[Federal Register Volume 87, Number 68 (Friday, April 8, 2022)]
[Notices]
[Pages 20863-20865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07519]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-22-1254]


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 
[insert November 22, 2021] 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. Comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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 Study) 
(OMB Control No. 0920-1254)--Reinstatement with Change--National Center 
for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    The four viruses that cause dengue are transmitted by Aedes species

[[Page 20864]]

mosquitoes and were introduced to the Americas over the past several 
hundred years where they have since become endemic. Puerto Rico, a 
Caribbean island and U.S. commonwealth, has the highest burden of 
dengue virus in the U.S., and recent years have seen the emergence of 
two epidemic arthropod-borne viruses (arboviruses) also transmitted by 
Aedes 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, the first 
arbovirus that can also be transmitted through sexual contact, was 
first detected in the Americas in 2014 and has been associated with 
devastating birth defects and Guillain-Barre syndrome. Yellow fever 
virus has recently caused large outbreaks in Brazil, and there is risk 
of importation to Puerto Rico and other counties in the Americas.
    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. 
Moreover, the rapid speed with which new arboviruses spread generally 
does not provide the time needed to plan and implement community-level 
interventions to decrease viral transmission. Although several 
candidate vaccines for chikungunya and Zika viruses are currently in 
clinical development, none are yet available. A dengue vaccine was 
recently recommended for children 9-16 years old with previous dengue 
infection and living in dengue-endemic parts of the United States. 
However, this will only benefit a small proportion of the population at 
risk for dengue infection.
    The purpose of the Communities Organized to Prevent Arboviruses 
(COPA) project is to measure the incidence of arboviral infections and 
assess suitability, acceptability, and impact of community-level 
mosquito control interventions in 38 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, and community members' knowledge, 
attitudes, and behaviors for avoiding mosquito bites. This information 
is needed to inform decision-making regarding the location, design, and 
content of mosquito control interventions to be implemented, as well as 
to evaluate their effectiveness in reducing the arbovirus burden. 
Additionally, the COPA project can act as a research platform to assess 
acceptability of arbovirus vaccines and other individual level 
prevention measures in Puerto Rico and provide community-level data on 
emerging diseases, including novel coronavirus 2019 (COVID-19).
    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 written or verbal assent (for minors) 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- or COVID-19-like illness (i.e., fever, rash, cough, sore 
throat, difficulty breathing, diarrhea, body pain, or loss of taste/
smell) in the past week and year. If so, we will collect details on the 
symptoms experienced during their illness. Questionnaire administration 
and study participation will be limited to residents from the 38 
communities in Ponce. Being a resident is defined by having slept in 
the house for at least four of the past seven nights. At the time of 
the questionnaire administration, ~15 mL of blood will be collected to 
conduct serological testing of arboviruses for a sero-survey. If the 
participant has COVID-19-like symptoms, an anterior nasal swab will 
also be collected.
    The questionnaire section will vary depending on the age of each 
participant. The Household questionnaire will be administered to one 
household representative in each home with one or more COPA 
participants. This questionnaire collects information on household 
composition, characteristics, and use of chemical insecticides and 
other preventive practices. The household 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 minor residing without an adult in the household may 
participate and act as a household representative if they have parent 
or legal guardian consent to do so.
    The Individual questionnaire will be administered to all 
participants to collect individual-level socio-demographic information. 
This questionnaire will collect information on past illnesses and 
health seeking behaviors, identify the main healthcare facilities used 
in the area, and estimate costs associated with acute febrile illness. 
Questions related to COVID-19 vaccine uptake, illness, and diagnosis 
are also included to describe and estimate the number of previous SARS-
CoV-2 infections and evaluate the success of ongoing COVID-19 
vaccination efforts in these communities.
    The mobility questionnaire will be administered to all participants 
to assess general individual-level mobility patterns, including time 
spent in and outside of the home each week. We will ask participants 
about the location and characteristics of places where they spend more 
than five hours a week to assess potential arboviral exposures outside 
of the home.
    The assessment of Knowledge, Attitudes, and Practices (KAP) 
questionnaire will be administered to participants 14-50 years old to 
collect information on knowledge, perceptions of risk and prevention 
measures, and experience with dengue and COVID-19. This data will be 
used to understand how community members view arboviral diseases and 
COVID-19 and how these perceptions relate to experience and willingness 
to adopt individual and community-level prevention measures. Questions 
related to general perceptions and confidence in vaccines will be asked 
to see how these relate to intentions to vaccinate against dengue and 
COVID-19.
    A Vector Control questionnaire will be administered to all 
household representatives to evaluate knowledge and acceptability of 
several mosquito control methods. This information will be shared with 
local governments and vector control agencies to inform selection and 
implementation of potential mosquito control interventions in the 
region.
    An Acute Illness Surveillance (AIS) project component is being 
implemented to better identify and assess the incidence of arboviral 
disease and COVID-19 among COPA participants. This additional weekly 
activity will use an automated text-messaging system to ask COPA 
household representatives and other household adults who consent to 
receive text messages if any COPA participants in the household have

[[Page 20865]]

experienced fever or other COVID-like symptoms in the past seven days. 
Project staff will contact households in which one or more participants 
reported symptoms to schedule an appointment to collect samples for 
arbovirus and SARS-CoV-2 molecular testing and to administer a AIS 
questionnaire about symptoms, exposure and health seeking behaviors. 
From previous febrile surveillance studies, we expect approximately 40% 
of household adults will respond to text messages each week and 10% of 
COPA participants will report acute symptoms and agree to a sample 
collection visit each year.
    Participants with a positive SARS-CoV-2 molecular test will be 
contacted by phone 2-4 weeks later for a COVID-19 Case Follow-Up 
questionnaire on symptoms, health care seeking, potential exposures, 
and outcomes of SARS-CoV-2 infection. We are expecting that 20% of 
participants who report symptoms will have a positive COVID-19 result 
and respond to this follow-up questionnaire.
    The central COPA questionnaires (Household, Individual, KAP, 
Mobility, and Vector Control) will be repeated among approximately 
3,800 participants every 12 months, up to a period of five years. The 
AIS and COVID-19 Follow-Up components will be renewed and modified 
annually as applicable according to research and funding priorities. 
This project will allow us to better understand the risk, perceptions, 
and burden of arboviral infections and COVID-19 and evaluate a 
community-based approach for vector control in 38 communities in Ponce, 
Puerto Rico. The information obtained will inform decision making 
regarding the location, design, content, and evaluation of future 
mosquito control interventions implemented in Puerto Rico. Data on 
incidence and perception of COVID-19 disease will also be used to 
inform local control programs and fill the current knowledge gaps.
    CDC requests OMB approval for an estimated 4,309 annual burden 
hours. There is no cost to respondents other than the time needed to 
participate.

                                        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 from the 38 selected    Household Representative           2,700               1           10/60
 communities 21 years and older or       questionnaire.
 emancipated minor.
Ponce residents from the 38 selected    Individual questionnaire           3,800               1           20/60
 communities 1-50 years old.
Ponce residents from the 38 selected    Specimen collection.....           3,800               1            5/60
 communities 1-50 years old.
Ponce residents from the 38 selected    Knowledge, Attitudes,              3,090               1           15/60
 communities 14-50 years old.            and Practices
                                         questionnaire.
Ponce residents from the 38 selected    Mobility questionnaire..           3,800               1           10/60
 communities 1-50 years old.
Ponce residents from the 38 selected    Vector Control                     2,500               1           10/60
 communities 21 years and older.         questionnaire.
Ponce residents from the 38 selected    AIS text message........           1,000              52          0.5/60
 communities 21 years and older.
Ponce residents from the 38 selected    AIS questionnaire.......             380               1            8/60
 communities with inclusion criteria.
Ponce residents from the 38 selected    COVID-19 Case Follow-Up               75               1            6/60
 communities with inclusion criteria     questionnaire.
 that tested positive for SAR-CoV-2.
----------------------------------------------------------------------------------------------------------------


Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2022-07519 Filed 4-7-22; 8:45 am]
BILLING CODE 4163-18-P