Source: U.S. Federal Register
Volume 71, Number 161, p 48550
Date: August 21, 2006
URL: http://frwebgate3.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=176881187+9+0+0&WAISaction=retrieve
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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Centers for Disease Control and Prevention
[60Day-06-06BN]
Proposed Data Collections Submitted for Public Comment and Recommendations
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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 [log in to unmask]
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
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Average
Number of Number of burden per Total burden
Respondent respondents responses per response (hours)
respondent (hours)
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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
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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
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(c) 2006 Federal Register
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