Notice2022-07519
Agency Forms Undergoing Paperwork Reduction Act Review
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 8, 2022
Issuing agencies
Health and Human Services DepartmentCenters for Disease Control and Prevention
Full Text
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<title>Federal Register, Volume 87 Issue 68 (Friday, April 8, 2022)</title>
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[Federal Register Volume 87, Number 68 (Friday, April 8, 2022)]
[Notices]
[Pages 20863-20865]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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
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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 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.
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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. 2022-07519 Filed 4-7-22; 8:45 am]
BILLING CODE 4163-18-P
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</html>Indexed from Federal Register on April 8, 2022.
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