[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]


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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.

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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
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                                                                                                             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.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  .......................................             715
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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