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 Department of Health and Human Services Centers for Disease Control and Prevention [30Day-21-20QS]
 In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Proposed Data Collection Multi-Site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM)” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a 60-day notice titled “Proposed Data Collection Submitted for Public Comment and Recommendations” on August 3, 2020 to obtain comments from the public and affected agencies. CDC received three comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments. CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, 
                    *e.g.,*
                     permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                    *www.reginfo.gov/​public/​do/​PRAMain.*
                     Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication. Proposed Project Multi-Site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM)—Existing collection in use without an OMB Control Number—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description This Multi-site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM) study uses a standardized approach for data collection to examine the heterogeneity of patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (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. Children and adolescents with ME/CFS and healthy participants were also enrolled. The MCAM study has been conducted in multiple stages following multiple study protocols. The time burden estimates are based on the 2012-2019 data collection, which is the most recent stage of data collection completed. Estimated Annualized Burden Hours
Type of
                             respondents
Form name
Number of
                             participants
Number of
                             responses per 
                             participant
Average
                             burden per 
                             response 
                             (in hrs.)Adult
CDC Symptom Inventory (CDC-SI)/Form A
45
1
12/60Adult
CDC Symptom Inventory (CDC-SI)/Form B
20
1
10/60Adult
CDC Symptom Inventory (CDC-SI)
20
1
8/60Adult
Short Form CDC-SI/Checklist
85
1
10/60Adult
Medical Outcomes Study Short Form 36
85
1
7/60( print page 7395)Adult
Multidimensional Fatigue Inventory (MFI-20)
85
1
5/60Adult
DePaul Symptom Questionnaire (DSQ)
45
1
24/60Adult
DSQ, 26 selected questions
65
1
12/60Adult
DSQ, 18 selected questions
85
1
6/60Adult
PROMIS Short Form (PROMIS SF—Fatigue, SD, SRI, PB, PI) & Sleep Data Collection Form
85
1
5/60Adult
PROMIS SF—Fatigue, SD, SRI, PB, PI
85
1
4/60Adult
Brief Pain Inventory (BPI)
85
1
13/60Adult
Patient Health Questionnaire (PHQ-8), Generalized Anxiety Disorder (GAD-7), CDC Health-Related Quality of Life (HRQoL-4)
85
1
10/60Adult
CDC HRQoL-4
85
1
3/60Adult
CDC HRQoL-4 with activity limitation questions
85
1
4/60Adult
Self-Rating Depression Scale (SDS)
45
1
7/60Adult
Illness Impact Questionnaire
85
1
3/60Adult
Saliva Data Collection Sheet
85
1
5/60Adult
Orthostatic Grading Scale (OGS)
85
1
3/60Adult
COMPosite Autonomic Symptom Score 31 (COMPASS-31)
85
1
5/60Adult
CDC Symptom Inventory (CDC-SI)/Form A
24
1
42/60Adult
CDC Symptom Inventory (CDC-SI)/Form B
30
1
20/60Adult
CDC Symptom Inventory (CDC-SI)
15
1
10/60Adult
Short Form CDC-SI/Checklist
69
1
20/60Adult
Medical Outcomes Study Short Form 36
69
1
17/60Adult
Multidimensional Fatigue Inventory (MFI-20)
69
1
10/60Adult
DePaul Symptom Questionnaire (DSQ)
24
1
36/60Adult
DSQ, 26 selected questions
45
1
18/60Adult
DSQ, 18 selected questions
69
1
20/60Adult
PROMIS Short Form (PROMIS SF—Fatigue, SD, SRI, PB, PI) & Sleep Data Collection Form
24
1
6/60Adult
PROMIS SF—Fatigue, SD, SRI, PB, PI
69
1
5/60Adult
Brief Pain Inventory (BPI)
24
1
13/60Adult
Patient Health Questionnaire (PHQ-8), Generalized Anxiety Disorder (GAD-7), CDC Health-Related Quality of Life (HRQoL-4)
24
1
10/60Adult
CDC HRQoL-4
69
1
4/60Adult
CDC HRQoL-4 with activity limitation questions
69
1
7/60Adult
Self-Rating Depression Scale (SDS)
24
1
7/60Adult
Illness Impact Questionnaire
69
1
3/60Adult
Saliva Data Collection Sheet
69
1
5/60Adult
Orthostatic Grading Scale (OGS)
69
1
5/60Adult
COMPosite Autonomic Symptom Score 31 (COMPASS-31)
69
1
7/60Pediatric
CDC Symptom Inventory: For Baseline Subjects Pediatrics
36
1
8/60Pediatric
CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics
29
1
6/60Pediatric
SF-36 Health Survey
64
1
5/60Pediatric
Multidimensional Fatigue Inventory (MFI-20)
64
1
2/60Pediatric
Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions
64
1
5/60Pediatric
PROMIS Pediatric Instruments (Fatigue & Pain)
64
1
2/60Pediatric
Pediatric Pain Questionnaire (PPQ)
64
1
7/60Pediatric
Visual Analogue Scale
64
1
6/60Pediatric
Hospital Anxiety and Depression Scale
64
1
5/60Pediatric
Pediatric Daytime Sleepiness Scale
64
1
2/60Pediatric
Social Participation Form Pediatric
64
1
7/60Pediatric
Sociability Form
64
1
3/60Pediatric
Saliva Collection Form
64
1
5/60Pediatric
CDC Symptom Inventory: For Baseline Subjects Pediatrics
3
1
20/60Pediatric
CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics
3
1
9/60Pediatric
SF-36 Health Survey
3
1
9/60Pediatric
Multidimensional Fatigue Inventory (MFI-20)
3
1
7/60Pediatric
Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions
3
1
10/60Pediatric
PROMIS Pediatric Instruments (Fatigue & Pain)
3
1
3/60Pediatric
Pediatric Pain Questionnaire (PPQ)
3
1
15/60Pediatric
Visual Analogue Scale
3
1
8/60Pediatric
Hospital Anxiety and Depression Scale
3
1
7/60Pediatric
Pediatric Daytime Sleepiness Scale
3
1
3/60Pediatric
Social Participation Form Pediatric
3
1
10/60( print page 7396)Pediatric
Sociability Form
3
1
5/60Pediatric
Saliva Collection Form
3
1
5/60Adult
CogState Practice Section
109
1
17/60Adult
CogState Baseline Section
109
1
27/60Adult
WAIS IV DS F+B, TOPF
109
1
10/60Adult
Exercise (Bike) Testing
64
1
30/60Adult
CogState Time 1 Section
109
1
22/60Adult
CogState Time 2 Section
109
1
12/60Adult
CogState Time 3 Section
109
1
12/60Adult
CogState Time 4 Section
109
1
12/60Adult
Visual Analogue Scale for CFS Symptoms
60
1
8/60Adult
EQ-5D-Y Health Questionnaire
60
1
6/60Adult
PROMIS SF v1—Physical Function
60
1
5/60Adult
Physical Fitness and Exercise Activity Levels of Scale
60
1
2/60Adult
International Physical Activity Questionnaire (Self-Administered Long Form)
60
1
5/60Adult
Physical Activity Readiness Questionnaire
60
1
5/60Adult
Visual Analogue Scale for CFS Symptoms
49
1
8/60Adult
EQ-5D-Y Health Questionnaire
49
1
6/60Adult
PROMIS SF v1—Physical Function
49
1
5/60Adult
Physical Fitness and Exercise Activity Levels of Scale
49
1
2/60Adult
International Physical Activity Questionnaire (Self-Administered Long Form)
49
1
5/60Adult
Physical Activity Readiness Questionnaire
49
1
5/60
 Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.


[FR Doc. 2021-01914 Filed 1-27-21; 8:45 am] BILLING CODE 4163-18-P