[Federal Register Volume 72, Number 246 (Wednesday, December 26, 2007)]
[Notices]
[Pages 73023-73024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-24933]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-08-06BN]


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 e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
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
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of
                              Form                                   Number of     responses per   Average hours
                                                                    respondents     respondent     per response
----------------------------------------------------------------------------------------------------------------
Health Care Provider Verification Form..........................             583               1           17/60
Health Care Provider Knowledge, Attitudes and Beliefs                        466               1            8/60
 Questionnaire (Pre-intervention)...............................
Health Care Provider Knowledge, Attitudes and Beliefs                        373               1            8/60
 Questionnaire (Post Intervention)..............................
Health Care Provider Knowledge Attitudes and Beliefs                         100               1            8/60
 Questionnaire (at CDC presentations)...........................
Referral/Consent to Contact Form................................             373               2            8/60

[[Page 73024]]

 
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.
 [FR Doc. E7-24933 Filed 12-21-07; 8:45 am]
BILLING CODE 4163-18-P