Proposed Data Collection Submitted for Public Comment and Recommendations

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Published

November 22, 2021

Issuing agencies

Health and Human Services DepartmentCenters for Disease Control and Prevention

Abstract

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.

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<title>Federal Register, Volume 86 Issue 222 (Monday, November 22, 2021)</title>
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[Federal Register Volume 86, Number 222 (Monday, November 22, 2021)]
[Notices]
[Pages 66311-66313]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="http://Regulations.gov">Regulations.gov</a>. Follow the
instructions for submitting comments.
<bullet> 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 <a href="http://Regulations.gov">Regulations.gov</a>.
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:
<a href="/cdn-cgi/l/email-protection#7d12101f3d1e191e531a120b"><span class="__cf_email__" data-cfemail="5e31333c1e3d3a3d70393128">[email&#160;protected]</span></a>.

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.

[[Page 66313]]

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.
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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

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