Follow-up Study of Chronic Fatigue Syndrome in Georgia (Survey of Chronic Fatigue Syndrome & Chronic Unwellness in Georgia-Baseline Survey)

Forms and Documents

Document Name	Status
Followup CFS in GA - OMB Supporting Statement Rev 05-22-08.doc Supplementary Document	2008-06-17
Supporting Statement B.doc Supporting Statement B	2007-11-28
Attachment 4 GA protocol 4121.doc Supplementary Document	2007-11-28
Attachment 7B Refusal Letter.doc Supplementary Document	2007-11-28
Attachment 7A Non-Contact Letter.doc Supplementary Document	2007-11-28
Attachment 6 Advance Letter.doc Supplementary Document	2007-11-28
Supporting Statment A.doc Supporting Statement A	2007-12-06

IC Document Collections

IC ID	Document Title	Status
7106	Follow-up Study of Chronic Fatigue Syndrome in Georgia (Survey of Chronic Fatigue Syndrome & Chronic Unwellness in Georgia-Base Line Survey) Instruction	Modified

ICR Details

OMB Control No: 0920-0638	ICR Reference No: 200712-0920-006
Status: Historical Active	Previous ICR Reference No: 200402-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Follow-up Study of Chronic Fatigue Syndrome in Georgia (Survey of Chronic Fatigue Syndrome & Chronic Unwellness in Georgia-Baseline Survey)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/30/2008
	Date Received in OIRA: 12/18/2007
Terms of Clearance: Approved consistent with CDC revisions outlined in Agency memo. CDC has agreed that the results of the survey are not generalizable and will not be used to generate prevalence/cost estimates associated with CFS at either the state or national level.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	36 Months From Approved
Responses	2,870	0	0
Time Burden (Hours)	861	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Survey of Chronic Fatigue Syndrome and Chronic Unwellness in Georgia (Baseline Survey), conducted between 2004 and 2005, provided baseline information on CFS in metropolitan, urban, and rural regions of Georgia. Our Follow-up Study addresses the need to determine factors that are associated with improvement in clinical course, in order to decrease the morbidity (burden) of this illness. The goal of the Follow-up Study is to build on the Baseline Survey and identify risk factors for and biomarkers of CFS morbidity by evaluating changes in clinical parameters of CFS over the interval since the Baseline Survey.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: The Public Health and Welfare
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	71 FR 62473	10/25/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 65735	11/23/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Follow-up Study of Chronic Fatigue Syndrome in Georgia (Survey of Chronic Fatigue Syndrome & Chronic Unwellness in Georgia-Base Line Survey)

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	2,870	0	0	2,870	0	0
Annual Time Burden (Hours)	861	0	0	861	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The goal of the Follow-up Study is to build on the Baseline Survey and identify risk factors for and biomarkers of CFS morbidity by evaluating changes in clinical parameters of CFS over the interval since the Baseline Survey.

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Annual Cost to Federal Government: $320,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 12/17/2007

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