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

ICR 202102-0920-001

OMB:

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Supplementary Document
2021-02-08
Supplementary Document
2021-02-08
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2021-02-08
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2021-02-08
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2021-02-08
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2021-02-08
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2021-02-08
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2021-02-08
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2021-02-08
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2021-02-01
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2021-02-01
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2021-02-01
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2021-02-01
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2021-02-01
Supporting Statement B
2021-02-01
Supporting Statement A
2021-04-06
Supplementary Document
2021-02-01
Supplementary Document
2021-02-01
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ICR Details
202102-0920-001
Received in OIRA
HHS/CDC 0920-20QS
Multi-site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM)
Existing collection in use without an OMB Control Number   Yes
Regular 04/06/2021
  Requested Previously Approved
36 Months From Approved
4,712 0
711 0
0 0

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.

None
US Code: 42 USC 241 Name of Law: Public Health Service Act

Not associated with rulemaking

  85 FR 46633 08/03/2020
86 FR 7394 01/28/2021
Yes

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

  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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.

$1,220,000
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Odion Clunis 770 488-0045 [email protected]

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

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
04/06/2021


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