[Federal Register Volume 71, Number 161 (Monday, August 21, 2006)]
[Notices]
[Page 48550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13721]



[[Page 48550]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-06-06BN]


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 Seleda Perryman, CDC Assistant Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to [email protected].
    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

    Conduct a Chronic Fatigue Syndrome Registry Pilot Test (Bibb 
County, Georgia)--New--National Center for Infectious Diseases (NCID) 
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 annualized burden hours are 2,557.

Estimate of Annualized Burden Hours

----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
                   Respondent                       respondents    responses per     response         (hours)
                                                                    respondent        (hours)
----------------------------------------------------------------------------------------------------------------
Referring Providers.............................             400               2            5/60              67
Patient consent to be contacted.................             677               1           10/60             113
Patient Telephone Interview.....................             541               1           30/60             271
Patient Clinical Evaluation.....................             234               1          540/60           2,106
                                                 ---------------------------------------------------------------
    Total Burden................................  ..............  ..............  ..............           2,557
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    Dated: August 15, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
 [FR Doc. E6-13721 Filed 8-18-06; 8:45 am]
BILLING CODE 4163-18-P