[Federal Register Volume 86, Number 17 (Thursday, January 28, 2021)]
[Notices]
[Pages 7394-7396]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01914]


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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 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 
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
                                                                   participants     participant      (in hrs.)
----------------------------------------------------------------------------------------------------------------
Adult..............................  CDC Symptom Inventory (CDC-              45               1           12/60
                                      SI)/Form A.
Adult..............................  CDC Symptom Inventory (CDC-              20               1           10/60
                                      SI)/Form B.
Adult..............................  CDC Symptom Inventory (CDC-              20               1            8/60
                                      SI).
Adult..............................  Short Form CDC-SI/Checklist              85               1           10/60
Adult..............................  Medical Outcomes Study                   85               1            7/60
                                      Short Form 36.

[[Page 7395]]

 
Adult..............................  Multidimensional Fatigue                 85               1            5/60
                                      Inventory (MFI-20).
Adult..............................  DePaul Symptom                           45               1           24/60
                                      Questionnaire (DSQ).
Adult..............................  DSQ, 26 selected questions.              65               1           12/60
Adult..............................  DSQ, 18 selected questions.              85               1            6/60
Adult..............................  PROMIS Short Form (PROMIS                85               1            5/60
                                      SF--Fatigue, SD, SRI, PB,
                                      PI) & Sleep Data
                                      Collection Form.
Adult..............................  PROMIS SF--Fatigue, SD,                  85               1            4/60
                                      SRI, PB, PI.
Adult..............................  Brief Pain Inventory (BPI).              85               1           13/60
Adult..............................  Patient Health                           85               1           10/60
                                      Questionnaire (PHQ-8),
                                      Generalized Anxiety
                                      Disorder (GAD-7), CDC
                                      Health-Related Quality of
                                      Life (HRQoL-4).
Adult..............................  CDC HRQoL-4................              85               1            3/60
Adult..............................  CDC HRQoL-4 with activity                85               1            4/60
                                      limitation questions.
Adult..............................  Self-Rating Depression                   45               1            7/60
                                      Scale (SDS).
Adult..............................  Illness Impact                           85               1            3/60
                                      Questionnaire.
Adult..............................  Saliva Data Collection                   85               1            5/60
                                      Sheet.
Adult..............................  Orthostatic Grading Scale                85               1            3/60
                                      (OGS).
Adult..............................  COMPosite Autonomic Symptom              85               1            5/60
                                      Score 31 (COMPASS-31).
Adult..............................  CDC Symptom Inventory (CDC-              24               1           42/60
                                      SI)/Form A.
Adult..............................  CDC Symptom Inventory (CDC-              30               1           20/60
                                      SI)/Form B.
Adult..............................  CDC Symptom Inventory (CDC-              15               1           10/60
                                      SI).
Adult..............................  Short Form CDC-SI/Checklist              69               1           20/60
Adult..............................  Medical Outcomes Study                   69               1           17/60
                                      Short Form 36.
Adult..............................  Multidimensional Fatigue                 69               1           10/60
                                      Inventory (MFI-20).
Adult..............................  DePaul Symptom                           24               1           36/60
                                      Questionnaire (DSQ).
Adult..............................  DSQ, 26 selected questions.              45               1           18/60
Adult..............................  DSQ, 18 selected questions.              69               1           20/60
Adult..............................  PROMIS Short Form (PROMIS                24               1            6/60
                                      SF--Fatigue, SD, SRI, PB,
                                      PI) & Sleep Data
                                      Collection Form.
Adult..............................  PROMIS SF--Fatigue, SD,                  69               1            5/60
                                      SRI, PB, PI.
Adult..............................  Brief Pain Inventory (BPI).              24               1           13/60
Adult..............................  Patient Health                           24               1           10/60
                                      Questionnaire (PHQ-8),
                                      Generalized Anxiety
                                      Disorder (GAD-7), CDC
                                      Health-Related Quality of
                                      Life (HRQoL-4).
Adult..............................  CDC HRQoL-4................              69               1            4/60
Adult..............................  CDC HRQoL-4 with activity                69               1            7/60
                                      limitation questions.
Adult..............................  Self-Rating Depression                   24               1            7/60
                                      Scale (SDS).
Adult..............................  Illness Impact                           69               1            3/60
                                      Questionnaire.
Adult..............................  Saliva Data Collection                   69               1            5/60
                                      Sheet.
Adult..............................  Orthostatic Grading Scale                69               1            5/60
                                      (OGS).
Adult..............................  COMPosite Autonomic Symptom              69               1            7/60
                                      Score 31 (COMPASS-31).
Pediatric..........................  CDC Symptom Inventory: For               36               1            8/60
                                      Baseline Subjects
                                      Pediatrics.
Pediatric..........................  CDC Symptom Inventory: For               29               1            6/60
                                      the Follow-Up Subjects
                                      Pediatrics.
Pediatric..........................  SF-36 Health Survey........              64               1            5/60
Pediatric..........................  Multidimensional Fatigue                 64               1            2/60
                                      Inventory (MFI-20).
Pediatric..........................  Selected Questions from                  64               1            5/60
                                      DePaul Pediatric Health
                                      Questionnaire (DPHQ), 19
                                      Questions.
Pediatric..........................  PROMIS Pediatric                         64               1            2/60
                                      Instruments (Fatigue &
                                      Pain).
Pediatric..........................  Pediatric Pain                           64               1            7/60
                                      Questionnaire (PPQ).
Pediatric..........................  Visual Analogue Scale......              64               1            6/60
Pediatric..........................  Hospital Anxiety and                     64               1            5/60
                                      Depression Scale.
Pediatric..........................  Pediatric Daytime                        64               1            2/60
                                      Sleepiness Scale.
Pediatric..........................  Social Participation Form                64               1            7/60
                                      Pediatric.
Pediatric..........................  Sociability Form...........              64               1            3/60
Pediatric..........................  Saliva Collection Form.....              64               1            5/60
Pediatric..........................  CDC Symptom Inventory: For                3               1           20/60
                                      Baseline Subjects
                                      Pediatrics.
Pediatric..........................  CDC Symptom Inventory: For                3               1            9/60
                                      the Follow-Up Subjects
                                      Pediatrics.
Pediatric..........................  SF-36 Health Survey........               3               1            9/60
Pediatric..........................  Multidimensional Fatigue                  3               1            7/60
                                      Inventory (MFI-20).
Pediatric..........................  Selected Questions from                   3               1           10/60
                                      DePaul Pediatric Health
                                      Questionnaire (DPHQ), 19
                                      Questions.
Pediatric..........................  PROMIS Pediatric                          3               1            3/60
                                      Instruments (Fatigue &
                                      Pain).
Pediatric..........................  Pediatric Pain                            3               1           15/60
                                      Questionnaire (PPQ).
Pediatric..........................  Visual Analogue Scale......               3               1            8/60
Pediatric..........................  Hospital Anxiety and                      3               1            7/60
                                      Depression Scale.
Pediatric..........................  Pediatric Daytime                         3               1            3/60
                                      Sleepiness Scale.
Pediatric..........................  Social Participation Form                 3               1           10/60
                                      Pediatric.

[[Page 7396]]

 
Pediatric..........................  Sociability Form...........               3               1            5/60
Pediatric..........................  Saliva Collection Form.....               3               1            5/60
Adult..............................  CogState Practice Section..             109               1           17/60
Adult..............................  CogState Baseline Section..             109               1           27/60
Adult..............................  WAIS IV DS F+B, TOPF.......             109               1           10/60
Adult..............................  Exercise (Bike) Testing....              64               1           30/60
Adult..............................  CogState Time 1 Section....             109               1           22/60
Adult..............................  CogState Time 2 Section....             109               1           12/60
Adult..............................  CogState Time 3 Section....             109               1           12/60
Adult..............................  CogState Time 4 Section....             109               1           12/60
Adult..............................  Visual Analogue Scale for                60               1            8/60
                                      CFS Symptoms.
Adult..............................  EQ-5D-Y Health                           60               1            6/60
                                      Questionnaire.
Adult..............................  PROMIS SF v1--Physical                   60               1            5/60
                                      Function.
Adult..............................  Physical Fitness and                     60               1            2/60
                                      Exercise Activity Levels
                                      of Scale.
Adult..............................  International Physical                   60               1            5/60
                                      Activity Questionnaire
                                      (Self-Administered Long
                                      Form).
Adult..............................  Physical Activity Readiness              60               1            5/60
                                      Questionnaire.
Adult..............................  Visual Analogue Scale for                49               1            8/60
                                      CFS Symptoms.
Adult..............................  EQ-5D-Y Health                           49               1            6/60
                                      Questionnaire.
Adult..............................  PROMIS SF v1--Physical                   49               1            5/60
                                      Function.
Adult..............................  Physical Fitness and                     49               1            2/60
                                      Exercise Activity Levels
                                      of Scale.
Adult..............................  International Physical                   49               1            5/60
                                      Activity Questionnaire
                                      (Self-Administered Long
                                      Form).
Adult..............................  Physical Activity Readiness              49               1            5/60
                                      Questionnaire.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-01914 Filed 1-27-21; 8:45 am]
BILLING CODE 4163-18-P