Multi-site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM)

Forms and Documents

Document Name	Status
Form 0920-20QS Multi-site Clinical Assessment of Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (MCAM)ATT.5 Form and Instruction	New
Form 092-20QS Multi-site Clinical Assessment of Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (MCAM) ATT.4 Form and Instruction	New
Form 0920-20QS Multi-site Clinical Assessment of Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (MCAM)ATT.3 Form and Instruction	New
0_Description_CogState&Exercise_Testing.docx Supplementary Document	2021-07-07
Attachment6.6_Protocol1-4_MCAM_Nova IRB Approval thru 20191022.pdf Supplementary Document	2021-06-29
Attachment6.5_Protocol1-4_MCAM_MSBI IRB Approval thru 20191222.pdf Supplementary Document	2021-06-29
Attachment6.4_Protocol4_MCAM_NK_WIRB_OMI_Approval thru 20210307.pdf Supplementary Document	2021-06-29
Attachment6.3_Protocol3_MCAM_CE_WIRB_OMI Approval thru 20210210.pdf Supplementary Document	2021-06-29
Attachment6.2_Protocol2_MCAM_Pediatric_WIRB_OMI_Approval thru 20210710.pdf Supplementary Document	2021-06-29
Attachment6.1_Protocol1_MCAM_Adults_WIRB_OMI_Approval thru 20210312.pdf Supplementary Document	2021-06-29
Attachment1_Authorizing_Legislation.pdf Supplementary Document	2021-06-29
60DAY FRN 080320.pdf Supplementary Document	2021-06-29
30DAY FRN 012821.pdf Supplementary Document	2021-06-29
OMB_Supporting Statement B_MCAM_20200709.docx Supporting Statement B	2021-06-29
Supporting Statement A_MCAM_20210622_clean.docx Supporting Statement A	2021-06-29

IC Document Collections

IC ID	Document Title	Status
248257	Multi-site Clinical Assessment of Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (MCAM)ATT.5 Form and Instruction	New
248256	Multi-site Clinical Assessment of Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (MCAM) ATT.4 Form and Instruction	New
248111	Multi-site Clinical Assessment of Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (MCAM)ATT.3 Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202106-0920-021
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20QS
Title: Multi-site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM)
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  Yes
Type of Review Request: Regular	Date Submitted to OIRA: 07/07/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	3,525	0
Time Burden (Hours)	715	0
Cost Burden (Dollars)	0	0

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Abstract: This study uses a standardized approach for data collection to examine the heterogeneity of patients with ME/CFS using a clinical epidemiologic longitudinal study with a retrospective and prospective rolling cohort design. The study also aims to address the issue of ME/CFS case definition and improve measures of illness domains by using evidence-based data from multiple clinical practices in the United States. Healthy adults and those with illnesses that share some features with ME/CFS were enrolled in comparison groups. Child and adolescent ME/CFS and healthy participants were also enrolled.

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Authorizing Statute(s): None

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:
	85 FR 46633	08/30/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 7394	01/28/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Multi-site Clinical Assessment of Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (MCAM) ATT.4	092-20QS, 920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS	1_CDC Symptom Inventory_For Baseline Subjects Pediatrics ,   2_CDC Symptom Inventory_For the Follow-Up Subjects Pediatrics ,   3_SF-36 Health Survey ,   4_Multidimensional Fatigue Inventory_MFI-20 ,   5_Selected Questions from DePaul Pediatric Health Questionnaire_DPHQ ,   6_PROMIS Pediatric Instruments ,   7_Pediatric Pain Questionnaire_PPQ ,   8_Visual Analogue Scale ,   9_Hospital Anxiety and Depression Scale ,   10_Pediatric Daytime Sleepiness Scale ,   11_Social Participation Form Pediatric ,   12_Sociability Form ,   13_Saliva Data Collection Sheet
Multi-site Clinical Assessment of Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (MCAM)ATT.3	0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS	1_CDC Symptom Inventory (CDC-SI)_Form A ,   2_CDC Symptom Inventory (CDC-SI)_Form B ,   3_CDC Symptom Inventory (CDC-SI) ,   4_Short Form CDC-SI_Checklist ,   5_Medical Outcomes Study Short Form 36 ,   6_Multidimensional Fatigue Inventory_MFI-20 ,   7_DePaul Symptom Questionnaire_DSQ ,   8_DSQ_26 selected questions ,   9_DSQ_18 selected questions ,   10_PROMIS Short Forms&Sleep ,   11_PROMIS SF - Fatigue_SD_SRI_PB_PI ,   12_Brief Pain Inventory_BPI.pdf ,   13_Patient Health Questionnaire_PHQ-8_GAD-7_HRQoL ,   14_CDC HRQoL-4 ,   15_CDC HRQoL-4 with activity limitation questions ,   16_Self-Rating Depression Scale_SDS ,   17_Illness Impact Questionnaire ,   18_Saliva Data Collection Sheet ,   19_Orthostatic Grading Scale_OGS ,   20_COMPosite Autonomic Symptom Score 31_COMPASS-31
Multi-site Clinical Assessment of Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (MCAM)ATT.5	0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS, 0920-20QS	1_Visual Analogue Scale for CFS Symptoms ,   2_EQ-5D-Y Health Questionnaire ,   3_PROMIS SFv1 Physical Function ,   4_Physical Fitness and Exercise Activity Levels of Scale ,   5_International Physical Activity Questionnaire_Self-Administered Long Form ,   6_Physical Activity Readiness Questionnaire_PAR-Q

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ICR Summary of Burden

	Total Request	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	3,525	0	0	0	0	3,525
Annual Time Burden (Hours)	715	0	0	0	0	715
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $1,220,000

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  Yes

Description/Changes for Common Form Usage: 

Approved RCFs using this ICR

Agency/Sub Agency	RCF ID	RCF Title	RCF Status	IC Title

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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: 07/07/2021

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