80_FR_67972 80 FR 67760 - Agency Forms Undergoing Paperwork Reduction Act Review

80 FR 67760 - Agency Forms Undergoing Paperwork Reduction Act Review

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

Federal Register Volume 80, Issue 212 (November 3, 2015)

Page Range67760-67761
FR Document2015-27889

Federal Register, Volume 80 Issue 212 (Tuesday, November 3, 2015)
[Federal Register Volume 80, Number 212 (Tuesday, November 3, 2015)]
[Notices]
[Pages 67760-67761]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27889]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-15-0960]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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]. Written comments and/or 
suggestions regarding the items contained in this notice should be 
directed to the Attention: CDC Desk Officer, Office of Management and 
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written 
comments should be received within 30 days of this notice.

Proposed Project

    Epidemiologic Study of Health Effects Associated With Low Pressure 
Events in Drinking Water Distribution Systems (OMB Control No. 0920-
0960, expiration 3/31/2016)--Extension--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. A study conducted in Norway from 2003-2004 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 six 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 11 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 30 months. An estimated 6,750 individuals will 
be contacted and we anticipate 4,050 utility customers (18 years of age 
or older) will consent to participate in this study. The total 
estimated annualized hours associated with this study is expected to be 
548.
    There are no costs to respondents other than their time.

[[Page 67761]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Households............................  Paper-based                        1,215               1           12/60
                                         questionnaire.
Households............................  Web-based questionnaire.             810               1           12/60
Utility employees.....................  Household listing.......               6               5               3
Utility employees.....................  Water sample collection                6               3          130/60
                                         (grab samples).
Utility employees.....................  Water sample collection                6               2           30/60
                                         (ultrafiltration
                                         samples).
Utility employees.....................  Low pressure event form.               6               5           15/60
----------------------------------------------------------------------------------------------------------------


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. 2015-27889 Filed 11-2-15; 8:45 am]
 BILLING CODE 4163-18-P



                                                  67760                      Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices

                                                  Leroy A. Richardson,                                    comments and/or suggestions regarding                 be, to our knowledge, the first U.S.
                                                  Chief, Information Collection Review Office,            the items contained in this notice                    study to systematically examine the
                                                  Office of Scientific Integrity, Office of the           should be directed to the Attention:                  association between low pressure events
                                                  Associate Director for Science, Office of the           CDC Desk Officer, Office of Management                and acute gastrointestinal and
                                                  Director, Centers for Disease Control and               and Budget, Washington, DC 20503 or                   respiratory illnesses. Study findings will
                                                  Prevention.
                                                                                                          by fax to (202) 395–5806. Written                     inform the Environmental Protection
                                                  [FR Doc. 2015–27890 Filed 11–2–15; 8:45 am]
                                                                                                          comments should be received within 30                 Agency (EPA), CDC, and other drinking
                                                  BILLING CODE 4163–18–P                                  days of this notice.                                  water stakeholders of the potential
                                                                                                                                                                health risks associated with low
                                                                                                          Proposed Project
                                                                                                                                                                pressure events in drinking water
                                                  DEPARTMENT OF HEALTH AND                                  Epidemiologic Study of Health Effects               distribution systems and whether
                                                  HUMAN SERVICES                                          Associated With Low Pressure Events in                additional measures (e.g., new
                                                  Centers for Disease Control and                         Drinking Water Distribution Systems                   standards, additional research, or policy
                                                  Prevention                                              (OMB Control No. 0920–0960,                           development) are needed to reduce the
                                                                                                          expiration 3/31/2016)—Extension—                      risk for health effects associated with
                                                  [30Day–15–0960]                                         National Center for Emerging and                      low pressure events in the drinking
                                                                                                          Zoonotic Infectious Diseases (NCEZID),                water distribution system.
                                                  Agency Forms Undergoing Paperwork                       Centers for Disease Control and
                                                  Reduction Act Review                                                                                             We will conduct a cohort study
                                                                                                          Prevention (CDC).                                     among households that receive water
                                                     The Centers for Disease Control and                  Background and Brief Description                      from six water utilities across the U.S.
                                                  Prevention (CDC) has submitted the                                                                            The water systems will be
                                                  following information collection request                   In the United States (U.S.), drinking
                                                                                                                                                                geographically diverse and will include
                                                  to the Office of Management and Budget                  water distribution systems are designed
                                                                                                                                                                both chlorinated and chloraminated
                                                  (OMB) for review and approval in                        to deliver safe, pressurized drinking
                                                                                                                                                                systems. These water utilities will
                                                  accordance with the Paperwork                           water to our homes, hospitals, schools
                                                                                                                                                                provide information about low pressure
                                                  Reduction Act of 1995. The notice for                   and businesses. However, the water
                                                                                                                                                                events that occur during the study
                                                  the proposed information collection is                  distribution infrastructure is 50–100
                                                                                                                                                                period using a standardized form
                                                  published to obtain comments from the                   years old in much of the U.S. and an
                                                                                                                                                                (approximately 11 events per utility).
                                                  public and affected agencies.                           estimated 240,000 water main breaks
                                                                                                                                                                Utilities will provide address listings of
                                                     Written comments and suggestions                     occur each year. Failures in the
                                                                                                                                                                households in areas exposed to the low
                                                  from the public and affected agencies                   distribution system such as water main
                                                                                                                                                                pressure event and comparable
                                                  concerning the proposed collection of                   breaks, cross-connections, back-flow,
                                                                                                                                                                households in an unexposed area to
                                                  information are encouraged. Your                        and pressure fluctuations can result in
                                                                                                                                                                CDC staff, who will randomly select
                                                  comments should address any of the                      potential intrusion of microbes and
                                                                                                                                                                participants and send them an
                                                  following: (a) Evaluate whether the                     other contaminants that can cause
                                                                                                                                                                introductory letter and questionnaire.
                                                  proposed collection of information is                   health effects, including acute
                                                                                                                                                                Consenting household respondents will
                                                  necessary for the proper performance of                 gastrointestinal and respiratory illness.
                                                                                                                                                                be asked about symptoms and duration
                                                  the functions of the agency, including                     Approximately 200 million cases of
                                                                                                                                                                of any recent gastrointestinal or
                                                  whether the information will have                       acute gastrointestinal illness occur in
                                                                                                                                                                respiratory illness, tap water
                                                  practical utility; (b) Evaluate the                     the U.S. each year, but we lack reliable
                                                                                                                                                                consumption, and other exposures
                                                  accuracy of the agencies estimate of the                data to assess how many of these cases
                                                                                                                                                                including international travel, daycare
                                                  burden of the proposed collection of                    are associated with drinking water.
                                                                                                                                                                attendance or employment, animal
                                                  information, including the validity of                  Further, data are even more limited on
                                                                                                                                                                contacts, and recreational water
                                                  the methodology and assumptions used;                   the human health risks associated with
                                                                                                                                                                exposures. Study participants may
                                                  (c) Enhance the quality, utility, and                   exposure to drinking water during and
                                                                                                                                                                choose between two methods of survey
                                                  clarity of the information to be                        after the occurrence of low pressure
                                                                                                                                                                response: A mail-in paper survey and a
                                                  collected; (d) Minimize the burden of                   events (such as water main breaks) in
                                                                                                                                                                Web-based survey.
                                                  the collection of information on those                  drinking water distribution systems. A
                                                  who are to respond, including through                   study conducted in Norway from 2003–                     Participation in this study will be
                                                  the use of appropriate automated,                       2004 found that people exposed to low                 voluntary. No financial compensation
                                                  electronic, mechanical, or other                        pressure events in the water distribution             will be provided to study participants.
                                                  technological collection techniques or                  system had a higher risk for                          The study duration is anticipated to last
                                                  other forms of information technology,                  gastrointestinal illness. A similar study             30 months. An estimated 6,750
                                                  e.g., permitting electronic submission of               is needed in the United States.                       individuals will be contacted and we
                                                  responses; and (e) Assess information                      The purpose of this data collection is             anticipate 4,050 utility customers (18
                                                  collection costs.                                       to conduct an epidemiologic study in                  years of age or older) will consent to
                                                     To request additional information on                 the U.S. to assess whether individuals                participate in this study. The total
                                                  the proposed project or to obtain a copy                exposed to low pressure events in the                 estimated annualized hours associated
                                                  of the information collection plan and                  water distribution system are at an                   with this study is expected to be 548.
                                                  instruments, call (404) 639–7570 or                     increased risk for acute gastrointestinal                There are no costs to respondents
                                                  send an email to omb@cdc.gov. Written                   or respiratory illness. This study would              other than their time.
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                                                                                   Federal Register / Vol. 80, No. 212 / Tuesday, November 3, 2015 / Notices                                                             67761

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

                                                  Households .......................................   Paper-based questionnaire ...........................................                 1,215               1          12/60
                                                  Households .......................................   Web-based questionnaire .............................................                   810               1          12/60
                                                  Utility employees ..............................     Household listing ..........................................................              6               5              3
                                                  Utility employees ..............................     Water sample collection (grab samples) ......................                             6               3         130/60
                                                  Utility employees ..............................     Water sample collection (ultrafiltration samples) ..........                              6               2          30/60
                                                  Utility employees ..............................     Low pressure event form ..............................................                    6               5          15/60



                                                  Leroy A. Richardson,                                               confidential information that you or a                            copies total. One copy will include the
                                                  Chief, Information Collection Review Office,                       third party may not wish to be posted,                            information you claim to be confidential
                                                  Office of Scientific Integrity, Office of the                      such as medical information, your or                              with a heading or cover note that states
                                                  Associate Director for Science, Office of the                      anyone else’s Social Security number, or                          ‘‘THIS DOCUMENT CONTAINS
                                                  Director, Centers for Disease Control and                          confidential business information, such                           CONFIDENTIAL INFORMATION.’’ The
                                                  Prevention.                                                        as a manufacturing process. Please note                           Agency will review this copy, including
                                                  [FR Doc. 2015–27889 Filed 11–2–15; 8:45 am]                        that if you include your name, contact                            the claimed confidential information, in
                                                  BILLING CODE 4163–18–P                                             information, or other information that                            its consideration of comments. The
                                                                                                                     identifies you in the body of your                                second copy, which will have the
                                                                                                                     comments, that information will be                                claimed confidential information
                                                  DEPARTMENT OF HEALTH AND                                           posted on http://www.regulations.gov.                             redacted/blacked out, will be available
                                                  HUMAN SERVICES                                                       • If you want to submit a comment                               for public viewing and posted on
                                                                                                                     with confidential information that you                            http://www.regulations.gov. Submit
                                                  Food and Drug Administration                                       do not wish to be made available to the                           both copies to the Division of Dockets
                                                  [Docket No. FDA–2013–D–0589]                                       public, submit the comment as a                                   Management. If you do not wish your
                                                                                                                     written/paper submission and in the                               name and contact information to be
                                                  Human Immunodeficiency Virus-1                                     manner detailed (see ‘‘Written/Paper                              made publicly available, you can
                                                  Infection: Developing Antiretroviral                               Submissions’’ and ‘‘Instructions’’).                              provide this information on the cover
                                                  Drugs for Treatment; Guidance for                                                                                                    sheet and not in the body of your
                                                  Industry; Availability                                             Written/Paper Submissions
                                                                                                                                                                                       comments and you must identify this
                                                                                                                        Submit written/paper submissions as                            information as ‘‘confidential.’’ Any
                                                  AGENCY:      Food and Drug Administration,                         follows:
                                                  HHS.                                                                                                                                 information marked as ‘‘confidential’’
                                                                                                                        • Mail/Hand delivery/Courier (for
                                                  ACTION:     Notice of availability.                                                                                                  will not be disclosed except in
                                                                                                                     written/paper submissions): Division of
                                                                                                                                                                                       accordance with 21 CFR 10.20 and other
                                                                                                                     Dockets Management (HFA–305), Food
                                                  SUMMARY:   The Food and Drug                                                                                                         applicable disclosure law. For more
                                                                                                                     and Drug Administration, 5630 Fishers
                                                  Administration (FDA or Agency) is                                                                                                    information about FDA’s posting of
                                                                                                                     Lane, Rm. 1061, Rockville, MD 20852.
                                                  announcing the availability of a                                      • For written/paper comments                                   comments to public dockets, see 80 FR
                                                  guidance for industry entitled ‘‘Human                             submitted to the Division of Dockets                              56469, September 18, 2015, or access
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                                                  Developing Antiretroviral Drugs for                                comment, as well as any attachments,                              regulatoryinformation/dockets/
                                                  Treatment.’’ The purpose of this                                   except for information submitted,                                 default.htm.
                                                  guidance is to assist sponsors in all                              marked and identified, as confidential,                              Docket: For access to the docket to
                                                  phases of development of antiretroviral                            if submitted as detailed in                                       read background documents or the
                                                  drugs and therapeutic biologic products                            ‘‘Instructions.’’                                                 electronic and written/paper comments
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                                                  DATES: Submit either electronic or                                 must include the Docket No. FDA–                                  www.regulations.gov and insert the
                                                  written comments on Agency guidances                               2013–D–0589 for ‘‘Human                                           docket number, found in brackets in the
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                                                  ADDRESSES: You may submit comments                                 Developing Antiretroviral Drugs for                               ‘‘Search’’ box and follow the prompts
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                                                                                                                     Availability.’’ Received comments will                            Management, 5630 Fishers Lane, Rm.
                                                  Electronic Submissions                                             be placed in the docket and, except for                           1061, Rockville, MD 20852.
                                                    Submit electronic comments in the                                those submitted as ‘‘Confidential                                    Submit written requests for single
                                                  following way:                                                     Submissions,’’ publicly viewable at                               copies of this guidance to the Division
                                                    • Federal eRulemaking Portal: http://                            http://www.regulations.gov or at the                              of Drug Information, Center for Drug
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                                                  instructions for submitting comments.                              between 9 a.m. and 4 p.m., Monday                                 Drug Administration, 10001 New
                                                  Comments submitted electronically,                                 through Friday.                                                   Hampshire Ave., Hillandale Building,
                                                  including attachments, to http://                                     • Confidential Submissions—To                                  4th Floor, Silver Spring, MD 20993–
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                                                  comment does not include any                                       submission. You should submit two                                 access to the guidance document.


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Document Created: 2018-03-01 11:32:10
Document Modified: 2018-03-01 11:32:10
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
FR Citation80 FR 67760 

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