82_FR_8541 82 FR 8525 - Proposed Data Collection Submitted for Public Comment and Recommendations

82 FR 8525 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry

Federal Register Volume 82, Issue 16 (January 26, 2017)

Page Range8525-8527
FR Document2017-01741

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.

Federal Register, Volume 82 Issue 16 (Thursday, January 26, 2017)
[Federal Register Volume 82, Number 16 (Thursday, January 26, 2017)]
[Notices]
[Pages 8525-8527]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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.

[[Page 8526]]

    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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per    of response    Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------



[[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



                                                                               Federal Register / Vol. 82, No. 16 / Thursday, January 26, 2017 / Notices                                            8525

                                                  DEPARTMENT OF HEALTH AND                                Collection Review Office, Centers for                  Toxic Substances and Disease Registry
                                                  HUMAN SERVICES                                          Disease Control and Prevention, 1600                   (ATSDR).
                                                                                                          Clifton Road NE., MS–D74, Atlanta,
                                                  Agency for Toxic Substances and                                                                                Background and Brief Description
                                                                                                          Georgia 30329; phone: 404–639–7570;
                                                  Disease Registry                                        Email: omb@cdc.gov.                                       The Agency for Toxic Substances and
                                                  [60 Day–17–17KN; Docket No. ATSDR–
                                                                                                                                                                 Disease Registry (ATSDR) is requesting
                                                                                                          SUPPLEMENTARY INFORMATION:       Under the             a two-year clearance for a new
                                                  2017–0001]                                              Paperwork Reduction Act of 1995 (PRA)                  information collection request (ICR)
                                                                                                          (44 U.S.C. 3501–3520), Federal agencies                titled ‘‘Cognition, Behavior, and
                                                  Proposed Data Collection Submitted
                                                                                                          must obtain approval from the Office of                Caregiver Burden in Amyotrophic
                                                  for Public Comment and
                                                                                                          Management and Budget (OMB) for each                   Lateral Sclerosis (ALS).’’ ATSDR
                                                  Recommendations
                                                                                                          collection of information they conduct                 awarded funds to Boston Veterans
                                                  AGENCY:  Agency for Toxic Substances                    or sponsor. In addition, the PRA also                  Affairs Research Institute (BVARI)
                                                  and Disease Registry (ATSDR),                           requires Federal agencies to provide a                 through a contract (200–2014–59030) to
                                                  Department of Health and Human                          60-day notice in the Federal Register                  conduct this study. This new
                                                  Services (HHS).                                         concerning each proposed collection of                 information collection will enhance the
                                                  ACTION: Notice with comment period.                     information, including each new                        scientific value of the ATSDR’s National
                                                                                                          proposed collection, each proposed                     ALS Registry (OMB Control No. 0923–
                                                  SUMMARY:    The Agency for Toxic                        extension of existing collection of                    0041; expiration 11/30/2019) and focus
                                                  Substances and Disease Registry                         information, and each reinstatement of                 on two topic areas: (a) Risk factors for
                                                  (ATSDR), as part of its continuing                      previously approved information                        ALS and (b) the burden that ALS places
                                                  efforts to reduce public burden and                     collection before submitting the                       on persons with ALS (PALS), their
                                                  maximize the utility of government                      collection to OMB for approval. To                     family and caregivers, and whether
                                                  information, invites the general public                 comply with this requirement, we are                   these relationships affect ALS disease
                                                  and other Federal agencies to take this                 publishing this notice of a proposed                   progression over a 1-year interval.
                                                  opportunity to comment on proposed                      data collection as described below.                       ALS is an adult-onset, rapidly fatal,
                                                  and/or continuing information                              Comments are invited on: (a) Whether                neurodegenerative disease of unknown
                                                  collections, as required by the                         the proposed collection of information                 etiology that has been linked to genetic
                                                  Paperwork Reduction Act of 1995. This                   is necessary for the proper performance                and environmental risk factors.
                                                  notice invites comment on ‘‘Cognition,                  of the functions of the agency, including              Although ALS is primarily a motor
                                                  Behavior, and Caregiver Burden in                       whether the information shall have                     neuron disease, there is a growing
                                                  Amyotrophic Lateral Sclerosis (ALS).’’                  practical utility; (b) the accuracy of the             consensus about impaired cognitive
                                                  Measures of ALS severity, cognition,                    agency’s estimate of the burden of the                 function and behavioral disturbance in
                                                  mood and behavior, and caregiver                        proposed collection of information; (c)                the disease, with prevalence estimates
                                                  burden will be completed by telephone                   ways to enhance the quality, utility, and              ranging from 10–75 percent for
                                                  and by mail.                                            clarity of the information to be                       cognitive and behavioral disturbance
                                                  DATES: Written comments must be                         collected; (d) ways to minimize the                    and 15–41 percent for dementia.
                                                  received on or before March 27, 2017.                   burden of the collection of information                Cognitive and behavioral dysfunction in
                                                  ADDRESSES: You may submit comments,                     on respondents, including through the                  PALS is associated with shorter
                                                  identified by Docket No. ATSDR–2017–                    use of automated collection techniques                 survival, and, perhaps, ALS disease
                                                  0001 by any of the following methods:                   or other forms of information                          progression. Research reported
                                                     • Federal eRulemaking Portal:                        technology; and (e) estimates of capital               demonstrates that there is scarce
                                                  Regulations.gov. Follow the instructions                or start-up costs and costs of operation,              information on risk factors for
                                                  for submitting comments.                                maintenance, and purchase of services                  developing specific cognitive and
                                                     • Mail: Leroy A. Richardson,                         to provide information. Burden means                   behavioral ALS subtypes and whether
                                                  Information Collection Review Office,                   the total time, effort, or financial                   these subtypes represent a continuum of
                                                  Centers for Disease Control and                         resources expended by persons to                       cognitive and behavioral impairment
                                                  Prevention, 1600 Clifton Road NE., MS–                  generate, maintain, retain, disclose or                associated with ALS disease
                                                  D74, Atlanta, Georgia 30329.                            provide information to or for a Federal                progression. Better understanding of
                                                     Instructions: All submissions received               agency. This includes the time needed                  ALS subtypes and caregiver burden will
                                                  must include the agency name and                        to review instructions; to develop,                    provide crucial insights into the risk
                                                  Docket Number. All relevant comments                    acquire, install and utilize technology                factors for and pathophysiology of the
                                                  received will be posted without change                  and systems for the purpose of                         disease and caregiver burden.
                                                  to Regulations.gov, including any                       collecting, validating and verifying                      This is a prospective study. A
                                                  personal information provided. For                      information, processing and                            national sample of PALS and their
                                                  access to the docket to read background                 maintaining information, and disclosing                caregivers (dyads) will be recruited from
                                                  documents or comments received, go to                   and providing information; to train                    the ATSDR National ALS Registry to
                                                  Regulations.gov.                                        personnel and to be able to respond to                 study the following aims:
                                                     Please note: All public comment                      a collection of information, to search                    1. Characterize the cognitive/
                                                  should be submitted through the                         data sources, to complete and review                   behavioral subtypes in a large national
                                                  Federal eRulemaking portal                              the collection of information; and to                  cohort of PALS and identify risk factors
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  (Regulations.gov) or by U.S. mail to the                transmit or otherwise disclose the                     for these subtypes;
                                                  address listed above.                                   information.                                              2. Study cross-sectional and
                                                  FOR FURTHER INFORMATION CONTACT: To                     Proposed Project                                       longitudinal relationships among
                                                  request more information on the                                                                                cognitive/behavioral subtypes in PALS
                                                  proposed project or to obtain a copy of                   Cognition, Behavior, and Caregiver                   and caregiver giver burden, and whether
                                                  the information collection plan and                     Burden in Amyotrophic Lateral                          these relationships affect ALS disease
                                                  instruments, contact the Information                    Sclerosis (ALS)—New—Agency for                         progression over a one year interval.


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                                                  8526                                Federal Register / Vol. 82, No. 16 / Thursday, January 26, 2017 / Notices

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

                                                                                                                         ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                    Average
                                                                                                                                                                                                      Number of
                                                                                                                                                                           Number of                                               burden of              Total burden
                                                       Type of respondents                                               Form name                                                                  responses per
                                                                                                                                                                          respondents                                              response                  hours
                                                                                                                                                                                                      respondent                   (in hours)

                                                  Persons with ALS (PALS)                      Recruitment and Enrollment Telephone                                                     1,500                             1                   30/60                750
                                                    and caregiver dyads.                         Script.
                                                  Person with ALS ...................          ALS Functional Rating Score—Extended                                                        150                            2                   30/60                150
                                                                                                 Edition (ALSFRS–EX).
                                                                                               Telephone Interview for Cognitive Status-                                                   150                            2                   20/60                100
                                                                                                 modified (TICSm).
                                                                                               ALS Cognitive Behavioral Screen (ALS–                                                       150                            2                   15/60                 75
                                                                                                 CBS).
                                                                                               Primary Care Evaluation of Mental Dis-                                                      150                            2                   10/60                 50
                                                                                                 orders Patient Health Questionnaire
                                                                                                 (PRIME–MD PHQ).
                                                                                               Beck Depression Inventory-II (BDI–II) .........                                            150                             2                   10/60                 50
                                                                                               Beck Hopelessness Scale (BHS) ................                                             150                             2                    5/60                 25
                                                                                               Dysexecutive Questionnaire (DEX) .............                                             150                             2                   10/60                 50
                                                  Caregiver proxy for person                   ALS Functional Rating Score—Extended                                                       150                             2                   30/60                150
                                                    with ALS (PALS).                             Edition (ALSFRS–EX).
                                                                                               Primary Care Evaluation of Mental Dis-                                                      150                            2                   10/60                 50
                                                                                                 orders Patient Health Questionnaire
                                                                                                 (PRIME–MD PHQ).
                                                                                               Beck Depression Inventory-II (BDI–II) .........                                             150                            2                   10/60                 50
                                                                                               Beck Hopelessness Scale (BHS) ................                                              150                            2                    5/60                 25
                                                                                               Dysexecutive Questionnaire (DEX) .............                                              150                            2                   10/60                 50
                                                                                               Cambridge Behavioural Inventory Revised                                                     150                            2                   10/60                 50
                                                                                                 (CBI–R).
                                                  Caregiver of person with ALS                 Primary Care Evaluation of Mental Dis-                                                      300                            2                   10/60                100
                                                    (PALS).                                      orders Patient Health Questionnaire
                                                                                                 (PRIME–MD PHQ).
                                                                                               Beck Depression Inventory-II (BDI–II) .........                                             300                           3                    10/60                150
                                                                                               Beck Hopelessness Scale (BHS) ................                                              300                           3                     5/60                 75
                                                                                               Dysexecutive Questionnaire (DEX) .............                                              300                           2                    10/60                100
                                                                                               Zarit Burden Interview (ZBI) .........................                                      300                           3                    10/60                150
                                                                                               Social Support Questionnaire Short Form                                                     300                           3                    10/60                150
                                                                                                 (SSQSF).
                                                                                               Kosberg Cost of Care Index ........................                                         300                           3                      5/60                75
                                                                                               ALS Cognitive Behavioral Screen (ALS–                                                       300                           3                      5/60                75
                                                                                                 CBS)—Caregiver portion.
                                                                                               Brief COPE ...................................................                             300                             3                   10/60                150
                                                                                               Perceived Stress Scale (PSS) .....................                                         300                             3                    5/60                 75

                                                       Total ...............................   .......................................................................   ........................   ........................   ........................          2,725
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                                                                               Federal Register / Vol. 82, No. 16 / Thursday, January 26, 2017 / Notices                                            8527

                                                  Leroy A. Richardson,                                    Prevention, 1600 Clifton Road NE., MS–                 technology; and (e) estimates of capital
                                                  Chief, Information Collection Review Office,            D74, Atlanta, Georgia 30329.                           or start-up costs and costs of operation,
                                                  Office of Scientific Integrity, Office of the              Instructions: All submissions received              maintenance, and purchase of services
                                                  Associate Director for Science, Office of the           must include the agency name and                       to provide information. Burden means
                                                  Director, Centers for Disease Control and               Docket Number. All relevant comments                   the total time, effort, or financial
                                                  Prevention.                                             received will be posted without change                 resources expended by persons to
                                                  [FR Doc. 2017–01741 Filed 1–25–17; 8:45 am]             to Regulations.gov, including any                      generate, maintain, retain, disclose or
                                                  BILLING CODE 4163–18–P                                  personal information provided. For                     provide information to or for a Federal
                                                                                                          access to the docket to read background                agency. This includes the time needed
                                                                                                          documents or comments received, go to                  to review instructions; to develop,
                                                  DEPARTMENT OF HEALTH AND                                Regulations.gov.                                       acquire, install and utilize technology
                                                  HUMAN SERVICES                                             Please note: All public comment                     and systems for the purpose of
                                                                                                          should be submitted through the                        collecting, validating and verifying
                                                  Centers for Disease Control and
                                                                                                          Federal eRulemaking portal                             information, processing and
                                                  Prevention
                                                                                                          (Regulations.gov) or by U.S. mail to the               maintaining information, and disclosing
                                                  [60Day–17–0006; Docket No. CDC–2017–                    address listed above.                                  and providing information; to train
                                                  0004]                                                   FOR FURTHER INFORMATION CONTACT: To                    personnel and to be able to respond to
                                                                                                          request more information on the                        a collection of information, to search
                                                  Proposed Data Collection Submitted                                                                             data sources, to complete and review
                                                  for Public Comment and                                  proposed project or to obtain a copy of
                                                                                                          the information collection plan and                    the collection of information; and to
                                                  Recommendations                                                                                                transmit or otherwise disclose the
                                                                                                          instruments, contact the Information
                                                  AGENCY: Centers for Disease Control and                 Collection Review Office, Centers for                  information.
                                                  Prevention (CDC), Department of Health                  Disease Control and Prevention, 1600                   Proposed Project
                                                  and Human Services (HHS).                               Clifton Road NE., MS–D74, Atlanta,
                                                  ACTION: Notice with comment period.                     Georgia 30329; phone: 404–639–7570;                      Statements in Support of Application
                                                                                                          Email: omb@cdc.gov.                                    of Waiver of Inadmissibility (OMB
                                                  SUMMARY:   The Centers for Disease                      SUPPLEMENTARY INFORMATION:                             Control No. 0920–0006; Expires 8/31/
                                                  Control and Prevention (CDC), as part of                   Under the Paperwork Reduction Act                   2017)—Extension—National Center for
                                                  its continuing efforts to reduce public                 of 1995 (PRA) (44 U.S.C. 3501–3520),                   Emerging and Zoonotic Infectious
                                                  burden and maximize the utility of                      Federal agencies must obtain approval                  Diseases (NCEZID), Centers for Disease
                                                  government information, invites the                     from the Office of Management and                      Control and Prevention (CDC).
                                                  general public and other Federal                        Budget (OMB) for each collection of                    Background and Brief Description
                                                  agencies to take this opportunity to                    information they conduct or sponsor. In
                                                  comment on proposed and/or                              addition, the PRA also requires Federal                   Section 212(a)(1) of the Immigration
                                                  continuing information collections, as                  agencies to provide a 60-day notice in                 and Nationality Act states that aliens
                                                  required by the Paperwork Reduction                     the Federal Register concerning each                   with specific health related conditions
                                                  Act of 1995. This notice invites                        proposed collection of information,                    are ineligible for admission into the
                                                  comment on an extension request for                     including each new proposed                            United States. The Attorney General
                                                  the information collection titled                       collection, each proposed extension of                 may waive application of this
                                                  ‘‘Statements in Support of Application                  existing collection of information, and                inadmissibility on health-related
                                                  of Waiver of Inadmissibility.’’ Approved                each reinstatement of previously                       grounds if an application for waiver is
                                                  under Office of Management and Budget                   approved information collection before                 filed and approved by the consular
                                                  (OMB) Control Number 0920–0006, this                    submitting the collection to OMB for                   office considering the application for
                                                  information collection allows CDC to                    approval. To comply with this                          visa. CDC uses this application
                                                  review Class A medical waiver                           requirement, we are publishing this                    primarily to collect information to
                                                  applications for prospective immigrants                 notice of a proposed data collection as                establish and maintain records of waiver
                                                  to the United States. CDC assists DHS/                  described below.                                       applicants in order to notify the U.S.
                                                  USCIS in determining whether or not a                      Comments are invited on: (a) Whether                Citizenship and Immigration Services
                                                  prospective immigrant with a Class A                    the proposed collection of information                 when terms, conditions and controls
                                                  mental health designation may be                        is necessary for the proper performance                imposed by waiver are not met.
                                                  admitted into the United States.                        of the functions of the agency, including                 CDC is requesting approval from OMB
                                                  DATES: Written comments must be                         whether the information shall have                     to collect this data for another three
                                                  received on or before March 27, 2017.                   practical utility; (b) the accuracy of the             years. Based on a review of the number
                                                  ADDRESSES: You may submit comments,                     agency’s estimate of the burden of the                 of waivers processed by CDC over the
                                                  identified by Docket No. CDC–2017–                      proposed collection of information; (c)                last three years, CDC does not request a
                                                  0004 by any of the following methods:                   ways to enhance the quality, utility, and              change in the amount of burden.
                                                     • Federal eRulemaking Portal:                        clarity of the information to be                          Respondents must mail these
                                                  Regulations.gov. Follow the instructions                collected; (d) ways to minimize the                    documents to CDC, and this entails an
                                                  for submitting comments.                                burden of the collection of information                additional cost. CDC estimates that
                                                     • Mail: Leroy A. Richardson,                         on respondents, including through the                  respondents will spend approximately
jstallworth on DSK7TPTVN1PROD with NOTICES




                                                  Information Collection Review Office,                   use of automated collection techniques                 $15 per year on postal fees, for a total
                                                  Centers for Disease Control and                         or other forms of information                          of $3,000 annually.




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Document Created: 2017-01-26 00:04:57
Document Modified: 2017-01-26 00:04:57
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before March 27, 2017.
ContactTo 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]
FR Citation82 FR 8525 

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