Registry of Unexplained Fatiguing Illnesses and Chronic Fatigue Syndrome (CFS): A Pilot Study

Forms and Documents

Document Name	Status
Form No number Health Care Provider Knowledge, Attitudes and Beliefs Questionnaire (at CDC presentation) Form and Instruction	New
Form No number Social Support Questionnaire Form	New
Form No number Ways of Coping Questionnaire Form	New
Form No number Illness Management Questionnaire Form	New
Form No number Ironson-Woods Spirituality / Religiousness Index Form and Instruction	New
Form No number Davidson Trauma Scale Form	New
Form No number Illness Perception Questionnaire Form	New
Form No number Zung Self-Rating Depression Scale Form	New
Form No number Multi-dimensional Fatigue Inventory Form	New
Form No number Medical Outcomes Study Short Form Form	New
Form No number Symptoms Inventory Form	New
Form No number Adolescent Health Questionnaire Form	New
Form No number Adolescent Subject Fatigue Questionnaire Form	New
Form No number Life Experiences Survey Form	New
Form No number Traumatic Life Events Questionnaire Form	New
Form No number Childhood Trauma Questionnaire Form	New
Form No number Personality Diagnostic Questionnaire Form	New
Form No number Spielberger State-Trait Anxiety Inventory Form	New
Form No number Economic Impact Form	New
Form No number Health Care Utilization (for parent of adolescent) Form	New
Form No number Health Care Utilization/Sense of Community (for adult) Form	New
Form No number CATI Detailed Telephone Interview Form	New
Form No number Referral/Consent to Contact Form - Patient Form	New
Form No number Referral/Consent to Contact Form - Provider Form	New
Form No number Health Care Provider Knowledge, Attitudes and Beliefs Questionnaire (Post Intervention) Form and Instruction	New
Form No number Health Care Provider Knowledge, Attitudes and Beliefs Questionnaire - Pre-Intervention Form and Instruction	New
Form No number Health Care Provider Verification Form Form and Instruction	New
Followup CFS in GA - OMB Supporting Statement Rev 05-22-08.doc Supplementary Document	2008-08-18
OMB Supporting Statement for Registry Redlined May 2008.doc Supplementary Document	2008-08-18
Attachment 22 Symptoms Inventory.doc Supplementary Document	2007-12-19
Attachment 20 Clinic Appointment letters for adults.doc Supplementary Document	2007-12-19
Attachment 19 Post clinical evaluation ineligibility letter.doc Supplementary Document	2007-12-19
Attachment 18-Hard to contact letter.doc Supplementary Document	2007-12-19
Attachment 17 Justification of Non exempted Clniical Questionnaires .doc Supplementary Document	2007-12-19
Attachment 16 Psychiatric history - structured clinical interview for the DSM IV Scoring.doc Supplementary Document	2007-12-19
Attachment 15 Physical Exam Form.doc Supplementary Document	2007-12-19
Attachment 14. Two week medication usage history.doc Supplementary Document	2007-12-19
Attachment 13 12 hour urine collection instructions.doc Supplementary Document	2007-12-19
Attachment 12 Saliva specimen collection instructions.doc Supplementary Document	2007-12-19
Attachment 11b Adolescent gynecologic history form.doc Supplementary Document	2007-12-19
Attachment 10b Adolescent Medical History Form.doc Supplementary Document	2007-12-19
Attachment 10a Adult Medical history Form.doc Supplementary Document	2007-12-19
Attachment 8b Website content for general public.doc Supplementary Document	2007-12-19
Attachment 8a.1 Recruitment Letter for Adults.doc Supplementary Document	2007-12-19
Attachment 11a Adult gynecological history form.doc Supplementary Document	2007-12-19
2007 Registry Pilot 60-day notice.pdf Supplementary Document	2007-12-18
Attachment 2 Congressional Language 2003-2006.doc Supplementary Document	2007-12-18
Attachment 1 Authorizing Legislation.doc Supplementary Document	2007-12-18
Attachment 24 Social Support Questionnaire OMB Cover page.doc Supplementary Document	2007-12-19
Attachment 24 Ways of Coping Questionnaire OMB cover page.doc Supplementary Document	2007-12-19
Attachment 23 Davidson Trauma Scale OMB Cover page.doc Supplementary Document	2007-12-19
Attachment 24 Illness Perception Questionnaire OMB Cover sheet.doc Supplementary Document	2007-12-19
Attachment 23 Zung Self-Rating Depression Scale OMB cover page.doc Supplementary Document	2007-12-19
Attachment 22 Multi-dimensional Fatigue Inventory OMB cover sheet.doc Supplementary Document	2007-12-19
Attachment 22 Multi-dimensional Fatigue Inventory OMB cover sheet.doc Supplementary Document	2007-12-19
Attachment 25 Life Experiences Survey for adults OMB Cover page.doc Supplementary Document	2007-12-19
Attachment 25 Traumatic Life Events Questionnaire OMB Cover Page.doc Supplementary Document	2007-12-19
Attachment 25 Childhood Trauma Questionniare for adults OMB cover page.doc Supplementary Document	2007-12-19
Attachment 23 Personality Diagnostic Questionnaire (PDQ4+) OMB cover page.doc Supplementary Document	2007-12-19
Attachment 23 State Trait Anxiety Inventory for adults OMB cover page.doc Supplementary Document	2007-12-19
Attachment 6a Non-physician referral instructions.doc Supplementary Document	2007-12-19
Attachment 6a Physician Referral Instructions.doc Supplementary Document	2007-12-19
Attachment 6a Physician Referral Instructions.doc Supplementary Document	2007-12-19
Attachment 6a Non-physician referral instructions.doc Supplementary Document	2007-12-19
Attachment 5b Provider website Frequently Asked Questions.doc Supplementary Document	2007-12-19
Attachment 5a.3. Frequently Asked Questions by Healthcare Providers .doc Supplementary Document	2007-12-19
Attachment 5a.1.Provider recruitment letter.doc Supplementary Document	2007-12-19
OMB Supporting Statement for Registry 4 120107.doc Supporting Statement A	2008-01-31

IC Document Collections

IC ID	Document Title	Status
183881	Health Care Provider Knowledge, Attitudes and Beliefs Questionnaire (at CDC presentation) Form and Instruction	New
183880	Social Support Questionnaire Form	New
183879	Ways of Coping Questionnaire Form	New
183878	Illness Management Questionnaire Form	New
183877	Ironson-Woods Spirituality / Religiousness Index Form and Instruction	New
183876	Davidson Trauma Scale Form	New
183875	Illness Perception Questionnaire Form	New
183874	Zung Self-Rating Depression Scale Form	New
183873	Multi-dimensional Fatigue Inventory Form	New
183872	Medical Outcomes Study Short Form Form	New
183871	Symptoms Inventory Form	New
183870	Adolescent Health Questionnaire Form	New
183869	Adolescent Subject Fatigue Questionnaire Form	New
183868	Life Experiences Survey Form	New
183867	Traumatic Life Events Questionnaire Form	New
183866	Childhood Trauma Questionnaire Form	New
183865	Personality Diagnostic Questionnaire Form	New
183864	Spielberger State-Trait Anxiety Inventory Form	New
183863	Economic Impact Form	New
183862	Health Care Utilization (for parent of adolescent) Form	New
183861	Health Care Utilization/Sense of Community (for adult) Form	New
183860	CATI Detailed Telephone Interview Form	New
183859	Referral/Consent to Contact Form - Patient Form	New
183858	Referral/Consent to Contact Form - Provider Form	New
183857	Health Care Provider Knowledge, Attitudes and Beliefs Questionnaire (Post Intervention) Form and Instruction	New
183856	Health Care Provider Knowledge, Attitudes and Beliefs Questionnaire - Pre-Intervention Form and Instruction	New
183855	Health Care Provider Verification Form Form and Instruction	New

ICR Details

OMB Control No: 0920-0788	ICR Reference No: 200802-0920-009
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: Registry of Unexplained Fatiguing Illnesses and Chronic Fatigue Syndrome (CFS): A Pilot Study
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/25/2008
	Date Received in OIRA: 02/25/2008
Terms of Clearance: Approved consistent with revisions reflecting the limitations of the sample frame.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2009	12 Months From Approved
Responses	7,152	0	0
Time Burden (Hours)	2,077	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: CDC will recruit specific types of physicians and other health care providers who practice in Bibb County, GA and areas within 30 miles of Bibb County, to screen patients for eligibility in a registry of unexplained fatiguing illness. Eligible subjects will be invited to the CDC clinic in Macon, GA for a clinical evaluation.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

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:
	72 FR 41758	07/31/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 73023	12/26/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 27

IC Title	Form No.	Form Name
Health Care Utilization (for parent of adolescent)	No number	Health Services Utilization - Consent
CATI Detailed Telephone Interview	No number	CATI Detailed Telephone Interview
Health Care Utilization/Sense of Community (for adult)	No number	Health Services Utilization - Sense of Community Questionnaire
Economic Impact	No number	Economic Impact Questionnaire for Adults
Spielberger State-Trait Anxiety Inventory	No number	State-Trait Anxiety Inventory
Personality Diagnostic Questionnaire	No number	Personality Diagnostic Questionnaire
Childhood Trauma Questionnaire	No number	Childhood Trauma Questionnaire
Traumatic Life Events Questionnaire	No number	Traumatic Life Events Questionnaire
Life Experiences Survey	No number	Life Experiences Survey
Adolescent Subject Fatigue Questionnaire	No number	Adolescent Subject Fatigue Questionnaire
Adolescent Health Questionnaire	No number	Adolescent Health Questionnaire
Symptoms Inventory	No number	Symptoms Inventory
Medical Outcomes Study Short Form	No number	Medical Outcomes Study Short Form
Multi-dimensional Fatigue Inventory	No number	Multi-dimensional Fatigue Inventory
Illness Management Questionnaire	No number	Illness Management Questionnaire
Zung Self-Rating Depression Scale	No number	Zung Self-Rating Depression Scale
Illness Perception Questionnaire	No number	Illness Perception Questionnaire
Davidson Trauma Scale	No number	Davidson Trauma Scale
Ironson-Woods Spirituality / Religiousness Index	No number	Ironson-Woods Spirituality /Religiousness Index
Ways of Coping Questionnaire	No number	Ways of Coping Questionnaire
Social Support Questionnaire	No number	Social Support Questionnaire
Health Care Provider Knowledge, Attitudes and Beliefs Questionnaire (at CDC presentation)	No number	Health Care Provider Knowledge, Attitudes and Beliefs Questionnaire (at CDC presentations)
Referral/Consent to Contact Form - Provider	No number	Referral/Consent to Contact Form - Provider
Referral/Consent to Contact Form - Patient	No number	Referral/Consent to Contact Form - Patient
Health Care Provider Verification Form	No number	Attachment 5 - Healthcare Provider Verification
Health Care Provider Knowledge, Attitudes and Beliefs Questionnaire - Pre-Intervention	No number	Provider Questionnaire - Pre-intervention
Health Care Provider Knowledge, Attitudes and Beliefs Questionnaire (Post Intervention)	No number	Provider Questionnaire - Post-intervention

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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	7,152	0	0	7,152	0	0
Annual Time Burden (Hours)	2,077	0	0	2,077	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: This is a new data collection.

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Annual Cost to Federal Government: $1,702,799

Does this IC contain surveys, censuses, or employ statistical methods? No

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: 02/25/2008

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