30 Day FRN

30DAY FRN 012821.pdf

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

30 Day FRN

OMB:

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7394

Federal Register / Vol. 86, No. 17 / Thursday, January 28, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents

Number of
respondents

Form name

Actual Experiment 1—Mobile Robot .............................
Actual Experiment 2—Collaborative Robot ..................
NASA Task Load Index ................................................
Perceived Safety Questionnaire ...................................
Robot Trust Questionnaire ............................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–01692 Filed 1–27–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–20QS]

Agency Forms Undergoing Paperwork
Reduction Act Review
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

Number of
responses per
respondent

37
37
37
37
37

Average
burden per
response
(in hours)

1
1
63
63
63

70/60
70/60
1/60
1/60
1/60

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 evidencebased 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
Adult
Adult
Adult
Adult
Adult

........................................
........................................
........................................
........................................
........................................

VerDate Sep<11>2014

17:16 Jan 27, 2021

Number of
participants

Form name

CDC Symptom Inventory (CDC–SI)/Form A ..........................
CDC Symptom Inventory (CDC–SI)/Form B ..........................
CDC Symptom Inventory (CDC–SI) .......................................
Short Form CDC–SI/Checklist ...............................................
Medical Outcomes Study Short Form 36 ...............................

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45
20
20
85
85

28JAN1

Number of
responses per
participant
1
1
1
1
1

Average
burden per
response
(in hrs.)
12/60
10/60
8/60
10/60
7/60

7395

Federal Register / Vol. 86, No. 17 / Thursday, January 28, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of
respondents
Adult
Adult
Adult
Adult
Adult

........................................
........................................
........................................
........................................
........................................

Adult ........................................
Adult ........................................
Adult ........................................
Adult
Adult
Adult
Adult
Adult
Adult
Adult
Adult
Adult
Adult
Adult
Adult
Adult
Adult
Adult
Adult
Adult

........................................
........................................
........................................
........................................
........................................
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Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Pediatric ..................................
Pediatric ..................................
Pediatric ..................................
Pediatric ..................................
Pediatric ..................................
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric

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Pediatric ..................................
Pediatric ..................................
Pediatric ..................................
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric

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..................................
..................................
..................................
..................................
..................................

VerDate Sep<11>2014

17:16 Jan 27, 2021

Multidimensional Fatigue Inventory (MFI–20) ........................
DePaul Symptom Questionnaire (DSQ) ................................
DSQ, 26 selected questions ..................................................
DSQ, 18 selected questions ..................................................
PROMIS Short Form (PROMIS SF—Fatigue, SD, SRI, PB,
PI) & Sleep Data Collection Form.
PROMIS SF—Fatigue, SD, SRI, PB, PI ................................
Brief Pain Inventory (BPI) ......................................................
Patient Health Questionnaire (PHQ–8), Generalized Anxiety
Disorder (GAD–7), CDC Health-Related Quality of Life
(HRQoL–4).
CDC HRQoL–4 .......................................................................
CDC HRQoL–4 with activity limitation questions ...................
Self-Rating Depression Scale (SDS) .....................................
Illness Impact Questionnaire ..................................................
Saliva Data Collection Sheet .................................................
Orthostatic Grading Scale (OGS) ..........................................
COMPosite Autonomic Symptom Score 31 (COMPASS–31)
CDC Symptom Inventory (CDC–SI)/Form A ..........................
CDC Symptom Inventory (CDC–SI)/Form B ..........................
CDC Symptom Inventory (CDC–SI) .......................................
Short Form CDC–SI/Checklist ...............................................
Medical Outcomes Study Short Form 36 ...............................
Multidimensional Fatigue Inventory (MFI–20) ........................
DePaul Symptom Questionnaire (DSQ) ................................
DSQ, 26 selected questions ..................................................
DSQ, 18 selected questions ..................................................
PROMIS Short Form (PROMIS SF—Fatigue, SD, SRI, PB,
PI) & Sleep Data Collection Form.
PROMIS SF—Fatigue, SD, SRI, PB, PI ................................
Brief Pain Inventory (BPI) ......................................................
Patient Health Questionnaire (PHQ–8), Generalized Anxiety
Disorder (GAD–7), CDC Health-Related Quality of Life
(HRQoL–4).
CDC HRQoL–4 .......................................................................
CDC HRQoL–4 with activity limitation questions ...................
Self-Rating Depression Scale (SDS) .....................................
Illness Impact Questionnaire ..................................................
Saliva Data Collection Sheet .................................................
Orthostatic Grading Scale (OGS) ..........................................
COMPosite Autonomic Symptom Score 31 (COMPASS–31)
CDC Symptom Inventory: For Baseline Subjects Pediatrics
CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics.
SF–36 Health Survey .............................................................
Multidimensional Fatigue Inventory (MFI–20) ........................
Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions.
PROMIS Pediatric Instruments (Fatigue & Pain) ...................
Pediatric Pain Questionnaire (PPQ) ......................................
Visual Analogue Scale ...........................................................
Hospital Anxiety and Depression Scale .................................
Pediatric Daytime Sleepiness Scale ......................................
Social Participation Form Pediatric ........................................
Sociability Form ......................................................................
Saliva Collection Form ...........................................................
CDC Symptom Inventory: For Baseline Subjects Pediatrics
CDC Symptom Inventory: For the Follow-Up Subjects Pediatrics.
SF–36 Health Survey .............................................................
Multidimensional Fatigue Inventory (MFI–20) ........................
Selected Questions from DePaul Pediatric Health Questionnaire (DPHQ), 19 Questions.
PROMIS Pediatric Instruments (Fatigue & Pain) ...................
Pediatric Pain Questionnaire (PPQ) ......................................
Visual Analogue Scale ...........................................................
Hospital Anxiety and Depression Scale .................................
Pediatric Daytime Sleepiness Scale ......................................
Social Participation Form Pediatric ........................................

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Number of
responses per
participant

Number of
participants

Form name

Sfmt 4703

E:\FR\FM\28JAN1.SGM

Average
burden per
response
(in hrs.)

85
45
65
85
85

1
1
1
1
1

5/60
24/60
12/60
6/60
5/60

85
85
85

1
1
1

4/60
13/60
10/60

85
85
45
85
85
85
85
24
30
15
69
69
69
24
45
69
24

1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1

3/60
4/60
7/60
3/60
5/60
3/60
5/60
42/60
20/60
10/60
20/60
17/60
10/60
36/60
18/60
20/60
6/60

69
24
24

1
1
1

5/60
13/60
10/60

69
69
24
69
69
69
69
36
29

1
1
1
1
1
1
1
1
1

4/60
7/60
7/60
3/60
5/60
5/60
7/60
8/60
6/60

64
64
64

1
1
1

5/60
2/60
5/60

64
64
64
64
64
64
64
64
3
3

1
1
1
1
1
1
1
1
1
1

2/60
7/60
6/60
5/60
2/60
7/60
3/60
5/60
20/60
9/60

3
3
3

1
1
1

9/60
7/60
10/60

3
3
3
3
3
3

1
1
1
1
1
1

3/60
15/60
8/60
7/60
3/60
10/60

28JAN1

7396

Federal Register / Vol. 86, No. 17 / Thursday, January 28, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of
respondents

Form name

Pediatric ..................................
Pediatric ..................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................
Adult ........................................

Sociability Form ......................................................................
Saliva Collection Form ...........................................................
CogState Practice Section .....................................................
CogState Baseline Section ....................................................
WAIS IV DS F+B, TOPF ........................................................
Exercise (Bike) Testing ..........................................................
CogState Time 1 Section .......................................................
CogState Time 2 Section .......................................................
CogState Time 3 Section .......................................................
CogState Time 4 Section .......................................................
Visual Analogue Scale for CFS Symptoms ...........................
EQ–5D–Y Health Questionnaire ............................................
PROMIS SF v1—Physical Function .......................................
Physical Fitness and Exercise Activity Levels of Scale .........
International Physical Activity Questionnaire (Self-Administered Long Form).
Physical Activity Readiness Questionnaire ............................
Visual Analogue Scale for CFS Symptoms ...........................
EQ–5D–Y Health Questionnaire ............................................
PROMIS SF v1—Physical Function .......................................
Physical Fitness and Exercise Activity Levels of Scale .........
International Physical Activity Questionnaire (Self-Administered Long Form).
Physical Activity Readiness Questionnaire ............................

Adult
Adult
Adult
Adult
Adult
Adult

........................................
........................................
........................................
........................................
........................................
........................................

Adult ........................................

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

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–1129]

Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Improving Fetal
Alcohol Spectrum Disorders Prevention
and Practice through National
Partnerships to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on October
13, 2020 to obtain comments from the
public and affected agencies. CDC did
not receive 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.

VerDate Sep<11>2014

17:16 Jan 27, 2021

Jkt 253001

Number of
participants

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

PO 00000

Frm 00044

Fmt 4703

Sfmt 4703

Number of
responses per
participant

Average
burden per
response
(in hrs.)

3
3
109
109
109
64
109
109
109
109
60
60
60
60
60

1
1
1
1
1
1
1
1
1
1
1
1
1
1
1

5/60
5/60
17/60
27/60
10/60
30/60
22/60
12/60
12/60
12/60
8/60
6/60
5/60
2/60
5/60

60
49
49
49
49
49

1
1
1
1
1
1

5/60
8/60
6/60
5/60
2/60
5/60

49

1

5/60

‘‘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
Improving Fetal Alcohol Spectrum
Disorders Prevention and Practice
through National Partnerships (OMB
Control No. 0920–1129, Exp. 8/31/
2019)—Reinstatement with Change—
National Centrer for Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The National Center on Birth Defects
and Developmental Disabilities
(NCBDDD) seeks to collect training
evaluation data from healthcare
practitioners and staff in health systems
where FASD-related practice and
systems changes are implemented, and
from grantees of national partner
organizations related to prevention,
identification, and treatment of fetal
alcohol spectrum disorders (FASDs).
Prenatal exposure to alcohol is a
leading preventable cause of birth
defects and developmental disabilities.

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28JAN1


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File Created2021-01-28

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