Proposed Data Collection Submitted for Public Comment and Recommendations, 46633-46635 [2020-16797]
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46633
Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–16795 Filed 7–31–20; 8:45 am]
BILLING CODE 4163–18–P
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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
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.
SUMMARY:
• 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.
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,
FOR FURTHER INFORMATION CONTACT:
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 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.
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Adult
Adult
Adult
Adult
Adult
..............
..............
..............
..............
..............
VerDate Sep<11>2014
Number of
respondents
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 ............................
20:39 Jul 31, 2020
Jkt 250001
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Average
burden
per
response
(in hours)
Number of
responses
per
respondent
45
20
20
85
85
E:\FR\FM\03AUN1.SGM
1
1
1
1
1
03AUN1
12/60
10/60
8/60
10/60
7/60
Total
burden
(in hours)
9
3
3
14
10
46634
Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / 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
..............
..............
..............
..............
..............
..............
..............
..............
..............
..............
Adult ..............
Adult ..............
Adult ..............
Adult
Adult
Adult
Adult
Adult
Adult
Adult
..............
..............
..............
..............
..............
..............
..............
Pediatric .........
Pediatric .........
khammond on DSKJM1Z7X2PROD with NOTICES
Pediatric .........
Pediatric .........
Pediatric .........
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric
Pediatric
.........
.........
.........
.........
.........
.........
.........
.........
.........
Pediatric .........
Pediatric .........
Pediatric .........
Pediatric .........
Pediatric .........
VerDate Sep<11>2014
Form name
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) ................
20:39 Jul 31, 2020
Jkt 250001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Average
burden
per
response
(in hours)
Number of
responses
per
respondent
Number of
respondents
Total
burden
(in hours)
85
45
65
85
85
1
1
1
1
1
5/60
24/60
12/60
6/60
5/60
7
18
13
9
7
85
85
85
1
1
1
4/60
13/60
10/60
6
18
14
85
85
45
85
85
85
85
1
1
1
1
1
1
1
3/60
4/60
7/60
3/60
5/60
3/60
5/60
4
6
5
4
7
4
7
24
30
15
69
69
69
24
45
69
24
1
1
1
1
1
1
1
1
1
1
42/60
20/60
10/60
20/60
17/60
10/60
36/60
18/60
20/60
6/60
17
10
3
23
20
12
14
14
23
2
69
24
24
1
1
1
5/60
13/60
10/60
6
5
4
69
69
24
69
69
69
69
1
1
1
1
1
1
1
4/60
7/60
7/60
3/60
5/60
5/60
7/60
5
8
3
3
6
6
8
36
1
8/60
5
29
1
6/60
3
64
64
64
1
1
1
5/60
2/60
5/60
5
2
5
64
64
64
64
64
64
64
64
3
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
2
8
6
5
2
8
3
5
1
3
1
9/60
0
3
3
3
1
1
1
9/60
7/60
10/60
0
0
0
3
1
3/60
0
E:\FR\FM\03AUN1.SGM
03AUN1
46635
Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Total
burden
(in hours)
Pediatric .........
Pediatric .........
Pediatric .........
Pediatric .........
Pediatric .........
Pediatric .........
Pediatric .........
Adult ..............
Adult ..............
Adult ..............
Adult ..............
Adult ..............
Adult ..............
Adult ..............
Adult ..............
Adult ..............
Adult ..............
Adult ..............
Adult ..............
Adult ..............
3
3
3
3
3
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
1
1
1
1
1
15/60
8/60
7/60
3/60
10/60
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
1
0
0
0
0
0
0
31
49
18
32
40
22
22
22
8
6
5
2
5
60
49
49
49
49
49
1
1
1
1
1
1
5/60
8/60
6/60
5/60
2/60
5/60
5
6
5
4
2
4
Adult ..............
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 .........................................................
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 .........................
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]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0806]
Animal Drug User Fee Rates and
Payment Procedures for Fiscal Year
2021
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
fee rates and payment procedures for
fiscal year (FY) 2021 animal drug user
fees. The Federal Food, Drug, and
Cosmetic Act (FD&C Act), as amended
by the Animal Drug User Fee
Amendments of 2018 (ADUFA IV),
authorizes FDA to collect user fees for
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Average
burden
per
response
(in hours)
Form name
Adult
Adult
Adult
Adult
Adult
Adult
VerDate Sep<11>2014
20:39 Jul 31, 2020
Jkt 250001
Number of
respondents
Number of
responses
per
respondent
Type of
respondents
certain animal drug applications and
supplements, for certain animal drug
products, for certain establishments
where such products are made, and for
certain sponsors of such animal drug
applications and/or investigational
animal drug submissions. This notice
establishes the fee rates for FY 2021.
FOR FURTHER INFORMATION CONTACT: Visit
FDA’s website at https://www.fda.gov/
ForIndustry/UserFees/AnimalDrug
UserFeeActADUFA/default.htm or
contact Lisa Kable, Center for Veterinary
Medicine (HFV–10), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–6888,
Lisa.Kable@fda.hhs.gov. For general
questions, you may also email the
Center for Veterinary Medicine (CVM)
at: cvmadufa@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 740 of the FD&C Act (21
U.S.C. 379j–12) establishes four
different types of user fees: (1) Fees for
certain types of animal drug
applications and supplements; (2)
annual fees for certain animal drug
products; (3) annual fees for certain
establishments where such products are
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
made; and (4) annual fees for certain
sponsors of animal drug applications
and/or investigational animal drug
submissions (21 U.S.C. 379j–12(a)).
When certain conditions are met, FDA
will waive or reduce fees (21 U.S.C.
379j–12(d)).
For FYs 2019 through 2023, the FD&C
Act establishes aggregate yearly base
revenue amounts for each fiscal year (21
U.S.C. 379j–12(b)(1)). Base revenue
amounts are subject to adjustment for
inflation and workload (21 U.S.C. 379j–
12(c)(2) and (3)). Beginning with FY
2021, the annual fee revenue amounts
are also subject to adjustment to reduce
workload-based increases by the amount
of certain excess collections or to
account for certain collection shortfalls.
(21 U.S.C. 379j–12(c)(3) and (g)(5)). Fees
for applications, establishments,
products, and sponsors are to be
established each year by FDA so that the
percentages of the total revenue that are
derived from each type of user fee will
be as follows: (1) Revenue from
application fees shall be 20 percent of
total fee revenue; (2) revenue from
product fees shall be 27 percent of total
fee revenue; (3) revenue from
establishment fees shall be 26 percent of
E:\FR\FM\03AUN1.SGM
03AUN1
]]>Agencies
[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46633-46635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16797]
-----------------------------------------------------------------------
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:
[email protected].
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hours) (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
[[Page 46634]]
Adult.......................................... Multidimensional Fatigue Inventory (MFI- 85 1 5/60 7
20).
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, 85 1 5/60 7
SD, SRI, PB, PI) & Sleep Data
Collection Form.
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), 85 1 10/60 14
Generalized Anxiety Disorder (GAD-7),
CDC Health-Related Quality of Life
(HRQoL-4).
Adult.......................................... CDC HRQoL-4............................ 85 1 3/60 4
Adult.......................................... CDC HRQoL-4 with activity limitation 85 1 4/60 6
questions.
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 85 1 5/60 7
(COMPASS-31).
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- 69 1 10/60 12
20).
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, 24 1 6/60 2
SD, SRI, PB, PI) & Sleep Data
Collection Form.
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), 24 1 10/60 4
Generalized Anxiety Disorder (GAD-7),
CDC Health-Related Quality of Life
(HRQoL-4).
Adult.......................................... CDC HRQoL-4............................ 69 1 4/60 5
Adult.......................................... CDC HRQoL-4 with activity limitation 69 1 7/60 8
questions.
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 69 1 7/60 8
(COMPASS-31).
Pediatric...................................... CDC Symptom Inventory: For Baseline 36 1 8/60 5
Subjects Pediatrics.
Pediatric...................................... CDC Symptom Inventory: For the Follow- 29 1 6/60 3
Up Subjects Pediatrics.
Pediatric...................................... SF-36 Health Survey.................... 64 1 5/60 5
Pediatric...................................... Multidimensional Fatigue Inventory (MFI- 64 1 2/60 2
20).
Pediatric...................................... Selected Questions from DePaul 64 1 5/60 5
Pediatric Health Questionnaire (DPHQ),
19 Questions.
Pediatric...................................... PROMIS Pediatric Instruments (Fatigue & 64 1 2/60 2
Pain).
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 3 1 20/60 1
Subjects Pediatrics.
Pediatric...................................... CDC Symptom Inventory: For the Follow- 3 1 9/60 0
Up Subjects Pediatrics.
Pediatric...................................... SF-36 Health Survey.................... 3 1 9/60 0
Pediatric...................................... Multidimensional Fatigue Inventory (MFI- 3 1 7/60 0
20).
Pediatric...................................... Selected Questions from DePaul 3 1 10/60 0
Pediatric Health Questionnaire (DPHQ),
19 Questions.
Pediatric...................................... PROMIS Pediatric Instruments (Fatigue & 3 1 3/60 0
Pain).
[[Page 46635]]
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 60 1 2/60 2
Levels of Scale.
Adult.......................................... International Physical Activity 60 1 5/60 5
Questionnaire (Self-Administered Long
Form).
Adult.......................................... Physical Activity Readiness 60 1 5/60 5
Questionnaire.
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 49 1 2/60 2
Levels of Scale.
Adult.......................................... International Physical Activity 49 1 5/60 4
Questionnaire (Self-Administered Long
Form).
Adult.......................................... Physical Activity Readiness 49 1 5/60 4
Questionnaire.
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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]
BILLING CODE 4163-18-P
