[Federal Register Volume 82, Number 16 (Thursday, January 26, 2017)]
[Notices]
[Pages 8525-8527]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-01741]



[[Page 8525]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60 Day-17-17KN; Docket No. ATSDR-2017-0001]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), 
Department of Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR), 
as part of its continuing efforts to reduce public burden and maximize 
the utility of government information, invites the general public and 
other Federal agencies to take this opportunity to comment on proposed 
and/or continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on ``Cognition, 
Behavior, and Caregiver Burden in Amyotrophic Lateral Sclerosis 
(ALS).'' Measures of ALS severity, cognition, mood and behavior, and 
caregiver burden will be completed by telephone and by mail.

DATES: Written comments must be received on or before March 27, 2017.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2017-0001 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted 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 the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Cognition, Behavior, and Caregiver Burden in Amyotrophic Lateral 
Sclerosis (ALS)--New--Agency for Toxic Substances and Disease Registry 
(ATSDR).

Background and Brief Description

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
requesting a two-year clearance for a new information collection 
request (ICR) titled ``Cognition, Behavior, and Caregiver Burden in 
Amyotrophic Lateral Sclerosis (ALS).'' ATSDR awarded funds to Boston 
Veterans Affairs Research Institute (BVARI) through a contract (200-
2014-59030) to conduct this study. This new information collection will 
enhance the scientific value of the ATSDR's National ALS Registry (OMB 
Control No. 0923-0041; expiration 11/30/2019) and focus on two topic 
areas: (a) Risk factors for ALS and (b) the burden that ALS places on 
persons with ALS (PALS), their family and caregivers, and whether these 
relationships affect ALS disease progression over a 1-year interval.
    ALS is an adult-onset, rapidly fatal, neurodegenerative disease of 
unknown etiology that has been linked to genetic and environmental risk 
factors. Although ALS is primarily a motor neuron disease, there is a 
growing consensus about impaired cognitive function and behavioral 
disturbance in the disease, with prevalence estimates ranging from 10-
75 percent for cognitive and behavioral disturbance and 15-41 percent 
for dementia. Cognitive and behavioral dysfunction in PALS is 
associated with shorter survival, and, perhaps, ALS disease 
progression. Research reported demonstrates that there is scarce 
information on risk factors for developing specific cognitive and 
behavioral ALS subtypes and whether these subtypes represent a 
continuum of cognitive and behavioral impairment associated with ALS 
disease progression. Better understanding of ALS subtypes and caregiver 
burden will provide crucial insights into the risk factors for and 
pathophysiology of the disease and caregiver burden.
    This is a prospective study. A national sample of PALS and their 
caregivers (dyads) will be recruited from the ATSDR National ALS 
Registry to study the following aims:
    1. Characterize the cognitive/behavioral subtypes in a large 
national cohort of PALS and identify risk factors for these subtypes;
    2. Study cross-sectional and longitudinal relationships among 
cognitive/behavioral subtypes in PALS and caregiver giver burden, and 
whether these relationships affect ALS disease progression over a one 
year interval.

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    The study sample will be composed of men and women with ALS and 
their caregivers (i.e., patient/caregiver dyads) from across the U.S. 
All patient enrollees will have a diagnosis of possible, probable or 
definite ALS according to the El Escorial World Federation of Neurology 
criteria for the diagnosis of ALS. Examining the effects of cognitive 
and mood changes in PALS on disease progression and caregiver burden 
may illustrate new ways to slow the rapid progression of the disease 
and develop better coping strategies to help caregivers provide 
effective care for longer periods.
    Data will be collected on ALS severity, cognition, mood and 
behavior, and caregiver burden measures will be completed by telephone 
or by mail. In PALS, measures of ALS severity, cognition, and mood and 
behavior will be collected at baseline and at follow-up one year 
thereafter. In caregivers, measures related to caregiver burden will be 
collected at baseline and every 6 months thereafter. Furthermore, 
caregivers may be asked to complete additional measures if PALS are 
unable, including cognition of PALS and ALS severity in PALS at 
baseline and annual follow-up.
    We estimate that 1,500 PALS/caregiver dyads will be screened for 
recruitment and 300 dyads will be enrolled. In addition, the 300 
caregivers will respond for themselves. Participation in the study is 
voluntary and there are no costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per    of response    Total burden
                                                    respondents     respondent      (in hours)         hours
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Persons with ALS (PALS) and     Recruitment and            1,500               1           30/60             750
 caregiver dyads.                Enrollment
                                 Telephone
                                 Script.
Person with ALS...............  ALS Functional               150               2           30/60             150
                                 Rating Score--
                                 Extended
                                 Edition (ALSFRS-
                                 EX).
                                Telephone                    150               2           20/60             100
                                 Interview for
                                 Cognitive
                                 Status-modified
                                 (TICSm).
                                ALS Cognitive                150               2           15/60              75
                                 Behavioral
                                 Screen (ALS-
                                 CBS).
                                Primary Care                 150               2           10/60              50
                                 Evaluation of
                                 Mental
                                 Disorders
                                 Patient Health
                                 Questionnaire
                                 (PRIME-MD PHQ).
                                Beck Depression              150               2           10/60              50
                                 Inventory-II
                                 (BDI-II).
                                Beck                         150               2            5/60              25
                                 Hopelessness
                                 Scale (BHS).
                                Dysexecutive                 150               2           10/60              50
                                 Questionnaire
                                 (DEX).
Caregiver proxy for person      ALS Functional               150               2           30/60             150
 with ALS (PALS).                Rating Score--
                                 Extended
                                 Edition (ALSFRS-
                                 EX).
                                Primary Care                 150               2           10/60              50
                                 Evaluation of
                                 Mental
                                 Disorders
                                 Patient Health
                                 Questionnaire
                                 (PRIME-MD PHQ).
                                Beck Depression              150               2           10/60              50
                                 Inventory-II
                                 (BDI-II).
                                Beck                         150               2            5/60              25
                                 Hopelessness
                                 Scale (BHS).
                                Dysexecutive                 150               2           10/60              50
                                 Questionnaire
                                 (DEX).
                                Cambridge                    150               2           10/60              50
                                 Behavioural
                                 Inventory
                                 Revised (CBI-R).
Caregiver of person with ALS    Primary Care                 300               2           10/60             100
 (PALS).                         Evaluation of
                                 Mental
                                 Disorders
                                 Patient Health
                                 Questionnaire
                                 (PRIME-MD PHQ).
                                Beck Depression              300               3           10/60             150
                                 Inventory-II
                                 (BDI-II).
                                Beck                         300               3            5/60              75
                                 Hopelessness
                                 Scale (BHS).
                                Dysexecutive                 300               2           10/60             100
                                 Questionnaire
                                 (DEX).
                                Zarit Burden                 300               3           10/60             150
                                 Interview (ZBI).
                                Social Support               300               3           10/60             150
                                 Questionnaire
                                 Short Form
                                 (SSQSF).
                                Kosberg Cost of              300               3            5/60              75
                                 Care Index.
                                ALS Cognitive                300               3            5/60              75
                                 Behavioral
                                 Screen (ALS-
                                 CBS)--Caregiver
                                 portion.
                                Brief COPE......             300               3           10/60             150
                                Perceived Stress             300               3            5/60              75
                                 Scale (PSS).
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           2,725
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[[Page 8527]]

Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2017-01741 Filed 1-25-17; 8:45 am]
 BILLING CODE 4163-18-P