Agency Forms Undergoing Paperwork Reduction Act Review

Published date26 December 2018
Citation83 FR 66267
Record Number2018-27852
SectionNotices
CourtCenters For Disease Control And Prevention
Federal Register, Volume 83 Issue 246 (Wednesday, December 26, 2018)
[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 omb@cdc.gov. 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
                

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