83_FR_819 83 FR 814 - Agency Forms Undergoing Paperwork Reduction Act Review

83 FR 814 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 83, Issue 5 (January 8, 2018)

Page Range814-815
FR Document2018-00141

Federal Register, Volume 83 Issue 5 (Monday, January 8, 2018)
[Federal Register Volume 83, Number 5 (Monday, January 8, 2018)]
[Notices]
[Pages 814-815]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-00141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-18-0051]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Agency 
for Toxic Substances and Disease Registry (ATSDR) has submitted the 
information collection request titled Assessment of Chemical Exposures 
(ACE) Investigations to the Office of Management and Budget (OMB) for 
review and approval. ATSDR previously published a ``Proposed Data 
Collection Submitted for Public Comment and Recommendations'' notice on 
August 30, 2017 to obtain comments from the public and affected 
agencies. ATSDR did not receive comments related to the previous 
notice. This notice serves to allow an additional 30 days for public 
and affected agency comments.
    ATSDR 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 or send an email to [email protected]. 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

    Assessment of Chemical Exposures (ACE) Investigations OMB Control 
No: 0923-0051 (Expiration Date: 03/31/2018)--Revision--Agency for Toxic 
Substances and Disease Registry (ATSDR).

Background and Brief Description

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
requesting a three-year Paperwork Reduction Act (PRA) revision of 
generic clearance information collection request 0923-0051 titled 
``Assessment of Chemical Exposures (ACE) Investigations'' to assist 
state and local health departments after toxic substance spills or 
chemical incidents. The PRA clearance for this information collection 
request expires 3/31/2018. In this revision, we are renaming the form 
previously titled the Rapid Response Registry Form as the ACE Short 
Form. This revision better describes the use of the ACE Short Form in 
time-limited investigations where longer surveys are not possible. We 
do not use the form to establish registries. In addition, we are 
removing two insurance questions from the ACE Short Form, as they are 
not currently asked in the longer surveys. There are no changes to the 
requested burden hours.
    ATSDR has successfully completed three investigations to date using 
this PRA clearance and would like to continue this impactful 
information collection. Briefly summarized below are the 
accomplishments of this information collection:
     During 2015, in U.S. Virgin Islands there was a methyl 
bromide exposure at a condominium resort. Under this ACE investigation, 
awareness was raised among pest control companies that methyl bromide 
was prohibited for use in homes and other residential settings. 
Additionally, awareness was raised for clinicians about the toxicologic 
syndrome caused by exposure to methyl bromide and the importance of 
notifying first responders immediately when they have encountered 
contaminated patients.
     During 2016, ACE team conducted a rash investigation in 
Flint, Michigan. Persons who were exposed to Flint municipal water and 
had current or worsening rashes were surveyed and referred to free 
dermatologist screening if desired. Findings revealed that when the 
city was using water from the Flint River, there were large swings in 
chorine, pH, and hardness, which could be one possible explanation for 
the eczema-related rashes.
     During 2016, ACE team also conducted a follow-up 
investigation for people who were exposed to the Flint municipal water 
and sought care from the free dermatologists. Data analysis for this 
project is in process and results are pending. However, the follow-up 
interviews resulted in improving the exam and referral processes that 
were still on going at the time.
    The ACE investigations focus on performing rapid epidemiological 
assessments to assist state, regional, local, or tribal health 
departments (the requesting agencies) to respond to or prepare for 
acute chemical releases.
    The main objectives for performing these rapid assessments are to:
    1. Characterize exposure and acute health effects of respondents 
exposed to toxic substances from discrete, chemical

[[Page 815]]

releases and determine their health statuses;
    2. Identify needs (i.e. medical and basic) of those exposed during 
the releases to aid in planning interventions in the community;
    3. Assess the impact of the incidents on health services use and 
share lessons learned for use in hospital, local, and state planning 
for chemical incidents.
    Because each chemical incident is different, it is not possible to 
predict in advance exactly what type of and how many respondents will 
need to be consented and interviewed to effectively evaluate the 
incident. Respondents typically include, but are not limited to 
emergency responders such as police, fire, hazardous material 
technicians, emergency medical services, and personnel at hospitals 
where patients from the incident were treated. Incidents may occur at 
businesses or in the community setting; therefore, respondents may also 
include business owners, managers, workers, customers, community 
residents, pet owners, and those passing through the affected area.
    Data will be collected by the multidisciplinary ACE team consisting 
of staff from ATSDR, the Centers for Disease Control and Prevention 
(CDC), and the requesting agencies. ATSDR has developed a series of 
draft survey forms that can be quickly tailored in the field to collect 
data that will meet the goals of the investigation. They will be 
administered based on time permitted and urgency. For example, it is 
preferable to administer the General Survey to as many respondents as 
possible. However, if there are time constraints, the shorter Household 
Survey or the ACE Short Form may be administered instead. The 
individual surveys collect information about exposure, acute health 
effects, health services use, medical history, needs resulting from the 
incident, communication during the release, health impact on children 
and pets, and demographic data. Hospital personnel are asked about the 
surge, response and communication, decontamination, and lessons 
learned.
    Depending on the situation, data may be collected by face-to-face 
interviews, telephone interviews, written surveys, mailed surveys, or 
on-line surveys. Medical and veterinary charts may also be reviewed. In 
rare situations, an investigation might involve collection of clinical 
specimens.
    ATSDR anticipates up to four ACE investigations per year. The 
number of participants has ranged from 30-715, averaging about 300 per 
year. Therefore, the total annualized estimated burden will be 591 
hours per year. Participation in ACE investigations is voluntary and 
there are no anticipated costs to respondents other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Residents, first responders, business   General Survey..........             800               1           30/60
 owners, employees, customers.          ACE Short Form..........              50               1            7/60
Residents.............................  Household Survey........             120               1           15/60
Hospital staff........................  Hospital Survey.........              40               1           30/60
Staff from state, local, or tribal      Medical Chart                        250               1           30/60
 health agencies.                        Abstraction Form.                    30               1           20/60
                                        Veterinary Chart
                                         Abstraction Form.
----------------------------------------------------------------------------------------------------------------


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. 2018-00141 Filed 1-5-18; 8:45 am]
 BILLING CODE 4163-18-P



                                                814                            Federal Register / Vol. 83, No. 5 / Monday, January 8, 2018 / Notices

                                                FEDERAL RESERVE SYSTEM                                  30, 2017 to obtain comments from the                   information collection request expires
                                                                                                        public and affected agencies. ATSDR                    3/31/2018. In this revision, we are
                                                Change in Bank Control Notices;                         did not receive comments related to the                renaming the form previously titled the
                                                Acquisitions of Shares of a Bank or                     previous notice. This notice serves to                 Rapid Response Registry Form as the
                                                Bank Holding Company                                    allow an additional 30 days for public                 ACE Short Form. This revision better
                                                  The notificants listed below have                     and affected agency comments.                          describes the use of the ACE Short Form
                                                applied under the Change in Bank                           ATSDR will accept all comments for                  in time-limited investigations where
                                                Control Act (12 U.S.C. 1817(j)) and                     this proposed information collection                   longer surveys are not possible. We do
                                                § 225.41 of the Board’s Regulation Y (12                project. The Office of Management and                  not use the form to establish registries.
                                                CFR 225.41) to acquire shares of a bank                 Budget is particularly interested in                   In addition, we are removing two
                                                or bank holding company. The factors                    comments that:                                         insurance questions from the ACE Short
                                                                                                           (a) Evaluate whether the proposed                   Form, as they are not currently asked in
                                                that are considered in acting on the
                                                                                                        collection of information is necessary                 the longer surveys. There are no changes
                                                notices are set forth in paragraph 7 of
                                                                                                        for the proper performance of the                      to the requested burden hours.
                                                the Act (12 U.S.C. 1817(j)(7)).
                                                  The notices are available for                         functions of the agency, including                        ATSDR has successfully completed
                                                immediate inspection at the Federal                     whether the information will have                      three investigations to date using this
                                                Reserve Bank indicated. The notices                     practical utility;                                     PRA clearance and would like to
                                                                                                           (b) Evaluate the accuracy of the                    continue this impactful information
                                                also will be available for inspection at
                                                                                                        agencies estimate of the burden of the                 collection. Briefly summarized below
                                                the offices of the Board of Governors.
                                                                                                        proposed collection of information,                    are the accomplishments of this
                                                Interested persons may express their
                                                                                                        including the validity of the                          information collection:
                                                views in writing to the Reserve Bank
                                                                                                        methodology and assumptions used;                         • During 2015, in U.S. Virgin Islands
                                                indicated for that notice or to the offices                (c) Enhance the quality, utility, and
                                                of the Board of Governors. Comments                                                                            there was a methyl bromide exposure at
                                                                                                        clarity of the information to be                       a condominium resort. Under this ACE
                                                must be received not later than January                 collected;
                                                22, 2018.                                                                                                      investigation, awareness was raised
                                                                                                           (d) Minimize the burden of the                      among pest control companies that
                                                  A. Federal Reserve Bank of Kansas
                                                                                                        collection of information on those who                 methyl bromide was prohibited for use
                                                City (Dennis Denney, Assistant Vice
                                                                                                        are to respond, including, through the                 in homes and other residential settings.
                                                President) 1 Memorial Drive, Kansas
                                                                                                        use of appropriate automated,                          Additionally, awareness was raised for
                                                City, Missouri 64198–0001:
                                                                                                        electronic, mechanical, or other                       clinicians about the toxicologic
                                                  1. Robert J. Arnold Family Living
                                                                                                        technological collection techniques or                 syndrome caused by exposure to methyl
                                                Trust, and Robert J. Arnold and Margie
                                                                                                        other forms of information technology,                 bromide and the importance of notifying
                                                E. Arnold as co-trustees, all of
                                                                                                        e.g., permitting electronic submission of              first responders immediately when they
                                                McPherson, Kansas, and Larry G.
                                                                                                        responses; and                                         have encountered contaminated
                                                Arnold, Castle Rock, Colorado; to retain
                                                                                                           (e) Assess information collection
                                                voting shares of Ramona Bankshares,                                                                            patients.
                                                                                                        costs.
                                                Inc. and thereby indirectly retain shares                  To request additional information on                   • During 2016, ACE team conducted
                                                of Hillsboro State Bank, both of                        the proposed project or to obtain a copy               a rash investigation in Flint, Michigan.
                                                Hillsboro, Kansas.                                      of the information collection plan and                 Persons who were exposed to Flint
                                                  Board of Governors of the Federal Reserve             instruments, call (404) 639–7570 or                    municipal water and had current or
                                                System, January 2, 2018.                                send an email to OMB@cdc.gov. Direct                   worsening rashes were surveyed and
                                                Ann E. Misback,                                         written comments and/or suggestions                    referred to free dermatologist screening
                                                Secretary of the Board.                                 regarding the items contained in this                  if desired. Findings revealed that when
                                                                                                        notice to the Attention: CDC Desk                      the city was using water from the Flint
                                                [FR Doc. 2018–00064 Filed 1–5–18; 8:45 am]
                                                                                                        Officer, Office of Management and                      River, there were large swings in
                                                BILLING CODE 6210–01–P
                                                                                                        Budget, 725 17th Street NW,                            chorine, pH, and hardness, which could
                                                                                                        Washington, DC 20503 or by fax to (202)                be one possible explanation for the
                                                                                                        395–5806. Provide written comments                     eczema-related rashes.
                                                DEPARTMENT OF HEALTH AND                                                                                          • During 2016, ACE team also
                                                HUMAN SERVICES                                          within 30 days of notice publication.
                                                                                                                                                               conducted a follow-up investigation for
                                                Agency for Toxic Substances and                         Proposed Project                                       people who were exposed to the Flint
                                                Disease Registry                                          Assessment of Chemical Exposures                     municipal water and sought care from
                                                                                                        (ACE) Investigations OMB Control No:                   the free dermatologists. Data analysis for
                                                [30Day–18–0051]                                                                                                this project is in process and results are
                                                                                                        0923–0051 (Expiration Date:
                                                                                                        03/31/2018)—Revision—Agency for                        pending. However, the follow-up
                                                Agency Forms Undergoing Paperwork                                                                              interviews resulted in improving the
                                                Reduction Act Review                                    Toxic Substances and Disease Registry
                                                                                                        (ATSDR).                                               exam and referral processes that were
                                                  In accordance with the Paperwork                                                                             still on going at the time.
                                                Reduction Act of 1995, the Agency for                   Background and Brief Description                          The ACE investigations focus on
                                                Toxic Substances and Disease Registry                      The Agency for Toxic Substances and                 performing rapid epidemiological
                                                (ATSDR) has submitted the information                   Disease Registry (ATSDR) is requesting                 assessments to assist state, regional,
                                                collection request titled Assessment of                 a three-year Paperwork Reduction Act                   local, or tribal health departments (the
sradovich on DSK3GMQ082PROD with NOTICES




                                                Chemical Exposures (ACE)                                (PRA) revision of generic clearance                    requesting agencies) to respond to or
                                                Investigations to the Office of                         information collection request 0923–                   prepare for acute chemical releases.
                                                Management and Budget (OMB) for                         0051 titled ‘‘Assessment of Chemical                      The main objectives for performing
                                                review and approval. ATSDR previously                   Exposures (ACE) Investigations’’ to                    these rapid assessments are to:
                                                published a ‘‘Proposed Data Collection                  assist state and local health departments                 1. Characterize exposure and acute
                                                Submitted for Public Comment and                        after toxic substance spills or chemical               health effects of respondents exposed to
                                                Recommendations’’ notice on August                      incidents. The PRA clearance for this                  toxic substances from discrete, chemical


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                                                                                        Federal Register / Vol. 83, No. 5 / Monday, January 8, 2018 / Notices                                                                815

                                                releases and determine their health                                   respondents may also include business                            resulting from the incident,
                                                statuses;                                                             owners, managers, workers, customers,                            communication during the release,
                                                   2. Identify needs (i.e. medical and                                community residents, pet owners, and                             health impact on children and pets, and
                                                basic) of those exposed during the                                    those passing through the affected area.                         demographic data. Hospital personnel
                                                releases to aid in planning interventions                               Data will be collected by the                                  are asked about the surge, response and
                                                in the community;                                                     multidisciplinary ACE team consisting                            communication, decontamination, and
                                                   3. Assess the impact of the incidents                              of staff from ATSDR, the Centers for                             lessons learned.
                                                on health services use and share lessons                              Disease Control and Prevention (CDC),                               Depending on the situation, data may
                                                learned for use in hospital, local, and                               and the requesting agencies. ATSDR has                           be collected by face-to-face interviews,
                                                state planning for chemical incidents.                                developed a series of draft survey forms                         telephone interviews, written surveys,
                                                   Because each chemical incident is                                  that can be quickly tailored in the field                        mailed surveys, or on-line surveys.
                                                different, it is not possible to predict in                           to collect data that will meet the goals                         Medical and veterinary charts may also
                                                advance exactly what type of and how                                  of the investigation. They will be                               be reviewed. In rare situations, an
                                                many respondents will need to be                                      administered based on time permitted                             investigation might involve collection of
                                                consented and interviewed to effectively                              and urgency. For example, it is                                  clinical specimens.
                                                evaluate the incident. Respondents                                    preferable to administer the General                                ATSDR anticipates up to four ACE
                                                typically include, but are not limited to                             Survey to as many respondents as                                 investigations per year. The number of
                                                emergency responders such as police,                                  possible. However, if there are time                             participants has ranged from 30–715,
                                                fire, hazardous material technicians,                                 constraints, the shorter Household                               averaging about 300 per year. Therefore,
                                                emergency medical services, and                                       Survey or the ACE Short Form may be                              the total annualized estimated burden
                                                personnel at hospitals where patients                                 administered instead. The individual                             will be 591 hours per year. Participation
                                                from the incident were treated.                                       surveys collect information about                                in ACE investigations is voluntary and
                                                Incidents may occur at businesses or in                               exposure, acute health effects, health                           there are no anticipated costs to
                                                the community setting; therefore,                                     services use, medical history, needs                             respondents other than their time.

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

                                                Residents, first responders, business owners,                        General Survey ..............................................            800                 1          30/60
                                                  employees, customers.                                              ACE Short Form .............................................              50                 1           7/60
                                                Residents ........................................................   Household Survey ..........................................              120                 1          15/60
                                                Hospital staff ...................................................   Hospital Survey ..............................................            40                 1          30/60
                                                Staff from state, local, or tribal health agen-                      Medical Chart Abstraction Form ....................                      250                 1          30/60
                                                  cies.                                                              Veterinary Chart Abstraction Form ................                        30                 1          20/60



                                                Leroy A. Richardson,                                                  Comment and Recommendations’’                                    use of appropriate automated,
                                                Chief, Information Collection Review Office,                          notice on September 6, 2017 to obtain                            electronic, mechanical, or other
                                                Office of Scientific Integrity, Office of the                         comments from the public and affected                            technological collection techniques or
                                                Associate Director for Science, Office of the                         agencies. CDC did not receive comments                           other forms of information technology,
                                                Director, Centers for Disease Control and                             related to the previous notice. This                             e.g., permitting electronic submission of
                                                Prevention.                                                           notice serves to allow an additional 30                          responses; and
                                                [FR Doc. 2018–00141 Filed 1–5–18; 8:45 am]                            days for public and affected agency
                                                                                                                                                                                         (e) Assess information collection
                                                BILLING CODE 4163–18–P                                                comments.
                                                                                                                         CDC will accept all comments for this                         costs.
                                                                                                                      proposed information collection project.                           To request additional information on
                                                DEPARTMENT OF HEALTH AND                                              The Office of Management and Budget                              the proposed project or to obtain a copy
                                                HUMAN SERVICES                                                        is particularly interested in comments                           of the information collection plan and
                                                                                                                      that:                                                            instruments, call (404) 639–7570 or
                                                Centers for Disease Control and                                          (a) Evaluate whether the proposed                             send an email to omb@cdc.gov. Direct
                                                Prevention                                                            collection of information is necessary                           written comments and/or suggestions
                                                [30Day–18–17AUQ]                                                      for the proper performance of the                                regarding the items contained in this
                                                                                                                      functions of the agency, including                               notice to the Attention: CDC Desk
                                                Agency Forms Undergoing Paperwork                                     whether the information will have                                Officer, Office of Management and
                                                Reduction Act Review                                                  practical utility;                                               Budget, 725 17th Street NW,
                                                                                                                         (b) Evaluate the accuracy of the                              Washington, DC 20503 or by fax to (202)
                                                  In accordance with the Paperwork                                    agencies estimate of the burden of the
                                                Reduction Act of 1995, the Centers for                                                                                                 395–5806. Provide written comments
                                                                                                                      proposed collection of information,                              within 30 days of notice publication.
                                                Disease Control and Prevention (CDC)
sradovich on DSK3GMQ082PROD with NOTICES




                                                                                                                      including the validity of the
                                                has submitted the information                                         methodology and assumptions used;                                Proposed Project
                                                collection request titled Mobile                                         (c) Enhance the quality, utility, and
                                                Proximity Initial User Feedback to the                                clarity of the information to be                                   Mobile Proximity Initial User
                                                Office of Management and Budget                                       collected;                                                       Feedback—NEW—National Institute for
                                                (OMB) for review and approval. CDC                                       (d) Minimize the burden of the                                Occupational Safety and Health
                                                previously published a ‘‘Proposed Data                                collection of information on those who                           (NIOSH), Centers for Disease Control
                                                Collection Submitted for Public                                       are to respond, including, through the                           and Prevention (CDC).


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Document Created: 2018-01-06 02:32:00
Document Modified: 2018-01-06 02:32:00
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
Dates03/31/2018)--Revision--Agency for Toxic Substances and Disease Registry (ATSDR).
FR Citation83 FR 814 

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