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

Forms and Documents

Document Name	Status
Form 0920-20QS Physical Activity Readiness Questionnaire Form and Instruction	New
Form 0920-20QS International Physical Activity Questionnaire (Self-Administered Long Form) Form and Instruction	New
Form 020-20QS Physical Fitness and Exercise Activity Levels of Scale Form and Instruction	New
Form 0920-20QS PROMIS SF v1 – Physical Function Form	New
Form 0920-20QS Physical Activity Readiness Questionnaire Form and Instruction	New
Form 0920-20QS International Physical Activity Questionnaire (Self-Administered Long Form) Form and Instruction	New
Form 020-20QS Physical Fitness and Exercise Activity Levels of Scale Form and Instruction	New
Form 0920-20QS PROMIS SF v1 – Physical Function Form and Instruction	New
Form 0920-20QS EQ-5D-Y Health Questionnaire Form and Instruction	New
Form 0920-20QS EQ-5D-Y Health Questionnaire Form and Instruction	New
Form 0920-20QS Visual Analogue Scale for CFS Symptoms Form and Instruction	New
Form 0920-20QS Visual Analogue Scale for CFS Symptoms Form and Instruction	New
Form 0920-20QS CogState Time 4 Section Form	New
Form 0920-20QS CogState Time 3 Section Form	New
Form 0920-20QS CogState Time 2 Section Form	New
Form 0920-20QS CogState Time 1 Section Form	New
Form 0920-20QS Exercise (Bike) Testing Form	New
Form 0920-20QS WAIS IV DS F+B, TOPF Form	New
Form 0920-20QS CogState Baseline Section Form	New
Form 0920-20QS CogState Practice Section Form	New
Form 0920-20QS Saliva Data Collection Sheet Form and Instruction	New
Form 09920-20QS Sociability Form Form and Instruction	New
Form 0920-20QS Social Participation Form Pediatric Form and Instruction	New
Form 0920-20QS Pediatric Daytime Sleepiness Scale Form and Instruction	New
Form 0920-20QS Hospital Anxiety and Depression Scale Form and Instruction	New
Form 0920-20QS Visual Analogue Scale Form and Instruction	New
Form 0920-20QS Pediatric Pain Questionnaire (PPQ) Form and Instruction	New
Form 0920-20QS PROMIS Pediatric Instruments (Fatigue & Pain) Form and Instruction	New
Form 0920-20QS Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions Form and Instruction	New
Form 092-20QS Multidimensional Fatigue Inventory (MFI-20) Form and Instruction	New
Form 020-02QS SF-36 Health Survey Form and Instruction	New
Form 0920-20QS CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics Form and Instruction	New
Form 0920-20QS CDC Symptom Inventory: For Baseline Subjects Pediatrics Form	New
Form 0920-20QS Saliva Collection Form Form and Instruction	New
Form 09920-20QS Sociability Form Form and Instruction	New
Form 0920-20QS Social Participation Form Pediatric Form and Instruction	New
Form 0920-20QS Pediatric Daytime Sleepiness Scale Form and Instruction	New
Form 0920-20QS Hospital Anxiety and Depression Scale Form and Instruction	New
Form 0920-20QS Visual Analogue Scale Form and Instruction	New
Form 0920-20QS Pediatric Pain Questionnaire (PPQ) Form and Instruction	New
Form 0920-20QS PROMIS Pediatric Instruments (Fatigue & Pain) Form and Instruction	New
Form 0920-20QS Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions Form and Instruction	New
Form 0920-20QS Multidimensional Fatigue Inventory (MFI-20) Form and Instruction	New
Form 0920-20QS SF-36 Health Survey Form and Instruction	New
Form 0920-20QS CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics Form and Instruction	New
Form 0920-20QS CDC Symptom Inventory: For Baseline Subjects Pediatrics Form and Instruction	New
Form 09200-20QS CDC Symptom Inventory (CDC-SI)/Form B Form and Instruction	New
Form 0920-20QS COMPosite Autonomic Symptom Score 31 (COMPASS-31) Form and Instruction	New
Form 0920-20QS Orthostatic Grading Scale (OGS) Form and Instruction	New
Form 0920-20QS Saliva Data Collection Sheet Form and Instruction	New
Form 0920-20QS Illness Impact Questionnaire Form and Instruction	New
Form 0920-20QS Self-Rating Depression Scale (SDS) Form and Instruction	New
Form 0920-20QS CDC HRQoL-4 with activity limitation questions Form and Instruction	New
Form 0920-20QS CDC HRQoL-4 Form and Instruction	New
Form 0920-20QS Patient Health Questionnaire (PHQ-8), Generalized Anxiety Disorder (GAD-7), CDC Health-Related Quality of Life (HRQoL-4) Form and Instruction	New
Form 0920-20QS Brief Pain Inventory (BPI) Form and Instruction	New
Form 0920-20QS PROMIS SF - Fatigue, SD, SRI, PB, PI Form and Instruction	New
Form 0920-20QS PROMIS Short Form (PROMIS SF - Fatigue, SD, SRI, PB, PI) & Sleep Data Collection Form Form and Instruction	New
Form 0920-20QS DSQ, 18 selected questions Form and Instruction	New
Form 0920-20QS DSQ, 26 selected questions Form and Instruction	New
Form 092-20QS DePaul Symptom Questionnaire (DSQ) Form	New
Form 0920-20QS Multidimensional Fatigue Inventory (MFI-20) Form and Instruction	New
Form 0920-20QS Medical Outcomes Study Short Form 36 Form and Instruction	New
Form 092-20QS Short Form CDC-SI/Checklist Form and Instruction	New
Form 092-20QS CDC Symptom Inventory (CDC-SI) Form and Instruction	New
Form 0920-20QS CDC Symptom Inventory (CDC-SI)/Form A Form and Instruction	New
Form 0920-20QS COMPosite Autonomic Symptom Score 31 (COMPASS-31) Form and Instruction	New
Form 0920-20QS Orthostatic Grading Scale (OGS) Form and Instruction	New
Form 0920-20QS Saliva Data Collection Sheet Form and Instruction	New
Form 0920-20QS Illness Impact Questionnaire Form and Instruction	New
Form 0920-20QS Self-Rating Depression Scale (SDS) Form and Instruction	New
Form 0920-20QS CDC HRQoL-4 with activity limitation questions Form and Instruction	New
Form 0920-20QS CDC HRQoL-4 Form and Instruction	New
Form 0920-20QS Patient Health Questionnaire (PHQ-8), Generalized Anxiety Disorder (GAD-7), CDC Health-Related Quality of Life (HRQoL-4) Form and Instruction	New
Form 0920-20QS Brief Pain Inventory (BPI) Form and Instruction	New
Form 0920-20QS PROMIS SF - Fatigue, SD, SRI, PB, PI Form and Instruction	New
Form 0920-20QS PROMIS Short Form (PROMIS SF - Fatigue, SD, SRI, PB, PI) & Sleep Data Collection Form Form and Instruction	New
Form 0920-20QS DSQ, 18 selected questions Form and Instruction	New
Form 0920-20QS DSQ, 26 selected questions Form and Instruction	New
Form 0920-20QS DePaul Symptom Questionnaire (DSQ) Form and Instruction	New
Form 0920-20QS Short Form CDC-SI/Checklist Form and Instruction	New
Form 0920-20QS Multidimensional Fatigue Inventory (MFI-20) Form and Instruction	New
Form 0920-20QS Medical Outcomes Study Short Form 36 Form and Instruction	New
Form 0920-20QS CDC Symptom Inventory (CDC-SI) Form and Instruction	New
Form 0920-20QS CDC Symptom Inventory (CDC-SI)/Form B Form and Instruction	New
Form 0920-20QS CDC Symptom Inventory (CDC-SI)/Form A Form and Instruction	New
privacy narrative-DOH Basic Screening Survey 12-07-2020 rks cla.pdf Supplementary Document	2021-02-08
5_ASTDD sample screening budget.pdf Supplementary Document	2021-02-08
4_IRB exemption.pdf Supplementary Document	2021-02-08
2h_request and reminder email to states for data_03122020_clean.docx Supplementary Document	2021-02-08
2g_notice of screening results.docx Supplementary Document	2021-02-08
2d_invitation to schools.docx Supplementary Document	2021-02-08
2c_guidance on data analysis.pdf Supplementary Document	2021-02-08
2b_guidance on sampling design.pdf Supplementary Document	2021-02-08
2a_Children BSS manual 11172020_clean.docx Supplementary Document	2021-02-08
Attachment7_Responses_Public_Comments.docx Supplementary Document	2021-02-01
Attachment5_Appendices_Protocol #3_MCAM_CE_v3.pdf Supplementary Document	2021-02-01
Attachment4_Appendices_Protocol #2_MCAM_Pediatric_v3.pdf Supplementary Document	2021-02-01
Attachment3_Appendices_Protocol #1_MCMA_Adults_v3.pdf Supplementary Document	2021-02-01
Attachment1_Authorizing_Legislation.pdf Supplementary Document	2021-02-01
Supporting Statement B_MCAM.docx Supporting Statement B	2021-02-01
OMB Supporting Statement A_MCAM_20200709.docx Supporting Statement A	2021-04-06
30DAY FRN 012821.pdf Supplementary Document	2021-02-01
60DAY FRN 080320.pdf Supplementary Document	2021-02-01

IC Document Collections

IC ID	Document Title	Status
246669	Physical Activity Readiness Questionnaire Form and Instruction	New
246668	International Physical Activity Questionnaire (Self-Administered Long Form) Form and Instruction	New
246667	Physical Fitness and Exercise Activity Levels of Scale Form and Instruction	New
246666	PROMIS SF v1 – Physical Function Form	New
246665	Physical Activity Readiness Questionnaire Form and Instruction	New
246664	International Physical Activity Questionnaire (Self-Administered Long Form) Form and Instruction	New
246663	Physical Fitness and Exercise Activity Levels of Scale Form and Instruction	New
246662	PROMIS SF v1 – Physical Function Form and Instruction	New
246661	EQ-5D-Y Health Questionnaire Form and Instruction	New
246658	EQ-5D-Y Health Questionnaire Form and Instruction	New
246657	Visual Analogue Scale for CFS Symptoms Form and Instruction	New
246656	Visual Analogue Scale for CFS Symptoms Form and Instruction	New
246655	CogState Time 4 Section Form	New
246654	CogState Time 3 Section Form	New
246653	CogState Time 2 Section Form	New
246652	CogState Time 1 Section Form	New
246651	Exercise (Bike) Testing Form	New
246650	WAIS IV DS F+B, TOPF Form	New
246648	CogState Baseline Section Form	New
246647	CogState Practice Section Form	New
246646	Saliva Data Collection Sheet Form and Instruction	New
246645	Sociability Form Form and Instruction	New
246644	Social Participation Form Pediatric Form and Instruction	New
246643	Pediatric Daytime Sleepiness Scale Form and Instruction	New
246642	Hospital Anxiety and Depression Scale Form and Instruction	New
246641	Visual Analogue Scale Form and Instruction	New
246640	Pediatric Pain Questionnaire (PPQ) Form and Instruction	New
246639	PROMIS Pediatric Instruments (Fatigue & Pain) Form and Instruction	New
246638	Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions Form and Instruction	New
246637	Multidimensional Fatigue Inventory (MFI-20) Form and Instruction	New
246603	SF-36 Health Survey Form and Instruction	New
246602	CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics Form and Instruction	New
246601	CDC Symptom Inventory: For Baseline Subjects Pediatrics Form	New
246600	Saliva Collection Form Form and Instruction	New
246599	Sociability Form Form and Instruction	New
246598	Social Participation Form Pediatric Form and Instruction	New
246597	Pediatric Daytime Sleepiness Scale Form and Instruction	New
246596	Hospital Anxiety and Depression Scale Form and Instruction	New
246595	Visual Analogue Scale Form and Instruction	New
246594	Pediatric Pain Questionnaire (PPQ) Form and Instruction	New
246593	PROMIS Pediatric Instruments (Fatigue & Pain) Form and Instruction	New
246592	Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions Form and Instruction	New
246591	Multidimensional Fatigue Inventory (MFI-20) Form and Instruction	New
246590	SF-36 Health Survey Form and Instruction	New
246589	CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics Form and Instruction	New
246588	CDC Symptom Inventory: For Baseline Subjects Pediatrics Form and Instruction	New
246587	CDC Symptom Inventory (CDC-SI)/Form B Form and Instruction	New
246586	COMPosite Autonomic Symptom Score 31 (COMPASS-31) Form and Instruction	New
246585	Orthostatic Grading Scale (OGS) Form and Instruction	New
246584	Saliva Data Collection Sheet Form and Instruction	New
246583	Illness Impact Questionnaire Form and Instruction	New
246582	Self-Rating Depression Scale (SDS) Form and Instruction	New
246581	CDC HRQoL-4 with activity limitation questions Form and Instruction	New
246580	CDC HRQoL-4 Form and Instruction	New
246579	Patient Health Questionnaire (PHQ-8), Generalized Anxiety Disorder (GAD-7), CDC Health-Related Quality of Life (HRQoL-4) Form and Instruction	New
246578	Brief Pain Inventory (BPI) Form and Instruction	New
246577	PROMIS SF - Fatigue, SD, SRI, PB, PI Form and Instruction	New
246576	PROMIS Short Form (PROMIS SF - Fatigue, SD, SRI, PB, PI) & Sleep Data Collection Form Form and Instruction	New
246575	DSQ, 18 selected questions Form and Instruction	New
246574	DSQ, 26 selected questions Form and Instruction	New
246573	DePaul Symptom Questionnaire (DSQ) Form	New
246572	Multidimensional Fatigue Inventory (MFI-20) Form and Instruction	New
246571	Medical Outcomes Study Short Form 36 Form and Instruction	New
246570	Short Form CDC-SI/Checklist Form and Instruction	New
246569	CDC Symptom Inventory (CDC-SI) Form and Instruction	New
246568	CDC Symptom Inventory (CDC-SI)/Form A Form and Instruction	New
246567	COMPosite Autonomic Symptom Score 31 (COMPASS-31) Form and Instruction	New
246566	Orthostatic Grading Scale (OGS) Form and Instruction	New
246565	Saliva Data Collection Sheet Form and Instruction	New
246564	Illness Impact Questionnaire Form and Instruction	New
246563	Self-Rating Depression Scale (SDS) Form and Instruction	New
246562	CDC HRQoL-4 with activity limitation questions Form and Instruction	New
246561	CDC HRQoL-4 Form and Instruction	New
246345	Patient Health Questionnaire (PHQ-8), Generalized Anxiety Disorder (GAD-7), CDC Health-Related Quality of Life (HRQoL-4) Form and Instruction	New
246344	Brief Pain Inventory (BPI) Form and Instruction	New
246343	PROMIS SF - Fatigue, SD, SRI, PB, PI Form and Instruction	New
246342	PROMIS Short Form (PROMIS SF - Fatigue, SD, SRI, PB, PI) & Sleep Data Collection Form Form and Instruction	New
246341	DSQ, 18 selected questions Form and Instruction	New
246340	DSQ, 26 selected questions Form and Instruction	New
246339	DePaul Symptom Questionnaire (DSQ) Form and Instruction	New
246338	Short Form CDC-SI/Checklist Form and Instruction	New
246337	Multidimensional Fatigue Inventory (MFI-20) Form and Instruction	New
246336	Medical Outcomes Study Short Form 36 Form and Instruction	New
246335	CDC Symptom Inventory (CDC-SI) Form and Instruction	New
246334	CDC Symptom Inventory (CDC-SI)/Form B Form and Instruction	New
246333	CDC Symptom Inventory (CDC-SI)/Form A Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 202102-0920-001
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: 04/06/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	4,712	0
Time Burden (Hours)	711	0
Cost Burden (Dollars)	0	0

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Abstract: CDC collects state-level prevalence of dental caries and sealants among children from state oral health programs and publishes on CDC's public-facing website to 1) facilitate state oral health surveillance capacity to monitor oral health status, trends, and disparities, and to compare with other states; 2) inform planning and evaluation of oral health programs and policies; 3) measure progress toward the Healthy People objectives; and 4) educate the public and policy makers regarding cross-cutting public health programs. CDC also uses the data to evaluate performance of CDC oral health funding recipients.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: US Code: 42 USC 241 Name of Law: Public Health Service Act

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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	08/03/2020
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: 86

IC Title	Form No.	Form Name
Brief Pain Inventory (BPI)	0920-20QS	Brief Pain Inventory (BPI)
Brief Pain Inventory (BPI)	0920-20QS	Brief Pain Inventory (BPI)
CDC HRQoL-4	0920-20QS	CDC HRQoL-4
CDC HRQoL-4	0920-20QS	CDC HRQoL-4
CDC HRQoL-4 with activity limitation questions	0920-20QS	HRQoL-4 with activity limitation questions
CDC HRQoL-4 with activity limitation questions	0920-20QS	CDC HRQoL-4 with activity limitation questions
CDC Symptom Inventory (CDC-SI)	0920-20QS	CDC Symptom Inventory (CDC-SI)
CDC Symptom Inventory (CDC-SI)	092-20QS	CDC Symptom Inventory (CDC-SI)
CDC Symptom Inventory (CDC-SI)/Form A	0920-20QS	CDC Symptom Inventory (CDC-SI)/Form A
CDC Symptom Inventory (CDC-SI)/Form A	0920-20QS	CDC Symptom Inventory (CDC-SI)/Form A
CDC Symptom Inventory (CDC-SI)/Form B	09200-20QS	CDC Symptom Inventory (CDC-SI)/Form B
CDC Symptom Inventory (CDC-SI)/Form B	0920-20QS	CDC Symptom Inventory (CDC-SI)/Form B
CDC Symptom Inventory: For Baseline Subjects Pediatrics	0920-20QS	CDC Symptom Inventory: For Baseline Subjects Pediatrics
CDC Symptom Inventory: For Baseline Subjects Pediatrics	0920-20QS	CDC Symptom Inventory: For Baseline Subjects Pediatrics
CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics	0920-20QS	CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics
CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics	0920-20QS	1_CDC Symptom Inventory_For Baseline Subjects Pediatrics
COMPosite Autonomic Symptom Score 31 (COMPASS-31)	0920-20QS	COMPosite Autonomic Symptom Score 31 (COMPASS-31)
COMPosite Autonomic Symptom Score 31 (COMPASS-31)	0920-20QS	COMPosite Autonomic Symptom Score 31 (COMPASS-31)
CogState Baseline Section	0920-20QS	CogState Baseline Section
CogState Practice Section	0920-20QS	CogState Practice Section
CogState Time 1 Section	0920-20QS	CogState Time 1 Section
CogState Time 2 Section	0920-20QS	CogState Time 2 Section
CogState Time 3 Section	0920-20QS	CogState Time 3 Section
CogState Time 4 Section	0920-20QS	CogState Time 4 Section
DSQ, 18 selected questions	0920-20QS	DSQ, 18 selected questions
DSQ, 18 selected questions	0920-20QS	DSQ, 18 selected questions
DSQ, 26 selected questions	0920-20QS	DSQ, 26 selected questions
DSQ, 26 selected questions	0920-20QS	DSQ, 26 selected questions
DePaul Symptom Questionnaire (DSQ)	0920-20QS	DePaul Symptom Questionnaire (DSQ)
DePaul Symptom Questionnaire (DSQ)	092-20QS	DePaul Symptom Questionnaire (DSQ)
EQ-5D-Y Health Questionnaire	0920-20QS	EQ-5D-Y Health Questionnaire
EQ-5D-Y Health Questionnaire	0920-20QS	EQ-5D-Y Health Questionnaire
Exercise (Bike) Testing	0920-20QS	Exercise (Bike) Testing
Hospital Anxiety and Depression Scale	0920-20QS	Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale	0920-20QS	Hospital Anxiety and Depression Scale
Illness Impact Questionnaire	0920-20QS	Illness Impact Questionnaire
Illness Impact Questionnaire	0920-20QS	Illness Impact Questionnaire
International Physical Activity Questionnaire (Self-Administered Long Form)	0920-20QS	International Physical Activity Questionnaire (Self-Administered Long Form)
International Physical Activity Questionnaire (Self-Administered Long Form)	0920-20QS	International Physical Activity Questionnaire (Self-Administered Long Form)
Medical Outcomes Study Short Form 36	0920-20QS	Medical Outcomes Study Short Form 36
Medical Outcomes Study Short Form 36	0920-20QS	Medical Outcomes Study Short Form 36
Multidimensional Fatigue Inventory (MFI-20)	092-20QS	Multidimensional Fatigue Inventory (MFI-20)
Multidimensional Fatigue Inventory (MFI-20)	0920-20QS	Multidimensional Fatigue Inventory (MFI-20)
Multidimensional Fatigue Inventory (MFI-20)	0920-20QS	Multidimensional Fatigue Inventory (MFI-20)
Multidimensional Fatigue Inventory (MFI-20)	0920-20QS	Multidimensional Fatigue Inventory (MFI-20)
Orthostatic Grading Scale (OGS)	0920-20QS	Orthostatic Grading Scale (OGS)
Orthostatic Grading Scale (OGS)	0920-20QS	Orthostatic Grading Scale (OGS)
PROMIS Pediatric Instruments (Fatigue & Pain)	0920-20QS	PROMIS Pediatric Instruments (Fatigue & Pain)
PROMIS Pediatric Instruments (Fatigue & Pain)	0920-20QS	PROMIS Pediatric Instruments (Fatigue & Pain)
PROMIS SF - Fatigue, SD, SRI, PB, PI	0920-20QS	PROMIS SF - Fatigue, SD, SRI, PB, PI
PROMIS SF - Fatigue, SD, SRI, PB, PI	0920-20QS	PROMIS SF - Fatigue, SD, SRI, PB, PI
PROMIS SF v1 – Physical Function	0920-20QS	PROMIS SF v1 – Physical Function
PROMIS SF v1 – Physical Function	0920-20QS	PROMIS SF v1 – Physical Function
PROMIS Short Form (PROMIS SF - Fatigue, SD, SRI, PB, PI) & Sleep Data Collection Form	0920-20QS	PROMIS Short Form (PROMIS SF - Fatigue, SD, SRI, PB, PI) & Sleep Data Collection Form
PROMIS Short Form (PROMIS SF - Fatigue, SD, SRI, PB, PI) & Sleep Data Collection Form	0920-20QS	PROMIS Short Forms&Sleep
Patient Health Questionnaire (PHQ-8), Generalized Anxiety Disorder (GAD-7), CDC Health-Related Quality of Life (HRQoL-4)	0920-20QS	Patient Health Questionnaire_PHQ-8_GAD-7_HRQoL
Patient Health Questionnaire (PHQ-8), Generalized Anxiety Disorder (GAD-7), CDC Health-Related Quality of Life (HRQoL-4)	0920-20QS	Patient Health Questionnaire (PHQ-8), Generalized Anxiety Disorder (GAD-7), CDC Health-Related Quality of Life (HRQoL-4)
Pediatric Daytime Sleepiness Scale	0920-20QS	Pediatric Daytime Sleepiness Scale
Pediatric Daytime Sleepiness Scale	0920-20QS	Pediatric Daytime Sleepiness Scale
Pediatric Pain Questionnaire (PPQ)	0920-20QS	Pediatric Pain Questionnaire (PPQ)
Pediatric Pain Questionnaire (PPQ)	0920-20QS	Pediatric Pain Questionnaire (PPQ)
Physical Activity Readiness Questionnaire	0920-20QS	6_Physical Activity Readiness Questionnaire_PAR-Q
Physical Activity Readiness Questionnaire	0920-20QS	6_Physical Activity Readiness Questionnaire_PAR-Q
Physical Fitness and Exercise Activity Levels of Scale	020-20QS	Physical Fitness and Exercise Activity Levels of Scale
Physical Fitness and Exercise Activity Levels of Scale	020-20QS	Physical Fitness and Exercise Activity Levels of Scale
SF-36 Health Survey	0920-20QS	SF-36 Health Survey
SF-36 Health Survey	020-02QS	SF-36 Health Survey
Saliva Collection Form	0920-20QS	Saliva Collection Form
Saliva Data Collection Sheet	0920-20QS	Saliva Data Collection Sheet
Saliva Data Collection Sheet	0920-20QS	Saliva Data Collection Sheet
Saliva Data Collection Sheet	0920-20QS	Saliva Data Collection Sheet
Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions	0920-20QS	Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions
Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions	0920-20QS	Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions
Self-Rating Depression Scale (SDS)	0920-20QS	Self-Rating Depression Scale (SDS)
Self-Rating Depression Scale (SDS)	0920-20QS	Self-Rating Depression Scale_SDS
Short Form CDC-SI/Checklist	092-20QS	Short Form CDC-SI/Checklist
Short Form CDC-SI/Checklist	0920-20QS	Short Form CDC-SI/Checklist
Sociability Form	09920-20QS	Sociability Form
Sociability Form	09920-20QS	Sociability Form
Social Participation Form Pediatric	0920-20QS	Social Participation Form Pediatric
Social Participation Form Pediatric	0920-20QS	Social Participation Form Pediatric
Visual Analogue Scale	0920-20QS	Visual Analogue Scale
Visual Analogue Scale	0920-20QS	Visual Analogue Scale
Visual Analogue Scale for CFS Symptoms	0920-20QS	1_Visual Analogue Scale for CFS Symptoms
Visual Analogue Scale for CFS Symptoms	0920-20QS	1_Visual Analogue Scale for CFS Symptoms
WAIS IV DS F+B, TOPF	0920-20QS	WAIS IV DS F+B, TOPF

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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	4,712	0	0	3,147	1,565	0
Annual Time Burden (Hours)	711	0	0	443	268	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This collection 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 and requesting 711 burden hours.

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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:  This project was not previously understood to be applicable to the paperwork reduction act (PRA), but upon routine review of the contracts, it was determined that PRA is, in fact, applicable. We are pursuing OMB clearance at this time to bring the project into compliance for the remaining duration of the study.

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: 04/06/2021

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