[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)
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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
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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]
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