[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Notices]
[Pages 66311-66313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25449]



[[Page 66311]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-22-1254; Docket No. CDC-2021-0121]


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.

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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 
measure the incidence of arboviral infections in 38 communities in 
southern Puerto Rico.

DATES: CDC must receive written comments on or before January 21, 2022.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2021-
0121 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 H21-8, 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 H21-8, 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;
    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; and
    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)--Revision--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 
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 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 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, or community members' knowledge, 
attitudes, and practices

[[Page 66312]]

regarding behaviors intended to avoid mosquitos. Such information will 
be 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).
    CDC plans to 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, fever, cough, 
sore throat, difficulty breathing, diarrhea, body pain, or loss of 
taste/smell in the last week) in the past week and year. If so, we will 
collect details on the symptoms experienced during their illness. The 
questionnaires will be administered to Ponce residents from the 38 
communities in Ponce, Puerto Rico. 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 representative should be 21 years or older or an 
emancipated minor. This information is key to understand the household 
composition, characteristics, and use of chemical insecticides and 
other preventive practices. 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.
    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 per 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 past experience with dengue and COVID-19. 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 Tools 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 
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 
participant that report symptoms will have a positive COVID-19 result 
and respond to this follow-up questionnaire.
    The central COPA questionnaires (Household, Individual, KAP, 
Mobility, 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.
    There is no burden on respondents other than the time needed to 
participate. Estimated annual burden is 4,309 hours.

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                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Ponce residents from the 38     Household                  2,700               1           10/60             450
 selected communities 21 years   Representative
 and older or emancipated        questionnaire.
 minor.
Ponce residents from the 38     Individual                 3,800               1           20/60           1,267
 selected communities 1-50       questionnaire.
 years old.
Ponce residents from the 38     Specimen                   3,800               1            5/60             317
 selected communities 1-50       Collection.
 years old.
Ponce residents from the 38     Knowledge,                 3,090               1           15/60             773
 selected communities 14-50      Attitudes, and
 years old.                      Practices
                                 questionnaire.
Ponce residents from the 38     Mobility........           3,800               1           10/60             633
 selected communities 1-50
 years old.
Ponce residents from the 38     Vector Control..           2,500               1           10/60             417
 selected communities 21 years
 and older.
Ponce residents from the 38     AIS text message           1,000              52          0.5/60             433
 selected communities 21 years
 and older.
Ponce residents from the 38     AIS                          380               1            8/60              51
 selected communities with       questionnaire.
 inclusion criteria.
Ponce residents from the 38     COVID-19 case                 75               1            6/60               8
 selected communities with       follow-up
 inclusion criteria that         questionnaire.
 tested positive for SAR-CoV-2.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           4,309
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2021-25449 Filed 11-19-21; 8:45 am]
BILLING CODE 4163-18-P