[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 [email protected]. 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
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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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
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[[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