[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Notices]
[Pages 66267-66269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27852]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-19-18ANU]


Agency Forms Undergoing Paperwork Reduction Act Review

    In accordance with the Paperwork Reduction Act of 1995, the Centers 
for Disease Control and Prevention (CDC) has submitted the information 
collection request 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) to the Office of Management and Budget (OMB) for 
review and approval. CDC previously published a ``Proposed Data 
Collection Submitted for Public Comment and Recommendations'' notice on 
July 20, 2018 to obtain comments from the public and affected agencies. 
CDC did not receive comments related to the previous notice. This 
notice serves to allow an additional 30 days for public and affected 
agency comments.
    CDC will accept all comments for this proposed information 
collection project. The Office of Management and Budget is particularly 
interested in comments that:
    (a) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (b) Evaluate the accuracy of the agencies estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected;
    (d) Minimize the burden of the collection of information on those 
who are to respond, including, through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses; and
    (e) Assess information collection costs.
    To request additional information on the proposed project or to 
obtain a copy of the information collection plan and instruments, call 
(404) 639-7570 or send an email to <a href="/cdn-cgi/l/email-protection#7916141b391a1d1a571e160f"><span class="__cf_email__" data-cfemail="e38c8e81a3808780cd848c95">[email protected]</span></a>. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th 
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide 
written comments within 30 days of notice publication.

Proposed Project

    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)--
Existing Collection in use without an OMB Control Number--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, and has since been associated with devastating birth defects, 
Guillain-Barre syndrome, and is the first arbovirus that can also be 
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

[[Page 66268]]

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
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Ponce residents....................  Household representative              2,506               1           10/60
                                      questionnaire.
                                     Socio-demographic                     2,996               1           15/60
                                      questionnaire.
                                     Knowledge, attitudes, and             2,996               1           15/60
                                      practices individual
                                      questionnaire.
                                     Vector control tools                    600               1           25/60
                                      questionnaire.
                                     Specimen collection........           2,996               1            5/60
----------------------------------------------------------------------------------------------------------------



[[Page 66269]]

Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2018-27852 Filed 12-21-18; 8:45 am]
BILLING CODE 4163-18-P


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