83_FR_34726 83 FR 34586 - Proposed Data Collection Submitted for Public Comment and Recommendations

83 FR 34586 - 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 140 (July 20, 2018)

Page Range34586-34588
FR Document2018-15529

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 Communities Organized to Prevent Arboviruses: Assessment of Knowledge, Attitudes, and Vector Control Practices and Sero-Prevalence and Incidence of Arboviral Infection in Ponce, Puerto Rico (COPA Study). The purpose of this study is to establish longitudinal follow-up of a community cohort and evaluate the impact of vector control interventions in 14 communities in southern Puerto Rico.

Federal Register, Volume 83 Issue 140 (Friday, July 20, 2018)
[Federal Register Volume 83, Number 140 (Friday, July 20, 2018)]
[Notices]
[Pages 34586-34588]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-15529]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-18-18ANU; Docket No. CDC-2018-0058]


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 Communities Organized to Prevent 
Arboviruses: Assessment of Knowledge, Attitudes, and Vector Control 
Practices and Sero-Prevalence and Incidence of Arboviral Infection in 
Ponce, Puerto Rico (COPA Study). The purpose of this study is to 
establish longitudinal follow-up of a community cohort and evaluate the 
impact of vector control interventions in 14 communities in southern 
Puerto Rico.

DATES: CDC must receive written comments on or before September 18, 
2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0058 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;
    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

    Communities Organized To Prevent Arboviruses: Assessment of 
Knowledge, Attitudes, and Vector Control Practices and Sero-Prevalence 
and Incidence of Arboviral Infection in Ponce, Puerto Rico (COPA 
Study)--NEW--National Center for Emerging and Zoonotic Infectious 
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Recent years have seen the emergence of two epidemic arthropod-
borne viruses (arboviruses) that are transmitted by Aedes aegypti 
mosquitoes. Chikungunya virus was introduced into the Caribbean in late 
2013, and caused large epidemics of fever with severe joint pain 
throughout the Caribbean and Americas in 2014. Zika virus was first 
detected in the Americas in Brazil in 2014, spread throughout the 
Americas, has since been associated with devastating birth defects, 
Guillain-Barre syndrome, and is the first arbovirus that can also be

[[Page 34587]]

transmitted through sexual contact. In addition, the four viruses that 
cause dengue were introduced to the Americas over the past several 
hundred years and have since become endemic, and yellow fever virus has 
recently caused large outbreaks in Brazil and there is risk of 
importation to other counties in the Americas.
    In all of these cases, the public health response to the spread of 
these arboviruses throughout the tropics, where their mosquito vectors 
thrive, has been hampered by a lack of sustainable and effective 
interventions to prevent infection with any of these arboviruses at the 
community level. Additionally, the rapid speed with which new 
arboviruses spread does not often provide the time needed to plan and 
implement community-level interventions to decrease disease 
transmission. Although several candidate vaccines for chikungunya and 
Zika are currently in clinical development, none are yet available. A 
dengue vaccine has been licensed in several countries, but initial 
analyses have suggested that decades will be needed before it results 
in reduction in transmission of dengue virus. In recent years, 
community based strategies for vector control have been studied and 
implemented in different countries as an alternative to vertical 
strategies (e.g. insecticide spraying delivered by government 
agencies). A new intervention has recently been demonstrated to reduce 
the rates of infection with common tropical arboviruses transmitted by 
Ae. aegypti mosquitos (i.e., dengue, chikungunya, and Zika viruses). 
The Camino Verde approach utilizes community mobilization to motivate 
clean-up campaigns to reduce rates of dengue virus infections in 
Nicaragua and Mexico. However, the intervention occurred in small 
communities, and has not been evaluated in an urban setting. There is 
therefore, a need to determine the effectiveness of such types of 
interventions in relatively large, urban communities.
    Research suggests that vector control programs that have 
substantial community participation can have significant and lasting 
impacts on vector density, and are more cost-effective than vertically 
structured programs. In addition, these types of programs have been 
reported to readily integrate with other health or development 
programs, promote an enduring sense of pride in the home and community, 
and make use of politically viable vector control strategies.
    The purpose of this study is to establish longitudinal follow-up of 
a community cohort and evaluate the impact of vector control 
interventions in 14 communities in southern Puerto Rico. The study 
investigators have prior experience working in these communities; 
however, there is minimal available information regarding the 
prevalence or incidence of infection with tropical arboviruses, density 
of Ae. aegypti mosquitos, or community members' knowledge, attitudes, 
and practices regarding behaviors intended to avoid mosquitos. Such 
information will be needed to inform decision-making regarding the 
location, design, and content of interventions to be implemented and 
evaluated to reduce the burden of these pathogens.
    The questionnaire section will vary depending on age and day of 
birth of each participant. A questionnaire with general household 
questions will be administered to one household representative in each 
home with one or more participants. This representative should be 21 
years or older or an emancipated minor. If all eligible household 
members are unemancipated minors, a household member over the age of 50 
may act as household representative and complete this section of the 
survey only. A questionnaire on socio-demographic information will be 
administered to all participants. The assessment of knowledge, 
attitudes, and practices questionnaire will be administered to all 
participants seven years and older with questions adapted for ages: 7-
11 (younger child), 12-13 (older child), 14-50 (adult). A vector 
control tools questionnaire will be administered to all participants 21 
years or older born on an odd numbered day of the month. The 
questionnaire will be administered after written consent and verbal 
assent (when appropriate) from those present in the household at the 
time of the visit. The knowledge, attitudes, and practices 
questionnaire will be focused on vector control, healthcare-seeking 
behavior, and disease occurrence. We will collect demographic 
information (e.g., age, sex, duration of time residing in Puerto Rico), 
travel history, and information on recent illnesses from all 
participants via household (and individual) questionnaires. Parents or 
guardians will serve as proxy respondents for children aged <7 years. 
The questionnaires will be administered after written consent and 
verbal assent (when appropriate) from those present in the household at 
the time of the visit. GPS coordinates will also be collected for each 
household visited to later assess for potential clustering of arboviral 
infections within communities. We will ask participants if they have 
been ill with arbovirus-like illness (i.e., fever, rash, joint pain, 
and conjunctivitis) in the past year. If so, we will collect details on 
the symptoms experienced during their illness. The questionnaires will 
be administered to all randomly selected residents of the 14 
communities in Ponce. At the time of the questionnaire administration, 
~15 mL of blood will be collected to conduct serological testing of 
arboviruses for a sero-survey. The sero-survey and socio-demographic 
questionnaire will be repeated every 12 months after the initial 
assessment, up to a period of five years. OMB clearance will be 
extended after three years. This project will allow the evaluation of a 
community based approach for vector control strategies in Ponce, Puerto 
Rico. The information obtained will inform decision making regarding 
the location, design, and content of future interventions to be 
implemented and evaluated to reduce the burden of arboviral disease in 
Puerto Rico. Incidence and prevalence of arboviral disease will be 
estimated to guide control programs development and fill the current 
knowledge gaps.
    There is no burden on respondents other than the time needed to 
participate. Estimated annual burden is 2,416 hours. Authorizing 
legislation comes from Section 301 of the Public Health Service Act.

                                                            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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Ponce residents................................  Household representative questionnaire.           2,506               1           10/60             418
                                                 Socio-demographic questionnaire........           2,996               1           15/60             749
                                                 Knowledge, attitudes, and practices               2,996               1           15/60             749
                                                  individual questionnaire.

[[Page 34588]]

 
                                                 Vector control tools questionnaire.....             600               1           25/60             250
                                                 Specimen collection....................           2,996               1            5/60             250
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           2,416
--------------------------------------------------------------------------------------------------------------------------------------------------------


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. 2018-15529 Filed 7-19-18; 8:45 am]
 BILLING CODE 4163-18-P



                                               34586                                     Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices

                                                                                                                      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)

                                               Natural science managers ................                Semi-Structured Interview                        Guide                           10                            1                          2              20
                                                                                                          (Subject Matter Experts).
                                               Postsecondary Teachers ..................                Semi-Structured Interview                        Guide                           12                           1                          2               24
                                                                                                          (Grantees).
                                               Industrial production managers ........                  Semi-Structured Interview                        Guide                              8                          1                          2              16
                                                                                                          (Research users).

                                                    Total ...........................................   ...........................................................   ........................   ........................   ........................             60



                                               Jeffrey M. Zirger,                                                      ADDRESSES:   You may submit comments,                                           1. Evaluate whether the proposed
                                               Acting Chief, Information Collection Review                             identified by Docket No. CDC–2018–                                            collection of information is necessary
                                               Office, Office of Scientific Integrity, Office                          0058 by any of the following methods:                                         for the proper performance of the
                                               of the Associate Director for Science, Office                              • Federal eRulemaking Portal:                                              functions of the agency, including
                                               of the Director, Centers for Disease Control                            Regulations.gov. Follow the instructions                                      whether the information will have
                                               and Prevention.                                                                                                                                       practical utility;
                                                                                                                       for submitting comments.
                                               [FR Doc. 2018–15527 Filed 7–19–18; 8:45 am]                                • Mail: Jeffrey M. Zirger, Information                                       2. Evaluate the accuracy of the
                                               BILLING CODE 4163–18–P                                                  Collection Review Office, Centers for                                         agency’s estimate of the burden of the
                                                                                                                       Disease Control and Prevention, 1600                                          proposed collection of information,
                                                                                                                       Clifton Road NE, MS–D74, Atlanta,                                             including the validity of the
                                               DEPARTMENT OF HEALTH AND                                                Georgia 30329.                                                                methodology and assumptions used;
                                               HUMAN SERVICES                                                             Instructions: All submissions received                                       3. Enhance the quality, utility, and
                                                                                                                       must include the agency name and                                              clarity of the information to be
                                               Centers for Disease Control and
                                                                                                                       Docket Number. CDC will post, without                                         collected; and
                                               Prevention                                                                                                                                              4. Minimize the burden of the
                                                                                                                       change, all relevant comments to
                                               [60Day–18–18ANU; Docket No. CDC–2018–                                   Regulations.gov.                                                              collection of information on those who
                                               0058]                                                                      Please note: Submit all comments                                           are to respond, including through the
                                                                                                                       through the Federal eRulemaking portal                                        use of appropriate automated,
                                               Proposed Data Collection Submitted                                      (regulations.gov) or by U.S. mail to the                                      electronic, mechanical, or other
                                               for Public Comment and                                                  address listed above.                                                         technological collection techniques or
                                               Recommendations                                                                                                                                       other forms of information technology,
                                                                                                                       FOR FURTHER INFORMATION CONTACT: To
                                                                                                                       request more information on the                                               e.g., permitting electronic submissions
                                               AGENCY: Centers for Disease Control and                                                                                                               of responses.
                                               Prevention (CDC), Department of Health                                  proposed project or to obtain a copy of
                                                                                                                                                                                                       5. Assess information collection costs.
                                               and Human Services (HHS).                                               the information collection plan and
                                               ACTION: Notice with comment period.                                     instruments, contact Jeffrey M. Zirger,                                       Proposed Project
                                                                                                                       Information Collection Review Office,                                           Communities Organized To Prevent
                                               SUMMARY:   The Centers for Disease                                      Centers for Disease Control and                                               Arboviruses: Assessment of Knowledge,
                                               Control and Prevention (CDC), as part of                                Prevention, 1600 Clifton Road NE, MS–                                         Attitudes, and Vector Control Practices
                                               its continuing effort to reduce public                                  D74, Atlanta, Georgia 30329; phone:                                           and Sero-Prevalence and Incidence of
                                               burden and maximize the utility of                                      404–639–7570; Email: omb@cdc.gov.                                             Arboviral Infection in Ponce, Puerto
                                               government information, invites the                                     SUPPLEMENTARY INFORMATION: Under the                                          Rico (COPA Study)—NEW—National
                                               general public and other Federal                                        Paperwork Reduction Act of 1995 (PRA)                                         Center for Emerging and Zoonotic
                                               agencies the opportunity to comment on                                  (44 U.S.C. 3501–3520), Federal agencies                                       Infectious Diseases (NCEZID), Centers
                                               a proposed and/or continuing                                            must obtain approval from the Office of                                       for Disease Control and Prevention
                                               information collection, as required by                                  Management and Budget (OMB) for each                                          (CDC).
                                               the Paperwork Reduction Act of 1995.                                    collection of information they conduct
                                               This notice invites comment on a                                        or sponsor. In addition, the PRA also                                         Background and Brief Description
                                               proposed information collection project                                 requires Federal agencies to provide a                                           Recent years have seen the emergence
                                               titled Communities Organized to                                         60-day notice in the Federal Register                                         of two epidemic arthropod-borne
                                               Prevent Arboviruses: Assessment of                                      concerning each proposed collection of                                        viruses (arboviruses) that are
                                               Knowledge, Attitudes, and Vector                                        information, including each new                                               transmitted by Aedes aegypti
                                               Control Practices and Sero-Prevalence                                   proposed collection, each proposed                                            mosquitoes. Chikungunya virus was
                                               and Incidence of Arboviral Infection in                                 extension of existing collection of                                           introduced into the Caribbean in late
                                               Ponce, Puerto Rico (COPA Study). The                                    information, and each reinstatement of                                        2013, and caused large epidemics of
                                               purpose of this study is to establish                                   previously approved information                                               fever with severe joint pain throughout
daltland on DSKBBV9HB2PROD with NOTICES




                                               longitudinal follow-up of a community                                   collection before submitting the                                              the Caribbean and Americas in 2014.
                                               cohort and evaluate the impact of vector                                collection to the OMB for approval. To                                        Zika virus was first detected in the
                                               control interventions in 14 communities                                 comply with this requirement, we are                                          Americas in Brazil in 2014, spread
                                               in southern Puerto Rico.                                                publishing this notice of a proposed                                          throughout the Americas, has since been
                                               DATES: CDC must receive written                                         data collection as described below.                                           associated with devastating birth
                                               comments on or before September 18,                                        The OMB is particularly interested in                                      defects, Guillain-Barre syndrome, and is
                                               2018.                                                                   comments that will help:                                                      the first arbovirus that can also be


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                                                                                 Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices                                             34587

                                               transmitted through sexual contact. In                   density, and are more cost-effective than             time of the visit. The knowledge,
                                               addition, the four viruses that cause                    vertically structured programs. In                    attitudes, and practices questionnaire
                                               dengue were introduced to the Americas                   addition, these types of programs have                will be focused on vector control,
                                               over the past several hundred years and                  been reported to readily integrate with               healthcare-seeking behavior, and
                                               have since become endemic, and yellow                    other health or development programs,                 disease occurrence. We will collect
                                               fever virus has recently caused large                    promote an enduring sense of pride in                 demographic information (e.g., age, sex,
                                               outbreaks in Brazil and there is risk of                 the home and community, and make use                  duration of time residing in Puerto
                                               importation to other counties in the                     of politically viable vector control                  Rico), travel history, and information on
                                               Americas.                                                strategies.                                           recent illnesses from all participants via
                                                  In all of these cases, the public health                 The purpose of this study is to                    household (and individual)
                                               response to the spread of these                          establish longitudinal follow-up of a                 questionnaires. Parents or guardians
                                               arboviruses throughout the tropics,                      community cohort and evaluate the                     will serve as proxy respondents for
                                               where their mosquito vectors thrive, has                 impact of vector control interventions in             children aged <7 years. The
                                               been hampered by a lack of sustainable                   14 communities in southern Puerto                     questionnaires will be administered
                                               and effective interventions to prevent                   Rico. The study investigators have prior              after written consent and verbal assent
                                               infection with any of these arboviruses                  experience working in these                           (when appropriate) from those present
                                               at the community level. Additionally,                    communities; however, there is minimal                in the household at the time of the visit.
                                               the rapid speed with which new                           available information regarding the                   GPS coordinates will also be collected
                                               arboviruses spread does not often                        prevalence or incidence of infection                  for each household visited to later
                                               provide the time needed to plan and                      with tropical arboviruses, density of Ae.             assess for potential clustering of
                                               implement community-level                                aegypti mosquitos, or community
                                                                                                                                                              arboviral infections within
                                               interventions to decrease disease                        members’ knowledge, attitudes, and
                                                                                                                                                              communities. We will ask participants if
                                               transmission. Although several                           practices regarding behaviors intended
                                                                                                                                                              they have been ill with arbovirus-like
                                               candidate vaccines for chikungunya and                   to avoid mosquitos. Such information
                                                                                                                                                              illness (i.e., fever, rash, joint pain, and
                                               Zika are currently in clinical                           will be needed to inform decision-
                                                                                                                                                              conjunctivitis) in the past year. If so, we
                                               development, none are yet available. A                   making regarding the location, design,
                                                                                                                                                              will collect details on the symptoms
                                               dengue vaccine has been licensed in                      and content of interventions to be
                                                                                                                                                              experienced during their illness. The
                                               several countries, but initial analyses                  implemented and evaluated to reduce
                                                                                                                                                              questionnaires will be administered to
                                               have suggested that decades will be                      the burden of these pathogens.
                                                                                                           The questionnaire section will vary                all randomly selected residents of the 14
                                               needed before it results in reduction in
                                                                                                        depending on age and day of birth of                  communities in Ponce. At the time of
                                               transmission of dengue virus. In recent
                                                                                                        each participant. A questionnaire with                the questionnaire administration, ∼15
                                               years, community based strategies for
                                               vector control have been studied and                     general household questions will be                   mL of blood will be collected to conduct
                                               implemented in different countries as                    administered to one household                         serological testing of arboviruses for a
                                               an alternative to vertical strategies (e.g.              representative in each home with one or               sero-survey. The sero-survey and socio-
                                               insecticide spraying delivered by                        more participants. This representative                demographic questionnaire will be
                                               government agencies). A new                              should be 21 years or older or an                     repeated every 12 months after the
                                               intervention has recently been                           emancipated minor. If all eligible                    initial assessment, up to a period of five
                                               demonstrated to reduce the rates of                      household members are unemancipated                   years. OMB clearance will be extended
                                               infection with common tropical                           minors, a household member over the                   after three years. This project will allow
                                               arboviruses transmitted by Ae. aegypti                   age of 50 may act as household                        the evaluation of a community based
                                               mosquitos (i.e., dengue, chikungunya,                    representative and complete this section              approach for vector control strategies in
                                               and Zika viruses). The Camino Verde                      of the survey only. A questionnaire on                Ponce, Puerto Rico. The information
                                               approach utilizes community                              socio-demographic information will be                 obtained will inform decision making
                                               mobilization to motivate clean-up                        administered to all participants. The                 regarding the location, design, and
                                               campaigns to reduce rates of dengue                      assessment of knowledge, attitudes, and               content of future interventions to be
                                               virus infections in Nicaragua and                        practices questionnaire will be                       implemented and evaluated to reduce
                                               Mexico. However, the intervention                        administered to all participants seven                the burden of arboviral disease in Puerto
                                               occurred in small communities, and has                   years and older with questions adapted                Rico. Incidence and prevalence of
                                               not been evaluated in an urban setting.                  for ages: 7–11 (younger child), 12–13                 arboviral disease will be estimated to
                                               There is therefore, a need to determine                  (older child), 14–50 (adult). A vector                guide control programs development
                                               the effectiveness of such types of                       control tools questionnaire will be                   and fill the current knowledge gaps.
                                               interventions in relatively large, urban                 administered to all participants 21 years                There is no burden on respondents
                                               communities.                                             or older born on an odd numbered day                  other than the time needed to
                                                  Research suggests that vector control                 of the month. The questionnaire will be               participate. Estimated annual burden is
                                               programs that have substantial                           administered after written consent and                2,416 hours. Authorizing legislation
                                               community participation can have                         verbal assent (when appropriate) from                 comes from Section 301 of the Public
                                               significant and lasting impacts on vector                those present in the household at the                 Health Service Act.

                                                                                                       ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                 Average
daltland on DSKBBV9HB2PROD with NOTICES




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

                                               Ponce residents .............   Household representative questionnaire .............                 2,506                 1           10/60            418
                                                                               Socio-demographic questionnaire .......................              2,996                 1           15/60            749
                                                                               Knowledge, attitudes, and practices individual                       2,996                 1           15/60            749
                                                                                 questionnaire.



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                                               34588                                   Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices

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

                                                                                     Vector control tools questionnaire .......................                                        600                             1                   25/60                250
                                                                                     Specimen collection .............................................                               2,996                             1                    5/60                250

                                                    Total ........................   ..............................................................................   ........................   ........................   ........................          2,416



                                               Jeffrey M. Zirger,                                                      including the validity of the                                                 prevent unintended pregnancy among
                                               Acting Chief, Information Collection Review                             methodology and assumptions used;                                             women at risk of Zika virus infection.
                                               Office, Office of Scientific Integrity, Office                            (c) Enhance the quality, utility, and                                       To this end, an initiative was launched
                                               of the Associate Director for Science, Office                           clarity of the information to be                                              in April 2016 to train physicians at
                                               of the Director, Centers for Disease Control                            collected;                                                                    clinics across Puerto Rico to provide
                                               and Prevention.
                                                                                                                         (d) Minimize the burden of the                                              patient-centered services to women who
                                               [FR Doc. 2018–15529 Filed 7–19–18; 8:45 am]                                                                                                           chose to delay or avoid pregnancy
                                                                                                                       collection of information on those who
                                               BILLING CODE 4163–18–P
                                                                                                                       are to respond, including, through the                                        during the Zika virus outbreak.
                                                                                                                       use of appropriate automated,                                                    As part of the public health response
                                                                                                                       electronic, mechanical, or other                                              to the Zika virus outbreak, CDC seeks to
                                               DEPARTMENT OF HEALTH AND
                                                                                                                       technological collection techniques or                                        assess approaches to mitigating the
                                               HUMAN SERVICES
                                                                                                                       other forms of information technology,                                        effects of Zika virus infection and
                                               Centers for Disease Control and                                         e.g., permitting electronic submission of                                     determine which approaches have
                                               Prevention                                                              responses; and                                                                utility. Previous assessment of the
                                                                                                                         (e) Assess information collection                                           prevention program indicated high
                                               [30Day–18–18TH]                                                         costs.                                                                        satisfaction of patients with program
                                                                                                                         To request additional information on                                        services. The specific objectives of this
                                               Agency Forms Undergoing Paperwork                                                                                                                     data collection are to assess (1)
                                               Reduction Act Review                                                    the proposed project or to obtain a copy
                                                                                                                       of the information collection plan and                                        prevention strategy adherence among
                                                  In accordance with the Paperwork                                     instruments, call (404) 639–7570 or                                           patients at approximately 18 months
                                               Reduction Act of 1995, the Centers for                                  send an email to omb@cdc.gov. Direct                                          after receipt of program services; and (2)
                                               Disease Control and Prevention (CDC)                                    written comments and/or suggestions                                           prevention strategy adherence, patient
                                               has submitted the information                                           regarding the items contained in this                                         satisfaction, and unmet need for
                                               collection request titled ‘‘Assessment of                               notice to the Attention: CDC Desk                                             services among participants at
                                               a Preventive Service Program in the                                     Officer, Office of Management and                                             approximately 30 months after receipt
                                               Context of a Zika Virus Outbreak in                                     Budget, 725 17th Street NW,                                                   of program services. The practical utility
                                               Puerto Rico’’ to the Office of                                          Washington, DC 20503 or by fax to (202)                                       of the information to be collected as part
                                               Management and Budget (OMB) for                                         395–5806. Provide written comments                                            of this project is to assess services
                                               review and approval. CDC previously                                     within 30 days of notice publication.                                         delivered to women in Puerto Rico,
                                               published a ‘‘Proposed Data Collection                                                                                                                monitor outcomes of interest, and
                                                                                                                       Proposed Project                                                              determine potential for replication/
                                               Submitted for Public Comment and
                                               Recommendations’’ notice on March 30,                                     Assessment of a Preventive Service                                          adaptation in other jurisdictions
                                               2018 to obtain comments from the                                        Program in the Context of a Zika Virus                                        similarly affected by the Zika virus or
                                               public and affected agencies. CDC                                       Outbreak in Puerto Rico—New—                                                  during other emergency responses. For
                                               received one non-substantive comment                                    National Center for Chronic Disease                                           the information collection, CDC plans to
                                               to the previous notice. This notice                                     Prevention and Health Promotion                                               conduct online surveys with 1,920
                                               serves to allow an additional 30 days for                               (NCCDPHP), Centers for Disease Control                                        patients approximately 18 months after
                                               public and affected agency comments.                                    and Prevention (CDC).                                                         receiving program services and 1,760
                                                  CDC will accept all comments for this                                                                                                              patients approximately 30 months after
                                                                                                                       Background and Brief Description                                              receiving program services. The number
                                               proposed information collection project.
                                               The Office of Management and Budget                                        Puerto Rico has reported the highest                                       of patients surveyed is based on an
                                               is particularly interested in comments                                  number of Zika virus infections in the                                        initial sample of 3,200 patients invited
                                               that:                                                                   United States, including infections in                                        to participate, anticipating a 60%
                                                  (a) Evaluate whether the proposed                                    pregnant women. Zika virus infection                                          response rate at 18 months and a 55%
                                               collection of information is necessary                                  during pregnancy has been identified as                                       response rate at 30 months.
                                               for the proper performance of the                                       a cause of microcephaly and other                                                Participation in all data collection
                                               functions of the agency, including                                      severe brain abnormalities, and has been                                      activities will be completely voluntary.
                                               whether the information will have                                       linked to other problems such as                                              OMB approval is requested for two
daltland on DSKBBV9HB2PROD with NOTICES




                                               practical utility;                                                      miscarriage, stillbirth, defects of the eye,                                  years. Total Annualized Burden Hours
                                                  (b) Evaluate the accuracy of the                                     hearing deficits, limb abnormalities, and                                     are estimated to be 259, and there are no
                                               agencies estimate of the burden of the                                  impaired growth. One strategy to                                              costs to respondents other than their
                                               proposed collection of information,                                     prevent these devastating outcomes is to                                      time.




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Document Created: 2018-07-20 01:18:58
Document Modified: 2018-07-20 01:18:58
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 September 18, 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 34586 

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