Proposed Data Collection Submitted for Public Comment and Recommendations
Federal RegisterAug 3, 2020
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-20-20QS; Docket No. CDC-2020-0086]
Proposed Data Collection Submitted for Public Comment and Recommendations
AGENCY:
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
ACTION:
Notice with comment period.
SUMMARY:
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Multi-site Clinical Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM). This collection is designed to assess and characterize illness heterogeneity of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), and uses a standardized approach including standardized protocols with standardized tests and instruments to collect data on patients from multiple clinical practices.
DATES:
CDC must receive written comments on or before October 2, 2020.
ADDRESSES:
You may submit comments, identified by Docket No. CDC-2020-0086 by any of the following methods:
•
Federal eRulemaking Portal:
Regulations.gov
. Follow the instructions for submitting comments.
•
Mail:
Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329.
Instructions:
All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to
Regulations.gov
.
Please note:
Submit all comments through the Federal eRulemaking portal (
regulations.gov
) or by U.S. mail to the address listed above.
FOR FURTHER INFORMATION CONTACT:
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7118; Email:
omb@cdc.gov.
SUPPLEMENTARY INFORMATION:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Federal Register
concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. 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 submissions of responses.
5. Assess information collection costs.
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
respondents
Number of
responses
per
respondent
Average
burden
per
response
(in hours)
Total
burden
(in hours)
Adult
CDC Symptom Inventory (CDC-SI)/Form A
45
1
12/60
9
Adult
CDC Symptom Inventory (CDC-SI)/Form B
20
1
10/60
3
Adult
CDC Symptom Inventory (CDC-SI)
20
1
8/60
3
Adult
Short Form CDC-SI/Checklist
85
1
10/60
14
Adult
Medical Outcomes Study Short Form 36
85
1
7/60
10
Adult
Multidimensional Fatigue Inventory (MFI-20)
85
1
5/60
7
Adult
DePaul Symptom Questionnaire (DSQ)
45
1
24/60
18
Adult
DSQ, 26 selected questions
65
1
12/60
13
Adult
DSQ, 18 selected questions
85
1
6/60
9
Adult
PROMIS Short Form (PROMIS SF—Fatigue, SD, SRI, PB, PI) & Sleep Data Collection Form
85
1
5/60
7
Adult
PROMIS SF—Fatigue, SD, SRI, PB, PI
85
1
4/60
6
Adult
Brief Pain Inventory (BPI)
85
1
13/60
18
Adult
Patient Health Questionnaire (PHQ-8), Generalized Anxiety Disorder (GAD-7), CDC Health-Related Quality of Life (HRQoL-4)
85
1
10/60
14
Adult
CDC HRQoL-4
85
1
3/60
4
Adult
CDC HRQoL-4 with activity limitation questions
85
1
4/60
6
Adult
Self-Rating Depression Scale (SDS)
45
1
7/60
5
Adult
Illness Impact Questionnaire
85
1
3/60
4
Adult
Saliva Data Collection Sheet
85
1
5/60
7
Adult
Orthostatic Grading Scale (OGS)
85
1
3/60
4
Adult
COMPosite Autonomic Symptom Score 31 (COMPASS-31)
85
1
5/60
7
Adult
CDC Symptom Inventory (CDC-SI)/Form A
24
1
42/60
17
Adult
CDC Symptom Inventory (CDC-SI)/Form B
30
1
20/60
10
Adult
CDC Symptom Inventory (CDC-SI)
15
1
10/60
3
Adult
Short Form CDC-SI/Checklist
69
1
20/60
23
Adult
Medical Outcomes Study Short Form 36
69
1
17/60
20
Adult
Multidimensional Fatigue Inventory (MFI-20)
69
1
10/60
12
Adult
DePaul Symptom Questionnaire (DSQ)
24
1
36/60
14
Adult
DSQ, 26 selected questions
45
1
18/60
14
Adult
DSQ, 18 selected questions
69
1
20/60
23
Adult
PROMIS Short Form (PROMIS SF—Fatigue, SD, SRI, PB, PI) & Sleep Data Collection Form
24
1
6/60
2
Adult
PROMIS SF—Fatigue, SD, SRI, PB, PI
69
1
5/60
6
Adult
Brief Pain Inventory (BPI)
24
1
13/60
5
Adult
Patient Health Questionnaire (PHQ-8), Generalized Anxiety Disorder (GAD-7), CDC Health-Related Quality of Life (HRQoL-4)
24
1
10/60
4
Adult
CDC HRQoL-4
69
1
4/60
5
Adult
CDC HRQoL-4 with activity limitation questions
69
1
7/60
8
Adult
Self-Rating Depression Scale (SDS)
24
1
7/60
3
Adult
Illness Impact Questionnaire
69
1
3/60
3
Adult
Saliva Data Collection Sheet
69
1
5/60
6
Adult
Orthostatic Grading Scale (OGS)
69
1
5/60
6
Adult
COMPosite Autonomic Symptom Score 31 (COMPASS-31)
69
1
7/60
8
Pediatric
CDC Symptom Inventory: For Baseline Subjects Pediatrics
36
1
8/60
5
Pediatric
CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics
29
1
6/60
3
Pediatric
SF-36 Health Survey
64
1
5/60
5
Pediatric
Multidimensional Fatigue Inventory (MFI-20)
64
1
2/60
2
Pediatric
Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions
64
1
5/60
5
Pediatric
PROMIS Pediatric Instruments (Fatigue & Pain)
64
1
2/60
2
Pediatric
Pediatric Pain Questionnaire (PPQ)
64
1
7/60
8
Pediatric
Visual Analogue Scale
64
1
6/60
6
Pediatric
Hospital Anxiety and Depression Scale
64
1
5/60
5
Pediatric
Pediatric Daytime Sleepiness Scale
64
1
2/60
2
Pediatric
Social Participation Form Pediatric
64
1
7/60
8
Pediatric
Sociability Form
64
1
3/60
3
Pediatric
Saliva Collection Form
64
1
5/60
5
Pediatric
CDC Symptom Inventory: For Baseline Subjects Pediatrics
3
1
20/60
1
Pediatric
CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics
3
1
9/60
0
Pediatric
SF-36 Health Survey
3
1
9/60
0
Pediatric
Multidimensional Fatigue Inventory (MFI-20)
3
1
7/60
0
Pediatric
Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions
3
1
10/60
0
Pediatric
PROMIS Pediatric Instruments (Fatigue & Pain)
3
1
3/60
0
Pediatric
Pediatric Pain Questionnaire (PPQ)
3
1
15/60
1
Pediatric
Visual Analogue Scale
3
1
8/60
0
Pediatric
Hospital Anxiety and Depression Scale
3
1
7/60
0
Pediatric
Pediatric Daytime Sleepiness Scale
3
1
3/60
0
Pediatric
Social Participation Form Pediatric
3
1
10/60
0
Pediatric
Sociability Form
3
1
5/60
0
Pediatric
Saliva Collection Form
3
1
5/60
0
Adult
CogState Practice Section
109
1
17/60
31
Adult
CogState Baseline Section
109
1
27/60
49
Adult
WAIS IV DS F+B, TOPF
109
1
10/60
18
Adult
Exercise (Bike) Testing
64
1
30/60
32
Adult
CogState Time 1 Section
109
1
22/60
40
Adult
CogState Time 2 Section
109
1
12/60
22
Adult
CogState Time 3 Section
109
1
12/60
22
Adult
CogState Time 4 Section
109
1
12/60
22
Adult
Visual Analogue Scale for CFS Symptoms
60
1
8/60
8
Adult
EQ-5D-Y Health Questionnaire
60
1
6/60
6
Adult
PROMIS SF v1—Physical Function
60
1
5/60
5
Adult
Physical Fitness and Exercise Activity Levels of Scale
60
1
2/60
2
Adult
International Physical Activity Questionnaire (Self-Administered Long Form)
60
1
5/60
5
Adult
Physical Activity Readiness Questionnaire
60
1
5/60
5
Adult
Visual Analogue Scale for CFS Symptoms
49
1
8/60
6
Adult
EQ-5D-Y Health Questionnaire
49
1
6/60
5
Adult
PROMIS SF v1—Physical Function
49
1
5/60
4
Adult
Physical Fitness and Exercise Activity Levels of Scale
49
1
2/60
2
Adult
International Physical Activity Questionnaire (Self-Administered Long Form)
49
1
5/60
4
Adult
Physical Activity Readiness Questionnaire
49
1
5/60
4
Total
715
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.
[FR Doc. 2020-16797 Filed 7-31-20; 8:45 am]
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