8/60
Referral/Consent to Contact Form	373	2	8/60
Referral/Consent to Contact Form (Patient)	507	1	12/60
CATI Detailed Telephone Interview	395	1	42/60
Health Care Utilization/Sense of Community (for adult)	196	1	20/60
Health Care Utilization (for parent of adolescent)	50	1	20/60
Economic Impact (adult)	196	1	20/60
Spielberger State-Trait Anxiety Inventory (for adult subjects)	196	1	20/60
Personality Diagnostic Questionnaire (PDQ-4+) (for adults)	196	1	42/60
Childhood Trauma Questionnaire (for adult subjects)	196	1	25/60
Traumatic Life Events Questionnaire (for adult subjects)	196	1	20/60
Life Experiences Survey (for adult subjects)	196	1	20/60
Adolescent Subject Fatigue Questionnaire	50	1	8/60
Adolescent Health Questionnaire	50	1	20/60
Symptoms Inventory	246	1	12/60
Medical Outcomes Study Short Form 36	246	1	20/60
Multi-dimensional Fatigue Inventory	246	1	12/60
Zung Self-Rating Depression Scale	246	1	20/60
Illness Perception Questionnaire	246	1	20/60
Davidson Trauma Scale	246	1	12/60
Ironson-Woods Spirituality/Religiousness Index	246	1	8/60
Illness Management Questionnaire	246	1	20/60
Ways of Coping Questionnaire	246	1	33/60
Social Support Questionnaire	246	1	20/60

Dated: December 14, 2007.

Maryam I. Daneshvar,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.