83_FR_44221 83 FR 44053 - Proposed Data Collection Submitted for Public Comment and Recommendations

83 FR 44053 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 83, Issue 168 (August 29, 2018)

Page Range44053-44054
FR Document2018-18699

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Epidemiologic Study of Health Effects Associated With Low Pressure Events in Drinking Water Distribution Systems.

Federal Register, Volume 83 Issue 168 (Wednesday, August 29, 2018)
[Federal Register Volume 83, Number 168 (Wednesday, August 29, 2018)]
[Notices]
[Pages 44053-44054]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-18699]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-0960; Docket No. CDC-2018-0074]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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

SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled Epidemiologic Study of Health 
Effects Associated With Low Pressure Events in Drinking Water 
Distribution Systems.

DATES: CDC must receive written comments on or before October 29, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0074 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; 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 the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;

[[Page 44054]]

    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Epidemiologic Study of Health Effects Associated With Low Pressure 
Events in Drinking Water Distribution Systems--Reinstatement With 
Change--National Center for Emerging and Zoonotic Infectious Diseases 
(NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    In the United States (U.S.), drinking water distribution systems 
are designed to deliver safe, pressurized drinking water to our homes, 
hospitals, schools and businesses. However, the water distribution 
infrastructure is 50-100 years old in much of the U.S. and an estimated 
240,000 water main breaks occur each year. Failures in the distribution 
system such as water main breaks, cross-connections, back-flow, and 
pressure fluctuations can result in potential intrusion of microbes and 
other contaminants that can cause health effects, including acute 
gastrointestinal and respiratory illness.
    Approximately 200 million cases of acute gastrointestinal illness 
occur in the U.S. each year, but we lack reliable data to assess how 
many of these cases are associated with drinking water. Further, data 
are even more limited on the human health risks associated with 
exposure to drinking water during and after the occurrence of low 
pressure events (such as water main breaks) in drinking water 
distribution systems. Studies in both Norway and Sweden found that 
people exposed to low pressure events in the water distribution system 
had a higher risk for gastrointestinal illness. A similar study is 
needed in the United States.
    The purpose of this data collection is to conduct an epidemiologic 
study in the U.S. to assess whether individuals exposed to low pressure 
events in the water distribution system are at an increased risk for 
acute gastrointestinal or respiratory illness. This study would be, to 
our knowledge, the first U.S. study to systematically examine the 
association between low pressure events and acute gastrointestinal and 
respiratory illnesses. Study findings will inform the Environmental 
Protection Agency (EPA), CDC, and other drinking water stakeholders of 
the potential health risks associated with low pressure events in 
drinking water distribution systems and whether additional measures 
(e.g., new standards, additional research, or policy development) are 
needed to reduce the risk for health effects associated with low 
pressure events in the drinking water distribution system.
    We will conduct a cohort study among households that receive water 
from seven water utilities across the U.S.
    The water systems will be geographically diverse and will include 
both chlorinated and chloraminated systems. These water utilities will 
provide information about low pressure events that occur during the 
study period using a standardized form (approximately 13 events per 
utility). Utilities will provide address listings of households in 
areas exposed to the low pressure event and comparable households in an 
unexposed area to CDC staff, who will randomly select participants and 
send them an introductory letter and questionnaire. Consenting 
household respondents will be asked about symptoms and duration of any 
recent gastrointestinal or respiratory illness, tap water consumption, 
and other exposures including international travel, daycare attendance 
or employment, animal contacts, and recreational water exposures. Study 
participants may choose between two methods of survey response: A mail-
in paper survey and a web-based survey.
    Participation in this study will be voluntary. No financial 
compensation will be provided to study participants. The study duration 
is anticipated to last 78 months. An estimated 7,900 individuals will 
be contacted and we anticipate 6,320 utility customers (18 years of age 
or older) will consent to participate in this study. The total 
estimated annualized hours associated with this study reinstatement is 
expected to be 199 hours per year. 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   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Water Utility customer........  Paper-based                  240               1         (12/60)              48
                                 questionnaire.
                                Web-based                    160               1         (12/60)              32
                                 questionnaire.
Water utility maintenance       LPE form,                      5               3        (145/60)              36
 worker.                         ultrafilter and
                                 grab samples.
                                LPE form, grab                 5               2         (45/60)               8
                                 samples.
Water Utility Environmental     Line listings...               5               5               2              50
 Engineer.
Water Utility Billing clerk...  Line listings...               5               5               1              25
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             199
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Acting 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. 2018-18699 Filed 8-28-18; 8:45 am]
 BILLING CODE 4163-18-P



                                                                           Federal Register / Vol. 83, No. 168 / Wednesday, August 29, 2018 / Notices                                          44053

                                                ‘‘Information Collection 9000–0035,                     collection of information is necessary                DATES:CDC must receive written
                                                Claims and Appeals’’ on your attached                   for the proper performance of functions               comments on or before October 29,
                                                document.                                               of the FAR, and whether it will have                  2018.
                                                   • Mail: General Services                             practical utility; whether our estimate of
                                                Administration, Regulatory Secretariat                                                                        ADDRESSES:   You may submit comments,
                                                                                                        the public burden of this collection of
                                                Division (MVCB), 1800 F Street NW,                                                                            identified by Docket No. CDC–2018–
                                                                                                        information is accurate, and based on
                                                Washington, DC 20405. ATTN: Ms.                                                                               0074 by any of the following methods:
                                                                                                        valid assumptions and methodology;
                                                Mandell/IC 9000–0035, Claims and                        ways to enhance the quality, utility, and                • Federal eRulemaking Portal:
                                                Appeals.                                                clarity of the information to be                      Regulations.gov. Follow the instructions
                                                   Instructions: Please submit comments                 collected; and ways in which we can                   for submitting comments.
                                                only and cite Information Collection                    minimize the burden of the collection of                 • Mail: Jeffrey M. Zirger, Information
                                                9000–0035, Claims and Appeals, in all                   information on those who are to                       Collection Review Office, Centers for
                                                correspondence related to this                          respond, through the use of appropriate               Disease Control and Prevention, 1600
                                                collection. Comments received generally                 technological collection techniques or                Clifton Road NE, MS–D74, Atlanta,
                                                will be posted without change to http://                other forms of information technology.                Georgia 30329.
                                                www.regulations.gov, including any                         Obtaining Copies of Proposals:                        Instructions: All submissions received
                                                personal and/or business confidential                   Requesters may obtain a copy of the                   must include the agency name and
                                                information provided. To confirm                        information collection documents from                 Docket Number. CDC will post, without
                                                receipt of your comment(s), please                      the General Services Administration,                  change, all relevant comments to
                                                check http://www.regulations.gov,                       Regulatory Secretariat Division (MVCB),               Regulations.gov.
                                                approximately two to three days after                   1800 F Street NW, Washington, DC                         Please note: Submit all comments
                                                submission to verify posting (except                    20405, telephone 202–501–4755. Please                 through the Federal eRulemaking portal
                                                allow 30 days for posting of comments                   cite OMB Control No. 9000–0035,                       (regulations.gov) or by U.S. mail to the
                                                submitted by mail).                                     Claims and Appeals, in all                            address listed above.
                                                FOR FURTHER INFORMATION CONTACT: Mr.                    correspondence.                                       FOR FURTHER INFORMATION CONTACT: To
                                                Charles Gray, Procurement Analyst,                        Dated: August 22, 2018.                             request more information on the
                                                Federal Acquisition Policy Division,                    William F. Clark,                                     proposed project or to obtain a copy of
                                                GSA, 703–795–6328 or via email at
                                                                                                        Director, Office of Governmentwide                    the information collection plan and
                                                charles.gray@gsa.gov.                                   Acquisition Policy, Office of Acquisition             instruments, contact Jeffrey M. Zirger,
                                                SUPPLEMENTARY INFORMATION:                              Policy, Office of Governmentwide Policy.              Information Collection Review Office,
                                                A. Purpose                                              [FR Doc. 2018–18751 Filed 8–28–18; 8:45 am]           Centers for Disease Control and
                                                                                                        BILLING CODE 6820–EP–P                                Prevention, 1600 Clifton Road NE, MS–
                                                   It is the Government’s policy to try to
                                                                                                                                                              D74, Atlanta, Georgia 30329; phone:
                                                resolve all contractual issues by mutual
                                                                                                                                                              404–639–7570; Email: omb@cdc.gov.
                                                agreement at the contracting officer’s
                                                level without litigation. Reasonable                                                                          SUPPLEMENTARY INFORMATION: Under the
                                                                                                        DEPARTMENT OF HEALTH AND
                                                efforts should be made to resolve                       HUMAN SERVICES                                        Paperwork Reduction Act of 1995 (PRA)
                                                controversies prior to submission of a                                                                        (44 U.S.C. 3501–3520), Federal agencies
                                                contractor’s claim. The Contract                        Centers for Disease Control and                       must obtain approval from the Office of
                                                Disputes Act of 1978 (41 U.S.C. 7103)                   Prevention                                            Management and Budget (OMB) for each
                                                requires that claims exceeding $100,000                                                                       collection of information they conduct
                                                must be accompanied by a certification                  [60Day–18–0960; Docket No. CDC–2018–                  or sponsor. In addition, the PRA also
                                                that (1) the claim is made in good faith;               0074]                                                 requires Federal agencies to provide a
                                                (2) supporting data are accurate and                                                                          60-day notice in the Federal Register
                                                complete; and (3) the amount requested                  Proposed Data Collection Submitted                    concerning each proposed collection of
                                                accurately reflects the contract                        for Public Comment and                                information, including each new
                                                adjustment for which the contractor                     Recommendations                                       proposed collection, each proposed
                                                believes the Government is liable. The                                                                        extension of existing collection of
                                                                                                        AGENCY: Centers for Disease Control and
                                                information, as required by FAR clause                                                                        information, and each reinstatement of
                                                                                                        Prevention (CDC), Department of Health
                                                52.233–1, Disputes, is used by a                                                                              previously approved information
                                                                                                        and Human Services (HHS).
                                                contracting officer to decide or resolve                                                                      collection before submitting the
                                                                                                        ACTION: Notice with comment period.                   collection to the OMB for approval. To
                                                the claim. Contractors may appeal the
                                                contracting officer’s decision by                       SUMMARY:   The Centers for Disease                    comply with this requirement, we are
                                                submitting written appeals to the                       Control and Prevention (CDC), as part of              publishing this notice of a proposed
                                                appropriate officials.                                  its continuing effort to reduce public                data collection as described below.
                                                                                                        burden and maximize the utility of                       The OMB is particularly interested in
                                                B. Annual Reporting Burden
                                                                                                        government information, invites the                   comments that will help:
                                                  Respondents: 4,500.                                                                                            1. Evaluate whether the proposed
                                                  Responses per Respondent: 3.                          general public and other Federal
                                                                                                        agencies the opportunity to comment on                collection of information is necessary
                                                  Annual Responses: 13,500.
                                                  Hours per Response: 1.                                a proposed and/or continuing                          for the proper performance of the
                                                                                                        information collection, as required by                functions of the agency, including
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                                                  Total Burden Hours: 13,500.
                                                                                                        the Paperwork Reduction Act of 1995.                  whether the information will have
                                                C. Public Comments                                      This notice invites comment on a                      practical utility;
                                                  A 60-day notice published in the                      proposed information collection project                  2. Evaluate the accuracy of the
                                                Federal Register at 83 FR 22687, on                     titled Epidemiologic Study of Health                  agency’s estimate of the burden of the
                                                May 16, 2018. No comments were                          Effects Associated With Low Pressure                  proposed collection of information,
                                                received. Public comments are                           Events in Drinking Water Distribution                 including the validity of the
                                                particularly invited on: Whether this                   Systems.                                              methodology and assumptions used;


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                                                44054                                    Federal Register / Vol. 83, No. 168 / Wednesday, August 29, 2018 / Notices

                                                  3. Enhance the quality, utility, and                                              the U.S. each year, but we lack reliable                                                     The water systems will be
                                                clarity of the information to be                                                    data to assess how many of these cases                                                    geographically diverse and will include
                                                collected; and                                                                      are associated with drinking water.                                                       both chlorinated and chloraminated
                                                  4. Minimize the burden of the                                                     Further, data are even more limited on                                                    systems. These water utilities will
                                                collection of information on those who                                              the human health risks associated with                                                    provide information about low pressure
                                                are to respond, including through the                                               exposure to drinking water during and                                                     events that occur during the study
                                                use of appropriate automated,                                                       after the occurrence of low pressure                                                      period using a standardized form
                                                electronic, mechanical, or other                                                    events (such as water main breaks) in                                                     (approximately 13 events per utility).
                                                technological collection techniques or                                              drinking water distribution systems.                                                      Utilities will provide address listings of
                                                other forms of information technology,                                              Studies in both Norway and Sweden                                                         households in areas exposed to the low
                                                e.g., permitting electronic submissions                                             found that people exposed to low
                                                                                                                                                                                                                              pressure event and comparable
                                                of responses.                                                                       pressure events in the water distribution
                                                                                                                                                                                                                              households in an unexposed area to
                                                  5. Assess information collection costs.                                           system had a higher risk for
                                                                                                                                                                                                                              CDC staff, who will randomly select
                                                                                                                                    gastrointestinal illness. A similar study
                                                Proposed Project                                                                                                                                                              participants and send them an
                                                                                                                                    is needed in the United States.
                                                  Epidemiologic Study of Health Effects                                                The purpose of this data collection is                                                 introductory letter and questionnaire.
                                                Associated With Low Pressure Events in                                              to conduct an epidemiologic study in                                                      Consenting household respondents will
                                                Drinking Water Distribution Systems—                                                the U.S. to assess whether individuals                                                    be asked about symptoms and duration
                                                Reinstatement With Change—National                                                  exposed to low pressure events in the                                                     of any recent gastrointestinal or
                                                Center for Emerging and Zoonotic                                                    water distribution system are at an                                                       respiratory illness, tap water
                                                Infectious Diseases (NCEZID), Centers                                               increased risk for acute gastrointestinal                                                 consumption, and other exposures
                                                for Disease Control and Prevention                                                  or respiratory illness. This study would                                                  including international travel, daycare
                                                (CDC).                                                                              be, to our knowledge, the first U.S.                                                      attendance or employment, animal
                                                                                                                                    study to systematically examine the                                                       contacts, and recreational water
                                                Background and Brief Description
                                                                                                                                    association between low pressure events                                                   exposures. Study participants may
                                                  In the United States (U.S.), drinking                                             and acute gastrointestinal and                                                            choose between two methods of survey
                                                water distribution systems are designed                                             respiratory illnesses. Study findings will                                                response: A mail-in paper survey and a
                                                to deliver safe, pressurized drinking                                               inform the Environmental Protection                                                       web-based survey.
                                                water to our homes, hospitals, schools                                              Agency (EPA), CDC, and other drinking
                                                and businesses. However, the water                                                                                                                                              Participation in this study will be
                                                                                                                                    water stakeholders of the potential
                                                distribution infrastructure is 50–100                                                                                                                                         voluntary. No financial compensation
                                                                                                                                    health risks associated with low
                                                years old in much of the U.S. and an                                                pressure events in drinking water                                                         will be provided to study participants.
                                                estimated 240,000 water main breaks                                                 distribution systems and whether                                                          The study duration is anticipated to last
                                                occur each year. Failures in the                                                    additional measures (e.g., new                                                            78 months. An estimated 7,900
                                                distribution system such as water main                                              standards, additional research, or policy                                                 individuals will be contacted and we
                                                breaks, cross-connections, back-flow,                                               development) are needed to reduce the                                                     anticipate 6,320 utility customers (18
                                                and pressure fluctuations can result in                                             risk for health effects associated with                                                   years of age or older) will consent to
                                                potential intrusion of microbes and                                                 low pressure events in the drinking                                                       participate in this study. The total
                                                other contaminants that can cause                                                   water distribution system.                                                                estimated annualized hours associated
                                                health effects, including acute                                                        We will conduct a cohort study                                                         with this study reinstatement is
                                                gastrointestinal and respiratory illness.                                           among households that receive water                                                       expected to be 199 hours per year. There
                                                  Approximately 200 million cases of                                                from seven water utilities across the                                                     are no costs to respondents other than
                                                acute gastrointestinal illness occur in                                             U.S.                                                                                      their time.
                                                                                                                                   ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                                                    Average
                                                                                                                                                                                                                                      Number of
                                                                                                                                                                                                           Number of                                              burden per              Total burden
                                                                   Type of respondents                                                                Form name                                                                     responses per
                                                                                                                                                                                                          respondents                                              response                (in hours)
                                                                                                                                                                                                                                      respondent                   (in hours)

                                                Water Utility customer .......................................             Paper-based questionnaire ...............................                                       240                           1                (12/60)                   48
                                                                                                                           Web-based questionnaire .................................                                       160                           1                (12/60)                   32
                                                Water utility maintenance worker ......................                    LPE form, ultrafilter and grab samples .............                                              5                           3               (145/60)                   36
                                                                                                                           LPE form, grab samples ...................................                                        5                           2                (45/60)                    8
                                                Water Utility Environmental Engineer ...............                       Line listings .......................................................                             5                           5                      2                   50
                                                Water Utility Billing clerk ....................................           Line listings .......................................................                             5                           5                      1                   25

                                                      Total ............................................................   ...........................................................................   ........................   ........................   ........................            199



                                                Jeffrey M. Zirger,
                                                Acting Chief, Information Collection Review
sradovich on DSK3GMQ082PROD with NOTICES




                                                Office, Office of Scientific Integrity, Office
                                                of the Associate Director for Science, Office
                                                of the Director, Centers for Disease Control
                                                and Prevention.
                                                [FR Doc. 2018–18699 Filed 8–28–18; 8:45 am]
                                                BILLING CODE 4163–18–P




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Document Created: 2018-08-29 00:12:33
Document Modified: 2018-08-29 00:12:33
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.
DatesCDC must receive written comments on or before October 29, 2018.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]
FR Citation83 FR 44053 

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