60 Day FRN

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: [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,
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 ............................

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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) ................

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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,
[email protected]. For general
questions, you may also email the
Center for Veterinary Medicine (CVM)
at: [email protected].
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

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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

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03AUN1